DETAILED ACTION
Claims 1-15 and 18-22 are currently pending. Claims 1-2, 4-8, 10-13 and 18-22 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/07/2025 has been entered.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 11/07/2025 and 02/04/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejections
The prior rejection of claim(s) 1-2, 4-7 and 10-13 under 35 U.S.C. 102(a)(1) as being anticipated by Sun is withdrawn in light of Applicant’s amendment to specify the body is formed from an ionic polymer and active agent that Sun does not teach.
Examiner’s Note
Applicant's amendments and arguments filed 11/07/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 11/07/2025, it is noted that claim 1 has been amended and claims 21-22 are newly added. No new matter or claims have been added.
New Rejections:
The following rejections are newly applied.
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.
Claims 21-22 are 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 21 is directed to “wherein the body is formed from a compounded mixture comprising the ionic polymer ionically bonded to the active agent”. Instant claim 1 is directed to “a body formed from an ionic polymer ionically bonded to an active agent, the body imbibed with the active agent”. The instant specification teaches imbibing is a process of soaking in a drug containing solution [0098] wherein compounded is taught as mixing the polymer and the active agent [0048]. It is unclear how the active is taught as being added through soaking in a solution (imbibing) and additional through compounding (mixing the polymer and the drug), thus leading to unclear metes and bounds of the instant claim. Claims 22 is rejected as not clarifying the ambiguity of claim 21.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21-22 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21 is directed to “wherein the body is formed from a compounded mixture comprising the ionic polymer ionically bonded to the active agent”. Instant claim 1 is directed to “a body formed from an ionic polymer ionically bonded to an active agent, the body imbibed with the active agent”. The instant specification teaches imbibing is a process of soaking in a drug containing solution [0098] wherein compounded is taught as mixing the polymer and the active agent [0048]. Thus claim 21 does not further limit the medical device of claim 1, but provides an alternative method of forming the body, and thus does not further limit. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-2, 4-6 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0263431 (previously applied) in view of Allen (Allen, Michael J., et al, Biochemical and Biophysical Research Communications 318 (2004) pgs. 397-404).
Regarding claims 1-2, 4-5 and 21, the limitation of a medical device comprising an ionic polymer ionically bonded to an active agent, the ionic polymer comprising an anionic polymer, optionally a nonionic base polymer wherein the anionic polymer comprises a functional group selected form one or more of carboxylate (-COO) is met by the ‘431 publication teaching polyurethane foams (abstract). The polymer is taught as an anionically hydrophilized polyurethane dispersion, a cationic coagulant and at least one additionally active including antiseptics [0008]. The polyurethane is taught to have a COO group ([0017], [0050]). Polyurethane thickeners are taught to be included [0107]. The active agent is taught to include biguanide that have an antimicrobial effect [0121] and a cationic anticoagulant [0124]. Process of forming the wound contact product includes anionic polyurethane and a cationic coagulant (claim 1) wherein a dispersion is formed by stirring, which would result in ionic bonding as the anionic and cationic components are brough into contact with one another and read on imbibing and compounding.
Regarding claim 6, the ‘431 publication teaches cationic active agent [0008].
Regarding claim 19-20, the limitation of further comprising at least one excipient wherein the at least one excipient includes antioxidants is met by the ‘431 publication teaching antioxidants [0101].
The ‘431 publication does not specifically teach the active agent is cationic.
Allen teaches cationic biocide polyhexamethylene biguanide to nucleic acid (title) wherein polyhexamethylene biguanide (PHBM) is taught to be an antimicrobial agent (abstract) which is cationic (Fig 1). PHMB is taught to be polycationic and to bind polyanionic (deoxy)ribose phosphate backbones in the form of electrostatic interaction to form a complex and precipitate (page 400, last paragraph).
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, an anionic polyurethane polymer, cationic active agent attached ionically and a polyurethane thickener) from within the prior art disclosure of the ‘431 publication, to arrive at the instantly claimed medical device “yielding no more than one would have expected from such an arrangement”. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention that PHBM would bind to the anionic polyurethane polymer as the ‘431 teaches mixing of PHBM and polyurethane wherein the polyurethane is anionically hydrophilized polyurethane to form a dispersion and Allen teaches the use of cationic PHMB is known to bind anionic agents to form a complex and precipitate, thus it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention that cationic PHBM would bind to anionic polyurethane when mixed based on the teachings of the ‘431 publication and Allen.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0263431 and Allen as applied to claims 1-2, 4-6 and 19-21 above, and further in view of US 2004/0106912 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-2, 4-6 and 19-21 are taught by the ‘431 publication and Allen.
The combination of references does not specifically teach the active agent is an antimicrobial agent specifically chlorhexidine acetate (claims 7-8).
The ‘912 publication teaches a medical device imparting antibacterial properties to the device. Anti-microbial substances with anti-infective properties having cationic nature such as chlorhexidine may be used (abstract). Anti-bacterial agents with cationic characteristics are taught to be used including biguanidines, for example, chlorhexidine digluconate (diacetate) [0103].
It would have been obvious to one of ordinary skill in the art to substitute a first medicinal agent as taught by the ‘431 publication with a second medicinal agent, i.e. chlorhexidine diacetate, as taught by the ‘912 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in substituting the cationic agent of the ‘413 publication for chlorhexidine diacetate taught by the ‘912 publication because both active agents are taught to be cationic and used in medical devices. One of ordinary skill in the art before the filing date of the claimed invention would have a motivation to use chlorhexidine diacetate in the devices of the ‘413 publication because the ‘912 publication teaches it to be a biguanide and an anti-infective and the ‘413 publication teaches the use of biguanides for antimicrobial affect in the wound material.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0263431, Allen and US 2004/0106912 as applied to claims 1-2, 4-8 and 19-21 above, and further in view of Sun (Applicant provided IDS dated 04/11/2023, previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-2, 4-6 and 17-21 are taught by the ‘431 publication.
The combination of references does not specifically teach the active agent released over a span of at least 24 hours, at least 3 days, at least 7 days and at least 30 days (claims 10-13).
Sun teaching functional modification of biomaterial to manage microbial biofilm formation (Title). Drug delivery systems are taught (page 1, last paragraph). Synthesis of waterborne polyurethane is taught (page 82) wherein anionic waterborne polyurethane dispersion containing a COOH group is taught (page 83). Antibiotics are taught as loaded onto coated PUs to form complexes with the anionic PU having broad spectrum inhibitory activity wherein the active agent is taught to be rifampin and miconazole (page 84). Antibiotics are taught as loaded onto the previously treated PU films through soaking (page 86), reading on imbibing. Drug release was taught over 180 days (Figure 4.6, page 98) wherein the films are medical materials (page 99). Anionic waterborne polyurethane was cast onto a polyurethane surface (page 83), thus teaching nonionic based polymer body to which the nonionic modified polymer is cast as a film onto. Cationic or anionic antibiotics are taught to bound to the anionic waterborne polyurethanes, wherein catheter coatings are taught (pg 80, first paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention that the cationic active agent binding to anionic polymer as taught by the ‘431 publication would result in delivery over the claimed range as Sun teaches the anionic polyurethane with cationic drug bound to the surface resulting in drug release up to 180 days. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to obtain the release time over at least 30 days as Sun teaches the release rate of 180 days to inhibit microbial colonization and control the biofilm (page 98, first paragraph) and the desire for antimicrobial properties of the wound material. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to imbibe the polyurethane/anionic polyurethane foam taught by the ‘431 publication with antibiotic taught by the ‘912 publication as Sun teaches the device may be loaded onto previously treated films, thus teaching the option to charge the films with active agent after forming and additionally recharge the active agent as use.
Claim(s) 18 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0263431, US 2004/0106912 and Sun as applied to claims 1-2, 4-8, 10-13 and 19-20 above, and further in view of US 5,061,254 (previously applied), US 5,525,348 (previously applied) and WO 2019/204712
As mentioned in the above 103(a) rejection, all the limitations of claims 1-2, 4-6 and 17-21 are taught by the ‘431 publication, Allen, the ‘912 publication and Sun.
The combination of references does not specifically teach wherein the medical device is in the form of a catheter or component of a catheter (claim 18).
The combination of references does not specifically teach wherein the compounded mixture is molded or extruded into the body (claim 22).
The ‘254 patent teaches a melt extruded catheter of thermoplastic elastomeric hydrophilic polyurethane. The catheter may include an antithrombogenic agent, anti-infective agent and radiopaque agent (abstract), specifically a catheter tubing (column 1, lines 60-70). Anti-infective agents are taught to include chlorhexidine and the material are surface coated onto expandable catheter by dipping (column 5, lines 45-55).
The ’712 publication teaches polymers for biomedical applications (title). The device is taught to be a catheter (page 28, first paragraph) and the polymer is taught to be urethane [00128]. The polyurethane is taught as molded into the implantable devices [00144]. The device is taught to be coated with or formed of the polymer [0082].
The ’348 patent teaches antimicrobial pharmaceutical compositions which may be reacted with quaternary ammonium components or other ionic surfactants and bound water insoluble polymer (abstract). The polyurethane was taught to form tubing (Example 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polyurethane material containing anti-infective as taught by the ‘431 publication and Sun to form a catheter tubing as the ‘254 patent teaches polyurethanes containing anti-infective materials used to form catheter tubing and the ‘348 publication teaches antimicrobial containing polyurethane polymers used to form tubing. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘431 publication teaches the polyurethane known to be used to form biomedical articles and have good mechanical strength and elasticity and the ’254 patent and the ’348 patent teaches specific uses for anti-infective polyurethanes to be used to form catheter tubing. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘712 publication teaches that it was known to mold charged polyurethane polymers into implantable medical devices such as catheters and the ‘431 publication is directed to a polyurethane polymer which is charged.
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.
Claim 1-2, 4-8 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/680,657 (reference application), now Patent 12,370,291. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘291 patent teaches a polyurethane-based reason with an anionic modifier for a medical article with a cationic agent such as an antimicrobial attached.
Claim 1-2 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-10, 14-24 and 26-28 of copending Application No. 17/680,649 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘649 application teaches a polyurethane-based resin with an cationic modifier for a medical article with a anionic agent such as an antimicrobial attached.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-2 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US patent 12,102,736 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘736 patent teaches a polyurethane-based reason with an zwitterionic modifier for a medical article with a ionic agent through ionic bonding such as an antimicrobial attached through imbibing in the polymer.
Claim 1-2, 4-8, 10-13 and 18-20 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 instant application and the ‘938 application teaches a polyurethane-based reson with an anionic modifier for a medical article with a cationic agent such as an antimicrobial attached via imbibing the body of the medical device. The instant claims and the ‘938 application are directed to an overlapping release rate, chlorheixidne acetate cationic agent and at least one additional ingredient such as antioxidants.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-2, 6-8, 10-13, 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-24 of copending Application No. 18/367,131 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘131 application teaches a polymers containing anionic groups such as COO- groups for a medical article with a cationic agent such as an antimicrobial attached, containing an overlapping release rate and overlapping excipients wherein the active agent is added by imbibing.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-2, 6-8, 10-13, 18-20 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) now patent 12,594,365. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and the ‘365 patent teaches a polymers containing anionic groups such as COO- groups for a medical article with a cationic agent such as an antimicrobial attached, containing an overlapping release rate and overlapping excipients.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
103: the ‘431 publication (Fugmann)
Applicant argues the ‘431 publication the claims require an ionic polymer ionically bonded to an active agent. Active agent is defined in the specification to be antimicrobial agent, antithrombotic agent or combination thereof. The bonding with cationic coagulant would not be relevant. While some ionic interaction between oppositely charged species may occur at some point during the process nowhere does the ’431 publication teach such ionic interaction do in fact occur. Applicant argues the ‘431 foam would not necessarily be formed form an ionic polymer ionically bonded to an active agent.
In response, the ‘431 publication teaches anionically hydrophilized polyurethane dispersion, cationic coagulant and at least one active including antiseptics (claim 1) wherein the antiseptic is taught to be PHMB ([0121]-[0122]) wherein the PHMB is taught as mixed with polyurethane [0169]. Allen teaches PHMB is cationic and bonds to anionic (title, page 400, last paragraph). Thus the cationic PHMB would necessarily form an ionic complex with the anionic polyurethane based on the ‘431 publication teaching mixing of the components and Allen teaching the formation of ionic complexes of PHMB and anionic material.
103: the ‘431 publication in view of the ‘912 publication (Rosinskaya)
Applicant argues the ‘912 publication relates to a method of coating the surface of a preexisting medical device and does not teach an ionic polymer iconically bonded to an active agent.
In response, Applicant arguments regarding an ionic polymer iconically bonded to an active agent are addressed above as first presented.
103: the ‘431 publication, the ‘912 publication (Rosinskaya) and Sun
Applicant argues Sun does not remedy the deficiencies of the ‘431 publication and the ‘912 publication.
In response Applicant’s arguments regarding the ‘431 publication and the ‘912 publication are addressed above as first presented.
103: the ‘431 publication, the ‘912 publication (Rosinskaya), Sun and the ‘254 patent (Karakelle) and the ‘348 patent (Whitbourne)
Applicant argues the ‘254 patent and the ‘348 patent does not remedy the deficiencies of the ‘431 publication and the ‘912 publication.
In response Applicant’s arguments regarding the ‘431 publication and the ‘912 publication are addressed above as first presented.
Applicant argues Sun discloses surface modification without causing bulk structure/property changes of the polymer. The ‘254 patent teaches melt extruded catheter form hydrophilic polyurethane and an agent dispersed therein however fails to teach ionic bonding. None of the reference teach a body formed form an ionic polymer ionically bonded to an active agent, the body imbibed with the active agent.
In response, the ‘431 publication teaches anionically hydrophilized polyurethane dispersion, cationic coagulant and at least one active including antiseptics (claim 1) wherein the antiseptic is taught to be PHMB ([0121]-[0122]) wherein the PHMB is taught as mixed with polyurethane [0169]. Allen teaches PHMB is cationic and bonds to anionic (title, page 400, last paragraph). Thus the cationic PHMB would necessarily form an ionic complex with the anionic polyurethane based on the ‘431 publication teaching mixing of the components and Allen teaching the formation of ionic complexes of PHMB and anionic material.
Double Patenting:
Applicant will consider filing terminal disclaimer if appropriate when allowable subject matter is identified.
In response, the rejections are maintained for reasons of record as no substantive arguments are presented.
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
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