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 with traverse of Group I, claims 1-16 in the reply filed on 01/20/2026 is acknowledged. The traversal is on the ground(s) that it does not meet the burden of showing an undue burden for search and examination. This is not found persuasive because the showing of lack of unity are governed by and PCT Rules 13.1 and 13.2. The showing of an examination and search burden is made under US practice, along with a showing of the differing classification. However , this application is 371 continuation of PCT/US2022/071460, and restrictions must follow the PCT rules set out under 13.1 and 13.2. Applicant did not argue the lack of unity teaching shown by the references.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/20/2026.
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 1-16 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.
Applicant sets out “ a sterile hydrophilic polymer and sterile aqueous excipient into a mixing vessel at a concentration of above 5% w/w” . It is indefinite as to whether this refers to the hydrophilic polymer or aqueous excipient, or the total concentration of hydrophilic polymer in an aqueous excipient. Clarification is requested.
Further, it is questioned if applicant is using a sterilization step prior to addition of the sterilized hydrophilic polymer and aqueous excipient. Clarification is requested as to whether this initial method step has been left out of the claims, or sterile hydrophilic polymers and aqueous excipients, are readily available. Clarification is requested.
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 3 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. 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.
Claim 3 depends on Claim 1, which already sets out that the hydrophilic polymer and aqueous excipient are sterile. Correction is requested.
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.
Claim(s) 1 , 4 , 6 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/122707 A1 (UMC Utrecht Holding).
UMC Utrecht Holding teaches a method for manufacturing a hydrogel (page 1, lines 5-6). UMC Utrecht Holding teaches mixing a hydrophilic polymer with an aqueous solvent in a mixing vessel (page 5, line 30, to page 6, line 4). The obtained hydrogel is submerged in a solution containing a medication. This allows for diffusion of the medication into the hydrogel. At page 7, lines 32-34, the hydrogel is immersed in a bupivacaine solution with a glycerol concentration of 30%. The hydrophilic polymer is preferably hyaluronic acid (see claim 5). No shearing force is taught. UMC Utrecht Holding does not teach introduction of sterile hydrophilic polymers or sterile aqueous excipients, however those of ordinary skill would know to use aseptic polymers and excipients prior to introducing them to such an implant mixture, even if sterilization of some type were to follow formation of the medicated hydrogel. Therefore, the instantly claimed method would have been obvious to one of ordinary skill in the art at the time of filing, given the teachings of UMC Utrecht Holding.
Conclusion
No claims are allowed.
Correspondence
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/CARLOS A AZPURU/Primary Examiner, Art Unit 1617 caz