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 .
Status of the Application
The Response to Non-Final Office Action filed October 20, 2025 is acknowledged.
Claims 30-51 were pending. Claims 30, 32-43, 46, and 48-51 are being examined on the merits. Claims 31, 44-45 and 47 are canceled.
Response to Arguments
Applicant’s arguments filed October 20, 2025 have been fully considered.
The following rejections are WITHDRAWN in view of Applicant’s arguments and claim amendments:
Rejection of claims 30-51 under 35 USC § 112(b), indefiniteness
Rejection of claims 30-51 under 35 USC § 112(a), new matter
The following rejections are MODIFIED in view of Applicant’s arguments and claim amendments:
Double patenting rejections
Response to arguments regarding double patenting rejections
Applicant argues that the double patenting rejections should be withdrawn because the ‘479 patent and Gunson do not teach or suggest all of the limitations of independent claims 30 and 40, in particular. Specifically, Applicant argues that the cited references do not teach or suggest the limitation requiring that the quantifying of the total number of viral capsids and the quantifying of the total viral DNA are determined by performing digital PCR using a same reaction mixture in a viral DNA-specific PCR duplex assay and different fluorescent dyes (Remarks, pp. 5-6).
The Examiner disagrees. As noted below, the ‘479 patent teaches quantifying the total number of viral capsids and the quantifying the total viral DNA, and teaches using digital PCR to do so, while Gunson teaches detecting viral nucleic acid sequences in a multiplex format with different fluorescent dyes.
These rejections are modified in view of the instant claim amendments.
Claim Interpretation
In claim 30, the limitations reciting “wherein the quantifying of the total number of viral capsids and the quantifying of the total viral DNA are performed … using a same reaction mixture in a viral DNA-specific PCR duplex assay and … wherein the reaction mixture includes the viral preparation subjected to the [PLA]” are being interpreted as requiring that the quantifying of the total number of capsids and the quantifying of the total viral DNA are performed in the same reaction volume. Claim 40 is construed with corresponding reasoning.
Claim Rejections - 35 USC § 112
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.
Claim 32 is 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.
Claim 32 recites the limitation “wherein the viral DNA-specific PCR duplex assay is
performed using primers specific for the released viral DNA”, the meaning of which is unclear. Specifically, claim 30, from which claim 32 depends, recites that the “viral DNA-specific PCR duplex assay” is used to quantify both the “total number of viral capsids” and the “total viral DNA”. While primers specific for the released viral DNA would be capable of performing the latter step, it is not clear how such primers specific for the released viral DNA would also be capable of being used in an assay to quantify the total number of viral capsids. Since the ordinary artisan would not be able to determine the metes and bounds of the claim, it is indefinite.
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.
Claim 35 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.
Claims 35 recites the limitation that “the quantifying of the total number of viral
capsids, and the quantifying of the total viral DNA are performed at the same time”. Claim 30, from which claim 35 depends, recites that the two quantifying steps are “determined by performing digital PCR using a same reaction mixture in a … PCR duplex assay”. The ordinary artisans understands that duplex/multiplex PCR assays involve the simultaneous amplification of two/multiple analytes. Thus, the claim 35 limitation “performed at the same time” does not further limit the claim 30 limitation of a “PCR duplex assay”, and consequently claim 35 is in improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Prior Art
Independent claims 30 and 40, and their respective dependent claims, are free of the art. Nordengrahn1 (Evaluation of a novel proximity ligation assay for the sensitive and rapid detection of foot-and-mouth disease virus, Veterinary Microbiology, 127, 227-236, 2008) is the closest art. The teachings of Nordengrahn are discussed, at least, in the Non-Final Office Action mailed June 21, 2024. However, Nordengrahn does not teach or suggest performing both PLA and quantitative detection of DNA with digital PCR in the same reaction volume. In addition, there is no other art that suggests performing PLA and quantitative detection of DNA in the same reaction volume. Further, there would not appear to be any motivation to combine these two assays, as doing so would increase the likelihood of, e.g., generating undesirable reactions.
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 30, 32-43 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-11 and 17 of U.S. Patent No. 11,649,479 (hereinafter, the ‘479 patent) in view of Gunson (Using multiplex real time PCR in order to streamline a routine diagnostic service, Journal of Clinical Virology, 43, 372).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of the ’479 patent teaches all of the limitations of instant claim 30, except for the limitation requiring that the quantifying of the total number of viral capsids and the quantifying of the total viral DNA are performed in a duplex/multiplex format using different fluorescent dyes. However, Gunson teaches this limitation (section 2.3).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to incorporate different fluorescent dyes in the detection system of the method of the ‘479 patent with the expectation that doing so would result in the advantage of a multiplex detection system which would result in a more efficient assay. The ordinary artisan would have had an expectation of success since the design and modification of qPCR detection systems is well-known in the art.
In addition, claims 4, 5, 6, 7, 8, 9 and 10 of the ‘479 patent teach all the limitations of instant claims 33, 34, 35, 36, 37, 38, 39, respectively.
Finally, regarding instant claim 32, as noted above, the claim is indefinite. However, claim 11 of the ‘479 patent teaches or suggests at least some of the limitations of instant claim 32. That is, instant claim 32 recites that the viral DNA-specific PCR is performed using primers specific for the released viral DNA. Claim 11 of the ‘479 patent recites using a viral DNA-specific qPCR assay, but does not recite primers specific for the viral DNA, per se. However, the ordinary artisan understands that target-specific primers would be used in a target-specific PCR.
In addition, although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-2 of the ’479 patent teaches all of the limitations of instant claim 40, except for the limitation requiring that the quantifying of the total number of viral capsids and the quantifying of the total viral DNA are performed using different fluorescent dyes. However, Gunson teaches this limitation (section 2.3).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to incorporate different fluorescent dyes in the detection system of the method of the ‘479 patent with the expectation that doing so would result in the advantage of a multiplex detection system which would result in a more efficient assay. The ordinary artisan would have had an expectation of success since the design and modification of qPCR detection systems is well-known in the art.
Further, claims 8, 9 and 17 of the ‘479 patent teaches all the limitations of instant claims 41/42, 43 and 46, respectively.
Allowable Subject Matter
Claims 48-51 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 30, 32-43, 46, and 48-51 are being examined. Claims 30, 32-43 and 46 are rejected. Claims 48-51 are objected to. No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Examiner, Art Unit 1681
1 Nordengrahn was cited in the PTO-892 Notice of References Cited mailed June 21, 2024.