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 .
Claims 11-18, 21 and 22 are pending in the application.
This action is in response to applicants' amendment dated September 23, 2026. Claims 11, 13 and 14 have been amended, claims 19 and 20 have been canceled and claim 22 is newly added.
Response to Amendment
Applicant's arguments filed September 23, 2026 have been fully considered with the following effect:
With regards to the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 2) in the last office action, the applicant’s amendments and Declaration under rule 1.132 have been fully considered but they are not found persuasive. The applicants’ stated the mechanisms of the two components in the pharmaceutical composition “were understood by the person of ordinary skill in the art as of the filing date and that the endpoints reported in Example 5 and 7 through 10 are not fracture specific clinical endpoints but rather, they are measurements of bone formation, cellular proliferation, defect filling, bone quality and mechanical competence. While the pharmaceutical composition has been shown to be affective for the treatment of fractured bones it does not provide enablement for the use of β-caryophyllene and a statin selected from the group consisting of lovastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin, pitavastatin, and any combinations thereof for the treatment of a bone-related disease or disorder generally. A bone-related disease or a disorder includes many diseases or disorders that are neither supported nor contemplated as well as diseases and disorders not even known at this time. It is difficult to treat many of the disorders claimed herein.
There are over 770 disease and/or disorders that are in the category “bone-related disease or a disorder”. The following are bone related disorders known as of May 1, 2023 (Unger et al. herein provided) many of which are neither supported nor contemplated: Thanatophoric dysplasia (type 1), Thanatophoric dysplasia (type 2), Severe achondroplasia with developmental delay and acanthosis nigricans, Achondroplasia, Hypochondroplasia, Achondrogenesis, Hypochondrogenesis, Platyspondylic dysplasia, type Torrance, Spondyloepiphyseal dysplasia congenita, Spondyloepimetaphyseal dysplasia, Kniest dysplasia, Spondyloperipheral dysplasia, SED with metatarsal shortening, Stickler syndrome, Dysplasia of the proximal femoral epiphyses, Marshall syndrome, Fibrochondrogenesis, Otospondylomegaepiphyseal dysplasia, Atelosteogenesis, Diastrophic dysplasia, Multiple epiphyseal dysplasia, Spondylo-epi-metaphyseal dysplasia, Chondrodysplasia with congenital joint dislocations, Chondrodysplasia with hypomyelinating leucodystrophy, Ehlers-Danlos syndrome, musculocontractural type, Osteochondrodysplasia, brachydactyly, Developmental Delay with Corpus Callosum, Skeletal, and Renal Abnormalities, Baratela-Scott syndrome, Desbuquois dysplasia, SEMD with joint laxity, Ehlers-Danlos syndrome, spondylodysplastic type 1, Skeletal dysplasia with joint laxity and advanced bone age, Skeletal dysplasia with joint dislocations and amelogenesis imperfecta, Frontometaphyseal dysplasia, Cardiospondylocarpofacial syndrome, Melnick-Needles syndrome, Otopalatodigital syndrome type 1, Otopalatodigital syndrome type 2, Terminal osseous dysplasia, Larsen syndrome, Atelosteogenesis type 1, Atelosteogenesis type 3, Spondylocarpotarsal synostosis syndrome, Frank-ter Haar syndrome, Dyssegmental dysplasia, Myotonic chondrodystrophy, Spondylo-epiphyseal dysplasia, Spondylo-epi-metaphyseal dysplasia, Short stature with advanced bone age, Metatropic dysplasia, etc.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
Claims 11-18, 21 and 22 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, for reasons of record and stated above.
The applicants’ amendments are sufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection, labeled paragraph 3) in the last office action, which is hereby withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
