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, claims 1-10 and 17-20, in the reply filed on 7/23/26 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Claims 11-16 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of preparing a composition (opposed to a method of treating a subject), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/23/26.
Accordingly, claims 1-10 and 17-20 as filed 9/9/2024 are pending and under current examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/24 has been considered by the examiner.
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.
Claims 1-3, 5, 6, 9, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 11,623,029B2 (Costella et al., hereafter “Costella”).
The instant claims are drawn to a method comprising administering a composition to a target site of a subject, wherein administering the composition includes combining particles that comprise chitosan and tripolyphosphate with calcium ions to form a crosslinked material, as further specified in the claims.
Regarding claims 1-3, Costella teaches a material for physically separating tissue wherein said material comprises chitosan, calcium chloride as a first ionic crosslinker, and sodium tripolyphosphate as a second ionic crosslinker (see column 1 ad column 3, lines 34-49); the formulations are in suspension form (see paragraph bridging columns 2 and 3 for instance)(limitation of claim 17). Costella’s products are administered by a step of spraying to a target site (see title, in particular) for instance to an injured site and neighboring tissue, a step which appears the same or substantially the same as a fistula target site as recited in claim 5 and soft tissue layer separation as in claim 6 (see description of FIGS. 3A and 3B); limitation of claim 19. Costella specifies an intended use of the method of application to be a use in laparoscopic or open-abdominal procedures (column 2, lines 2-3)(“abdominal cavity” as in claim 7).
Regarding the stepwise components of “combining” and as a portion of “administering” as in claim 1 and further regarding claim 9, Costella teaches mixing of the formulation components immediately followed by spraying to the surgical (target) site (see column 26, claim 1, step (iii)). It would have been prima facie obvious to change the order or to make integral Costella’s steps, with a reasonable expectation of success. One would have been motivated to do so as a part of streamlining Costella’s process for immediate mixing and application. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
Claims 4, 8, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 11,623,029B2 (Costella et al., hereafter “Costella”) as applied to claims 1-3, 5, 6, 9, 17, and 19 above, and further in view of WO03/013552A1 (Han et al., hereafter “Han”).
Costella does not teach the particle size feature described in claim 4.
Han cures this deficiency. Han teaches embolic materials comprising chitin and/or chitosan and their preparation methods (see title, in particular). Han also teaches methods of using said materials for embolization of blood vessels by inserting a catheter into a blood vessel and inserting the material through the catheter (limitation of claims 8 and 20). Han’s materials are embolic materials crosslinked (see Han claim 4). The embolic materials are prepared from chitosan particles having an average diameter of 50 to 1000 micrometers, a range overlapping with the range recited in claim 4.
Both Costella and Han pertain to chitosan-derived materials for biological insertion or applications. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to substitute Han’s size of chitosan functional particles or materials in place of Costella’s generally disclosed chitosan materials particularly for use in embolization methods as taught by Han, with a reasonable expectation of success. One would have been motivated to do so since Han specifically teaches chitosan functional materials embolic materials to be used desirably to occlude blood vessel structures via catheter insertion methodologies.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 11,623,029B2 (Costella et al., hereafter “Costella”) as applied to claims 1-3, 5, 6, 9, 17, and 19 above, and further in view of US 2008/0032934A1 (Ellis-Behnke et al., hereafter “Ellis-Behnke”).
The teachings of Costella have been delineated above. Costella does not specify the target site as in claim 7 or the saline step as in claim 10.
Ellis-Behnke cures this deficiency. Ellis-Behnke teaches methods for administering to a site in need a self-assembling material forming a barrier to adhesion formation (see abstract, in particular). Chitosan is among Ellis-Behnke’s bioadhesive polymers that are state of the art, and they may be in microparticle form (see [0124] and [0125]). Ellis-Behnke’s adhesions may be those on or adjacent to the gall bladder or pancreas for instance (see [0003] and [0100])(limitation of claim 7).
Costella and Ellis-Behnke are both directed to methods of facilitating barriers to undesired tissue adhesion formation. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to apply Costella’s chitosan materials in Ellis-Behnke’s methods of application to the gall bladder and therefore adjacent space and/or tissue or pancreas and therefore adjacent space and/or tissue using Costella’s chitosan materials, with a reasonable expectation of success. One would have been motivated to do so in a method of preventing undesired tissue adhesion for instance in a post-surgical environment as taught by Ellis-Behnke.
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 11,623,029B2 (Costella et al., hereafter “Costella”) as applied to claims 1-3, 5, 6, 9, 17, and 19 above, and further in view of WO2017/161331A1 (Mantri et al.; hereafter “Mantri”).
The teachings of Costella have been delineated above. Costella does not specify a saline removal step as in claim 10 or an additional component as in claim 18. Mantri cures this deficiency.
Mantri teaches methods of treating hemostasis in a bleeding closed tissue volume by using a catheter inserted into a tissue space to deliver a hemostatic agent (see title and abstract, in particular). Chitosan is among named hemostatic and other sealing agents (see [0306]). Mantri teaches a method wherein after delivering a sealant to a cavity, excess material may be removed by flushing the area with saline (see [0328])(limitation of claim 10). Mantri further teaches that a sealant may be made of chitosan and, further, a mixture of chitosan and polyethylene glycol (see [0309] for instance).
Costella and Mantri both pertain to hemostatic or fibrin-type active agent delivery methods in biomedical applications. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use saline to rinse (remove) remaining material by flushing it after delivery as taught by Mantri and to add polyethylene glycol to chitosan in a sealant mixture as in the methods of Costella, with a reasonable expectation of success. One would have been motivated to do so to remove excess material and keep a clean cavity after hemostatic or sealant agent delivery as suggested by Mantri and, respectively, to provide good sealant and/or self-expanding gel properties to the chitosan therapeutic material as taught by Mantri.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AUDREA B CONIGLIO whose telephone number is (571)270-1336. The examiner can normally be reached Monday - Thursday 7:00 a.m. - 5:30 p.m..
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/AUDREA B CONIGLIO/ Primary Examiner, Art Unit 1617
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