DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicants elected group I and SEQ ID 1 with traverse in the reply filed on 20 Feb, 2026. The traversal was found unpersuasive, and the election/restriction requirement made final in the office action of 11 March, 2026.
Claims Status
Claims 1, 4-15, 17, 24, and 25 are pending.
Claims 1, 4-8, and 25 are allowable.
Claims 10-15 and 17 have been withdrawn from consideration due to an election/restriction requirement.
Maintained/Modified Objections
Drawings
The drawings are objected to because some of the figures are not decipherable without color. Figs 6a, and 20a need color to interpret. Applicants are required to either modify these figures to be interpretable without color or delete them. If this is not possible without losing information that applicants believe to be important, they can petition for color drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should 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 an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
response to applicant’s arguments
Applicants have petitioned for color drawings.
Applicant's arguments filed 10 July, 2026 have been fully considered but they are not persuasive.
Applicants have petitioned for color drawings. However, the petition has not yet been granted. Once it is granted, the objection will be withdrawn.
Withdrawn Rejections
The rejection of claims 1, 2, 24, and 25 under 35 U.S.C. 101 because they read on a judicial exception is hereby withdrawn due to amendment.
The rejection of claims 1-3, 24, and 25 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to length requirements is hereby withdrawn due to amendment.
The rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to “preferably” language in the sequence listing of listed peptides is hereby withdrawn due to amendment.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is hereby withdrawn due to amendment.
The rejection of claim(s) 1-3, 24, and 25 under 35 U.S.C. 102(a)(1) as being anticipated by Serasinghe et al (J. Chem. Biol. (2010) 285(1) p620-630) is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Improper Markush
Claim 24 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of 24 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Claim 24 describes a kit that could comprise a peptide or a polynucleotide. These compounds have no chemical similarity, and are used for different purposes (peptide is a therapeutic, the polynucleotide is to generate the peptide). Thus, there is no single structural similarity, or common use between the elements of this Markush group.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
response to applicant’s arguments
Applicants state that they have amended around this rejection.
Applicant's arguments filed 10 July, 2026 have been fully considered but they are not persuasive.
The claim still lists a Markush group comprising a polypeptide and a polynucleotide and polynucleotide constructs, which is the basis of the rejection.
New Rejections
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 requires that the peptides of the claim comprise one of a Markush group of sequences including SEQ IDs 31 and 32. However, these sequences both have one or more variable residues, with the residue defined using “preferably” language. This is indefinite because it is not clear if these are limitations or not, if the claims are limited to the “preferable” residues or not.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
Examiner interviews are available via telephoneand video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658
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