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
Claims 7-24 are pending in the instant application.
Election/Restrictions
Applicant elected without traverse Group 2 (claims 7-14) drawn to a modified Alloferon and without traverse SEQ ID NO:1 with all D-amino acids in the response filed February 17, 2026. Please note that Applicant elected the peptide listed in claim 10 which is actually wherein all the amino acids are in their D-form. However, Applicants also stated in the response (except glycine) however, claim 10 claims all D-amino acids. Thus, the election of species will be interpreted as the peptide of claim 10 which requires all amino acids be in their D-form.
The restriction is deemed proper and is made FINAL in this office action. Claims 11-12, 15-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected
invention/species, there being no allowable generic or linking claim.
Claims 7-10, 13-14 and 24 are examined on the merits of this office action.
Claim Objection
Claim 7 is objected to for the following informality: Based on Applicant’s specification, it is suggested that claim 7 be amended as follows: “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 the corresponding D-form of the amino acid.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-9 and 13-14 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Scope of the Claims
Claim 7 is directed to a modified alloferon peptide comprising SEQ ID NO: 1, wherein at least one amino acid is substituted with a D-form amino acid. Under the broadest reasonable interpretation, this language encompasses substitution of any amino acid residue at any position in the peptide with any D-amino acid, including D-amino acids having side chains different from the original residue (i.e., sequence variants). Dependent claims 11 and 12 further recite specific substitution patterns, including substitution of all amino acids except selected residues (e.g., histidines or specific positional residues). These claims encompass peptides having defined combinations of substituted and unsubstituted residues across the full length of the sequence. Accordingly, the claims encompass a broad genus of peptide variants given that SEQ ID NO:1 can be completely substituted with any d-amino acids.
Actual Reduction to Practice
The specification provides examples of modified alloferon peptides in which amino acid residues are substituted with the corresponding D-form of the same amino acid. The examples include partial substitutions (i.e., substitution at one or more positions with the corresponding D-amino acid), and full substitutions (i.e., substitution of all residues with their corresponding D-enantiomers). However, the specification does not describe or exemplify substitution of an amino acid residue with a different amino acid (i.e. variants of SEQ ID NO:1 with D-amino acids).
Sufficient Relevant Identifying Characteristics
To satisfy the written description requirement, the specification must reasonably convey to one of ordinary skill in the art that the inventor had possession of the claimed genus, including through disclosure of sufficient relevant identifying characteristics such as sequence, structure, or a representative number of species.
In the instant application, the specification discloses peptides in which amino acid residues are converted from L- to D-configuration while maintaining the same amino acid identity. However, the claims (particularly claim 7 under its broadest reasonable interpretation) encompass substitution with any D-amino acid (changing the sequence of SEQ ID NO:1). The specification lacks identification of amino acid positions amenable to substitution with different residues, description of structural features common to variants across the full scope of substitutions, and a representative number of species spanning substitutions involving different amino acid identities. Accordingly, the specification does not provide sufficient identifying characteristics to demonstrate possession of the full scope of the claimed genus.
Physical and/or Chemical Properties
The specification does not describe physical or chemical properties of peptides that would allow one of ordinary skill in the art to recognize which amino acid substitutions (particularly substitutions involving different amino acid identities) would be operable across the full scope of the claims. While stereochemical inversion (L→D) may affect stability or protease resistance, the specification does not provide guidance regarding how substitution with different D-amino acids (i.e., different side chains) would impact peptide structure, folding, or interactions. Thus, the specification does not provide a unifying set of physical or chemical characteristics applicable across the full breadth of claimed substitutions.
Functional Characteristics Coupled with Known or Disclosed Correlation Between Structure and Function
The specification does not establish a correlation between structure and function that would allow one of ordinary skill in the art to predict which substitutions across the claimed scope would retain the desired biological activity. In particular, the specification does not demonstrate that substitution with different amino acid residues (i.e., variants) would maintain function. There is no structure-function relationship is provided linking specific residues or positions to functional tolerance for substitution, and the examples are limited to corresponding L to D substitutions, which do not reasonably represent the broader genus of variants encompassed by the claims.
Accordingly, the specification does not provide functional characteristics correlated with structure sufficient to support the full scope of the claims.
Method of Making
Although methods for synthesizing peptides and incorporating D-amino acids are generally known in the art, the ability to make peptides falling within the scope of the claims does not, by itself, demonstrate possession of the claimed subject matter. The specification does not provide guidance for selecting appropriate substitutions across the full scope of the claims, particularly substitutions involving different amino acid identities. Thus, the disclosure of methods of making does not cure the lack of written description support for the claimed genus.
Conclusion
In view of the above, the specification does not reasonably convey to one of ordinary skill in the art that the inventor had possession of the full scope of the claimed invention at the time of filing. Specifically, the claims encompass substitution of amino acid residues with any D-amino acid, including those having different side chains, whereas the specification is limited to substitution with the corresponding D-form of the same amino acid and does not provide sufficient guidance, representative species, or structure-function correlation to support the broader scope.
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) 7-10, 13-14 and 24 are 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. Kim is silent to wherein the sequence is substituted with a D-form amino acid (or any D-amino acids within the sequence). Regarding claims 14 and 24, Kim teaches that the alloferon peptide is the active ingredient (see claims 7, 10-11).
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 8-10, 13, the peptide of Kim has four histidine residues. 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 claims 8-10 and 13. Regarding claims 14 and 24, 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).
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 7-10, 13-14, 24 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 112 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.
Conclusion
No claims are allowed.
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.
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/ERINNE R DABKOWSKI/ Examiner, Art Unit 1654