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 .
Claim Status
Claims 1-16 are pending. Claims 1-16 are examined on merits.
Priority
This application is a continuation-in-part of U.S. Non-Provisional Patent Application 18/128,858, filed on March 30, 2023, which claims the benefit of U.S. Provisional Patent Application No. 63/325,260, filed on March 30, 2022.
Information Disclosure Statement
The IDS submitted on 03/05/2024 is under consideration.
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, 2, and 5 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 1, and claims dependent on it, comprises low molecular weight hydrolyzed collagen with a molecular weight of about 10-499 Daltons. However, the composition further comprising bovine sourced hydrolyzed collagen, marine sourced hydrolyzed collagen, and hydrolyzed whey makes it unclear what the actual constituent percentage of each of the collagen component is present in the composition to read on the claim. For example, (i) the composition including some or any of the bovine and/or marine sourced hydrolyzed collagen, and/or hydrolyzed whey along with the low molecular weight hydrolyzed collagen; or (ii) the composition of low molecular weight hydrolyzed collagen is made of bovine, marine hydrolyzed collagen; and hydrolyzed whey protein only. It is to be noted that claims 2 and 5 also has multiple collagen components in the composition.
Claim 2 recite “further comprising bovine sourced hydrolyzed collagen, marine sourced hydrolyzed collagen, and hydrolyzed whey”. However, claim 2 depends upon claim 1, and parent claim 1 is silent about the exact composition. The phrase “further comprising” is a relative term which renders the claim indefinite. The phrase “further comprising” is unclear, the instant specification does not provide if (i) the collagen from claim 1 and one of the two additional collagens or whey protein are included; or (ii) if “further comprising bovine sourced hydrolyzed collagen, marine sourced hydrolyzed collagen, and hydrolyzed whey” is further limiting the collagen composition of claim 1 to bovine and marine collagen including the addition of whey. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP §2173.05(d).
Claim 5 recite “the composition comprises about 70% by weight bovine sourced hydrolyzed collagen, about 20% by weight marine sourced hydrolyzed collagen, and about 10% by weight hydrolyzed whey”. The instant specification defines the term “about” as refers to a ±15% variation from the nominal value unless otherwise indicated or inferred (see page 5, 4th paragraph). Additionally, the specification states that the composition may include about 1% by weight to about 99% by weight hydrolyzed collagen. For example, the composition may include about 10% by weight to about 85% by weight hydrolyzed collagen or about 20% by weight to about 75% by weight hydrolyzed collagen, or about 30% by weight to about 65% by weight hydrolyzed collagen. The hydrolyzed collagen is preferably LMW hydrolyzed collagen. The composition may include about 0.1% by weight to about 65% by weight of soluble or insoluble native collagen. For example, the composition may include about 2% by weight to about 45% by weight of soluble or insoluble native collagen, or about 10% by weight to about 30% by weight of soluble or insoluble native collagen. The composition may include hydrolyzed collagen cross-linked with native collagen. For example, the composition may include about 0.1% by weight to about 65% by weight insoluble or soluble native collagen crosslinked with LMW hydrolyzed collagen. Other amounts below and above these ranges may be used (see page 11, 2nd paragraph). Claim 5 depends upon claim 2, which is dependent on claim 1, and the parent claim 1 is silent about the exact composition. Therefore, it is unclear if (i) the composition comprise % collagen specified in claim 5 and the collagen as claimed in claim 1; or (ii) does claim 5 further limits collagen composition of claim 1. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See MPEP §2173.05(d).
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.
Claims 1-4, 7-9, 11, 13, and 14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hausmanns et. al. (WO2020127929A1; published June 25, 2020; see attached translation obtained from EPO on 05/28/2026).
For claim 1: Hausmanns et. al. teaches collagen peptide for use in a method for the treatment of the human or animal body by therapy, the peptide having a molecular weight in a range of 0.18 to 10.0 kDa (see Abstract). Hausmanns et. al. further discloses preferred embodiment, collagen peptide, for use in a method for the therapeutic treatment of the human or animal body, has a molecular weight in the range of 0.18 to 0.98 kDa, preferably 0.19 to 0.98 kDa, preferably 0.20 to 0.98 kDa, preferably 0.25 to 0.98 kDa, preferably 0.30 to 0.98 kDa, preferably 0.35 to 0.98 kDa, preferably 0.40 to 0.98 kDa, preferably 0.45 to 0.98 kDa, preferably 0.50 to 0.98 kDa (see [0063). Hausmanns et. al. teaches collagen is used in denatured form, or in the form of hydrolyzates (see [0008]). Further specifies a preferred embodiment of the invention, the collagen peptide is not used as the only physiologically active constituent of a product, in particular a pharmaceutical composition, a food supplement, a cosmetic composition or a foodstuff or luxury food, it can be combined with one or more further components which have a positive effect on general health….such components are …. other proteins, hydrolyzates and peptides such as soy, wheat and whey protein (see [0096]).
Therefore, a composition comprising low molecular weight hydrolyzed collagen is anticipated.
For claim 2: Hausmanns et. al. discloses collagen peptide according to the invention comprises an amino acid sequence occurring in collagen from vertebrates, in particular from fish, amphibians, reptiles, birds and mammals, especially in human, bovine, porcine, equine or avian collagen (see [0055]); as well as other proteins, hydrolyzates and peptides such as soy, wheat and whey protein (see [0096]).
Thus Hausmanns et. al. anticipates composition comprising bovine sourced hydrolyzed collagen, marine sourced hydrolyzed collagen, and hydrolyzed whey protein.
For claims 3 and 4: Hausmanns et. al. teaches collagen peptide with a molecular weight in a range from 0.18 to 10.0 kDa, in particular 0.18 to 5.0 kDa, in particular 1.1 up to 5.0 kDa (see [0024]). And Hausmanns et. al. also teaches about production of composition of collagen peptide of a vertebrate, in particular a mammal, a bird, a fish, an amphibian, a reptile or an invertebrate (see claim 16).
Therefore, Hausmanns et. al. anticipates using a low molecular weight bovine or marine sourced collagen in a pharmaceutical or food composition.
For claim 7: Hausmanns et. al. discloses the present invention relates to a food supplement comprising a collagen peptide according to the invention and at least one food-acceptable additive, and the food supplement for use in a method for the therapeutic treatment of the human or animal body (see [0093]). This is in direct correlation to the definition of medical food in the instant specification which states “Medical foods are foods that are formulated to be consumed or administered under supervision of a physician and which are intended for the specific dietary management of a disease condition for which distinctive nutritional requirements are established by medical evaluation. The composition formulated for use as a medical food may be formulated for oral consumption or for tube feeding” (see page 16, 1st paragraph).
Hausmanns et. al. further discloses the food supplement…… contain no further proteins or peptides, in particular no further collagen peptides, in addition to the collagen peptide according to the invention (see [0097]).
For claim 8: Hausmanns et. al. teaches the nutritional supplement according to the invention is particularly advantageously in the form of a tablet, lozenge, sachet, solution, suspension or gel, for example in an ampoule, as granules or powder. Due to its good solubility, the collagen peptide according to the invention can also be added to various beverages without causing cloudiness (see [0093]).
For claim 9: Hausmanns et. al. discloses the present invention also relates to a cosmetic product comprising a collagen peptide according to the invention and at least one skin-compatible additive, as well as the cosmetic product for use in a method for the therapeutic treatment of the human or animal body, in particular for use in at least one of the aforementioned indications(see [0094]).
For claim 11: Hausmanns et. al. discloses produced collagen peptide, for use in a method for treating wounds, in particular chronic wounds, acute wounds and / or burns (see [0073]).
For claims 13 and 14: Hausmanns et. al. discloses the non-therapeutic use of the collagen peptide for the visual and structural improvement of the skin, in particular for reducing wrinkles, improving skin elasticity, increasing skin resilience, increasing the moisture content of the skin, reducing cellulite and/or reducing stretch marks (see [0082] [0083]). Aging related wrinkles is in direct correlation as the instant specification states “compositions may be formulated for topical cosmetic applications, such as for anti-aging or anti-wrinkle applications” (see page 19, 1st paragraph). Accordingly, the claims are anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hausmanns et. al. (WO2020127929A1; published June 25, 2020; see attached translation obtained from EPO on 05/28/2026), as previously applied to claims 1-4, 7-9, 11, 13, and 14; and further in view of Petito (US 20160220645 A1; published August 04, 2016).
Hausmanns et. al. discusses the use of collagen peptide for the treatment of the human or animal body, the peptides having a molecular weight in a range of 0.18 to 10.0 kDa (see Abstract). Hausmanns et. al. further discloses that the collagen peptide, for use in a method for the therapeutic treatment of the human or animal body, has a molecular weight in the range of 0.18 to 0.98 kDa (see [0063]). As noted above, this reference anticipates claims 1-4, 7-9, 11, 13, and 14.
The difference between this reference and the remaining claims is that it does not specify the additional components of the composition, e.g., glucosamine, glycosaminoglycans, aloe, benzocaine, lidocaine, glutamine, zinc, alginates, cellulose, bioactive glass, and/or honey, etc.
Petito teaches the composition for tissue/cell repair facilitates healing of damaged tissues, promoting tissue and cell growth, protecting cells and tissues, and reducing scar tissue. The composition includes hydrolyzed collagen; the hydrolyzed collagen may be combined with native collagen and/or at least one other therapeutic agent. For example, the therapeutic agent may be a polysulfated glycosaminoglycan, a glucosamine salt, or mixtures thereof (see Abstract). This reference links hydrolyzed collagen composition taught by Hausmanns et. al. to additional components of the composition in the instant therapeutic agent.Therefore, it would be obvious to use lower molecular weight collagen peptide as taught by Hausmanns et. al. As the reference uses hydrolyzed collagen of molecular weight of about 10-499 Daltons (which mostly encompasses and overlaps with the instant claim range), an artisan in this field would predict that such a range would be effective in preparations of medical, cosmetic, pharmaceutical, and nutritional compositions with a reasonable expectation of success.
Regarding claim 5: Petito discloses the composition comprises: about 10% to about 70% by weight bovine sourced hydrolyzed collagen, about 20% to about 80% by weight marine sourced hydrolyzed collagen, and about 5% to about 30% by weight whey protein (see claim 14). Petito also claims the method of treating a wound further comprising administering to the patient a second composition after the first composition is administered and during the closing phase of wound healing, the second composition including about 50% by weight bovine sourced hydrolyzed collagen, about 20% to about 30% by weight marine sourced hydrolyzed collagen, up to about 10% by weight hydrolyzed whey protein, and up to about 20% by weight elastin (see claim 18).
Regarding claim 6: Petito discloses the composition can include one or more therapeutic agents, such as an antibiotic, and/or one or more additives, such as glutamine, glycosaminoclycans, zinc, alginates, cellulose, and/or honey (see [0027]).
Thus regarding claims 5 and 6, it would have been obvious to combine the teachings of Hausmanns et. al. and Petito before the effective filing date of the claimed invention by modifying the compositions to arrive at the claimed composition. One of ordinary skill in the art would have been motivated to optimize the percentage compositions taught by Hausmaans et. al. along with additional therapeutic agents taught by Petito. Thus, one skilled in the art can adjust the composition of hydrolyzed collagen of low molecular weight (instant claim) so that it is optimally effective for would healing, skin repair, and food/nutritional supplements.
Regarding claim 10: Petito discloses the composition comprising at least one of a glycosaminoglycan, zinc, an alginate, cellulose, antibiotic, honey, and glutamine (see claim 13). Petito further teaches the composition may be formulated; for example, at least one of vitamin A, vitamin C, vitamin E, vitamin B12, magnesium oxide, chelated manganese, grape seed extract, zinc, an alginate, cellulose, honey, chromium picolinate, selenium, glutamine, and glycosaminoglycans can be added to the composition (see [0036]).
Regarding claim 12: Petito teaches the method and composition for tissue/cell repair facilitates healing of damaged tissues, promoting tissue and cell growth, protecting cells and tissues, and reducing scar tissue; and the therapeutic agent may be a polysulfated glycosaminoglycan, a glucosamine salt, or mixtures thereof (see [0010]). Petito teaches the composition may be formulated as a nutritional supplement. For example, at least one of vitamin A, vitamin C, vitamin E, vitamin B12, magnesium oxide, chelated manganese, grape seed extract, zinc, an alginate, cellulose, honey, chromium picolinate, selenium, glutamine, and glycosaminoglycans can be added to the composition to produce a nutrient composition for oral intake (see [0036]). Petito teaches a composition for promoting wound healing, comprising: a marine sourced collagen; whey protein; and at least one of a bovine sourced collagen and a porcine sourced collagen (see claim 10). Petito further teaches a method of treating a wound, comprising: administering to a patient a first composition, the first composition including a marine sourced collagen, a whey protein, and at least one of a bovine sourced collagen and a porcine sourced collagen (see claim 16).
Regarding claim 15: Petito teaches the composition may be used to heal topical and/or internal wound sites. For example, the composition may be used prior to and after surgery to minimize cell damage and to expedite wound healing. The composition may be useful during surgery to foster separation of tissue to prevent adhesion formation. The composition may be used as a filler for a wound site and remain in the wound site as it heals, becoming part of the granulated tissue (see [0030]).
Regarding claim 16: Petito teaches hydrolyzed collagen achieves bacteriostasis faster and longer than hydrolyzed collagen having a molecular weight less than 10,000 Daltons. Achieving bacteriostasis quickly and for an extended duration promotes better cell migration, and thereby accelerates recovery. Also, use of the composition may require fewer dressing changes, thereby minimizing costs for recovery (see 0015]).
The MPEP states that if prior art used in its normal and usual operation would perform the method claimed, then the method is considered anticipated by the prior art device [see MPEP 2112.02]. While Petito claims a composition containing 1% to about 99% by weight hydrolyzed collagen; and about 0.1% to about 65% by weight native collagen, and at least one antioxidant selected from the group consisting of lipoic acid, a vitamin, an omega compound, an omega-3-fatty acid compound, an antioxidant, and a phytochemical, wherein the hydrolyzed collagen is a high molecular weight collagen [claims 1-7], in the specifications Petito shows healing of damaged tissues, promoting tissue and cell growth (see [0012]). The method of using a hydrolyzed collagen treatment is thus, expected.
Thus regarding claims 10, 12, 15 and 16, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Hausmaans et.al. using hydrolyzed collagen of lower molecular weight and optimize the composition with addition of therapeutic agents as taught by Petito. One would be motivated to do so with a reasonable expectation to succeed because using the range encompassed by 0.18 to 0.98 kDa molecular weight of the bovine, marine, and whey sourced hydrolyzed collagen (see [0145]) as taught by Hausmanns et. al., would lead to tissue/cell repair, facilitate healing of damaged tissues, promoting tissue and cell growth, protecting cells and tissues, and reducing scar tissue (see Abstract) as taught by Petito.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use the combination of bovine and marine sourced hydrolyzed collagen and hydrolyzed whey protein as taught by Petito.
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e., applicants individual components in the composition of low molecular weight hydrolyzed collagen and their use in treating wound, minimize cell damage, skin repair, etc. were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art. Therefore, it would have been obvious to one of ordinary skill in the art to make the instantly claimed low molecular weight hydrolyzed collagen composition with a reasonable expectation of succeed.
Conclusion
No claim is allowed.
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/KOYELI BANERJEE/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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