DETAILED ACTION
Status of Claims
The amendment submitted August 22, 2025 has been entered.
Claims 1-5 and 7-39 are pending and under consideration.
Claim 6 was previously cancelled by Applicant.
Claims 2, 4, 7, 9, 10, 11, 12, 14-24, 30, 32, and 34-39 are withdrawn as explained below in the Election/Restriction section.
Claims 1, 3, 5, 8, 13, 25-29, 31, and 33 are under consideration in the instant office action as explained below in the Election/Restriction section.
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 the first compound in claim 33 (shown below) as a species of Formula (III)’ and acid maltase deficiency (Pompe disease) as a species of disease in the reply filed on August 6, 2025 is acknowledged.
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The elected species reads on claim 3, where A is O, Y is N, R1 is C2-alkyl substituted with three halogen substituents, n is 0, p is 0, R30 and R31 are hydrogen, and R2 is a heteroaryl substituted with a halogen.
The elected species also reads on claim 1 where A is O, X is N, R1 is C2-alkyl substituted with three halogen substituents, n is 0, p is 0, R30 and R31 are hydrogen, and R2 is a heteroaryl substituted with a halogen.
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The elected species does not read on claim 2, Formula (II) as shown below) as the elected species is a biheteroaryl compound.
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The elected species of disease, Pompe disease is a species of metabolic myopathy; therefore, in combination with the elected compound, reads on claims 1, 3, 5, 8, 13, 25-29, 31, and 33.
Consequently, the elected species of a compound of Formula (III’) and of a disease do not read on claims 2, 4, 7, 9, 10, 11, 12, 14-24, 30, 32, and 34-39.
Claims 2, 4, 7, 9, 10, 11, 12, 14-24, 30, 32, and 34-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 22, 2025.
Claims 1, 3, 5, 8, 13, 25-29, 31, and 33 are under consideration and are the subject of this Office Action.
Information Disclosure Statement
Six information disclosure statements (IDS) submitted on April 18, 2025; March 18, 2025; August 23, 2024; February 14, 2024; December 20, 2023 and August 4, 2023 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to because:
Figures 7-10, the graphs are fuzzy and difficult to read and the deficiencies are not corrected by the supplemental drawings provided.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Examiner’s Suggestion
At line 3 of claim 1 and line 4 of claim 3, the examiner suggests deleting the phrase “or a salt thereof” to improve clarity and remove redundancies.
Claim Interpretation
The Examiner notes for claim 13 that Pompe disease is an equivalent for acid maltase deficiency, Cori disease and Forbes disease are both equivalents for debrancher enzyme deficiency, and Tarui disease is an equivalent for phosphofructokinase deficiency as denoted by Applicant’s use of parenthesis and evidenced by what is well-known in the medicinal arts (Pompe disease: “Metabolic Myopathies-Acid maltase deficiency (Pompe disease),” https://www.mda.org/disease/metabolic-myopathies/types/acid-maltase-deficiency-pompe-disease, Accessed December 9, 2025; Cori and Forbes disease: “Metabolic Myopathies-Debrancher enzyme deficiency (Cori or Forbes disease),” https://www.mda.org/disease/metabolic-myopathies/types/cori-forbes-disease, Accessed December 9, 2025; “Metabolic Myopathies- Phosphofructokinase deficiency (Tarui disease),” https://www.mda.org/disease/metabolic-myopathies/types/tarui-disease, Accessed December 9, 2025.
Claim Rejections - 35 USC § 112(a)
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, 5, 8, 13, 25-29, 31, and 33 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01 (a).
Upon consideration of the factors discussed below, the examiner concludes that one skilled in the art would be unable to practice the invention as disclosed without being burdened with undue experimentation based on the information provided by the applicant.
A discussion of these factors in relation to the pending claims follows.
The breadth of the claims and the nature of the invention
Claims 1, 3, 5, 8, 13, 25-29, 31, 33 are directed towards methods of treating a disease comprising administering to a subject in need thereof a compound or salt of Formula (III’)…wherein the disease is selected from tendinitis, carpal tunnel syndrome, Multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, cerebral palsy, stroke, traumatic brain injury, spinal cord injury, hypoxia, meningitis, encephalitis, phenylketonuria, amyotrophic lateral sclerosis, Congenital muscular dystrophies (CMD), Emery-Dreifuss muscular dystrophy (EDMD),Muscle-eye-brain diseases (MEBs), Rigid spine syndromes, Walker-Warburg syndromes(WWS), Congenital myopathies, distal myopathies, endocrine myopathies, inflammatory myopathies, metabolic myopathies, myofibrillar myopathies (MFM), scapuloperoneal myopathy, and cardiomyopathies.
Applicant’s listing of diseases is broad and inclusive of a wide-range of heterogenous diseases and conditions varying in etiology, pathology, and treatment options.
By example only, meningitis can be caused by viral infections, bacterial infections, fungal infections, parasites, amoeba, injuries, cancer, and certain drugs (Center for Disease Control, “About Meningitis,” https://www.cdc.gov/meningitis/about/index.html#:~:text=Causes,Certain%20drugs, Accessed December 12, 2025).
It is also well known that “If healthcare providers suspect meningitis, they may collect samples of blood or cerebrospinal fluid (fluid surrounding the spinal cord). Then laboratories can perform specific tests, depending on the type of infection suspected. Knowing the specific cause is important because treatment differs depending on the cause.”
Similarly, hypoxia is also a condition with divergent causes and treatment options ranging from anemia, asthma, bronchitis, and sleep apnea; consequently, “the treatment for hypoxia depends on the underlying cause. The cause might be a one-time event or it could be an ongoing condition (Cleveland Clinic, “Hypoxia,” https://my.clevelandclinic.org/health/diseases/23063-hypoxia#management-and-treatment, Accessed December 9, 2025).”
Consequently, it is reasonable to conclude Applicant’s claims are broad pertaining the disease.
Applicant’s compounds of Formula (III’) encompass compounds with high variability in sterics, electronics and functional groups across the substituents recited. By example only, Applicant’s Formula includes more than one group of biheteroaryl classes.
Consequently, it is reasonable to conclude Applicant’s claims are broad pertaining the compound administered.
On page 21, paragraph [0054], Applicant defines “treatment” or “treating” as “an approach for obtaining beneficial or desired results with respect to a disease, disorder, or medical condition including but not limited to a therapeutic benefit and/or a prophylactic benefit. A therapeutic benefit can include, for example, the eradication or amelioration of the underlying disorder being treated. Also, a therapeutic benefit can include, for example, the eradication or amelioration of one or more of the physiological symptoms associated with the underlying disorder such that an improvement is observed in the subject, notwithstanding that the subject may still be afflicted with the underlying disorder. In certain embodiments, for prophylactic benefit, the compositions are administered to a subject at risk of developing a particular disease, or to a subject reporting one or more of the physiological symptoms of a disease, even though a diagnosis of this disease may not have been made.”
Consequently, the definition for “treating” is broad and inclusive of prevention and/or prophylaxis.
Applicant has provided no definition for what is encompassed by subject; consequently, subject is broadly interpreted to be inclusive of cells, humans, animals, and other biological materials commonly employed in the medicinal arts.
On this basis, it is reasonable to conclude that all the claims are additionally broad with respect to the subject.
In summary, it is reasonable to conclude that the claims are broad with respect to the disease and/or condition, treating, and subject.
The 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 the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). See Pac. Biosciences 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 enablement requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP § 2164.05 (a).
To the best of the Examiner’s knowledge, there is no pharmacological agent capable of treating and/or preventing the broad range of diseases claimed by Applicant. Many of the diseases recited are known to be incurable, including Pompe disease.
“Although Pompe is a single disease, it is classified into two forms. The early-onset infantile form is the more severe of the two. It starts before 12 months of age and involves the heart muscle. The later-onset juvenile or adult form may start at any age after 12 months of age, and the heart is less likely to be severely affected (Muscular Dystrophy Association, “Pompe Disease Treatment Fact Sheet,” https://www.mda.org/sites/default/files/2021/09/MDA-Pompe-disease-Fact-Sheet-2021.pdf, Accessed December 9, 2025).”
Applicant has provided no indication that the claimed invention is capable of treating or preventing Pompe disease in infant and/or pediatric patients, which would encompass treating both early-onset and later-onset Pompe disease.
Additionally, it is well-known that “There is no cure for Pompe disease, but medication and therapy can help manage some symptoms and potentially slow the course of the disease.”
Consequently, Applicant has failed to demonstrate evidence supporting that the full scope of compounds claimed can be used to treat Pompe disease based on what is claimed.
The level of one of ordinary skill
The person of ordinary skill in the art is a hypothetical 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 medicine, nutrition, and pharmacology. One of ordinary skill would be a person with training in medicine, veterinary medicine, pharmacology, nutrition science, biochemistry or a related technical discipline.
The 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 in 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 is 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 arts, 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. See MPEP § 2164.03.
Consequently, technologies involving physiological activity as opposed to mechanical or electrical inventions are generally regarded as being unpredictable sciences.
As aforementioned, Applicant’s invention is directed towards a broad class of compounds, disease and subjects. Many of the disease are incurable and/or significantly vary in treatment depending on etiology, and patient population.
Pompe disease in itself is incurable and commonly treated using enzyme replacement therapy.
Based on these culminative factors, it is reasonable to conclude that predictability in the art is extremely low.
Consequently, the applicant would need to provide more details, working examples and guidance in order for the claimed invention to be enabling based on the scope and nature of the claimed invention.
The amount of direction provided by the inventor
As aforementioned, the amount of direction provided depends on the prior art and predictability of in the art. Based on the scope of protection sought by the applicant and the discussion aforementioned, the inventor has failed to provide sufficient direction for one ordinarily skilled in the art to practice the disclosed invention as claimed.
The existence of working examples
Applicant provided the following working examples:
Synthesis and characterization data of compounds of Formula (III)
Skeletal myofibril ATPase Assay (in vitro)
Cardiac myofibril ATPase Assay (in vitro)
Tibialis anterior muscle assay (in vitro, and in vivo)
Comparison of biomarkers in muscular dystrophies.
Creatine Kinase Assay
Although Applicant has data supporting enablement for treating Duchenne muscular dystrophy, McArdles, and Becker muscular dystrophy for some compounds; Applicant has furnished no support for prevention of these same diseases across the full scope of compounds claimed and subjects claimed.
Applicant has also failed to provide working examples covering the full scope of diseases and conditions claimed, including multiple sclerosis, Parkinson’s disease, stroke, and the various myopathies claimed, including Pompe disease.
One ordinarily skilled in the art would be met with undue experimentation in order to practice the invention as claimed based on the sparse experimental details, guidance and support for the working invention pertaining many of the diseases, compounds, subjects and goal of treating which is inclusive of prevention.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As discussed, the quantity of experimentation depends on the prior art, the predictability of the art, and the direction provided by the inventor.
In order for one ordinarily skilled in the art to practice the invention as disclosed, one would require but are not limited to the following:
In vivo and/or in vitro studies demonstrating effectiveness of across the diverse genus of Formula (III’) and heterogenous diseases and conditions claimed.
Methods for identifying a population of subjects at risk and guidance for determining such populations across the broad range of diseases and subjects claimed.
Methods to determine if a subject will develop or not develop the diseases claimed based on using the claimed invention, and reoccurrence of said diseases.
Treatment plans (amounts, timing, dosage, etc.) encompassing the full scope of subjects claimed (e.g., infants and pediatric patients).
Based on weighting the evidence, the examiner concludes that one ordinarily skilled in the art would require undue experimentation in order to practice invention across the full scope of invention as defined in 1, 3, 5, 8, 13, 25-29, 31, 33
Consequently, Claims 1, 3, 5, 8, 13, 25-29, 31, and 33 are rejected in accordance with 112(a) for lacking enablement.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 8, 25-29, and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hunt et al (USPN 11,091,464 B2) as evidenced by Venugopal (Venugopal V, Pavlakis S. Duchenne Muscular Dystrophy. [Updated 2023 Jul 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482346/).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Hunt teaches the elected species and methods for treating many of the diseases recited in claims 1, 3, 8, 25-29, and 33.
Specifically, Hunt teaches the elected species as compound 1 (Table 1, column 153-154, first compound).
Hunt teaches that the compounds can be used to treat neuromuscular conditions such as Duchenne Muscular Dystrophy (abstract), which is well-known in the art as “ one of the most common and most severe congenital myopathies” as evidenced by Venugopal (Venugopal V, Pavlakis S. Duchenne Muscular Dystrophy. [Updated 2023 Jul 10]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482346/).
Hunt also teaches methods for treatment for other diseases such as “multiple sclerosis, Parkinson's disease, Alzheimer's disease, or cerebral palsy, or injury, or a traumatic event such as stroke, traumatic brain injury, spinal cord injury, hypoxia, meningitis, encephalitis, phenylketonuria, or amyotrophic lateral sclerosis (column 1, lines 38-62).”
Consequently, Hunt teaches the elements of claims 3, 1, 8, and 33
Hunt also teaches combination therapies, specifically that “Also contemplated herein are combination therapies, for example, co-administering a disclosed compound and an additional active agent, as part of a specific treatment regimen intended to provide the beneficial effect from the co-action of these therapeutic agents (column 91, lines 35-51).”
Consequently, Hunt teaches the elements of claim 25, “further comprising administering an additional active agent.”
Hunt also teaches administration of oral corticosteroids, specifically that “In certain embodiments, a compound or salt of the disclosure may be administered in combination with an oral corticosteroid. In certain embodiments, a compound or salt of the disclosure is administered in combination with deflazacort. In certain embodiments, a compound or salt of the disclosure is administered in combination with prednisone (column 92, lines 11-15).”
Consequently, Hunt teaches the elements of instant claims 26-29, “wherein the additional active agent comprises a corticosteroid,” “administered orally,” and where the corticosteroid is “deflazacort” and “prednisone.”
Therefore, claims 1, 3, 8, 25-29, and 33 are rejected as being anticipated by Hunt.
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.
Claim 1, 3, 5, 8, 13, 25-29, 31, 33, and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 30 of U.S. Patent No. 11,091,464 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘464 recites methods for treating neuromuscular conditions using the identical compounds as the instant invention; therefore, contain substantially identical subject matter to the instant claims, which is directed towards treating specific neuromuscular conditions using identical compounds.
"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01, II.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the condition of treatment from generic neuromuscular conditions to the specific neuromuscular conditions (i.e.: Duchenne Muscular Dystrophy (DMD)) as recited in instant claims.
Therefore, the subject matter of the claims in not patentably distinguishable.
Consequently, the claims are rejected on grounds of nonstatutory obviousness-type double patenting.
Conclusion
Claims 1, 3, 5, 8, 13, 25-29, 31, and 33 are under consideration and are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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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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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622