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
Acknowledgement is hereby made of receipt and entry of the communication filed on May 28, 2026. Claims 1-2 and 5-22 are pending and currently examined.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
(Previous Rejection – Maintained and Extended to New Claims) Claims 1-2 and 5-22 are rejected under 35 U.S.C. 103 as being unpatentable over Muhammed et al. (PLoS ONE, 2017, 12(3): e0174223), Ly-Chatain et al. (International Journal of Microbiology Volume 2011, Article ID 594369, 9 pages), Verreault et al. (APPLIED AND ENVIRONMENTAL MICROBIOLOGY, Jan. 2011, p. 491–497, Vol. 77, No. 2), GenBank: KP793114.1 (Lactococcus phage 936 group phage Phi17, complete genome. Dated Mar. 2, 2015), and Thornton et al. (BIOCHEMISTRY AND MOLECULAR BIOLOGY EDUCATION, Vol. 39, No. 2, pp. 145–154, 2011).
Applicant argues based on the following aspects: (1) the Office has failed to articulate why “routine optimization” would yield the claimed robustness, (2) the robustness parameter was not a recognized result-effective variable, (3) no motivation to target structural protein 1, (4) the prior art teaches away from performing qPCR without DNA extraction on dairy matrices, (5) no reasonable expectation of success, (6) unexpected results, and (7) response to the Office’s remaining arguments.
Applicant’s arguments are not persuasive.
Regarding aspects (1) and (2), the claims do not relate the robustness to any specific primer sequences nor PCR conditions except for the requirement that the primer pair anneals to a region of a gene encoding structural protein 1 of a lactococcal phage from the subgroup 936. Therefore, the robustness as specified in the claims, i.e., a delta Cq lower than 1.0 cycle when tested when tested in a temperature range of 55.0-70.0 degree Celsius, is considered as an intended efficacy of a qPCR. Since any qPCR has a delta Cq when tested in a temperature range of 55.0-70.0 degree Celsius, one of skill in the art would have found it obvious to test various primer pairs as well as various qPCR conditions to arrive at a desired detection efficacy, including the ones as claimed, based on the teachings of the prior art cited in the rejection.
As to Applicant’s argument that the robustness parameter was not a recognized result-effective variable, one of skill in the art would have reasonably envisaged that any qPCR would inherently have a delta Cq value regardless if it is known as a result-effective variable or not.
Regarding argument (3), it is not required that the cited references must teach or suggest combination of prior arts as long as there is a rationale to support a conclusion of obviousness. A "motivation to combine may be found explicitly or implicitly in market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill." Zup v. Nash Mfg., 896 F.3d 1365, 1371, 127 USPQ2d 1423, 1427 (Fed. Cir. 2018) (quoting Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 [107 USPQ2d 1706] (Fed. Cir. 2013) (citing Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328 [92 USPQ2d 1849] (Fed. Cir. 2009) (quoting KSR, 550 U.S. at 418-21)). See MPEP § 2143.01.
The entire genome sequence of the phage to be detected is known in the art at the time of invention. Any region in the phage genome may potentially be targeted for qPCR detection as long as a proper primer pair can be designed (Thornton et al. cited in the rejection teaches how primers can be designed for qPCR). The structural protein 1 gene region is considered as equivalent to other genome sequence regions in the design of qPCR primers, unclear there is evidence that the region is critical.
Regarding argument (4), MPEP section 2145 X.D relates to assertions that the art teaches away from the claimed invention. Such teachings are not considered to be a teaching away merely by indicating that something is in some manner inferior to another. In essence, a teaching away must criticize, discredit, or otherwise discourage the solution. Here, no prior art references effectively criticize, discredit, or otherwise discourage not extracting nucleic acid from a dairy sample before PCR. On the other hand, there is an apparent motivation not to extract nucleic acid from a dairy sample before PCR to simplify the detection process.
Regarding argument (5), the claims are directed to a generic qPCR kit comprising a generic primer pair annealing to a sequence region in the structural protein 1 gene of a phage from the subgroup 936 (except for claim 5) with only one requirement for an intended detection efficacy - the robustness as specified in the claims, i.e., a delta Cq lower than 1.0 cycle when tested when tested in a temperature range of 55.0-70.0 degree Celsius. The application does not show that the qPCR target region is special. The claimed robustness is considered as inherent to a qPCR design that can be obtained by routine experimental optimization.
Regarding argument (6), as an initial matter, “the burden of showing unexpected results rests on he who asserts them. Thus it is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference.” In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) (citation omitted). Moreover, “[i]t is well settled that unexpected results must be established by factual evidence. Mere argument or conclusory statements in the specification does not suffice.” In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984) (citation omitted). Applicant’s attention is directed to MPEP 716.02(b)-(e) for how unexpected results can be established. E.g., to evaluate if the claimed invention produces unexpected results, one must consider if the results produced by the claimed invention are commensurate in scope with the claims and how the results compare with the closest prior art. See MPEP Section 716.02(d) and (e). Here, applicant has not provided sufficient information for the Office to consider if the results produced by the claimed invention are commensurate in scope with the claims and how the results compare with the closest prior art.
Regarding argument (7), to the Examiner’s standing that the claims specify neither the primer sequences nor qPCR conditions used in obtaining the claimed “robustness”, Applicant argues that claim 1 as amended specifies that the primer pair anneals to a region of a gene encoding structural protein 1 in a 936 phage, and that dependent claim 5 further specifies the primer pair as SEQ ID NO: 6/SEQ ID NO: 7. Applicant argues that the claims need not recite every experimental condition to be patentable, that the Office has not provided any evidence or reasoning as to why a PHOSITA would select structural protein 1 over the terS gene (Muhmmed), orf6 (verreault) or msp (Labrie) that were already used in the prior art.
Applicant’s arguments are not persuasive. As indicated in the discussions above, a robustness defined in delta Cq value is inherently associated with any primer pairs properly designed for qPCR. Since there is no evidence that the claimed structural protein 1 gene region is any better as target of qPCR than other regions in the phage genome, it is considered as equivalent of other regions. Such a combination, or a substitution of one element for another known in the field to have the same function, is evidence that the claimed invention may be found obvious. See MPEP 2144.06 and KSR International v. Teleflex Inc., 82 U.S.P.Q.2d 1385, at 1395. Here, the sequence region of structural protein 1 gene is considered to have the same function of being used as a qPCR target region as other regions known to have been used for the same purpose. Therefore, the instant invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
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 extension fee 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 NIANXIANG (NICK) ZOU whose telephone number is (571)272-2850. The examiner can normally be reached on Monday - Friday, 8:30 am - 5:00 pm, EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL ALLEN, on (571) 270-3497, can be reached. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NIANXIANG ZOU/Primary Examiner, Art Unit 1671
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