DETAILED ACTION
Claims 1-24 are currently pending. Claims 1-4, 8, 10-13, 15-24 are currently 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’s election without traverse of the active agent is chlorhexidine acetate, ionic additive of anionic additive comprising a COO- functional group, the base polymer is thermoplastic polyurethane (TPU), the form is catheter and excipient is thermal stabilizer in the reply filed on 10/21/2025 is acknowledged.
Claims 5-7, 9, 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/21/2025.
Priority
The instant application claims priority to provisional application 63/412,933, filed 10/04/2022.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 11/16/2023, 01/05/2024 and 11/19/2025 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 contains the phrase “and the like” in the last line which renders the claim indefinite as it is unclear what “and the like” encompasses leading to unclear metes and bounds. Regarding claim 24, the phrase "or the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 8, 11-13, 15-20 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5,525,348 (IDS dated 01/05/2024).
Regarding claim 1, the limitation of a medical device comprising an ionic compound ionically bonded to an active agent, the ionic compound comprising an ionic additive incorporated into a base polymer is met by the ‘348 publication teaching anti-microbial pharmaceutical ingredients or other pharmaceutical agents which may be reacted with quaternary ammonium components or other ionic surfactants, wherein the pharmaceutical ingredient is taught to be ionic (abstract). The drug-quaternary ammonium compound is mixed in solution with a water insoluble polymer (column 2, lines 10-20, lines 27-67, column 3, line 31-67, claims 1-2, 5-12, 14, 21-26 and 30).
Regarding claim 2, the limitation of the ionic additive is selected from an anionic additive, cationic additive and zwitterionic additive is met by the ‘348 publication teaching quaternary ammonium compounds (abstract) and may be anionic surfactants (claim 26-29).
Regarding claim 3, the limitation of wherein the base polymer is selected form a nonionic base polymer and an ionic base polymer is met by the ‘348 publication teaching cellulose esters and polyurethane polymer (column 2, lines 34-40, claim 3).
Regarding claim 4, the limitation of wherein the anionic additive comprises functional groups selected form a group including carboxylate and organosulfate is met by the ‘348 publication teaching sodium lauryl sulfate, diacetyl phosphate and sodium striate (claim 11, 26-27).
Regarding claim 8, the limitation of wherein the nonionic base polymer comprises one or more of polyurethane and cellulose acetate is met by the ‘348 publication teaching cellulose acetate (claim 3).
Regarding claim 11, the limitation of wherein the active agent comprises one or more of an anionic active and cationic active agent is met by the ‘348 publication teaching an anionic active agent or cationic active agent (abstract, claim 7-10, 17-19 and 21).
Regarding claims 12-13, the limitation of wherein the active agent is selected from the group consisting of an antimicrobial agent such as benzalkonium chloride is met by the ‘348 publication teaching benzalkonium chloride (column 4, lines 25-30, example 1), per the instant specification [0018].
Regarding claims 15-18, the limitation of wherein the active agent is released over a span of at least 24 hours, 3 days, 7 days or 30 days is met by the ‘348 publication teaching the present invention provides release over a relatively long period of time (over one month) with desired longer time period release (column 1, lines 40-60, claim 37). Additionally, the ‘348 patent teaches the claimed structure of the devices and thus would necessarily have the functional limitation of release rate absent factual evidence to the contrary.
Regarding claims 19-20, the limitation of wherein the ionic compound and the active agent on a body of the medical device is met by the ‘348 patent teaching the drug-quaternary ammonium compound maybe mixed in a solution with the water-insoluble polymer or it may be coated on top of the coating of the water insoluble polymer which is applied to the surface beforehand (column 2, lines 5-25, column 10, lines 4-67))
Regarding claim 22, the limitation of the medical device in the form of a catheter is met by the ‘348 patent teaching a catheter (claim 14).
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 5,525,348 as applied to claim 1 above, and further in view of Weaver et al. (WO2013/090808, IDS dated 11/19/2025).
Regarding claim 21, the ‘348 patent. does not teach wherein a body of the medical device comprises the ionic compound, and ionically bonding the comprises imbibing the body of the medical device with the active agent. However, Weaver et al. teaches that the additive may be incorporated into and/or onto the substrate by various techniques. In one such method, the substrate is imbibed with the additive; that is, the additive is absorbed into the substrate (see para 233-244). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Whitbourne et al. with the teaching of Weaver et al. since Weaver et al. teaches and alternative process of ionically bonding the active agent to the ionic compound.
Claim(s) 1-4, 8, 10-13, 15-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/3048015 (IDS dated 01/05/2024).
Regarding claims 1-2, the limitation of a medical device comprising an ionic compound ionically bonded to an active agent, the ionic compound comprising an ionic additive incorporated into a base polymer, the ionic additive is anionic is met by the ‘015 publication teaching a biologically active ion-exchange polymer salt made by exchanging biologically active ionic agents onto ion exchange polymer (abstract). The agents may be incorporated into polymeric biomaterial or coatings ([0009], [0011]). Catheters and wound dressings are taught [0105].
Regarding claims 3, 8 and 10, the limitation of wherein the base polymer is selected from nonionic base polymer, such as polyurethane is met by the ‘015 publication teaching thermoplastic polymer selected from a group including polyurethane polymers ([0113], claim 11).
Regarding claim 4, the limitation of the anionic additive contains carboxylate or sulfonate is met by the ‘815 publication teaching chlorhexidine ion exchange with polystyrene sulfonate [0247] and may comprise carboxylate weak ion exchanges such as Amberlite IRP64 [0253].
Regarding claim 11-13, the limitation of wherein the active agent is cationic, selected from a group including antimicrobial agent and is chlorhexidine acetate is met by the ‘815 publication teaching chlorhexidine diacetate [0044].
Regarding claims 15-18, the limitation of wherein the active agent is released over a span of 24 hours, 3 days, 7 days at least 30 days is met by the ‘815 publication teaching release of 1-3 days or weeks or 1-3 months or longer [0082]. Further the ‘815 publication teaches the claimed structure of the device, see claim 1, and thus would necessarily have the functional features of release rate absent factual evidence to the contrary.
Regarding claim 19, the limitation of comprising a coating of the ionic compound and the active agent on a body of the medical device is met by the ‘815 publication teaching coatings ([0001], [0009], [0013]).
Regarding claim 20, the limitation of comprising a compounded mixture of the ionic compound and the active agent is met by the ‘815 publication teaching chlorhexidine is bound to PSS wherein mixtures of biologically active ion exchange polymer salt comprise mixture is taught ([0247], claim 150).
Regarding claim 21, the limitation of comprising body including the ionic compound imbibed with the active agent is met by the ‘815 publication teaching the activated resin material incorporated in solid polymer composite molded ([0016], [0036]) into medical devices ([0102], [0105]). The structure of the device comprising the ionic compound and active agent is taught, wherein the imbibing is a product by process limitation. MPEP 2113 - “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Regarding claim 22, the medical device is taught to be catheter ([0012], [0105]).
Regarding claims 23-24, the limitation of further comprising at least one excipient selected form a group including thermal stabilizer, light stabilizer, antioxidants is met by the ‘815 publication teaching additional stabilizing materials such as antioxidants, UV stabilizer, fillers, colorants and the like [0153] wherein the desire to prevent thermal degradation is taught ([0151], [0247]).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of disclosed ingredients (for example, chlorhexidine acetate with carboxylate weak ion exchanges such as Amberlite IRP64 and polyurethane to form a catheter) from within the prior art disclosure of the ‘815 publication, to arrive at the instantly claimed medical device “yielding no more than one would have expected from such an arrangement”.
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 8, 10-13 and 15-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/367,133 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘133 application teaches a medical device comprising ionic additive containing a COO group and an active agent including chlorhexidine gluconate incorporated into a nonionic base polymer through imbibing or compounded with the active agent and formed into the medical device. The ‘133 application teaches a release rate over 30 days. The ‘133 application teaches additive such as thermal stabilizers and antioxidants. The ‘133 application teaches coating the ionically bonded ionic compound and active agent on the body of a medical device. Thus the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 8, 11-13 and 15-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 18-22 of copending Application No. 17/991,937 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘937 application teaches a medical device comprising ionic additive containing a COO group and an active agent including chlorhexidine gluconate incorporated into a nonionic base polymer through coating or compounded with the active agent and formed into the medical device. The ‘937 application teaches a release rate over 30 days. The ‘937 application teaches additive such as thermal stabilizers and antioxidants. The ‘937 application teaches coating the ionically bonded ionic compound and active agent on the body of a medical device. The instant claims are directed to a structure of the medical device, therefor the method of forming the device, such as imbibing is a product by process limitation. The ‘937 patent teaching a compounded mixture of the ionic compound and the active agent extruded into the body meet the structural limitations of the body including the ionic compound and active agent. Thus the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 11-13 and 15-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 17/991,938 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘937 application teaches a medical device comprising ionic additive containing a COO group and an active agent including chlorhexidine gluconate incorporated into a nonionic base polymer through coating, imbibing or compounded with the active agent and formed into the medical device. The ‘937 application teaches a release rate over 30 days. The ‘937 application teaches additive such as thermal stabilizers and antioxidants. The ‘937 application teaches coating the ionically bonded ionic compound and active agent on the body of a medical device. Thus the instant claims are anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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