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 .
This office action is in response to the amendment filed on January 9, 2026. Claims 1, 8-13, 20, 22-25, 27, and 29-35 are currently pending. Claims 2-7, 14-19, 21, 26, and 28 have been cancelled. Claims 13, 20, 22-25, 27, and 29-34 have been withdrawn. Claims 1, 8-12, and 35 are currently under examination.
Any objections and rejections not reiterated below are hereby withdrawn.
Withdrawal of Rejections
The rejection of claims 1, 8-12, and 35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn based on the amendment to claim 1 to remove reference to the polynucleotides in a panel composed of polypeptides.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on November 21, 2025, March 3, 2026, May 27, 2026, June 12, 2026, and July 31, 2026 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Pending Rejections
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, 8-12, and 35 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.
In claim 1, it is unclear what characterizing endometriosis is referring to. What character of endometriosis does the panel convey?
Claims dependent on a rejected claim are rejected for failing to cure the indefiniteness.
Response to Remarks
Applicant’s state that where the scope of the subject matter embraced by the claim is clear, the claim should not be found to be indefinite. Applicant’s state that Merriam Webster Dictionary defines the term “characterize” as “to describe the character or quality of” or “to be characteristic of”. Applicant’s state the present application further citing paragraph [0031] that the claimed markers can be useful in characterizing the subject as having or at risk of developing endometriosis. Further, the claimed biomarkers are differentially present depending on endometriosis status, subjects having endometriosis can be differentiated from subjects that do not have endometriosis using the presently claimed panel. Applicant's arguments filed January 9, 2026 have been fully considered but they are not persuasive. Applicant’s pending claim 1 is drawn to a panel comprising peptide markers, but not stating how the markers relate to the quality of endometriosis or how a subject maybe classified as having the risk of developing endometriosis based on the panel. The scope of the subject matter of claim 1 is not clear. It appears anyone who menstruates can develop endometriosis and therefore would be at risk of developing endometriosis, so it is unclear how the markers describe the character or quality of endometriosis.
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 1, 8-12, and 35 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims are rejected because of undue experimentation to make and use any panel for non-invasively characterizing endometriosis in a biological sample of a subject. The undue experimentation arises due to the unpredictability based on the differing conditions of starting materials, such as the genus of peptide biomarkers being claimed to characterize endometriosis.
In In re Wands, 8 USPQ2d 1400 (Fed. Cir., 1988) eight factors should be addressed in determining enablement.
While the analysis and conclusion of a lack of enablement are based on the factors discussed in MPEP § 2164.01(a) and the evidence as a whole, it is not necessary to discuss each factor in the written enablement rejection. The language should focus on those factors, reasons, and evidence that lead the examiner to conclude that the specification fails to teach how to make and use the claimed invention without undue experimentation, or that the scope of any enablement provided to one skilled in the art is not commensurate with the scope of protection sought by the claims. This can be done by making specific findings of fact, supported by the evidence, and then drawing conclusions based on these findings of fact. For example, doubt may arise about enablement because information is missing about one or more essential parts or relationships between parts which one skilled in the art could not develop without undue experimentation. In such a case, the examiner should specifically identify what information is missing and why one skilled in the art could not supply the information without undue experimentation. See MPEP § 2164.06(a). References should be supplied if possible to support a prima facie case of lack of enablement, but are not always required. In re Marzocchi, 439 F.2d 220, 224, 169 USPQ 367, 370 (CCPA 1971). However, specific technical reasons are always required.
1) The nature of the invention: the instant claims are directed to a panel for non-invasively characterizing endometriosis in a biological sample of a subject, the panel comprising one of the following sets of polypeptide markers enumerated in claim 1. The panel has markers that are bound to a capture molecule. The capture molecule is bound to a substrate. The capture molecule can be an antibody or a polynucleotide. Claim 35 is also drawn to a kit for detecting endometriosis in a biological sample, the kit comprising a set of capture molecules each of which specifically binds a marker of peptide markers of claim 1.
3) The predictability or unpredictability of the art: & 6) The quantity of experimentation necessary: & 7.) The state of the prior art: the prior art has shown a large quantity of experimentation is often necessary to overcome the unpredictable nature of non-invasively characterizing endometriosis in a biological sample of a subject. The intrinsic heterogeneity of endometriosis, evident in its varied phenotypes and clinical manifestations, further complicates both precise diagnosis and efficacious treatment (see Nino, abstract). May et al. were unable to identify a single biomarker or panel of biomarkers that have unequivocally been shown to be clinically useful (see First page, Box with Results section). Anastasiu et al. state “As of yet, reliable laboratory biomarkers for this gynecological pathology remains elusive.” (see Introduction, 2nd paragraph, 3rd sentence). Despite considerable research on this topic (biomarkers from the biological fluids of affected patients), noninvasive biomarkers of endometriosis have eluded the transition from bench to bedside (see Anastasiu et al., page 2 of 24, Introduction, 6th paragraph, 2nd sentence). Despite extensive research, neither a single biomarker nor a panel of biomolecules has been considered sufficiently specific and sensitive to be used as a diagnostic test for endometriosis (see Anastasiu et al., page 7 of 24, last sentence in Section 6.) Proteomics is a new and challenging perspective in the field of noninvasive biomarkers for early detection of endometriosis, which includes all the protein “fingerprints” used for endometriosis diagnosis. Despite promising results, these technologies need better standardization and are cost and time-intensive (see Anastasiu et al., page 11 of 24, section 6.1.7, 1st paragraph). Therefore, the unpredictability arises due to the differing conditions of starting materials, such as the genus of biomarkers being claimed.
Consequently, there would be a large quantity of experimentation necessary to determine what conditions are required to make and use a panel with what peptide biomarkers.
How would one of skilled in the art make and use the panel if it is unknown what peptide biomarkers can be used to characterize endometriosis?
8.) Level of skill in the art: the level of skill in this art is high, at least that of a doctoral scientist with several years of experience in the art.
In consideration of the Wands factors, it is apparent that there is undue experimentation because of variability in prediction of outcome that is not addressed by the present application disclosure, examples, teaching, and guidance presented. Absent factual data to the contrary, the amount and level of experimentation needed is undue.
Response to Remarks
Applicants state the analysis of the Wands factors providing in the action is flawed. Applicants state that clinical usefulness is not the standard for enablement at the USPTO. Applicants state the action misapplies the undue experimentation standard and ignores the contents of the claims. Applicants state the action ignores the examples of the disclosure. Applicants state the claims are enabled.
Applicant's arguments filed January 9, 2026 have been fully considered but they are not persuasive. The claims are rejected because of undue experimentation to make and use any panel for non-invasively characterizing endometriosis in a biological sample of a subject. The instant claims are directed to a panel for non-invasively characterizing endometriosis in a biological sample of a subject, the panel comprising one of the following sets of polypeptide markers enumerated in claim 1. Applicant’s pending claim 1 is drawn to a panel comprising peptide markers, but not stating how the markers relate to characterizing the quality of endometriosis or how a subject maybe classified as having the risk of developing endometriosis based on the panel. The prior art has shown a large quantity of experimentation is often necessary to overcome the unpredictable nature of non-invasively characterizing endometriosis in a biological sample of a subject. The intrinsic heterogeneity of endometriosis, evident in its varied phenotypes and clinical manifestations, further complicates both precise diagnosis and efficacious treatment (see Nino, abstract). Despite extensive research, neither a single biomarker nor a panel of biomolecules has been considered sufficiently specific and sensitive to be used as a diagnostic test for endometriosis (see Anastasiu et al., page 7 of 24, last sentence in Section 6.). In consideration of the Wands factors, it is apparent that there is undue experimentation because of variability in prediction of outcome that is not addressed by the present application disclosure, examples, teaching, and guidance presented. Absent factual data to the contrary, the amount and level of experimentation needed is undue.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ANAND U DESAI whose telephone number is (571)272-0947. The examiner can normally be reached 9:00-5:30 EST.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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