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 .
Status of the Claim
Claims 1-3, 8-13 and 15-22 are pending. Claims 1-3, 8-10, 15-16 and 20-22 are under examination. Claims 11-13 and 17-19 are withdrawn from consideration. Any objections or rejections not repeated below have been withdrawn.
Claim Rejections - 35 USC § 112
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.
Claims 1-3, 8-10, 15-16 and 20-22 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 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites, “A composition comprising elastin… wherein the elastin is insoluble.” However, upon further review of the specification it is found that this limitation is never disclosed in regards to the elastin composition, which is formed from the method steps outlined in the invention summary, see pg. 2 lines 1-15. The specification only states the solubility of the elastin in its natural form before any processing of the animal skin. Page 3 line 1 of the specification states, “Elastin is an insoluble protein found in the skin of animals.” Thus, the limitation regarding the solubility of the elastin, in the composition comprising elastin, is considered new matter since it is not present in the disclosure.
Claims 2-3, 8-10, 15-16 and 20-22 are included in the rejection because they depend from or otherwise include the rejected base claim.
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 1-3, 8-10, 15-16 and 20-22 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 line 6 recites, “wherein the elastin is insoluble.” However, it is unclear what medium the elastin is insoluble in. Is it insoluble in water, organic solvent, etc.? Further review of the specification does not provide clarification. The specification pg. 3 line 1 states, “Elastin is an insoluble protein” but does not specify the medium that the elastin is insoluble in, e.g. water insoluble. For the purpose of examination, the limitation “wherein the elastin is insoluble” will be viewed as water insoluble elastin, including water insoluble elastin that has been hydrolyzed or otherwise treated for degradation.
Claims 2-3, 8-10, 15-16 and 20-22 are included in the rejection because they depend from or otherwise include the rejected base claim.
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.
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.
Claims 1-3, 8-10, 15-16 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kitagawa et al. (US20160303021), as evidenced by Neuman et al., The Determination of Hydroxyproline, University of Cincinnati.
Regarding claim 1 and claim 2, Kitagawa teaches a composition comprising elastin [0001], as required by claim 1.
Kitagawa teaches the composition comprising elastin also comprises collagen and proteoglycan, where the weight ratio of collagen to the sum weight of elastin + proteoglycan can be 1:10 and the weight ratio of collagen to proteoglycan can be 1:0.2 ([0015-0016], [0018], Claims 1 and 3). Therefore, the weight ratio of collagen to elastin to proteoglycan will be viewed as 1:9.8:0.2, or 9% collagen, 89% elastin and 2% proteoglycan. Kitagawa does not explicitly state the protein content in their composition. However, since collagen and elastin are both protein, the composition of Kitagawa, which comprises a total of about 98% combined elastin and collagen, is viewed as having a protein content of at least 98%. This is within the claimed range of the composition having a protein content of at least 60 wt%, as required by claim 1.
Kitagawa does not teach particle size of the composition but does teach that the composition can be present in an oral composition that is in the form of powders ready for dissolving [0053] and Kitagawa also discusses how the collagen portion of the composition is dried and reduced to a powder form [0033]. It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention to utilize a particle size as defined by claim 1, where 90 V% of the composition has a particle size of less than 310 µm, since particle size is a matter of application for the product and can be easily reduced to whatever size is needed [0033] [0053].
Kitagawa does not discuss the amount of hydroxyproline in the composition. However, as evidenced by Neuman, hydroxyproline naturally occurs in elastin and collagen (pg. 6 Table II). The average amount of hydroxyproline from various collagen sources listed in Neuman is 13.0 wt%. This average amount of hydroxyproline from collagen is calculated from the 11 collagen sources listed, starting with the row “Cattle hide” at 13.2 down to the row listing “Fish skin” at 9.1. The average amount of hydroxyproline from various elastin sources listed in Neuman is 1.6 wt%. This average amount of hydroxyproline from elastin is calculated from the 6 elastin sources listed, starting with the row “Cattle ligamentum nuchae” at 1.84 down to the row listing “Sheep aorta” at 1.46, elastin sources (pg. 6 Table II).
Looking at the amount of 9% collagen and 89% elastin in Kitagawa, the total amount of hydroxyproline can be calculated in the composition. It is noted, proteoglycan does not contain the amino acid hydroxyproline.
Amount of hydroxyproline from collagen source: 9% collagen X 0.13 hydroxyproline = 1.17 wt%
Amount of hydroxyproline from elastin source: 89% elastin X 0.016 hydroxyproline = 1.42 wt%
Total amount of hydroxyproline in the composition is 2.59 wt %.
As shown by the above calculations, Kitagawa teaches the composition has a collagen content of about 9%, based on the ratios taught ([0015-0016], [0018], Claims 1 and 3). This is near the claimed range for collagen content of 2 to 8 wt. %. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I), Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kitagawa to incorporate the amount of collagen within the claimed range because Kitagawa does not particularly limit the amount of collagen in the composition [0015], [0036]. While the composition of Kitagawa can encompass the embodiments of collagen to elastin + proteoglycan ratios, it is not particularly limited to those embodiments [0015-0016]. Kitagawa states that the content of collagen in the composition can range from 1 to 99.9 wt. % based on different factors of the composition [0036].
Kitagawa teaches wherein the elastin is insoluble (elastin that can be used include water insoluble elastin that is hydrolyzed or otherwise treated for degradation; [0038]).
Regarding claims 3, 8-10 and 16, Kitagawa comprises a composition that is substantially identical to the claimed composition, as shown in the rejection for claims 1 and 2 above. Therefore, composition of Kitagawa is considered to have the properties as claimed in claims 3, 8-10 and 16. Specifically the composition of Kitagawa is considered to have a pH of from 4 to 5.5, as required by claims 3 and 16; to have a water binding capacity at 20°C of 200 to 500%, as required by claim 8, to have an oil binding capacity at 20°C of 110 to 350%, as required by claim 9, and to have an emulsification capacity of 60 to 95%, as required by claim 10. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (MPEP §2112.01 (I)).
Regarding claim 15, Kitagawa teaches a food or pet food comprising the composition of claim 1 and further food or pet food ingredients (the composition is used in an oral food or beverage composition, e.g. dissolved in foods such as coffee, tea, juice, yoghurt, soup, etc. or mixed in cooked food; composition is a health food or beverages or used in foods and beverages for pets, feeds for livestock, etc.; composition is mixed with other edible ingredients; [0053], [0062]).
Regarding claim 20, Kitagawa teaches the food or pet food of claim 15. Kitagawa does not explicitly state the percentage of the composition in the food or pet food. However, Kitagawa teaches 6.5 grams of the composition can be dissolved in water or fruit juice to provide a suitable beverage [0085]. Assuming an 8 fl. oz serving size of water, the composition would comprise about 2.7 wt. % of the composition. This is within the claimed range of 0.5 to 10 wt. % of the composition in the food or pet food.
Regarding claim 21, Kitagawa teaches the composition of claim 1. Kitagawa discloses the composition is an animal skin residue composition (derived from animals, in particular the connective tissues in the skin; extracts from living tissues of animals; [0031], [0038]).
Regarding claim 22, Kitagawa teaches the composition of claim 21. It is noted, the recitation, “wherein the animal skin residue composition is processed animal skin obtained from at least a partial collagen extraction” does not limit the claim, but is merely directed towards process steps to make the composition, instead of the composition. See MPEP 2113.I. Therefore, if the product in the product-by-process recitation in claim 21, is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Thus, the composition of Kitagawa, which is an animal skin residue composition is considered to meet the claim.
Response to Arguments
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive.
Claim Rejections – 35 USC § 103
Applicant argues, on pgs. 5-6 of their remarks, that collagen peptide and collagen are not the same substance and that elastin peptide and elastin are not the same substance. They explain that collagen peptide and elastin peptide are the hydrolyzed products of collagen and elastin. Applicant contends that the composition of claim 1 comprises collagen and water insoluble elastin, but Kitagawa is directed to a composition containing completely different constituents, specifically the hydrolyzed forms of collagen peptide and elastin peptide. They state it would not have been obvious to use the non-hydrolyzed elastin and collagen in Kitagawa. Applicant argues the composition of claim 1 is not obvious over Kitagawa or Neuman. However, the Office disagrees for the following reasons.
Upon reviewing claim 1, it is noted that the claim does not exclude elastin or collagen in their hydrolyzed peptide form. The Office still considers hydrolyzed elastin to still be a form of elastin and hydrolyzed collagen to still be a form of collagen. Kitagawa meets the claim limitations of claim 1 as a composition comprising elastin and collagen, since hydrolyzed elastin is elastin and hydrolyzed collagen is collagen.
Regarding the newly added limitation in claim 1, “wherein the elastin is insoluble,” it is unclear from the claim language what medium the elastin is insoluble in as this is not stated in the claim. Is it insoluble in water, organic solvent, etc.? Further review of the specification does not provide clarification. The specification pg. 3 line 1 states, “Elastin is an insoluble protein” but does not specify the medium that the elastin is insoluble in, e.g. water insoluble.
Additionally, the statement in the specification on pg. 3 line 1 is directed to the solubility of the elastin in its natural form before any processing of the animal skin. The specification never discloses the solubility of the elastin composition after it has been formed from the method steps outlined in the invention summary, see pg. 2 lines 1-15. Thus, as outlined in the 112(b) rejection, the limitation “wherein the elastin is insoluble” will be viewed as water insoluble elastin, including water insoluble elastin that has been hydrolyzed or otherwise treated for degradation. Therefore, Kitagawa is considered to teach the limitation “wherein the elastin is insoluble,” because it teaches the composition may comprise water insoluble elastin that is hydrolyzed or otherwise treated for degradation [0038]. Accordingly, the composition of claim 1 is rendered obvious by Kitagawa.
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.
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/S.R.G./Examiner, Art Unit 1791
/ELIZABETH GWARTNEY/Primary Examiner, Art Unit 1759