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
Applicant's election with traverse of group I and SEQ ID 1 in the reply filed on 20 Feb, 2026 is acknowledged. The traversal is on the ground(s) that the peptide is a special technical feature that unifies the invention. This is not found persuasive because the demonstration of lack of unity was due to multiple product groups.
Applicants argue that the peptides are the special technical feature that unifies the claims. There are two issues with this argument. First, group II has no peptides. Second, lack of unity was demonstrated by the fact that there were multiple product groups, which, as noted in the election/restriction requirement, indicates a lack of unity under 37 CFR 1.475(b).
The requirement is still deemed proper and is therefore made FINAL.
Applicants elected SEQ ID 1. A search was conducted for this invention, and it was determined to be novel and unobvious over the prior art. Following Markush practice, the search was expanded to claim 3; the Markush claim, which was also determined to be novel and unobvious over the prior art. The closest prior art found was Serasinghe et al (J. Chem. Biol. (2010) 285(1) p620-630, cited by applicants). This reference discloses a sequence identical to a fragment of SEQ ID 1, minus the first two amino acids (Fig 1b, sequence ph13). However, there is no reason found in this reference, or any other, to add a dipeptide to the N-terminus of this sequence to generate applicant’s sequence. Thus, the subject matter of claim 3 is both novel and unobvious over the prior art (although non-art rejections apply).
The search was then expanded to claim 1, and a reference was found that anticipate the claim. As a result, claims 1-3, 24, and 25 were examined, and claims 4-15 and 17 were withdrawn from consideration. Applicants state that they believe claims 4-14 also read on the elected species, but those claims describe sequences that applicants have not elected, and are thus properly withdrawn.
Claims Status
Claims 1-15, 17, 24, and 25 are pending.
Claims 4-15 and 17 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 20 Feb, 2026.
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 24, and 25 are rejected under 35 U.S.C. 101 because they read on a judicial exception (natural phenomenon).
The Supreme Court has given a three part test for eligibility under this statute.
1) Does the claim read on a process, machine, manufacture, or composition of matter?
2a) If the first test is passed, does a judicial exception apply?
2b) If a judicial exception applies, is there anything beyond the judicial exception?
Applying the test
The claims are drawn to peptides, a composition of matter, passing the first test.
2a) King et al (WO 2014160465) discloses SEQ ID 1621, with the sequence QLQPFPHPQL PYPHPQ, which is described as a protein of wheat (comment in sequence listing), a product of nature. Note that this comprises SEQ IDs 33, 34, and 38, anticipating claims 1 and 2. Applicants have not defined a kit as requiring anything other than the polypeptide, so it also anticipates claim 24. A pharmaceutical carrier can be another natural product, such as water, meaning that claim 25 can also be met by a combination of natural products.
2b) Most of the claims can be met with just the polypeptide, so there can be nothing beyond the natural product for those claims. For the remaining claim, the limitations can be met with the peptide in water. There is no evidence of record that a carrier meaningfully changes the properties of the formulation, so the claims are not patent eligible.
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.
first rejection
Claims 1-3, 24, and 25 are 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 1, and claims dependent on it, describe an inhibitory peptide, that can be between 5-65 amino acids in length. But the claim uses open language (“comprising”), which allows additional amino acids, and applicants explicitly describe adding additional amino acids (note withdrawn claim 4). That makes it unclear how long a sequence will read on the claims.
second rejection
Claim 2 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 2 lists SEQ IDs 22 and 34. These residues have a variable residue, described as “any amino acid, preferably A or H.” The issue is the term “preferably” in the definition of these sequences, as it is not clear if these are limitations or not.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
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 for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 depends from claim 1, which requires a sequence LPYPH (SEQ ID 38). However, claim 2 also describes SEQ IDs 33 and 34, where the amino acid corresponding to the His residue of SEQ ID 38 are not necessarily His, making this claim broader in this aspect than the claim from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 24, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Serasinghe et al (J. Chem. Biol. (2010) 285(1) p620-630, cited by applicants).
Serasinghe et al describe phage display of the 6 cytostolic helices of hFis1 (abstract), yielding a sequence KHDPLPYPHF LL (Fig 1B, sequence ph13), anticipating claims 1 and 2. Note that this sequence also meets all the requirements for a kit as defined by applicants, so the reference also anticipates claim 24. The peptides were synthesized and dissolved in an aqueous formulation (p621, 2nd column, 2nd paragraph), a pharmaceutically acceptable carrier, anticipating claim 25.
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.
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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