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 .
DETAILED OFFICE ACTION
This Office Action is in response to the papers filed on 03 December 2025
CLAIMS UNDER EXAMINATION
Claims 1-6 and 8-11 have been examined on their merits.
PRIORITY
Foreign Priority document JP2020-011428, filed on 28 January 2020, is acknowledged. A certified translation has not been provided.
WITHDRAWN OBJECTIONS
The objection to claims 4-8 and 9-11 has been withdrawn due to claim amendment.
WITHDRAWN REJECTIONS
The previous rejections have been withdrawn due to claim amendment.
NEW REJECTIONS
New grounds of rejection have been necessitated by claim amendment.
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 5 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.
Claim 5 recites “a polymer concentration” in the first and second regions. Claim 1 has been amended to recite polymers with a PEG backbone. It is unclear if the polymers recited in claim 5 are the PEG polymer recited in claim 1. The metes and bounds of the claim are unclear. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Broguiere et al. (previously cited; Macroporous hydrogels derived from aqueous dynamic phase separation. Biomaterials 200 (2019) 56-5; available online 02 February 2019).
Broguiere et al. generate a macroporous hydrogel based on partitioning polyethylene glycol (PEG) and high viscous polysaccharides (Abstract). PEG is a polymer. As evidenced by the specification, polyethylene glycol is hydrophilic ([0060]). PEG is cross-linked with a cross-linker (see page 57, right column, third paragraph). Hydrogels are formed using ultrapure water (a solvent; see page 13, first paragraph of “gel formation”).
The art teaches the gels have a “PEG phase” (see page 59 left column, last paragraph; right column third paragraph) and a liquid filled polysaccharide phase (see page 57, left column, second paragraph; also see text of Figure 3). The PEG phase is interpreted to read on a first region with polymer units with a higher concentration. The liquid phase reads on a second region with polymer units at a lower concentration.
The art teaches the disclosed gels have pore sizes ranging from approximately 0.5 to 50 µm, and a thread-like, fully interconnected morphology (page 57, right column, first paragraph).
In a specific embodiment, the art teaches a macroporous PEG gel (PEG 1.5% + MA 1.4% (w/v)) of 50 µm in each dimension (Supplemental data, page 16, last paragraph). The PEG is a 4arm-PEG (see second paragraph of page 13). Therefore the art teaches a PEG backbone. This embodiment reads on the claimed mesh size recited in claim 1. Therefore claim 1 is anticipated.
Because the claimed gel is anticipated, it would inherently have the characteristics recited in claims 2-4 (see MPEP 2112.01).
The art teaches 1.9% PEG (page 16, second paragraph of Supplemental). This reads on a polymer content of 5% wt or less. Claim 6 is included in this rejection.
Claims 10-11 recite the intended use of the claimed product. Because the claimed gel is anticipated, it is capable of being used as claimed. Therefore claims 10-11 are included in this rejection.
Therefore Applicant’s Invention is anticipated as claimed.
RESPONSE TO APPLICANT’S ARGUMENTS
The arguments made in the response filed on 03 December 2025 are acknowledged.
Argument 1: The Applicant argues the pore size taught by Broguiere is smaller than 10-500 µm. The Applicant argues the art does not teach the use of only PEG polymers.
Response to Argument 1: Broguiere teaches a gel with a mesh size of 50 µm. Broguiere teaches a gel comprising PEG polymers. PEG is crosslinked. The art teaches a 4arm-PEG. The specification states a PEG backbone comprises a plurality of arms ([0060] of PG Pub). Therefore the art teaches a PEG backbone. While the art teaches crosslinking in the presence of polysaccharides, the claims do not exclude additional components in the gel. Therefore the arguments are not persuasive.
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.
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 1-6 and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al. (Process For Producing Low-Concentration Gel Using Gel-Precursor Clusters l, and Gel Obtained by Said Production Process. US2018/0030205 2018) in view of Broguiere et al. (Injectable microporous hydrogels. US20180264176A1).
Sakai teaches a polymer gel in which gel precursor clusters have been crosslinked with one another to form a three-dimensional structure (Abstract; [0009])
The gel precursor clusters comprise a first polymer unit having one or more nucleophilic functional groups in a side chain or at an end and a second polymer unit having one or more ([0016]). At [0100] Sakai teaches the following:
In a preferred embodiment, when the gel precursor clusters comprise a first polymer unit having one or more nucleophilic functional groups in a side chain or at an end and a second polymer unit having one or more electrophilic functional groups in a side chain or at an end, two types of gel precursor clusters, a first gel precursor cluster of a composition in which the content of the first polymer units is greater than the content of the second polymer units and a second gel precursor cluster of a composition in which the content of the second polymer units is greater than the content of the first polymer units, can be used as the gel precursor clusters, and a polymer gel of a three-dimensional network structure in which these type types of gel precursor clusters of different compositions are crosslinked with each other can be made.
The polymer unit has a polyethylene glycol skeleton (hence, backbone) ([0015] [0063]).
The gel precursors contain a solvent ([0022]). The solvent can be water ([0087]).
The gel precursor clusters in the present invention preferably have a diameter of 10-1000 nm (hence, 0.01µm-1.0µm) ([0061]).
The art is silent regarding a larger mesh size.
Broguiere et al. teach a method for generating a macroporous hydrogel (Abstract). The gel is used to support tissue regeneration ([0050]). The hydrogel comprises a cross-linked polymer that is a derivative of polyethylene glycol (PEG) and a kosmotropik (Abstract). The hydrogel exhibits interconnected macropores with a size of 200 nm to 1000 μm (Abstract; 0049]).
The art also teaches the following:
The kosmotropik agent which forms a diphasic system in aqueous solutions ([0012]). This simultaneously initiates gelation of the polymer and phase-separation, thus creating a macroporous hydrogel (Abstract; [0013]). Pore size is adjusted by adding kosmotropik agents (Hyaluronic acid and mannuronan ([0090]). The disclosed method and gels simultaneously provide all the desired properties of an injectable macroporous hydrogel. These include biocompatibility with cell encapsulation, in situ pore formation and full tunability of the macropore size ([0061]).
It would have been obvious to try adding a kosmotropik agent to prepare the crosslinked gel taught by Sakai. One would have been motivated to do so to create a tunable hydrogel for tissue regeneration. One would have had a reasonable expectation of success since Broguiere teaches kosmotropic agents can be added during cross-linking to produce PEG macroporous gels. One would have expected similar results since both references are directed to PEG gels comprising two phases. Therefore claim 1 is rendered obvious.
Sakai teaches a gel that can have a mesh size of 1.0 µm. As evidenced by the speciation, a gel with a mesh size of 1.0 µm has a lower transmittance than a transmittance of the polymer prior to gelation, the gel material has an osmotic pressure of ⅕ to ½ of an osmotic pressure of the polymer units before gelation; and an osmotic pressure (Πos) and an elastic pressure (Πel) after a lapse of a certain period of time from gelation have a relationship of Πel > Πos ([0008] [0009]). Therefore the gel taught by Sakai would be expected to have the properties recited in claims 2-4.
Example 7 discloses Tetra-PEG-maleimide (TMPEG) and tetra-PEG-thiol (TTPEG) were weighed out to make the following substance ratios: 1:0.16. The skilled artisan would optimize the ratio since the art teaches the second region can have a lower concentration. Therefore claim 5 is rendered obvious.
Sakai teaches the polymer content in the polymer gel of the present invention is 50 g/L or less, preferably 40 g/L or less ([0096]). In specific embodiments, the art teaches 8 g/L ([0125]) and 7 g/L ([0126]). See MPEP 2133.03. Therefore the range recited in claim 6 is rendered obvious.
Sakai teaches the gel precursor clusters comprise a first polymer unit having one or more nucleophilic functional groups in a side chain or at an end and a second polymer unit having one or more ([0016]). This reads on claim 8.
Sakai teaches the nucleophilic functional groups are selected from the group consisting go an amino group —SH, and —Co2PhNO2, and the electrophilic functional groups are selected from the group consisting of an N-hydroxysuccinimidyl (NHS) group, sulfosuccinimidyl group, maleimidyl group, phthalimidyl group, imidazoyl group, acryloyl group, and nitrophenyl group ([0028]). This reads on claim 9.
Claims 10-11 recite the intended use of the claimed product. Because the claimed gel is rendered obvious, it would be expected to be capable of being used as claimed. Therefore claims 10-11 are included in this rejection.
Therefore Applicant’s Invention is rendered obvious as claimed.
Double Patenting
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 obviousness-type double patenting rejection is appropriate where the conflicting claims 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 conflicting 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.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-6 and 8-11 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 4-10 of US Patent 12,227642 (18 February 2025).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claim limitations of the Instant Application encompass claim limitations of the patent.
Claim 1 of the ‘642 Patent is drawn to a polymer gel comprising polymer units cross-linked with each other. The polymer gel contains a solvent and has a three-dimensional network structure having two regions: a first region in which the solvophilic polymer units are densely present (a higher concentration) and a second region in which the solvophilic polymer units are sparsely present (a lower concentration), and a mesh size composed of the first region is in the range of 1 to 500 μm. Claim 8 recites the hydrophilic polymer units are polymers having a polyethylene glycol backbone.
The embodiment in claim 7 comprises solvent as water and hydrophilic polymer units.
Claim 4 of the Patent recites wherein an osmotic pressure (Πos) and an elastic pressure (Πel) after a lapse of a certain period of time from gelation have a relationship of Πel>Πos.
Claim 5 recites the polymer concentration in the first region is from 10 to 99 wt %, and a polymer concentration in the second region is from 0 to 1 wt %.
Claim 6 of the Patent recites the polymer gel has a polymer content of 5 wt % or less.
Claim 9 of the Patent recites the solvophilic polymer units comprise a first polymer unit having one or more nucleophilic functional groups in a side chain or at an end and a second polymer unit having one or more electrophilic functional groups in a side chain or at an end.
Claim 10 of the Patent recites the one or more nucleophilic functional groups are selected from the group consisting of a thiol group, an amino group, and —CO2PhNO2, and the one or more electrophilic functional groups are selected from the group consisting of a maleimidyl group, an N-hydroxy-succinimidyl (NHS) group, a sulfosuccinimidyl group, a phthalimidyl group, an imidazolyl group, an acryloyl group, and a nitrophenyl group. The intended use recited in instant claims 10-11 does not distinguish the claimed gel from that of the prior art.
CONCLUSION
No Claims Are Allowed
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE MOSS whose telephone number is (571) 270-7439. The examiner can normally be reached on Monday-Friday, 8am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached on (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/NATALIE M MOSS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653
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