DETAILED ACTION
Claims 12, 16-19 and 22-36 are currently pending and under examination.
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 confirms the election of Group II without traverse; thus the restriction is made final.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 07/30/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Interpretation
Claim 18 contains the limitation using “/” for e.g. iothalamate/meglumine. The limitations using “/” will be interested as “and” e.g. the combination of iothalamate and meglumine.
Withdrawn Rejections
The prior rejection of claims 12 and 15-21 under 112(a) Written Description is withdrawn as a result of Applicant removing limitations directed to the functional language of storage modulus, loss modius and chemical reaction when delivered into the aneurysm.
The prior rejection claim 20 under 112(b) is withdrawn as a result of Applicant canceling claim 20.
The prior rejection of claims 12, 15, 18 and 20-21 under 103 as being unpatentable over US 10,576,099 and US 2019/0247306 is withdrawn as a result of Applicant amending instant claim 12 to specify the concentration and molecular weight of PVA, which the combination of references does not teach.
Examiner’s Note
Applicant's amendments and arguments filed 07/30/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 07/30/2026, it is noted that claim 12 is amended and claims 22-36 has been newly added. No new matter or claims have been added.
New Rejection:
The following rejection is newly applied based on Applicant’s claim amendments.
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.
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) 12, 16-18, 22-25, 27-31 and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,576,099 (IDS dated 06/18/2025) in view of US 2013/0108574, Wang (Wang, Menghan, et al., International Journal of Polymer Science, Vol 2021, Article ID 2225426, 16 pages) and WO 2015/105459.
Regarding claims 12, 18, 27 and 30-31, the limitation of a method for treating an aneurysm, the method comprising delivering an injectable hydrogel into the aneurysm to occlude the aneurysm and prevent blood flow into the aneurysm, wherein the injectable hydrogel a contrast agent and water is met by the ‘099 patent teaching a method of treating an aneurysm comprising intravascularly delivering a mixture including biopolymer and a chemical crosslinking agent to an aneurysm. The mixture exits the catheter as a single cohesive strand that agglomerates to form a mass occupying at least 75% of a total internal volume of the aneurysm (abstract, figure 7). The storage modulus is taught to be over 100 Pa (Figure 13). The method for treating aneurysms includes introducing an injectable scaffold material into the internal volume of an intracranial aneurysm (column 6, lines 60-67). The desire for high viscosity at the time of delivery is taught as desired to cause an agglomeration of the tissue scaffold material to remain within the internal volume of the aneurysm (column 10, lines 10-18) and suitable viscosities for delivery are taught as desired (column 10, lines 25-35). A contrast agent is taught as added to the precursor material and includes iohexol (column 11, lines 25-35). The mass of tissue scaffold material was found to be stable within the model aneurysm under blood flow (column 13, lines 10-25). Chitosan is taught to be present at 3.8% w/v (Example 1).
Regarding claims 16 and 28, the limitation of wherein the injectable hydrogel is physically crosslinked is met by the ‘099 patent teaching physical crosslinking (column 4, lines 20-30).
Regarding claims 23 and 34, the limitation of wherein the injectable hydrogel is delivered into the aneurysm via a microcatheter is met by the ‘099 patent teaching injection via microcatheter (column 13, lines 25-40).
Regarding claim 24-25 the limitation of further comprising positioning a neck cover within the aneurysm is met by the ‘099 patent teaching reinforce neck of aneurysm before injection of the materials into the aneurysm (Figure 2).
Regarding claims 35-36, the limitation of further comprising positioning a braided mesh within the aneurysm wherein the braided mesh is positioned within the aneurysm before delivering the embolic composition into the aneurysm is met by the ‘099 patent teaching the flow diverter is a mesh tube (column 1, lines 35-45) wherein the flow diverter is a braided tube (column 8, lines 25-35) wherein the mesh tube is placed before the composition is introduced (Figures 5-8).
The ‘099 patent does not specifically teach the hydrogel comprises polyI(vinyl alcohol) (PVA), wherein the injectable hydrogel comprises form 1% w/v to 10% w/v of the PVA and wherein the PVA has a weight average molecular weight within a range from 100 kDa to 200 kDa (claim 12 and 33) specifically 5% w/v to 10% w/v of the PVA (claim 22).
The ‘574 publication teaches radiopaque, non-biodegradable water-insoluble iodinated benzyl ether of poly(vinyl alcohol) consisting of PVA having covalently grafted thereon iodinated benzyl groups comprising 1-4 iodine atoms per benzyl group. The composition is injectable and capable of forming a cohesive mass upon contact with a body fluid by precipitation of the iodo-benzylether-PVA (abstract). New iodinated poly(vinyl alcohol) has improved stability with respect to hydrolysis [0033]. The iod-benzylether-PVA is present from 5-65 w/w% so that the composition is capable of forming a cohesive mass upon contact with a body fluid by precipitation of the iodo-benzylether-PVA [0037]. It is noted that iodo-benzylethere-PVA having to high a molar mass would not be appropriate for use because it would lead to an embolization compristion to viscous to be injected via a catheter and to low would not precipitate in a cohesive mass forming a solid or semi-solid embolic implant [0095]. The molar mass of PVA is taught to not be smaller than 5,000 Daltons and not greater than 200,000 Daltons [0107]. The viscosity of the embolizing compristion can be tailored by iodo-benzylether-PVA concentration and type and solvent nature to obtain the high viscosity required for aneurysm embolization [0256]. The injectable embolizing compristion was injected into the aneurysm model with a 22 G needle [0263].
Wang teaches hydrogels have three-dimensional network with high water content and good flexibility. PVA hydrogel is one of the oldest composite hydrogels and has chemical stability, non-toxic, good biocompatibility, biological aging resistance and easy processing (abstract). By utilizing intermolecular force between polymer chains to form molecular aggregates the composite system with excellent properties could be achieved. Physical crosslinking chitosan (CS)/PVA blend hydrogels with only PVA gelated networks have been widely used in mainly fields. Physically gelated PVA as the stretchable polymer network together with alkaline polysaccharides CS showed improved mechanical strength of such blend systems (page 4, 2.3.4). Physically or chemically crosslinked CS/PVA is taught (Figure 3).
The ‘459 publication teaches embolic device for use in vascular system comprising biodegradable shape memory element (abstract). Embolization is taught to include aneurysm [0004]. Water responsive elements may include a hydrogel wherein the hydrogel materials are selected from a group including polyvinyl alcohol, chitosan and any combination thereof [0074].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a combination of PVA and chitosan to form an injectable hydrogel to treat an aneurysm because the ‘099 patent teaches chitosan to treat aneurysms and the ‘574 publication teaches PVA to treat aneurysms. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It would have been prima facie obvious to combine PVA and chitosan polymers for aneurysm treatment as both are known in the art to be used in treating aneurysms. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to add PVA to the composition of the ‘099 patent as Wang teaches PVA is known to have chemical stability, non-toxic, good biocompatibility, biological aging resistance and easy processing and wherein blends of PVA/chitosan is taught to have improved mechanical properties. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘459 publication teaches the combination of PVA and chitosan as water soluble hydrogels in the treatment of aneurysm was known. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use physical and not chemical crosslinking the chitosan/PVA hydrogel as Wang teaches the use of chemical or physical crosslinking of chitosan/PVA hydrogels was known and the ‘574 publication teaches the use of PVA in aneurysms wherein chemical crosslinking is not utilized.
It would have been prima facie obvious to one of ordinary skill in the art to use known concentrations of hydrogel components and optimize as the ‘099 patent teaches specifically the use of 3.8 w/v% chitosan and the ‘574 publication teaches PVA polymer to be present 5-65% and teaches the concentration to be tailed to obtain the desired viscosity. Thus it would have been prima facie obvious to one of ordinary skill in the the art before the filing date of the claimed invention to optimize the concentration and molecular weight of the PVA polymer to obtain the desired viscosity and hydrogel properties of the injectable composition. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 19 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,576,099, US 2013/0108574, Wang and WO 2015/105459 as applied to claims 12, 16-18, 22-25, 27-31 and 33-36 above, and further in view of Coutu (Applicant provided).
As mentioned in the above 103 rejection, all the limitations of claims 12, 16-18, 22-25, 27-31 and 33-36 are taught by the combination of the ‘099 patent, the ‘574 publication, Wang and the ‘459 publication.
Coutu teaches radiopaque embolizing agent (title) wherein the contrast agents include isovue and are used in aneurysm repair (abstract). The contrast agent is taught to be used at 0, 10, 20 ro 30 v/v isovue (page 155, first column, first paragraph). Viscosity was taught to increase linearly with the increasing concentration of the contrast agent wherein high viscosity was taught as preferable to help control the injection.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known amounts of contrast agent as taught by Coutu in the hydrogels taught by the ‘099 patent as the Coutu, the ‘099 patent and the ‘459 publication are all directed to gels which contain contrast agent to treat aneurysms. One of ordinary skill in the art would be motivated to use a known amount of contrast agent as taught by Coutu and optimize as Coutu teaches the amount of contrast agent affects the viscosity and may help control injection. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 10,576,099, US 2013/0108574, Wang and WO 2015/105459 as applied to claims 12, 16-18, 22-25, 27-31 and 33-36 above, and further in view of US 2020/0009290.
As mentioned in the above 103 rejection, all the limitations of claims 12, 16-18, 22-25, 27-31 and 33-36 are taught by the combination of the ‘099 patent, the ‘574 publication, Wang and the ‘459 publication.
The combination of references does not specifically teach cerebral aneurysm (claim 26).
The ‘290 publication teaches a liquid embolic compristion capable of solving problem of conventional embolic agents which can be used in treatment of a vascular disease such as cerebral aneurysm. The liquid embolic agents form a hydrogel comprising polyvinyl acetate (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to treat a cerebral aneurysm with the composition taught by the ‘099 patent and the ’574 publication because the ‘099 patent and the ‘574 publication teach the treatment of aneurysms in the vascular system and the ‘290 publication teaches the specific vascular disease to be treated to include cerebral aneurism. Thus it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use compositions known to treat aneurysms to treat the specific cerebral aneurism as taught by the ‘290 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘290 publication teaches the use of PVA to treat cerebral aneurysm and the ‘574 publication teaches the use of PVA to treat aneurysms, thus providing an expectation of success in using the compositions of the ‘099 patent and the ‘574 publication to treat the specific type of aneurysms, cerebral aneurysms.
Response to Arguments:
Applicant’s arguments have been fully considered.
103:
Applicant argues the newly added limitation of “to occlude the aneurysm and prevent blood flow into the aneurysm”. Applicant argues the ‘306 publication (Cleek) is directed to gel that dissolved in blood, which is contradictory to the claimed hydrogel.
In response, the rejection over the ‘306 publication has been withdrawn based on Applicant’s arguments. Newly applied ‘574 publication is directed to PVA to treat aneurysms. The ‘099 patent teaches the mass of tissue scaffold material was found to be stable within the model aneurysm under blood flow (column 13, lines 10-25). It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a combination of PVA and chitosan to form an injectable hydrogel to treat an aneurysm because the ‘099 patent teaches chitosan to treat aneurysms and the ‘574 publication teaches PVA to treat aneurysms.
Applicant argues Ren and Bodugoz-Senturk do not cure the deficiencies of the ‘099 patent and the ‘306 publication.
In response, Applicant’s arguments regarding the ‘306 publication are addressed as first presented above.
Applicant argues Ren and Bodugoz-Senturk do not cure the deficiencies of Coutu.
In response, Applicant’s arguments regarding the ‘306 publication are addressed as first presented above.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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