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 .
Status of the Claims
Claims 3-63, 65-67, 72-75, 79-81, 88-97, 99-104, and 106-126 are cancelled.
Claims 69-71, 76-78, 82-87, 98, and 105 are withdrawn.
Claims 1, 2, 64, and 68 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to a panel of isolated nucleic acid biomarkers in the reply filed on 27 August 2026 is acknowledged. Further applicant has elected the following panel:
hsa-miR-98-5p/hsa-miR-485-5p; hsa- miR-1306-3p/hsa-miR-1224-5p; hsa-miR-330-5p/hsa-miR-550a-3-5p-hsa-miR-550a-5p.
Claims 68-71, 76-78, 82-87, 98, and 105 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 27 August 2026.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites "nucleic acid biomarker pairs as listed in Table 6.” MPEP 2173.05(s) states: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claim 2 recites the marker: hsa-miR-550a-3-5p-hsa-miR-550a-5p. This is not a typical recitation of a miR and is potentially a typo.
Appropriate correction is required.
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 64 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.
Claim 64 is indefinite because it is not clear how many biomarkers are claimed. Claim 2 recites “wherein the combination of nucleic acid biomarker pairs is selected from the group consisting of” and then recites groups of nucleic acid pairs. The use of the term combination in the claim indicates that some grouping of biomarker pairs comprises the panel. Claim 64 recites “wherein the combination of nucleic biomarker pairs consists of one or more of the combinations.” It is not clear if applicant is intending to claim more than one pair or more than one panel of combinations. Applicant has elected one panel in the response to the restriction requirement and the claims are examined as such. Claim 64 is not included in the rejection under 35 USC 103 below because it is not clear what is claimed.
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, 2, 64, and 68 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a natural phenomenon, natural product, and an abstract idea) without significantly more. The claim(s) recite(s) a panel of biomarkers. This judicial exception is not integrated into a practical application based on the reasoning below:
The unpatentability of laws of nature and abstract ideas was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S., (2010) (slip op., at 5). “Phenomena 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).
Additionally, the unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Inti, 134 S. Ct. 2347, 2354 (2014).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter? Yes, the claims are directed to a composition.
Step 2A, prong 1. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes, where the claims recite biomarkers, they encompass a natural product. Further, claim 68 recites that the biomarkers are either labeled or amplified. While the biomarkers are in a panel, they are still biomarkers and naturally occurring. Stating that they are part of a panel does not structurally change the biomarkers. Amplifying a biomarker is a copy of the biomarker and therefore still has the same structure as the naturally occurring biomarker and is not significantly different.
Step 2A, prong 2. Does the claim recite additional elements that integrate the exception into a practical application? No, the judicial exceptions to which the claims are directed are not integrated into a practical application because the claims do not recite any additional elements.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No, the claims do not recite any additional elements.
For these reasons, the claims are rejected under USC 35 section 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, and 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boniface, et al. (WO 2020/123404 A2, published 18 June 2020) in view of Nair et al. (Clinical Science, 2018).
Regarding claims 1 and 2, Boniface et al. teach nucleic acid biomarkers for placental dysfunction. Boniface et al. teach that more than two biomarkers are used. (claims 14 and 15). Boniface et al. teach a panel of isolated nucleic acid biomarkers comprising a pair of biomarkers which includes hsa-miR-98-5p/hsa-miR-485-5p (claim 9) and teaches the following other biomarkers:
hsa-miR-1306-3p – Table 9
hsa-miR-1224-5p – Table 15
hsa-miR-330-5p – Table 7
hsa-miR-550a-3-5p-hsa-miR-550a-5p – Table 8. It is noted that the same Table also recites hsa-miR-550a-3-5p.
hsa-miR-221-5p – claim 9
Regarding claim 68, Boniface et al. teach a composition that is labeled or amplified. (for example claim 14).
Boniface et al. do not teach biomarker hsa-miR-197-3p. Nair et al. teach that miR-197-3p is upregulated in gestational diabetes mellitus. (figure 4, pages 2462 and 2463). Therefore, one of ordinary skill in the art would have been motivated to include additional microRNAs in the methods and compositions taught by Boniface et al. because both Boniface et al. and Nair et al. are interested in gestational health. Thus, one of ordinary skill in the art would have been motivated to make the composition for detecting gestational abnormalities more robust by including additional microRNAs. Furthermore, Boniface et al. teaches numerous combinations of microRNAs. For example, Boniface et al. teach in claim 9 to combine hsa-miR-155-5p with many other microRNAs. Therefore, one of ordinary skill in the art would have been motivated to try other microRNA combinations based on the information provided by Boniface et al. in view of Nair et al. who both teach the use of microRNAs to identify gestational issues.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MINDY G BROWN whose telephone number is (571)270-5605. The examiner can normally be reached Monday -Friday, 9:00 am - 5:00 pm EST.
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/MINDY G BROWN/Patent Examiner, Art Unit 1683
/ANNE M. GUSSOW/Supervisory Patent Examiner, Art Unit 1683
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