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 .
Response to Amendment
Applicant’s amendment filed 11/14/2025 is acknowledged. Claims 1, 13, 15, 17, 19, 20, 22, 24 and 26 are amended and claims 2 and 29-36 are canceled. Since claim 1 is allowable, Applicant is entitled to consideration of claims to additional species and claims 13, 14, 17, 18 and 26 are hereby rejoined. Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the species election requirement as set forth at pages 4-5 in the Office action mailed on 05/19/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the species election requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1, 13-22, 24 and 26 are under examination.
Objections/Rejections Withdrawn
The previous objection to claim 2 is withdrawn in response to Applicant’s cancelation of that claim.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
The objection to claims 1, 15, 19, 20 and 24 is withdrawn in response to Applicant’s amendment of the claims correcting the minor informalities.
Claim Rejections - 35 USC § 101
The rejection of claims 1, 15, 20 and 21 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more is withdrawn in response to Applicant’s amendment of claim 1 to affirmatively require treating a patient diagnosed with uveitis by administering a glucocorticoid steroid, a cycloplegic agent, an antimetabolite, a T-cell inhibitor, an anti-tumor necrosis factor (TNF) agent, a biologic agent, or an alkylating agent.
Claim Rejections - 35 USC § 103
The rejection of claim 24 under 35 U.S.C. 103 as being unpatentable over Aapola et al. (WO2019/122538—published 06/27/2019) is withdrawn in response to Applicant’s amendment to make claim 24 dependent upon claim 15, which was not included in this rejection.
Rejection Maintained
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.
The rejection of claim 24 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more is maintained for reasons of record and the following. In addition, rejoined and amended claims 22 and 26 are hereby included in this rejection. This is necessitated by Applicant’s amendment. The amendment to claims 1, 13, 15 and 17 to affirmatively require particular treatments is acknowledged. Although claims 22, 24, and 26 depend from claims 13, 15 and 17, respectively, they introduce an additional judicial exception without integrating it into a practical application. The claims recite methods of analyzing and monitoring uveitis comprising measuring biomarker expression levels and comparing said levels to control. The claims are drawn to a process. See Step 1 of the Revised Guidelines.
The first step in determining whether a claim recites patent eligible subject matter is to consider whether the claims recite an abstract idea, law of nature or a natural phenomenon. See Prong One of Step 2A in the Revised Guidelines. Claims 22, 24 and 26 recite additional prognostic/theragnostic method steps. Claim 22 recites:
a) obtaining a first and second vitreous sample from the eye of the patient at a first time point and second time point;
b) measuring one or more biomarkers in the first and second vitreous samples selected from the group consisting of CHIT1, MPO, LCN2, and LCP1;
c) analyzing the expression levels of the one or more biomarkers in conjunction with respective reference value ranges for said biomarkers, wherein increased expression levels of one or more CHIT1, MPO, LCN2, and LCP1 in the second vitreous sample compared to the first vitreous sample indicate that the patient is worsening, and detection of decreased expression levels of one or more of CHIT1, MPO, LCN2, and LCP1 in the second vitreous sample compared to the first vitreous sample indicate that the patient is improving; and
d) altering treatment of the patient when the patient is worsening.
Claim 24 is similarly worded except that the biomarkers are selected from the group consisting of CST4, CNTN1, HPD, and MINP1, and detection of increased expression levels of one or more of CST4, CNTN1, HPD or MINP1 in the second vitreous sample compared to the first vitreous sample indicate that the patient is worsening, and detection of decreased expression levels of one or more CST4, CNTN1, HPD or MINP1 in the second vitreous sample compared to the first vitreous sample indicate that the patient is improving. In addition, claim 26 is similarly worded except that the biomarkers are selected from the group consisting of MMP8, CAP1, and SERPINA3 and wherein detection of increased expression levels of MMP8, CAP1 or SERPINA3 in the second vitreous sample compared to the first vitreous sample indicate that the patient is worsening, and detection of decreased expression levels of the one or more of MMP8, CAP1 or SERPINA3 in the second vitreous sample compared to the first vitreous sample indicate that the patient is improving.
The judicial exception in each of the claims is the relationship between changing levels of one or more of a select set of biomarkers and the patient’s worsening (if levels are increased) or improving (if levels are decreased) uveitis. The prognostic/ theragnostic methods require comparing biomarker levels in order to make a decision about uveitis worsening or improving. (The term “analyzing” in the claims is interpreted as comparing. The mental step of comparing biomarker levels is similar to comparing information regarding a sample or test subject to a control or target data (see Univ. of Utah Research Found, v. Ambry Genetics Corp., 113 USPQ2d 1241 (Fed. Cir. 2014), or diagnosing an abnormal condition by performing clinical tests and thinking about the results (see In re Grams, 12 USPQ2d 1824 (Fed. Cir. 1989). The answer to Prong One of Step 2A is yes.
The second step in determining patent eligibility of claimed subject matter is to consider whether the claims recite additional elements that integrate the judicial exception into a practical application. Claims 22, 24 and 26 all require the active steps of obtaining vitreous samples and measuring biomarkers, however, obtaining samples and measuring biomarkers represent mere necessary data gathering steps. Further, all three claims, part (d) require “altering treatment of the patient when the patient is worsening”, though there is no particular treatment recited. This is different from the situation in Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018), which recited a particular treatment. Although Vanda’s claims recited a law of nature (the naturally occurring relationship between the patient’s genotype and the risk of QTc prolongation), the claims used the recited law of nature to more safely treat the patients with the drug, thereby reducing the patient’s risk of QTc prolongation. The administering steps in Vanda were particular:
if the patient has a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount of 12 mg/day or less, and
if the patient does not have a CYP2D6 poor metabolizer genotype, then internally administering iloperidone to the patient in an amount that is greater than 12 mg/day, up to 24 mg/day.
In contrast, amended claims 22, 24 and 26 direct the practitioner to alter treatment if the patient is worsening, which is akin to a direction to “administer a suitable medication to a patient”, which is not particular, and is instead merely instructions to “apply” the exception in a generic way. See MPEP 2106.04(d)(2). Thus, the administration step does not integrate the mental analysis step into a practical application, and the answer to Step 2A, Prong Two, is no.
The final step in determining whether the claims recite patent eligible subject matter is to consider whether they recite additional elements that amount to significantly more than the judicial exception. Although the claims require measuring biomarkers, such measurement is routine in the art. For example, Bosch et al. (US2015/0141273—of record) disclose antibody-binding assays that measure ELANE, PGLYRP1, MMP9 and S100A8, among others. Further, the treatment step (d) recited in claims 22, 24 and 26 is not particular for the reasons outlined in the previous paragraph. In summary, these additional elements are not sufficient to amount to significantly more than the judicial exception, thus, claims 22, 24 and 26 are not patent eligible.
Conclusion
Claims 1, 13-21 are allowed and claims 22, 24 and 26 are 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 CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675