DETAILED ACTION
Claims 1-3, 14, 16-18, 23, 28-29 and 47-55, submitted on 17 February 2026, are pending in the application. Claims 28-29 and 47-55 are withdrawn. Claims 1-3, 14, 16-18 and 23 are under examination in the instant Office Action.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 14, 16-18, and 23, and the elected species,
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, in the reply filed on 17 February 2026 is acknowledged.
Claims 28-29 and 47-55 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 February 2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 14, 16-18, and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of heterotropic calcifications and chondrocyte calcifications associated with osteoarthritis, does not reasonably provide enablement for the treatment and/or prevention of all diseases or conditions associated with hypermineralization, such as diseases associated with ectopic mineralization like osteogenesis imperfecta or kidney stones. 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.
Breadth of the Claims
Claim 1 recites “A method of treatment and/or prevention of a disease or condition associated with hypermineralization in a subject in need thereof”. Claim 1 is not drawn to any particular disease or condition associated with hypermineralization, and thus can be interpreted to encompass all diseases or conditions associated with hypermineralization.
As it reads, claim 1 encompasses preventative treatment of a disease or condition associated with hypermineralization. Prevention is defined in the instant specification on page , which states, “…the term "prevention" or "preventing" means any administration of a composition, pharmaceutical composition, therapeutic agent, compound, etc... of the disclosure to a subject for the purpose of preventing the disease, that is, causing the clinical symptoms of the disease not to develop”.
Nature of the Invention
The nature of the invention is within the pharmaceutical arts with regards to the treatment and/or prevention of a disease or condition associated with hypermineralization in a subject in need thereof.
State of the Prior Art
The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to those in the art at the time the application was filed. See MPEP 2164.05(b). See Pac. Bioscience of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enabled requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP 2165.05(a).
Misof ("Bone quality and mineralization and effects of treatment in osteogenesis imperfecta." Calcified tissue international 115.6 (2024): 777-804.) teaches wherein the hypermineralization condition, osteogenesis imperfecta (OI), is a rare congenital condition characterized by high fracture rates and broad variations in clinical manifestations ranging from mild to increasingly sever and perinatal lethal forms (Abstract). Misof additionally teaches that a frequent finding observed in the majority of OI forms is the hypermineralization of the bone matrix (pg. 779, Section “Introduction”, Left Col., 1st paragraph). Since osteogenesis imperfecta is a congenital disease, it would follow that there is unpredictability of the ability of the compounds of the claimed invention to prevent a disease prenatal.
Additionally, Mu et al. ("Physiological and pathological/ectopic mineralization: from composition to microstructure." Microstructures 3.4 (2023): 2023030.), teaches pathological (ectopic) mineralization can occur not only in the skeletal system but also in soft tissues, such as the breast, blood vessels, kidney, pancreas, and prostate (pg. 6, Section “Pathological (ectopic) Mineralization in Major Organs”, 1st paragraph). In the same paragraph, Mu states “Pathological/ectopic calcification occurs in both genetic and acquired clinical conditions and affects the prognosis of diseases.” Additionally, Mu teaches that “a more comprehensive understanding of how the structures are formed, progressed, and adapted to changing needs enables us to conceive new insights into the progression of the pathological condition and guide future therapeutic designs to prevent and manage pathological/ectopic mineralization” (pgs. 13-14, Section “Conclusions and Future Perspectives”, 1st paragraph bridging pages). As the Mu reference was published in July of 2023, which is after the effective filing date of the instantly claimed invention, and as the reference teaches that more understanding is necessary to prevent these diseases, it can be understood that there is unpredictability in the ability of all of the compounds of the claimed invention to treat and/or prevent all disorders associated with hypermineralization.
Level of Skill in the Art
The person of ordinary skill in the art is a person who is presumed to have known
the relevant art at the relevant time. Factors that may be considered in determining the
level of ordinary skill in the art may include: (A) "type of problems encountered in the
art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are
made;" (D) "sophistication of the technology; and" (E) "educational level of active
workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121
(Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955,
962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil
Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP 2141.03 (I).
The invention described pertains to the medical or pharmaceutical arts. One of ordinary skill would be trained in pharmacology, biochemistry, medicine, or a related art field with a Ph. D or other advanced degree in these or other related fields.
Level of Predictability in the Art
The amount of guidance or direction needed to enable the invention is inversely
related to the amount of knowledge in the state of the art as well as the predictability of
the art. In re Fisher, 427, F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount
of guidance or direction” refers to that information in the application, as originally filed,
that teaches exactly how to make or use the invention. The more that is known in the
prior art about the nature of the invention, how to make, and how to use the invention,
and the more predictable the art is, the less information needs to be explicitly stated in
the specification. In contrast, if little is known in the prior art about the nature of the
invention and the art in unpredictable, the specification would need more detail as to
how to make and use the invention in order to be enabling. The scope of the required
enablement varies inversely with the degree of predictability involved, but even in
unpredictable art, a disclosure of every operable species is not required. A single
embodiment may provide broad enablement in cases involving predictable factors, such
as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA
1971). However, in applications directed to inventions in arts where the results are
unpredictable, the disclosure of a single species usually does not provide an adequate
basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA
1938). In cases involving unpredictable factors, such as most chemical reactions and
physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166
USPQ 18, 24 (CCPA 1970). See MPEP 2164.03. The applicant would need to provide
more objective evidence to support the enablement of the aforementioned claims to
contrast the unpredictability of the subject matter art.
There is unpredictability in the field of endeavor in regards to the currently claimed method of treating and/or preventing all diseases or conditions associated with hypermineralization in a subject with a singular compound. Unpredictability stems from the lack of prior art which would suggest that the compounds of the claimed invention can be administered to treat and/or prevent the above-mentioned diseases or conditions.
Amount of Direction Provided by the Inventor
The amount of direction provided by the inventor is correlated by the nature of
the unpredictability of the art. Given the context and scope of the claims mentioned
above, the inventor failed to provide the necessary amount of direction for one skilled in
the art to adequately use the invention across all suggested utility in the broadly stated
disease and disorders disclosed above. (See: Section (A) Breadth of the Claims).
The Applicant provided guidance for certain aspects of the instantly claimed invention. Guidance was provided pertaining to the synthesis of the compounds of the instantly claimed invention. Additionally, the Applicant provided data for the cystathionine-gamma-lyase enzyme (Cse) expression regulation of heterotropic calcification in a mouse model, in vitro regulation of chondrocyte calcification and IL-6 secretion, as well as some compounds ability to activate Cse and to inhibit calcification.
Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
As previously stated, the amount of experimentation depends on the art, the
predictability of the art, and the direction provided by the inventor. For one skilled in the
art to practice the invention as disclosed, the artisan trying to practice Applicant’s
claimed invention would be required to undertake unduly burdensome activities
including:
Experimentation to demonstrate the compounds of the instantly claimed invention to treat and/or prevent the aforementioned diseases and conditions associated with hypermineralization.
Experimentation to show the dosage and frequency to require to treat and/or prevent said diseases and conditions.
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 1-3, 14, 16-18, and 23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase "e.g." after “inverse amide” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2 and 3 recite the limitation "alkyl" in line 2 of each respective claim. There is insufficient antecedent basis for this limitation in the claim. There is a lack of antecedent basis on the fact that “alkyl” is recited as an option in claim 1 for two separate moieties (i.e., variable moiety R1 and variable moiety Y). This makes it unclear when alkyl is defined in the same or subsequent claims as to which moiety is being referenced.
Claims 14, 16-18 and 23 are rejected because they are dependent of a rejected independent claim.
Conclusion
No claims allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
STN File Registry No. 2396104-45-1. Entered the database on 22 December 2019. Accessed 09 March 2026. STN File Reg. No. 2396104-45-1 reads on the instantly recited genus of compounds. However, it does not teach or fairly suggest the claimed method of use for said compounds. Therefore, it does not teach all limitations of the instant claims.
Burch et al. (WO 2016/091916 A1). Burch teaches a genus similar to that of the Applicant’s recited genus of compounds. However, the method of use taught by Burch is related to the treatment of inflammatory disease and cancer and not to the treatment or prevention of a disease or condition associated with hypermineralization similar that of the instantly claimed invention. Therefore, it does not teach all limitations of the instant claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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