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 19, 2026. Claims 1-6, 10, 23-25 and 27-36 are pending. Claims 1-6 and 10 are withdrawn. Claims 23-25 and 27-36 are currently examined.
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.
(Previous Rejection – Withdrawn) Claim 25 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
This rejection is withdrawn in view of the amendment filed on May 19, 2026.
Claim Rejections - 35 USC § 101
35 U.S.C. §101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Previous Rejection – Maintained) Claims 23-24 are rejected under 35 U.S.C. §101 because the claimed invention is directed to non-statutory matter. The instant claims are directed to a naturally-occurring nucleic acid sequence or fragment thereof, whether isolated or not, that is not patent-eligible pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc., 56 U.S. ____, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (June 13, 2013) (Myriad), which expresses the Supreme Court’s long-standing “rule against patents on naturally occurring things” as in its earlier precedent including Diamond v. Chakrabarty, 447 U.S. 303 (1980) (Charkrabarty) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289, 101 USPQ2d 1961 (2012) (Myriad). While the holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving natural products should be examined for a marked difference under Chakrabarty.
This rejection is extended to new claims 33-34.
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) Claims 23-24 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Feng et al. (Nature Communications, volume 8, Article number: 370 (2017)) and Protocol Online ("PCR primers for introducing tag"; https://www.protocol-online.org/biology-forums/posts/39765.html# Dated 2008).
This rejection is extended to new claims 28-36.
Regarding new claim 29, neither the specification nor the claim defines what “paper test article” is or does, except for the teaching that the paper test article may be a “freeze dried paper article”. See [0096]. Therefore, the limitation “paper test article” as claimed is interpreted as reading on any “paper article” that can be included in a “kit” of relevance.
Feng teaches using nitrocellulose membrane in the study. See page 9, para 2. One of skill in the art would have found it obvious to include a nitrocellulose membrane in a kit comprising primers and other reagents, as claimed, based on the teachings of Feng.
Regarding claim 30, since it is known and routinely practiced in the art to introduce various sequence elements in a gene expression construct, as discussed in the rejection body in the previous Office action, one of skill in the art would have found it obvious to include the elements specified in claim 30, i.e., a second peptide reporter (if necessary), and to include a device for the detection of any reporter that is relevant.
Regarding claims 31-32, it would have been obvious to include any type of device that is useful in a “kit” in a relevant study, such as a study disclosed in Feng.
Response to Applicant’s Arguments
Applicant’s arguments filed on May 19, 2026 have been fully considered and addressed as follows.
To the 101 rejection, Applicant argues that the configuration of the reverse primer is similar in that the primer is complementary to a second portion of the target gene, and it does not encode or correlate to the naturally occurring 3’ region of the gene, but rather allows for hybridization of the primer to the naturally occurring gene for transcription and tagging of the gene with a reporter gene and a stop codon.
Applicant’s arguments are not persuasive. The DNA encoding a gene and additional regulatory elements is commonly double-stranded. The reverse primer as claimed reads on a sequence on the complementary strand of the double-stranded DNA of a naturally occurring gene expression locus.
To the 103 rejection, Applicant argues that claim 23 is amended to recite that the forward primer comprises a nucleic acid sequence “complementary to” a first portion of target nucleic acid, and that no combination of Feng and Protocol Online disclose a primer set comprising the claimed features. Applicant argues that the primers in Protocol Online do not include all of the claimed elements. Applicant argues that Feng and Protocol Online are directed to expressing fusion proteins using constructs in which the full fusion protein is encoded while the claimed primers are designed for detecting a target gene.
Applicant’s arguments are not persuasive. Primers for PCR amplification routinely comprise sequences “complementary” to either one of the strands of the double-stranded DNA target. As to Applicant’s argument that Feng and Protocol Online do not disclose all of the claimed sequence elements, teachings of Protocol Online suggest that long primers can be used to introduce desired sequence elements into a gene expression construct via PCR. One of skill in the art would have found it obvious to design a long primer that includes any desired sequence features to build them into a gene expression construct. The claimed sequence elements, e.g., RBS and sequence encoding a peptide tag, etc., are common knowledge at the time of invention. As to Applicant’s argument that claimed primers are designed for detecting a target gene, this argument is not germane to the rejection. Even though PCR reaction using the claimed primers can be used in “detecting” a target sequence, such primers as claimed are more reminiscent of those used for incorporating various sequence elements into a PCR product, such as an expression cassette for a fusion protein.
Conclusion
No claims are allowable.
Claim 25 is 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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