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 7/17/2026 have been entered. By amendment applicants have included the features of withdrawn claim 8 into claim 1. Claim 8 has been further amended to specify more specific aspects of formula IV and is no longer withdrawn and is rejoined herein for examination.
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) 1-8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koole et al. (US 2009/0297612 A1), in view of Moine et al. (US 2013/0344159 A1), in view of Figulty et al. (US 2007/0237742), this modified rejection was necessitated by amendment.
Koole teaches embolic spherical particles produced from polymers that include at least one radio opaque monomers including MAOETIB (meeting elected monomer b), mixtures of hydrophilic monomers including PVP, PEGMA (meeting elected monomer a) and methacrylic and acrylic acid (meeting formula IV in claims 1 and 8) and crosslinkers including dimethacrylate crosslinkers. See entire disclosure, especially abstract,[0020] [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 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 7/17/2026 have been fully considered but they are not persuasive.
Applicants assert Koole only teaches monomer a and b. The examiner disagrees, the hydrophilic monomers such as PVP and PEGMA (monomer a) and acrylic acid (formula IV) can be present in mixture, thus Koole teaches monomer a,b and e.
Applicants pick on Moine for teaching biodegradable monomers and not the resorbable polymer of the invention. Applicants assert the combination is only by impermissible hindsight.
The relevance of this assertion is very unclear. First, the claims do not preclude biodegradable monomers. Secondly, Moine was only used as a secondary reference for its teaching on hexanethiol chain transfer agent and was not bodily incorporated into the primary reference. That is only the part of chain transfer agent of Moine was combined with the primary reference, not the polymer matrix.
Applicants assert the secondary reference Figuly exemplifies amounts of 50 mol% acrylic acid, while their claims recite lower amount of ionizable monomer.
Again, the relevance of this assertion is very unclear. The Figuly reference simply was not used for its teaching of ionizable monomers which was not even a claimed feature until applicants most recent claim amendment. Figuly was used for the disclosure within that dimethacrylate PEG (PEGDMA) was a well-known crosslinker useful in embolization polymer particles. The polymer matrix of Figuly was not bodily incorporated into the primary reference. Only the part of PEGDMA crosslinker was added to the primary reference.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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.
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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618
