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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/5/2026 has been entered.
Amendments
Applicants’ amendments to the claims filed 1/6/2026 have been entered. Any objection\rejections from the previous office action filed 11/6/2025 not addressed below has been withdrawn.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) 1-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koole et al. (US 2009/0297612 A1), cited previously, in view of Moine et al. (US 2013/0344159 A1), in view of Figulty et al. (US 2007/0237742).
Koole teaches embolic spherical particles produced from polymers that include at least one radio opaque monomers including MAOETIB (meeting elected monomer b), at least one hydrophilic monomer including PEGMA (meeting elected monomer a) and crosslinkers including dimethacrylate crosslinkers. See entire disclosure, especially abstract, [0035], and claims 1-4.. Koole is silent with respect to specific monomer amounts within the claimed ranges. However, the preparation of copolymer compositions having variable amount of monomer is within the level of skill of one having 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). One of ordinary skill would adjust the amount of hydrophilic monomer to adjust the solubility properties and the radio opaque monomer would be adjusted sufficient for imaging purposes.
Koole is silent with respect to the crosslinkers and the use of chain transfer agents recited in the claims.
Moine is used for the disclosure within that hexanethiol was a well-known chain transfer agent useful in producing polymer embolization particles. See entire disclosure, especially abstract, [0046]-[0050]. Moine notes that “oftentimes, the active species used to initiate polymerization are highly reactive and may conduct in some cases to undesirable side reactions such as chain transfer. This can lead to the production of short or long branches or even more problematically to the formation of non-resorbable crosslinking. These structural changes can have adverse effects on the biocompatibility of the material. To avoid these side reactions, some chain transfer agents may be added, advantageously in appropriate levels, to the monomer solution without affecting the network formation. These molecules with high transfer reactivity, also called "regulators", are very efficient even at small concentrations. Furthermore the use of at least one transfer agent is an additional way to reduce/control the molecular weight of the polymer chain residue”.
Since the two references are related in their teachings of polymers used for making occluding particles one of ordinary skill in the art would have a high expectation of success in adding the chain transfer agents of Moine including hexanethiol to improve the polymer particles of Koole. Reason to make such a modification stems from the teaching of Moine that chain transfer agents mitigate side reactions and can control molecular weight of the polymer.
Figuly is used primary for the disclosure within that dimethacrylate PEG (PEGDMA) was a well-known crosslinker useful in embolization polymer particles. See abstract and claims, especially 1. The particles of Figuly displayed high density, low fracture, high swell capability rapid swell and deformability. Since Koole already teaches use of crosslinking agents containing dimethacrylate one of ordinary skill would have a high expectation of success in adding the specific dimethacrylate PEGDMA. The artisan would recognize that, based on the disclosure of Koole in view of Figuly that numerous dimethacrylate crosslinkers, including PEGDMA could be substituted into the composition with similar results. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 1/6/2026 have been fully considered but they are not persuasive. Applicants assert Koole and Moine do not teach the claimed crosslinkers.
As noted in the new rejection above the claimed crosslinkers would be obvious when Figuly is considered.
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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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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