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 .
Election/Restrictions
Applicant's election with traverse of Group I (claims 1-11 and 13) and species CD74, IFNg, CD177, S100A9, CX3CR1 and/or TAP2 in the reply filed on 10/27/2025 is acknowledged. The traversal is on the ground(s) that there is no burden to search and examine all of the claim in the application. This is not found persuasive because search and/or examination burden is not relevant for claims restricted under 35 U.S.C. § 372 (Lack of Unity).
The requirement is still deemed proper and is therefore made FINAL.
Status of the Claims
Claim 12 has been withdraw as being directed to a non-elected invention. Claims 9-10 have been withdrawn as being directed to a non-elected species. Claims 1-8, 11 and 13 are under examination at this time.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 13 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.
First, as written, claim 13 is not clear and does not make sense. Second, claim 13 is a method for determining the risk of incidence of complication in a patient, however, there are no active method steps. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
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.
Claim(s) 1-8 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (WO 2020/096984; May 14, 2020).
The instant claims are directed to an in vitro or ex vivo method for determining the risk of complication in a patient comprising a step of measuring the expression of C3AR1 in a biological sample from said patient.
Lee et al. teaches a method of diagnosing sepsis in a subject including detecting or measuring expression of the set of at least six genes in a sample from a subject, wherein the subject is diagnosed with sepsis when expression of a panel of genes including CCR1, C3AR1, C9orf95, BATF, C9orf103, GNA15, CD177, CD63, EMR1, FCERIG, FES, PLAC8, and/or SEPHS2 is increased compared to a control (see, for example, page 2, lines 26- 29).
For claims 2-5, Lee et al. teaches measuring “the expression of at least one gene selected from the following genes” GNLY, S100A9, ADGRE3, CD177, CX3CR1, IFIH1, OAS2, and OAS3. CD177 is gene that encodes a molecule involved in the innate immune system (as defined in the instant specification).
For claim 6, Lee et al. teaches that the sample can be a blood sample (see page 10, lines 33-37).
For claims 7 and 8, Lee et al. teaches that determining the level expression in either a qualitative, semi-quantitative, or quantitative manner is done by detection of nucleic acid molecules (e.g., DNA, RNA, and/or mRNA) or proteins. Exemplary methods include microarray analysis, PCR (such as RT-PCR, real-time PCR, or qRT-PCR), Northern blot, Western blot, ELISA, and mass spectrometry (see page 10, lines 29-32 and page 21, line 3 to page 22, line 14).
For claim 11, Lee et al. teaches comparing the expression level of the panel of genes to control genes, such as one or more housekeeping or internal control genes (see page 2, lines 26-29 and page 13, line 36 to page 14, line 4 and page 16, lines 7-12).
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 1-8 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8-12 of copending Application No. 18/880056 (reference application).
The instant claims are directed to an in vitro or ex vivo method for determining the risk of complication in a patient comprising a step of measuring the expression of C3AR1 and additional genes such as CD74, IFNg, CD177, S100A9, CX3CR1 and/or TAP2 in a biological sample from said patient.
The copending claims are directed to an in vitro or ex vivo method for determining the risk of death of a subject infected with a respiratory virus, comprising a step of measuring the expression level of the CD74 gene in a biological sample from said subject, where the method further comprises measuring the expression of one or more other additional genes in the biological sample from the subject, said genes being involved in host response and being selected from ADGRE3, ARL14EP, BPGM, C3AR1, CCNB1IP1, CD274, CD3D, CIITA, CTLA4, CX3CR1, GNLY, IFNG, IL10, IL1RN, IL7R, IP10/CXCL10, MDC1, OAS2, S100A9 and combinations thereof in the biological sample from the subject.
Copending claim 8 teaches instant claim 6.
Copending claim 9 teaches instant claim 7.
Copending claim 10 teaches instant claim 8.
Copending claim 11 teaches instant claim 11.
Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672