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 .
Detail Action
Claims 1-3, 5, 7, 14, 16, 18-23, 24-30 submitted on 9/10/2026 are pending for examination.
Applicants’ election on 9/10/2026 without traverse of group I (claims 1-3, 5, 7, 14, 16, 18-23 ) directed to a method for increasing calcium absorption in a mammal, the mammal having a diet that includes calcium, the method comprising: administering to the mammal a therapeutically effective amount of a chondroprotective nutraceutical composition sufficient to increase calcium absorption in the mammal, the chondroprotective nutraceutical composition comprising a collagen, in their response against the restriction requirement of 7/14/2026 is acknowledged. Restriction requirement of 7/14/2026 comprise non elected subject of claims 24-30 are withdrawn.
Claims 1-3, 5, 7, 14, 16, 18-23 are for examination. Election made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4//16/2024 in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the IDS statement.
Claim Objections
Claim 2-3, 5, 7, 14, 16, 18-23 are objected for the following reason:
Claims 2-3, 5, 7, 14, 16, 18-23 depends on claim 1 and claims 2-3, 5, 7, 14, 16, 18-23 recite :A method. Each claim of Claims 2-3, 5, 7, 14, 16, 18-23 should recite The method. Correction is required.
Claim Rejections: 35 USC § 112(b)
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 19, 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
Claim 19 is indefinite in reciting “at least about 10mg ” make the claims unclear because it lack metes and bound. It may be at least 10mg or it can be about 10mg.
. Correction is required.
Claim 19 is indefinite in reciting “less than about 3,000 mg” make the claims unclear because it lack metes and bound. It may be less than 3,000 mg or it can be about 300mg.
. Correction is required.
Claim 23 is indefinite in reciting “the diet of the mammal is calcium deficient” make the claims unclear because the claim 23 depends on claim 1 and claim 1 recites a diet that includes calcium. Therefore dependent claim cannot be calcium deficient. Clarity required.
Claim Rejections, 35 U.S.C 112(a) 1st Paragraph
The following is a quotation of the first paragraph of 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, 7, 14, 16, 18-23 are rejected under 35 U.S.C. 112(a), first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claim 1-3, 5, 7, 14, 16, 18-23 is rejected under 35 U.S.C. § 112, first paragraph, as the disclosure is enabling only for claims limited to an amount of a chondroprotective nutraceutical composition comprising 10mg to 300mg UCII collagen to increase calcium absorption in the mammal not enabling treating any diseases related to Calcium deficiency using therapeutically effective amount of a chondroprotective nutraceutical composition to increase calcium absorption in the mammal, the chondroprotective nutraceutical composition comprising any collagen of any amount.
Factors to be considered in determining whether undue experimentation is required, are summarized in re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988) [ Ex parte Forman [230 USPQ 546 (Bd. Pat. App. & Int. 1986)]. The Wands factors are: (a) the quantity of experimentation necessary, (b) the amount of direction or guidance presented, (c) the presence or absence of working example, (d) the nature of the invention, (e) the state of the prior art, (f) the relative skill of those in the art, (g) the predictability or unpredictability of the art, and (h) the breadth of the claim.
It is neither taught nor any data is provided for using administering to the mammal any therapeutically effective amount of a chondroprotective nutraceutical composition comprising any collagen for the treatment of any of the diseases or disorders associated with calcium deficiency. There is no evidence presented that any collagen is associated with any of the known diseases or disorders associated calcium deficiency or can be treated by administering any collagen of any amount. Without such a data or evidence, claims to composition comprising therapeutically effective amount of any collagen, would amount to a composition or potential drug for treatment for any disorder or disease associated calcium deficiency by using any chondroprotective nutraceutical composition comprising any collagen, which is not enabled. Given the lack of direction or guidance and the nature of the invention, obtaining such a y therapeutically effective composition for one of skill in the art would be highly unpredictable. This is because the polypeptide like collagen when associated with a particular disease or disorder would be expressed differentially. Manipulating or controlling these levels depends upon the disease or disorder and may not always be controlled by supplementing with such a collagen composition. Further, no guidance in provided, pertaining to the fate of the administrated polypeptide in vivo.
Since it is not routine in the art to engage in de novo experimentation to prepare numerous compositions where the expectation "of success is unpredictable", the skilled artisan would require additional guidance, specific to individual disorder or disease, in order to make and use any therapeutically effective compositions in a manner reasonably commensurate with the scope of the claims. Without such guidance, the experimentation left to those skilled in the art is undue.
Conclusion
Claims 1-3, 5, 7, 14, 16, 18-23 are rejected and no claim is allowable.
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to Mohammad Meah whose telephone number is 571-272-
1261. The examiner can normally be reached on 8:30-5PM.
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supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number
for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/Examiner, Art Unit 1652
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