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. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the cited rejections 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.
3. Response to Election/Restriction filed on 12/15/2025 is acknowledged.
4. Claim filed on 4/6/2023 is acknowledged.
5. Claims 1-20 have been cancelled.
6. New claims 21-40 have been added.
7. Claims 21-40 are pending in this application.
8. Claims 22, 24, 26 and 36-38 are withdrawn from consideration as being drawn to non-elected species.
9. Claims 21, 23, 25, 27-35, 39 and 40 are under examination.
Election/Restrictions
10. Applicant’s election 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 is acknowledged. The traverse is on the ground that “the Office has failed to show by appropriate explanation any separate classification, separate status in the art when classifiable together, or a different field of search for the claimed subject matter.” This is not found to be persuasive because: First, with regards to different classes/subclasses, as an example, a non-therapeutic method such as cosmetic treatment is classified in class A61Q, while a therapeutic treatment is classified in class A61P. And the subject/patient population in these methods are different. Second, with regards to the recited composition, different search terms are required for different methods and/or different enzymes for preparing such collagen hydrolysate, the extra active substance, the form of the composition and so on. It appears to the Examiner that Applicant is assuming any prior reference disclosing collagen hydrolysate would disclose all the claim limitations recited in instant claims 21-40. However, in the instant case, considering the broadness of instant claimed method, the Examiner would like to point out that it is likely a prior reference disclosing collagen hydrolysate would Not disclose all the claim limitations recited in instant claims 21-40, as evidenced by the references cited in Sections 26-28 below. Therefore, there is a serious burden on the office and the Examiner to examine all the species recited in instant claims 21-40. Taken all these together, the requirement is deemed proper and is made Final in this office action.
Please note: 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.
The instant claims 21-40 are drawn to a method for delaying the ageing of cells in the body of a human or an animal, comprising the administration of collagen hydrolysate to the human or the animal. A search was conducted on the elected species; and prior art was found. Claims 22, 24, 26 and 36-38 are withdrawn from consideration as being drawn to non-elected species. Claims 21, 23, 25, 27-35, 39 and 40 are examined on the merits in this office action.
Specification
11. Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
Objections
12. Claim 21 is objected to for the following minor informality: Applicant is suggested to amend claim 21 as “A method for delaying aging of cells in the body of a human or an animal, wherein the method comprises administering collagen hydrolysate to the human or the animal”.
13. Claims 23, 25, 27, 29, 31, 35, 39 and 40 are objected to for the following minor informality: Applicant is suggested to amend the recited “Claim” as “claim”.
14. Claim 28 is objected to for the following minor informality: Applicant is suggested to amend claim 28 as “The method according to claim 27, wherein the collagen hydrolysate is administered in the form of powder, solution, gel, tablet or capsule".
15. Claim 30 is objected to for the following minor informality: Applicant is suggested to amend claim 30 as "The method according to claim 21, wherein the collagen hydrolysate has an average molecular weight of from 500 to 15,000 Da”.
16. Claim 32 is objected to for the following minor informality: Applicant is suggested to amend claim 32 as “The method according to claim 31, wherein the collagen-containing starting material is selected from skin or bone of vertebrate”.
17. Claim 33 is objected to for the following minor informality: Applicant is suggested to amend claim 33 as “The method according to claim 31, wherein the collagen hydrolysate is produced by successive action of at least…”.
18. Claim 34 is objected to for the following minor informality: Applicant is suggested to amend claim 34 as “The method according to claim 33, wherein the metalloproteases and/or serine proteases are selected from enzymes from Bacillus subtilis…”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
19. 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.
20. Claims 34, 35, 39 and 40 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 pre-AIA the applicant regards as the invention.
21. Claim 34, which depends on claim 33, recites the limitation “the metalloproteases and/or serine proteases”. There is insufficient antecedent basis for this limitation in the claim. Claim 33 does not mention “metalloproteases and/or serine proteases”. It is not clear to what the said phrase is referring. Because claim 35 depends from indefinite claim 34, and it does not clarify the point of confusion, it must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
22. Claim 35 recites the term “hydrophobic amino acids”. With regards to the term “hydrophobic amino acids”, the instant specification fails to define it. It is well known in the art that even with the twenty amino acids, the list of hydrophobic acid varies. As an example, the Amin Acid Physical Properties document (from ThermoFisher Scientific, 2026, enclosed pages 1-2) discloses amino acids A, V, G, I, L, F, P and Y as hydrophobic amino acids. The Amino Acid Chart document (2026, enclosed pages 1-9, from https://chemistrytalk.org/amino-acid-chart/) discloses amino acids A, V, I, L, M, F, W and Y as hydrophobic amino acids (see the Table on page 3). And the Amino Acid Diagram documents (2026, enclosed pages 1-2, from https://www.ctahr.hawaii.edu/huen/aminoacids_files/aminoacids.html) discloses amino acids V, I, L, M and F as hydrophobic amino acids. Therefore, it is unclear what is encompassed within the recited “hydrophobic amino acids”. Thus, the metes and bounds of instant claim 35 is vague and indefinite.
23. 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. Because claim 40 depends from indefinite claim 39, and it does not clarify the point of confusion, it must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
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).
24. Claim 40 recites the term “substantially”. With regards to the term “substantially”, the instant specification fails to define it. Therefore, it is unclear what is encompassed within the recited composition consisting substantially entirely of the collagen hydrolysate. Thus, the metes and bounds of instant claim 40 is vague and indefinite.
Claim Rejections - 35 U.S.C. § 102(a)(1)
25. 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.
26. Please note: during the search for the elected species, prior art was found for the non-elected species of form of collagen hydrolysate.
Claims 21, 23, 25, 27-35 and 39 are 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, 27-35 and 39 are drawn to a method for delaying the ageing of cells in the body of a human or an animal, comprising the administration of collagen hydrolysate to the human or the animal.
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 “for delaying the ageing 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 the ageing of cells in the body of a human.
With regards to 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 functionality 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 counters the shortening of telomeres in the cells of the body. 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. 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.
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, 27-35 and 39.
Since the reference teaches all the limitations of instant claims 21, 23, 25, 27-35 and 39; the reference anticipates instant claims 21, 23, 25, 27-35 and 39.
27. Please note: during the search for the elected species, prior art was found for the non-elected species of form of collagen hydrolysate.
Claims 21, 23, 25, 27-35 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Proksch et al (Skin Pharmacol Physiol, 2014, 27, pages 113-119).
The instant claims 21, 23, 25, 27-35 and 39 are drawn to a method for delaying the ageing of cells in the body of a human or an animal, comprising the administration of collagen hydrolysate to the human or the animal.
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 “for delaying the ageing 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 in Proksch et al comprises administering the same compound to the same subject via the same route, therefore, the method in Proksch et al would result in the same effect, i.e. delaying the ageing of cells in the body of a human.
With regards to the limitations recited in instant claims 25 and 30-35, 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. 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.
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, 27-35 and 39.
Since the reference teaches all the limitations of instant claims 21, 23, 25, 27-35 and 39; the reference anticipates instant claims 21, 23, 25, 27-35 and 39.
28. Please note: during the search for the elected species, prior art was found for the non-elected species of collagen hydrolysate to be administered.
Claims 21, 23, 25, 27-32, 39 and 40 are rejected 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).
The instant claims 21, 23, 25, 27-32, 39 and 40 are drawn to a method for delaying the ageing of cells in the body of a human or an animal, comprising the administration of collagen hydrolysate to the human or the animal.
Asami et al, throughout the patent, teach a muscle increasing agent comprising collagen hydrolysate, wherein the collagen hydrolysate is obtained from enzymatic hydrolysis of skin or bone of fish; wherein the mean molecular weight (weight-average Mw) of the collagen hydrolysate is typically in the range of 500 to 1500 Da; and wherein the collagen hydrolysate can be administering orally in the form of powder, tablet, capsule or solution at a daily intake of preferably about 1 to 20 g, more preferably 5 to 15 g; and wherein the content of collagen hydrolysate in the muscle increasing agent is preferably large such as from 80 to 100% (w/w), for example, Overview; claims 1-5; page 4, paragraph [0008]; page 5, paragraphs [0012] and [0013]; pages 6-7, paragraphs [0017]-[0019]; and page 9, paragraph [0024]. Therefore, in view of the teachings of Asami et al as a whole, one of ordinary skilled in the art would immediately envision a non-therapeutic method for increasing muscle in a human or animal, wherein the method comprises orally administering a muscle increasing agent consisting substantially entirely of a collagen hydrolysate in the form of powder; wherein the collagen hydrolysate is obtained from enzymatic hydrolysis of skin or bone of fish; wherein the mean molecular weight (weight-average Mw) of the collagen hydrolysate is typically in the range of 500 to 1500 Da; and wherein the collagen hydrolysate is administering at a daily intake of preferably about 1 to 20 g, more preferably 5 to 15 g.
With regards to the limitation “for delaying the ageing 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 the ageing of cells in the body of a human. Therefore, the method above reads on non-therapeutic method as the elected species of method and/or effect; and powder as the elected species of form of the collagen hydrolysate. And it meets the limitations of instant claims 21, 23, 27-32, 39 and 40.
With regards to 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 the collagen hydrolysate recited in instant claim 21, the collagen hydrolysate in the method above would necessarily have the same properties and/or functionality of the collagen hydrolysate recited in instant claim 21. Therefore, the collagen hydrolysate in the method above counters the shortening of telomeres in the cells of the body. It 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.
Since the reference teaches all the limitations of instant claims 21, 23, 25, 27-32, 39 and 40; the reference anticipates instant claims 21, 23, 25, 27-32, 39 and 40.
Obviousness Double Patenting
29. 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.
30. Claims 21, 25 and 27-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US patent 8778422 B2.
31. Instant claims 21, 25 and 27-31 are drawn to a method for delaying the ageing of cells in the body of a human or an animal, comprising the administration of collagen hydrolysate to the human or the animal.
32. 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.
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 approximately 0.3 kDa to approximately 30 kDa.
With regards to the limitation “for delaying the ageing 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 the ageing of cells in the body of a human.
With regards to 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 functionality 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 counters the shortening of telomeres in the cells of the body. 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.
33. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 23, 25, 27, 29-35 and 39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of US patent 9072724 B2.
34. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 23, 25, 27, 30-32 and 39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 10364283 B2.
35. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 23, 25, 27, 30-32 and 39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 11673940 B2.
36. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 23, 25, 27, 29-32 and 39 are 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.
37. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 25, 27, 29-35 and 39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US patent 12138297 B2.
38. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 23, 25, 27 and 39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 12528857 B2.
39. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 25, 27, 28 and 39 are provisionally rejected 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.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
40. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 23, 25, 27, 30, 31 and 39 are 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.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
41. For the same/similar reasoning/rational as the rejection set forth in Sections 30-32 above, instant claims 21, 25, 27, 28 and 39 are provisionally rejected 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.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
42. Claims 21, 23, 25, 27-32, 39 and 40 are provisionally rejected 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).
43. Instant claims 21, 23, 25, 27-32, 39 and 40 are drawn to a method for delaying the ageing of cells in the body of a human or an animal, comprising the administration of collagen hydrolysate to the human or the animal.
44. Claims 1-8 and 10-16 of co-pending Application No. 17/736430 are drawn to a method for producing collagen peptides from bones.
In the instant case, claims 1-8 and 10-16 of co-pending Application No. 17/736430 are in possession of a collagen hydrolysate/peptide.
45. The difference between claims 1-8 and 10-16 of co-pending Application No. 17/736430 and instant claims 21, 23, 25, 27-32, 39 and 40 is that claims 1-8 and 10-16 of co-pending Application No. 17/736430 do not teach applying the collagen hydrolysate/peptide in a method recited in instant claims 21, 23, 25, 27-32, 39 and 40.
However, in view of the teachings of Asami et al as set forth in Section 28 above, it would have been obvious to one of ordinary skilled in the art to apply the collagen hydrolysate/peptide obtained in the method recited in claims 1-8 and 10-16 of co-pending Application No. 17/736430 and develop the method recited in instant claims 21, 23, 27-32, 39 and 40.
With regards to the limitation recited in instant claim 25, in the instant case, since the collagen hydrolysate in the method developed above meets all the structural limitations of the collagen hydrolysate recited in instant claim 21, the collagen hydrolysate in the method developed above would necessarily have the same properties and functionality of the collagen hydrolysate recited in instant claim 21. Therefore, the collagen hydrolysate in the method developed above counters the shortening of telomeres in the cells of the body. 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.
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. 17/736430 share the same applicant (GELITA AG, Eberbach, GERMANY).
46. For the same/similar reasoning/rational as the rejection set forth in Sections 42-45 above, instant claims 21, 23, 25, 27-30, 39 and 40 are provisionally rejected 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 the teachings of Asami et al (JP 2013227228 A, machine translation used and enclosed pages 1-16) as set forth in Section 28 above.
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. 17/997980 share the same applicant (GELITA AG, Eberbach, GERMANY).
47. For the same/similar reasoning/rational as the rejection set forth in Sections 42-45 above, instant claims 21, 23, 25, 27-30, 39 and 40 are 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 the teachings of Asami et al (JP 2013227228 A, machine translation used and enclosed pages 1-16) as set forth in Section 28 above.
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).
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658