DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/15/2026 has been entered.
Response to Applicant’s Amendments
It is noted that Applicant has not provided any substantive arguments regarding the objections and rejections presented in the Final Rejection mailed 1/15/2026.
Claim Objections
Claims 9, 10-12, and 15-16 were objected to for minor informalities. In light of Applicant’s amendments to the claims submitted 4/15/2026, these objections have been withdrawn, but see new grounds of objection below.
35 USC 112(b) Rejections
Claim 16 was rejected due to an indefiniteness issue. Though Applicant has amended step (c) of the claim, which was the portion noted in the rejection, the amended language does not overcome the rejection. Thus, this rejection has been maintained. See the 35 USC 112(b) Rejections section below, and see also new grounds of rejection below.
35 USC 112(d) Rejection
Claims 2-4 were rejected for being of improper dependent form. As these claims have been canceled, these rejections have been rendered moot.
35 USC 101 Rejections
Claims 2-6 and 8-16 were rejected for being directed to judicial exceptions without significantly more. Claims 2-6 and 8 have been canceled, and so these rejections have been rendered moot. The rejections for claims 9-16 have been withdrawn due to Applicant’s inclusion of novel primer sequences (SEQ ID NOs: 3-6), which amount to more than well-understood, routine, and conventional activity.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that SEQ ID NO: 6 as listed in the specification (see Table 2 on page 4) is not present in the Sequence Listing. The sequence labeled in the Sequence Listing as SEQ ID NO: 6 is actually an erroneous duplicate of SEQ ID NO: 3. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claim 9 is objected to because of the following informality: in step (c), lines 1-2 read “with the methylation level of a CpG site in the same gene” but should read “with the methylation level of the CpG site in the same gene,” as it is believed to be Applicant’s intent that the same CpG site is examined in the clinical sample and in the control group. Appropriate correction is required.
Claims 10-14 are objected to based on their dependence on objected to claim 9.
Claim 14 is objected to because of the following informality: in line 2, “measurement of the methylation level” should read “measuring the methylation level” to better match the language of claim 9, from which this claim depends. Appropriate correction is required.
Claim 15 is objected to because of the following informality: in step (c), lines 1-2 read “with the methylation level of a CpG site in the same gene” but should read “with the methylation level of the CpG site in the same gene,” as it is believed to be Applicant’s intent that the same CpG site is examined in the clinical sample and in the control group. Appropriate correction is required.
Claim 16 is objected to because of the following informality: in step (b), the newly amended “with a preparation” should read “via use of a preparation,” as “acquiring” as recited at the beginning of the step does not inherently imply active manipulation of a sample. Appropriate correction is required.
Applicant is advised that should claim 9 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Though the claims have different preambles, these preambles do not impact the scope of the recited methods, and the language for said methods is identical in both claims.
Claim Rejections - 35 USC § 112(b)
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 10-12 and 16 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.
Claims 10-12 are each rejected for the same reasoning. The term “the risk of recurrence of diabetic foot ulcers is high” in line 3 of each claim is a relative term which renders the claim indefinite. The term “high risk” or similar wording is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In Figure 2, Applicant examines the methylation level of MORN1 and correlated that with the number of patients that had recurrence of diabetic foot ulcers (see the joining para. of pages 14-15 of the instant specification), and concluded that this level contributed to high risk of recurrence, but does not specifically define what high risk is or provide values that would constitute a high risk (page 15, para. 2). Thus, “the risk of recurrence of diabetic foot ulcers is high” is considered to be indefinite in scope. It is recommended that Applicant amend these claims to read “predicting
Claim 16 is rejected because the relationship between the "at least one gene" in step (b) and the "one or more genes" in step (c) is unclear. Specifically, step (b) requires the use of at least one of three specific genes. In step (c), genes "associated with the recurrence of diabetic foot ulcer" are screened "based on the methylation levels acquired in step (b)". However, it is unclear which, if any, of the genes recited in step (b) are actually associated with diabetic foot ulcers, and so it is unclear which, if any, of these genes are required to be analyzed in step (c). It is recommended to have step (c) read, "screening the genelevel acquired in step (b) using a decision tree for predicting the recurrence of diabetic foot ulcers".
Conclusion
Claims 9-16 are objected to. Claims 10-12 and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm.
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, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRANCESCA FILIPPA GIAMMONA/Examiner, Art Unit 1681
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