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 2-12 are pending. Claim 1 is canceled. This is the first office action on the merits.
Priority
This application claims to be a divisional of U.S. Patent Application No. 17/377,693, filed July 16, 2021 which is a divisional of U.S. Patent Application No. 14/807,989, filed July 24, 2015, but does not appear to meet the definition of a divisional application. Specifically, the application does not disclose and claim only the subject matter disclosed in the earlier or parent application and the application is not a later application for an independent and distinct invention that was carved out of a nonprovisional application. Instead, the instant application has claims that are directed to the same invention that was elected in the parent U.S. Patent Application No. 14/807989, which is now abandoned.
Applicant is thus requested to change the application relationship to that of a continuation application. See MPEP Section 201.06 for the definition of a divisional application.
This application identifies itself as a divisional of U.S. Patent Application No. 17/377,693, filed July 16, 2021, which is a divisional of U.S. Patent Application No. 14/807,989, filed July 24, 2015. If applicant desires to claim the benefit of a prior-filed application under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), the instant application must contain, or be amended to contain, a specific reference to the prior-filed application in compliance with 37 CFR 1.78. If the application was filed before September 16, 2012, the specific reference must be included in the first sentence(s) of the specification following the title or in an application data sheet (ADS) in compliance with pre-AIA 37 CFR 1.76; if the application was filed on or after September 16, 2012, the specific reference must be included in an ADS in compliance with 37 CFR 1.76. For benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c), the reference must include the relationship (i.e., continuation, divisional, or continuation-in-part) of the applications.
If the instant application is a utility or plant application filed under 35 U.S.C. 111(a), the specific reference must be submitted during the pendency of the application and within the later of four months from the actual filing date of the application or sixteen months from the filing date of the prior application. If the application is a national stage application under 35 U.S.C. 371, the specific reference must be submitted during the pendency of the application and within the later of four months from the date on which the national stage commenced under 35 U.S.C. 371(b) or (f), four months from the date of the initial submission under 35 U.S.C. 371 to enter the national stage, or sixteen months from the filing date of the prior application. See 37 CFR 1.78(a)(4) for benefit claims under 35 U.S.C. 119(e) and 37 CFR 1.78(d)(3) for benefit claims under 35 U.S.C. 120, 121, 365(c), or 386(c). This time period is not extendable and a failure to submit the reference required by 35 U.S.C. 119(e) and/or 120, where applicable, within this time period is considered a waiver of any benefit of such prior application(s) under 35 U.S.C. 119(e), 120, 121, 365(c), and 386(c). A benefit claim filed after the required time period may be accepted if it is accompanied by a grantable petition to accept an unintentionally delayed benefit claim under 35 U.S.C. 119(e) (see 37 CFR 1.78(c)) or under 35 U.S.C. 120, 121, 365(c), or 386(c) (see 37 CFR 1.78(e)). The petition must be accompanied by (1) the reference required by 35 U.S.C. 120 or 119(e) and by 37 CFR 1.78 to the prior application (unless previously submitted), (2) the petition fee under 37 CFR 1.17(m), and (3) a statement that the entire delay between the date the benefit claim was due under 37 CFR 1.78 and the date the claim was filed was unintentional. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
Applicant is required to submit a correct reference in compliance with 37 CFR 1.78 by filing an ADS in compliance with 37 CFR 1.76 with the correct reference (or, if the application was filed before September 16, 2012, by filing either an amendment to the first sentence(s) of the specification or an ADS in compliance with pre-AIA 37 CFR 1.76). See MPEP § 211.02.
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) 2-5 and 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Minami et al. US 5709870 (1/20/1998) in view of Karandikar et al. (WO2014/179353A1), Schmitz et al. (United States Patent Publication 2013/0274415) and Becker et al. US 2007/0179522 (10/9/2012).
Minami et al. teach a silver-containing antimicrobial agent that is very stable and impervious to heat and light and methods for creating them. Minami teaches that its silver containing antimicrobial agent is excellent in its affinity to fiber. (See Abstract). It comprises carboxymethyl cellulose containing silver salt in the amount of 0.01 to 1% by weight. (See Abstract). The carboxymethyl cellulose can be crosslinked to make the antimicrobial agent water resistant. (See Abstract).
Minami teaches methods of preparing antimicrobial silver compositions with silver carboxymethylcellulose. The composition can be made with either an aqueous or methanol solvent. Minami teaches that in a mixture of aqueous organic solvent, such as an aqueous methanol solution the mixing ratio is 2:8 water: methanol. (See col. 3, lines 40-46). Methods of making the antimicrobial coating include preparing a coating solution having silver carboxymethylcellulose, applying the coating to the surface of an article and removing the solvent, thereby drying the coating. (See col. 4, lines 23-30).
The antimicrobial solution is prepared by dissolving or suspending the silver CMC salt in what Minami describes as a binder. (See col. 4, lines 23-30). The binder can be cellulose polymers such as methylcellulose or hydroxyethylcellulose. (See col. 4, lines 30-41). Methylcellulose is called for in instant claim 8. Cellulosic polymers are called for in instant claims 1, 4 and 8.
The antimicrobial composition can surface coat a substrate or impregnate a substrate. (See col. 4, lines 23-30). Minami teaches mixing cellulose fiber with the antimicrobial composition. See col. 4, lines 23-30). Minami teaches that its antimicrobial composition contains a carboxymethyl cellulose containing silver salt in the amount of 0.01 to 1% by weight. (See Abstract). Minami teaches that its silver salt is an antimicrobial agent that is capable of killing bacteria and is thus a results-effective variable. (See It would be therefore routine experimentation to experiment to find the ideal concentration for the antimicrobial agent as called for in instant claim 2.
The coating solution can be either water based or can be made of organic solvents including methanol. (See col. 3, lines 38-46). Minami thus teaches a solvent system that is a liquid (2:8 water : methanol) that contains hydroxyethyl cellulose polymer, so the polymer is dispersed in the solvent system.
Minami teaches hydroxyethylcellulose polymer binders but does not teach hydroxypropyl cellulose. Minami does not teach a substrate that is a fibrous wound dressing article made of cross-linked PVA absorbent fibers. Minami does not teach silver nitrate. Minami also does not teach a dried substrate with an outer layer and a multilayered interior made of multiple layers containing coatings with an antimicrobial agent in polymers on the surface of cross-linked PVA absorbent fibers. These deficiencies are made up for with the teachings of Karandikar, Schmitz and Becker et al.
Karandikar et al. teaches absorbent wound care materials treated with antimicrobial silver compositions and methods of making them, 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 wound dressing that can be either woven or non-woven substrates such as wound dressings or can be embedded in these substrates, see pages 13 and 34. The substrate fibrous material can be either woven or non-woven and be rendered antimicrobial with the antimicrobial composition.
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 as called for in instant claims 8 and 9, which is a cellulosic polymer as called for in instant claim 7.
The polymer can include hydroxypropyl cellulose and cellulose polymers, see pages 10,11, 14, and 34. Cellulosic polymers are called for in instant claims 4 and 7. Polyvinyl alcohol is another polymer that can be used. (See 10,11, 14, and 34). Hydroxypropyl cellulose is called for in instant claims 8 and 9. The polyvinyl alcohol is called for in instant claim 3. Hydroxypropyl cellulose is called for in instant claim 9.
Karandikar teaches hydroxypropylcellulose as the polymer that is part of the coating composition but cellulose polymers in general are also 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.
Thus, it would have been prima facie obvious before the earliest effective filing date of the invention making the wound dressing of Minami to prepare a coating solution having silver carboxymethylcellulose with a cellulosic polymer, applying the coating to polyvinyl fibers and to use hydroxypropyl cellulose as the cellulosic polymer used with the silver salt in the antibacterial solution. Silver salt is called for in instant claim 11 which is an antimicrobial agent which comprises silver as called for in instant claim 10. Silver nitrate is taught to be such a suitable silver salt as called for in instant claim 12. (See Karandikar claim 9)
It is prima facie obvious to substitute one component for another, each of which is recognized by the art as equivalents for the same purpose. Minami teaches that hydroxyethylcellulose is a suitable polymer to combine with the silver salt of CMC in an antimicrobial solution and Kirandikar teaches that hydroxypropylcellulose is a suitable polymer to combine with a silver salt in an antimicrobial solution. Hydroxyethylcellulose and hydroxypropylcellulose are thus art recognized equivalences for the same purpose. In light of this equivalency, a person of ordinary skill in the art would substitute hydroxypropylcellulose for hydroxyethylcellulose in the Mirami method. 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).
There would have been a reasonable expectation of success given cellulose polymers including hydroxypropylcellulose since cellulose polymers are already taught to be suitable for combination with silver CMC by Minami.
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 for wound exudate and form a stable hydrogel with an exceptionally high maximum breaking force and maximum breaking elongation, see paragraphs [0003], [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]. Cross-linked polyvinyl alcohol fibers are thus cross-linked absorbent fibers called for in instant claim 2.
In Example 8 Schmidt teaches providing the fibers with an antimicrobial finish from an ethanolic solution. (See Example 8). Schmidt teaches that ethanolic solution, water and mixtures thereof are suitable solvents. This reads on the cross-linked fibers having an antimicrobial coating in claim 1.
Becker teaches a multilayer wound dressing with antibacterial and antifungal properties. (See Abstract). The dressing includes a layer of silver-containing fabric, a layer of absorbent material and a layer of flexible air-permeable and water permeable material. (See Abstract). Becker teaches that its wound dressing includes layers of fibrous fabric that contains a metal having bactericidal properties and a layer of absorbent material and outer layers of air permeable and water permeable material. (See [0013], [0038] and claims 27-28). The silver is attached to the fibers. (See Backett claim 33). The silver can be deposited on the fabric with fibers. (See [0011]). This reads on a coating of the cross-linked polyvinyl alcohol as called for in instant claim 2.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the wound dressing of Minami to follow the steps of preparing the coating solution having silver nitrate salt and hydroxypropyl methylcellulose, applying the liquid coating to the surface of a fibrous wound dressing substrate and drying the coating in order to have a wound dressing that can be applied to a variety of wounds and possesses 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 making the wound dressing of Minami to apply the silver salt and cellulose polymer to a fibrous wound dressing substrate with fibers including cross-linked polyvinyl alcohol as taught by Karandikar and Schmidt. 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 and are useful for wound dressings having high absorption capacity which can absorb wound exudate and form a hydrogel of exceptional strength. 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.”
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the wound dressing of Minami to apply the silver salt and cellulose polymer taught by Karandikar to a wound dressing with multiple layers as taught by Becker to coat multiple layers of cross-linked polyvinyl alcohol fibers and make them antibacterial as taught by Schmidt. It would have been obvious to have outer layers of perforated plastic to contain the multiple layers of coated polyvinyl alcohol fibers and keep them together as taught by Becker in order to allow the wound exudate to pass through the outer layer and access the absorbent inner layers as taught by Beckett.
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 and are useful for wound dressings having high absorption capacity which can absorb wound exudate and form a hydrogel of exceptional strength.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Minami et al. US 5709870 (1/20/1998) in view of Karandikar et al. (WO2014/179353A1) and Schmitz et al. (United States Patent Publication 2013/0274415-see IDS filed 10/19/2021) and Becker et al. US 2007/0179522 (10/9/2012) as applied to claim(s) 1-5 and 7-12 above, and further in view of Sun et al. (United States Patent Publication 20030139714).
The teachings of Minami in view of Karandikar, Schmitz and Becker are discussed above.
However, neither Minami, Karandikar, Schmitz nor Becker 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]. More than 100 kDa overlaps with the 50-1500 kDa called for in instant claim 6.
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 Mirami in view of Karandikar, Schmitz and Becker wound dressing to use hydroxypropyl cellulose with a molecular weight of 100kDa or more as the hydroxypropyl cellulosic polymer used with the silver nitrate in the antibacterial coating of the cross-linked polyvinyl alcohol fibers. 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.
Conclusion
Currently, all claims are rejected and no claims are allowed.
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/SARAH CHICKOS/
Examiner, Art Unit 1619
/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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