DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The examiner acknowledges receipt of preliminary amendment filed and IDS filed 04/29/2024.
Claims 5-6 and 9-10 are amended,
Claims 1-10 are pending.
Priority
This application is a 371 of PCT/CN2022/079518 filed 03/07/2022 and which claims benefit of China application 202111296151.2 filed 11/03/2021.
Information Disclosure Statement
The IDS filed 04/29/2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 5 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 4 and 5 recite GDMA and AI102 without an initial designation of what these abbreviations/acronyms are. The specification does not also define what these abbreviations/acronyms are.
A google search indicates that AI102 is hydrolysable, degradable crosslinker known as poly(DL-lactide)-b-poly(ethylene glycol)-b-poly(DL-lactide)-diacrylate (PLA-PEG-PLA) triblock copolymer crosslinker and also known as PLA-PEG-PLA diacrylate triblock copolymer. The acronym can also mean something different from the above. GOOGLE search also indicates GDMA crosslinker is glycerol dimethylacrylate.
Claim 2 also recites I2959 without an initial designation of what this abbreviation/acronym stand for. The specification does not also define what this abbreviations/acronym is. A search on GOOGLE indicates I2959 as Irgacure 2959 or Darocur 2959.
It is suggested that the specific compounds be written out with the acronyms/abbreviations be placed in parenthesis for future use in the claims without writing out the full meaning of the abbreviations.
For claim 10, the recitation, “the application of the pH responsive …” in line 1 of the claim lacks antecedent support from claim 6, upon which claim 10 depends or claim 1 upon which claim 6 depends, because claim 6 does not say of applying or application.
Correction is respectfully requested.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by YU SHAN et al. (CN111592618 (A) using Espacenet Eng. Translation).
YU SHAN discloses methacrylic anhydride modified hyaluronic acid hydrogel which meets the limitation of methacrylated hyaluronic acid; the methacrylic anhydride modified hyaluronic acid is crosslinked using 365 nm ultraviolet light in the presence of photo-initiator and crosslinking agent; one crosslinking agent N,N'-vinylbisacrylamide and N,N'-methylenebisacrylamide (BIS); the photo-initiator in YU SHAN is LAP (phenyl-2,4,6-trimethylbenzoylphosphonate lithium) or 2-hydroxy-2-methyl-1-[4-(2-hydroxyethoxy)phenyl]-1-propanone which is I2959 or Irgacure 2959 or photo-initiator 2959 (see paragraphs [0006]-[0007], [0009], [0012]-[0013], [0016]-[0018], [0020], [0045]), with the hydrogel being pH responsive.
Thus, YU SHAN teaches claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 2-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over YU SHAN et al. (CN 111592618 (A) using Espacenet Eng. Translation), as applied to claim 1, in view of Pang (US 20190351068 A1) and CAI SUSU et al. (CN 113244377 (A) using Eng Trans from Espacenet).
YU SHAN has been described above to teach claim 1.
Claims 2, 3 and 5 depend from claim 1. Claim 4 depends from claim 2.
YU SHAN teaches pH responsive hydrogel biocarrier comprising methacrylated hyaluronic acid (methacrylic anhydride modified hyaluronic acid hydrogel), a reaction product of methacrylic anhydride modified hyaluronic acid crosslinked using 365 nm ultraviolet light in the presence of photo-initiator and crosslinking agent. The crosslinking agent is N,N'-vinylbisacrylamide and N,N'-methylenebisacrylamide (BIS). The photo-initiator in YU SHAN is LAP (phenyl-2,4,6-trimethylbenzoylphosphonate lithium) or 2-hydroxy-2-methyl-1-[4-(2-hydroxyethoxy)phenyl]-1-propanone which is I2959 or Irgacure 2959 or photo-initiator 2959.
For claim 2, YU SHAN differs from claim 2 by teaching Irgacure 2959 photo-initiator or I2929 photo-initiator and N,N'-vinylbisacrylamide and N,N'-methylenebisacrylamide (BIS) crosslinker. Thus, YU SHAN does not teach the crosslinkers glycerol dimethylacrylate (GDMA) and PLA-PEG-PLA diacrylate triblock copolymer (AI102 crosslinker).
However, it is known in the art that GDMA and N,N'-methylenebisacrylamide (BIS) are cross-linkers (paragraphs [0037], [0129] and claim 35 of Pang). It is also known in the art that AI102 and GDMA are crosslinking agents used together in a ratio of (1-4): (0-2) (paragraphs [n0018]-[n0019] under paragraph [0007], Table 1 of CAI SUSU), and CAI SUSU contemplates delivery of platelet derived growth Factors (paragraphs [0001], [n0002]).
Therefore, before the effective date of the invention, the artisan guided by the Pang would use GDMA in place of N,N'-methylenebisacrylamide (BIS) as the crosslinker in YU SHAN since GDMA and N,N'-methylenebisacrylamide (BIS) are cross-linkers and one functionally equivalent crosslinker can be used in place of the other with the expectation of predictably producing the hydrogel bioactive carrier of the claim.
For claims 2 and 4, CAI SUSU teaches that AI102 and GDMA are crosslinking agents used together in a ratio of (1-4): (0-2) (paragraphs [n0018]-[n0019] under paragraph [0007], Table 1).
For claim 3, YU SHAN does not teach the ratio of sodium hyaluronate to methacrylic anhydride of 1:30 of claim 3. However, one having ordinary skill in the art would use amounts of the hyaluronate and the methacrylic anhydride that would react to produce the methacrylated hyaluronic acid. The principles rooted in in re Aller, 220 F.2d 454, 456 USPQ 233, 235 (CCPA 1955) suggests that it is generally not inventive to discover optimum or workable ranges through routine experimentation, when the general conditions of a claims are disclosed in the prior art. In the instant case, YU SHAN discloses methacrylic anhydride modified hyaluronic acid hydrogel which meets the limitation of methacrylated hyaluronic acid and where the hyaluronate is reacted with methacrylic anhydride (paragraph [p0043]).
For claim 5, the crosslinking reaction is irradiated at 365 nm ultraviolet light and the teaching of YU SHAN combined with Pang and CAI SUSU uses crosslinkers GDMA and AI102.
For claims 6 and 7 and 9 and 10, freeze drying is a process of making the hydrogel biocarrier. However, in YU SHAN the methacrylated hyaluronic acid (methacrylic anhydride modified hyaluronic acid hydrogel) is obtained by freeze drying (paragraphs [0043], [0065]). Pang contemplates using its hydrogel (paragraph [0165]) for delivery of bioactive agents/therapeutic proteins (at least paragraphs [0006], [0037]), and in some embodiments, the bioactive agent is platelet derived growth factors (PDGF) (paragraphs [0058], [0078]), and CAI SUSU also contemplates delivery of platelet derived growth factors (claims 1-5).
For claim 8, CAI SUSU teaches PDGF-BB (paragraphs [n0003], [n0005]) which meets the BB type dimer of claim 8.
Thus, YU SHAN in combination with Pang and CAI SUSU renders claims 2-10 prima facie obvious.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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