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 9/9/2026 is acknowledged.
3. Claim filed on 9/9/2026 is acknowledged.
4. Claims 2, 3, 5-8, 10-25, 28-32, 34, 36, 39, 41-59, 61-68, 70, 71 and 74 have been cancelled.
5. New claims 75-77 have been added.
6. Claims 1, 4, 9, 26, 27, 33, 35, 37, 38, 40, 60, 69, 72, 73 and 75-77 are pending in this application.
7. Claims 38, 40, 60, 69, 72 and 73 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Claims 35 and 77 remain/are withdrawn from consideration as being drawn to non-elected species.
8. Applicant elected without traverse of Group 1 (claims 1, 4, 9, 22, 23, 26, 27, 33, 35, 37 and 68) and elected without traverse of a composition with GVR28 (SEQ ID NO: 1) being the first collagen type VI polypeptide, SFV33 (SEQ ID NO: 5) being the second collagen type VI polypeptide and a pharmaceutically acceptable carrier being the additional component as species of composition in the reply filed on 3/5/2026.
Restriction requirement was deemed proper and made FINAL in the previous office action. Group 1 is drawn to a composition comprising: (a) a first collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 1 or a variant thereof which retains the wound healing activity of SEQ ID NO: 1, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1 and wherein the first collagen type VI polypeptide is between 25 and 35 amino acids in length; and (b) a second collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 5 or a variant thereof which retains the antimicrobial activity of SEQ ID NO: 5, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 5 and wherein the second collagen type VI polypeptide is between 25 and 35 amino acids in length. A search was conducted on the elected species; and prior art was found. Claims 35 and 77 remain/are withdrawn from consideration as being drawn to non-elected species. Claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 are examined on the merits in this office action
Withdrawn Objections and Rejections
9. Objection to the specification is hereby withdrawn in view of Applicant’s amendment to the specification.
10. Objection to claims 9, 22, 23, 37 and 68 is hereby withdrawn in view of Applicant’s amendment to the claim.
11. Rejection to claims 1, 4, 9, 22, 23, 26, 27, 33, 37 and 68 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (written description) is hereby withdrawn in view of Applicant’s amendment to the claim.
12. Rejection to claims 1, 4, 9, 22, 23, 26, 27, 33, 37 and 68 under 35 U.S.C. 102(a)(1) as being anticipated by Sambursky et al (US 2016/0279194 A1), and as evidenced by Du et al (Front. Cell. Infect. Microbiol., 2017, 7, pages 1-12) is hereby withdrawn in view of Applicant’s amendment to the claim.
13. Rejection to claims 1, 4, 9, 22, 23, 26, 27, 33, 37 and 68 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US patent 12134640 B2; and in view of the teachings of Mörgelin et al (WO 2017/125585 A2, filed with IDS) is hereby withdrawn in view of Applicant’s amendment to the claim.
14. Rejection to claims 1, 4, 9, 22, 23, 26, 27, 33, 37 and 68 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 63-81 of co-pending Application No. 18/899857; and in view of the teachings of Mörgelin et al (WO 2017/125585 A2, filed with IDS) is hereby withdrawn in view of Applicant’s amendment to the claim.
Maintained/Revised Objections
15. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as "A composition comprising: (a) a first collagen type VI polypeptide comprising the amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO: 1, wherein the first collagen type VI polypeptide is between 25 and 35 amino acids in length, and wherein the first collagen type VI polypeptide exhibits wound healing activity; and (b) a second collagen type VI polypeptide comprising the amino acid sequence that is at least 90% identical to the amino acid sequence of SEQ ID NO: 5, wherein the second collagen type VI polypeptide is between 25 and 35 amino acids in length, and wherein the second collagen type VI polypeptide exhibits antimicrobial activity".
16. (Revised due to Applicant’s amendment to the claim) Claim 4 remains objected to for the following minor informality: Applicant is suggested to amend claim 4 as “…wherein the first and/or second polypeptide: a) binds…”.
17. (Revised due to Applicant’s amendment to the claim) Claim 26 remains objected to for the following minor informality: Applicant is suggested to amend claim 26 as “…wherein the first polypeptide comprises the amino acid sequence that is at least 95% identical to SEQ ID NO: 1 and/or wherein the second polypeptide comprises the amino acid sequence that is at least 95% identical to SEQ ID NO: 5”.
18. (Revised due to Applicant’s amendment to the claim) Claim 27 remains objected to for the following minor informality: Applicant is suggested to amend claim 27 as “…(b) the first and second polypeptides are present in the composition at a ratio of at least 0.5:1 or 1:0.5”.
19. (Revised due to Applicant’s amendment to the claim) Claim 33 remains objected to for the following minor informality: Applicant is suggested to amend claim 33 as “…wherein: (a) the first polypeptide comprises the amino acid sequence of SEQ ID NO: 1; and/or (b) the second polypeptide comprises the amino acid sequence of SEQ ID NO: 5”.
Response to Applicant's Arguments
20. Applicant either fails to address all the minor issues in these claims or Applicant’s amendment to the claim introduces additional minor issues into these claims. Therefore, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 101
21. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
22. (Revised due to Applicant’s amendment to the claim) Claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 are directed to a composition comprising multiple fragments of natural product.
Both polypeptides in the recited composition can be fragments of the naturally occurring collagen type VI protein.
In the broadest reasonable interpretation, water is a pharmaceutically acceptable excipient recited in instant claim 37. And as evidenced by the Water document (from http://www.biology-online.org/dictionary/Water, 2014, pages 1-3, cited and enclosed in the previous office action), water is a natural product.
The claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed composition in instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 does not recite features or steps demonstrating a marked difference from what exists in nature; and the claimed composition in instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 does not recite meaningful limitations that add something of significance to the judicial exception. Therefore, the claimed composition in instant claims 11, 4, 9, 26, 27, 33, 37, 75 and 76 is not significantly different than a judicial exception (natural product).
Response to Applicant's Arguments
23. Applicant argues that “claim 1 is directed to a specific composition comprising two defined collagen VI-derived peptides, rather than a naturally occurring protein or isolated peptide fragment. The specification also clearly demonstrates that the claimed combination exhibits synergistic wound-healing and antimicrobial effects that are markedly different from the properties of the individual peptides and naturally occurring collagen VI (see hereinbelow with regard to the rejection under 35 U.S.C. §103). Accordingly, Applicant submits that the claims also satisfy the markedly different characteristics analysis (MPEP 2106.04(c)) and, therefore, are drawn to patentable subject matter.”
24. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner would like to point out that as stated in Section 22 above, both polypeptides in the recited composition can be fragments of the naturally occurring collagen type VI protein. With regards to Applicant’s arguments about synergistic wound-healing and antimicrobial effects presented for the rejection under 35 U.S.C. §103 in Section 34 below, please see Section 35 below for detailed response. Taken all these together, the claimed composition does not recite features or steps demonstrating a marked difference from what exists in nature; and the claimed composition does not recite meaningful limitations that add something of significance to the judicial exception. Therefore, the rejection is deemed proper and is hereby maintained.
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
25. 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.
26. Claim 1, 4, 9, 26, 27, 37 and 76 remain/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.
27. (Revised due to Applicant’s amendment to the claim) Claim 1 recites the limitations “(a) a first collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 1 or a variant thereof which retains the wound healing activity of SEQ ID NO: 1, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1 and wherein the first collagen type VI polypeptide is between 25 and 35 amino acids in length”; and “(b) a second collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 5 or a variant thereof which retains the antimicrobial activity of SEQ ID NO: 5, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 5 and wherein the second collagen type VI polypeptide is between 25 and 35 amino acids in length”. In the instant case, the polypeptide of instant SEQ ID NO: 1 is 28 amino acids in length; and the polypeptide of instant SEQ ID NO: 5 is 33 amino acids in length. Therefore, a variant of instant SEQ ID NO: 1 having the amino acid sequence that is at least 90% identical to instant SEQ ID NO: 1 needs to be at least 26 amino acids in length; and a variant of instant SEQ ID NO: 5 having the amino acid sequence that is at least 90% identical to instant SEQ ID NO: 5 needs to be at least 30 amino acids in length. Therefore, it is unclear what is encompassed within the instant claimed first collagen type VI polypeptide and second collagen type VI polypeptide. Thus, the metes and bounds of instant claim 1 is vague and indefinite. Because claims 4, 9, 26, 27, 37 and 76 depend from indefinite claim 1, and they do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
28. (Revised due to Applicant’s amendment to the claim) Claim 27 recites the limitation of “a ratio of at least 0.5:1…”. It is unclear what the unit of the recited ratio is, such as molar ration, weight ratio and so on.
Furthermore, claim 27 recites the limitation of the first and/or the second collagen type VI polypeptide is “at least 28 amino acids in length”. As stated in Section 27 above, the polypeptide of instant SEQ ID NO: 5 is 33 amino acids in length. Therefore, a variant of instant SEQ ID NO: 5 having the amino acid sequence that is at least 90% identical to instant SEQ ID NO: 5 needs to be at least 30 amino acids in length. Thus, it is unclear what is encompassed within the instant claimed second collagen type VI polypeptide.
Taken all these together, the metes and bounds of instant claim 27 is vague and indefinite
Response to Applicant's Arguments
29. With regards to the rejection set forth in Section 28 above, Applicant argues that “Applicant respectfully disagrees with the Examiner's position and submit that the skilled person would understand that the recited ratios may be interpreted as molar ratios. This interpretation is consistent with page 58 lines 1-5 of the application as filed, which discusses a 1:1 ratio mixture being made up of 1.5 µM of each polypeptide.”
30. Applicant's arguments have been fully considered but have not been found persuasive.
In the instant case, due to Applicant’s amendment to instant claim 1, instant claims 1, 4, 9, 26, 27, 37 and 76 remain/are under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph as set forth in Section 27 above.
In response to Applicant’s arguments about instant rejection set forth in Section 28 above, first, the Examiner understands that the recited ratios may be interpretated as molar ratios. However, it may also be interpretated as weight ratio, volume ratio and so on. Second, the Examiner would like to point out that the claim is interpretated as it is presented. There is no reason that the claim is limited with what is disclosed in instant specification.
Taken all these together, these rejections are deemed proper and are hereby maintained.
Claim Rejections - 35 U.S.C. § 103
31. 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.
32. 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.
33. (Revised due to Applicant’s amendment to the claim) Claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Mörgelin et al (WO 2017/125585 A2, filed with IDS).
The instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 are drawn to a composition comprising: (a) a first collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 1 or a variant thereof which retains the wound healing activity of SEQ ID NO: 1, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1 and wherein the first collagen type VI polypeptide is between 25 and 35 amino acids in length; and (b) a second collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 5 or a variant thereof which retains the antimicrobial activity of SEQ ID NO: 5, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 5 and wherein the second collagen type VI polypeptide is between 25 and 35 amino acids in length.
Mörgelin et al, throughout the patent, teach polypeptides comprising an amino acid sequence derived from collagen type VI that is capable of killing or attenuating the growth of microorganism; a pharmaceutical composition comprising such polypeptide and a pharmaceutically acceptable carrier; and method of using such polypeptide and/or pharmaceutical composition for wound care, including promoting wound closure and/or wound healing, for example, Abstract; page 1, lines 10-15; page 4, lines 36-37; page 5, lines 9-10; and page 18, lines 34-36. It meets the limitation of “a pharmaceutically acceptable carrier” recited in instant claim 37. Mörgelin et al further teach polypeptide of SEQ ID NO: 1 (GVR28, identical to the polypeptide of instant SEQ ID NO: 1) promotes wound healing, for example, page 45, Table3; and Figure 13. It meets the limitations of the first polypeptide recited in instant claims 1, 4, 26, 27, 33, 75 and 76. Mörgelin et al also teach polypeptides of SEQ ID NOs: 1-5 (identical to the polypeptides of instant SEQ ID NOs: 1-5) exert antimicrobial effects, including antibacterial effects; and polypeptide of SEQ ID NO: 5 (SFV33, identical to the polypeptide of instant SEQ ID NO: 5) is the only one that exerts antimicrobial effects under various test conditions, for example, page 45, Table3; and Figures 6-11 and 14-17. It meets the limitations of the second polypeptide recited in instant claims 1, 4, 26, 27, 33, 75 and 76.
The difference between the reference and instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 is that the reference does not explicitly teach a composition with GVR28 (SEQ ID NO: 1) being the first collagen type VI polypeptide, SFV33 (SEQ ID NO: 5) being the second collagen type VI polypeptide and a pharmaceutically acceptable carrier being the additional component as the elected species of composition; and the limitations of instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76.
However, Mörgelin et al teach the pharmaceutical composition may comprise one or more such polypeptides comprising an amino acid sequence derived from collagen type VI, for example one, two, three or four different peptides; and by using a combination of different peptides the antimicrobial effect may be increased, for example, page 20, lines 36-38.
Therefore, in view of the teachings of Mörgelin et al as a whole, it would have been obvious to one of ordinary skilled in the art to develop a pharmaceutical composition comprising: the first polypeptide being SEQ ID NO: 1 (GVR28, identical to the polypeptide of instant SEQ ID NO: 1), wherein the first polypeptide promotes wound healing; the second polypeptide being SEQ ID NO: 5 (SFV33, identical to the polypeptide of instant SEQ ID NO: 5), wherein the second polypeptide exerts antimicrobial activity, such as antibacterial activity; and a pharmaceutically acceptable carrier; wherein the pharmaceutical composition is for wound care, including promoting wound closure and/or wound healing. It reads on a composition with GVR28 (SEQ ID NO: 1) being the first collagen type VI polypeptide, SFV33 (SEQ ID NO: 5) being the second collagen type VI polypeptide and a pharmaceutically acceptable carrier being additional component as the elected species of composition.
In view of the teachings of Mörgelin et al as a whole, one of ordinary skilled in the art would have been motivated to develop a pharmaceutical composition comprising: the first polypeptide being SEQ ID NO: 1 (GVR28, identical to the polypeptide of instant SEQ ID NO: 1), wherein the first polypeptide promotes wound healing; the second polypeptide being SEQ ID NO: 5 (SFV33, identical to the polypeptide of instant SEQ ID NO: 5), wherein the second polypeptide exerts antimicrobial activity, such as antibacterial activity; and a pharmaceutically acceptable carrier; wherein the pharmaceutical composition is for wound care, including promoting wound closure and/or wound healing, because Mörgelin et al teach the pharmaceutical composition may comprise one or more such polypeptides comprising an amino acid sequence derived from collagen type VI, for example one, two, three or four different peptides; and by using a combination of different peptides the antimicrobial effect may be increased. Furthermore, the MPEP states “"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose...” (see MPEP § 2144.06).
In view of the teachings of Mörgelin et al as a whole, a person of ordinary skilled in the art would have reasonable expectation of success in developing a pharmaceutical composition comprising: the first polypeptide being SEQ ID NO: 1 (GVR28, identical to the polypeptide of instant SEQ ID NO: 1), wherein the first polypeptide promotes wound healing; the second polypeptide being SEQ ID NO: 5 (SFV33, identical to the polypeptide of instant SEQ ID NO: 5), wherein the second polypeptide exerts antimicrobial activity, such as antibacterial activity; and a pharmaceutically acceptable carrier; wherein the pharmaceutical composition is for wound care, including promoting wound closure and/or wound healing.
Response to Applicant's Arguments
34. Applicant argues about unexpected synergistic results as presented in Example 1 of instant specification.
35. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about unexpected synergistic results as presented in Example 1 of instant specification:
First, with regards to the combination of the polypeptide of instant SEQ ID NO: 1 (GVR28) and the polypeptide of instant SEQ ID NO: 5 (SFV33), based on the data obtained from Example 1, in particular instant Figures 1 and 2, and Tables 2-7, it is unclear to the Examiner whether such effect is an additive effect or a synergistic effect. Applicant is suggested to provide additional information to confirm such results are indeed synergistic.
Second, the Examiner would like to point out that as stated in MPEP: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." (see MPEP § 716.02(d)); and "The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." (see MPEP § 716.02(b)). In the instant case, the composition recited in instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 includes all combinations with each polypeptide at any possible amounts and ratios between the 2 polypeptides. Furthermore, the data presented in instant Figures 1 and 2, and Tables 2-7 do not have any statistical analysis.
Taken all these together, the unexpected synergistic results as presented in Example 1 of instant specification are insufficient to overcome instant rejection. Therefore, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
36. 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.
37. (Revised due to Applicant’s amendment to the claim) Claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 remain/are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-9 of US patent 10793618 B2 and in view of Mörgelin et al (WO 2017/125585 A2, filed with IDS).
38. Instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 are drawn to a composition comprising: (a) a first collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 1 or a variant thereof which retains the wound healing activity of SEQ ID NO: 1, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 1 and wherein the first collagen type VI polypeptide is between 25 and 35 amino acids in length; and (b) a second collagen type VI polypeptide comprising or consisting of an amino acid sequence of SEQ ID NO: 5 or a variant thereof which retains the antimicrobial activity of SEQ ID NO: 5, wherein the variant has an amino acid sequence with at least 90% identity to the amino acid sequence of SEQ ID NO: 5 and wherein the second collagen type VI polypeptide is between 25 and 35 amino acids in length.
39. Claims 1-9 of US patent 10793618 B2 are drawn to a polypeptide comprising an amino acid sequence selected from the group consisting of: (a) SEQ ID NO: 1 from the α3 chain of collagen type VI; (b) a fragment of SEQ ID NO: 1, wherein the fragment of SEQ ID NO: 1 comprises at least 20 contiguous amino acids of SEQ ID NO: 1; and (c) a variant of SEQ ID NO: 1, wherein the variant comprises an amino acid sequence with at least 80% sequence identity to SEQ ID NO: 1, wherein the polypeptide is between 20 and 200 amino acids in length, and wherein the polypeptide has antimicrobial activity.
The polypeptide of SEQ ID NO: 1 recited in claims 1-9 of US patent 10793618 B2 is identical to the polypeptide of instant SEQ ID NO: 1.
40. The difference between instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 and claims 1-9 of US patent 10793618 B2 is that claims 1-9 of US patent 10793618 B2 do not teach apply the polypeptide in a composition recited in instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76.
However, in view of the teachings of Mörgelin et al as set forth in Section 33 above, it would have been obvious to one of ordinary skilled in the art to apply the polypeptide recited in claims 1-9 of US patent 10793618 B2 in a composition recited in instant claims 11, 4, 9, 26, 27, 33, 37, 75 and 76.
41. (Revised due to Applicant’s amendment to the claim) For the same and/or similar reasoning/rational as the rejection set forth in Sections 37-40 above, instant claims 1, 4, 9, 26, 27, 33, 37, 75 and 76 remain/are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US patent 11136374 B2 and claims 1-5 of US patent 11814422 B2; and in view of the teachings of Mörgelin et al (WO 2017/125585 A2, filed with IDS) as set forth in Section 33 above.
In the instant case, claims 1-5 of US patent 11814422 B2 are in possession of a pharmaceutical composition comprising the polypeptide of instant SEQ ID NO: 1.
Response to Applicant's Arguments
42. Applicant argues about the same unexpected synergistic results as presented in Section 34 above.
43. Applicant's arguments have been fully considered but have not been found persuasive.
Applicant’s arguments presented in Section 34 above have been addressed in Section 35 above.
Therefore, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are maintained.
New Objections
44. Claim 75 is objected to for the following minor informality: Applicant is suggested to amend claim 75 as “The composition of claim 1, wherein: (a) the first polypeptide consists of the amino acid sequence of SEQ ID NO: 1; and/or (b) the second polypeptide consists of the amino acid sequence of SEQ ID NO: 5”.
45. Claim 76 objected to for the following minor informality: Applicant is suggested to amend claim 76 as “…wherein the net positive charge of the first polypeptide…”.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
