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 .
Election/Restrictions
Applicant’s election without traverse of Group I, 1, 6, 20, 22, 35,94, and 96 in the reply filed on 6/11/2026 is acknowledged.
Claims 9-10, 51-53, 87, 91-93, 97, 102, 109, and 113 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed 6/11/2026.
In response to the species election, applicant elected SEQ ID NO: 155 consisting of NYTYFTTVTVETLETQPGEEALDEVMKTTKA. The examiner found the elected species of SEQ ID NO: 155 does NOT read on the base claim 1. Thus, the examiner is examining the elected species of SEQ ID NO: 155 and the base claim 1 on the merit and all other claims 6, 20, 22, 35,94, and 96 in group I are withdrawn.
Claim Status
Claims 1, 6, 9-10, 20, 22, 35, 51-53, 87, 91-94, 96-97, 102, 109, and 113 are pending.
Claims 2-6, 7-8, 11-19, 21, 23-34, 36-50, 54-86, 88-90, 95, 98-101, 103-108, and 110-112 are cancelled.
Claims 9-10, 51-53, 87, 91-93, 97, 102, 109, and 113 are withdrawn as being directed to a non-elected invention, the election having been made on 6/11/2026. Claims 6, 20, 22, 35, 94, and 96 are further withdrawn as the elected SEQ ID NO: 155 does NOT read on the base claim 1.
Claim 1 and the elected peptide species of SEQ ID NO: 155 have been examined.
Priority
This application is a 371 of PCT/IB2022/056357 filed on 07/08/2022
PCT/IB2022/056357 has PRO 63/219,670 filed on 07/08/2021
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/28/201324 and 8/27/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim 1 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “comprising” a domain of a Leucine Rich Repeat Containing 4 ("LRRC4") protein family member, and the claim also recites “consisting of” a domain of a Leucine Rich Repeat Containing 4 ("LRRC4") protein family member which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (Mol Biol Cell. 2006 Aug;17(8):3534–3542, cited in IDS 8/27/2025) and evidenced by (i) NP_071426.1 (https://www.ncbi.nlm.nih.gov/protein/NP_071426.1/report=genbank&log$protalign&blast_rank=1&RID=UPUUWSD7014, previously cited 3/11/2026), (ii) Li et al. (Hindawi Disease Markers. Volume 2020, Article ID 8895900, 5 pages) and (iii) de Wit et al. (Annu. Rev. Cell Dev. Biol. 2011. 27:697–729).
Claim 1 is drawn to an isolated polypeptide comprising the amino acid sequence of SEQ ID NO: 4, 5, or 6, and the isolated Leucine Rich Repeat Containing 4 ("LRRC4") protein family member protein is capable of binding to a Family with Sequence Similarity 19, Member AS ("FAM 19 AS") protein; wherein, the isolated polypeptide is shorter than its full-length wild type peptide sequence
Wu et al. show deletion mutants of LRRC4 protein are shorter than the wild-type LRRC4
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protein as shown follows (p3537, Fig 2). The sequence alignment of ∆Tm (without the signal peptide of aa 1-38 and absence of transmembrane starting from aa 528) is inherent with 100% homology to the instant SEQ ID NO: 4 as evidenced by NP_071426.1 shown follows.
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Li et al. is cited as evidence to show Family with sequence similarity 19 member A5 (FAM19A5) protein inherent as a chemokine-like peptide and a secreted protein (Title and
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Abstract). Thus, one of ordinary skill in the art would at once envisage that FAM19A5 protein is secreted from a cell and binds to an extracellular domain of cellular motif proteins/receptors before the effective filing date of this invention.
de Wit et al. is cited as evidence to show the LRR motifs are inherent extracellular domains for binding to a biomolecule ligand. Thus, one of ordinary skill in the art would at once envisage that the extracellular domain of LRRC4 protein able to bind bioactive molecules. Since Wu’s LRRC4 protein satisfies the limitation of polypeptide’s structure as claimed would be necessary to have the function of binding to a ligand of FAM19A5 as claimed.
“Product and apparatus claims - When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. See MPEP 2112.01 (I).
Also, inherent feature needs not be recognized at the relevant time. See MPEP 2112(II).
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 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/552,290 (the ‘290 application, 6/26/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘290 application disclosed a compound obvious to the instant claim 1.
Claim 1 of the ‘290 application disclosed a Leucine Rich Repeat Containing 4 ("LRRC4") molecule able to inhibit FAM19A5 as shown follows.
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In search pf the scope of a Leucine Rich Repeat Containing 4 ("LRRC4") molecule able to interact with FAM19A5 in claim 1, the specification of the ‘290 application disclosed LRRC4 molecule NO: 155 encompassing the elected peptide of SEQ ID (nYTYFTTVTVETLETQPG-EEALDEVMKTTKa) [0138] as well as many other peptides listed in Table 6 [0279, p88-90].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of copending Application No. 18/552,293 (the ‘293 application, 5/9/2024). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘293 application disclosed a compound obvious to the instant claim 1.
Claim 13 of the ‘293 application disclosed a Leucine Rich Containing 4 (''LRRC4'') family mimic molecule, which is capable of specifically binding to the F AMI 9A5 protein.
In search for the scope of a Leucine Rich Containing 4 (''LRRC4'') family mimic molecule, which is capable of specifically binding to the FAMI 9A5 protein in claim 13, the specification of the ‘293 application disclosed a Leucine Rich Containing 4 (''LRRC4'') family mimic molecule encompassing a polypeptide shorter than the full-length LRRC4 protein family member of SEQ ID NOs: 4-6 as shown follows.
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Examiner’s Note:
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The examiner did not find a peptide sequence of SEQ ID NO: 155. The closest prior art, Belvin et al. (WO 03/035833 A2), disclosed a peptide with 68.4% of the elected SEQ ID NO: 155 as shown follows. However, SEQ ID NO: 155 is under provisional rejection by the copending Application No. 18/552,290 shown above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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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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/J.L/Examiner, Art Unit 1658
28-August-2026
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights