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 .
Applicants filed response on 2/5/2026 has been received.
Claims 7 and 11-14 have been canceled.
Claim 20 is added.
Claims 1-6, 8-10 and 15-20 are pending and under examination.
The objection on claim 7 is withdrawn because of amendment.
The rejection on claim 7, 11-13 under 35 USC 112(b) is withdrawn because of amendment.
The rejection on claims 1-19 under 35 USC 101 is partially withdrawn because of practical application and uncommon practice in the field (see below).
The rejection on claim(s) 1-7, 11-12, 15-16 and 18-19 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Liang is withdrawn because Liang’s biomarkers for onset of labor are not overlapped with the current invention.
The rejection on claim(s) 1-7, 11-12, 15-16 and 19 under 35 U.S.C. 103(a) as being unpatentable by Dorr is withdrawn because the biomarkers of Dorr are not overlapped with the current invention.
The rejection on claim(s) 1-7, 11-12, 15-19 under 35 U.S.C. 103(a) as being unpatentable by Gomez-Lopez is withdrawn because the biomarkers of Dorr are not overlapped with the current invention.
In view of the amendment, a new office action is set forth below.
Claim Objections
Claim is objected to because of the following informalities: please provide full name of the abbreviation, PLXB2, DDR1, LPS, GM-CSF, pCREB. Appropriate correction is required.
It is also noted that Angiopoietin-2 is recited twice.
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 1-6, 8, 15-16 and 18-20 are rejected under 35 U.S.C. 101 the claimed invention is directed to assessing time to onset of labor without significantly more. The claim(s) recite(s) law of nature. Thus the law of nature refers to the (1) measuring natural molecules from a subject, i.e. recited biomarker natural molecules in samples in at least two time points, and (2) correlating changes of the biomarker for onset of labor. Therefore, the natural relationship is the biomarker(s) correlating with a “condition” under judicial exception. (See Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012).
This judicial exception is not integrated into a practical application because no extra feature/or step is included. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because IL-1R4, activin-a, siglic-6, ATIII, (Stie)-2, cortisol, PLXB2, DDR1, are all natural molecules in the body . MPEP 2106.04(d)(2) states “[e]xaminers should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition.” (also see Vanda Pharm. Inc. v. West-Ward Pharm. Int’l Ltd., 887 F.3d 1117, 126 USPQ2d 1266 (Fed. Cir. 2018). Therefore no patentable weight is given on mere “treatment”.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because all the sample obtaining, processing and measuring specific natural molecules are common, routine, and well-known in the field, such as ELISA, immunoassay, flow cytometry (section 0067, 0128). These steps are recited at a high level of generality, and are necessary data gathering steps that feed into the determining step. One cannot do the determining step without getting the data. This weighs against it being significantly more.
Applicants’ arguments are summarized below:
“Applicant submits that the pending claims are patent-eligible, for at least the reason that under the Step 2B analysis of the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG), the instant claims as a whole provide an inventive concept that amounts to significantly more than the alleged judicial exception. Even assuming arguendo that claim 1 includes a judicial exception in the form of an abstract idea as alleged by the Office (which Applicant does not concede), it should be noted that the first steps of the claim, at least, are physical laboratory elements that do not include a judicial exception that falls into any of the categories listed in MPEP 2106. As such. these claim limitations should be considered "elements in addition" to be considered in combination under Step 2B of the patent eligibility analysis.
The quantitation of specific sets of markers, as provided in the instant claims, was not well-understood, routine, or conventional as of the effective filing date of the Application. In particular, it was not well-understood, routine, or conventional for one of skill in the art to quantitate specific panels of markers, as recited in each of the independent claims.
Applicant respectfully points the Office to M.P.E.P. § 2106.05, which states that "[c]onsideration of the elements in combination is particularly important, because even if an additional element does not amount to significantly more on its own, it can still amount to significantly more when considered in combination with the other elements of the claim. See, e.g., Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1051, 119 USPQ2d 1370, 1375 (Fed. Cir. 2016) (process reciting combination of individually well-known freezing and thawing steps was "far from routine and conventional" and thus eligible); BASCOM Global Internet Servs. v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (inventive concept may be found in the non-conventional and non-generic arrangement of components that are individually well-known and conventional)" (emphases added). Further, M.P.E.P. § 2106.05 also states that "the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) ('the inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.')" (emphases added).
Applicant submits that the claimed invention recites additional elements that amount to significantly more than the alleged judicial exception and thus provide an inventive concept.
In view of the amendments and remarks, withdrawal of the rejection is requested.”
Applicant’s arguments have been considered but are not persuasive.
Claim 1 directs to measure at least 5 biomarkers from the Markush group. As has been discussed above, at least the IL-1R4, activin-a, siglic-6, ATIII, (Stie)-2, angiopoietin-2, VEGF121, cortisol, PLXB2, DDR1 are all natural molecules exist in the body. Therefore law of nature remains effective. The same rationale also applies to claim 8.
Note, claim 9 and claim 10 are significantly more than law of nature because of dendritic cell pSTAT6 response to interferon alpha, CD69-CD56'OCD16+NK cell pSTAT1 response to IFNalpha, PERK and PCREB signals in classical monocytes (cMCs) in response to LPS and GM-CSF, and PCREB response in non-classical monocytes (ncMCs) in response to GM- CSF. These are not naturally exist in the body, i.e. need of external stimulus such as interferon, and GM-CSF.
Claims 9-10 and 17 are allowed. The closest prior art is the applicants’ earlier meeting abstract (Stelzer Reproductive Sciences 2020 March Vol. 27, page 89A #O-081) where applicants provide three biomarkers overlapped with the current invention, i.e. IL-1R4, angiopoietin and ATIII for assessing onset of labor.
Conclusion
Claims 1-6, 8, 15-16 and 18-20 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.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678