DETAILED ACTION
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 76-80 are withdrawn.
Claims 1, 27, 47-49, and 65 are pending and represent all claims currently under consideration.
Response to Amendment
The amendment filed 08/04/2025 has been entered.
Claims 2-26, 28-46, 50-64, 66-75, and 81-98 were canceled. Claims 1, 27, and 47 were amended. No new material was added.
Applicant’s amendments have overcome the previous objections to the specification.
The objections of claims 2, 4, 6, 12, and 26, and the rejections of claims 2-4, 6, 8-9, 11-12, 18, 22-24, 26, 30-31, 36, 40, and 46 are moot, because the claims were canceled.
The rejection of claims 1, 27, 47-49, and 65 under 35 U.S.C. 103 has been modified to address the amendment and maintained.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/04/2025, with respect to the rejection(s) of claim(s) 1, 27, 47-49, and 65 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Seliktar and Bhatia.
New 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.
Claim 1 is 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.
Regarding claim 1, it is not clear how the biomaterial can simultaneously comprise the claimed weight percentage ranges and molar ratios. As claimed, a linear PEG moiety, a first protease-cleavable component, and a second protease-cleavable component are each optional embodiments, because the weight range of each component includes 0%. The recitation of the molar ratios including these components suggesting a molar amount of each is required, which would therefore not allow for a weight percent of 0%. Therefore, it is unclear what the metes and bounds of this claim are.
For the purpose of examination, the Examiner has interpreted the claim to include each of the components in the claimed weight percent, and interpreted each “molar ratio” clause as being dependent on the presence of the individual components. The Examiner suggests rewording each “molar ratio” clause appropriately (e.g., “wherein the molar ratio of the linear PEG to the 4-armed PEG is…” should read “wherein, if present, the linear PEG and the 4-armed PEG are in a molar ratio of…”).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 48 does not further limit claim 47, because claim 48 states the microsphere has “a diameter of between about 0.05 mm and about 1.0 mm”, while claim 47 is already limited to the biomaterial of the independent claim 1, which is a hydrogel microparticle with “a longest dimension (i.e., diameter) of between about 0.05 mm and about 1.0 mm” and which is a microsphere. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
New Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 27, 47-49, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Seliktar (US 20110038828 A1; IDS reference, 07/19/2022), further in view of Bhatia (WO 2010101627 A2). The references were cited previously by the Examiner.
Regarding claim 1, Seliktar teaches a PEGylated fibrinogen hydrogel (i.e., a hydrogel biomaterial; Seliktar, page 4, paragraph 0059), and teaches a PEGylated polymer in 2-3% by weight (Seliktar, page 12, example 1, paragraph 0157) and teaches the synthetic polymer can be linearized and branched PEG molecules, for example 4-arm PEG, and can be any molecular weight, for example 6 or 20 kDa, individually or in combinations thereof (Seliktar, page 7, paragraph 0105), which lies within the claimed range of 0-50% of the linear polymer component and 0.1-50% of the branched polymer component. Seliktar further teaches a PEGylated fibrinogen (i.e., a fibrinogen molecule derivatized with a plurality of PEG/polymeric linkers) in 5-35% by weight (Seliktar, page 9, paragraph 0124), which overlaps the claimed range of 0.25-10% by weight, and teaches any molecular weight of PEG can be used (i.e., a 3.5 kDa PEG would be acceptable; Seliktar, page 7, paragraph 0105). 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). Seliktar teaches the hydrogel without protease-cleavable components comprising the peptides of SEQ ID 19 or 7 (Seliktar, page 11, example 1), suggesting 0% of each is present, which lies within the claimed ranges of each individual component. As each protease-cleavable component is present in 0% as claimed, the molar ratio is not required, and the limitations of the claim are met. Seliktar further teaches those of skill in the art are capable of adjusting the molar ratio of the synthetic polymer (e.g. PEG) and fibrinogen to obtain the desired formulation with the optimal physical and biological characteristics (Seliktar, page 9, paragraph 0125).
Seliktar does not specify the hydrogel biomaterial is a hydrogel microparticle of the claimed size. Bhatia, however, teaches a polymer-based hydrogel (Bhatia, page 51, line 2), which can comprise microparticles (Bhatia, page 28, line 3) with a diameter of 1000 micrometers or less (i.e., 1 mm or less; Bhatia, page 28, line 6), overlapping with the claimed range of 0.05-1.0 mm. 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).
Seliktar and Bhatia are considered to be analogous to the claimed invention, because all are in the same field of pharmaceutical polymeric hydrogels. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Seliktar to have included the specific particle size taught by Bhatia to arrive at the claimed invention, because Bhatia teaches particles of less than 1000 micrometers are preferable (Bhatia, page 28, line 6) and teaches properties such as particle size can be selected for ideal renal excretion and liver clearance rates (Bhatia, page 43, lines 1-2).
Regarding claim 27, Seliktar and Bhatia together teach all the elements of the invention as applied to claim 1. Seliktar teaches the hydrogel composition comprises a PEGylated fibrinogen in 5-35% by weight (Seliktar, page 9, paragraph 0124), and specifically tests examples with 1.5% and 3% of the PEGylated fibrinogen (Seliktar, Fig 5; page 4, paragraph 0057).
Regarding claim 47, Seliktar and Bhatia together teach all the elements of the invention as applied to claim 1. As above, Seliktar does not specify the hydrogel biomaterial is a hydrogel microsphere. Bhatia, however, teaches a polymer-based hydrogel (Bhatia, page 51, line 2), which can comprise microparticles (Bhatia, page 28, line 3), and further teaches the microparticle can be spherical (Bhatia, page 28, line 3). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Seliktar to have included the specific particle type taught by Bhatia to arrive at the claimed invention, because Seliktar teaches therapeutics can be encapsulated in the hydrogel network (Seliktar, page 17, paragraph 0199) and Bhatia teaches microscopic spherical particles can be used to enclose (i.e., encapsulate) aqueous components and drugs (Bhatia, page 27, lines 17-21).
Regarding claim 48, Seliktar and Bhatia together teach all the elements of the invention as applied to claim 47. As noted above, this claim does not further limit claim 47. Therefore, Seliktar and Bhatia teach all the elements of the current claim.
Regarding claim 49, Seliktar and Bhatia together teach all the elements of the invention as applied to claim 1. Seliktar teaches a preferred modulus of elasticity (i.e., storage modulus) of 0.02-0.11 kPa (i.e., 20-110 Pa; Seliktar, claim 15), which overlaps the claimed range. 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).
Regarding claim 65, Seliktar and Bhatia together teach all the elements of the invention as applied to claim 1. Seliktar teaches the fibrinogen used as bovine fibrinogen (Seliktar, page 11, example 1, paragraph 0153).
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.
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/C.P.J./Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613