DETAILED ACTION
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 .
Priority
The instant claims herein are examined utilizing the accepted effective filing date of 5/20/2021 for the basis of any prior art rejections as the instant application is a continuation of 17/748,611.
Drawings
The drawings are objected to because Figs. 5-7 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claims 1-2 are objected to because of the following informalities:
Claim 1 has a typographical error. “KCVN2” is misspelled twice in claim 1 and should be replaced with “KCNV2”, per the specification.
Claim 2 is not grammatically correct. Claim 2 recites “wherein the method comprising an administration”. However, this should be written as “wherein the method comprises.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 2-9 are 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 2 recites the limitation "wherein the method comprises an administration of the viral vector into at least one of a retinal. subretinal, or intravitreal region of an eye".
Claim 3 recites “wherein the method comprises the administration of the viral vector the retinal region of the eye”.
Claim 4 recites “wherein the method comprises the administration of the viral vector into the subretinal region of the eye”.
Claim 5 recites “wherein the method comprises the administration of the viral vector into the intravitreal region of the eye”.
Claims 6-9 also recite “the method of claim . . .”
Claim 1, which is a product, is drawn to “a viral vector comprising a modified KCVN2 nucleotide sequence as set forth in SEQ ID NO:2 for use in a method for treating retinal dysfunction based on one or more mutations in the KCVN2 gene”. The limitation “for use in a method for treating retinal dysfunction based on one or more mutations in the KCVN2 gene” is an intended use of the instantly claimed vector, and thus, does not limit the claimed vector. Instant claim 1 does not recite any administration step and claims 2-9 fail to further limit instant claim 1 because these claims do not recite any limitations to the claimed viral vector itself; rather they limit the intended use 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 Interpretation
Claim 1 recites, inter alia, “for use in a method for treating retinal dysfunction based on one or more mutations in the KCVN2 gene”. The examiner is interpreting that this is an intended use of the instantly claimed viral vector as stated in the 112(d) rejection above (see also MPEP).
For the purposes of compact prosecution, the examiner is interpreting that claims 2-9 are also intended uses of the instantly claimed vector.
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 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12116395. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the 12116395 would anticipate or render obvious the instant claims.
Claims 1 and 2 of ‘395 patent recite “A modified KCNV2 nucleotide sequence as set forth in SEQ ID NO: 2, said sequence coding the peptide of SEQ ID NO: 11, said sequence capable of restoring photoreceptor activity” and “a vector comprising the modified KCNV2 nucleotide sequence of claim 1”. This would anticipate or otherwise render obvious “a viral vector comprising a modified KCVN2 nucleotide sequence as set forth in SEQ ID NO:2 for use in a method for treating retinal dysfunction based on one or more mutations in the KCVN2 gene” as in instant claim 1. Instantly claimed SEQ ID NO:2 is 100% identical to SEQ ID NO: 2 of the ‘395 patent.
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The ‘395 patent does not explicitly claim “administration of the viral vector into at least one of a retinal, subretinal, or intravitreal region of an eye” as in instant claim 2, “administration of the viral vector into the retinal region of an eye.” as in instant claim 3, “administration of the viral vector into the subretinal region of an eye.” as in instant claim 4, “administration of the viral vector into the intravitreal region of an eye” as in instant claim 5, or “wherein the administration leads to an expression of a full-length Kv8.2 protein or a functional fragment thereof” as in instant claims 6-9. However, given the interpretation that these limitations are intended uses/results of said use, the viral vector comprising SEQ ID NO: 2 would be able to perform the claimed steps as presently claimed.
Thus, the instant claims are obvious variants of the viral vector and nucleotide of the ‘395 patent.
Examiner’s Note – No Prior Art Rejections Made of Record
SEQ ID NO: 2, which is required by the instant claims is free of the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 9-5.
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, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.R./Examiner, Art Unit 1632
/DAVID A MONTANARI/Examiner, Art Unit 1632
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