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 .
Claim Status
Claims 1-20 are pending. Claims 19-20 were newly added, and claims 17-18 were amended in the Reply filed 8/10/2026. Claims 13-20 are withdrawn as directed to a non-elected species. Claims 1-12 are presently considered.
Election/Restriction
Applicant's election with traverse of the species of “(4) Example 8” in the reply filed on 8/10/2026 is acknowledged. The traversal is on the grounds that “the search and examination burden on the Examiner is not undue” (see Reply filed 8/10/2026 at 9). This is not found persuasive because Applicant does not address or dispute the basis for lack of unity of invention over the prior art (see, e.g., Requirement mailed 4/10/2026 at 5-7), and despite alleging that the search burden is “undue”, fails to identify that the claim scope is limited to obvious variants of BT051 administration methods, but rather admits that the claim scope is “not limited to a particular animal model, dose, or dosing schedule” (see Reply filed 8/10/2026 at 9). Accordingly, the traversal is undue because Applicant fails to dispute the determination of lack of unity of invention and provides arguments supporting the need for a species election without clearly admitting that such different species are obvious variants of one another.
The requirement is still deemed proper and is therefore made FINAL.
The originally elected species is understood to be:
(4) Example 8, administration of BT051, orally, once a day, at 200 mg/kg and 10 mL/kg, for two weeks, to diet-induced obese mice (see, e.g., Spec. filed 10/18/2023 at Example 8 at ¶¶[0201]-[0206]).
The species is identified as improving tolerance and insulin sensitivity diet-induced obese mice (see, e.g., Spec. filed 10/18/2023 at Example 8 at ¶¶[0200]-[0201]). The subjects were given a high-fat diet (see id. at ¶[0202]), and treated with BT051 in PBS, orally, once a day, at 200 mg/kg and 10 mL/kg, for two weeks (see, e.g., Spec. filed 10/18/2023 at Example 8 at ¶¶[0201]-[0206]). The structure of BT051 is understood to be
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(see, e.g., Spec. filed 10/18/2023 at ¶[0142]), which is understood to be CAS Registry No. 2412193-70-3 (11-mer cyclic peptide with sequence AALLVXXXLVL, wherein the X refers to α-aminocapric acid-6, α-aminobutanoic acid-7, sarcosine-8, and wherein alanine-2 is a D-amino acid). Accordingly, at claim 1, L1 is a C2 alkyl group (ethylene), and R is a CH3-O-(CH2CH2O)44-CH2CH2CH2NH-, which is understood to be a PEG with 44 ethylene oxide units coupled with an L2 linker of -CH2CH2CH2NH-, which is understood to be an “unsubstituted heteroalkylene group”. The structure of BT051 is understood to comprise the structure of “Formula IA” as recited at instant claim 7. In addition, it is the Examiner’s understanding that Applicant is alleging that the species is an obvious variant for treatment of humans “for glucose intolerance”, which is understood in view of the elected species to be obesity-induced glucose intolerance associated with diet-induced obesity (see Reply filed 8/10/2026 at 10-11 at bridging ¶).
Although Applicant failed to identify the pending claims that read upon the single, elected species of the invention (see, e.g., Requirement mailed 4/10/2026 at 4 at penultimate ¶), the originally elected species is understood to read upon instant claims 1-12. However, the originally elected species does not read upon instant claims 13-20 because the elected species does not “further comprise” the a “therapeutically effective amount” of “one or more” additional compounds.
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 1-12 are rejected in view of the originally elected species and claims that do not read upon the originally elected species are withdrawn.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/10/2026.
Claims 1-12 are presently considered.
Priority
The priority claim to provisional Application No. 63/177,238 (filed 4/20/2021) is acknowledged.
Information Disclosure Statement
The IDS filed 10/18/2023 is acknowledged and presently considered.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Claim 12 differs from claim 1 only by recitation of intended and expected results, but fails to further limit the claim scope (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not require steps to be performed or by claim language that does not limit a claim to a particular structure). Accordingly, both claims appear to cover the same scope absent clarification that claim 12 amounts to a functional limitation corresponding to a structure/function limitation (Note: Examiner has found no such structure/function relationship has been identified on record commensurate in scope with the claims). 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).
Claim Interpretation
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Claim 1 is representative of the pending claim scope, and is directed to a method “for treating glucose intolerance in a mammalian subject in need thereof” comprising administering (via any route) an unspecified “therapeutically effective amount” of a compound of Formula I as defined in the body of claim 1. The applicable claim interpretations are discussed below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
“Glucose intolerance” is utilized to describe an ill-defined genera of diseases and disorders. More specifically, the specification identifies that it is closely related to “inflammatory stress” (see, e.g., Spec. filed 10/18/2023 at ¶[0003]), and can be “obesity-induced” (see, e.g., Spec. filed 10/18/2023 at ¶[0007]), but the molecular mechanism linking obesity and diabetes is “largely unknown” (see, e.g., Spec. filed 10/18/2023 at ¶[0003]). “Glucose intolerance” appears to include at least “impaired glucose tolerance”, Type 2 diabetes, and is “part of a dysmetabolic syndrome (syndrome X) that includes insulin resistance, hyperinsulinemia, obesity, hypertension, and dyslipidemia” (see, e.g., Spec. filed 10/18/2023 at ¶[0063]). “Variable degrees of glucose intolerance” can be caused by “various genetic defects…insulin action, diseases of the exocrine pancreas, endocrinopathies, drugs, chemical agents, infections, immune disorders, and genetic syndromes” (see, e.g., Spec. filed 10/18/2023 at ¶[0066]), and is disclosed as associated with numerous diseases and disorders (see, e.g., Spec. filed 10/18/2023 at ¶¶[0063]-[0073], instant claim 10). Accordingly, numerous patient populations would reasonably be understood to be “at risk” of glucose intolerance.
“Mammalian subject” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0053]) and is understood to include human and non-human mammals.
“Subject in need thereof” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0053]), and is understood as follows:
A subject "in need" of treatment according to the methods and/or compositions of the present technology includes
a subject that is "suffering" from glucose intolerance and/or diseases or disorders associated with glucose intolerance, or inflammation . . . . and
a subject "at risk" of glucose intolerance and/or diseases or disorders associated with glucose intolerance, or inflammation.
(see, e.g., Spec. filed 10/18/2023 at ¶[0053], spacing altered for clarification of two included subgroups). Accordingly, a “subject in need thereof” is understood to include patients having a disease or disorder and also patients “at risk” of having such diseases and disorders.
“Administering” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0032]), and is understood to include prophylactic administration “before the disease and/or one or more symptoms of the disease are detectable”, and “therapeutic administration” (after the disease and/or one or more symptoms are detectable”) (see id).
“For treating” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0050]), and includes:
(i) inhibiting a disease or disorder, i.e., arresting its development; (ii) relieving a disease or disorder, i.e., causing regression of the disorder; (iii) slowing progression of the disorder; and/or (iv) inhibiting, relieving, or slowing progression of one or more symptoms of the disease or disorder.
(see id.). This is pertinent because “inhibiting a disease or disorder” with a prophylactic administration “before the disease and/or one or more symptoms of the disease are detectable” (see, e.g., Spec. filed 10/18/2023 at ¶[0032]) would be understood to be a “cure” that completely prevents the disease or disorder from developing (see, e.g., Spec. filed 10/18/2023 at ¶[0050]).
“Therapeutically effective amount” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0037]), and is understood to be functionally defined as referring
to a quantity sufficient to achieve a desired therapeutic and/or prophylactic effect, e.g., an amount which results in the full or partial amelioration of glucose intolerance or disease or disorders or symptoms associated with glucose intolerance in a subject in need thereof
(see id), which is identified as depending upon the “type and severity of the disease and on the characteristics of the individual, such as general health, age, sex, body weight and tolerance to drugs” and also “degree, severity and type of disease” (see id). The amount required to be therapeutically effective in all patient populations recited at claim 10 are not identified, but are instead left for artisans to figure out (see id., alleging that “The skilled artisan will be able to determine appropriate dosages”).
“Diet-induced obesity” at claim 11 is understood to be clinical obesity caused by, for example, a high-fat diet (see, e.g., Spec. filed 10/18/2023 at ¶[0202]). However, if “diet-induced obesity” is meant to be utilized to refer to a specific type of “obesity” defined as result of a process (i.e., “high-fat diet”), wherein such language excludes some forms of obesity caused by other “diets” that may or may not be characterizable as “high-fat”, Examiner notes that such language may be intended to limit the patient population by process language nested with a method of treatment. This is pertinent because such language would be analogous to product-by-process language, and the proper analysis of product-by-process language nested within a method of treatment has been directly addressed by the Federal Circuit in Biogen MA Inc. v. EMD Serono, Inc. (976 F.3d 1326, 2020 U.S.P.Q.2d 11129 (Fed. Cir. 2020); hereafter “Biogen”). The Court in Biogen specifically identified that
...a source limitation alone cannot confer novelty unless the product itself is novel.
(see, e.g., Biogen at 1332);
The nesting of the product-by-process limitation within a method of treatment claim does not change the proper construction of the product-by-process limitation itself.
(see, e.g., Biogen at 1334); and
There is no logical reason why the nesting of a product-by-process limitation within a method of treatment claim should change how novelty of that limitation is evaluated.
(see, e.g., Biogen at 1334).
The Court explained that not applying product-by-process analysis to method claims
....could have the absurd result that a recombinant composition could be non-novel, the method of administration could be non-novel, but the method of administration of the composition defined by the process of its manufacture would be novel as a matter of law.
(see, e.g., Biogen at 1334).
Accordingly, to the extent that “diet-induced obesity” is utilized to refer to a specific obesity defined as result of a process (i.e., high-fat diet), the language is interpreted consistent with the guidance at MPEP § 2113. Critically, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself” (see, e.g., MPEP § 2113). Accordingly, the nested product-by-process limitations pertaining to the source of a material used within the method of the independent claim are presently understood to be fully satisfied by any prior art pharmaceutical product satisfying the structure implied by the product-by-process language at the instant claims. Here, at most, the structure implied by the product-by-process language of instant claims include “obesity”. Therefore, any prior art teaching the process and pharmaceutical product of claim 1, wherein any “obese” patients are treated, is reasonably inferred to fully satisfy the analogous product-by-process limitations set forth at instant claim 11. This is reasonable because “diet-induced” obesity is not defined, and diet is presumably at least one factor in all forms of obesity.
Claim 12 recites a “wherein” clause, namely
…wherein treatment comprises one or more of improved glucose tolerance, improved insulin sensitivity, and increased plasma glucagon-like peptide 1 (GLP-1) levels as compared to untreated control subjects.
Notably, these phrases do not correspond to any particular structure/function relationship of record commensurate in scope with the instant claims, and therefore this “wherein” clause is understood to be a recitation of intended and expected results, fully satisfied by all embodiments that satisfy the steps and structural limitations set forth in the body of claim 1 (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not require steps to be performed or by claim language that does not limit a claim to a particular structure). In the absence of any evidence that such “wherein” clauses further limit any steps or structures of claim 1 in a meaningful, ascertainable manner, such limitations are therefore understood to be non-limiting recitations of intended and expected results fully satisfied by any embodiment satisfying the structures and steps of instant claim 1.
Additional claim interpretations are disclosed below.
Claim Rejections
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 1-12 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 phrase regarding L1 that it may be “optionally substituted with one or more F”. Here “F” is undefined, and it is unclear if Applicant is referring to an undefined functional group (e.g., like an R or L1 moiety), if “F” refers to fluorine, or if “F” refers to Phenylalanine residues. Because there are multiple potential interpretations that impact the claim scope, and it is unclear which interpretation is correct, the claim scope is rendered indefinite. For purposes of applying prior art, the optional substituents are not considered limiting per MPEP §2111.04(I) (noting that optional language does not limit claim scope).
Claim 1 recites and requires a “therapeutically effective amount”, but identifies and admits that this term is a functional limitation that may vary depending upon multiple factors (see, e.g., Spec. filed 10/18/2023 at ¶[0037]). This is problematic because it is prima facie unknown what “amounts” of a particular species of Formula I or IA are “therapeutically effective” and therefore included or not “therapeutically effective” and therefore excluded by the pending claim scope. Per MPEP § 2173.05(g),
[T]he use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. . .
Here, the claims merely recite a description of functions or results to be achieved by the invention rather than a description of the structures and amounts actually capable of achieving the desired functions, and therefore the claims are indefinite per MPEP § 2173.05(g). This is reasonable because MPEP § 2173 identifies that the primary purpose of the requirement is to inform the public of the boundaries of what constitutes infringement of the patent, but here it is unclear what amounts of a particular species of Formula I or IA in a particular patient population is “therapeutically effective” and therefore infringes upon the scope of the pending claims. As admitted in the original disclosure, the amount encompassed by this term may vary depending upon multiple unspecified factors (see, e.g., Spec. filed 10/18/2023 at ¶[0037], noting that the “effective amount” varies on agent, sex, weight, drug tolerance, severity of disease, type of disease, etc.), which means the interpretation of “therapeutically effective” may vary from artisan to artisan. Notably, the amount is therefore unknown, but admittedly variable (see id), and therefore renders the claim indefinite (see, e.g., MPEP § 2173.05(b)). Accordingly, the metes and bounds of claim 1 are indefinite due to the usage of ill-defined, but variable functional limitations, which are associated with an ill-defined and vast patient population “in need thereof” for treatment (including prophylactic treatment) of “glucose intolerance”. Furthermore, close prior art exists (see rejection below under 35 USC 103, in view of WO2020041378A1, and in the absence of clarification, it is unclear how the concentration ranges of WO’378 differ (if at all) from the “therapeutically effective” amounts presently claimed.
Claim 3 depends from claim 1, which recites Formula I, which varies at positions R, L1, optional positions L2, and optional substitutions “F” (see, e.g., instant claim 1); however, claim 3 confusingly recites and defines “R”, but not L1, or L2 (or optional substitutions “F”), but after identifying the R, claim 3 recites parentheticals ostensibly referring to “BT051”, “BT090”, and “BT070”. This is confusing because it is unclear if claim 3 is defining all positions and limiting the scope of claim 3 to only the three exact compounds of “BT051”, “BT090”, and “BT070”; or alternatively if claim 3 is defining only position R and permitting L1, L2, and optional substitutions “F” to vary in structure. Accordingly, claim 3 is rejected as indefinite because it is unclear if the parentheticals amount to exemplary language, or if the parentheticals are provided as required limitations, and therefore the proper interpretation of the parentheticals substantially alters the pending claim scope (see, e.g., MPEP § 2173.05(d)).
Claims 1-12 depend directly or indirectly from an indefinite base claim, but fail to reconcile or clarify the indefiniteness of the base claim. Accordingly, claims 1-12 are rejected for the reasons applied to claim 1, above.
Accordingly, claims 1-12 are rejected.
Claim Rejections - 35 USC § 112(a), Written Description
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 1-12 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 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.
Brief Statement of the Issue(s)
The claims recite methods of “treating glucose intolerance in a mammalian subject in need thereof” (i.e., a functionally-defined genus of diseases and disorders) by administering a functionally-defined “therapeutically effective amount” of a compound, wherein “therapeutically effective” including prophylactically inhibiting unspecified signs and symptoms of such diseases.
Claim Scope
Claim 1 is representative of the pending claims scope and recites a method of “treating glucose intolerance in a mammalian subject in need thereof” (see claim 1), wherein the terms and scope are understood as follows:
“For treating” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0050]), and broadly includes:
(i) inhibiting a disease or disorder, i.e., arresting its development; (ii) relieving a disease or disorder, i.e., causing regression of the disorder; (iii) slowing progression of the disorder; and/or (iv) inhibiting, relieving, or slowing progression of one or more symptoms of the disease or disorder.
(see id.). This is pertinent because “inhibiting a disease or disorder” with a prophylactic administration “before the disease and/or one or more symptoms of the disease are detectable” (see, e.g., Spec. filed 10/18/2023 at ¶[0032]) would be understood to include be a “cure” that may completely prevent the disease or disorder from developing (see, e.g., Spec. filed 10/18/2023 at ¶[0050]).
“Glucose intolerance” is utilized to describe an ill-defined but vast genera of highly varied diseases and disorders. “Glucose intolerance” appears to include at least “impaired glucose tolerance”, Type 2 diabetes, and is “part of a dysmetabolic syndrome (syndrome X) that includes insulin resistance, hyperinsulinemia, obesity, hypertension, and dyslipidemia” (see, e.g., Spec. filed 10/18/2023 at ¶[0063]). Critically, “Variable degrees of glucose intolerance” can be caused by “various genetic defects…insulin action, diseases of the exocrine pancreas, endocrinopathies, drugs, chemical agents, infections, immune disorders, and genetic syndromes” (see, e.g., Spec. filed 10/18/2023 at ¶[0066]), and is disclosed as associated with numerous diseases and disorders (see, e.g., Spec. filed 10/18/2023 at ¶¶[0063]-[0073], instant claim 10). Accordingly, presumably patients “in need thereof” of the claimed treatment include patient with “variable degrees of glucose intolerance” caused by “drugs” (unspecified), “chemical agents” (unspecified), “infections” (unspecified), “genetic defects” (unspecified), and “immune disorders” (unspecified). Accordingly, numerous patient populations would reasonably be understood to have or otherwise be “at risk” of “glucose intolerance”.
“Mammalian subject” include human and non-human mammals (see, e.g., Spec. filed 10/18/2023 at ¶[0053]).
“Subject in need thereof” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0053]), and is understood as follows:
A subject "in need" of treatment according to the methods and/or compositions of the present technology includes
a subject that is "suffering" from glucose intolerance and/or diseases or disorders associated with glucose intolerance, or inflammation . . . . and
a subject "at risk" of glucose intolerance and/or diseases or disorders associated with glucose intolerance, or inflammation.
(see, e.g., Spec. filed 10/18/2023 at ¶[0053]). Accordingly, a “subject in need thereof” is understood to include patients having a disease or disorder and also patients “at risk” of having such diseases and disorders, wherein such “diseases and disorders” include patients having or at risk of having “variable degrees of glucose intolerance” caused by “drugs” (unspecified), “chemical agents” (unspecified), “infections” (unspecified), “genetic defects” (unspecified), and “immune disorders” (unspecified) (see, e.g., Spec. filed 10/18/2023 at ¶[0066]; see also id. at ¶¶[0063]-[0073], claim 10).
“Administering” includes timing and numerous routes of administration (see, e.g., Spec. filed 10/18/2023 at ¶[0032], [00128]), including prophylactic administration “before the disease and/or one or more symptoms of the disease are detectable”, and “therapeutic administration” (after the disease and/or one or more symptoms are detectable”) (see, e.g., Spec. filed 10/18/2023 at ¶[0032]).
“Therapeutically effective amount” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0037]), and is understood to be functionally defined as referring
to a quantity sufficient to achieve a desired therapeutic and/or prophylactic effect, e.g., an amount which results in the full or partial amelioration of glucose intolerance or disease or disorders or symptoms associated with glucose intolerance in a subject in need thereof
(see id), which is identified as depending upon the “type and severity of the disease and on the characteristics of the individual, such as general health, age, sex, body weight and tolerance to drugs” and also “degree, severity and type of disease” (see id). The amount required to be therapeutically effective in all patient populations recited at claim 10 are not identified, but are instead left for artisans to figure out (see id., alleging that “The skilled artisan will be able to determine appropriate dosages”).
Additional applicable claim interpretations have been set forth above under 35 USC 112(b) and in a separate claim interpretation section. Those discussions are incorporated herein.
In sum, the scope of the pending claims is ill-described because it is unclear what patients are “in need thereof” or not in view of the functional descriptions of the patient populations, and the scope of the pending claims is ill-defined because it is unclear what amounts of a particular compound are “therapeutically effective amounts” for the treatment (e.g., including prophylactic treatment resulting in inhibition of all symptoms of a disease) of patients with asthma, COPD, Alzheimer’s disease, cancers, Klinefelter Syndrom, PCOS, cirrhosis, etc., etc. as instantly claimed.
Therefore, it is unclear if the claimed methods encompass trillions of species of treating (and curing) numerous diseases, via all forms of administration (e.g., topical, anal, oral, intramuscular, intravenous, etc.), at any possible dosage (e.g., 0.000001 ng/kg or less, up to 1 or more kg/kg), or if the claimed methods include only one or two treatable symptoms in a limited patient population and via limited routes of administration and at specific dosages. Accordingly, the claim scope appears to be vast and highly varied.
Actual Reduction to Practice
The originally-filed disclosure provided four highly similar examples of the claimed, in vivo methods, namely:
Example 4, administration of BT090, orally, at 10 mg/kg at a dose rate of 10 mL/kg at t=0 h, to fasted Sprague-Dawley rat (see, e.g., Spec. filed 10/18/2024 at Example 4 at ¶¶[0l68]-[0l71]);
Example 4, administration of BT051, orally, at 10 mg/kg at a dose rate of 10 mL/kg at t=0 h, to fasted Sprague-Dawley rat (see, e.g., Spec. filed 10/18/2024 at Example 4 at ¶¶[0l68]-[0l71]);
Example 4, administration of BT070, orally, at 10 mg/kg at a dose rate of 10 mL/kg at t=0 h, to fasted Sprague-Dawley rat (see, e.g., Spec. filed 10/18/2024 at Example 4 at ¶¶[0l68]-[0l71]); and
Example 8, administration of BT051, orally, once a day, at 200 mg/kg and 10 mL/kg, for two weeks, to diet-induced obese mice (see, e.g., Spec. filed 10/18/2024 at Example 8 at ¶¶[0201]-[0206]).
Accordingly, only one route of administration was tested (oral), only two dosages were tested (10 mg/kg and 200 mg/kg), the only mammals treated were rodents, and only three compounds of Formula I or IA were tested or reduced to practice, wherein the three compounds only differ with respect to the R moiety of Formula I or IA.
Zero examples of therapeutically treating or prophylactically treating any “glucose intolerance” caused by “various genetic defects…insulin action, diseases of the exocrine pancreas, endocrinopathies, drugs, chemical agents, infections, immune disorders, and genetic syndromes” (see, e.g., Spec. filed 10/18/2023 at ¶[0066]; see also id. at ¶¶[0063]-[0073], instant claim 10) were tested or reduced to practice other than diet-induced obesity using 200 mg/kg and 10 mL/kg for two weeks (see, e.g., Spec. filed 10/18/2024 at Example 8 at ¶¶[0201]-[0206]).
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including type 2 diabetes mellitus was reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including type 1 diabetes mellitus was reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including gestational diabetes mellitus was reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including neonatal diabetes was reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including maturity-onset diabetes of the young were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including drug-induced diabetes was reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including chemical-induced diabetes were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including hyperglycemia were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including impaired glucose tolerance (IGT) were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including “impaired fasting glucose (IFT)” were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including “insulin resistance” were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including “metabolic syndrome” were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including asthma were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including chronic obstructive pulmonary disease (COPD) were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including Alzheimer's disease were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including cancers were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including Klinefelter Syndrome were reduced to practice.
Zero examples of treatment (prophylactic or otherwise) of any patients having “one or more diseases” including Turner Syndrome, Wolfram Syndrome, Cystic Fibrosis, Friedreich's ataxia, multiple sclerosis, down syndrome, muscular dystrophy, polycystic ovary syndrome (PCOS), uremia, cirrhosis, chronic renal failure, or HAART-treated HIV infection were reduced to practice.
Zero examples of a “therapeutically effective amount” of any compound sufficient to
Result[] in the full or partial amelioration of glucose intolerance or disease or disorders or symptoms associated with glucose intolerance in a subject in need thereof
(see, e.g., Spec. filed 10/18/2023 at ¶[0037]) “before the disease and/or one or more symptoms of the disease are detectable” (see, e.g., Spec. filed 10/18/2023 at ¶[0032]) was reduced to practice.
These statements are not exhaustive, but illustrate that the claim scope is substantially and materially broader than the limited reduction to practice provided on the instant record.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus (see, e.g., MPEP § 2163(II)(3)(a), MPEP §2163.03(V)). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. In this case, the claims encompass an essentially infinite number of methods of treating subjects having (or at risk of having) any form or level of “glucose intolerance” associated with myriad diseases and conditions, by administering a compound via an unspecified route an in an unspecified “therapeutically effective amount” sufficient to achieve an unspecified beneficial outcome, but the record provides limited supporting evidence in the form of reductions to practice, wherein zero embodiments of the claimed methods were actually reduced to practice wherein any patient was treated (prophylactically or otherwise) having “one or more diseases” including type 2 diabetes mellitus, type 1 diabetes mellitus, gestational diabetes mellitus, neonatal diabetes, maturity-onset diabetes of the young, drug-induced diabetes, chemical-induced diabetes, hyperglycemia, impaired glucose tolerance (IGT), “impaired fasting glucose (IFT)”, “insulin resistance”, “metabolic syndrome”, asthma, chronic obstructive pulmonary disease (COPD), Alzheimer's disease, cancers, Klinefelter Syndrome, Turner Syndrome, Wolfram Syndrome, Cystic Fibrosis, Friedreich's ataxia, multiple sclerosis, down syndrome, muscular dystrophy, polycystic ovary syndrome (PCOS), uremia, cirrhosis, chronic renal failure, or HAART-treated HIV infection, using any “therapeutically effective amount” of any compound via any route of administration.
Although the MPEP does not define what constitutes a sufficient number of representative species, the Courts have indicated that the disclosure of zero species within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d at 1012, 10 USPQ2d at 1618. Similarly, the disclosure of zero examples of any methods of treating any subjects using any compound at any “therapeutically effective amount” via any route of administration, wherein the subject was treated (prophylactically or otherwise) and described as having (or at risk of having) “one or more diseases” including type 2 diabetes mellitus, type 1 diabetes mellitus, gestational diabetes mellitus, neonatal diabetes, maturity-onset diabetes of the young, drug-induced diabetes, chemical-induced diabetes, hyperglycemia, impaired glucose tolerance (IGT), “impaired fasting glucose (IFT)”, “insulin resistance”, “metabolic syndrome”, asthma, chronic obstructive pulmonary disease (COPD), Alzheimer's disease, cancers, Klinefelter Syndrome, Turner Syndrome, Wolfram Syndrome, Cystic Fibrosis, Friedreich's ataxia, multiple sclerosis, down syndrome, muscular dystrophy, polycystic ovary syndrome (PCOS), uremia, cirrhosis, chronic renal failure, or HAART-treated HIV infection, does not describe that subgenus.
Accordingly, the limited reductions to practice of the claimed invention does not provide sufficient disclosure to satisfy the written description requirement for the instantly claimed genus.
Identifying characteristics of the genus
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
However, the instant specification provides limited guidance permitting an artisan to meaningfully identify the claimed invention, which does not weigh in favor of a determination that applicant was “in possession of the claimed genus”:
The patient population at issue is ill-defined, such that an artisan could not meaningfully distinguish a “mammalian subject in need thereof” from a “mammalian subject” that was NOT “in need thereof”. This is because the patient population is functionally defined as including any subject “in need thereof” including patients having unspecified diseases or disorders and also patients “at risk” of having unspecified diseases and disorders, wherein such unspecified “diseases and disorders” ostensibly include patients having or at risk of having “variable degrees of glucose intolerance” caused by “drugs” (unspecified), “chemical agents” (unspecified), “infections” (unspecified), “genetic defects” (unspecified), and “immune disorders” (unspecified) (see, e.g., Spec. filed 10/18/2023 at ¶[0066]; see also id. at ¶¶[0063]-[0073], claim 10). This raises substantial concerns, such as “what infections cause ‘glucose intolerance’ within the scope of the claimed invention?”; “what drugs cause ‘glucose intolerance’ within the scope of the claimed invention?”; “what chemical agents cause ‘glucose intolerance’ within the scope of the claimed invention?”; “what immune disorders cause ‘glucose intolerance’ within the scope of the claimed invention?; “what genetic defects cause ‘glucose intolerance’ within the scope of the claimed invention?”. These questions are not addressed.
The “therapeutically effective amount” required is not defined, but is instead left up to future artisans to “discover”: The term “therapeutically effective amount” is interpreted in view of the description provided in the original disclosure (see, e.g., Spec. filed 10/18/2023 at ¶[0037]), and is understood to be functionally defined as referring
to a quantity sufficient to achieve a desired therapeutic and/or prophylactic effect, e.g., an amount which results in the full or partial amelioration of glucose intolerance or disease or disorders or symptoms associated with glucose intolerance in a subject in need thereof
(see id). However, it is prima facie unknown what specific “symptoms” are being referenced. Furthermore, the original disclosure admits that the “therapeutically effective amount” depends upon multiple factors including the “type and severity of the disease and on the characteristics of the individual, such as general health, age, sex, body weight and tolerance to drugs” and also “degree, severity and type of disease” (see id). However, zero structure/function relationships or suitable ranges of concentrations expected and predicted to be “therapeutically effective” for a particular patient population. Rather, after admitting that a “therapeutically effective amount” required to practice the Applicant’s claimed invention depends on may factors, the specification places the burden of discovering the metes and bounds of Applicant’s invention to future artisans to discover and “figure out” (see, e.g., Spec. filed 10/18/2023 at ¶[0037], alleging that “The skilled artisan will be able to determine appropriate dosages”).
Accordingly, the originally filed disclosure provides little guidance in the way of identifying “therapeutically effective amounts” of compounds of formula I or IA, for any particular patient population, and furthermore the originally filed disclosure provides little guidance permitting artisans to meaningfully identify and distinguish among patients “in need thereof” and patients that are not “in need thereof”.
Zero disclosure regarding what does or does not constitute an “therapeutically effective amount” for any specific disease or disorder was provided on record other than diet-induced obesity. At best, the originally filed disclosure provides vague and highly generic guidance regarding what they hope and desire an “effective amount” will be able to achieve (see, e.g., Spec. filed 10/18/2023 at ¶[0037]); however, such disclosures fail to meaningfully inform artisans of any usable and specific dosage formulations or dosage ranges that would be capable of satisfying the limitations of the claimed methods. Accordingly, the phrase “therapeutically effective amount” is understood to be utilized only as a vague functional limitation attempting to capture some unknown claim scope that Applicant hopes and desires that the disclosed invention is able to achieve (see, e.g., Spec. filed 10/18/2023 at ¶[0037]); but does not meaningfully relate to a structure/function relationship such that one of ordinary skill in the art is meaningfully made aware of what exact dosages of a specific compound are “effective” to any extent in the treatment of any particular patient population.
Zero disclosure regarding what the successful outcome of a “treatment” or “treating” for any particular species is provided on record, because the outcome is variable and is only identified by reference to unspecified “symptoms” (see, e.g., Spec. filed 10/18/2023 at ¶[0037]). Stated alternatively, it is prima facie unclear what exact outcome is supposed to be achieved by a “therapeutically effective amount” of any particular compound in a particular patient population within the scope of instant claim 1. Accordingly, one of skill in the art would not know if 0.001µg/kg, 0.01g/kg, 1g/kg, 10 g/kg, etc. was included or excluded from the pending claim scope for any particular species of compound for any particular species of method claimed because they would not know what “symptom” to observe (e.g., headaches, back pain, glucose levels, inflammation markers, blood pressure, tumor volume, etc., etc.).
Notably, the basic mechanistic details identified by the Specification explains that the compounds are expected to inhibit N-formyl peptide receptors (FPRs), such as FPR1, which can inhibit inflammation (see, e.g., Spec. filed 10/18/2023 at ¶¶[0003], [0057], [0075], [0099], [0117], [0172]-[0180]). However, regarding how such inhibition relates to “glucose intolerance”, the specification provides little guidance, but instead notes that
Inflammatory stress is closely related to metabolic disease, insulin resistance, and glucose intolerance. Although the precise cellular mechanism linking obesity and diabetes is largely unknown, many obese individuals develop glucose intolerance and chronic inflammation, which are associated with diseases and syndromes including not only obesity, but also diabetes and its complications . . . N-formyl peptides, such as fMet-Leu-Phe (fMLP or fMLF), which act through binding to N-formyl peptide receptors (FPRs) such as FPRI leading to inflammation, have been shown to be altered in conditions associated with glucose intolerance, such as obesity, and can directly impair glucose homeostasis. Hence, inhibition of FPRs, such as FPRI, is an avenue for the treatment or prevention of diseases and conditions associated with glucose intolerance.
(see, e.g., Spec. filed 10/18/2023 at ¶[0003]). Accordingly, although the desired and hoped for patient population appears to be “glucose intolerance”, the actual mechanism of action appears to be inhibition of FPRs to reduce inflammation, wherein the “precise cellular mechanism” linking inflammation to “glucose intolerance” is “largely unknown” and not addressed with specificity. This distinction is pertinent because the prior art already taught and disclosed such methods (see, e.g., WO2020/041378A1 at title, abs, claims; see rejection under 103, below), wherein it was already known and appreciate that “inhibition of FPR1 is an avenue for the treatment or prevention of gliadin-related conditions”, including “diabetes” (see, e.g., WO’378 at abs, ¶¶[0004], [0036], [0070], [0170]-[0178]). Accordingly, the instant disclosure appears to recite “glucose intolerance” as a patient population, but the evidence of record suggests that such patient population merely corresponds to FPR1 inhibition as taught and suggested by the prior art. In the absence of clarification, it is unclear how the pending claim scope actually corresponds to prior art evidence and disclosures, such as WO2020/041378A1. For example, it is unclear if the exact same dosages taught and suggested by WO’378 are identical to the instantly claimed “therapeutically effective amounts” or if the instant claims have distinct concentration ranges relative to WO’378.
Accordingly, basic identifying characteristics pertinent to the claimed genus are left unanswered, including “which compounds can actually treat any particular species of disorder?”, “what concentration of compound is ‘effective’ for any particular species of disorder?”, “what exact outcome constitutes a successful ‘treatment’?, etc.
Predictability in the Art
Although the level of skill in the art is high, the predictability in the clinical arts is low due to the complexity of biological systems, differences in patient populations, differences between species of “glucose intolerance”, concentration effects, administration route effects, dosage frequency effects, and arbitrary metrics defining “success” or “failure” of a treatment among artisans in the absence of what does or does not constitute a “symptom”. Specifically, an artisan would not be able to predict or identify, a priori, and in the absence of any guidance, the minimal, common structures, and “effective” concentrations, of compounds capable of successfully “treating” vastly different conditions of glucose intolerance related to highly different causations (drug, genetic variations, chemical agents, immune disorders, etc), which were not tested or reduced to practice record.
Accordingly, in the absence of sufficient structure/function teachings identifying a “therapeutically effective amount” of any particular compound for the successful treatment of any species of “glucose intolerance”, as required by the claims, an artisan would not reasonably conclude that Applicant possessed the full scope of the broad and highly varied genus of methods recited and encompassed by the instant claims.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789).
The courts have held that a claim to a therapeutic method requiring administration of an “effective” amount of a compound at specific dosage range set forth in the disclosure for the treatment of a broad array of disorders failed to satisfy the Written Description Requirement because the disclosure addressed only “basic research and broad []dosage ranges”, but did not establish possession of a “therapeutically effective [] dose at the time of filing” (see, e.g., Biogen Int'l GmbH v. Mylan Pharm. Inc., 18 F.4th 1333, 1343, 2021 U.S.P.Q.2d 1170, 2021 BL 455178, at *8 (Fed. Cir. 2021). The court clarified that although
An inventor need not "prove that a claimed pharmaceutical compound actually achieves a certain result. But when the inventor expressly claims that result, our case law provides that [such] result must be supported by adequate disclosure in the specification.”
See Biogen Int'l GmbH v. Mylan Pharm. Inc., 18 F.4th 1333, 1343 (Fed. Cir. 2021).
The court further explained that
That Biogen later established the therapeutic efficacy of [a known compound at a specific dosage] is of no import to the written-description analysis. What matters for purposes of the inquiry [*1344] in this case is whether, at the time of filing the disclosure—well before the Phase III study even commenced—a skilled artisan could deduce simply from reading the specification that [a known compound at a specific dosage] would be a therapeutically effective treatment for MS. As to this point, the specification's focus on drug discovery and basic research further buttresses the district court's conclusion that the specification lacks an adequate written description to support the [] claims. . . . the law is clear that a patent cannot be awarded for mere theoretical research without more, see Ariad, 598 F.3d at 1353 . The written-description requirement limits patent protection only to individuals who perform the difficult work of producing a complete and final invention featuring all its claimed limitations and publicly disclose the fruits of that effort.
See Biogen Int'l GmbH v. Mylan Pharm. Inc., 18 F.4th 1333, 1344, 2021 U.S.P.Q.2d 1170, 2021 BL 455178, at *9 (Fed. Cir. 2021); emphasis added
Here, like in Biogen, the Specification is directed to basic research without clear clinical data sharing a nexus with the claims because highly limited embodiments in rodents pertaining only to obesity and oral administration were actually reduced to practice or discussed with specificity. Furthermore, unlike Biogen, here the claims further attempt to draw a fence around the treatment of all possible species of “glucose intolerance”, using all possible “therapeutically effective” concentrations, via all possible routes of administration, in all possible patient populations. Therefore, the instant claims are substantially broader in scope than the claims of Biogen, but the disclosure of the instant Specification appears to provide substantially less guidance than that of the specification at issue in Biogen. Therefore, like Biogen, the instant claims lack written description support because an artisan “simply from reading the specification” could not deduce which compound at what concentration would be “therapeutically effective” for the treatment of any particular symptom of any particular patient having any particular “glucose intolerance”, commensurate in scope with the claims.
Accordingly, claims 1-12 are rejected.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020041378A11.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Additional claim interpretations are set forth below.
WO2020041378A1 pertains to prior art methods of administering the same compounds to the same or overlapping patient populations. More specifically, regarding instant claims 1-7, and the structures of Formula I, Formula IA, and BT051, WO’378 teaches, claims, and directs artisans to the same structures, namely cyclosporine compounds of instant Formula I (compare WO’378 at ¶[0005] with instant claim 1 at Formula I; compare WO’378 at ¶¶[0005]-[0006] with instant claims 2-3; compare WO’378 at ¶¶[0007] with instant claim 4; compare WO’378 at ¶[0008] with instant claims 5; compare WO’378 at ¶¶[0009]-[0010] with instant claim 6; compare WO’378 at ¶[0011] with instant claim 7). More specifically, WO’378 teaches and discloses the cyclosporine compound BT051 (see, e.g., WO’378 at ¶¶[0005]-[0006], [0013]-[0014], [0140], [0146]), wherein BT051 is understood to satisfy instant claims 1-7, wherein L1 is a C2 alkyl group (ethylene), and R is a CH3-O-(CH2CH2O)44-CH2CH2CH2NH-, which is understood to be a PEG with 44 ethylene oxide units coupled with an L2 linker of -CH2CH2CH2NH-, which is understood to be an “unsubstituted heteroalkylene group” (compare instant claims 1-8 with WO’378 at ¶¶[0005]-[0011], [0013]-[0014], [0140]). Accordingly, the cyclosporine of BT-051 is a prior art element. Regarding instant claims 1-8, and the treatment of a patient population by administering a pharmaceutical compound, WO’378 explicitly teaches and discloses methods of administering such compounds to mammalian subjects “in need thereof” of treatment for any “disease associated with neutrophil-mediated inflammation” (see, e.g., WO’378 at claims 1-17); wherein “the compound is formulated as a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier” (compare WO’378 at claim 17 with instant claim 8). Regarding instant claims 1-8 and the routes of administration, WO’378 reasonably informs artisans that “administering” include oral, intravenous, intradermal, intramuscular, subcutaneous, parenteral, and transdermal administration routes (see, e.g., WO’378 at ¶¶[0045], [0126]-[0127]). Regarding instant claims 1-8 and a “therapeutically effective amount, wherein “therapeutically effective amount” is defined (see, e.g., WO’378 at ¶¶[0050]), and includes at least 10 mg/kg at a dose rate of 10 mL/kg (see, e.g., WO’378 at ¶¶[0167]), and 10 µM and 1 µM concentrations (see, e.g., WO’378 at ¶¶[0173]), which are understood to overlap in scope with the effective amounts instantly claimed or implied (see, e.g., MPEP § 2144.05(I), explaining that “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”). Regarding higher or lower concentrations not explicitly exemplified by WO’378, WO’378 identifies that the concentrations utilized may often change (see, e.g., WO’378 at ¶¶[0050]) and identifies the general conditions of the claimed methods; per MPEP § 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". Here, the specific patient populations, administration routes, chemical compounds, and experimental outcomes are disclosed by WO’378, wherein WO’378 identifies that the concentrations utilized may often change (see, e.g., WO’378 at ¶¶[0050]). Accordingly, absence evidence of criticality of range, such differences in concentration are not presumed to be critical, but instead reasonably understood to be routinely optimizable in the art. Regarding instant claim 12 and the “wherein” clause, the “wherein” clause at instant claim 12 is understood to be a recitation of intended and expected results, fully satisfied by all embodiments that satisfy the steps and structural limitations set forth in the body of claim 1 (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not require steps to be performed or by claim language that does not limit a claim to a particular structure). Accordingly, claim 12 is rejected for the reasons applicable to instant claim 1, and is understood to be necessarily and inherently satisfied by all methods that satisfy the active method steps set forth in the body of instant claim 1.
The primary reference differs from the instant claims as follows: WO’378 differs with respect to the instant claims in a single respect, namely WO’378 recites a different functionally-defined patient population relative to the instant claims (i.e., WO’378 claims methods for “treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof”, but the instant claims are ostensibly limited to methods of “treating glucose intolerance in a mammalian subject in need thereof”. Accordingly, the issue is whether or not these two functionally-defined patient populations are sufficient to render the instant claim scope non-obvious.
Regarding instant claims 1, 9-12, and the functionally-defined patient population of patients “in need” of treatment of “glucose intolerance”, including patients having obesity, COPD, and diabetes: Although the metes and bounds of diseases that are or are not characterizable by “glucose intolerance” as presently claimed are ill-described, it is clear that the instant claim scope reads at least upon administering the treatment recited at instant claim 1 to patients having obesity, chronic obstructive pulmonary disease (COPD), and diabetes (see, e.g., instant claims 1 and 9-11). However, this patient population materially and substantially overlaps in scope with the patient populations identified, taught, and claimed by the prior art:
First, WO’378 explicitly teaches that the methods may be utilized to treat chronic obstructive pulmonary disease (COPD) (see, e.g., WO’378 at ¶¶[0018], [0095], claims 18 and 21).
Second, WO’378 identifies that the methods of “treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof” include treating subjects “in need” or “at risk” of “‘suffering’ from inflammation”, wherein inflammation is exemplified by “a subject that is experiencing and/or exhibiting one or more clinical and or subclinical symptoms of inflammation” (see, e.g., WO’378 at ¶[0067]), and wherein a “subject ‘at risk’ of inflammation” includes “a subject that is not currently exhibiting inflammation symptoms and is predisposed to expressing one or more symptoms” (see id). This is pertinent because WO’378 explicitly identifies and discloses that diabetes and obesity are characterized by inflammation (see, e.g., WO’378 at ¶[0003]), and that gliadin “acts as a neutrophil chemoattractant”, and that gliadin is implicated in diabetes (see, e.g., WO’378 at ¶[0004]). This is pertinent because the patient population of WO’378 encompasses any non-infectious inflammation (see, e.g., WO’378 at claim 10 and 27), which would include non-infectious inflammation associated with diabetes (see, e.g., WO’378 at ¶¶[0003], [0004]). Because WO’378 utilizes “obesity” and “diabetes” generally (see, e.g., WO’378 at ¶¶[0003], [0004]), WO’378 would be understood to be applicable to any and all types of diabetes and obesity.
Accordingly, WO’378 teach and disclose the administration of identical compounds via identical administration routes, at the same or overlapping “therapeutically effective” concentrations, to the identical or overlapping patient populations, including patients that have any type of COPD, obesity, or diabetes.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s):
The claimed invention is the obvious combination of prior art elements (i.e., known cyclosporine compounds of WO’378, including BT-051), according to known methods (i.e., treatment of patients having COPD, diabetes, and/or obesity by administering a therapeutically effective amount of a cyclosporine compound such as BT-051 as taught by WO’378), to yield predictable results, namely the treatment of one or more symptoms of such patients (see, e.g., MPEP §§ 2143(I)(A), (C), (F), (G)). Furthermore, each element merely performs its art-recognized function in combination as it does separately.
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date. It is noted that performing the same steps, with the same compounds, upon the same patient population is obvious, even if a different rationale may exist (see, e.g., MPEP § 2144(IV)); furthermore, the recognition of additional advantages that would flow naturally from following the suggestion of the prior art (i.e., treating patients with COPD, obesity, and/or diabetes with the same cyclosporine drugs, at the same or overlapping concentrations) cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well-within the ordinary skill in the art to treat a known patient population (i.e., patients with COPD, obesity, and/or any type of diabetes) with a known compound (e.g., a cyclosporine compound such as BT-051) at a known or overlapping concentration, via the same routes of administration, exactly as taught and disclosed by the prior art, with a reasonable expectation of successfully achieving the results and benefits taught, disclosed, and suggested by the prior art.
Accordingly, claims 1-12 are rejected.
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 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-16 and 18-23 of U.S. Patent No. 12,252,556 B22. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim Interpretation: The Applicable claim interpretation is set forth above. Additional claim interpretations are set forth below.
Legal analysis: The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
Regarding instant claims 1-12, the issued claims are directed to methods “for treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof”, wherein the methods comprise “administering to the subject” a “therapeutically effective amount” of a “compound of formula I” as shown at claim 7 of US’556 (see, e.g., US’556 at claim 7). Regarding instant claims 1-8 and the structures of Formula I, Formula IA, and BT051, US’556 identifies that a “compound of formula I” (see, e.g., US’556 at claim 7) may have an L1 that is a C2 alkyl group (ethylene), and R is a CH3-O-(CH2CH2O)44-CH2CH2CH2NH-, which is understood to be a PEG with 44 ethylene oxide units coupled with an L2 linker of -CH2CH2CH2NH-, which is understood to be an “unsubstituted heteroalkylene group” (compare instant claims 1-8 with US’556 at claims 7-11). Regarding instant claim 1-8 and routes of administration, the issued claims of US’556 recite “administering to the subject”, and the term “administering” is understood to include any parenteral, intravenous, intradermal, intramuscular, subcutaneous, or transdermal administration routes (see, e.g., US’556 at col. 29 at lines 1-26; see, e.g., MPEP § 804(II)(B)(1)), explaining that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim). Regarding instant claim 12 and the “wherein” clause, the “wherein” clause at instant claim 12 is understood to be a recitation of intended and expected results, fully satisfied by all embodiments that satisfy the steps and structural limitations set forth in the body of claim 1 (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not require steps to be performed or by claim language that does not limit a claim to a particular structure). Accordingly, claim 12 is rejected for the reasons applicable to instant claim 1, and is understood to be necessarily and inherently satisfied by all methods that satisfy the active method steps set forth in the body of instant claim 1.
The issued claims and the instant claims appear to ostensibly differ only by recitation of functionally defined patient populations, wherein the issued claims are directed to methods “for treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof”, but the instant claims are directed to methods “for treating glucose intolerance in a mammalian subject in need thereof”; accordingly, the issue is whether or not the two patient populations substantially and materially overlap in scope, such that practicing both claim sets would direct artisans to perform the same active method steps upon the same patients (i.e., same compound, same administration route, same dosage, same patient populations).
Regarding instant claims 1, 9-12, and the functionally-defined patient population of patients “in need” of treatment of “glucose intolerance”, including patients having obesity, COPD, and diabetes: Although the metes and bounds of diseases that are or are not characterizable by “glucose intolerance” as presently claimed are ill-described, it is clear that the instant claim scope reads at least upon administering the treatment recited at instant claim 1 to patients having obesity, chronic obstructive pulmonary disease (COPD), and diabetes (see, e.g., instant claims 1 and 9-11). However, this patient population materially and substantially overlaps in scope with the patient populations identified, taught, and claimed by the prior art:
First, US’556 explicitly claims the treatment of patients with chronic obstructive pulmonary disease (COPD) (see, e.g., US’556 at claims 7-13 at ¶¶[0018], [0095], claims 18 and 21).
Second, US’556 identifies that the methods of “treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof” include treating subjects with “non-infectious inflammation” (see, e.g., US’556 at claims 7 and 15). Per MPEP § 804(II)(B)(1)), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and it is also permissible to rely upon a specification for identification of obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”). Here, the applicable patient population (and obvious variants thereof) is defined and described in US’556 to specifically include any “subject that is experiencing and/or exhibiting one or more clinical and or subclinical symptoms of inflammation” (see, e.g., US’556 at claims 7 and 15, col. 16 at lines 10-31), which is relevant because “non-infectious inflammation” (see, e.g., US’556 at claim 15) would be readily understood and interpreted to include any and all forms of diabetes and/or obesity (see, e.g., US’556 at claims 7, 15, and col. 1 at lines 30-45 and lines 59-67).
Accordingly, US’556 is understood to claim methods of treating the same patient populations, having the same or overlapping diseases or conditions (e.g., COPD, obesity, or diabetes), by administering the same compounds via the same administration routes, at the same or overlapping “therapeutically effective” concentrations.
In sum, the differences between the reference claims and instant claims appear to be minor because both claim sets recite to claim methods of treating the same patient populations, having the same or overlapping diseases or conditions (e.g., COPD, obesity, or diabetes), by administering the same compounds via the same administration routes, at the same or overlapping “therapeutically effective” concentrations [2], and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”[3] is clearly “yes”.
Anticipation analysis: MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the methods recited in the reference claims using the exact, explicitly recited methods presently claimed (see, e.g., MPEP § 804(II)(B)(2)).
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a different, but materially overlapping patient populations, but wherein both claim sets read upon species of the same methods using the same compounds administered at the same or overlapping concentrations via the same or overlapping routes of administration, and therefore would be expected to achieve the same predicted and expected outcomes absent objective evidence to the contrary (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform known methods using known compounds on known patients at known dosages via known administration routes (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (F), (G)).
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to the same or an obvious, claimed variant of the patent claims, namely the claims are directed to methods of treating the same patient populations, having the same or overlapping diseases or conditions (e.g., COPD, obesity, or diabetes), by administering the same compounds via the same administration routes, at the same or overlapping “therapeutically effective” concentrations as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 1-12 are rejected.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 38-40, 42, and 44-49 of copending Application No. 19/045,2193 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as described below.
Claim Interpretation: The Applicable claim interpretation is set forth above. Additional claim interpretations are set forth below.
Legal analysis: The applicable analysis for Nonstatutory Double Patenting is set forth at MPEP § 804(II), and specifically at MPEP § 804(II)(B). Here, although the same invention is not being claimed twice (see, e.g., MPEP § 804(II)(A), discussing Statutory Double Patenting), a Nonstatutory Double Patenting rejection is appropriate because although the conflicting claims are not identical, at least one examined application claim is not patentably distinct from the reference claims because the examined application claim is either anticipated by, or would have been obvious over, the reference claims for the reasons set forth in the following paragraph[1]: Per MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences”. Accordingly, a comparison of the teachings of the reference claims and the instant pending claims are set forth below:
Regarding instant claims 1-12, the copending claims are directed to methods “for treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof”, wherein the methods comprise “administering to the subject” a “therapeutically effective amount” of a “compound of formula I” as shown at claim 10 of App’219 (see, e.g., App’219 at claim 38, 40). Regarding instant claims 1-8 and the structures of Formula I, Formula IA, and BT051, App’219 identifies that a “compound of formula I” (see, e.g., App’219 at claim 38-40) may have an L1 that is a C2 alkyl group (ethylene), and R is a CH3-O-(CH2CH2O)44-CH2CH2CH2NH-, which is understood to be a PEG with 44 ethylene oxide units coupled with an L2 linker of -CH2CH2CH2NH-, which is understood to be an “unsubstituted heteroalkylene group” (compare instant claims 1-8 with App’219 at claims 38-40). Regarding instant claim 1-8 and routes of administration, the copending claims of App’219 recite “administering to the subject”, and the term “administering” is understood to include any parenteral, intravenous, intradermal, intramuscular, subcutaneous, or transdermal administration routes (see, e.g., App’219 at Spec. filed 2/04/2025 at ¶[0127]; see, e.g., MPEP § 804(II)(B)(1)), explaining that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim). Regarding instant claim 12 and the “wherein” clause, the “wherein” clause at instant claim 12 is understood to be a recitation of intended and expected results, fully satisfied by all embodiments that satisfy the steps and structural limitations set forth in the body of claim 1 (see, e.g., MPEP § 2111.04(I), noting that claim scope is not limited by claim language that does not require steps to be performed or by claim language that does not limit a claim to a particular structure). Accordingly, claim 12 is rejected for the reasons applicable to instant claim 1, and is understood to be necessarily and inherently satisfied by all methods that satisfy the active method steps set forth in the body of instant claim 1.
The copending claims and the instant claims appear to ostensibly differ only by recitation of functionally defined patient populations, wherein the copending claims are directed to methods “for treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof”, but the instant claims are directed to methods “for treating glucose intolerance in a mammalian subject in need thereof”; accordingly, the issue is whether or not the two patient populations substantially and materially overlap in scope, such that practicing both claim sets would direct artisans to perform the same active method steps upon the same patients (i.e., same compound, same administration route, same dosage, same patient populations).
Regarding instant claims 1, 9-12, and the functionally-defined patient population of patients “in need” of treatment of “glucose intolerance”, including patients having obesity, COPD, and diabetes: Although the metes and bounds of diseases that are or are not characterizable by “glucose intolerance” as presently claimed are ill-described, it is clear that the instant claim scope reads at least upon administering the treatment recited at instant claim 1 to patients having obesity, chronic obstructive pulmonary disease (COPD), and diabetes (see, e.g., instant claims 1 and 9-11). However, this patient population materially and substantially overlaps in scope with the patient populations identified, taught, and claimed by the copending claims:
First, App’219 explicitly claims the treatment of patients with chronic obstructive pulmonary disease (COPD) (see, e.g., App’219 at claim 40).
Second, App’219 identifies that the methods of “treating a disease associated with neutrophil-mediated inflammation in a target tissue of a mammalian subject in need thereof” include treating subjects with “non-infectious inflammation” (see, e.g., App’219 at claim 40, reciting “non-infectious inflammation”). Per MPEP § 804(II)(B)(1)), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and it is also permissible to rely upon a specification for identification of obvious variants (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”). Here, the applicable patient population (and obvious variants thereof) is defined and described in App’219 to specifically include any “subject that is experiencing and/or exhibiting one or more clinical and or subclinical symptoms of inflammation” (see, e.g., App’219 at claim 40, ¶[0067]), which is relevant because “non-infectious inflammation” (see, e.g., App’219 at claim 40) would be readily understood and interpreted to include any and all forms of diabetes and/or obesity (see, e.g., App’219 at claim 40, Spec. filed 2/04/2025 at ¶¶[0003]-[0004]).
Accordingly, App’219 is understood to claim methods of treating the same patient populations, having the same or overlapping diseases or conditions (e.g., COPD, obesity, or diabetes), by administering the same compounds via the same administration routes, at the same or overlapping “therapeutically effective” concentrations.
In sum, the differences between the reference claims and instant claims appear to be minor because both claim sets recite to claim methods of treating the same patient populations, having the same or overlapping diseases or conditions (e.g., COPD, obesity, or diabetes), by administering the same compounds via the same administration routes, at the same or overlapping “therapeutically effective” concentrations [2], and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”[3] is clearly “yes”.
Anticipation analysis: MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Here, it is the Examiner’s position that under an anticipation analysis an artisan would at once envisage the methods recited in the reference claims using the exact, explicitly recited methods presently claimed (see, e.g., MPEP § 804(II)(B)(2)).
Obviousness analysis: Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim a different, but materially overlapping patient populations, but wherein both claim sets read upon species of the same methods using the same compounds administered at the same or overlapping concentrations via the same or overlapping routes of administration, and therefore would be expected to achieve the same predicted and expected outcomes absent objective evidence to the contrary (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the representative claims because it is well-within the ordinary skill in the art to perform known methods using known compounds on known patients at known dosages via known administration routes (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (C), (F), (G)).
The reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to the same or an obvious, claimed variant of the patent claims, namely the claims are directed to methods of treating the same patient populations, having the same or overlapping diseases or conditions (e.g., COPD, obesity, or diabetes), by administering the same compounds via the same administration routes, at the same or overlapping “therapeutically effective” concentrations as set forth in the copending claims. Therefore, the instant claims substantially overlap in scope with the copending claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
Accordingly, instant claims 1-12 are provisionally rejected. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 12,421,281 B2 (corresponding to US 20230192771 A1) pertains to highly similar cyclosporine compounds having a modified L1 chain (compare US’281 at claims 15 and 16 with instant claims 1-8), which is presumed to be excluded by the structural limitations of instant claim 1.
US 20260103492 A1 (US Application 19/307,893) pertains to highly similar cyclosporine compounds having a modified L1 chain (compare US’281 at claims 15 and 16 with instant claims 1-8), which is presumed to be excluded by the structural limitations of instant claim 1.
US 20210277064 A1 corresponds to U.S. Patent No. 12,252,556 B2 and WO2020041378A1, which have been discussed above.
Kumar4 identifies that, circa 2019, the link between “neutrophil associated inflammation” and “glucose intolerance” in patients with diabetes, was already known in the art (see, e.g., Kumar at title, abs, 7 at col I-II at bridging ¶, 10 at col I-II at §§ “Diabetes”, explaining that with respect to diabetes, “enhanced levels of circulating FFA and triacylglycerols cause insulin resistance and also neutrophilic inflammation”). Accordingly, in view of WO’378 and Kumar, an artisan would readily appreciate that the methods of WO’378 could be advantageously practiced upon patients having any type of diabetes, wherein such treatment would predictably and advantageously treat inflammation associated with diabetes.
US2012/0196749 pertains to similar cyclosporin derivates (compare instant claims with US’749 at title, abs, claims), which are taught for use in methods of treating inflammatory diseases, diabetes, and COPD (see, e.g., US’749 at claim 13, ¶¶[0008]-[0009]).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. 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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/RANDALL L BEANE/ Primary Examiner, Art Unit 1654
1 Cited in Requirement mailed 4/10/2026.
2 This corresponds to earlier publication WO2020041378A1, applied under 35 USC §103, above. It also corresponds to US 20210277064 A1.
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
[2] See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences
[3] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
3 This corresponds to US 20250179121 A1.
[1] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
[2] See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences
[3] See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
4 Cited in Requirement mailed 4/10/2026.
Prosecution Insights