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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, SEQ ID NO: 1, and wherein the polypeptide further comprises the cell-penetrating peptide YGRKKRRQRRRGSG in the reply filed on 11/21/2025 is acknowledged.
Applicants elected species (i.e. SEQ ID NO: 1 linked to YGRKKRRQRRRGSG) was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that anticipated it. As a result, claims 1 and 5 have been examined and claims 2-4 and 6-13 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Status of the Claims
Claims 1-13 are pending in this application.
Claims 2-4 and 6-13 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1 and 5 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities: Claim 1 should be amended to include the phrase “(SEQ ID NO: 21)” following the amino acid sequence of the polypeptide I. Claim 5 should be rewritten as follows: “The polypeptide according to claim 1, wherein SEQ ID NO: 21 further comprises 1-5 amino acids at the N-terminus a deletion of 1-13 amino acids from the N-terminusa modification to the C-terminus . Appropriate correction is required.
Sequence Compliance
Applicant is advised that the application is not in compliance with 37 CFR §§ 1.821-1.825.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR §§ 1.821-1.825. Applicant must comply with the requirements of the sequence rules (37 CFR §§ 1.821- 1.825) in order to completely respond to this office action.
Specifically, the amino acid sequences presented in claim 1 (i.e. the polypeptide of formula I), and in the specification (paras [0015] and [0090]) require sequence identifiers. In order to satisfy the sequence rules requirements, Applicant needs to provide an amendment to the instant claims, specification and drawings to include reference to the appropriate sequence identifier “SEQ ID NO:” in parenthesis next to each of the sequences having 4 or more amino acids. Please confirm that all peptides having 4 or more than 4 amino acid residues have sequence identifiers and are included in the sequence listing.
In case of any new sequences not properly identified in the instant specification, Applicant is required to provide a substitute computer readable form (CRF) copy of a “Sequence Listing” which includes all of the sequences that are present in the instant application and encompassed by these rules, a new or substitute paper copy of that “Sequence Listing”, an amendment directing the entry of that paper copy into the specification, and a statement that the content of the paper and computer readable copies are the same and, where applicable, include no new matter, as required by 37 C.F.R. § 1.821(e) or 1.821(f) or 1.821(g) or 1.825(d). The instant specification will also need to be amended so that it complies with 37 C.F.R. § 1.821(d) which requires a reference to a particular sequence identifier (SEQ ID NO:) be made in the specification and claims wherever a reference is made to that sequence. For rules interpretation Applicant may call (571) 272-2533. See M.P.E.P. 2422.04.
Please direct all replies to the United States Patent and Trademark Office via one (1) of the following:
1. Electronically submitted through EFS-Bio (<http://www.uspto.gov/ebc/efs/downloads/documents.htm>, EFS Submission User Manual - ePave)
2. US Postal Service:
Commissioner for Patents
PO Box 22313-1450
Alexandria, VA 22313-1450
3. Hand carry, Federal Express, United Parcel Service, or other delivery service:
U.S. Patent and Trademark Office
Mail Stop Sequence
Customer Window, Randolph Building
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Alexandria, VA 22314
Claim Rejections - 35 USC § 112
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.
Claims 1 and 5 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 claims are drawn to a polypeptide used as a broad-spectrum anti-enterovirus inhibitor having a sequence selected from I, II, III and IV.
When referring to the polypeptide, the specification does not provide any structural attribute.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe what part of the sequence correlates with the required activity (i.e. a broad-spectrum anti-enterovirus inhibitor).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the polypeptide can be any polypeptide of sequence I wherein at least one amino acid is deleted, added or substituted, or a sequence having at least 50% homology with I or II.
However, the specification fails to provide a representative number of examples for the claimed polypeptide.
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 a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
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.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shanghai Public Health Clinical Center (CN108663523A).
With respect to claim 1, Shanghai Public Health Clinical Center teaches the polypeptide of SEQ ID NO: 6 (LIREYSNRSAIGNTIEALFQ), which corresponds to the instantly claimed polypeptide of formula I, wherein X1 is R, X2 is Y, X3 is S, X4 is N, X5 is S, X6 is A, X7 is I, X8 is G, X9 is N, X10 is T and X11 is I.
With respect to claim 5, it is noted that the polypeptide of Shanghai Public Health Clinical Center comprises the instantly claimed polypeptide of formula I and further comprises 2 amino acids at the N-terminus (i.e. Leu-Ile).
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.
Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11999806. Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same polypeptide.
With respect to claim 1, ‘806 teaches a polypeptide capable of inhibiting the activity of enterovirus protein 3A, wherein the polypeptide consists of a sequence selected from the group consisting of SEQ ID NOs: 2 to 14 (claim 1).
Please note that any of SEQ ID NOs: 2 to 14 corresponds to the instantly claimed polypeptide of formulas II-III.
With respect to claim 5, it is noted that the polypeptide of ‘806 (e.g. SEQ ID NO: 10) comprises the instantly claimed polypeptide of formula I (amino acids at position 5-22 of SEQ ID NO: 10) and further comprises 4 amino acids at the N-terminus (i.e. Tyr-Gly-Arg-Lys).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658