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 .
Claims Status
Claim 11 filed on 05/04/2026 are pending. Claims 1-10 & 12-14 are withdrawn from consideration as being drawn to a non-elected invention. Claim 11 are currently under examination directed to the elected species of CXCL2 in claim 11 (see response dated 11/18/2025). All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant application. Response to Applicant’s argument follow. This action is FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
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 11 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.
Regarding claim 11, the recitation of “wherein both of the first reagent and the second reagent are artificially optimized for detection with specificity of over 90%” in lines 8-9 of the claim is unclear. It is unclear what “artificially optimized” encompasses and how this provides “for detection with a specificity of over 90%”.
Claim Rejections - 35 USC § 101
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106, part II.
The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., , 133 S. Ct. 2107, 2116, (2013).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1). The claims were then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. The claims were then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)]. In the absence of a step(s) or element(s) that integrate the JE into a practical application, the additional elements/steps have been considered to determine whether they add significantly more to the JE (STEP 2B) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)]. It was found that the present claims fail to meet the elements required for patent eligibility.
The claims are directed to nucleic acid sequences and kits comprising them, and as such are directed to products. Accordingly, the claims are directed to one of the four statutory categories of invention.
The claims are drawn to nucleic acid sequences/nucleic acid primers including DNA or RNA, which are specific to CXCL2 or VEGFA which are naturally occurring sequences. As such the claims are directed to a product of nature which is a judicial exception.
This judicial exception is not integrated into a practical application because the nucleic acid molecules encompassed by the claims convey the same genetic information as their naturally occurring counterparts. The Supreme Court has made clear "separating [DNA] from surrounding genetic material is not an act of invention" Myriad, 133 S. Ct. at 2117. In Myriad v. Ambry CAFC 2014-1361,1366, December 17, 2014, the CAFC further (regarding a claim directed to a pair of primers) stated “In fact, the naturally occurring genetic sequences at issue here do not perform a significantly new function. Rather, the naturally occurring material is used to form the first step in a chain reaction—a function that is performed because the primer maintains the exact same nucleotide sequence as the relevant portion of the naturally occurring sequence. One of the primary functions of DNA’s structure in nature is that complementary nucleotide sequences bind to each other. It is this same function that is exploited here—the primer binds to its complementary nucleotide sequence. Thus, just as in nature, primers utilize the innate ability of DNA to bind to itself.”
With regard to claim 11, although the claim recites a diagnostic “kit” comprising measuring the expression level of CXCL2 and VEGFA, these elements do not add meaningful limitations to the claims as they are merely nominal or token extra solution activity and are nothing more than an attempt to generally link the product of nature into a particular technological environment. Furthermore, these limitations do not change the structures of the encompassed natural products.
The detection agents encompassed by the claims include nucleic acid sequences such as probes and primers that hybridize to, as well as fragments of the naturally occurring gene CXCL2 and/or gene VEGFA. None of these molecules or cells are patent eligible, whether isolated or not, pursuant to the Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics Inc., US (June 13, 2013). Accordingly, the claims are rejected as being directed to non-patentable subject matter.
Response to Arguments
The response traverses the rejection. The response asserts that claim 11 is amended to specify that “both of the first reagent and the second reagent are artificially optimized for detection with a specific of over 90%” and, in view of the above amendments, applicant submits that claim 11 is not directed to natural products. This argument has been thoroughly reviewed but was not found persuasive as claim 11 does not recite any non-naturally occurring or artificial components that change the structure of the naturally occurring sequences. Further, as discussed above, the claims are drawn to nucleic acid sequences/nucleic acid primers including DNA or RNA, which are specific to CXCL2 or VEGFA which are naturally occurring sequences. As such the claims are directed to a product of nature which is a judicial exception. In addition, although the claim recites a diagnostic “kit” comprising measuring the expression level of CXCL2 and VEGFA, these elements do not add meaningful limitations to the claims as they are merely nominal or token extra solution activity and are nothing more than an attempt to generally link the product of nature into a particular technological environment. Furthermore, these limitations do not change the structures of the encompassed natural products.
For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims.
Claim Rejections - 35 USC § 102
Claim(s) 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei (Wei et al.; Cancer Biology & Therapy, Vol. 14, pages 164-174, November 2012).
Regarding amended claim 11, it is noted that the specification of the instant application teaches that CXCL2 is a types of CXC chemokine and is also sometimes referred to as Gro-β, GRO2, or MIP-2α.
Wei teaches a reagent that measures the expression of GRO-β/CXCL-2 (a first reagent that is used for measuring an expression level of CXCL2 in a sample) and a reagent that that measures the expression of VEGF-A in a sample (a second reagent that is used for measuring an expression level of VEGFA in the same sample) (pg. 167 column 1 1st full paragraph lines 10-14; pg. 167 column 1 2nd full paragraph lines 8-15; Fig. 2E-F).
Response to Arguments
The response traverses the rejection. The response asserts that Dong does not describe “a first reagent that is used for measuring an expression level of CXCL2 in a sample and a second reagent that is used for measuring an expression level of VEGFA in the same sample” as recited in applicants amended claim, and therefore, Dong does not describe all of the elements of amended claim 11. Further, the response asserts that, as noted in the specification of the present application, measuring the expression levels of both CXCL2 and VEGFA in the sample provides higher sensitivity. This argument has been thoroughly reviewed but was not found persuasive. First, as the teachings of Dong are no longer relied upon, as necessitated by the amendments to claim 11, the teachings of Dong will not be further discussed. Further, the teachings of Wei, as applied to claim 11 as necessitated by amendment, teach all of the limitations of currently pending amended claim 11 as discussed above. Further, the amendment to claim 11 reciting “wherein both of the first reagent and the second reagent are artificially optimized for detection with a specificity of over 90%” does not structurally limit the first and second reagent cited in claim 11 and further does not structurally distinguish the claimed diagnostic kit from the prior art of Wei.
For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims.
Conclusion
Claim 11 is rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/ Primary Examiner, Art Unit 1682
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