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 .
Applicant’s election without traverse of group II and species in the reply filed on March 26, 2026 is acknowledged.
Claims 22-41 are pending. Claims 1-21 are canceled. Claims 22-41 are 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.
Claims 22-41 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.
Claims recite or encompass the term “wild-type state” which is confusing and ambiguous because the term is a relative term. It is not clear when a GPCR activity is in a “wild-type state” or non-wild-type state.
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.
Claims 21-33, 35-36, 39-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more. The claim(s) recite(s) generic system comprising generic naturally occurring adenylyl cyclase. This judicial exception is not integrated into a practical application because claims are drawn to naturally occurring product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are drawn to a method of using a generic naturally occurring products or non-naturally occurring products that are not markedly different from naturally occurring products. The claimed system generically comprises a system which encompass naturally occurring molecules. The product by process limitation does not exclude the naturally occurring product encompassed by the claim. Eligibility requires more than the “hand of man” but claimed product must be both non-naturally occurring and markedly different from naturally occurring products. The claim as a whole does not recite meaningful limitations that add something of significance to the judicial exception. The claims are recited at a high level of generality such the products encompass naturally occurring products. The product encompasses the naturally occurring product. The product by process is drawn to a well-known and routine methods using the natural products and the method is drawn to nothing more than a mere field of use because the assay methods were standard method for G-protein. The method steps are insignificant extra-solution activity because the steps were well known standard method for G-protein receptors. The Association for Molecula Pathology v. Myriad Genetics, Inc. 569 U.S. __, 133 S. Ct. 2107 2116, 106 USPQ2d 1972 (2013) held that naturally occurring products or non-naturally occurring products that are not markedly different from naturally occurring products are not patentable.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 22-36, 38-41 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Velasquez et al. (Molec. Pharmacol., 2018).
Velasquez teach method of stimulating with ligand to activate the HEK 293 cells comprising ADCY 3 and 6 (page 964, left column). The HEK293 cells inherently comprise the claimed system limited by product by process claim limitations. The term “wild-type state” is a relative term whose value is variable. Velasquez teach the method results in forskolin was reduced in mutant in comparison with Ac1-WT.
Claim(s) 22-41 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Chan et al. (WO 2020/243164).
Chan teach method activating with small molecule or peptide ligands with mammalian cells including HEK293 cells which have been transfected with 2 different synthetic transcription factors comprising reporter UMI and fluorescence which are reactive to GPCR (page 2, 8-9, 11, 13, 21-22, 24, 27-29). The transcriptional relay system vector can be integrated into genome (page 6). The HEK293 cells inherently comprise the claimed system limited by product by process claim limitations. GPCRs used in the system can either inhibit or increase the adenylate cyclase system (page 30).
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674
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