DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 3/31/2026 is acknowledged.
3. Claim filed on 3/31/2026 is acknowledged.
4. Claims 2, 13-18 and 21 have been cancelled.
5. Claims 1, 3-12, 19, 20 and 22-26 are pending in this application.
6. Claims 9-11, 19, 20 and 23-26 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 5, 6 and 8 remain withdrawn from consideration as being drawn to non-elected species.
7. Applicant elected without traverse of Group 1 (claims 1-8 and part of claims 12 and 22) and elected without traverse of SEQ ID NO: 1 as species of peptide in the reply filed on 8/28/2025. Since the elected species of peptide is a subgenus, not a species, the Examiner telephoned Applicant’s representative, Susan M. Michaud, for further species election. Applicant’s representative elected on the phone that SEQ ID NO: 6 as the species of peptide on 9/8/2025.
Restriction requirement was deemed proper and made FINAL in the previous office action. Group 1 is drawn to a peptide that blocks the function of human Guanine Nucleotide Exchange Factor-H1 (GEF-H1), wherein the peptide comprises the amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 13, SEQ ID NO: 14 or SEQ ID NO: 15; a pharmaceutical composition comprising such peptide and a pharmaceutically acceptable carrier; and a kit comprising such peptide or a pharmaceutical composition comprising (a) the peptide and (b) a pharmaceutically acceptable carrier, and instructions for use. A search was conducted on the elected species; this appears to be free of prior art. A search was extended to the genus in claim 1; and prior art was found. Claims 5, 6 and 8 remain withdrawn from consideration as being drawn to non-elected species. Claims 1, 3, 4, 7, 12 and 22 are examined on the merits in this office action.
Withdrawn Objections and Rejections
8. Objection to the specification is hereby withdrawn in view of Applicant's amendment to the specification.
9. Objection to the drawings is hereby withdrawn in view of Applicant's amendment to the drawings.
10. Objection to claims 2, 12 and 22 is hereby withdrawn in view of Applicant's amendment to the claim.
11. Rejection to claims 1-4, 7, 12 and 22 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) is hereby withdrawn in view of Applicant's amendment to the claim.
12. Rejection to claims 1-4, 7, 12 and 22 under 35 U.S.C. 102(a)(1) as being anticipated by Aijaz et al (Developmental Cell, 2005, 8, pages 777-786, filed with IDS), and as evidenced by the rho guanine nucleotide exchange factor 2 isoform A [Canis lupus familiaris] document (from NCBI, 2020, enclosed pages 1-5) and Tsapara et al (Molecular Biology of the Cell, 2010, 21, pages 860-870, filed with IDS) is hereby withdrawn in view of Applicant's amendment to the claim.
Maintained/Revised Objections
13. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as “…human Guanine Nucleotide Exchange Factor-H1 (GEF-H1), wherein…”.
14. (Revised due to Applicant’s amendment to the claim) Claim 3 remains objected to for the following minor informality: None of the peptides of instant SEQ ID NO: 1 and 13-15 recited in instant claim 3 is longer than 19 amino acids. Therefore, the recited “at least 95% identical” is the same as 100% identical. Thus, Applicant is suggested to amend claim 3 as “…wherein the peptide comprises the amino acid sequence of SEQ ID NO: 1…”.
Furthermore, claim 3 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
15. (Revised due to Applicant’s amendment to the claim) Claim 7 remains objected to for the following minor informality: Applicant is suggested to amend claim 7 as “…wherein the peptide comprises the amino acid sequence of SEQ ID NO: 1…”.
Furthermore, claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Applicant's Arguments
16. Applicant either fails to address all the minor issues in these claims, and/or Applicant’s amendment to the claim introduces additional minor issues in these claims. Therefore, these objections are deemed proper and are hereby maintained.
New Objections
17. Claim 4 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
New Rejections
Claim Rejections - 35 U.S.C. § 102(a)(1)
18. 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.
19. Claims 1 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by the WLM-domain-containing protein-Athelia psychrophile document (2016, from https://www.uniprot.org/uniprotkb/A0A166RZH4/entry, enclosed pages 1-5).
The instant claims 1 and 22 are drawn to a peptide that blocks the function of human Guanine Nucleotide Exchange Factor-H1 (GEF-H1), wherein the peptide comprises the amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO: 1, SEQ ID NO: 13, SEQ ID NO: 14 or SEQ ID NO: 15; and a kit comprising such peptide or a pharmaceutical composition comprising (a) the peptide and (b) a pharmaceutically acceptable carrier, and instructions for use.
The WLM-domain-containing protein-Athelia psychrophile document teaches WLM-domain-containing protein from Athelia psychrophile is 414 amino acids in length and comprises the amino acid sequence RLRPASAPDT (90% identical to the amino acid sequence of instant SEQ ID NO: 1), for example, page 4, Section “Sequence”. It meets the structural limitations of the peptide recited in instant claims 1 and 22.
With regards to the limitation “a peptide that blocks the function of human Guanine Nucleotide Exchange Factor-H1 (GEF-H1)” recited in instant claim 1, in the instant case, since the WLM-domain-containing protein from Athelia psychrophile meets all the structural limitations of the peptide recited in instant claim 1, the WLM-domain-containing protein from Athelia psychrophile would necessarily have the same properties and functionality of the peptide recited in instant claim 1. Therefore, the WLM-domain-containing protein from Athelia psychrophile would have the property of blocking the function of human GEF-H1. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.)” (see MPEP § 2112.01 I). And, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
Additionally, for a better understanding of how the examiner views the kit recited in instant claim 22, it should be noted that the claim is to a product, and products are not limited or novel based on the product’s non-functional instructions on how to use the product by being in a kit. “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art.” In re Ngai, 367 F.3d 1336, 2004 WL 1068957 (Fed. Cir. May 13, 2004) (see MPEP § 2112.01 III).
Since the reference teaches all the limitations of instant claims 1 and 22; the reference anticipates instant claims 1 and 22.
Examiner’s Notes
20. The peptide recited in instant claims 3, 4 and 7; and the pharmaceutical composition recited in instant claim 12 are free of prior art. The closest prior art is the WLM-domain-containing protein-Athelia psychrophile document (2016, from https://www.uniprot.org/uniprotkb/A0A166RZH4/entry, enclosed pages 1-5), and the teachings of such prior art reference have been set forth in Section 19 above. However, there is no teaching, motivation, or other type of suggestion to modify the WLM-domain-containing protein from Athelia psychrophile and arrive at the peptide recited in instant claims 3, 4 and 7; and the pharmaceutical composition recited in instant claim 12. Therefore, the peptide recited in instant claims 3, 4 and 7; and the pharmaceutical composition recited in instant claim 12 are both novel and unobvious over the prior arts of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Claims 1 and 22 are rejected. Claims 1, 3, 4 and 7 are objected. Claim 12 is allowed. Claims 5, 6, 8-11, 19, 20 and 23-26 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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