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 .
Election/Restrictions
Applicant’s election of group I and the species of hemostatic agent in the reply filed on 12/3/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 12-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim.
Claim Objections
Claims 4-11 are objected to under 37 CFR 1.75(c) as being in improper form because multiple dependent claims cannot depend upon another multiply dependent claim. See MPEP § 608.01(n). Accordingly, the claims 4-11 have not been further treated on the merits.
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) 1-3 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Sakai et al. (US 2018/0030205 A1), cited IDS.
Sakai discloses 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 pH of the buffer used in the examples was 5.8 and 5.9, within the claimed range, and the concentration of ion (same as ionic strength) was 81 mm, within the claimed range. See examples 2 and 7.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Sakai et al. WO 2014157186 A1, cited IDS, translation provided by examiner. Citations are for English translation provided.
‘186 discloses 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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai et al. (US 2018/0030205 A1).
Sakai is disclosed above. While the examiner believes the reference anticipates the claimed pH and ionic strength, the claimed limitations would also be obvious when the teachings are considered. Sakai teaches that “Tetra-PEG gels can also be produced on site easily by simple two-liquid mixing of each polymer solution, and the gelation time can also be controlled by adjusting the pH and ionic strength during gel preparation.” Therefore, adjusting the pH and ionic strength is within the skill of one of ordinary skill in the art at the time of the invention. 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).
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakai WO 2014157186 A1, cited IDS. Citations are for English translation provided by applicants.
‘186 is disclosed above. While the examiner believes the reference anticipates the claimed concentration, pH and ionic strength, the claimed limitations would also be obvious when the teachings are considered. As noted above the concentration is from 10-500 mg/ml, pH range is 5-9 and ionic concentration is 20-200 mM, these values overlap the claimed range. A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Therefor, based on the described overlap above, the instant claims would have been obvious to one of ordinary skill in the art. MPEP § 2144.05.
‘186 also teaches that “Tetra-PEG gels can also be produced on site easily by simple two-liquid mixing of each polymer solution, and the gelation time can also be controlled by adjusting the pH and ionic strength during gel preparation.” See ¶ bridging page 2-3. Therefore, adjusting the pH and ionic strength is within the skill of one of ordinary skill in the art at the time of the invention to adjust 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).
Conclusion
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.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618