DETAILED ACTION
Claims 1-3, 8-22 and 24-26 are currently pending. Claims 1-3, 8-10, 21-22 and 24-26 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 .
Examiner’s Note
Applicant's amendments and arguments filed 10/08/2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 10/08/2025, it is noted that claims 1 is amended and claims 24-26 are newly added. No new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments and newly added claims.
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) 1-3, 8-10, 22 and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287803 (IDS dated 6/1/2021) in view of US 2012/0171271 (previously applied), US 2016/0369435 (IDS dated 6/1/2021) and US 6,312,705 (previously applied).
Regarding claims 1, the limitation of a solvent-free method for providing a biocidal complex, the method comprising dry -mixing a polymer with a source of iodine in the form of elemental iodine (I), polyvinylpyrrolidone-iodine (PVP-I) and optional further ingredients, followed by solubilizing the mixture by subjecting the mixture to a hot melt extruded process to obtain in a homogeneous blend in which all ingredients are uniformly disturbed throughout the iodine complex is met by the ‘803 publication teaching melt extrudable composition comprising polyvinyl pyrrolidone-iodine complex in at least one polymer. The process of preparing the composition into a shaped article is taught through extrusion and thermoformed or molded shapes such as catheters and drug delivery systems (abstract). The melt temperature is below about 230 degrees C or less than 210 degrees C [0010]. A uniform and well-mixed composition is taught as desired and blending to yield a uniform and well mixed composition or extrusion is well known to those skilled in the art ([0016]-[0017]). Powder polyvinylpyrrolidone-iodine complex and polymer pellets are taught as fed into a suitable extruder such as a twin extruder ([0020], Example 1 and Table 2).
Regarding claim 8, the limitation of further comprising mixing the PA with the source of iodine and one or more further polymers, small molecules, additives is met by the ‘803 publication teaching the composition may include optional additives such as antioxidants and plasticizers [0022], wherein the polymer and PVP-I is mixed [0020].
Regarding claim 9, the limitation of wherein the hot melt extrusion process comprises the use of a multiple screw extruder is met by the ‘803 publication teaching the use of twin screw mixer for extrusion [0020].
Regarding claim 10, the limitation of wherein the temperature in the mixing zones of the extruder is in the range from 150 to 260 is met by the ‘803 publication teaching temperatures below about 210 degrees C).
The ‘803 publication does not specifically teach polyamide (claim 1) or wherein the elemental iodine melts and reacts with an amide functionality on the PA to provide a biocidal PA-I complex (claim 1).
The ‘803 publication does not specifically teach PA is a nylon, specifically polyamide 6 (claims 2-3).
The ‘803 publication does not specifically teach a lack of detectable coloration of surrounding material (claim 22).
The ‘271 publication teaches antimicrobial material consisting of particles comprising an antimicrobial agent and a carrier. The carrier is taught to comprise polyamide (abstract). The antimicrobial agent is taught to be a drug, chemical species or other substance that either kills, or slows down the growth of microbes [0004]. Polymer carrier can comprise more than one polymer i.e., a polyamide and one or more other polymers [0072]. The polyamide melting temperature is taught to be from 150 to 370 degrees C [0083]. Blends are taught to include nylon 6 and polyethylene glycol [0099]. Additives may further be included in the carrier [0100]. The composition is taught to be mixed, blended, heating the premix for a time and temperature which are suitable to flow out the polyamide without decamping it and extruding, cooling and cutting ([0105]-[0110]), wherein a homogenous mixture is taught [0180]. Nylons can be extruded on conventional equipment with settings known to those with skill in the art [0111]. Twin screw extruder is taught [0154]. The polyamide involves extruding the polymer amide into a series of interconnecting open-ended molds [0097].
The ‘435 publication teaches iodine based-antimicrobial agents, a dispersant and related polymer carrier substrate are bonded to obtain iodine based antimicrobial colored master batches and spun into yarns uniformly mixed (abstract). The master batches are mixed as a powder in a mixing unit and the material is melted and extruded [0009]. The mater batch is taught to comprise polymer substrate carrier, dispersant, antimicrobial agent and pigment wherein the polymer carrier includes Nylon 6 [0015] and the iodine-based compound is povidone-iodine [0015].
The ‘705 patent teaching a class of water insoluble iodophors comprising complexes of iodine with various nylons such as nylon 6 or other polyamides. These nylons complexed with iodine can be made in various forms such as molded objects and films and may find application in medicine (abstract). The Nylon 6 is taught to rapidly complex with iodine and release in a steady manner to provide germicidal properties for nylon (column 3, lines 30-40). Iodine is taught to destroy microbial organisms (column 2, lines 1-5). The ‘705 patent teaching elemental iodine (column 4, lines 35-50). The concentration of iodine was 15% elemental iodine by weight the total weight of iodine water solution (column 4, lines 35-45, column 6, lines 30-40, Table 1). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
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 nylon 6 as taught by the ‘271 publication for the polymer taught by the ’803 publication because the ‘803 publication teaches the formation through melt extrusion using an additional polymer to form an antimicrobial product and the ‘271 publication teaches the use of nylon 6 in melt extrusion antimicrobial product. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ’803 publication and the ‘271 publication are taught to be antimicrobial polymer compositions formed by melt extrusion in overlapping temperatures. One of ordinary skill in the art before the filing date of the claimed invention would have motivation and an expectation of success in using the Nylon 6 as the polymer in the composition of the ‘803 publication because the ‘435 publication teaches the combination of PVP-I and Nylon 6. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘435 publication teaches the use of Nylon6 and polyethylene as polymers to be melted with PVP-I and the ‘803 publication teaches PVP-I mixed with polyethylene, thus teaching interchangeability of polyethylene and Nylon 6 in the melt extrusion mixture taught by the ‘803 publication. The inclusion of the PVP-I and nylon 6 in the melt extrusion process as taught by the combination of the ‘803 publication and the ‘271 publication would necessarily result in the reaction and lack of detectable coloration, absent factual evidence to the contrary as the same ingredients and process steps are taught.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use elemental iodine as taught by the ‘705 patent in the composition taught by the ‘803 publication because the ‘705 patent teaches the use of iodine such as elemental iodine for complexation with nylon6 and the combination of the ‘803 publication and the ‘271 publication teach iodine nylon 6 complexes.
It would have been obvious to one of ordinary skill in the art to use a combination of a first iodine, PVP-I as taught by the ‘803 publication with a second iodine, elemental iodine, as taught by the ‘705 patent with a reasonable expectation of success because the ‘803 publication and the ‘705 patent are both directed to forming iodine and polymer containing medical materials for use as antimicrobial/germicide materials. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘803 publication it is known to use melt extrusion to form a composition of PVP-I and a second polymer to form an antimicrobial material, the ‘271 publication teaches polyamide material and antimicrobial agents are known to form melt extruded material, the ‘435 publication teaches iodine and nylon material to form antimicrobial composition and the ‘705 patent teaches the combination of elemental iodine and nylon to form antimicrobial products. Thus the combination of references teach it was known to process iodine material and nylon to form melt extruded material and the use of both PVP-I and elemental iodine was known to be used to form antimicrobial material, making it obvious to form PVP-I, elemental iodine and nylon material through melt extrusion. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0287803 in view of US 2012/0171271 and US 2016/0369435 as applied to claims 1-3, 8-10, 22 and 24-26 above, and further in view of US 2010/00130677 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-3, 8-10, 22 and 24-26 are taught by the combination of the ‘803 publication, the ‘271 publication, the ‘435 publication and the ‘705 patent.
The combination of references does not teach operating the multiple screw extruder at 300 to 500 rpm (claim 21).
The ‘677 publication teaches polyamide-based thermoplastic polymer compositions that exhibit good balance among the properties thereof, in particular mechanical properties and high fluidity in the molten state (abstract). The components molded from the thermoplastic composition are clean and uniform surface appearance [0007]. The compositions are prepared by melt blending, using twin screw extruder, the polyamides and additives. The extrusion conditions are between 240 and 280 degrees C, rotation speed between 200 and 300 rpm [00064].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known rotation speeds for melt extruding polyamide compositions for the melt extruded polyamide composition taught by the combination of the ‘803 patent and the ‘271 publication. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use known processing speeds and temperatures for polyamide as the ‘803 publication and the ‘271 publication are directed to polyamide composition. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘271 publication teaches polyamide melt extruded using temperatures of 150 to 370 degrees C using a twin-screw extruder and the ‘677 publication teaches 240 degrees extrusion of polyamide from a twin-screw extruder, thus teaching the same polymer processed in extrusion at an overlapping temperature. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to optimize rpm as taught by the ‘803 publication using known rpm ranges for melt extrusion as taught by the ‘677 publication. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘803 publication is silent about polyamide polymer and does not mention elemental iodine. The ‘435 relates to an apparatus but does not mention elemental iodine.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The ‘705 patent teaches the combination of nylon and elemental iodine.
Applicant argues neither the ‘803 and the ‘435 utilize hot melt extrusion to generate a PA-I complex and instead are focused on PVP-I blend in which all biocidal activity is due to the PVP-I complex. Applicant argues PP with elemental iodine and there is no PP-iodine complex and iodine thus quickly leaches.
In response, the ‘803 publication teaches a blend of polymer and PVP-I for melt extrusion. The ‘705 patent teaches iodine nylon complexes where nylon 6 and iodine rapidly form complex and release in a steady manner (abstract, column 3, lines 30-40). Thus 705 patent teaches the benefit of forming an iodine nylon complex for steady release and the ‘803 publication teaches that it was known to form polymer iodine compositions by melt extrusion.
Applicant argues the ‘271 and the ‘705 do not fill the deficiently of the ‘803 and the ‘435.
In response, Applicant’s arguments regarding the ‘803 and the ‘435 are addressed above as first presented.
Applicant argues the ‘705 patent does not teach a solvent free process but instead treats various nylons with a solvent containing an iodine source. The ‘705 process is fundamentally different.
In response, it would have been obvious to one of ordinary skill in the art to use a combination of a first iodine, PVP-I as taught by the ‘803 publication with a second iodine, elemental iodine, as taught by the ‘705 patent with a reasonable expectation of success because the ‘803 publication and the ‘705 patent are both directed to forming iodine and polymer containing medical materials for use as antimicrobial/germicide materials. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘803 publication it is known to use melt extrusion to form a composition of PVP-I and a second polymer to form an antimicrobial material, the ‘271 publication teaches polyamide material and antimicrobial agents are known to form melt extruded material, the ‘435 publication teaches iodine and nylon material to form antimicrobial composition and the ‘705 patent teaches the combination of elemental iodine and nylon to form antimicrobial products. Thus the combination of reference teach it was known to process iodine material and nylon to form melt extruded material and the use of both PVP-I and elemental iodine was known to be used to form antimicrobial material, making it obvious to form PVP-I, elemental iodine and nylon material through melt extrusion. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Applicant argues there is not suggestion in the ‘705 patent, the ‘271 or their combination that polyamide and elemental iodine result in homogenous mixtures in a melt phase that allows for complexation.
In response, the ‘803 publication teaches PVP-I and at least one polymer form uniform well mixed compositions (abstract, [0016]-[0017]). The ‘271 publication teaches polyamide melting temperatures and the formation of blends including additionally additives wherein homogenous mixtures are taught ([0072], [0100], [0180]). Thus the forming of homogenous mixtures of PVP-I, and additional polymer and polyamide and additives is known though melting the mixtures to form homogenous composition. It would be obvious to one of ordinary skill in the art that the use of polyamide polymers and additional element such as elemental iodine would result in a homogenous mixture as the melting and forming of homogeneous mixtures including polyamide polymers and additional additives was known at the time of the invention.
Applicant argues the ‘705 patent discloses a fundamentally different process, a two phase system with iodine solvent and nylon, there would be no motivation to combine the teachings of the ‘705 patent with those of the ‘803, 435 and ‘271.
It would have been obvious to one of ordinary skill in the art to use a combination of a first iodine, PVP-I as taught by the ‘803 publication with a second iodine, elemental iodine, as taught by the ‘705 patent with a reasonable expectation of success because the ‘803 publication and the ‘705 patent are both directed to forming iodine and polymer containing medical materials for use as antimicrobial/germicide materials. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘803 publication it is known to use melt extrusion to form a composition of PVP-I and a second polymer to form an antimicrobial material, the ‘271 publication teaches polyamide material and antimicrobial agents are known to form melt extruded material, the ‘435 publication teaches iodine and nylon material to form antimicrobial composition and the ‘705 patent teaches the combination of elemental iodine and nylon to form antimicrobial products. Thus the combination of reference teach it was known to process iodine material and nylon to form melt extruded material and the use of both PVP-I and elemental iodine was known to be used to form antimicrobial material, making it obvious to form PVP-I, elemental iodine and nylon material through melt extrusion. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613