DETAILED ACTION
Claims 1-2, 6-19, 23-25, 27-33 are pending. Of these, claims 12-17, 27, and 32-33 are withdrawn as directed to a nonelected invention. Therefore, claims 1-2, 6-11, 18-19, 23-25, and 28-31 are under consideration on the merits.
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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restriction
Applicant’s election of Group I with traverse is acknowledged. The basis of the traversal is that Schutte does not teach or suggest a kit as required by the claims as presently amended.
In response, the claims are presently rejected over van Pinxteren et al. as primary reference, which does teach a kit (see 103 rejection, infra). Therefore, the claims are still viewed as rendering prima facie obvious the first appearing technical feature. The restriction requirement is still considered proper and is made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/6/24 and 7/17/24 was filed prior to the mailing date of a first Action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Claim Objections
Claims 2, 9, and 25 are objected to because of the following informalities: each of these claims recites “SVPs” without any definition of this term. At least the first occurrence of an abbreviation in the claims should be accompanied by the fully spelled out term for clarity. Correction is required.
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.
Claims 1-2, 6-11, 18-19, 23, 25, 28, and 30 are rejected under 35 U.S.C. 103 as unpatentable over van Pinxteren et al. (US Pat. Pub. 2019/0269764; of record in IDS) in view of Provincial Laboratory Services (published 3.26.2021).
As to claims 1-2, 6-11, 18-19, 23, 25, 28, and 30, van Pinxteren discloses a dry powder comprising thrombin and fibrinogen and having a residual moisture content of about 3 wt%, which is within the ranges of claims 1 and 19 (paragraphs 35, 398), along with a kit comprising a container comprising the powder along with a dispensing device (paragraph 30).
Regarding claims 6 and 23, the powder further may comprise polysorbate, trehalose, arginine (an “amino acid”), sodium chloride and sodium citrate (“salts”), and fillers (“bulking agents”) (paragraphs 130, 335-336, 399-400).
As to claim 8, van Pinxteren does not disclose incorporating albumin, saccharose, or glutamate into the fibrinogen drug product, thus reading on the recited amounts.
Regarding claims 2, 9, and 25, the composition is suitable for reconstitution in an aqueous solution (paragraph 488).
As to claim 18, the fibrinogen product may be lyophilized (paragraph 119).
Regarding claim 30, the use of water for injection as the solvent (Table 1).
As to claims 1-2, 6-11, 18-19, 23, 25, 28, and 30, van Pinxteren does not further expressly disclose that the kit comprises a “suitable container comprising an aqueous solvent for dissolving the drug product” and a “transfer device suitable for facilitating clean or sterile transfer of a suitable solvent from a container comprising said solvent into the container comprising the drug product” as recited by claim 1, and wherein the transfer device comprises one or more filters (claim 28). Nor does van Pinxteren expressly disclose the number of subvisible particles having the specified size ranges of claims 2, 9 and 25 upon reconstitution of 1g of fibrinogen in an aqueous solution as recited by these claims and at the concentration of 20 g/L as recited by claims 7-8, nor that the fibrinogen drug product is stable for at least 6 months at 2-25 degrees Celsius (claim 10) and comprises less than 20% of aggregates (claim 11).
Provincial Laboratory Services discloses a vial container comprising fibrinogen concentrate in the form of a powder (“RiaSTAP”), and teaches that the RiaSTAP is prepared for use by transferring sterile water for injection from a container comprising the water (a “suitable container comprising an aqueous solvent for dissolving the drug product” of claim 1) into the product vial comprising the fibrinogen, using an appropriate transfer device such as a syringe (a “transfer device suitable for facilitating clean or sterile transfer of a suitable solvent from a container comprising said solvent into the container comprising the drug product” of claim 1)(see page 9). A filter is screwed onto the syringe (page 10).
As to claims 1-2, 6-11, 18-19, 23, 25, 28, and 30, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the kit of van Pinxteren by incorporating a container comprising an aqueous solvent for dissolving the drug product and a transfer device comprising a syringe comprising a filter and which is suitable for facilitating clean or sterile transfer of the aqueous solvent from the container comprising said aqueous solvent into a container comprising the drug product, because van Pinxteren expressly teaches that the fibrinogen composition is suitable for reconstitution in an aqueous solution and that the kit may comprise a dispensing device, and Provincial Laboratory Services teaches that a container comprising fibrinogen may be reconstituted as an aqueous solution by using a syringe comprising a filter as a transfer device for transferring water from a container containing the water into a container comprising the fibrinogen, such that the skilled artisan reasonably would have expected that the fibrinogen drug product in the van Pinxteren kit could be reconstituted in an aqueous solution in the same manner. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
The resulting kit will comprise a fibrinogen drug product that will possess the recited number of subvisible particles having the specified size ranges of claims 2, 9 and 25 upon reconstitution of 1g of fibrinogen in an aqueous solution as recited by these claims, and at the concentration of 20 g/L as recited by claims 7-8, with an amount of albumin that is within the range of claim 8, and will be stable for at least 6 months at 2-25 degrees Celsius (claim 10) and comprises less than 20% of aggregates (claim 11), because it comprises the same ingredients recited by the claims and a product cannot be separated from its properties. The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the countless ways that an Applicant may present previously unmeasured characteristics. When the prior art appears to contain the same ingredients that are disclosed by Applicants' own specification as suitable for use in the invention, a prima facie case of obviousness has been established, and the burden is properly shifted to Applicants to demonstrate otherwise. See MPEP 2112.01.
Claim 24 is rejected under 35 U.S.C. 103 as unpatentable over van Pinxteren et al. (US Pat. Pub. 2019/0269764) in view of Provincial Laboratory Services as applied to claims 1-2, 6-11, 18-19, 23, 25, 28, and 30 above, and further in view of Hirashima et al. (J. Biochem. 2016;159(2):261-270).
The teachings of van Pinxteren and Provincial Laboratory Services are relied upon as discussed above, but they do not further expressly disclose that the polysorbate is polysorbate 80 as recited by claim 24.
Hirashima discloses the preparation of recombinant human fibrinogen as a biopharmaceutical (Title) and teaches the use of polysorbate 80 as the type of surfactant used to formulate a solution of human fibrinogen (“Purification of fibrinogen” section on page 263).
As to claim 24, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the kit of van Pinxteren and Provincial Laboratory Services as combined supra by selecting polysorbate 80 as the type of polysorbate, because van Pinxteren does not place any limits on the type of polysorbate that may be used and Hirashima teaches that polysorbate 80 is a suitable polysorbate for use as a surfactant in a fibrinogen solution, such that the skilled artisan reasonably would have expected that it could be used as the type of polysorbate surfactant in the van Pinxteren fibrinogen drug product.
Claim 29 is rejected under 35 U.S.C. 103 as unpatentable over van Pinxteren et al. (US Pat. Pub. 2019/0269764) in view of Provincial Laboratory Services as applied to claims 1-2, 6-11, 18-19, 23, 25, 28, and 30 above, and further in view of Aurora Scientific PTFE Syringe Filters (hereinafter “Aurora Scientific; dated 2/19/2019 as indicated by the Google search results page).
The teachings of van Pinxteren and Provincial Laboratory Services are relied upon as discussed above, but they do not further expressly disclose that the filter has a pore size of 3 to 10 microns.
Aurora Scientific discloses syringe filters having pore sizes of from 0.22 to 10 microns, which encompasses the claimed range, and teaches that they are designed for laboratory use and are superior in removing particles or microorganisms.
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the kit of van Pinxteren and Provincial Laboratory Services as combined supra by selecting a filter that has a pore size within the claimed range, because Aurora Scientific teaches that syringe filters having pore sizes within this range are good for removing unwanted particles, and further because it would have been within the purview of the skilled artisan to select a pore size that is appropriate for removing any unwanted particles that are present in the aqueous fibrinogen solution. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 31 is rejected under 35 U.S.C. 103 as unpatentable over van Pinxteren et al. (US Pat. Pub. 2019/0269764) in view of Provincial Laboratory Services as applied to claims 1-2, 6-11, 18-19, 23, 25, 28, and 30 above, and further in view of Eibl (US Pat. Pub. 20110114524).
The teachings of van Pinxteren and Provincial Laboratory Services are relied upon as discussed above, but they do not further expressly disclose that the reconstituted fibrinogen solution is suitable for intravenous administration to a patient, since the solution would also contain thrombin, which would form a clot with the fibrinogen.
Eibl discloses that thrombin will cause fibrinogen to form into an insoluble aggregate (paragraph 3). Eibl discloses a storage stable fibrinogen (paragraph 1) and teaches that fibrinogen concentrates are suitable both for topical application to achieve hemostasis and tissue sealing, and for intravenous infusion to treat dysfibrinogenemia and consumption coagulopathy (paragraph 5).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the kit of van Pinxteren and Provincial Laboratory Services as combined supra by omitting the thrombin from the composition so that it would be suitable for intravenous administration, because Eibl teaches that fibrinogen concentrates are suitable both for topical application to achieve hemostasis and tissue sealing, as well as for intravenous infusion to treat dysfibrinogenemia and consumption coagulopathy, but also that thrombin will cause fibrinogen to form into an insoluble aggregate, such that the skilled artisan seeking to administer fibrinogen intravenously to treat dysfibrinogenemia and consumption coagulopathy would have recognized that the fibrinogen should be administered intravenously by itself without thrombin so as to prevent undesirable formation of fibrin aggregates.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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