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 .
Amendments
Applicants’ amendments to the claims filed 5/21/2026 have been entered. Any objection\rejections from the previous office action filed 1/26/2026 not addressed below has been withdrawn.
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.
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) 1-2,5,7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al. (US 2018/0030205 A1), cited previously. This new rejection was necessitated by amendment.
Sakai teaches a process for producing a gel by crosslinking two gel precurser clusters, the first gel precurser includes amine or thiol terminated nucleophilic multi-arm PEG (including 4 arm) and the second precursor includes NHS substituted tetra PEG, the gel having a polymer content of 60 g/l, within the claimed range. See entire disclosure, especially abstract, [0010]-[0017],[0028]-[0033],[0063], example 2 and claims. The MW of the polymers was most preferably 1x104 to 2x104 Da, within the range claimed. See [0070]. The two precursors could be contained separately in a dual chamber syringe and mixed right before use, the syringe is considered to read on a kit. See [0087]. Furthermore, the examples which contain the two solutions separately in vials is also considered to read on the kit claimed. See example 2. The concentration of ion (same as ionic strength) was 81 mm, within the claimed range. See examples 2 and 7.
Sakai is silent with respect to the pH of the two solutions and the pH of the mixture when mixed within the range claimed. However, Sakai notes that the gelation time can also be controlled by adjusting the pH and ionic strength during gel preparation. See [0063]. Therefore adjusting the pH of the solutions before and after mixing is within the level of skill of one having ordinary skill in the art at the time of the invention in order to yield the desired gelation time. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Regarding the recitation in claims 1,7-9 that the polymers when mixed at certain pH have a specific gelation time, swelling degree and modulus, it follows that since the polymers of Saikia are within the same scope of the claims, they will feature these same properties. Also regarding claims 10-11, which recite intended use of the polymer including hemostatic plug, it follows since the polymers of Saikai are within the scope of the claims they will also be capable of the same use as a hemostatic plug.
Claim(s) 1-2,5,7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al. WO 2014157186 A1, cited previously.
‘186 teaches methods to provide hydrogels produced from tetra armed PEG with nucleophilic groups including amino and thiol and temperature sensitive tetra armed PEG with electrophilic groups including NHS, provided in separate containers and reacted on site. See entire disclosure especially abstract, examples and claims. The MW was most preferably 1x104 to 2x104 Da, within the range claimed. See page 5 2nd ¶. The concentration of the polymer component of the formula (I) and the formula (II) in the solution is 10 mg / mL to 500 mg / mL, with 20 to 400 mg / mL is preferable, 50 mg / mL to 300 mg / mL is more preferable, and 100 to 200 mg / mL is more preferable, several of these data points are within the claimed range, note 10 mg/ml is the same as 10 g/l. See page 7 4th ¶. The pH buffer used in the first and second solution was from 5-9, including specific data points of 6 and 6.5, within the claimed range, and the concentration of ion (ionic strength) was from 20 to 200 mm, the data point of 20 is within the claimed range. See page 10 1st ¶- page 11 line 2. The two precursors could be contained separately in a dual chamber syringe and mixed right before use, the syringe is considered to read on a kit. See page 12 1st ¶. Furthermore, the examples which contain the two solutions separately in vials is also considered to read on a kit. See example 2.
Sakai is silent with respect to the pH of the mixture when mixed within the range claimed. However, Sakai notes that the gelation time can also be controlled by adjusting the pH and ionic strength during gel preparation. See 1st ¶ page 3. Therefore adjusting the pH of the solutions before and after mixing is within the level of skill of one having ordinary skill in the art at the time of the invention in order to yield the desired gelation time. It has also been held that the mere selection of proportions and ranges is not patentable absent a showing of criticality. See In re Russell, 439 F.2d 1228 169 USPQ 426 (CCPA 1971).
Regarding the recitation in claims 1,7-9 that the polymers when mixed at certain pH have a specific gelation time, swelling degree and modulus, it follows that since the polymers of Saikia are within the same scope of the claims, they will feature these same properties. Also regarding claims 10-11, which recite intended use of the polymer including hemostatic plug, it follows since the polymers of Saikai are within the scope of the claims they will also be capable of the same use as a hemostatic plug.
Response to Arguments
Applicant's arguments filed 5/21/2026 have been fully considered but they are not persuasive. Applicants assert the new limitation on pH distinguishes the claims from the Sakai references above.
While the Sakai references no longer anticipate the claims the newly recited limitations on pH are obvious as noted in the new rejections above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618
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