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 .
Response to Election/Restriction filed on September 15, 2026 is acknowledged.
Claims 1-6, 8, 10, 12 and 14-15 are pending in this application.
Priority
4. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP 21201661.2 on 10/08/2021. The foreign priority document is in English. Thus, the foreign priority date is 10/08/2021.
Restriction
5. Applicant’s election of Group 1 (claims 1-6) and the election of 100% identity to SEQ ID NO: 2, 100% sequence identity to SEQ ID NO: 4 as the species of a fusion protein sequence, cysteine as the species of a solid support attachment site, and Sf9 insect cells as the species of an insect cell expression system as in the reply filed on September 15, 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)). Restriction is deemed to be proper and is made FINAL In this office action. Claims 8, 10, 12 and 14-15 are withdrawn from consideration, pursuant to 37 CFR 1.142(b),as being drawn to nonelected inventions, there being no allowable generic or linking claims. Please note: as indicated in the office action, at page 6, paragraph 9, the species election of insect cell expression system is for Invention 5. Therefore, since Invention 1 has been elected, the cell expression system is not a species requested for Invention 1. Claims 1-6 are examined on the merits in this office action.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1 (i.e., a dipeptide within SEQ ID NO: 1), “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5’/3’ ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
Please note that the Examiner is interpreting the scope of claim 1 as the any dipeptide within the sequence of SEQ ID NO: 1 with or without additional amino acids at the N-/C-terminal ends or additional nucleotides at the 5’/3’ ends (the claim recites “comprising an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 1).
Objections
6. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention relates to novel proteins..” at line 2 of the abstract. Additionally, the term “novel” should be removed from lines 2 and 4 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b).
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Rejections
U.S.C. 112
7. 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.
8. Claims 1-6 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.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
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 “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gostelli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618.
In the instant case, the claims are drawn to a baculoviral envelope protein gp64 binding protein comprising an amino acid sequence with at least 90% sequence identity to SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3, wherein the baculoviral envelope protein gp64 binding protein has a binding affinity of less than 100 nM for gp64.The generic statements at least 90% sequence identity to SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3 do not provide ample written description for the compounds since the claims do not describe a single structural feature. The specification does not clearly define or provide examples of what qualify as compounds of the claimed invention.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable claim 1 is broad generics with respect all possible compounds encompassed by the claims. The possible structural variations are limitless to any class of peptide or a peptide-like molecule that can form amide bonds. It must not be forgotten that the MPEP states that if a peptide is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond compounds disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus since the specification does not provide any examples of derivatives. The specification is void of organic molecules that functions as a peptide-like molecule that qualify for the functional characteristics claimed as a peptide or a peptide-like molecule or other peptidic molecules, and other synthetic peptide or peptide-like molecule that can form amide bonds.
The specification is limited to 10 peptide sequences. Instant SEQ ID NO: 1 is:
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842
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. Instant SEQ ID NOs: 1-3 are 56 residue protein sequences. Thus, a protein having at least 90% sequence identity to SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3, would be 56 x 0.9 = 50.4. This implies that 51 residues must be the same and 5 residues can be different. Instant SEQ ID NO: 1 has a sequence wherein residues 23, 26, 27, 30, 31, 33, 34, 35, 40, 41, 42, 44, 45, 48, 49 and 52 can be “any amino acid”. Thus, from SEQ ID NO: 1 alone, there are 16 residues that can be different The working example 2 describes expression and purification of the gp64 binding proteins (see Example 2). The working example 3 describes binding analysis of proteins (see Example 3). The working example 4 describes affinity purification (see Example 4). The specification does not describe what amino acids are required in the protein sequence in order to maintain function of the protein. Description of SEQ ID NOs: 1-10 is not sufficient to encompass numerous other proteins that belong to the same genus. For example, there are varying lengths, varying amino acid compositions, and numerous distinct qualities that make up the genus. For example, Yampolsky et al teach that even a conservative substitution of an amino acid could change the activity/functionality of the peptide sequence (see for example, Table 3). Furthermore, there are 20 naturally occurring amino acid. Thus, a protein having at least 90% sequence identity to SEQ ID NO: 1, SEQ ID NO: 2, or SEQ ID NO: 3 (all are 56 residues), there would be 5 residues that can be different. Thus, 520 = 9.5 x 1013 different possibilities. There is not sufficient amount of examples provided to encompass the numerous characteristics of the whole genus claimed.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
CLOSEST ART OF INTEREST
9. The closest art to instant SEQ ID NOs: 1-3 is Fiedler et al (US 2022/0073564, cited in the previous office action or issued as US Patent No. 12466857). Fiedler et al teach a sequence, for example, AKFDEAQSSADSEILHLPNLTEEQRNAFRQSLSDDPSVSKEVLGEAQKLNDSQAPK (see SEQ ID NO: 9) that has 71% sequence identity to SEQ ID NO: 2; a sequence AKFDEAQSAADSEILHLPNLTEEQRNAFRQSLSDDPSVSLEVLGEAQKLNDSQAPK (see SEQ ID NO: 1) that has 72.2% sequence identity to instant SEQ ID NO: 3.
10. The closest art to instant SEQ ID NO: 4 is Fiedler et al (US 2023/0027132 or issued as US Patent No. 12286458). Fiedler et al teach a 171 residue protein sequence having 80.1% sequence identity to instant SEQ ID NO: 4 (see SEQ ID NO: 20).
11. Fiedler et al (US 2023/0027132 or issued as US Patent No. 12286458) teach a protein sequence that is 100% identical to instant SEQ ID NO: 6 (see SEQ ID NO: 21). Fiedler do not teach instant SEQ ID NOs: 1-3.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO 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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/JULIE HA/Primary Examiner, Art Unit 1654
9/25/2026
