DETAILED ACTION
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 .
Status of the Claims
Claims 1, 5-21 and 23-25 are pending. Claims 2-4 and 22 are canceled. Claims 1, 7-10 and 26 are amended.
Claims 5-6 are withdrawn. Claim 5 is withdrawn in view of the election to (PVA fibers) as the dressing material. The cellulose polymers elected are part of the solvent system with antimicrobial agent (e.g. the elected silver salts).
Claims 1, 7-21 and 23-25 are under current examination to the extent of the species elections to: hydroxypropylcellulose HPC, silver salts and cross-linked polyvinyl and cross-linked polyvinyl alcohol as the substrate.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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.
Rejections Withdrawn
In light of the amendments to the claims the rejection of claim(s) 1-4, 8-21 and 23-25 under 35 U.S.C. 103 as being unpatentable over Jung et al. Antimicrobial properties of hydrated cellulose membranes with silver nanoparticles, J Biomater Sci Polym Ed. 2009; 20(3):311-24 in view of Karandikar et al. (WO2014/179353A1), Trogolo et al. (United States Patent Publication 2003/0118664-see IDS filed 10/19/2021) and Schmitz et al. (United States Patent Publication 2013/0274415-see IDS filed 10/19/2021) is withdrawn.
In light of the amendments to the claims the rejection of claim 7 under 35 U.S.C. 103 as being unpatentable over Jung et al. Antimicrobial properties of hydrated cellulose membranes with silver nanoparticles, J Biomater Sci Polym Ed. 2009; 20(3):311-24 in view of Karandikar et al. (WO2014/179353A1), Trogolo et al. (United States Patent Publication 2003/0118664-see IDS filed 10/19/2021) and Schmitz et al. (United States Patent Publication 2013/0274415-see IDS filed 10/19/2021) as applied to claim(s) 1-4, 8-21 and 23-25 above, and further in view of Sun et al. (United States Patent Publicization 20030139714) is withdrawn.
New Rejections/Rejections Maintained
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) 1-4, 8-21 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Karandikar et al. (WO2014/179353A1) in view of Jung et al. Antimicrobial properties of hydrated cellulose membranes with silver nanoparticles, J Biomater Sci Polym Ed. 2009; 20(3):311-24, Trogolo et al. (United States Patent Publication 2003/0118664-see IDS filed 10/19/2021) and Schmitz et al. (United States Patent Publication 2013/0274415-see IDS filed 10/19/2021).
The instant claims are being examined to the extent of the species elections to hydroxypropylcellulose HPC (one or more polymer), silver salts and cross-linked polyvinyl alcohol as the substrate (absorbent fibers).
Claim interpretation: Claim 1 comprises three steps a) preparing an antimicrobial coating composition comprising one or more polymers in non-aqueous solvent and water soluble antimicrobial agent, b) contacting said antimicrobial composition with an absorbent non-woven fiber and c) drying which results in the antimicrobial wound dressing composition.
Karandikar et al. teach methods of preparing antimicrobial silver compositions and treating devices including absorbent wound care materials with such antimicrobial composition, see abstract, pages 4-6, 9, 12, 13 15,and 16,27,34, and entire document. The composition can be made with either an aqueous or non-aqueous solvent, see page 16, first paragraph. A non-aqueous solvent is called for in instant claim 23. The non-aqueous solvents comprise non-aqueous solvents as a major constituent. (See page 16).
Methods of making the antimicrobial coating include preparing a coating solution having silver compound, applying the coating to the surface of an article and drying the coating, see page 16. The antimicrobial composition can be blended to surface coat a device or can be embedded in either woven or non-woven substrates such as wound dressings, see pages 13 and 34. The substrate fibrous material can be either woven or non-woven and be rendered antimicrobial with the antimicrobial composition.
The coating solution can be either water based or can be made of non-aqueous solvents, see page 16. The non-aqueous solvent includes lower alcohols of C1-C6. This renders obvious ethanol (polar aprotic solvents) and methanol which are lower alkyl alcohols inclusive of C2 (ethanol), see pages 11, and 15-16. Polymers can further be added to the solution, see pages 10, 11,14, and 16. The method of making includes providing polymers in a non-aqueous solvent and then adding the active silver compounds, see page 16. The polymers can be hydroxypropyl cellulose alone ( a cellulosic polymer as called for in claim 1) as called for in instant claims 1 and 26.
Karandikar thus teaches a solvent system that is a liquid that contains hydroxypropyl cellulose polymer, so the polymer is dispersed in the solvent system as called for in instant claim 1. Applying the coating solution to the surface of an article reads on contacting the liquid antimicrobial coating composition with a dressing substrate as called for in instant claim 1b. The antimicrobial coating composition is liquid as called for in instant claims 7, 8, 9 and 10.
Silver salts in the composition include silver sulfate and silver acetate, see pages 8, 11, 34 and entire document. The polymer can include hydroxypropyl cellulose and cellulose polymers, see pages 10,11, 14, and 34. Polyvinyl alcohol is another polymer that can be used. (See 10,11, 14, and 34).
Cellulosic polymers are called for in instant claims 1 and 8. Hydroxypropyl cellulose is called for in instant claims 9-10. The polyvinyl alcohol is called for in instant claim 25.
Karandikar teaches selection of hydroxypropylcellulose as the polymer for the addition step (e.g. at page 16) as part of the coating composition but cellulose polymers is contemplated as a polymer that is combined with silver. Karandikar teaches that its coating is able to resist light and heat induced discoloration and is non-staining while providing excellent anti-microbial protection to woven wound dressings, see page 3.
Karandikar teaches does not teach antimicrobial silver compositions containing only a silver salt and a cellulose polymer. Karandikar teaches that the substrate can be a fibrous wound dressing device (see page 13), however does not expressly teach that their fibrous wound dressing article is made of cross-linked PVA absorbent fibers or that the coating application includes kiss coating. These deficiencies are made up for with the teachings of Jung, Trogolo and Schmitz.
Jung et al. (Jung) teaches methods of preparing antimicrobial silver compositions and their usefulness in an antimicrobial wound-dressing material for wounds and burns. (See Abstract and entire document). The antimicrobial composition consists of silver nitrate nanoparticles that are evenly adsorbed onto the overall surface of the cellulose nanofibrils and having a spherical shape with uniform size of 8 +/- 2 nm which allowed them to show antimicrobial properties. The interaction between the oxygen in cellulose and silver nanoparticles resulted in the stable adsorption of the silver nanoparticles on cellulose nanofibrils. (See Abstract). Jung teaches that its antimicrobial silver compositions contain only a silver salt and a cellulose polymer.
The antimicrobial agent can be silver nitrate which is called for in instant claims 1 and 26. The antimicrobial composition consists of only silver nitrate and the polymer, see Abstract, so the silver nitrate is the only antimicrobial agent present in the composition as called for in instant claims 1 and 26. The antimicrobial coating consists of the silver salt (the antimicrobial agent) and the cellulose polymer (the one or more polymers) as called for in instant claim 26. The composition can be applied to a wound care device such as wound dressings, see claim 14.
Trogolo et al. teaches that hydrophilic polymers including cellulose polymers enable good dispersion of particles and prevent agglomeration of the antimicrobial agent, see paragraph [0027] and [0051]-[0052]. Hydrophilic polymers are able to absorb water and enable the action of the encapsulated material to impart antimicrobial activity, see paragraph [0017] and [0033]. The polymers used to encapsulate antimicrobial agents includes cellulosic polymers and functions to absorb water, see paragraph [0027] of Trogolo.
Thus, it would have been prima facie obvious to select hydroxypropyl cellulose as the polymer used with the silver nitrate in the solution of Karandikar. One of ordinary skill in the art would have been motivated to do so as Trogolo teaches that cellulose polymers enable good dispersion of antimicrobial particles and prevent particle agglomeration. There would have been a reasonable expectation of success given cellulose polymers including hydroxypropylcellulose since they are already suggested by Karandikar for use with antimicrobial silver.
However, Schmitz et al. teach fibrous substrates configured to hydrogel (i.e. they are capable of forming gels) which comprise polyvinyl alcohol polymers, see clam 1 and abstract. The fibers are cross-linked, and are useful in forming wound dressings, see paragraphs [0003], [0010] and [0030]. These fibers are dry and form stable gels upon contact with wound exudate, thus the substrate is in a dried state and gel upon contact with wound fluids, see paragraphs [0009], [0014]-[0017], [0024], [0025], and [0030] and [0152]. According to Schmitz, the fibrous articles can contain antimicrobial additives including silver or silver salts. Such additives can be provided with ethanol solutions of antimicrobial agent to coat the fibers, see paragraphs [0061]-[0063]. According to Schmitz wound dressings make of polyvinyl alcohols are cost-effective and have a greater stability, especially a high maximum breaking force and maximum breaking elongation in the hydrogelled state so they can be removed in one piece from the wound or wound cavity, see paragraph [0012]. The polyvinyl alcohol fibrous structures furthermore have high absorption capacity, see paragraphs [0014]-[0015]. Schmitz teaches that fibers can be provided with ethanolic solutions having antimicrobial agent by using coating methods including kiss-coating, see paragraph [0063].
In Example 8 Schmidt teaches providing the nonwovens with an antimicrobial finish from an ethanolic solution. (See Example 8). Schmidt teaches that ethanolic solution, water and mixtures thereof are suitable solvents. Schmidt teaches an ethanolic solution with approximately 0% water, in that only ethanol is described in the solution. (See Example 8). Approximately 0% is less than 50% of water as called for in instant claim 1 and is less than 30% as called for in instant claim 24.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Karandikar method as modified by Jung to follow the steps of preparing the coating solution with an ethanol solvent having only a silver halide and hydroxypropyl methylcellulose, applying the liquid coating to the surface of an article and drying the coating in order to have a stable antimicrobial composition that that be applied to a variety of wound dressings and possess excellent long-term stability as taught by Karandikar.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date to provide the wound dressing fibers taught in Karandikar as cross-linked polyvinyl alcohol as the type of substrate material for the wound dressings.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Karandikar method as modified by Jung to follow the steps of preparing the coating solution with an ethanol solvent having only a silver halide and hydroxypropyl methylcellulose (a cellulose polymer) in order to have a simple antimicrobial solution that has stable adsorption of the silver nitrate nanoparticles on cellulose nanofibrils which provide antimicrobial properties with just a silver salt and cellulose polymer as taught by Jung.
One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success as Jung teaches that its antimicrobial composition can be used on various kinds of wound dressings. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success also because Karandikar teaches that the substrate material can comprise fibrous wound dressings and Schmitz teaches that fibers including cross-linked polyvinyl alcohol show greater stability are useful for wound dressings and have high absorption capacity. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success as Karandikar teaches that the substrate material can comprise fibrous wound dressings and Schmitz teaches that fibers including cross-linked polyvinyl alcohol show greater stability are useful for wound dressings and have high absorption capacity.
It would have additionally been obvious to coat the fibers of Karandikar using a kiss coating method as Schmitz expressly teaches that ethanolic solutions having an antimicrobial agent can be applied to polyvinyl alcohol fibers via the kiss coating method. The Examiner acknowledges that " the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int’l Co. V. Teleflex Inc. 550 U.S. 398, 416 (2007). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability.”
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Karandikar et al. (WO2014/179353A1) in view of Jung et al. Antimicrobial properties of hydrated cellulose membranes with silver nanoparticles, J Biomater Sci Polym Ed. 2009; 20(3):311-24, Trogolo et al. (United States Patent Publication 2003/0118664-see IDS filed 10/19/2021) and Schmitz et al. (United States Patent Publication 2013/0274415-see IDS filed 10/19/2021) as applied to claim(s) 1-4, 8-21 and 23-25 above, and further in view of Sun et al. (United States Patent Publicization 20030139714).
The teachings of Karandikar in view of Jung, Karandikar, Trogolo and Schmitz are discussed above. However, neither Karandikar or Trogolo teach that the hydroxypropyl cellulose polymer is a hydroxypropyl cellulose having an average molecular weight between 50-1500 kDa. This deficiency is made up for with the teachings of Sun.
Sun discloses water swellable polymers such as hydroxypropyl celluloses, see claims 1 and 7 and [0052]. According to Sun, the higher molecular weight polymers will exhibit more liquid absorbing capacity, see paragraph [0043]. Sun teaches water-swellable polymers having molecular weights of more than 100,000 (100kDa), see paragraph [0044].
It would have been prima facie obvious to a person of ordinary skill in the art at the earliest effective filing date to provide the hydroxypropyl cellulosic polymers of the Karandikar in view of Jung, Trogolo and Schmitz composition as hydroxypropylcellulose such that it has a molecular weight of 100kDa or more. A person of ordinary skill in the art would have been motivated to do so as the higher molecular weight hydroxypropyl celluloses exhibits more liquid absorbing capacity. There would have been a reasonable expectation of success given cellulose polymers are added as polymers in Karandikar and Capelli, Karandikar, and Sun disclose wound dressing compositions.
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.
The provisional rejection of claim(s) 1-4, 7-21, 23-25 and newly applied to claim 26 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-12,14 of copending Application No. 18/263145 (reference application) in view of Sabesan (US PgPub 20050118239) and Sun et al. (United States Patent Publicization 20030139714) is maintained.
Claim(s) 1-4, and 7-22 are directed to an invention not patentably distinct from claims 1-2, 10-12,14 of commonly assigned Application No. 18/263145.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘145 are directed to a process for making a modified fiber material by contacting a substrate inclusive of wound dressings with at least one antimicrobial silver containing agent and one or more polymers. The antimicrobial coating contains a non-aqueous solvent. Although the ‘145 patent application does not state mixing, since this portion of the composition contains both silver and polymer, mixing these is an obvious means for combining. Despite the absence of this limitation mixing, claim 1 of ‘145 specifically indicates that the product of part (2) contains both an antimicrobial and a polymer and ‘mixing’ these ingredients together would have been an obvious means for combining these ingredients prior to contacting this combination of agents with the wound dressing fibers. The active agent includes silver salts in both the instant claims and Application ‘145 and the polymers include cellulose or PVP polymers. The solvent can be a protic solvent in both applications.
Application ‘145 does not claim that the salt includes silver salts that are soluble (instant claims 12-13), that the protic solvent is ethanol or that the substrate is non-woven.
However, the protic solvents in Patent ‘145 are defined as including ethanol and other non-aqueous solvents [0097].
Sabesan, teach articles with antimicrobial properties can be woven or non-woven and contain water soluble agents such as silver nitrate to impart antimicrobial properties (see paragraphs [0038]-[0039]. The articles can be fibrous (paragraph [0039].
It would have been obvious to provide the wound dressing substrate of Application ‘145 as non-woven fibers containing soluble silver salts (e.g. silver nitrate) because Sabesan teaches that numerous articles including fibrous materials can be rendered antimicrobial with soluble silver salts.
However, Application ‘145 does not claim hydroxypropyl cellulose polymer is a hydroxypropyl cellulose having an average molecular weight between 50-1500 kDa as the polymer mixed with the silver antimicrobial agents.
Sun discloses water swellable polymers such as hydroxypropyl celluloses, see claims 1 and 7 and [0052]. According to Sun, the higher molecular weight polymers will exhibit more liquid absorbing capacity, see paragraph [0043]. Sun teaches water-swellable polymers having molecular weights of more than 100,000 (100kDa), see paragraph [0044].
It would have been prima facie obvious to a person of ordinary skill in the art before the time of filing to provide the hydroxypropyl cellulosic polymers that it has a molecular weight of 100kDa or more as the one or more polymer material of Application ‘145. A person of ordinary skill in the art would have been motivated to do so as the higher molecular weight hydroxypropyl celluloses exhibits more liquid absorbing capacity. There would have been a reasonable expectation of success given cellulose polymers are suggested as added as polymers in the ‘145 Application (claim 11).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 18/263145 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention. In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
Response to Arguments
Applicants’ arguments of March 10, 2026 have been fully considered and are found to be mostly unpersuasive.
Applicants note the amendment to the claims. Applicants argue that the claim 1 has been amended to require step a) to prepare a liquid antimicrobial coating composition wherein the one or more polymers are dispersed in the solvent system. This clarifies that the coating composition which contacts the absorbent non-woven dressing substrate in step b) is a liquid composition. Applicants assert that the cited prior art does not disclose or suggest such a method.
Applicants argue that Jung teaches cellulose membrane (i.e. a solid cellulose component) with silver nanoparticles adsorbed on the cellulose nanofibrils. The cellulose membrane is a solid piece of cellulose that is modified by silver nitrate. In Jung it is not possible for a solid cellulose membrane to be dispersed in a solvent system.
Applicants do not address the double patenting rejection other than to state that they will address it once the claims are otherwise allowable.
In light of the amendments to the claims, the rejection is withdrawn above and a new rejection is applied.
However, Applicants’ arguments have been fully reviewed and are not found to be persuasive. Applicants’ arguments that the cited prior art does not disclose or suggest a liquid antimicrobial coating composition wherein the one or more polymers are dispersed in the solvent system is not found to be persuasive because this teaching is found in Karandikar, now the primary reference in the new rejection applied above. Karandikar teaches a solvent system that is a liquid that contains hydroxypropyl cellulose polymer, so the polymer is dispersed in the solvent system as called for in instant claim 1. The antimicrobial coating composition is liquid as called for in the amended claims.
Specifically, as described in the rejection above Karandikar et al. teach methods of preparing antimicrobial silver compositions and treating devices including absorbent wound care materials with such antimicrobial composition, see abstract, pages 4-6, 9, 12, 13 15,and 16,27,34, and entire document. The composition can be made with either an aqueous or non-aqueous solvent, see page 16, first paragraph. Methods of making the antimicrobial coating include preparing a coating solution having silver compound, applying the coating to the surface of an article and drying the coating, see page 16. The antimicrobial composition can be blended to surface coat a device or can be embedded in either woven or non-woven substrates such as wound dressings, see pages 13 and 34. The coating solution can be either water based or can be made of non-aqueous solvents, see page 16. Polymers can further be added to the solution, see pages 10, 11,14, and 16. The method of making includes providing polymers in a non-aqueous solvent and then adding the active silver compounds, see page 16. The polymers can be hydroxypropyl cellulose alone ( a cellulosic polymer as called for in claim 1) as called for in instant claims 1 and 26. (See page 16).
Karandikar thus teaches a solvent system that is a liquid that contains hydroxypropyl cellulose polymer, so the polymer is dispersed in the solvent system as called for in instant claim 1. The antimicrobial coating composition is liquid as called for in the amended claims.
Thus, it would have been prima facie obvious to select hydroxypropyl cellulose as the polymer used with the silver nitrate in the solution of Karandikar. One of ordinary skill in the art would have been motivated to do so as Trogolo teaches that cellulose polymers enable good dispersion of antimicrobial particles and prevent particle agglomeration. There would have been a reasonable expectation of success given cellulose polymers including hydroxypropylcellulose since they are already suggested by Karandikar for use with antimicrobial silver.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Karandikar method as modified by Jung to follow the steps of preparing the coating solution with an ethanol solvent having only silver nitrate and hydroxypropyl methylcellulose, applying the liquid coating to the surface of an article and drying the coating in order to have a stable antimicrobial composition that that be applied to a variety of wound dressings and possess excellent long-term stability as taught by Karandikar. It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date to provide the wound dressing fibers taught in Karandikar as cross-linked polyvinyl alcohol as the type of substrate material for the wound dressings.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date following the Karandikar method as modified by Jung to follow the steps of preparing the coating solution with an ethanol solvent having only a silver nitrate and hydroxypropyl methylcellulose (a cellulose polymer) in order to have a simple antimicrobial solution that has stable adsorption of the silver nitrate nanoparticles on cellulose nanofibrils which provide antimicrobial properties with just a silver salt and cellulose polymer as taught by Jung.
One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success as Jung teaches that its antimicrobial composition can be used on various kinds of wound dressings. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success also because Karandikar teaches that the substrate material can comprise fibrous wound dressings and Schmitz teaches that fibers including cross-linked polyvinyl alcohol show greater stability are useful for wound dressings and have high absorption capacity. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success as Karandikar teaches that the substrate material can comprise fibrous wound dressings and Schmitz teaches that fibers including cross-linked polyvinyl alcohol show greater stability are useful for wound dressings and have high absorption capacity.
Applicants’ failure to address the double patenting rejection other than to state that they will address it once the claims are otherwise allowable is noted and the rejection is maintained.
The remaining arguments are moot in view of the new rejection applied above.
Conclusion
Currently, all claims are rejected and 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619