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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2020/038205 filed 06/17/2020, which claims the benefit of the priority of US Provisional application 62/863,666 filed 06/19/2019 and 62/863,651 filed 06/19/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Claims 51-58, 61-62 are withdrawn from further consideration pursuant to 37 CFR
1.142(b) as being drawn to a nonelected Group I, III-V or based on the elected species, there being no allowable generic or linking claim. Applicant canceled claims 1, 3, 13, 15-20, 22-23, 25, 28, 33, 35-36, 38 which were grouped under inventions of Group I, III-V. Thus, applicant has elected the invention of Group II. Applicant added new claims that depend on claim 4.
Applicant’s election of Group II drawn to a peptide, in the reply filed on 03/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP 818.01 (a)). Applicant further elects the species of SEQ ID NO: 69. As a result, claims 51-58, 61-62 are withdrawn from consideration.
Claim Status
Claims 4, 50-64 are pending. Claims 1-3, 5-49 are canceled. Claims 51-58, 61-62 are withdrawn. Claims 4, 50, 59-60, 63-64 are being examined on the merits in this office action.
Claim Objections
Claim 59 is objected to because of the following informalities:
Regarding claim 59, the articles “wherein the” in line 1 is repeated. Applicant can delete the articles “wherein the”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 4, 50, 59-60, 63-64 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 4 recites the limitation "crosslinking moiety" and further recites “crosslinking moieties” in 4. It is unclear what other moieties the limitation is referencing. There is insufficient antecedent basis for this limitation in the claim. Claims 50 has a similar issue.
Claims 59-60, 63-64 are rejected because they depend on a rejected claim 4 or 50.
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 Interpretation
The claim scope is interpreted as set forth below per the guidance set forth at the MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 211 l.0l(IV), describing how Applicant may act as their own lexicographer).
Independent claim 4 recites “…i and i+3, i and i+4 or i and i+7 positions….”. Examiner notes that these are terms of art and refer to amino acid position. For instance, the i and i+4 position is a specific spacing of four amino acid residues within a peptide.
Claims 4, 50, 59-60, 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Laurie (WO2015138604A1 – hereinafter “Laurie”) in view Yin (Biochem. 2012 Sep 26; 2012: 692190).
Laurie teaches a peptide with the amino acid sequence of SEQ ID NO: 5, (KQFIENGSEFAQKLLKKFS) and SEQ ID NO: 7 (KQFIENGSEFAQKLLKKFSLLKPWA) ([0029-0033]; claims 7-10, 13-16), which is identical to instant SEQ ID NO: 1, wherein the peptide may contain one to two amino acid substitutions at positions 4, 6, 8, 10, 17 and 19 (claims 7-9, 14-15, and [0200]). Examiner notes that substitution at position 4 and 8 read on i and i + 4 amino acid substitution.
Laurie does not teach on i and i + 3 amino acid substitution or does not teach the position modified by a crosslinking moiety.
Yin teaches constrained peptides and teaches modifying a peptide at position i and i+3 wherein the amino acids are substituted with a cysteine residue (See Fig. 1; Page 3, right col., line 1-3). Yin teaches that the peptide can be modified by a crosslinking moiety, wherein the crosslinker was covalently attached and that the peptide forms a helical presentation (Page 8, left col., last paragraph, last 2 sentences; Page 8, right col., 1st paragraph and last paragraph). Yin teaches that the modification is great for helix stabilization thus stabilizing the peptide.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Laurie and modify the peptide at the i and i + 3 position with amino acids such as cysteine or modify the positions with a crosslinking moiety as taught by Yin so as to stabilize the peptide. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the peptide of Laurie as taught by Yin, since Yin teaches that the method is great for helix stabilization. The disclosure renders obvious claim 4.
Regarding claim 50, Yin teaches constrained peptides and teaches modifying a peptide at position I and i+3 wherein the amino acids are substituted with a cysteine residue (See Fig. 1; Page 3, right col., line 1-3). Yin teaches that the peptide can be modified by a crosslinking moiety, wherein the crosslinker was covalently attached and that the peptide forms a helical presentation (Page 8, left col., last paragraph, last 2 sentences; Page 8, right col., 1st paragraph and last paragraph).
Regarding claim 59, Yin teaches constrained peptides and teaches modifying a peptide at position i and i+3 wherein the amino acids are substituted with a cysteine residue (See Fig. 1; Page 3, right col., line 1-3). Yin teaches that the peptide can be modified by a crosslinking moiety, wherein the crosslinker was covalently attached and that the peptide forms a helical presentation (Page 8, left col., last paragraph, last 2 sentences; Page 8, right col., 1st paragraph and last paragraph). Yin further teaches the residues covalently linked by disulfide bonds (Page 1, right col., 1st paragraph).
Regarding claim 60 and 63-64, Laurie teaches a peptide with the amino acid sequence of SEQ ID NO: 5, (KQFIENGSEFAQKLLKKFS) and SEQ ID NO: 7 (KQFIENGSEFAQKLLKKFSLLKPWA) ([0029-0033]; claims 7-10, 13-16), which is identical to instant SEQ ID NO: 1, wherein the peptide may contain one to two amino acid substitutions at positions 4, 6, 8, 10, 17 and 19 (claims 7-9, 14-15, and [0200]). The difference between the peptide of Laurie and the instant peptide is that position i and i+3 on the peptide is replaced with a cysteine. However, Yin teaches replacing position i and i+3 on a peptide with a cysteine and teaches great stabilization for such a modification. Yin further teaches the residues covalently linked by disulfide bonds (Page 1, right col., 1st paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Laurie and modify the peptide at the i and i + 3 position with amino acids such as cysteine as taught by Yin so as to stabilize the peptide.
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.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim of U.S. Patent No. US10302658B2 in view of Laurie (WO2015138604 A1 – hereinafter “Laurie”).
The claims of the patent recite a lacritin polypeptide is a polypeptide of SEQ ID NO: 1 or a bioactive fragment of lacritin selected from the group consisting of
KQFIENGSEFAQKLLKKFS (SEQ ID NO: 5); KQFIENGSEFAQKLLKKFSLLKPWA (SEQ ID NO: 7); a derivative of SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7 or SEQ ID NO: 8 that differs from SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7 or SEQ ID NO: 8 by one, two or three amino acid substitutions, additions or deletions (claim 8).
The claims of the patent do not recite where the amino acid substitution is made.
Laurie teaches a peptide with the amino acid sequence of SEQ ID NO: 5, (KQFIENGSEFAQKLLKKFS) and SEQ ID NO: 7 (KQFIENGSEFAQKLLKKFSLLKPWA) ([0029-0033]; claims 7-10, 13-16), which is identical to instant SEQ ID NO: 1, wherein the peptide may contain one to two amino acid substitutions at positions 4, 6, 8, 10, 17 and 19 (claims 7-9, 14-15, and [0200]). Examiner notes that substitution at position 4 and 8 read on i and i + 4 amino acid substitution.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of the patent and perform an amino acid substitution of the same peptide taught by the patent at position 4 and 8 which reads on i and i + 4 amino acid substitution to enhance peptide stability. One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in modifying the peptide of the patent as taught by Laurie since the patent teaches the same peptide as Laurie and also to enhance the stability of the peptide. The claims of the patent render obvious the instant claim.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. 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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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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