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 .
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 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.
Status of the Claims
Applicant’s election without traverse of Group I, drawn to a composition comprising Type II collagen combined with Vitamin A, carotenoid or mixtures thereof, was previously acknowledged. Election was made without traverse of collagen combined with Vitamin A, composition taken orally, undenatured collagen and lutein as the species of carotenoid. Upon further search and examination the elected species was broadened to include the non-elected species of carotenoids and topical application.
In the reply filed 1/8/26, Applicants amended claim 1.
Claims 1-3, 6-8, 10-12, 16-22 and 24-28 are pending.
Claims 16-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-3, 6-8, 10-12 and 24-28 read on the elected Group I and species and are under consideration.
Claim Objections-Withdrawn
The objected to claim 1 is withdrawn due to amendment of the claims
Claim Rejections - 35 USC § 112-Maintained
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.
The rejection of claims 1-3, 6-8, 10-12 and 24-28 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 written description requirement. The claim(s) contains 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 or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 1 is drawn to a composition for improving joint health comprising a type II collagen source comprising an undenatured and glycosylated collage, vitamin A and a carotenoid selected from the group consisting of lutein…..bacterioruberin and combinations thereof. The USPTO provides claim terms with broadest reasonable interpretation in light of the specification. The instant specification states that the composition contains one or more carotenoids (that are separate from the vitamin A species). The instant specification discloses that certain carotenoids are known to be antioxidant agents that can protect organisms from the adverse effects caused by active oxygen species (i.e. free radicals) [0035].The instant specification discloses suitable carotenoids in [0036-0037].
Assessment of whether species are support in the original specification
There were no embodiments of the invention that were reduced to practice at the time of filing. Applicants provided a list of potential carotenoids and vitamin A, however there were no embodiments of the composition reduced to practice.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, there is great variation within the genus of carotenoids. However, the instant specification did not provide adequate description of the entire genus.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of the carotenoids.
Carotenoids are a diverse class of naturally occurring pigments with antioxidant and signaling properties (Wurtzel; Plant Physiol. 2018;179(3):830-843). The biological activity of carotenoids differ substantially and there is no data that all carotenoids would provide benefit for joint tissue. In fact, The Mayo clinic (https://www.mayoclinic.org/drugs-supplements/beta-carotene-oral-route/description/drg-20066795 accessed 10/15/25) discloses that beta-carotene is associated with increased risk of lung cancer. Therefore, some carotenoids can be harmful in certain conditions. The instant specification does not provide data to suggest the physical basis for the activity and therefore do not describe which carotenoids would be expected to improve joint health.
In contrast, Imada et al. (Biochemical and biophysical research communications May 2016) teaches beta-cryptoxanthin exerts anti-arthritic actions and suggests that it is useful for blocking the progression of RA and osteoarthritis (Abstract).
This is an issue of written description. The specification does not make clear which carotenoids are in the genus and which are not because it does not describe the physical basis for the claimed activity.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession of beta-cryptoxanthin.
Response to Arguments
Applicant's arguments filed 1/8/26 have been fully considered but they are not persuasive. Applicants argue that the claims are not directed to a broad genus of carotenoids because the claims explicitly require the carotenoids to be selected from the group consisting of a finite list of structurally defined species. Applicants argue that the required group explicitly limits the claims to a structurally defined species. Applicants argue that each species is a chemically distinct carotenoid and one of ordinary skill in the art would recognize these compounds as well characterized carotenoids suitable for use in the composition as claimed. Applicants argue that the claim is limited to a finite list of carotenoids and each is readily identifiable in the art, thus the specification provides sufficient disclosure to demonstrate possession of these specific compounds. Applicants argue that the scope is fully supported and does not require a reduction to practice. Applicants argue that one of ordinary skill in the art would understand based on the disclosure that the inventor possessed knowledge to utilize the enumerated list as required by independent claim 1 to work effectively with type II collagen to increase effectiveness of the overall composition. Applicants argue that the claim does not encompass all carotenoids and each of the listed species is readily identifiable in the art and thus sufficient disclosure is demonstrated. Applicants argue that that the claims are drawn to species of carotenoids and the specification clearly describes the structural, physical and/or chemical properties of the required species. Applicants argue that the Office Action’s reliance on the alleged breadth and unpredictability of the carotenoids is inapposite as the claims do not encompass all carotenoids. Applicants argue that the Office Action’s application of the Mayo clinic document is over-reaching and PHOSITA would understand that some supplements may have adverse effects at different amounts in different combination or in different populations. Applicants argue that the specification clearly details the structural and chemical similarities of the carotenoids. For example, the specification highlights carotenoids with antioxidant activities such as lutein, zeaxanthin, lycopene crocetin etc.
These arguments were considered but are not persuasive because structural identification of genus members is insufficient to satisfy written description where the claim encompasses a broad genus of alternatively selected carotenoids in a specific multicomponent composition. Although each carotenoid may possess a known chemical structure, the specification must still reasonably convey the applicant had possession across the full scope of the recited carotenoid species, including the concentrations, and ratios with vitamin A and collagen. The specification provides no working examples, no representative formulations spanning the breadth of the claimed genus. Certain carotenoids may be associated with the relevant biological activity, however knowledge of some species does not establish possession of the full claimed genus. This is particularly true when the genus contains numerous structurally and functionally diverse carotenoids. With respect to the Mayo clinic document, the Examiner stated that “Therefore, some carotenoids can be harmful in certain conditions.”. Therefore, the Examiner acknowledges that it may have adverse effects under certain conditions. In summary, a broad list is not possession. For the reasons presented above, the rejection is maintained.
Conclusion
No claims are allowed.
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 TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/Examiner, Art Unit 1654
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