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 .
The claims dated 5/18/2026 are under consideration.
The amendments and arguments presented in the papers filed 5/18/2026 ("Remarks”) have been thoroughly considered. The issues raised in the Office action dated 12/18/2026 listed below have been reconsidered as indicated.
a) The amendments to the specification addressing trade name or mark usage and embedded hyperlinks are acknowledged.
b) The objection of claim 13 is withdrawn in view of the amendments to the claims.
c) The rejections of claims 1 and 4-14 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph are withdrawn in view of the enabling amendments to claim 1.
d) The rejections of claim(s) 1, 6-8, 10 and 12 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ikeda (US 2009/0306181 A1) as evidenced by Wagner (Frontiers in Genetics. 2013. 4:46, 9 pages) are withdrawn because the reference does not teach each of the recited miRNAs as required by amended claim 1.
e) The rejections of: claim(s) 4, 5 and 13-14 under 35 U.S.C. 103 as being unpatentable over Ikeda (US 2009/0306181 A1) in view of Jung (AJVR. 2018. 79(2):163-169) and as evidenced by Wagner (Frontiers in Genetics. 2013. 4:46, 9 pages); and claim(s) 9 and 11 under 35 U.S.C. 103 as being unpatentable over Ikeda (US 2009/0306181 A1) in view of Croce (US 2006/0105360 A1) and as evidenced by Wagner (Frontiers in Genetics. 2013. 4:46, 9 pages) are withdrawn because the reference does not teach each of the recited miRNAs as required by amended claim 1.
The Examiner’s responses to the Remarks regarding issues not listed above are detailed below in this Office action.
New and modified grounds of rejection necessitated by amendment are detailed below and this action is made FINAL.
Election/Restrictions
Applicant elected Group I, claims 1 and 4-14, in the reply filed on 11/10/2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15 and 16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/10/2025.
Priority
This application is a 371 national stage entry of PCT/GB2021/052339 (filed 9/9/2021), and claims benefit to UNITED KINGDOM 2014190.9 (filed 9/9/2020).
Priority is recognized.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or on a submitted IDS, they have not been considered.
Specification
The disclosure is objected to because of the following informalities: the amendments from 3/7/2023 are not included in the substitute specification filed 5/18/2026.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: it recites “pre-determined” and “predetermined”. It is suggested a single format of the term consistently be used in the claims. Appropriate correction is required.
Claim Interpretation
Claim 1 recites “a plurality of miRNAs” starting in line 3, which is interpreted as requiring each of the miRNAs recited in the last “wherein” clause of the claim.
In claim 9, the “off-species control miRNA molecule” is interpreted in view of p. 8, lines 7-8 of the instant specification as being “an miRNA from another species, i.e. not dogs, cats or humans”.
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 and 4-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions without significantly more.
The claim(s) recite(s):
“using one or more Artificial Intelligence (AI) model to diagnose heart disease in the subject based on the measured level of expression of each of the plurality of mRNA molecules” (claim 1); and
“the one or more Al model compares the level of expression of each miRNA molecule with at least one pre-determined reference level characteristic of a non-diseased subject for each one of the plurality of the miRNA molecules, and wherein a deviation of the level of expression of one or more of the plurality of miRNA molecules relative to the at least one predetermined reference level indicates the presence of heart disease” (claim 1).
The process performed with an AI model is one that may be performed by the human mind, but for the recitation of “using one or more Artificial Intelligence” in the step. That is, other than reciting “using one or more Artificial Intelligence” nothing in the step precludes the step from practically being performed in the human mind. For example, but for the “using one or more Artificial Intelligence” language, the step in the context of the claim encompasses a user manually analyzing data organized in a table regarding only 15 miRNAs. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or with the aid of pen or paper but for the recitation of generic AI steps, i.e., “using one or more Artificial Intelligence”, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the step recites an abstract idea. See MPEP 2106.04(a)(2)III.C.
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions. The claimed limitations are mere data gathering steps. MPEP 2106.05(g). Amended claim 1 does recite a step of “subjecting the subject diagnosed with heart disease to a therapeutic intervention directed to heart disease”. First the step is not required in all embodiments, only in those in which a subject is diagnosed with heart disease based on the measuring of a particular miRNA profile that is indicative of the presence of heart disease. The claim does not require an active method step of measuring a deviation of the level of one or more of the recited miRNAs, nor does it require an active method step of “diagnosing” the subject with heart disease. Additionally, the “subjecting” step is broadly recited and amounts to an direction “to apply” the abstract ideas in a manner in which a doctor would treat any other heart disease patient.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because: 1) they do not include additional elements; and 2) the claims encompass the use of commercially available reagents that are well-known and used in a conventional manner as described on p. 11 of the instant specification.
Response to the traversal of the 101 rejections
The Remarks summarize the rejections under 101 (p. 8).
The Examiner’s position is detailed in the above rejections.
The Remarks argue applicant has herein amended claim 1 to recite the additional step of "subjecting the subject diagnosed with heart disease to therapeutic intervention directed to heart disease." (p. 8). The Remarks further argue Applicant asserts that the pending claims are not directed merely toward judicial exceptions, but now expressly recite a treatment step performed based on the detected plurality of miRNAs, which integrates the method into a practical application (p. 8).
The arguments have been fully considered but are not persuasive. The “subjecting” step is conditioned on subjects being “diagnosed” with heart disease. However, the claim does not require any active method step of “diagnosing”. Thus, the claim embraces embodiments in which the patient is not diagnosed with heart disease and the “subjecting” step is not performed. Additionally, the “subjecting” step is recited at such a high level of generality that it amounts to directions “to apply” the abstract ideas.
The Remarks argue the present claims are essentially the same in nature to those of Vanda (p. 8-9).
Contrary to Vanda, which had two alternative active method steps of “administering” a drug to a patient based on a genotype, the present claims only have a single step of “subjecting” that is limited to only patients that are diagnosed with heart disease. However, as noted above, the claim does not require diagnosing a patient with heart disease. Thus, step (c) of “using” one or more AI models encompasses embodiments in which subjects are either diagnosed with heart disease or not diagnosed with heart disease. In Vanda, a subject may have one of two genotypes and in all embodiments the subject is administered some therapy based on which genotype the subject had. Lastly, the claims of Vanda required administering a particular drug at particular doses based on the subject’s genotype. Here, the “subjecting” step lacks that level of specificity as it is broadly “subjecting the subject” to a generic “therapeutic intervention directed to heart disease”.
The Remarks argue the pending claims additionally provide steps which are "significantly more" than a judicial exception, because the judicial exception to which the claims are directed is integrated into a practical application (treatment), given the particular practical steps related to the expression profile detection as recited in new step (c) of claim 1 (p. 9).
The arguments have been fully considered but are not persuasive. The “subjecting” step is not sufficiently tailored so as to integrate the abstract ideas into a practical application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The following are new rejections necessitated by the amendments to the claims.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 19 and 20 further limit the “therapeutic intervention” of claim 1. The “administering of a drug” in claim 19 and the particular “therapeutic interventions” of claim 20 are not supported by the instant specification.
The instant specification does not recite the term “drug” or any of the “therapeutic interventions” specifically recited in claim 20. Thus, verbatim support is lacking. There is no indication applicant contemplated treating a subject in any particular manner or with any particular regimen.
The Remarks rely on the “therapeutic interventions” were well-known and cites to the prior art of record for support (p. 7). This is not sufficient. The Remarks reliance on the prior art is evidence that the instant specification in and of itself does not specifically disclose the claim limitations. The cited prior art references were not relied upon in the specification by applicant in any manner.
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.
Claims 1 and 4-14 are 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 1, the claim recites “the subject diagnosed with heart disease”. The recitation lacks proper antecedent basis as the claim does not actively require the diagnosis of a subject in any manner.
Claims 4-14 depend from claim 1 and are rejected for the same reason.
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 and 4-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/043,498 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim sets encompass overlapping subject matter. For example, “predictive classification models” in the ‘498 claims overlaps with the broader “AI model” of the present claims. Both claim sets measure miRNAs. In the ‘498 claims, the miRNAs are identified by SEQ ID NOs and in the present claims that are identified by their name. However, a comparison between the sequences of the ‘498 claims and the sequences given in the specification for the claimed miRNAs, demonstrates they are the same miRNAs.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 4-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/817,580 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claim encompass overlapping subject matter. For example, “predictive classification models” in the ‘580 claims overlaps with the broader “AI model” of the present claims. Both claim sets measure miRNAs. In the ‘580 claims, the miRNAs are identified by SEQ ID NOs and in the present claims they are identified by their name. However, a comparison between the sequences of the ‘580 claims and the sequences given in the specification for the claimed miRNAs, demonstrates they are the same miRNAs.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to the traversal of the provisional double patenting rejections
The Remarks request the rejections be deferred until prosecution of the related applications has progressed further (p. 13).
The rejections have been maintained as the Remarks do not dispute the appropriateness of the rejections.
Conclusion
Claim 17 is allowable.
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 JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
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