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 .
CONTINUING DATA
This application has PRO 63/412,965 10/04/2022
This application has PRO 63/342,534 05/16/2022
Claims 1-20 are pending.
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 6 and 19-20 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 6 and claim 19 recite that the combination of L-carnosine and chondroitin-4-sulfate achieves a synergistic antioxidant and/or anti-inflammatory activity. This limitation is unclear because the specification does not provide any guidance for which amounts and ratios of L-carnosine and chondroitin-4-sulfate result in a synergistic effect. The skilled artisan would not know whether a given amount or ratio shows a synergistic effect because there is no guidance in the specification. For the purpose of examination, any composition meeting the amounts and ratios recited in the claims will be treated as though it achieves a synergistic effect.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 19 recites the broad recitation “5-15 wt%,” and the claim also recites “preferably, about 5-10 wt%,” which is the narrower statement of the range/limitation. Claim 19 also recites that “preferably,” the combination achieves a synergistic antioxidant and/or anti-inflammatory effect,” which is a narrower statement of the broader recitation of L-carnosine and chondroitin-4-sulfate. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 20 recites treating a disease “associated with an inflammatory and/or autoimmune reaction.” The specification paragraph [0049] exemplifies osteoarthritis, but does not define which other diseases are associated with an inflammatory and/or autoimmune reaction. “Associated with” inflammatory and/or autoimmune reaction could mean that the disease is caused by the inflammatory and/or autoimmune reaction, or that the disease itself causes inflammatory and/or autoimmune reactions, or that disease occurs at the same time as the inflammatory and/or autoimmune reaction, or some other association. The skilled artisan would not know the scope of diseases to be treated because the specification does not define the diseases or the meaning of “associated with.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4 and 7-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (products of nature) without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite a composition comprising L-carnosine, chondroitin-4-sulfate, and a vehicle or carrier which can be water (claims 1 and 11). The composition can also contain aloe vera (claim 12), which is naturally occurring in the aloe plant and a magnesium salt (claim 7), which can be found in seawater. L-carnosine, chondroitin-4-sulfate, and water are all naturally occurring in cartilage and/or muscle tissue. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, the claimed compounds L-carnosine and chondroitin-4-sulfate naturally occur in cartilage, although not necessarily in the claimed amount of 0.5-15 wt%. Thus, the closest naturally occurring counterpart for the claimed composition is the claimed compounds in cartilage. The specification states that the combination of L-carnosine and chondroitin-4-sulfate exhibits synergism, but there is no data in the specification to establish that synergy is indeed present (as opposed to an additive effect), or which ratios of compounds would provide synergy. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring L-carnosine and chondroitin-4-sulfate because there is no difference in the L-carnosine and chondroitin-4-sulfate structure, function, or other properties. Likewise, there is no apparent difference in the structure or properties of aloe vera or magnesium salts when they are also present in the composition. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition which is intended for topical use. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the intended topical use and the topical forms recited in claim 12. The claimed dosage forms do not amount to significantly more than a combination of judicial exception because topical dosage forms are well-understood, routine, and conventional in the field. Jackson LM, Schwinn DA, editors (Compounded Topical Pain Creams: Review of Select Ingredients for Safety, Effectiveness, and Use. Washington (DC): National Academies Press (US); 2020 May 13. Appendix C, Commissioned Paper: Topical Dosage Form Development and Evaluation) teaches that topical products are generally available as liquids, ointments, gels, creams, and foams. Page 260, first paragraph.
In addition, applicant’s intended topical use is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 6, 9, 11, 12, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JPS63229058A (1988, machine translation).
JPS63229058A teaches a composition containing 3 cc of preservative solution, 0.6 g of collagen, 4 g of chondroitin, 0.1 g of carnosine, and 0.1 g of lecithin, which were combined and dissolved. See page 5, Example 2. Carnosine is L-carnosine (page 3, third line from the bottom). Assuming the preservative solution is about 3 g, the examiner calculates that the composition comprised about 9.5% chondroitin sulfate and about 2.4% carnosine, for a total of about 11.9%
The chondroitin sulfate is chondroitin-4-sulfate or chondroitin-6-sulfate. Page 4, first paragraph. A generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure. Although Example 2 does not specification whether the chondroitin sulfate was chondroitin-4-sulfate or chondroitin-6-sulfate, the skilled artisan would have immediately envisaged chondroitin-4-sulfate because it is one of only two chondroitin sulfates disclosed.
JPS63229058A does not apply the composition topically, but “topical” is an intended use of the composition and does not require that the composition is actually applied topically to a subject. The composition taught by JPS63229058A was suitable for topical administration as it was provided in an aqueous carrier and did not contain any ingredients unsuitable for topical use.
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.
Claim(s) 1-4, 6, 8-9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 1491638 A (2008, machine translation) in view of JPH07277943A (1995, machine translation).
CN 1491638 A teaches a skin care cosmetic comprising 2% carnosine and 0.5% chondroitin sulfate, along with water (a carrier), antiseptic, and other cosmetic ingredients (claim 4 and disclosure). More broadly, carnosine may be 1-10% and chondroitin sulfate may be 0.05-2% (claim 3), which results in a total of 1.05-12 wt%. The product is emulsified (Disclosure), which reads on a cream. Carnosine is naturally found in the L-form.
CN 1491638 A is silent about whether the chondroitin sulfate was chondroitin-4-sulfate and does not teach a combined amount of 5-10- wt%.
JPH07277943A teaches skin cosmetics containing chondroitin sulfate, wherein the chondroitin sulfate can be chondroitin-4-sulfate or chondroitin-6-sulfate [0008].
It would have been obvious to one of ordinary skill in the art at the time the application was filed to prepare the CN 1491638 A composition using chondroitin-4-sulfate because the CN 1491638 A is a skin composition and chondroitin-4-sulfate is useful in skin compositions, as taught by JPH07277943A. The skilled artisan would have also optimized the amounts of carnosine and chondroitin-4-sulfate using the guidance provided by CN 1491638 A. The claimed range 5-10 wt% lies inside the prior art range of 1.05-12%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05. The broad ranges of carnosine and chondroitin sulfate taught by CN 1491638 A include a 1:1 ratio.
Conclusion
Claims 1-4, 6-13, and 19-20 are rejected. Claims 5 and 14-18 are objected to as being dependent on a rejected base claim. CN 1491638 A is the closest prior art, but does not teach liposomal chondroitin-4-sulfate or the additional ingredients recited in claims 14-18.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA D BERRY whose telephone number is (571)272-9572. The examiner can normally be reached 7:00-3:00 CST, M-F.
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/LAYLA D BERRY/ Primary Examiner, Art Unit 1693