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
Claim Status
Claims 1-13 are pending. Claims 1, 4 and 12 have been amended. In the response to the restriction requirement, Applicants elected Group I and SEQ ID NO: 1 linked to YGRKKRRQRRRGSG. Applicants elected species (i.e. SEQ ID NO: 1 linked to YGRKKRRQRRRGSG) was deemed to be free of the prior art. The search was extended to another species (i.e. a polypeptide comprising SEQ ID NO: 21 wherein 1-13 amino acids are deleted from the N-terminus). As a result, claims 1 and 5 have been examined and claims 2-4 and 6-13 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 should be rewritten to recite “A polypeptide used as a broad-spectrum anti-enterovirus inhibitor, having a sequence selected from the group consisting of:
(SEQ ID NO: 21) wherein: X1 is ; X2 is and X11 is selected from the group consisting of isoleucine (I) and leucine (L)”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 1 and 5 under 35 USC 112(a) is withdrawn in view of the amendments to the claims.
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.
This is a new rejection.
Claims 1 and 5 are 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 “SEQ ID NO: 21”, and the claim also recites wherein X1 is….arginine, which is the narrower statement of the range/limitation. Note that X1-X11 are narrower than X1-X11 of SEQ ID NO: 21 (see sequence listing). The claim(s) are 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.
Claim 5, which depends from claim 1, is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as this claim incorporates by dependency the indefiniteness of claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
This is a new rejection.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 is drawn to 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-terminus, a modification to the C-terminus, or a D configuration polypeptide thereof. Claim 1 is limited to polypeptide of SEQ ID NO: 21. Therefore, claim 5, which allows for deletion of 1-13 amino acids from the N-terminus of SEQ ID NO: 21, fails to include all the limitations of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Shanghai Public Health Clinical Center is withdrawn in view of the amendments to the claims.
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.
This is a new rejection.
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen et al. (WO 2016/172722).
Claim 5 is drawn to 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-terminus, a modification to the C-terminus, or a D configuration polypeptide thereof.
It is noted that the polypeptide of claim 1 recites the language “having a sequence”, which is interpreted as “comprises”.
Therefore, the requirement of the polypeptide of claim 5, is to comprise: 1) SEQ ID NO: 21; 2) SEQ ID NO: 21 with 1-5 amino acids added at the N-terminus; 3) SEQ ID NO: 21 with 1-13 amino acids deleted from the C-terminus; or 4) a D configuration of SEQ ID NO: 21.
Nguyen et al. teach the polypeptide of SEQ ID NO: 505241 (KQYEREYNN) (claim 42), which comprises SEQ ID NO: 21 with 13 amino acids deleted from the C-terminus (i.e. REYNN).
With respect to the limitation “used as a broad-spectrum anti-enterovirus inhibitor”, the MPEP 2111.02 states that “[I]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999)””
In the instant case, the preamble is an intended use of the product and is not given any patentable weight.
Double Patenting
The rejection of claims 1 and 5 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11999806 is withdrawn in view of the amendments to the claims.
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.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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