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 .
Priority
This application is a national stage entry of PCT/EP2022/086563 filed on 12/19/2022. Acknowledgment is made of applicant's claim for foreign priority based on application no. EP 21306858.8 filed in Europe on 12/20/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of (-)-epicatechin as a species of at least one catechin; FGFR3-related skeletal disease as a species of FGFR gain-of-function mutation; and hypochondroplasia as a species of a FGFR3-related skeletal disease in the reply filed on July 8, 2026 is acknowledged. The traversal is on the ground(s) that the technical feature, which is the treatment of FGFR-related bone repair and bone formation impairment by catechin administration is a special technical feature since Legeai-Mallet et al. WO2019/145356 only teaches correcting bone growth defects and increasing the length of femurs and not repairing bone including bone healing and fracture healing. This is not found persuasive because Legeai-Mallet et al. teaches a method of treating a FGFR3-related chondrodysplasia, which includes hypochondroplasia and achondroplasia, in a patient in need thereof consisting of administering to the patient a therapeutically effective amount of (-)-epicatechin (pages 2 and 4). Thus, Legeai-Mallet et al. teaches treating the same patient comprising the administration of the same compound and thus the method of Legeai-Mallet et al. will inherently result in the same treatment of FGFR-related bone repair and bone formation impairment as claimed in the instant claims. As such, no special technical feature exists among the species of the generic invention because the technical feature fails to make a contribution over the prior art due to a corresponding lack of novelty and thus the species do not relate to and are not so linked as to form a single general inventive concept.
The requirement is still deemed proper and is therefore made FINAL.
Claims 3-5 and 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 is reminded that if the elected species is deemed allowable, the search will be extended to include additional non-elected species until all species are examined and deemed allowable.
Claims 1, 6-10, 17 and 18 are currently being examined as they read on the elected species.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6-10, 17 and 18 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.
The term “FGFR-related” in claim 1 and “FGFR3-related” in claim 8 are relative terms which renders the claim indefinite. The terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In the instant specification it is broadly stated “As used herein, the term "FGFR-related bone repair and bone formation and quality impairment" or "FGFR-related bone repair and bone formation impairment" refer to deficiencies procedure in the bone repair and the bone formation. FGFR-related bone repair impairment refers to a defective bone reparation.” It is further stated “As used herein the term "FGFR3-related skeletal disease" is intended to mean a skeletal disease that is caused by an abnormal increased activation of FGFR3, in particular by expression of a constitutively active mutant of the FGFR3 receptor, in particular a constitutively active mutant of the FGFR3 receptor as described above.”
Other than the specific diseases listed in claim 9, a person of ordinary skill in the art would not be able to determine based on the claim language and the description in the instant specification, what is meant by FGFR-related or FGFR3-related or how to determine if a condition meets this description. It is unclear what changes and to what degree to the fibroblast growth factor receptor (FGFR) is necessary to be considered related. Thus, an ordinary skilled artisan would not be able to ascertain the scope of the claims and determine the metes and bound of the claims. Therefore claims 1, 8, and all claims dependent upon said claims are rejected.
For the sake of compact prosecution, FGFR-related bone repair and bone formation impairment is interpreted as bone repair and bone formation impairment due to the skeletal conditions as claimed in claim 9 of the instant application, which is elected to be hypochondroplasia, and FGFR3-related skeletal disease is interpreted as the skeletal diseases as claimed in claim 9, which is elected to be hypochondroplasia.
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, 6-10, 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11,951,090 B2 in view of TSUNODA et al. JP-2004161669 A (Machine English Translation provided). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claim of ‘090 are substantially overlapping in scope and mutually obvious.
Claims 1, 6-10, 17 and 18 of the instant application claim a method for the treatment of FGFR-related bone repair and bone formation impairment in a subject in need thereof such as a subject with hypochondroplasia, comprising administering to the subject a therapeutically effective amount of at least one catechin such as (-)-epicatechin, wherein the subject is an adult.
Claim 1 of ‘090 claims a method of treating a FGFR3-related chondrodysplasia in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a substantially pure (−)-epicatechin, wherein the step of administering comprises administering to the patient a pharmaceutical composition comprising the substantially pure (−)-epicatechin as an active principle and at least one pharmaceutically acceptable excipient, and wherein the pharmaceutical composition does not comprise a Theobroma cacao extract.
Claim 1 of ‘090 does not specifically claim treatment of bone repair and bone formation impairment. Claim 1 of ‘090 does not claim a food composition comprising (-)-epicatechin.
However, claim 1 of ‘090 specifically claims treating the same patient as claimed having a FGFR3-related chondrodysplasia, comprising the same compound which is (-)-epicatechin, and thus the treatment method of claim 1 of ‘090 will necessarily treat the bone repair and bone formation impairment in the same subject as claimed.
In addition, Tsunoda et al. specifically teaches that catechins including (-)-epicatechin can inhibit osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblast (abstract). Tsunoda et al. teaches an osteogenesis promoting agent containing a catechin or a catechin mixture as an active ingredient in the form of a food or drink that is useful as an osteoblast death inhibitor or an agent promoting osteoblast proliferation, differentiation or maturation and osteogenesis promotion [0011]. Tsunoda et al. specifically teaches the catechin can be selected as (-)-epicatechin as a bone formation promoting agent or bone promoting food or drink [0015]-[0016]. Thus Tsunoda et al. specifically teaches that (-)-epicatechin has the properties of repairing and forming bone.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat a FGFR3-related chondrodysplasia in a patient in need thereof comprising administering to the subject a therapeutically effective amount of a substantially pure (-)-epicatechin, as claimed in ‘090 with the expectation that said treatment would treat bone repair and bone formation impairment since Tsunoda et al. specifically teaches that (-)-epicatechin is a bone formation promoter that inhibits osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblasts. Thus since (-)-epicatechin is a bone formation promoter, an ordinary skilled artisan would have been motivated to administer (-)-epicatechin to treat FGFR3-related chondrodysplasia with a reasonable expectation that said treatment will also treat bone repair and bone formation impairment associated with the chondrodysplasia.
Claim 18 is rendered obvious since Tsunoda et al. teaches that the (-)-epicatechin is available as a food or drink and thus an ordinary skilled artisan would have been motivated to administer the (-)-epicatechin as a food with a reasonable expectation of success. Although ‘090 does not specifically specify treating adults, treatment of all patients including adults would have been contemplated since the claims do not exclude any particular subject.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claims 1, 6-10, 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 12,257,232 B2 in view of TSUNODA et al. JP-2004161669 A (Machine English Translation provided). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claim of ‘232 are substantially overlapping in scope and mutually obvious.
Claims 1, 6-10, 17 and 18 of the instant application claim a method for the treatment of FGFR-related bone repair and bone formation impairment in a subject in need thereof such as a subject with hypochondroplasia, comprising administering to the subject a therapeutically effective amount of at least one catechin such as (-)-epicatechin, wherein the subject is an adult.
Claims 1-3 of ‘232 claim a method of treating a FGFR3-related chondrodysplasia in a patient in need thereof comprising administering to the patient a therapeutically effective amount of a substantially pure (−)-epicatechin in a pharmaceutical composition that does not comprise flavonols, sweroside, hexenyl 5 xylopyranosyl glucopyranoside, procyanidin, catechin, cinchonain, or quercitin, wherein the FGFR3-related chondrodysplasia may be selected as hypochondroplasia.
The claims of ‘232 do not specifically claim treatment of bone repair and bone formation impairment or a food composition comprising (-)-epicatechin.
However, the claims of ‘232 specifically claim treating the same patient as claimed having a FGFR3-related chondrodysplasia, comprising the same compound which is (-)-epicatechin, and thus the treatment method of the claims of ‘232 will necessarily treat the bone repair and bone formation impairment in the same subject as claimed.
In addition, Tsunoda et al. specifically teaches that catechins including (-)-epicatechin can inhibit osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblast (abstract). Tsunoda et al. teaches an osteogenesis promoting agent containing a catechin or a catechin mixture as an active ingredient in the form of a food or drink that is useful as an osteoblast death inhibitor or an agent promoting osteoblast proliferation, differentiation or maturation and osteogenesis promotion [0011]. Tsunoda et al. specifically teaches the catechin can be selected as (-)-epicatechin as a bone formation promoting agent or bone promoting food or drink [0015]-[0016]. Thus Tsunoda et al. specifically teaches that (-)-epicatechin has the properties of repairing and forming bone.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat a FGFR3-related chondrodysplasia in a patient in need thereof comprising administering to the subject a therapeutically effective amount of a substantially pure (-)-epicatechin, as claimed in ‘232 with the expectation that said treatment would treat bone repair and bone formation impairment since Tsunoda et al. specifically teaches that (-)-epicatechin is a bone formation promoter that inhibits osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblasts. Thus since (-)-epicatechin is a bone formation promoter, an ordinary skilled artisan would have been motivated to administer (-)-epicatechin to treat FGFR3-related chondrodysplasia with a reasonable expectation that said treatment will also treat bone repair and bone formation impairment associated with the chondrodysplasia.
Claim 18 is rendered obvious since Tsunoda et al. teaches that the (-)-epicatechin is available as a food or drink and thus an ordinary skilled artisan would have been motivated to administer the (-)-epicatechin as a food with a reasonable expectation of success. Although ‘232 does not specifically specify treating adults, treatment of all patients including adults would have been contemplated since the claims do not exclude any particular subject.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claims 1, 6-10, 17 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/717,710 (U.S. Publication No. 2025/0041262 A1) in view of TSUNODA et al. JP-2004161669 A (Machine English Translation provided). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claim of copending ‘710 are substantially overlapping in scope and mutually obvious.
Claims 1, 6-10, 17 and 18 of the instant application claim a method for the treatment of FGFR-related bone repair and bone formation impairment in a subject in need thereof such as a subject with hypochondroplasia, comprising administering to the subject a therapeutically effective amount of at least one catechin such as (-)-epicatechin, wherein the subject is an adult.
Claims 1-18 of copending ‘710 claim a method of treating a FGFR3-related cognitive deficit in a subject in need thereof comprising administering to the subject a therapeutically effective amount of at least one catechin, wherein the subject is child or an adult, the at least one catechin is (-)-epicatechin, and the FGFR3-related skeletal disease is hypochondroplasia (HCH).
The claims of copending ‘710 do not specifically claim treatment of bone repair and bone formation impairment or a food composition comprising (-)-epicatechin.
However, the claims of copending ‘710 specifically claim treating the same patient as claimed having a FGFR3-related chondrodysplasia, comprising the same compound which is (-)-epicatechin, and thus the treatment method of the claims of copending ‘710 will necessarily treat the bone repair and bone formation impairment in the same subject as claimed.
In addition, Tsunoda et al. specifically teaches that catechins including (-)-epicatechin can inhibit osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblast (abstract). Tsunoda et al. teaches an osteogenesis promoting agent containing a catechin or a catechin mixture as an active ingredient in the form of a food or drink that is useful as an osteoblast death inhibitor or an agent promoting osteoblast proliferation, differentiation or maturation and osteogenesis promotion [0011]. Tsunoda et al. specifically teaches the catechin can be selected as (-)-epicatechin as a bone formation promoting agent or bone promoting food or drink [0015]-[0016]. Thus Tsunoda et al. specifically teaches that (-)-epicatechin has the properties of repairing and forming bone.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat a FGFR3-related chondrodysplasia in a patient in need thereof comprising administering to the subject a therapeutically effective amount of a substantially pure (-)-epicatechin, as claimed in copending ‘710 with the expectation that said treatment would treat bone repair and bone formation impairment since Tsunoda et al. specifically teaches that (-)-epicatechin is a bone formation promoter that inhibits osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblasts. Thus since (-)-epicatechin is a bone formation promoter, an ordinary skilled artisan would have been motivated to administer (-)-epicatechin to treat FGFR3-related chondrodysplasia with a reasonable expectation that said treatment will also treat bone repair and bone formation impairment associated with the chondrodysplasia.
Claim 18 is rendered obvious since Tsunoda et al. teaches that the (-)-epicatechin is available as a food or drink and thus an ordinary skilled artisan would have been motivated to administer the (-)-epicatechin as a food with a reasonable expectation of success.
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-10, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Legeai-Mallet et al. WO 2019/145356 (Provided on IDS) in view of TSUNODA et al. JP-2004161669 A (Machine English Translation provided).
Claims 1, 6-10, 17 and 18 of the instant application claim a method for the treatment of FGFR-related bone repair and bone formation impairment in a subject in need thereof such as a subject with hypochondroplasia, comprising administering to the subject a therapeutically effective amount of at least one catechin such as (-)-epicatechin, wherein the subject is an adult.
Legeai-Mallet et al. teaches the use of (-)-epicatechin for the treatment of FGFR3-related chondrodysplasias (abstract). Legeai-Mallet et al. teaches a method of treating a FGFR3-related chondrodysplasia in a patient in need thereof consisting of administering to the subject a therapeutically effective amount of a substantially pure (-)-epicatechin (page 2). Legeai-Mallet et al. teaches that the term“FGFR3-related chondrodysplasia” is intended to mean a skeletal disease that is caused by an abnormal increased activation of FGFR3, in particular by expression of a constitutively active mutant of the FGFR3 receptor, in particular a constitutively active mutant of the FGFR3 receptor (page 2).
Legeai-Mallet et al. teaches that in some embodiments, the FGFR3-related chondrodysplasia is an achondroplasia caused by expression of the G380R constitutively active mutant of the FGFR3 receptor (page 4). In some embodiments, the FGFR3-related chondrodysplasia is a hypochondroplasia caused by expression of the N540K, K650N, K650Q, S84L, R200C, N262H, G268C, Y278C, S279C, V381E, constitutively active mutant of the FGFR3 receptor (page 4).
Legeai-Mallet et al. teaches that treatment refers to both prophylactic or preventive treatment as well as curative, improving the patient’s condition or disease modifying treatment, including treatment of patient at risk of contracting the disease or suspected to have contracted the disease as well as patients who are ill or have been diagnosed as suffering from a disease or medical condition, and includes suppression of clinical relapse (page 4). The treatment may be administered to a subject having a medical disorder or who ultimately may acquire the disorder, in order to prevent, cure, delay the onset of, reduce the severity of, or ameliorate one or more symptoms of a disorder or recurring disorder, or in order to prolong the survival of a subject beyond that expected in the absence of such treatment (page 4).
Legeai-Mallet et al. teaches that the daily dosage of the products may be varied over a wide range from 0.01 to 1,000 mg per adult per day (page 7). Typically, the compositions contain 0.01, 0.05, 0.1, 0.5, 1.0, 2.5, 5.0, 10.0, 15.0, 25.0, 50.0, 100, 250 and 500 mg of the active ingredient for the symptomatic adjustment of the dosage to the subject to be treated. A medicament typically contains from about 0.01 mg to about 500 mg of the active ingredient, preferably from 1 mg to about 100 mg of the active ingredient. An effective amount of the drug is ordinarily supplied at a dosage level from 0.0002 mg/kg to about 20 mg/kg of body weight per day, especially from about 0.001 mg/kg to 7 mg/kg of body weight per day (page 7).
Claims 1-4 of Legeai-Mallet et al. claim a method of treating a FGFR3-related chondrodysplasia in a patient in need thereof consisting of administering to the subject a therapeutically effective amount of a substantially pure (-)-epicatechin, wherein the FGFR3-related skeletal diseases are selected from the group consisting of thanatophoric dysplasia type I, thanatophoric dysplasia type II, hypochondroplasia, achondroplasia, severe achondroplasia with developmental delay and acanthosis nigricans, and hypochondroplasia.
Legeai-Mallet et al. does not specifically teach treatment of bone repair and bone formation impairment. Legeai-Mallet et al. does not teach a food composition comprising (-)-epicatechin.
However, Legeai-Mallet et al. specifically teaches treating the same patient as claimed having a FGFR3-related chondrodysplasia such as hypochondroplasia, comprising the same compound which is (-)-epicatechin, and thus the treatment method of Legeai-Mallet et al. will necessarily treat the bone repair and bone formation impairment in the same subject as claimed. A compound and its properties are inseparable. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). "Products of identical chemical composition cannot have mutually exclusive properties." 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. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Thus, administration of the same compound to the same subject will necessarily have the same effects as claimed which is to treat bone repair and bone formation impairment.
In addition, Tsunoda et al. specifically teaches that catechins including (-)-epicatechin can inhibit osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblast (abstract). Tsunoda et al. teaches an osteogenesis promoting agent containing a catechin or a catechin mixture as an active ingredient in the form of a food or drink that is useful as an osteoblast death inhibitor or an agent promoting osteoblast proliferation, differentiation or maturation and osteogenesis promotion [0011]. Tsunoda et al. specifically teaches the catechin can be selected as (-)-epicatechin as a bone formation promoting agent or bone promoting food or drink [0015]-[0016]. Thus Tsunoda et al. specifically teaches that (-)-epicatechin has the properties of repairing and forming bone.
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to treat a FGFR3-related chondrodysplasia in a patient in need thereof consisting of administering to the subject a therapeutically effective amount of a substantially pure (-)-epicatechin, wherein the FGFR3-related skeletal diseases is hypochondroplasia, as taught by Legeai-Mallet et al., with the expectation that said treatment would treat bone repair and bone formation impairment since Tsunoda et al. specifically teaches that (-)-epicatechin is a bone formation promoter that inhibits osteoblast death to promote, osteogenesis by osteocytes through advancing (enhancing) the proliferation/differentiation or maturation of osteoblasts. Thus since (-)-epicatechin is a bone formation promoter, an ordinary skilled artisan would have been motivated to administer (-)-epicatechin to treat FGFR3-related hypochondroplasia with a reasonable expectation that said treatment will also treat bone repair and bone formation impairment associated with the hypochondroplasia.
Claim 18 is rendered obvious since Tsunoda et al. teaches that the (-)-epicatechin is available as a food or drink and thus an ordinary skilled artisan would have been motivated to administer the (-)-epicatechin as a food with a reasonable expectation of success.
With respect to the limitation of the treatment of an adult subject, since Legeai-Mallet et al. teaches that the daily dosage of the products may be varied over a wide range from 0.01 to 1,000 mg per adult per day, and thus provides dosages suitable for an adult, treatment of an adult subject as claimed is rendered obvious (page 7).
Thus, the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1, 6-10, 17 and 18 are rejected. Claim 2 is canceled. Claims 3-5 and 11-16 are withdrawn. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
Prosecution Insights