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 .
DETAILED ACTION
The amendment to the claims filed after non-final office action on June 24, 2026 is acknowledged. Claims 7 and 14 were amended, claims 1-6, 8-13, 19-23 were canceled and claims 7, 14-18 are pending in the instant application. The restriction was deemed proper and made final previous office action.
Claims 15-18 are withdrawn as being drawn to a non-elected species/invention. Claims 7 and 14 are examined on the merits of this office action.
Withdrawn Rejections/Objections
The objection of claims 7 is withdrawn in view of amendment of the claims filed June 24, 2026.
The rejection of claims 7-9 and 13-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of amendment of the claims filed June 24, 2026.
Maintained/Revised Rejections
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7 and 14 remain rejected under 35 U.S.C. 103 as being unpatentable over Kim (US20020151679 A1) in view of Schweizer (European Journal of Pharmacology 625 (2009) 190–194).
Kim teaches alloferon peptides having immunomodulatory activity, including peptides comprising His-gly-val-ser-gly-his-gly-gln-his-gly-val-his gly which is identical to instant SEQ ID NO:1 and related variants (see claims 1 and 7). Kim further teaches that such peptides may include variants in amino acid residues and sequence length, thereby encompassing the alloferon peptide sequence recited in instant claim 7. Regarding claim 14, Kim teaches that the alloferon peptide is the active ingredient (see claims 7, 10-11).
Kim is silent to wherein the sequence is substituted with D-amino acids.
However, Schweizer teaches cationic amphiphilic peptides (CAPs), including alloferon peptides (table 1, page 192, right column, first paragraph) and teaches that modification of peptides by partial or complete substitution of L-amino acids with D-amino acids improves resistance to proteolytic degradation while retaining biological activity (see page 192, section 3).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the alloferon peptides of Kim by substituting one or more amino acids with corresponding D-amino acids, as taught by Schweizer, because one of ordinary skill in the art would have been motivated to improve the stability and pharmacokinetic properties of the peptide while maintaining its biological activity. Furthermore, there would have been a reasonable expectation of success, as Schweizer expressly teaches that such substitutions retain activity in similar peptides.
Furthermore, it would have been obvious to substitute L-amino acids with their known more stable equivalents (D-amino acids) to obtain predictable results (enhanced proteolytic resistance) which constitutes simple substitution of one known element for another (see MPEP 2143).
Regarding claims 7, The combination of Kim and Schweizer teach partial or complete substitution of L amino acids with D-amino acids and thus, full substitution would meet the limitations of claim 7. Regarding claim 14, the combination of Kim and Schweizer render obvious the alloferon peptide with all D-amino acids in a pharmaceutical formulation for use as an active agent in treating numerous conditions (see abstract).
Response to Applicant’s Arguments
Applicant argues that Schweizer is directed to membranolytic peptides, not receptor mediated peptides like alloferon. Therefore its teachings are inapplicable.
Applicant’s arguments have been fully considered but not found persuasive. Schweizer is no relied upon for the specific biological mechanism of the peptides disclosed therein. Rather, Schweizer is relied upon for the general teaching that partial or complete substitution of L-amino acids with corresponding D-amino acids improves resistance to proteolytic degradation while retaining biological activity. The teaching is not limited to any single peptide sequence. Kim provides the specific alloferon peptide. Schweizer provides the modification technique. The combination merely applies a known modification to a known peptide to obtain the predictable benefit of improved stability.
Applicant argues Alloferon is receptor mediated and thus, D-substitution would destroy the activity of receptor binding. Applicant’s arguments have been fully considered but not found persuasive.
This argument is attorney argument unsupported by objective evidence (see MPEP 716.01(c)). Although applicant asserts that receptor mediated peptides would lose activity following complete D-substitution, Applicant has not provided experimental evidence demonstrating that a person of ordinary skill would have expected failure in the claimed peptide. Schweizer expressly teaches that complete substitution with D-amino acids may retain biological activity while improving stability. Therefore, the reference provides a reasonable expectation of success.
Applicant argues that scientists would instead design retro inverso-peptides rather than simple all D peptides. Applicant’s arguments have been fully considered but not found persuasive. The existence of alternative peptide design strategies does not negate the obviousness of another expressly taught modification. Schweizer specifically teaches partial or complete substitution with D-amino acids. The fact that others may also employ retro inverso peptides does not discourage the skill artisan from using the modification expressly suggested by Schweizer. A reference need not teach the preferred modification, only one that would have been obvious to try with a reasonable expectation of success.
Applicant argues that Schweizer teaches away because alloferon acts through NK-cell stimulation. Applicant’s arguments have been fully considered but not found persuasive. MPEP 2143.01 states “The court stated that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." Applicant has not identified any disclosure in Schweizer stating that complete D-substitution should not be applied to receptor mediated peptides or to alloferon specifically. Merely recognizing that alloferon acts through NK lymphocytes does not constitute a teaching away from D-amino acid substitution.
Applicant argues that the claimed peptide has unexpected therapeutic properties for neurodegenerative diseases. Applicant’s arguments have been fully considered but not found persuasive. Claims 7 and 14 are directed to the peptide and compositions comprising the peptide. The claims do not require treatment of Alzheimer’s disease, Parkinson’s disease, enhancement of autophagy, or clearance of protein aggregates. Accordingly, the alleged unexpected therapeutic properties are not persuasive evidence of nonobviousness of the presently claimed subject matter. Furthermore, evidence of unexpected results must compare the claimed invention with the closest prior art. In the present case, the closest prior art is Kim’s L alloferon peptide. Applicant has not provided comparative evidence demonstrating that the claimed all D alloferon peptide exhibits unexpected properties relative to the corresponding L alloferon peptide. Accordingly, the alleged unexpected results are not commensurate with the closest prior art and are insufficient to overcome the prima facie case of obviousness.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Copending Application No. 18/870226(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant application claims “A modified alloferon peptide in which at least one amino acid of an alloferon peptide having an amino acid sequence of SEQ ID NO: 1 is substituted with a D-form amino acid” (see claim 7). The instant application claims wherein all amino acids are in D-form (claim 10) which also encompasses claims 8-9, 13; and compositions thereof (claims 14 and 24).
Copending Application No. 18/870226 claims a peptide comprising SEQ ID NO:1 which is identical to instant SEQ ID NO:1 and that the amino acids can all be L-form or D-form (see claims 1-12 and also sequence listing for SEQ ID NO:1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant argues “the subsequent '226 application is directed to a separate "long-form" variant where only a specific, limited subset of amino acids is substituted with D-forms. Because the captioned application holds priority of filing, Applicants intend to resolve any potential overlap or patentable indistinctness "by amending the claims of the subsequent '226 application." Specifically, Applicants plan to introduce amendments in the '226 application to restrict its claims to the precise, specific amino acid sequences and distinct arrangement of D-substitutions unique to that later invention. By amending the subsequent application to clearly and patentably distinguish its scope from the foundational core sequence of the captioned application, any provisional double patenting concerns will be completely and properly obviated. Accordingly, given that the present claims are structurally distinct and belong to the senior application, Applicants respectfully request that this provisional rejection be withdrawn or be held in abeyance until the claims in the '226 application are amended.
Applicant’s arguments have been fully considered but not found persuasive. The provisional nonstatutory double patenting rejection is based on the claims presently pending in the instant application and the copending application. Applicant’s stated intent to amend the claims of the copending application at a future date is speculative and does not overcome the present rejection. Until such amendments are entered and the claims are patentably distinct, the provisional nonstatutory double patenting rejection is properly maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
Examiner interviews are available via telephone, in-person, and 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, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERINNE R DABKOWSKI/Primary Examiner, Art Unit 1654
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