DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 8/27/2026 is acknowledged.
3. Claim filed on 8/27/2026 is acknowledged.
4. Claims 1-20, 27, 30 and 35 have been cancelled.
5. Claims 21-26, 28, 29, 31-34 and 36-40 are pending in this application.
6. Claims 22, 24, 26 and 36-38 remain withdrawn from consideration as being drawn to non-elected species.
7. Applicant elected with traverse of non-therapeutic method as species of method and/or effect from claims 22-24; powder as species of form of collagen hydrolysate from claim 28; and a collagen hydrolysate produced by enzymatic hydrolysis from skin of vertebrates with enzymes from Bacillus subtilis, wherein the collagen hydrolysate counters the shortening of telomeres in the cells of the body and does not contain any further active substances other than the collagen hydrolysate, wherein the collagen hydrolysate has an average molecular weight from 1,000 to 8,000 Da and 50% of the N-terminal amino acids are alanine, leucine and isoleucine, and wherein the collagen hydrolysate is administered at a daily dose from approximately 2 to approximately 15 g as species of collagen hydrolysate to be administered in the reply filed on 12/15/2025.
Please note: As stated in the previous office action, in view of the disclosure of instant specification, for the purpose of this examination, the Examiner is interpretating the elected species of collagen hydrolysate is a collagen hydrolysate produced by enzymatic hydrolysis from skin of vertebrates with enzymes from Bacillus subtilis, wherein the collagen hydrolysate counters the shortening of telomeres in the cells of the body and does not contain any further active substance that counters shortening of telomeres in the cells of the body other than the collagen hydrolysate, wherein the collagen hydrolysate has an average molecular weight from 1,000 to 8,000 Da and 50% of the N-terminal amino acids are alanine, leucine and isoleucine, and wherein the collagen hydrolysate is administered at a daily dose from approximately 2 to approximately 15 g as species of collagen hydrolysate to be administered.
Restriction requirement was deemed proper and made FINAL in the previous office action. The instant claims 21-26, 28, 29, 31-34 and 36-40 are drawn to a method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate to the human or the animal, wherein the collagen hydrolysate has an average molecular weight of from 1,000 to 8,000 Da, and wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body. A search was conducted on the elected species; and prior art was found. Claims 22, 24, 26 and 36-38 remain withdrawn from consideration as being drawn to non-elected species. Claims 21, 23, 25, 28, 29, 31-34, 39 and 40 are examined on the merits in this office action.
Withdrawn Objections and Rejections
8. Objection to claims 21, 23, 25, 27-35, 39 and 40 is hereby withdrawn in view of Applicant's amendment to the claim.
9. Rejection to claims 34, 35 and 40 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant's amendment to the claim.
10. Rejection to claims 21, 23, 25, 27-32, 39 and 40 under 35 U.S.C. 102(a)(1) as being anticipated by Asami et al (JP 2013227228 A, machine translation used and enclosed pages 1-16) is hereby withdrawn in view of Applicant's amendment to the claim.
11. Rejection to claims 21, 25, 27, 28 and 39 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 9-11 and 13-20 of co-pending Application No. 18/283653 is hereby withdrawn in view of Applicant's amendment to the claim.
12. Rejection to claims 21, 25, 27, 28 and 39 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 8, 9, 12 and 14-16 of co-pending Application No. 18/723198 is hereby withdrawn in view of Applicant's amendment to the claim.
13. Rejection to claims 21, 23, 25, 27-32, 39 and 40 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 and 10-16 of co-pending Application No. 17/736430 in view of Asami et al (JP 2013227228 A, machine translation used and enclosed pages 1-16) is hereby withdrawn in view of Applicant's amendment to the claim.
14. Rejection to claims 21, 23, 25, 27-30, 39 and 40 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of co-pending Application No. 17/997980 and in view of Asami et al (JP 2013227228 A, machine translation used and enclosed pages 1-16) is hereby withdrawn in view of Applicant's abandonment of Application No. 17/997980.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
15. 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.
16. Claim 39 remains 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 pre-AIA the applicant regards as the invention.
17. Claim 39 recites “The method according to claim 21, wherein the collagen hydrolysate is administered in a composition which does not contain any further active substances other than the collagen hydrolysate”. With regards to the recited “active substances”, the instant specification fails to define it. Therefore, it is unclear whether the recited “active substances” is limited to “active substance that counters shortening of telomeres in the cells of the body” or not. Thus, the metes and bounds of instant claim 39 is vague and indefinite.
Furthermore, in the instant case, for the purpose of this examination, in particular, for applying prior art reference, the Examiner is interpretating the recited “active substances” is limited to “active substance that counters shortening of telomeres in the cells of the body” (see MPEP § 2173.06 II).
Response to Applicant's Arguments
18. Applicant argues that “paragraphs [0027] to [0030] of the specification clearly distinguish between active substances in general and active substances that counter shortening of telomeres. Therefore, contrary to the Office's interpretation, one of ordinary skill in the art would understand that the term "active substances" in claim 39 is not limited to "active substances that counter shortening of telomeres." It is respectfully submitted that the scope of claim 39 is clear so that the public is informed of the boundaries of what constitutes infringement of the patent.”
19. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner understands that the instant specification discusses active substances in general and active substances that counter shortening of telomeres. However, in the instant case, as stated in Section 17 above, with regards to the recited “active substances”, the instant specification fails to define it. Therefore, it is unclear whether the recited “active substances” is limited to “active substance that counters shortening of telomeres in the cells of the body” or not.
Taken all these together, the rejection is deemed proper and is hereby maintained.
Furthermore, the Examiner would like to point out that if the recited “active substance” is any substance in general, every substance has some kind of activity. Then, the scope of instant claim 39 would be identical to the scope of instant claim 40.
Claim Rejections - 35 U.S.C. § 102(a)(1)
20. 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.
21. Please note: during the search for the elected species, prior art was found for the non-elected species of form of collagen hydrolysate.
(Revised due to Applicant’s amendment to the claim) Claims 21, 23, 25, 28, 29, 31-34 and 39 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hausmanns et al (US 2013/0252899 A1, filed with IDS).
The instant claims 21, 23, 25, 28, 29, 31-34 and 39 are drawn to a method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate to the human or the animal, wherein the collagen hydrolysate has an average molecular weight of from 1,000 to 8,000 Da, and wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body.
Hausmanns et al, throughout the patent, teach a collagen hydrolysate for improving the health of human skin, hair and/or nail; wherein the collagen hydrolysate is obtained from enzymatic hydrolysis of skin of mammals, in particular from pigskin or bovine split; wherein the collagen hydrolysate is produced by the consecutive action of at least two endoproteases with a different specificity, in particular of at least two different metalloproteases and/or serine proteases from the microorganisms Bacillus subtilis, Bacillus licheniformis, Bacillus amyloliquefaciens, Aspergillus oryzae and Aspergillus melleus; wherein at least 50% of the N-terminal amino acids of the collagen hydrolysate are hydrophobic amino acids, in particular alanine, leucine and isoleucine; wherein the mean molecular weight (weight-average Mw) of the collagen hydrolysate is typically in the range of about 1,700 to about 2,300 Da; and wherein the collagen hydrolysate can be administering orally in the form of capsules, sugar coated tablets, pastilles or solution at a daily intake of about 1.5 to 5 g, preferably about 2 to 3 g, more preferably about 2.3 to 2.7 g, for example, Abstract; page 1, paragraphs [0001], [0008] and [0013]-[0016]; page 2, paragraphs [0023], [0025] and [0027]; and claims 1, 2, 4, 5 and 7-20. Therefore, in view of the teachings of Hausmanns et al as a whole, one of ordinary skilled in the art would immediately envision a non-therapeutic method for improving the health of human skin, hair and/or nail in a human, wherein the method comprises orally administering a collagen hydrolysate in the form of capsules, sugar coated tablets, pastilles or solution at a daily intake of about 1.5 to 5 g, preferably about 2 to 3 g, more preferably about 2.3 to 2.7 g; wherein the collagen hydrolysate is obtained from enzymatic hydrolysis of skin of mammals, in particular from pigskin or bovine split; wherein the collagen hydrolysate is produced by the consecutive action of at least two endoproteases with a different specificity, in particular of at least two different metalloproteases and/or serine proteases from the microorganisms Bacillus subtilis, Bacillus licheniformis, Bacillus amyloliquefaciens, Aspergillus oryzae and Aspergillus melleus; wherein at least 50% of the N-terminal amino acids of the collagen hydrolysate are hydrophobic amino acids, in particular alanine, leucine and isoleucine; and wherein the mean molecular weight (weight-average Mw) of the collagen hydrolysate is typically in the range of about 1,700 to about 2,300 Da.
With regards to the limitation “wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body” recited in instant claim 21 and the limitation recited in instant claim 25, in the instant case, since the collagen hydrolysate in the method above meets all the structural limitations of both the collagen hydrolysate recited in instant claim 21 and the elected species of collagen hydrolysate to be administered, the collagen hydrolysate in the method above would necessarily have the same properties and/or functionalities of the collagen hydrolysate recited in instant claim 21 and the elected species of collagen hydrolysate to be administered. Therefore, the collagen hydrolysate in the method above delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body and reduces the telomere shortening rate. It reads on a collagen hydrolysate produced by enzymatic hydrolysis from skin of vertebrates with enzymes from Bacillus subtilis, wherein the collagen hydrolysate counters the shortening of telomeres in the cells of the body and does not contain any further active substances other than the collagen hydrolysate, wherein the collagen hydrolysate has an average molecular weight from 1,000 to 8,000 Da and 50% of the N-terminal amino acids are alanine, leucine and isoleucine, and wherein the collagen hydrolysate is administered at a daily dose from approximately 2 to approximately 15 g as the elected species of collagen hydrolysate to be administered, and meets the limitations of instant claim 25. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitation “for delaying aging of cells in the body of a human or an animal” recited in instant claim 21, this is a result-oriented limitation. In the instant case, the method above comprises administering the same compound to the same subject via the same route, therefore, the method above would result in the same effect, i.e. delaying aging of cells in the body of a human.
Taken all these together, the method above reads on non-therapeutic method as the elected species of method and/or effect. And it meets the limitations of instant claims 21, 23, 25, 28, 29, 31-34 and 39.
Since the reference teaches all the limitations of instant claims 21, 23, 25, 28, 29, 31-34 and 39; the reference anticipates instant claims 21, 23, 25, 28, 29, 31-34 and 39.
22. Please note: during the search for the elected species, prior art was found for the non-elected species of form of collagen hydrolysate.
(Revised due to Applicant’s amendment to the claim) Claims 21, 23, 25, 28, 29, 31-34 and 39 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Proksch et al (Skin Pharmacol Physiol, 2014, 27, pages 113-119, cited and enclosed in the previous office action).
The instant claims 21, 23, 25, 28, 29, 31-34 and 39 are drawn to a method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate to the human or the animal, wherein the collagen hydrolysate has an average molecular weight of from 1,000 to 8,000 Da, and wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body.
Proksch et al, throughout the literature, teach a non-therapeutic method for reducing skin wrinkle and increasing dermal matrix synthesis in a human, wherein the method comprises orally administering the specific bioactive collagen peptide (BCP) VERISOL® solution at a daily intake of 2.5 g to the human, for example, Title; Abstract; and page 114, Sections “Test product” and “Subjects”.
With regards to the limitation “wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body” recited in instant claim 21 and the limitations recited in instant claims 25 and 31-34, in the instant case, the VERISOL® solution in the method in Proksch et al is identical to the only species of collagen hydrolysate disclosed and tested in instant specification. Since Applicant is required to elect a single disclosed species of collagen hydrolysate to be administered, the VERISOL® solution in the method in Proksch et al reads on a collagen hydrolysate produced by enzymatic hydrolysis from skin of vertebrates with enzymes from Bacillus subtilis, wherein the collagen hydrolysate counters the shortening of telomeres in the cells of the body and does not contain any further active substances other than the collagen hydrolysate, wherein the collagen hydrolysate has an average molecular weight from 1,000 to 8,000 Da and 50% of the N-terminal amino acids are alanine, leucine and isoleucine, and wherein the collagen hydrolysate is administered at a daily dose from approximately 2 to approximately 15 g as the elected species of collagen hydrolysate to be administered; and meets the limitation “wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body” recited in instant claim 21 and the limitations of instant claims 25 and 31-34. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitation “for delaying aging of cells in the body of a human or an animal” recited in instant claim 21, this is a result-oriented limitation. In the instant case, the method above comprises administering the same compound to the same subject via the same route, therefore, the method above would result in the same effect, i.e. delaying aging of cells in the body of a human.
Taken all these together, the method in Proksch et al reads on non-therapeutic method as the elected species of method and/or effect. And it meets the limitations of instant claims 21, 23, 25, 28, 29, 31-34 and 39.
Since the reference teaches all the limitations of instant claims 21, 23, 25, 28, 29, 31-34 and 39; the reference anticipates instant claims 21, 23, 25, 28, 29, 31-34 and 39.
Response to Applicant's Arguments
23. Applicant argues “None of the cited references disclose a "method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate," as claimed.”; and “As stated in M.P.E.P. § 2111.02(II), the claim preamble must be read in the context of the entire claim. If the preamble is not merely a statement of effect that may or may not be desired or appreciated, but rather is a statement of the intentional purpose for which the method must be performed, then the preamble reciting purpose or intended use should be given patentable weight. For example, the Applicant refers to granted U.S. Patent No. 12,023,369 of GELITA AG, claiming "a method for improving endurance performance by increasing mitochondrial activity in a person or animal." In that case, the claimed purpose and effect of the method clearly was given patentable weight by the USPTO.” Applicant further argues about unexpected results.
24. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about these rejections, the Examiner understands that none of these references explicitly teaches “a method for delaying aging of cells in the body of a human or an animal”. However, in the instant case, as stated in both Sections 21 and 22 above, this is a result-oriented limitation. In the instant case, the method in either of these references comprises administering the same compound to the same subject via the same route, therefore, the method above would result in the same effect, i.e. delaying aging of cells in the body of a human. Furthermore, with regards to MPEP § 2111.02 II, in the instant case, the preamble is merely a statement of desired effect. Therefore, it is unclear to the Examiner how and/why the Examiner’s interpretation of the preamble fails to follow the guidance set up in MPEP § 2111.02 II. Further clarification is required. In addition, with regards to US. Patent No. 12023369, patent examination is based on the guidance set up in MPEP, not based on what the other Examiner does.
With regards to Applicant’s arguments about unexpected results, allegation of unexpected results cannot be used to overcome rejection under 35 U.S.C. 102(a)(1) (see MPEP § 716.02).
Taken all these together, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
25. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
26. (Revised due to Applicant’s amendment to the claim) Claims 21, 25, 28, 29 and 31 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US patent 8778422 B2.
27. Instant claims 21, 25, 28, 29 and 31 are drawn to a method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate to the human or the animal, wherein the collagen hydrolysate has an average molecular weight of from 1,000 to 8,000 Da, and wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body.
28. Claims 1-16 of US patent 8778422 B2 are drawn to a composition comprising collagen hydrolysate and rosehip powder and/or rosehip extract wherein the dry mass weight ratio of collagen hydrolysate to rosehip powder and/or extract lies in the range of approximately 10: 1 to approximately 20: 1; a medication or food supplement comprising the composition according to claim 1; and a method of treating or inhibiting degenerative joint disease comprising orally administering the medication or food supplement according to claim 11 to a subject in need thereof.
Furthermore, the MPEP states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” (see MPEP § 2144.05 I).
Therefore, in the instant case, in view of the combined teachings of claims 1-16 of US patent 8778422 B2, it would have been obvious to one of ordinary skilled in the art to develop a method of treating or inhibiting degenerative joint disease in a human or an animal in need thereof, wherein the method comprises orally administering a composition comprising collagen hydrolysate in a daily dose of approximately 0.1 g to approximately 20 g to the human or animal; wherein the composition is in the form of tablets, film tablets, capsules, lozenges or sugar-coated pills; and wherein the collagen hydrolysate is obtained from enzymatic hydrolysis of type I and/or type II collagen and has an average molecular weight of from 1,000 to 8,000 Da.
With regards to the limitation “wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body” recited in instant claim 21 and the limitation recited in instant claim 25, in the instant case, since the collagen hydrolysate in the method developed from the combined teachings of claims 1-16 of US patent 8778422 B2 above meets all the structural limitations of the collagen hydrolysate recited in instant claim 21, the collagen hydrolysate in the method developed from the combined teachings of claims 1-16 of US patent 8778422 B2 above would necessarily have the same properties and functionalities of the collagen hydrolysate recited in instant claim 21. Therefore, the collagen hydrolysate in the method developed from the combined teachings of claims 1-16 of US patent 8778422 B2 above delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body and reduces the telomere shortening rate. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitation “for delaying aging of cells in the body of a human or an animal” recited in instant claim 21, this is a result-oriented limitation. In the instant case, the method developed from the combined teachings of claims 1-16 of US patent 8778422 B2 above comprises administering the same compound to the same subject via the same route, therefore, the method developed from the combined teachings of claims 1-16 of US patent 8778422 B2 above would result in the same effect, i.e. delaying aging of cells in the body of a human.
29. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 23, 25, 29, 31-34 and 39 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of US patent 9072724 B2.
30. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 23, 25, 31, 32 and 39 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 10364283 B2.
31. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 23, 25, 31, 32 and 39 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 11673940 B2.
32. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 23, 25, 29, 31, 32 and 39 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of US patent 11235034 B2; and claims 1-8 of US patent 12023369 B2.
33. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 25, 29, 31-34 and 39 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US patent 12138297 B2.
34. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 23, 25 and 39 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 12528857 B2.
35. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-28 above, instant claims 21, 23, 25, 31 and 39 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21-26 and 30-35 of co-pending Application No. 18/309462 (Notice of allowance mailed on 9/9/2026 and issue fee paid on 10/5/2026).
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
36. (Revised due to Applicant’s amendment to the claim) Claims 21, 23, 25, 28, 29 and 39 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of co-pending Application No. 19/013970 and in view of Hausmanns et al (US 2013/0252899 A1, filed with IDS).
37. Instant claims 21, 23, 25, 28, 29 and 39 are drawn to a method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate to the human or the animal, wherein the collagen hydrolysate has an average molecular weight of from 1,000 to 8,000 Da, and wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body.
38. Claims 1-23 of co-pending Application No. 19/013970 are drawn to a method to increase the rate of viscosity degradation of a gelatin, comprising the steps of: providing an aqueous solution of gelatin; combining the aqueous solution of gelatin with about 2 to about 20% reactive peptides (in terms of the weight fraction of the reactive peptides relative to the total dissolved protein content of the aqueous solution), wherein the reactive peptides comprise collagen peptides with an average molecular weight of about 100 to about 5,000 Da and/or amino acids; adjusting a pH of the aqueous solution about 3.4 to about 8.0; heating the aqueous solution to a temperature from about 60 to about 150 °C; and holding the aqueous solution at said temperature for a period of time sufficient to degrade the viscosity of the solution to be in a range from about 15 to about 25 mP, when measured at a total dissolved protein concentration of 6.67% w/w, at a temperature of 60 0C and at a pH of 5.3 to 5.5; a gelatin composition comprising gelatin and about 2 to about 20% reactive peptides (in terms of the weight fraction of the reactive peptides relative to the total protein content of the gelatin composition), wherein the reactive peptides comprise collagen peptides with an average molecular weight of about 100 to about 5,000 Da and/or amino acids, and wherein the gelatin composition has a viscosity from 15 to 17 mP and a Bloom value from 55 to 171 g, or a viscosity from 17 to 19 mP and a Bloom value from 73 to 189 g, or a viscosity from 19 to 21 mP and a Bloom value from 91 to 205 g, or a viscosity from 21 to 23 mP and a Bloom value from 109 to 220 g, or a viscosity from 23 to 25 mP and a Bloom value from 124 to 233 g, when measured at a total dissolved protein concentration of 6.67% w/w, at a temperature of 60 °C and at a pH of 5.3 to 5.5; and a gelatin composition comprising gelatin and about 2 to about 20% reactive peptides (in terms of the weight fraction of the reactive peptides relative to the total protein content of the gelatin composition), wherein the reactive peptides comprise collagen peptides with an average molecular weight of about 100 to about 5,000 Da and/or amino acids, and wherein the gelatin composition has a viscosity from 15 to 17 mP and a Bloom value from 55 to 171 g, or a viscosity from 17 to 19 mP and a Bloom value from 73 to 189 g, or a viscosity from 19 to 21 mP and a Bloom value from 91 to 205 g, or a viscosity from 21 to 23 mP and a Bloom value from 109 to 220 g, or a viscosity from 23 to 25 mP and a Bloom value from 124 to 233 g, when measured at a total dissolved protein concentration of 6.67% w/w, at a temperature of 60 °C and at a pH of 5.3 to 5.5, and wherein the gelatin is obtained by the method of claim 1/
In the instant case, claims 1-23 of co-pending Application No. 19/013970 are in possession of a collagen hydrolysate/peptide that meets all the structural limitations of the collagen hydrolysate recited in instant claim 21.
39. The difference between claims 1-23 of co-pending Application No. 19/013970 and instant claims 21, 23, 25, 28, 29 and 39 is that claims 1-23 of co-pending Application No. 19/013970 do not teach applying the collagen hydrolysate/peptide in a method recited in instant claims 21, 23, 25, 28, 29 and 39.
However, in view of the teachings of Hausmanns et al as set forth in Section 21 above, it would have been obvious to one of ordinary skilled in the art to apply the collagen hydrolysate/peptide recited in claims 1-23 of co-pending Application No. 19/013970 and develop the method recited in instant claims 21, 23, 25, 28, 29 and 39.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Please note: Instant application and co-pending Application No. 19/013970 share the same applicant (GELITA AG, Eberbach, GERMANY).
Response to Applicant's Arguments
40. With regards to the ODP rejections over various patents, Applicant argues that “The double patenting rejections are unfounded and should be withdrawn for the same reasons as those given for the anticipation rejections discussed above. None of the reference patent claims disclose or suggest the limitation of amended claim 21 "wherein the collagen hydrolysate delays the aging of cells in the body of the human or animal by countering the shortening of the telomeres in the cells of the body."”
With regards to the provisional ODP rejections, Applicant argues that instant application is an earlier filed Application.
41. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about the ODP rejections over various patents, this has been addressed in Section 24 above.
In response to Applicant’s arguments about the provisional ODP rejections, in the instant case, provisional ODP rejection is not the only rejection remaining in current office action.
Taken all these together, until a terminal disclaimed is filed and approved by the office, these rejections are deemed proper and are hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 103
42. 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 of this title, 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.
43. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
44. Claims 21, 23, 25, 28, 29, 31-34, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Proksch et al (Skin Pharmacol Physiol, 2014, 27, pages 113-119, cited and enclosed in the previous office action) in view of Asami et al (JP 2013227228 A, machine translation used, pages 1-16, cited and enclosed in the previous office action).
The instant claims 21, 23, 25, 28, 29, 31-34, 39 and 40 are drawn to a method for delaying aging of cells in the body of a human or an animal, wherein the method comprises orally administering collagen hydrolysate to the human or the animal, wherein the collagen hydrolysate has an average molecular weight of from 1,000 to 8,000 Da, and wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body.
Proksch et al, throughout the literature, teach a non-therapeutic method for reducing skin wrinkle and increasing dermal matrix synthesis in a human, wherein the method comprises orally administering the specific bioactive collagen peptide (BCP) VERISOL® solution at a daily intake of 2.5 g to the human, for example, Title; Abstract; and page 114, Sections “Test product” and “Subjects”.
With regards to the limitation “wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body” recited in instant claim 21 and the limitations recited in instant claims 25 and 31-34, in the instant case, the VERISOL® solution in the method in Proksch et al is identical to the only species of collagen hydrolysate disclosed and tested in instant specification. Since Applicant is required to elect a single disclosed species of collagen hydrolysate to be administered, the VERISOL® solution in the method in Proksch et al reads on a collagen hydrolysate produced by enzymatic hydrolysis from skin of vertebrates with enzymes from Bacillus subtilis, wherein the collagen hydrolysate counters the shortening of telomeres in the cells of the body and does not contain any further active substances other than the collagen hydrolysate, wherein the collagen hydrolysate has an average molecular weight from 1,000 to 8,000 Da and 50% of the N-terminal amino acids are alanine, leucine and isoleucine, and wherein the collagen hydrolysate is administered at a daily dose from approximately 2 to approximately 15 g as the elected species of collagen hydrolysate to be administered; and meets the limitation “wherein the collagen hydrolysate delays the aging of cells in the body of the human or the animal by countering the shortening of telomeres in the cells of the body” recited in instant claim 21 and the limitations of instant claims 25 and 31-34. Furthermore, the MPEP states “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).” (see MPEP § 2112.01 I). In addition, since the USPTO lacks the experimental facilities to make a further determination, the burden is on the Applicant to prove the otherwise.
With regards to the limitation “for delaying aging of cells in the body of a human or an animal” recited in instant claim 21, this is a result-oriented limitation. In the instant case, the method above comprises administering the same compound to the same subject via the same route, therefore, the method above would result in the same effect, i.e. delaying aging of cells in the body of a human.
Taken all these together, the method in Proksch et al reads on non-therapeutic method as the elected species of method and/or effect. And it meets the limitations of instant claims 21, 23, 25, 28, 29, 31-34 and 39.
The difference between the reference and instant claims 21, 23, 25, 28, 29, 31-34, 39 and 40 is that the reference does not teach powder as the elected species of form of collagen hydrolysate from claim 28; and the limitations of instant claim 40.
However, Asami et al teach collagen hydrolysate can be administered orally in the form of powder that consists entirely of such collagen hydrolysate, for example, Overview; claims 1-5; and pages 6-7, paragraphs [0017]-[0019].
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Proksch et al and Asami et al to develop a non-therapeutic method for delaying aging of cells in the body of a human, wherein the method comprises orally administering the specific bioactive collagen peptide (BCP) VERISOL® at a daily intake of 2.5 g to the human, and wherein the specific bioactive collagen peptide (BCP) VERISOL® is in a powder form that consists entirely of BCP. It reads on powder as the elected species of form of collagen hydrolysate from claim 28.
One of ordinary skilled in the art would have been motivated to combine the teachings of Proksch et al and Asami et al to develop a non-therapeutic method for delaying aging of cells in the body of a human, wherein the method comprises orally administering the specific bioactive collagen peptide (BCP) VERISOL® at a daily intake of 2.5 g to the human, and wherein the specific bioactive collagen peptide (BCP) VERISOL® is in a powder form that consists entirely of BCP, because Asami et al teach collagen hydrolysate can be administered orally in the form of powder that consists entirely of such collagen hydrolysate.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Proksch et al and Asami et al to develop a non-therapeutic method for delaying aging of cells in the body of a human, wherein the method comprises orally administering the specific bioactive collagen peptide (BCP) VERISOL® at a daily intake of 2.5 g to the human, and wherein the specific bioactive collagen peptide (BCP) VERISOL® is in a powder form that consists entirely of BCP.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached on 5712707430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LI N KOMATSU/Primary Examiner, Art Unit 1658
