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 .
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.
Election/Restrictions
Examiner have withdrawn all rejections on file.
This action is made non-final because New rejections are made.
Examiner did not find prior art on the full scope of independent claim 1, 15 and 18. Therefore election of species requirement is withdrawn.
Applicant cancelled claims 26-33 and 36, which were previously withdrawn.
Claims 1-6, 9,11-12, 15, 18, 23-25, 42 and 45-49 are examined in this office action.
Current Status of 17/910,723
This Office Action is in response to the amended claims of 03/27/2026.
Claims 3-6, 9, 11-12, and 23-25 are previously presented; claims 1-2,15 and 18, are original; claims 45-49 are new; and claim 42 is currently amended.
Claims 1-6, 9,11-12, 15, 18, 23-25, 42 and 45-49 are examined in this office action.
Priority
Effective filing date is 03/11/2020, claims find support ion provisional application no 62/988,239.
Response to Arguments
Examiner acknowledges the receipt of applicant’s claim amendment and remarks 03/28/2026. Examiner have reviewed these remarks and amendments.
Regarding 112 rejection, applicant deleted repetition of the phrase “or a combination thereof” from claim 42 thus overcoming the rejection. 112 rejection is withdrawn.
Regarding 103 rejections,
Applicant argue,
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Examiner response:
Examiner find applicant evidences of surprising and unexpected result convincing therefore 103 rejection is withdrawn.
Claim Rejections - 35 USC § 101(new)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, and 4-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more. The claim(s) recite(s) diagnostic and screening methods. This judicial exception is not integrated into a practical application because there is no particular, non-conventional assay or technological improvement recited and no transformation beyond data observation. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the rejected claims all recite screening/diagnostic processes relying on routine techniques to detect natural correlations/phenomena.
Step 1: Is the claim to a process, machine, manufacture, or composition of matter?
Yes, each of claims 1, and 4-6 are directed to a process/method.
Revised Step 2A
Prong 1: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
No, each of the claims 1, and 4-6 recite abstract ideas.
The broadest reasonable interpretation (BRI) of the claims 1, and 4-6 is to measuring the state during a maladaptive remodeling phase following myocardial infraction to administer carborane and carborane analog, this is an abstract idea which is judicial exception (JE).
For claim 4-6: The step of “entering” and “detecting” the subject reflects an abstract idea and “assessing” is a mental process. Thus, this constitutes an abstract ideas and is a JE.
Prong 2: Does the claim recite additional elements that integrate the JE into a practical application?
No. The recited steps of claim 1 during remodeling phase following the myocardial infraction- are high-level and generic. “Comparing” and “determining” can be performed mentally. There is no particular, non-conventional assay or technological improvement recited; no transformation beyond data observation.
No. Claims 4-6 does not disclose specific steps of detecting and assessing entering of maladaptive remodeling phase following myocardial infraction. Furthermore “entering of maladaptive remodeling phase following myocardial infraction” are high-level and generic.
Step 2B: Does the claim recite additional elements that amount to significantly more than the JE?
No, claim 1 does not recite additional elements. The detection/comparison are routine laboratory/analytical steps. Under Mayo, Cleveland Clinic, and Athena, this type of diagnostic claim is ineligible when the screening/diagnostic processes rely on routine techniques to detect natural correlations/phenomena as is the case with instant claim 1.
No, claim 4-6 does not recite additional elements. Nothing suggests an inventive concept beyond observing a natural interaction and making a selection. In fact, Cleveland Clinic and Athena found similar screening/diagnostic processes ineligible when they rely on routine techniques to detect natural correlations/phenomena.
Thus, claims 1 and 4-6 are not eligible subject matter and are each rejected under 35 USC 101.
Claim Rejections - 35 USC § 112(new)
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 1-6, 9, 11-12, 18, 23-25, 42, 45-47 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification and art, while being enabling for “treating” heart failure following myocardial infarction” does not have enablement for “preventing” “heart failure following myocardial infarction” as is instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Moreover, there is no enablement in the prior art or Specification for preventing any of the diseases of instant claim 18.
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention at the time of filing include:
(a) Breadth of the claims:
(b) Nature of the invention;
(c) State of the prior art;
(d) Level of one of ordinary skill;
(e) level of predictability art
(f) amount of direction provided by the inventor;
(g) existence of working examples;
(h) and Quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Breadth and nature of the claims and Nature of the Invention
Claims 1-6, 9, 11-12, 23-25, 42 and 45-47 are directed to treating and prevention of chronic heart failure following myocardial infarction with carborane and carborane analog; claims 18 and 49 is directed to method of treating or preventing graft-versus-host disease, multiple sclerosis (MS), and/or experimental autoimmune encephalomyelitis (EAE) with carborane and carborane analog.
State of the prior art:
Schwinger RHG. (Pathophysiology of heart failure. Cardiovasc Diagn Ther. 2021 Feb;11(1):263-276.) teaches heart failure as an epidemic disease which affects about 1% to 2% of the population worldwide. Both, the etiology and phenotype of heart failure differ largely. Following a cardiac injury (e.g., myocardial infarction, increased preload or afterload) cellular, structural and neurohumoral modulations occur that affect the phenotype being present. These processes influence the cell function among intra- as well as intercellular behavior. In consequence, activation of the sympathoadrenergic and renin-angiotensin aldosterone-system takes place leading to adaptive mechanisms, which are accompanied by volume overload There exists no heart failure specific clinical sign; the clinical symptomatic shows progressive deterioration acutely or chronically (Schwinger, abstract).
Claims 18 and 49 are directed to method of treating or preventing graft-versus-host disease, multiple sclerosis (MS), and/or experimental autoimmune encephalomyelitis (EAE) with carborane and carborane analog. For example, Graft vs host disease (GVHD), a complication of stem cell transplant, is a major cause of morbidity, nonrelapse mortality, and interference with quality of life (QOL). Concern that older adults are at higher risk for developing GVHD has limited the use of SCT in this population. Older adults are also at higher risk for adverse events from the mainstay treatment of GVHD: corticosteroids. There is no standard of care for the management of GVHD in older adults(abstract, Meyers G. (Graft versus host disease treatment and prevention in older adults: A single-database review. J Geriatr Oncol. 2026 Mar;17(2))
Level of one of ordinary skill/ Level of predictability art
Regarding claims 1-6, 9, 11-12, 23-25, 42 and 45-47, a person of ordinary skill in the art is an artisan who is a medicinal chemist and or cardiologist that has experience with chronic heart failure. Since there is no clinical sign of myocardial or chronic heart failure(Schwinger), A person skilled in the art would not be able to envision preventing would not be able to prevent chronic heart failure (Wands factor (d)) because the specification does not provide guidance for method of preventing chronic heart failure with carborane(e)). Moreover, preventions unpredictable because there is no clinical sign of chronic heart failure (wand factor (e)).
Regarding claims 18 and 49, A person of ordinary skill in the art is an artisan who is a medicinal chemist and or immunologist that has experience with immunotherapy. A person skilled in the art would not be able to envision treating or preventing would not be able to prevent GVHD (Wands factor (d)) because the specification does not provide guidance for method of preventing GVHD with carborane(e)). Moreover, preventions unpredictable because there is no known way to treat GVHD(wand factor (e)).
Amount of direction provided by the inventor:
Although the specification teaches a method of treating chronic heart failure following myocardial infraction there is no working example that shows prevention of chronic heart failure following myocardial infraction, in the specification
It would require undue experimentation and be undue burden to practice the claimed method of prevention for chronic heart failure after myocardial infraction because there is no clinical sign for chronic heart failure
There is no working example that shows in the specification that shows treatment of prevention of graft-versus-host disease, multiple sclerosis (MS), and/or experimental autoimmune encephalomyelitis (EAE) with carborane and carborane analog in the specification.
It would require undue experimentation and be undue burden to practice the claimed method of treatment or prevention graft-versus-host disease, multiple sclerosis (MS), and/or experimental autoimmune encephalomyelitis (EAE)
Therefore, method claims 1-6, 9, 11-12, 18, 23-25, 42, 45-47 and 49 are rejected for lacking scope of enablement for treating and prevention for graft-versus-host disease, multiple sclerosis (MS), and/or experimental autoimmune encephalomyelitis with carborane and carborane analog(EAE); and prevention of chronic heart failure after myocardial infraction with carborane and carborane analog.
Claims 1-6, 9,11-12, 15, 18, 23-25, 42 and 45-49 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. While Applicants have shown possession of some species of carboranes they do not show possession of a representative number of species of the broad genus “carborane” and “carborane analog”. This is a written description rejection.
MPEP 2163(I) states “The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.”
Instant claims 1, 15 and 18 are drawn very broadly to plurality of species within the broad genus of “carborane” and “carborane analog” for treating chronic heart failure in a subject following myocardial infarction; or treating graft versus host diseases, multiple sclerosis(MS, and/or experimental autoimmune encephalomyelitis(EAE); and inhibiting the activation and proliferation of CD4+T cells, without providing evidence for the use of plurality of compounds of carborane and carborane analogs. For example, the specifications describe a method of treating myocardial infarction with the compound
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on pages 71, but does not show have evidence of using any other carboranes or carboranes analogs. A person skilled in the arts would not be able to infer from the specification if the applicant is in possession of all the species of carborane and carborane analog as asserted in the method claims.
Therefore, claims 1, 15 and 18 are rejected for lacking written description.
Claims 2-6, 9,11-12, 23-25, 42 and 45-49 are also rejected for depending on rejected claims 1,15 and 18.
Conclusion
1-6, 9,11-12, 15, 18, 23-25, 42 and 45-49 are rejected.
Independent claim 15 and 18 are free of prior art for the reasons stated in paragraph [37] in office action of 12/29/2025.
Independent claim 1 is free of prior art for the reasons stated in paragraph[16] above.
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/R.I./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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