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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/11/24 has been considered by the examiner inasmuch as the listed documents have been submitted into the file wrapper in the instant application or a parent application.
Status of the Claims
Claims 1-30 are pending in the application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-8, 11-18, and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11738120. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a product which is a locking solution to be used for the very same purpose wherein the locking solution comprises a solution of a taurolidine comprising Polymorph A (see issued claim 1), Polymorph B (see issued claim 8), and a combination of polymorphs (see issued claim 15) wherein said polymorphs are defined as further detailed in the claims and wherein said taurolidine is present in combination with a biologically acceptable acid.
Further regarding claims 1, 3, the biologically acceptable acid may be citric or lactic (see issued claim 3).
As to claim 2, issued claim 2 is also drawn to a composition free of hexane and toluene.
As to claims 4-8 pertaining to the particular heparin, the same limitations and/or overlapping range limitations are recited in issued claims 4-7.
Limitations of claims 11-18 and 21-28 have been addressed above in regard to claims 1-8.
Because the claims are structured differently with the instant claims being broader than the issued claims, this rejection is made using obviousness rationale. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to combine the claimed elements particularly in a locking solution based on the ‘120 issued claims, with a reasonable expectation of success. One would have been motivated to do so based on the similarity and same intended use as in the issued claims.
Claims 9, 19, and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11738120 as applied to claims 1-8, 11-18, and 21-28 above, and further in view of CN101112627A (“Zhang”).
The claimed subject matter of U.S. Patent No. 11738120 has been delineated above as applicable against claims 1-8, 11-18, and 21-28. The ‘120 issued claims do not speak to the unfractionated heparin recited in claims 9, 19, and 29. Zhang cures this deficiency.
Zhang teaches injection materials and methods and otherwise mentions the state of the art with regard to locking solutions. Zhang explicitly teaches that unfractionated heparin may be desirably used as an anticoagulant where desired (top paragraph on page 3 of translation; see also Example 3).
Where 11738120 and Zhang both pertain to locking solutions or injection solutions, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to utilize unfractionated heparin as an anticoagulant functional agent, with a reasonable expectation of success, in the locking solution in place of the generic heparin of the issued claims. One would have been motivated to do so since Zhang teaches that unfractionated heparin was known to be used as an anticoagulant in injection solutions.
Claims 10, 20, and 30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11738120 as applied to claims 1-8, 11-18, and 21-28 above, and further in view of US 6350251B1 (“Prosl”).
The claimed subject matter of U.S. Patent No. 11738120 has been delineated above as applicable against claims 1-8, 11-18, and 21-28. The ‘120 issued claims do not speak to the inclusion of urokinase as in instant claims 10, 20, and 30.
Prosl cures this deficiency. Prosl teaches the state of the art with regard to biocidal locks wherein the formulations include an anticoagulant, a biocidal lock, and a non-antibiotic biocide for instance (see abstract, in particular). Prosl specifies that urokinase is a known anticoagulant ([0056]).
Both the ‘120 claims and Prosl pertain to locking solutions or biocidal formulations. It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to add urokinase as taught by Prosl to the locking solution of the instant claims, with a reasonable expectation of success. One would have been motivated to do so because Prosl specifies that urokinase is a known anticoagulant which may be used in analogous formulations.
Conclusion
The prior art does not reasonably teach the particular taurolidine polymorph components in a locking solution as claimed. The claim language “obtained from” is interpreted to characterize the particular taurolidine polymorph included int eh claimed locking solution.
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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