DETAILED ACTION
Examiner acknowledges receipt of the reply filed 5/26/2026, in response to the restriction requirement mailed 3/27/2026.
Claims 1, 12-14, 16, 18, 29, 30, 37, 38, 40-42, 48, and 66-71 are pending. Claims 18, 29, 30, 37, 38, 40-42, 48, and 66-71 are withdrawn from further prosecution for the reasons set forth herein.
Claims 1, 12-14, and 16 are being examined on the merits in this office 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 .
Priority
The filing receipt dated 11/22/2024 provides the following:
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Information Disclosure Statement
The listing of references in 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, they have not been considered.
Election/Restrictions
Applicant's election of Group I (claims 1, 12-14, and 16) with traverse in the reply filed on 5/26/2026 is acknowledged. The traversal is on the ground(s) that groups I and II both require detecting the presence of the same plurality of single nucleotide polymorphisms in a sample obtained from the same population type using a similar assay (reply at p. 8). Applicant further asserts that examination groups I and II can be performed without serious burden. Id. This is not found persuasive because Group I is directed to a method of treatment, vs group 2 is drawn to an assay. It is further noted that a lack unity of invention was asserted in the restriction requirement. Applicant did not address this part of the previous office action (restriction at pp. 6-7). Applicant reply is deemed to be an incomplete response.
The requirement is still deemed proper and is therefore made FINAL.
Claims 18, 29, 30, 37, 38, 40-42, 48, and 66-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 5/26/2026.
Applicant’s election of the following species without traverse in the reply filed on 5/26/2026 is acknowledged:
Combination of SNPs: rs1664232, rs1 1118997, rs9342434, rs2335852, rs11020655, rs1885034, rs6923761, rs17782313, rs3813929 and rs1047776
Detecting: sequencing assay
Claims 1, 12-14, and 16 read on the elected species.
Claim Objections
Claim 16 is objected to because of the following informalities:
claim 16 should be amended to recite “a delayed gastric emptying of [[for]] the mammal” for consistency with claim 14.
Appropriate correction is required.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
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, 12-14, 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.
Claim 1 recites the limitation "the subject" in part (b). There is insufficient antecedent basis for this limitation in the claim. The preamble and part (a) refer to a mammal, but not a subject. To overcome the rejection, amend the claim to recite “the mammal”.
The metes and bounds of claim 1 are deemed to be indefinite. The claim term “obesity-related co-morbidities” is not defined by the claim or the specification. The skilled artisan is not apprised of co-morbidities/disorders that fall within, or those that fall outside the claim scope. The skilled artisan is not provided any guidance as to ascertaining the bounds for the claim term,
Because claims 12-14 and 16 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Claim 14 recites the limitation "the gastric emptying". There is insufficient antecedent basis for this limitation in the claim. To overcome this rejection, claim 14 should be amended to recite “comprises measuring [[the]] gastric
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 depends from claim 14, which depends from claim 1.
Claim 1 recites: a method for treating obesity and/or one or more obesity-related co-morbidities in a mammal, the method comprising:
detecting the presence of a plurality of single nucleotide polymorphisms (SNPs) in a sample obtained from a mammal suffering from obesity, ….
[Subject has obesity and is selected for GLP-1 agonist treatment]
Claim 14 recites: the method of claim 1, further comprising assessing gastric motor function of the mammal …
Per claims 1 and 14: the subject has obesity and is selected for GLP-1 agonist treatment
Claim 16 recites: the method of claim 14, wherein a delay in gastric emptying for the mammal as compared to gastric emptying in a control selects the mammal for treatment with the GLP-1 agonist.
Claim 16 is not deemed to further limit claim 14. Specifically, claim 1 sets forth that the patient already has obesity. Claim 1, step (a) assesses SNPs for the subject, and step (b) administers a GLP-1 to treat the obese subject. Claim 16 at ll. 2-3 recites “selects the mammal for treatment with the GLP-1 agonist”, but the subject is already selected/treated with GLP-1 agonist in claim 1. Accordingly, claim 16 is not deemed to further limit claim 14.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
35 U.S.C. 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, 14, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 14, and 16 recite(s) an abstract idea, determining, observing and diagnosing. This judicial exception is not integrated into a practical application because the claims recite mental processes. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. This judicial exception is not integrated into a practical application because the claim recites abstract idea, which falls into the mental process grouping. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the following reasons.
Step 1: Is the claim drawn to a process, machine, manufacture or composition of matter? The instant claims are directed to a series of steps, therefore, is a process.
Step 2a Prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea? The claims recite a correlation between single nucleotide polymorphisms (SNPs) in a sample from an obese subject as indicative of treatment response to a given therapy, e g, GLP-1 agonist. This is a law of nature. The claims also recite an abstract idea by reciting measuring SNP levels [biomarkers] for directing selection of a treatment regimen. It is noted that the specification is generic as to administering a treatment regimen. The claims are deemed to be directed to methods of organizing human activity, specifically as managing a person behavior or interactions between people. These steps are construed as an abstract idea.
Step 2a Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The claims additionally include steps in addition to the judicial exception, e.g. the step of measuring the level of the SNPs in a sample (e.g., amplification, hybridization, and/or sequencing assay). While these are steps in addition to the judicial exception, they do not integrate the judicial exception into a practical application as they are merely performing necessary data gathering steps directly informed by the judicial exception. The steps are therefore considered to be insignificant extra-solution activity.
The suitable treatment regimen is directly informed by the judicial exception and therefore should not be considered to add significantly more over the judicial exception. Administering a GLP-1 agonist is recited at a high level of generality. There is, at best, a nominal relationship between treatment regimen and the judicial exception. See MPEP 2106.04(d)(2).
The claims are considered to be directed to the indicated judicial exceptions.
Step 2b: Do the claims recite additional elements that amount to significantly more than the judicial exception? The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. In addition to not integrating the judicial exception, they also fail to add significantly more to the claim over the judicial exception. The steps recite the detecting the SNPs and measuring naturally occurring biomarkers at high levels of generality, indicating that they are relying on well-understood routine and conventional methods for performing such detection and measuring, e.g., sequencing assay.
In view of this, the additional steps are also not considered to add significantly more, either individually or as a combination, to the claim.
In sum, when the relevant steps are analyzed, they weigh against a significant difference. The claims are therefore considered to be directed to a law of nature and an abstract idea recited in the claims without adding significantly more, and are therefore ineligible under 35 USC 101.
Regarding claim 14, the claim recites a further step of assessing gastric motor function of the mammal. The claim is also recited at a high level of generality and does not constitute and/or considered to add significantly more to the claim.
Regarding claim 16, the claim further recites an abstract step of assessing a delay in gastric emptying compared to a control for directing the mammal for treatment with the GLP-1 agonists. The claim is recited at a high level of generality and does not constitute and/or considered to add significantly more to the claim.
Accordingly, claims 1, 14, and 16 do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 12-14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Acosta (U.S. 2021/0072259- previously cited).
Acosta teaches methods and materials for assessing and/or treating obese mammals (e.g., obese humans). For example, methods and materials for using one or more interventions (e.g., one or more pharmacological interventions) to treat obesity and/or obesity-related comorbidities in a mammal (e.g., a human) identified as being likely to respond to a particular intervention (e.g., a pharmacological intervention) (abstract). Acosta teaches a method for treating obesity and/or one or more obesity-related co- morbidities in a mammal, the method comprising:(a) detecting the presence of a plurality of single nucleotide polymorphisms (SNPs) in a sample obtained from a mammal suffering from obesity, wherein the plurality of SNPs; and (b) administering a GLP-1 agonist to the subject when the plurality of SNPs are detected in the sample from the mammal, thereby treating the obesity and/or the one or more obesity-related co-morbidities (e.g., paras. [0008]-[0009]). Assays include mass spectrometry (e.g., triple-stage quadrupole mass spectrometry coupled with ultra-performance liquid chromatography (UPLC)), radioimmuno assays, and enzyme-linked immunosorbent assays can be used to determine the presence, absence, or level of one or more analyte in a sample (para. [0042]). SNPs include but are not limited to rs7903146, rs17782313, and rs3813929 (paras. [0008], [0011], [0040], Tables 3, 6, 8). Examiner expressly notes that the instant claims allow for any combination of the recited SNPs. Pharmacotherapy includes GLP-1 agonists, e.g., liraglutide (para. [0052], [0054], Table 1). Acosta discloses obesity phenotypes e.g., paras. [150]-[0171].
Accordingly, the limitations of instant claims 1, 12 and 13 are satisfied. Regarding claims 14 and 16, Acosta further teaches assessing gastric motor function of the mammal, e.g. measuring gastric emptying (e.g., paras [0159]-[0179], Example 4). Acosta discloses that compared to placebo, liraglutide and exenatide delayed gastric emptying of solids (e.g., paras. [0165]-[0170]).
Relevant Art not Relied Upon
Winter et al. (Obes Facts 4:290-296 (2011)- cited in IDS filed 5/27/2026). teach that 379 consecutive patients (BMI: Men: 28.0±3.7; Women: 28.6±6.5) with stroke/transient ischemic attacks (TIA) and 379 healthy population-based controls were recruited. Single-nucleotide polymorphisms (SNPs) rs9937053 (FTO), rs2229616 (MC4R V103I), s17782313 (188kb downstream of MC4R), and rs7903146 (TCF7L2) were evaluated for association with stroke using logistic regression analyses (abstract). The observed trends of obesity risk alleles for risk of stroke/TIA as well as the possible sex-specific differences in clinical outcomes are found for the TCF7L2 (rs7903146) (abstract). The association of the common genetic variants of FTO and MC4R with BMI was shown in large-scale genetic studies. The TCF7L2 polymorphism rs7903146 is associated with T2DM; interestingly, this major T2DM risk allele is also weakly negatively associated with obesity (p. 291). Genomic DNA was isolated from EDTA- anticoagulated blood using standard procedures (page 290, left col., Summary; page 292, Table 1; page 291, right col., para. 2).
Conclusion
Claims 1, 12-14, 16, 18, 29, 30, 37, 38, 40-42, 48, and 66-71 are pending. Claims 18, 29, 30, 37, 38, 40-42, 48, and 66-71 are withdrawn.
Claims 1, 12-14, and 16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
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