Notice of Pre-AIA or AIA Status
1. 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
Election/Restrictions
2. Applicant's election without traverse of Group I, claims 1-15, in the reply filed on 29 December 2025 is acknowledged. Applicant’s election of SEQ ID NO: 6 as the species of PACAP epitope, SEQ ID NO: 94 as the species of Th epitope, and SEQ ID NO: 114 as the species of single molecular embodiment of PACAP immunogen is also acknowledged. Claims 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 December 2025.
3. The restriction requirement is still deemed proper and is therefore made FINAL..
Status of Application, Amendments, and/or Claims
4. The Response to the Restriction Requirement filed 29 December 2025 has been entered in full. Claims 16-19 have been withdrawn as discussed supra. Therefore, 1-19 are pending, and claims 1-15 are the subject of this Office Action.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 22 July 2022, 15 May 2024, 19 February 2025, and 25 April 2025 have been considered by the Examiner.
Claim Rejections - 35 USC § 112
6. 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.
7. Claim 11 ais 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.
8. Claim 11 is rejected as being indefinite because a composition, by definition, must contain two or more elements.
Claim Rejections - 35 USC § 112, 1st Paragraph (Written Description)
9. The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
10. Claims 1-15 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
11. The U.S. Court of Appeals for the Federal Circuit recently reaffirmed, in an en banc decision, that the written description requirement for a genus may be satisfied either by (i) the disclosure of a representative number of species falling within the scope of the genus or (ii) structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. Ariad Pharmaceuticals', Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350, 94 U.S.P.Q.2d 1161, 1171 (en banc) (Fed. Cir. 2010), citing Regents" of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568-69, 43 U.S.P.Q.2d 1398, 1406 (Fed. Cir. 1997).
12. The representative ways of satisfying the written description requirement as set out by the Federal Circuit in Ariad Pharmaceuticals comport with statements set out in the USPTO's Manual of Patent Examining Procedure (M.P.E.P.). In particular, the M.P.E.P. provides that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species of relevant identifying characteristics. M.P.E.P. § 2163, II, A, 3, (a), (ii).
13. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed, and correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. “Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163.
14. The claims are drawn very broadly to a PACAP peptide immunogen construct having about 20 or more amino acids, represented by the formulae: (Th)m-(A)n-(PACAP functional B cell epitope peptide)-X or (PACAP functional B cell epitope peptide)-(A)n-(Th)m-X or (Th)m-(A)n-(PACAP functional B cell epitope peptide)-(A)n-(Th)m-X wherein Th is a heterologous T helper epitope; A is a heterologous spacer; (PACAP functional B cell epitope peptide) is a B cell epitope peptide having from 9 to about 22 amino acid residues of PACAP (SEQ ID NO: 1); X is an α-COOH or α-CONH2 of an amino acid; m is from 1 to about 4; and n is from 0 to about 10. The claims also recite wherein the PACAP functional B cell epitope peptide is selected from the group consisting of SEQ ID NOs: 2-20; or wherein the Th epitope is selected from the group consisting of SEQ ID NOs: 70-109 and 106-171; or wherein the PACAP functional B cell epitope peptide is selected from the group consisting of SEQ ID NOs: 2-20 and the Th epitope is selected from the group consisting of SEQ ID NOs: 70-109 and 106-171. The claims also recite wherein the peptide immunogen construct is selected from the group consisting of SEQ ID NOs: 110-159. The claims also recite a PACAP peptide immunogen construct comprising: a. a B cell epitope comprising from about 9 to about 22 amino acid residues from the PACAP38 sequence of SEQ ID NO: 1; b. a T helper epitope comprising an amino acid sequence selected from the group consisting of SEQ ID NOs: 70-109 and 160-171, and any combination thereof, and c. an optional heterologous spacer selected from the group consisting of an amino acid, Lys-, Gly-, Lys-Lys-Lys-, (α, ε-N)Lys, ε-N-Lys-Lys-Lys-Lys (SEQ ID NO: 68), Lys-Lys-Lys- ε- N-Lys (SEQ ID NO: 69), and Pro-Pro-Xaa-Pro-Xaa-Pro (SEQ ID NO: 67), and any combination thereof, wherein the B cell epitope is covalently linked to the T helper epitope directly or through the optional heterologous spacer; or wherein the B cell epitope is selected from the group consisting of SEQ ID NOs: 2-20; or wherein the optional heterologous spacer is (α, ε-N)Lys, ε-N-Lys-Lys-Lys-Lys (SEQ ID NO: 68), Lys-Lys-Lys-ε-N-Lys (SEQ ID NO: 69), or Pro-Pro-Xaa-Pro-Xaa-Pro (SEQ ID NO: 67), where Xaa is any amino acid. The claims also recite wherein the PACAP functional B cell epitope peptide is selected from the group consisting of SEQ ID NO: 2-20; the Th epitope is selected from the group consisting of SEQ ID NOs: 70-109 and 160-171; and the heterologous spacer is selected from the group consisting of an amino acid, Lys-, Gly-, Lys-Lys-Lys-, (α, ε-N)Lys, ε-N-Lys-Lys-Lys-Lys (SEQ ID NO: 68), Lys-Lys-Lys- ε-N-Lys (SEQ ID NO: 69), and Pro-Pro-Xaa-Pro-Xaa-Pro (SEQ ID NO:67), and any combination thereof; and wherein the PACAP peptide immunogen construct is mixed with an CpG oligodeoxynucleotide (ODN) to form a stabilized immunostimulatory complex. Thus, the claims have been broadly interpreted by the Examiner as reading upon an extremely large genus of peptide immunogens comprised of a wide variety of T helper epitopes, PACAP functional B cell epitopes, and spacers with varying arrangements.
15. For genus claims, an adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries. A patent must set forth either a representative number of species falling within the scope of the genus or structural features common to the members of the genus. Kubin, Exparte, 83 USPQ2d 1410 (Bd. Pat. App. & Int. 2007); Ariad Pharms., Inc. v. Eli Lilly& Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010).
A “patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”), see MPEP 2163.IIAii.
16. Several recent court decisions speak to the notion that claiming a molecule with unknowable structural heterogeneity solely by reciting its function is not sufficient to establish possession of a genus so claimed. For example, quoting Eli Lilly the court states in Ariad, 598 F.3d at 1350: "[A] sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." (quoting Eli Lilly, 119 F.3d at 1568-69).
17. A "representative number of species" means that the species which are described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG V. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
18. In the instant case, the claims encompass in their breadth a genus of peptide immunogens comprised of a wide variety of T helper epitopes, PACAP functional B cell epitopes, and spacers with varying arrangements.
19. In contrast to the breath of the claims, the specification provides adequate written description for 3 species of PACAP peptide immunogens defined by particular PACAP epitopes, attached via particular linkers, to a particular T helper epitope. These immunogens, PACAP381-20-KKK-εK-UBITh1 (SEQ ID NO: 112), PACAP386-27-KKK-εK-UBITh1 (SEQ ID NO: 114), and UBITh1-εK-KKK-PACAP3818-38 (SEQ ID NO: 127) are disclosed eliciting neutralizing antibodies that inhibit intracellular cAMP release (See Example 7 at pp. 45-46; Figure 9), and inhibited capsaicin-induced ear dermal blood flow at 6, 9, 12 and 15 weeks post-immunization (See Example 8 at pp. 46-47; Figure 10B). However, the Specification does not however provide adequate written description as to the structural features for the exceedingly large genus of PACAP immunogens encompassed by the scope of the claims that have the same specificity or function. Moreover, the art recognizes that the choice of the orientation of the individual components of a fusion protein can have a large impact on the functionality and production, as well as the selection of linkers (Schmidt. American Pharmaceutical Review. 2017).
20. In the instant case, there is insufficient guidance based on the reliance of disclosure of 3
species of PACAP immunogens, to direct a person of skill in the art to select or to predict other PCAP38 peptides, Th epitopes, and linkers, as well as rearrange the individual components, to that are essential for proper functioning. The only adequately described species are a PACAP immunogen comprising the amino acid sequence SEQ ID NO: 112, SEQ ID NO: 114, or SEQ ID NO: 127. Accordingly, the specification does not provide adequate written description of the claimed genus.
21. An adequate written description of a chemical invention requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”). See MPEP 2163IIA3(a).
22. Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus of PACAP peptide immunogens encompassed in the breadth of the instant claims.
23. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that in order to satisfy the written description requirement, “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed structure of the encompassed genus of PACAP immunogens, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
24. Without a correlation between structure and function, the claims do little more than define the claimed invention by function, which is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 ("definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is").
25. Therefore, only a PACAP immunogen comprising the amino acid sequence SEQ ID NO: 112, SEQ ID NO: 114, or SEQ ID NO: 127, but not the full breadth of the claims, meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Summary
26. No claim is allowed.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JON M LOCKARD/
Examiner, Art Unit 1647
April 30, 2026
Prosecution Insights