Guidelines

608.02(i)    Transfer of Drawings From Prior Applications [R-11.2013]

Drawings cannot normally be transferred from a first pending application to another as the Office no longer considers drawings as formal or informal. Drawings that do not comply with all of the form requirements of 37 CFR 1.84  may be acceptable for the purposes of publication and examination if the drawings are readable and reproducible for publication purposes.

608.02(j) - 608.02(o)    [Reserved]

608.02(p)    Correction of Drawings [R-07.2015]

37 C.F.R. 1.121   Manner of making amendments in applications.

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· (d) Drawings. One or more application drawings shall be amended in the following manner: Any changes to an application drawing must be in compliance with § 1.84  or, for a nonprovisional international design application, in compliance with §§ 1.84(c)  and 1.1026  and must be submitted on a replacement sheet of drawings which shall be an attachment to the amendment document and, in the top margin, labeled "Replacement Sheet." Any replacement sheet of drawings shall include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is amended. Any new sheet of drawings containing an additional figure must be labeled in the top margin as "New Sheet." All changes to the drawings shall be explained, in detail, in either the drawing amendment or remarks section of the amendment paper.

· (1) A marked-up copy of any amended drawing figure, including annotations indicating the changes made, may be included. The marked-up copy must be clearly labeled as "Annotated Sheet" and must be presented in the amendment or remarks section that explains the change to the drawings.

· (2) A marked-up copy of any amended drawing figure, including annotations indicating the changes made, must be provided when required by the examiner.

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37 C.F.R. 1.85   Corrections to drawings.

· (a) A utility or plant application will not be placed on the files for examination until objections to the drawings have been corrected. Except as provided in § 1.215(c), any patent application publication will not include drawings filed after the application has been placed on the files for examination. Unless applicant is otherwise notified in an Office action, objections to the drawings in a utility or plant application will not be held in abeyance, and a request to hold objections to the drawings in abeyance will not be considered a bona fide attempt to advance the application to final action (§ 1.135(c) ). If a drawing in a design application meets the requirements of § 1.84(e), (f), and (g)  and is suitable for reproduction, but is not otherwise in compliance with § 1.84, the drawing may be admitted for examination.

· (b) The Office will not release drawings for purposes of correction. If corrections are necessary, new corrected drawings must be submitted within the time set by the Office.

· (c) If a corrected drawing is required or if a drawing does not comply with § 1.84  or an amended drawing submitted under § 1.121(d)  in a nonprovisional international design application does not comply with § 1.1026  at the time an application is allowed, the Office may notify the applicant in a notice of allowability and set a three-month period of time from the mail date of the notice of allowability within which the applicant must file a corrected drawing in compliance with § 1.84  or 1.1026, as applicable, to avoid abandonment. This time period is not extendable under § 1.136  (see § 1.136(c) ).

See also MPEP § 608.02(b). For correction at allowance and issue, see MPEP § 608.02(w) and MPEP § 1302.05.

A canceled figure may be reinstated. An amendment should be made to the specification adding the brief description of the view if a canceled figure is reinstated.

The following form paragraphs may be used to notify applicants of drawing corrections.

¶ 6.39    USPTO Does Not Make Drawing Changes

The United States Patent and Trademark Office does not make drawing changes. It is applicant’s responsibility to ensure that the drawings are corrected. Corrections must be made in accordance with the instructions below.

Examiner Note:

This form paragraph is to be used whenever the applicant has filed a request for the Office to make drawing changes. Form paragraph 6.40 must follow.

¶ 6.40    Information on How To Effect Drawing Changes

INFORMATION ON HOW TO EFFECT DRAWING CHANGES

Replacement Drawing Sheets

Drawing changes must be made by presenting replacement sheets which incorporate the desired changes and which comply with 37 CFR 1.84. An explanation of the changes made must be presented either in the drawing amendments section, or remarks, section of the amendment paper. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). A replacement sheet must include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of the amended drawing(s) must not be labeled as "amended." If the changes to the drawing figure(s) are not accepted by the examiner, applicant will be notified of any required corrective action in the next Office action. No further drawing submission will be required, unless applicant is notified.

Identifying indicia, if provided, should include the title of the invention, inventor’s name, and application number, or docket number (if any) if an application number has not been assigned to the application. If this information is provided, it must be placed on the front of each sheet and within the top margin.

Annotated Drawing Sheets

A marked-up copy of any amended drawing figure, including annotations indicating the changes made, may be submitted or required by the examiner. The annotated drawing sheets must be clearly labeled as "Annotated Sheet" and must be presented in the amendment or remarks section that explains the change(s) to the drawings.

Timing of Corrections

Applicant is required to submit acceptable corrected drawings within the time period set in the Office action. See 37 CFR 1.85(a). Failure to take corrective action within the set period will result in ABANDONMENT of the application.

If corrected drawings are required in a Notice of Allowability (PTOL-37), the new drawings MUST be filed within the THREE MONTH shortened statutory period set for reply in the "Notice of Allowability." Extensions of time may NOT be obtained under the provisions of 37 CFR 1.136  for filing the corrected drawings after the mailing of a Notice of Allowability.

¶ 6.41    Reminder That USPTO Does Not Make Drawing Changes

Applicant is reminded that the U.S. Patent and Trademark Office does not make drawing changes and that it is applicant’s responsibility to ensure that the drawings are corrected in accordance with the instructions set forth in the paper mailed on [1].

Examiner Note:

This form paragraph is to be used when the applicant has been previously provided with information on how to effect drawing changes.

¶ 6.42    Reminder That Applicant Must Make Drawing Changes

Applicant is reminded that in order to avoid an abandonment of this application, the drawings must be corrected in accordance with the instructions set forth in the paper mailed on [1].

Examiner Note:

This form paragraph is to be used when allowing the application and when applicant has previously been provided with information on how to effect drawing changes.

¶ 6.43    Drawings Contain Informalities, Application Allowed

The drawings filed on [1] are acceptable subject to correction of the informalities indicated below. In order to avoid abandonment of this application, correction is required in reply to the Office action. The correction will not be held in abeyance.

Examiner Note:

1. Use this form paragraph when allowing the application, particularly at time of first action issue. Supply an explanation of drawings informalities (see MPEP § 608.02(b)§ 608.02(d) - § 608.02(h) and § 608.02(p)).

2. Form paragraph 6.40 or 6.41 must follow.

¶ 6.47    Examiner’s Amendment Involving Drawing Changes

The following changes to the drawings have been approved by the examiner and agreed upon by applicant: [1]. In order to avoid abandonment of the application, applicant must make these agreed upon drawing changes.

Examiner Note:

1. In bracket 1, insert the agreed upon drawing changes.

2. Form paragraphs 6.39 and 6.40 must follow.

608.02(q) - 608.02(s)    [Reserved]

608.02(t)    Cancelation of Figures [R-08.2012]

If a drawing figure is canceled, a replacement sheet of drawings must be submitted without the figure (see 37 CFR 1.121(d) ). If the canceled drawing figure was the only drawing on the sheet, then only a marked-up copy of the drawing sheet including an annotation showing that the drawing has been cancelled is required. The marked-up (annotated) copy must be clearly labeled as "Annotated Sheet" and must be presented in the amendment or remarks section of the amendment document which explains the changes to the drawings (see 37 CFR 1.121(d)(1) ). The brief description of the drawings should also be amended to reflect this change.

608.02(u)    [Reserved]

608.02(v)    Drawing Changes Which Require Annotated Sheets [R-08.2012]

When changes are to be made in the drawing itself, other than mere changes in reference characters, designations of figures, or inking over lines pale and rough, a marked-up copy of the drawing should be filed with a replacement drawing. The marked-up copy must be clearly labeled as "Annotated Sheet." See 37 CFR 1.84(c)  and 1.121(d). Ordinarily, broken lines may be changed to full without a sketch.

Annotated sheets filed by an applicant and used for correction of the drawing will not be returned. All such annotated sheets must be in ink or permanent prints.

608.02(w)    Drawing Changes Which May Be Made Without Applicant’s Annotated Sheets [R-11.2013]

Where an application is ready for issue except for a slight defect in the drawing not involving change in structure, the examiner will prepare a letter to the applicant indicating the change to be made and may include a marked-up copy of the drawing showing the addition or alteration to be made. The marked-up copy of the drawing should be attached to the letter to the applicant made of record in the application file.

As a guide to the examiner, the following corrections are illustrative of those that may be suggested without requiring annotated sheets from the applicant:

· (A) Adding two or three reference characters or exponents.

· (B) Changing one or two numerals or figure ordinals.

· (C) Removing superfluous matter.

· (D) Adding or reversing directional arrows.

· (E) Changing Roman Numerals to Arabic Numerals to agree with specification.

· (F) Adding section lines or brackets, where easily executed.

· (G) Changing lead lines.

· (H) Correcting misspelled legends.

608.02(x)    Drawing Corrections or Changes Accepted Unless Notified Otherwise [R-08.2012]

Drawing corrections or changes will be entered at the time they are presented, unless applicant is notified to the contrary by the examiner in the action following the amended drawing submission.

  CORRECTION OR CHANGE NOT ACCEPTED

Where the corrected or changed drawing is not accepted, for example, because the submitted corrections or changes are erroneous, or involve new matter or do not include all necessary corrections, the applicant will be notified and informed of any required corrective action in the next Office action. The examiner should explicitly and clearly set forth all the reasons for not approving the corrections to the drawings in the next communication to the applicant. See MPEP § 608.02(p) for suggested form paragraphs that may be used by examiners to notify applicants of drawing corrections.

608.02(y)    Return of Drawing [R-08.2012]

Drawings will not be returned to the applicant.

608.02(z)    Allowable Applications Needing Drawing Corrections or Corrected Drawings [R-07.2015]

If the drawings submitted in an application have been indicated by the applicant as "informal," but the drawings are considered acceptable by OPAP, the examiner should not require replacement of the drawings.

In IFW applications, generally, the most recently filed drawings will be used for printing, unless they have been indicated as "Not Entered."

If the examiner makes an objection to the drawings, the examiner should require correction in reply to the Office action that sets forth the objection. If an application is being allowed, and corrected drawings have not been filed, form PTOL-37 provides an appropriate check box for requiring corrected drawings.

Extensions of time to provide acceptable drawings in response to a notice of allowability are not permitted. If the Office of Data Management receives drawings that cannot be scanned or are otherwise unacceptable for publication, the Office of Data Management will mail a requirement for corrected drawings, giving applicant a shortened statutory period of two months to reply. The drawings will ordinarily not be returned to the examiner for corrections.

I.    UTILITY PATENT APPLICATIONS RECEIVING REPLACEMENT DRAWINGS AFTER THE NOTICE OF ALLOWABILITY

Where replacement drawings are received in utility patent applications after the Notice of Allowability was mailed, the replacement drawings are handled by the Office of Data Management. Submission to the examiner is not necessary unless an amendment to the specification accompanies the drawings, such as an amendment where the description of figures is added or canceled. It is applicant’s responsibility to see that no new matter is added when submitting replacement drawings after allowance because they will not normally be reviewed by an examiner.

II.    37 CFR 1.312 AMENDMENTS

For information on handling amendments to drawings filed under 37 CFR 1.312, see MPEP § 714.16.

608.03    Models, Exhibits, Specimens [R-08.2012]

35 U.S.C. 114   Models, specimens.

The Director may require the applicant to furnish a model of convenient size to exhibit advantageously the several parts of his invention.

When the invention relates to a composition of matter, the Director may require the applicant to furnish specimens or ingredients for the purpose of inspection or experiment.

37 C.F.R. 1.91   Models or exhibits not generally admitted as part of application or patent.

· (a) A model or exhibit will not be admitted as part of the record of an application unless it:

· (1) Substantially conforms to the requirements of § 1.52  or § 1.84;

· (2) Is specifically required by the Office; or

· (3) Is filed with a petition under this section including:

· (i) The fee set forth in § 1.17(h); and

· (ii) An explanation of why entry of the model or exhibit in the file record is necessary to demonstrate patentability.

· (b) Notwithstanding the provisions of paragraph (a) of this section, a model, working model, or other physical exhibit may be required by the Office if deemed necessary for any purpose in examination of the application.

· (c) Unless the model or exhibit substantially conforms to the requirements of § 1.52  or § 1.84  under paragraph (a)(1) of this section, it must be accompanied by photographs that show multiple views of the material features of the model or exhibit and that substantially conform to the requirements of § 1.84.

Models or exhibits are generally not admitted as part of an application or patent unless the requirements of 37 CFR 1.91  are satisfied.

With the exception of cases involving perpetual motion, a model is not ordinarily required by the Office to demonstrate the operability of a device. If operability of a device is questioned, the applicant must establish it to the satisfaction of the examiner, but he or she may choose his or her own way of so doing.

Models or exhibits that are required by the Office or filed with a petition under 37 CFR 1.91(a)(3)  must be accompanied by photographs that (A) show multiple views of the material features of the model or exhibit, and (B) substantially conform to the requirements of 37 CFR 1.84. See 37 CFR 1.91(c). Material features are considered to be those features which represent that portion(s) of the model or exhibit forming the basis for which the model or exhibit has been submitted. Where a video or DVD or similar item is submitted as a model or exhibit, applicant must submit photographs of what is depicted in the video or DVD (the content of the material such as a still image single frame of a movie) and not a photograph of a video cassette, DVD disc, or compact disc.

37 C.F.R. 1.93   Specimens.

When the invention relates to a composition of matter, the applicant may be required to furnish specimens of the composition, or of its ingredients or intermediates, for the purpose of inspection or experiment.

See MPEP Chapter 2400 regarding treatment of biological deposits.

608.03(a)    Handling of Models, Exhibits, and Specimens [R-07.2015]

All models and exhibits received in the U.S. Patent and Trademark Office should be taken to the Technology Center (TC) assigned the related application for examination. The receipt of all models and exhibits which are to be entered into the application file record must be properly recorded on an artifact sheet.

A label indicating the application number, filing date, and attorney’s name and address should be attached to the model or exhibit so that it is clearly identified and easily returned. The Office may return the model, exhibit, or specimen, at any time once it is no longer necessary for the conduct of business before the Office and return of the model or exhibit is appropriate. See 37 CFR 1.94.

If the model or exhibit cannot be conveniently stored in an artifact folder, it should not be accepted.

Models and exhibits may be presented for demonstration purposes during an interview. The models and exhibits should be taken away by applicant or his/her attorney or agent at the conclusion of the interview since models or exhibits are generally not permitted to be admitted as part of the application or patent unless the requirements of 37 CFR 1.91  are satisfied. See MPEP § 713.08. A full description of what was demonstrated or exhibited during the interview must be made of record. See 37 CFR 1.133. Any model or exhibit that is left with the examiner at the conclusion of the interview, which is not made part of the application or patent, may be disposed of at the discretion of the Office.

37 C.F.R. 1.94   Return of models, exhibits or specimens.

· (a) Models, exhibits, or specimens may be returned to the applicant if no longer necessary for the conduct of business before the Office. When applicant is notified that a model, exhibit, or specimen is no longer necessary for the conduct of business before the Office and will be returned, applicant must arrange for the return of the model, exhibit, or specimen at the applicant’s expense. The Office will dispose of perishables without notice to applicant unless applicant notifies the Office upon submission of the model, exhibit or specimen that a return is desired and makes arrangements for its return promptly upon notification by the Office that the model, exhibit or specimen is no longer necessary for the conduct of business before the Office.

· (b) Applicant is responsible for retaining the actual model, exhibit, or specimen for the enforceable life of any patent resulting from the application. The provisions of this paragraph do not apply to a model or exhibit that substantially conforms to the requirements of § 1.52  or § 1.84, where the model or exhibit has been described by photographs that substantially conform to § 1.84, or where the model, exhibit or specimen is perishable.

· (c) Where applicant is notified, pursuant to paragraph (a) of this section, of the need to arrange for return of a model, exhibit or specimen, applicant must arrange for the return within the period set in such notice, to avoid disposal of the model, exhibit or specimen by the Office. Extensions of time are available under § 1.136, except in the case of perishables. Failure to establish that the return of the item has been arranged for within the period set or failure to have the item removed from Office storage within a reasonable amount of time notwithstanding any arrangement for return, will permit the Office to dispose of the model, exhibit or specimen.

When applicant is notified that a model, exhibit, or specimen is no longer necessary for the conduct of business before the Office and will be returned, applicant must make arrangements for the return of the model, exhibit, or specimen at applicant’s expense. The Office may return the model, exhibit, or specimen at any time once it is no longer necessary for the conduct of business and need not wait until the close of prosecution or later. Where the model, exhibit, or specimen is a perishable, the Office will be presumed to have permission to dispose of the item without notice to applicant, unless applicant notifies the Office upon submission of the item that a return is desired and arrangements are promptly made for the item’s return upon notification by the Office.

For models, exhibits, or specimens that are returned, applicant is responsible for retaining the actual model, exhibit, or specimen for the enforceable life of any patent resulting from the application except where: (A) the model or exhibit substantially conforms to the requirements of 37 CFR 1.52  or 1.84; (B) the model or exhibit has been described by photographs that substantially conform to 37 CFR 1.84; or (C) the model, exhibit, or specimen is perishable. Applicant may be called upon to resubmit such returned model, exhibit, or specimen under appropriate circumstances, such as where a continuing application is filed.

The notification to applicant that a model, exhibit, or specimen is no longer necessary for the conduct of business before the Office will set a time period within which applicant must make arrangements for a return of a model, exhibit, or specimen. The time period is normally two months from the mailing date of the notification, unless the item is perishable, in which case the time period will be shorter. Extensions of time are available under 37 CFR 1.136, except in the case of perishables. Failure by applicant to establish that arrangements for the return of a model, exhibit, or specimen have been made within the time period set in the notice will result in the disposal of the model, exhibit, or specimen by the Office.

Form paragraph 6.48 may be used to notify applicant that the model, exhibit, or specimen is no longer necessary for the conduct of business before the Office and that applicant must make arrangement for the return of the model, exhibit, or specimen.

¶ 6.48    Model, Exhibit, or Specimen - Applicant Must Make Arrangements for Return

The [1] is no longer necessary for the conduct of business before the Office. Applicant must arrange for the return of the model, exhibit or specimen at the applicant’s expense in accordance with 37 CFR 1.94(a).

Applicant is given TWO MONTHS from the mailing date of this letter to make arrangements for return of the above-identified model, exhibit, or specimen to avoid its disposal in accordance with 37 CFR 1.94(c). Extensions of time are available under 37 CFR 1.136, except in the case of perishables.

Applicant is responsible for retaining the actual model, exhibit, or specimen for the enforceable life of any patent resulting from the application unless one of the exceptions set forth in 37 CFR 1.94(b)  applies.

Examiner Note:

1. In bracket 1, identify the model, exhibit, or specimen that is no longer needed by the Office.

2. The Office will dispose of perishables without notice to Applicant unless applicant notifies the Office upon submission of the model, exhibit or specimen that a return is desired and makes arrangements for its return promptly upon notification by the Office that the model, exhibit or specimen is no longer necessary for the conduct of business before the Office.

For plant specimens, see MPEP § 1607 and 37 CFR 1.166.

37 C.F.R. 1.95   Copies of exhibits.

Copies of models or other physical exhibits will not ordinarily be furnished by the Office, and any model or exhibit in an application or patent shall not be taken from the Office except in the custody of an employee of the Office specially authorized by the Director.

608.04    New Matter [R-10.2019]

35 U.S.C. 132   Notice of rejection; reexamination.

· (a) Whenever, on examination, any claim for a patent is rejected, or any objection or requirement made, the Director shall notify the applicant thereof, stating the reasons for such rejection, or objection or requirement, together with such information and references as may be useful in judging of the propriety of continuing the prosecution of his application; and if after receiving such notice, the applicant persists in his claim for a patent, with or without amendment, the application shall be reexamined. No amendment shall introduce new matter into the disclosure of the invention.

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37 C.F.R. 1.121   Manner of making amendments in applications.

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· (f) No new matter. No amendment may introduce new matter into the disclosure of an application.

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In establishing a disclosure, applicant may rely not only on the specification and drawing as filed but also on the claims present on the filing date of the application if their content justifies it. See MPEP § 608.01(l).

While amendments to the specification and claims involving new matter are ordinarily entered, such matter (i.e., subject matter not present in the specification, claims, or drawings on the application filing date) is required to be canceled from the descriptive portion of the specification, and the claims affected are rejected under 35 U.S.C. 112(a).

When new matter is introduced into the specification, the amendment should be objected to under 35 U.S.C. 132  (35 U.S.C. 251  if a reissue application) and a requirement made to cancel the new matter. The subject matter which is considered to be new matter must be clearly identified by the examiner. If the new matter has been entered into the claims or affects the scope of the claims, the claims affected should be rejected under 35 U.S.C. 112(a)  because the new matter is not described in the application as originally filed.

A "new matter" amendment of the drawing is ordinarily not entered; neither is an additional or substitute sheet containing "new matter" even though provisionally entered by the TC technical support staff. See MPEP § 608.02(h).

The examiner’s holding of new matter may be petitionable or appealable. See MPEP § 608.04(c).

For new matter in reissue application, see MPEP § 1411.02. For new matter in substitute specification, see MPEP § 608.01(q). For new matter in a continuation or divisional application, see MPEP § 211.05.

Note: No amendment is permitted in a provisional application after it receives a filing date.

608.04(a)    Matter Not Present in Specification, Claims, or Drawings on the Application Filing Date [R-10.2019]

Matter not present on the filing date of the application in the specification, claims, or drawings that is added after the application filing is usually new matter. See MPEP §§ 2163.06 and 2163.07 for guidance in determining whether an amendment adds new matter, and for a discussion of the relationship of new matter to 35 U.S.C. 112(a)  or pre-AIA 35 U.S.C. 112, first paragraph. See MPEP § 2163.07(a) to determine whether added characteristics such as chemical or physical properties, a new structural formula or a new use are inherent characteristics that do not introduce new matter.

New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.

In the examination of an application following amendment thereof, the examiner must be on the alert to detect new matter. 35 U.S.C. 132(a)  should be employed as a basis for objection to amendments to the abstract, specification, or drawings attempting to add new disclosure to that originally disclosed on filing. If new matter is added to the specification, it should be objected to by using Form Paragraph 7.28.

¶ 7.28    Objection to New Matter Added to Specification

The amendment filed [1] is objected to under 35 U.S.C. 132 (a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a)  states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: [2].

Applicant is required to cancel the new matter in the reply to this Office action.

Examiner Note:

1. This form paragraph is not to be used in reissue applications; use form paragraph 14.22.01 instead.

2. In bracket 2, identify the new matter by page and the line numbers and provide an appropriate explanation of your position. This explanation should address any statement by applicant to support the position that the subject matter is described in the specification as filed. It should further include any unresolved questions which raise a doubt as to the possession of the claimed invention at the time of filing.

3. If new matter is added to the claims, or affects the claims, a rejection under 35 U.S.C. 112(a)  or pre-AIA 35 U.S.C. 112, first paragraph, using form paragraph 7.31.01 should also be made. If new matter is added only to a claim, an objection using this paragraph should not be made, but the claim should be rejected using form paragraph 7.31.01. As to any other appropriate prior art or 35 U.S.C. 112  rejection, the new matter must be considered as part of the claimed subject matter and cannot be ignored.

If the new matter has been entered into the claims or affects the scope of the claims, the claims affected should be rejected under 35 U.S.C. 112(a)  or pre-AIA 35 U.S.C. 112, first paragraph, on the ground that it recites elements without support in the original disclosure. See Waldemar Link, GmbH & Co. v. Osteonics Corp., 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111, 1114 (Fed. Cir. 1991)(A written-description question often arises when an applicant, after filing a patent application, subsequently adds "new matter" not present in the original application.); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).

If subject matter capable of illustration is originally claimed and it is not shown in the drawing, the claim is not rejected but applicant is required to add it to the drawing. See MPEP § 608.01(l). Replacement drawings containing new matter should not be entered and the corrections necessary to obtain entry of the drawing(s) should be explained using form paragraph 6.37. See MPEP § 608.02(h).

For completeness of specification, see MPEP § 608.01(p). For trademarks and trade names, see MPEP § 608.01(v).

608.04(b)    New Matter by Preliminary Amendment [R-10.2019]

A preliminary amendment present on the filing date of the application (e.g., filed along with the filing of the application) is considered a part of the original disclosure. See MPEP § 714.01(e) and § 602. A preliminary amendment filed after the filing date of the application is not part of the original disclosure of the application. See MPEP § 608.04(a). For applications filed on or after September 21, 2004, the Office will automatically treat any preliminary amendment under 37 CFR 1.115(a)(1)  that is present on the filing date of the application as part of the original disclosure. Applicants can avoid the need to file a preliminary amendment by incorporating any desired amendments into the text of the specification, even where the application is a continuation or divisional application of a prior-filed application. Applicants are strongly encouraged to avoid submitting any preliminary amendments so as to minimize the burden on the Office in processing preliminary amendments and reduce delays in processing the application.

608.04(c)    Review of Examiner’s Holding of New Matter [R-11.2013]

Where the new matter is confined to amendments to the specification, review of the examiner’s requirement for cancelation is by way of petition. But where the alleged new matter is introduced into or affects the claims, thus necessitating their rejection on this ground, the question becomes an appealable one, and should not be considered on petition even though that new matter has been introduced into the specification also. See also MPEP § 2163.06.

608.05    "Sequence Listing," "Large Tables," or "Computer Program Listing Appendix" Submitted in ASCII Plain Text or a "Sequence Listing XML" Submitted as XML File Text [R-07.2022]

37 C.F.R. 1.52   Language, paper, writing, margins, read-only optical disc specifications.

· (a)

· *****

· (5) Papers that are submitted electronically to the Office must be formatted and transmitted in compliance with the Office’s electronic filing system requirements.

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· (e) Electronic documents submitted on a read-only optical disc that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application, reexamination, or supplemental examination proceeding.

· (1) The following documents may be submitted to the Office on a read-only optical disc in compliance with this paragraph (e):

· (i) A "Computer Program Listing Appendix" (see § 1.96(c) );

· (ii) A "Sequence Listing" (submitted under § 1.821(c)  in compliance with §§ 1.822  through 1.824 ) or a "Sequence Listing XML" (submitted under § 1.831(a)  in compliance with §§ 1.832  through 1.834 ); or

· (iii) "Large Tables" (see § 1.58(c) ).

· (2) Read-only optical disc as used in this part means a finalized disc, in conformance with International Organization for Standardization (ISO) 9660, on which the data is recorded so it is permanent and cannot be changed or erased, and is one of:

· (i) Compact Disc-Read-Only Memory (CD–ROM) or a Compact Disc-Recordable (CD–R); or

· (ii) Digital Video Disc-Recordable (DVD–R or DVD+R);

· (3) Each read-only optical disc must conform to the following requirements:

· (i) Computer compatibility: PC or Mac®;

· (ii) Operating system compatibility: MS–DOS®, MS–Windows®, MacOS®, or Unix®/Linux®;

· (iii) The contents of each read-only optical disc must be in American Standard Code for Information Interchange (ASCII) plain text and if compressed, must be compressed in accordance with § 1.58  for "Large Tables," with § 1.96  for a "Computer Program Listing Appendix," or § 1.824  for a "Sequence Listing" or Computer Readable Form (CRF) of the "Sequence Listing," as applicable; and

· (iv) The contents of each read-only optical disc for a "Sequence Listing XML" must be in eXtensible Markup Language (XML) file format, and if compressed, must be compressed in accordance with § 1.834.

· (4) Each read-only optical disc must be enclosed in a hard case within an unsealed, padded, and protective mailing envelope, and must be accompanied by a transmittal letter in accordance with paragraph (a) of this section, including the following information:

· (i) First-named inventor (if known);

· (ii) Title of the invention;

· (iii) Attorney docket or file reference number (if applicable);

· (iv) Application number and filing date (if known);

· (v) The operating system (MS–DOS®, MS-Windows®, Mac OS®, or Unix®/ Linux®) used to produce the disc; and

· (vi) The file(s) contained on the read-only optical disc, including the name of the file, the size of the file in bytes, and the date of creation.

· (5) Each read-only optical disc must have a label permanently affixed thereto on which the following information has been hand-printed or typed:

· (i) First-named inventor (if known);

· (ii) Title of the invention;

· (iii) Attorney docket or file reference number (if applicable);

· (iv) Application number and filing date (if known);

· (v) Date on which the data were recorded on the read-only optical disc; and

· (vi) Disc order (e.g., "1 of X"), if multiple read-only optical discs are submitted.

· (6) Read-only optical discs will not be returned to the applicant and may not be retained as part of the patent application file.

· (7) Any amendment to the information on a read-only optical disc must be by way of a replacement read-only optical disc, in compliance with § 1.58(g)  for "Large Tables," § 1.96(c)(5)  for a "Computer Program Listing Appendix," § 1.825(b)  for a "Sequence Listing" or CRF of a "Sequence Listing," and § 1.835(b)  for a "Sequence Listing XML."

· (8) The specification must contain an incorporation by reference of the material on each read-only optical disc in a separate paragraph (§ 1.77(b)(5) ), identifying the name of each file, their date of creation, and their size in bytes, except for an international application in the international stage. The Office may require the applicant to amend the specification to include the material incorporated by reference.

· (9) If a file is unreadable, it will be treated as not having been submitted, and a notice will be issued to require a compliant submission.

· (f) Determining application size fees for applications containing electronic documents submitted on a read-only optical disc or via the USPTO patent electronic filing system—

· (1) Submission on read-only optical discs. The application size fee required by § 1.16(s)  or § 1.492(j), for an application component submitted in part on a read-only optical disc in compliance with paragraph (e) of this section, shall be determined such that each three kilobytes of content submitted on a read-only optical disc shall be counted as a sheet of paper. Excluded from this determination is any ASCII plain text file or any XML file (as applicable) submitted on a read-only optical disc under paragraph (e) of this section containing:

· (i) Any "Sequence Listing" or CRF of a "Sequence Listing" in compliance with § 1.821(c)  or (e), or any "Sequence Listing XML" in compliance with § 1.831(a); or

· (ii) Any "Computer Program Listing Appendix" in compliance with § 1.96(c).

· (2) Submission via the USPTO patent electronic filing system. The application size fee required by § 1.16(s)  or § 1.492(j), for an application submitted in whole or in part via the USPTO patent electronic filing system, shall be determined such that the paper size equivalent will be considered to be 75% of the number of sheets of paper present in the specification and drawings for the application when entered into the Office records after being rendered by the USPTO patent electronic filing system. Excluded from this determination is any ASCII plain text file or any XML file (as applicable) submitted via the USPTO patent electronic filing system containing:

· (i) Any "Sequence Listing" or CRF of a "Sequence Listing" in compliance with § 1.821(c)(1)  or (e), or any "Sequence Listing XML" in compliance with § 1.831(a); or

· (ii) Any "Computer Program Listing Appendix" in compliance with § 1.96(c).

· (3) Oversized submission. Any submission of a "Sequence Listing" in electronic form or a "Sequence Listing XML" of 300 MB–800 MB filed in an application under 35 U.S.C. 111  or 371  will be subject to the fee set forth in § 1.21(o)(1). Any submission of a "Sequence Listing" in electronic form or a "Sequence Listing XML" that exceeds 800 MB filed in an application under 35 U.S.C. 111  or 371  will be subject to the fee set forth in § 1.21(o)(2).

37 C.F.R. 1.77   Arrangement of application elements.

· (a) The elements of the application, if applicable, should appear in the following order:

· (1) Utility application transmittal form.

· (2) Fee transmittal form.

· (3) Application data sheet (see § 1.76 ).

· (4) Specification.