ETAILED 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 .
Applicant’s Amendment, filed 06/30/2023, is acknowledged.
Claims 1-20 are pending.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-16) in the reply filed on 03/25/2026 is acknowledged. The traversal is on the ground(s) that the inventions are not separate/distinct there is not an undue search burden. This is not found persuasive because the inventions are separate/distinct and there is an undue search burden as set forth in the Restriction requirement, mailed 01/27/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention (Group II), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/25/2026.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/13/2023, 02/09/2024, 05/31/2024, 01/13/2025, and 09/02/2025 are acknowledged and the references cited therein have been considered.
Priority
Applicant states that this application is a divisional application of the prior-filed application. A divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed applications: the prior-filed applications do not contain any mention of the term “antigen test device”. The prior-filed application examples are directed to engineered cells, including genetically engineered diagnostic cells.
Accordingly, the priority is set at the filing date of the instant application 06/13/2023 for claims 1-10. The priority for claims 11-16 is set at the filing date of provisional application 62/216,538, which is 09/10/2015.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-10 encompass a broad genus of antigen test devices. However, the specification fails to disclose any devices that would test antigens. The specification fails to disclose a representative number of devices or a common structure for devices that test antigens.
The claimed invention recites in relevant part “a receptor element that encodes a chimeric antigen receptor (CAR) comprising an extracellular antigen binding domain operably linked to a transmembrane domain, and an intracellular signaling domain, wherein the extracellular antigen binding domain recognizes an antigen on a surface of a pathogen-infected cell from a sample or on a surface of a virus particle associated with a pathogen from a sample; an actuator element that encodes a transcription factor binding site that upregulates synthesis of a detectable reporter protein in response to the antigen binding domain of the CAR binding to the antigen;”.
The specification discloses that the receptor element can be reprogrammed by exchanging the single chain variable fragment (scFV) portion of CAR for an extracellular antigen binding domain specific for a different disease-associated antigen or general for an antibody or other molecule (e.g., cytokines, chemokines, proteins). Other receptor elements that can be used include, without limitation, CARs having specificity for antigens associated with autoimmune disorders, CARs having specificity for antigens associated with other viruses or pathogens and/or antibodies [0043].
The specification discloses that the transcription factor binding site 108 is selected from a nuclear factor of activated T-cell (NFAT) response element, a serum response element (SRE), and a cyclic AMP response element (CRE) [0054].
The claims merely recite by function alone that upregulation of reporter protein occurs due to binding of a target to the recited CAR. The claims lack any specificity in terms of the target and structure of the CAR extracellular antigen binding domain, and also lack reference to sufficient structure in terms of specific transcription factor binding site in order to achieve the function of reporter protein upregulation. The claims thus fail to recite critical elements necessary to carry out the invention, and are rejected therefore.
The Specification fails to provide adequate written description support for a genus of extracellular antigen binding domain and transcription factor binding sites having the desired functional properties required to practice the claimed antigen test device-the ability to test antigens.
With respect to representative number of species, see AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) Also, see MPEP 2163 II(A)(3)(a))(ii):
A representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").
Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1--9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ssemadaali et al. (Microbiology Spectrum, 2022; 10(4): 1-12).
Claim 1 is included because the prior art reference meets all the limitations of claim 1 (see Figure 1 and capture below). Ssemadaali et al. teaches a cell-based platform for antigen testing and its application for SARS-CoV-2 infection comprising genetically engineered diagnostic cell (the DxCell) comprising an exogenous polynucleotide sequence that includes, in operative association:
a receptor element that encodes a chimeric antigen receptor (CAR) comprising an extracellular antigen binding domain operably linked to a transmembrane domain, and an intracellular signaling domain, wherein the extracellular antigen binding domain recognizes an antigen on a surface of a pathogen-infected cell from a sample or on a surface of a virus particle associated with a pathogen from the sample;
an actuator element that encodes a transcription factor binding site that upregulates synthesis of a detectable reporter protein in response to the antigen binding domain of the CAR binding to the antigen; and an effector element that encodes the detectable reporter protein, wherein, in response to the antigen binding domain of the CAR binding to the antigen, the genetically engineered diagnostic cell (the DxCell) is configured to activate and, to synthesize the detectable reporter protein which indicates infection of the sample by the pathogen.
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Claim 2 is included because the amount of detectable reporter protein is proportional to the amount of the antigen present in the sample (pg. 3 second paragraph).
Claim 3 is included because the solution is configured to contain the sample.
Claim 4 is included because the extracellular binding domain was configured to recognize both antigen on the surface of the pathogen-infected cell and the antigen on the surface of the virus particle (see Fig. 1).
Claim 5 is included because the detectable reporter protein comprises a first and second detectable reporter proteins linked by a 2A linker peptide (pg. 2 third paragraph).
Claim 6 is included because the first and second detectable reporter proteins are each selected from fluorescent protein and luciferase (pg. 2 third paragraph).
Claim 7 is included because the DxCell platform was engineered to express GFP linked to Nluc through a self-cleavable peptide linker (GFP-2A-Nluc) as target-inducible reporters for quantitative assessment of the infection (see Fig. 1 and page 2, under Results).
Claim 8 is included because the pathogen is Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (see entire document).
Claim 9 is included because the extracellular antigen binding domain comprises a single-domain heavy chain (VHH) of an antibody that binds to the antigen (pg. 2 third paragraph).
While Ssemadaali does not teach the term device, the referenced platform is considered a device.
The reference teachings anticipate the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN ALFANO whose telephone number is (571)272-3092. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALAN ALFANO/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641
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