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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 17 April 2026 is acknowledged.
Claims 3-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim.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 17 April 2026.
The Examiner notes that Applicant’s remarks included comments regarding the requirement for restriction; as the election was made without traverse these comments are moot.
Specification
The extraordinarily lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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, 2, and 12-24 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “if the criteria are met”, and the claim also recites “optionally, if the criteria are not met” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 recites “if the criteria are met”; there is no antecedent basis for “the criteria” in the claim. It is unclear if “the criteria” refers to either of situation (1) or (2), or both, or some other criteria. Clarification is required.
Claim 12 recites “PLD” without identifying what this might stand for; claim 1, from which this depends, refers to “partial lipodystrophy” but does not indicate that it can be abbreviated as PLD. Clarification is required.
Claim 12 recites “having a pre-test probability of greater than or equal to about 0.7% or greater than or equal to about 1 in 142” but does not identify what this is a probability of. Clarification is required.
Claim 13 recites “LEPR agonist” without identifying what this might abbreviate; it is entirely unclear what an LEPR agonist might be. Clarification is required.
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.
Claim(s) 1, 2, and 12-24 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “determining (1) if (i)….”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. No additional elements are present in the claim as it is directed entirely to a mental comparison of data to a threshold. Therefore, no elements are present to add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2 and 12-24 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Claims 2, 12, 15, 16, 19, 20 merely recite inherent characteristics of a subject; claims 13, 14, 18, 21-24 are generally directed to providing a treatment but do not satisfy the requirements for particularity (see the Office’s 101 example 43); claim 17 is directed to the insignificant extrasolution activity of data gathering which is not positively recited as being performed as part of the method itself. Thus, claim(s) 1, 2, and 12-24 is/are rejected under 35 U.S.C. 101.
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, 2, 12, 15, 16, 17, 19, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Godoy-Matos (Godoy-Matos, A.F., Moreira, R.O., Valerio, C.M., Mory, P.B. and Moises, R.S. (2012), A New Method for Body Fat Evaluation, Body Adiposity Index, Is Useful in Women With Familial Partial Lipodystrophy. Obesity, 20: 440-443.).
Regarding claim 1, Godoy-Matos discloses a method for determining whether a subject has or is likely to have partial lipodystrophy comprising determining:
if (i) total body fat percentage is less than or equal to about 36%;and (ii) (trunk/leg fat percent ratio)-(0.0311 X total body fat percentage) > about 0.232 (see abstract, Results, Discussion; in particular Table 1 shows subjects having partial lipodystrophy with total body fat percentage less than or equal to about 36% and, using the data from the table, (trunk/leg fat percent ratio)-(0.0311 X total body fat percentage) = 1.86 – (0.0311x19.4) = 1.86-0.60334 = 1.25666, which is greater than 0.232)
wherein, if the criteria are met, the subject has or is likely to have partial lipodystrophy (abstract, results, discussion).
Regarding claim 2, Godoy-Matos further discloses that the subject is a female (abstract).
Regarding claim 12, Godoy-Matos further discloses that the subject is in a population of individuals in which the clinician notices an altered fat distribution (“Body fat analysis” section).
Regarding claim 15, Godoy-Matos further discloses that partial lipodystrophy is familial partial lipodystrophy (FPLD) (Abstract).
Regarding claim 16, Godoy-Matos further discloses that the partial lipodystrophy is familial partial lipodystrophy (FPLD) which is FPLD1, FPLD2, FPLD3, FPLD4, FPLD5, FPLD6 or FPLD7 (Abstract).
Regarding claim 17, Godoy-Matos further discloses that said fat percentages are determined by Dual-energy X-ray Absorptiometry using a 3-compartment model (abstract).
Regarding claim 19, Godoy-Matos further discloses that the subject suffers from one diabetes (“Results”)
Regarding claim 20, Godoy-Matos further discloses that the subject has a homozygous or heterozygous mutation in the LMNA, PPARG, PLIN1, AKT2, LIPE, CIDEC, ZMPSTE24, PIK3R1, ANDRA2A, CAVi, PCYTJA, PSMB8, WRN, POLD1, and/or the BLM gene (“Participants” section).
Claim Rejections - 35 USC § 103
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.
Claim(s) 13, 14, 18, 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Godoy-Matos in view of Gromada (US 2019/0309079).
Regarding claim 13, Godoy-Matos discloses determining whether the subject has or is likely to have partial lipodystrophy by the method of claim 1, as set forth above, but does not disclose if the subject has partial lipodystrophy or is likely to have lipodystrophy, then administering, to the subject, an effective amount of LEPR agonist. Gromada teaches a method of administering an “effective” amount of LEPR agonist to a subject that is determined to have or is likely to have lipodystrophy (abstract; paragraphs [0037]-[0038]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Godoy-Matos and further included administering an “effective” amount of LEPR agonist upon determination of lipodystrophy, as taught by Gromada, in order to improve the subject’s condition.
Regarding claim 14, Godoy-Matos discloses determining whether the subject has or is likely to have partial lipodystrophy by the method of claim 1, as set forth above, but does not disclose a method of treating the partial lipodystrophy in the subject in need thereof comprising administering a therapeutically effective amount of LEPR agonist to the identified subject. Gromada teaches a method of administering a “therapeutically effective” amount of LEPR agonist to a subject that is determined to have or is likely to have lipodystrophy (abstract; paragraphs [0037]-[0038]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Godoy-Matos and further included administering a “therapeutically effective” amount of LEPR agonist upon determination of lipodystrophy, as taught by Gromada, in order to improve the subject’s condition.
Regarding claim 18, Gromada’s LEPR agonist is an isolated agonist antibody or antigen-binding fragment that binds specifically to LEPR (paragraph [0002]).
Regarding claim 21, Gromada’s LEPR agonist is an isolated agonist antibody or antigen-binding fragment that binds specifically to LEPR (paragraph [0002])comprising: (i) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 2; (ii) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 18; (iii) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 26; (iv) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 34; (v) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 42; (vi) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 50; (vii) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 58; (viii) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 66; (ix) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 74; (x) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 90; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 82; (xi) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 90; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 98; or (xii) a light chain variable region that comprises the LCDR1, LCDR2 and LCDR3 of a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 90; and a heavy chain variable region that comprises the HCDR1, HCDR2 and HCDR3 of a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 106; or an antibody or antigen-binding fragment that binds to the same epitope as any one or more of (i)- (xii) and/or competes for binding to LEPR with any one or more of (i)-(xii) (paragraphs [0007]-[0009]).
Regarding claim 22, Gromada’s LEPR agonist is an isolated agonist antibody or antigen-binding fragment that binds specifically to LEPR comprising: (i) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 2; (ii) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 18; (iii) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 26; (iv) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 34; (v) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 42; (vi) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 50; (vii) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 58; Amendment Dated: April 17, 2026 Reply to: February 17, 2026 Restriction Requirement (viii) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 66; (ix) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 10; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 74; (x) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 90; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 82; (xi) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 90; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 98; or (xii) a light chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 90; and a heavy chain variable region that comprises the amino acid sequence set forth in SEQ ID NO: 106; or is an antibody or antigen-binding fragment that binds to the same epitope as any one or more of (i)-(xii) and/or competes for binding to LEPR with any one or more of (i)-(xii) or is mibavademab (paragraphs [0007]-[0009]).
Regarding claim 23, Gromada further teaches further administering, to the subject, a further therapeutic agent in association with the LEPR agonist (paragraph [0056]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Godoy-Matos, as modified by Gromada above, and further included administering a further therapeutic agent in association with the LEPR agonist, as further taught by Gromada, in order to improve the effectiveness of the therapy.
Regarding claim 24, Gromada’s further therapeutic agent is recombinant human leptin; metreleptin; a PCSK9 inhibitor; an anti-PCSK9 antibody or antigen-binding fragment thereof; alirocumab; evolocumab; bococizumab; lodelcizumab; ralpancizumab; an HMG CoA reductase inhibitor; atorvastatin; rosuvastatin; cerivastatin; pitavastatin; fluvastatin; simvastatin; lovastatin; pravastatin; ezetimibe; insulin; an insulin variant; an insulin secretagogue; metformin; a sulfonylurea; a sodium glucose cotransporter 2 (SGLT2) inhibitor; dapaglifozin; canaglifozin; empagliflozin; a GLP-1 agonist or analogue; exenatide; liraglutide; lixisenatide; albiglutide; dulaglutide; a glucagon (GCG) inhibitor; an anti-GCG antibody; a glucagon receptor (GCGR) inhibitor; an anti-GCGR antibody; a small molecule GCGR antagonist; a GCGR-specific antisense oligonucleotide; an anti-GCGR aptamer; a GCGR spiegelmer; an angiopoietin-like protein (ANGPTL) inhibitor; an anti-ANGPTL3 antibody; an anti-ANGPTL4 antibody; an anti-ANGPTL8 antibody; phentermine; orlistat; topiramate; bupropion; topiramate & phentermine; bupropion & naltrexone; bupropion & zonisamide; pramlintide & metreleptin; lorcaserin; cetilistat; tesofensine; velneperit; fish oil; pioglitazone; setmelanotide; a fibrate; fenofibrate; prednisone; niacin; anticonvulsants; digoxin; coumadin; vitamin D; thyroxine; a thyroid supplement; a vitamin supplement; a calcium supplement; carnitine; coenzyme Q10; an anti-constipation medication; an anti-allergic medication; gabapentin; a narcotic; ketamine; lidocaine; and/or venlafaxine hydrochloride (paragraph [0056]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Valerio (Valerio, C.M., Zajdenverg, L., de Oliveira, J.E.P. et al. Body composition study by dual-energy x-ray absorptiometry in familial partial lipodystrophy: finding new tools for an objective evaluation. Diabetol Metab Syndr 4, 40 (2012)), which discloses determining partial lipodystrophy if a trunk/leg fat percent ratio is greater than about 1.35
Freitas (Freitas, P., Carvalho, D., Santos, A.C. et al. Lipodystrophy defined by Fat Mass Ratio in HIV-infected patients is associated with a high prevalence of glucose disturbances and insulin resistance. BMC Infect Dis 12, 180 (2012)), which discloses determining partial lipodystrophy based on both a trunk/leg fat percent ratio greater than about 1.35 and a total body fat percentage
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/KAREN E TOTH/Examiner, Art Unit 3791
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