LED ACTION
Claims 1, 5-7, 10, 14, 17, 23-25, and 66-71 are pending. Of these, claims 1, 5-7, 10, 14, and 55-65 are withdrawn as directed to a nonelected invention. Therefore, claims 14, 17, 23-25, and 66-71 are under consideration on the merits.
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 Rejections
The 112(b) rejection is withdrawn in view of the amendment.
The 103 rejections are maintained, and new rejections are applied to the newly added claims as detailed below.
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.
Claims 14 and 24 are rejected under 35 U.S.C. 103 as unpatentable over Litinsky (WO 2015/005821; of record in IDS) as evidenced by the English translation thereof and in view of Jurgen Muller et al (WO 2002/030480) as evidenced by the English translation thereof and Henry (US Pat. No. 5,589,156).
As to claims 14 and 24, Litinsky discloses a device that is configured for delivering a coating that will solidify to form an open cell foam when applied to a tissue site as a wound dressing (a “flowable tissue dressing material”), the foam coating comprising polyurethane (the elected species of “reacted polymer”)(paragraphs 23, 48, 66). The polyurethane is formed from polyol and isocyanate precursor components (paragraph 23), which, upon mixing, will form a reacted polymer as recited by claim 14. Litinsky further teaches that the dressing material may be placed inside a container filled with a propellant as a carrier (paragraph 65).
As to 14 and 24, Litinsky does not further expressly disclose that the flowable material comprises water soluble particles in a carrier configured to soften or dissolve upon contact with water at the tissue site to form pores or fissures in the open cell foam as recited by claim 14, and wherein the carrier is the elected species, i.e., a low boiling point liquid such as a fluorocarbon of claim 24.
Jurgen Muller discloses biocompatible materials for use as wound coverings (page 1, lines 1-4), wherein the material comprises pores to allow wound exudate to drain and for air to reach the wound (page 4, 2nd paragraph from bottom). The pores are formed by incorporating water soluble particles that dissolve upon contact with the liquid, and the particles may be table salt (i.e., sodium chloride)(page 8, 1st full paragraph).
Henry discloses formulations comprising an anesthetic active for application to a skin wound, wherein the anesthetic is delivered using a propellant carrier comprising hydrofluorocarbons (paragraph bridging columns 1-2; first paragraph of Summary of the Invention at column 2).
As to 14 and 24, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Litinksy device by incorporating water soluble particles that will dissolve upon contact with water upon application to a tissue site so as to create pores in the material, because Jurgen Muller teaches that doing so will result in the advantage that the material will be able to drain wound exudate as well as pass air to the wound site.
It further would have been prima facie obvious to select a low boiling point liquid such as a fluorocarbon as the type of gas to serve as a carrier for the ingredients in the flowable material, because Henry teaches that fluorocarbons are suitable for use as carriers to deliver wound treating materials to a wound site, such that the skilled artisan reasonably would have expected that fluorocarbons could be used as the carrier to deliver the wound treating materials of the Litinsky device.
Claims 17 and 23 are rejected under 35 U.S.C. 103 as unpatentable over Litinsky (WO 2015/005821) as evidenced by the English translation thereof and in view of Jurgen Muller et al (WO 2002/030480) as evidenced by the English translation thereof and Henry (US Pat. No. 5,589,156) as applied to claims 14 and 24 above, and further in view of Heinrich et al. (US Pat. Pub. 2011/0147435).
The teachings of Litinsky, Jurgen Muller, and Henry are relied upon as discussed above, and Litinsky further teaches that the foam coating further may comprise a sorbent such as cellulose (paragraph 36), but these references do not further expressly disclose that the cellulose sorbent is oxidized regenerated cellulose as recited by claim 17 (i.e., the elected species of additional component), nor that the device further comprises a photoinitiator and UV light source for solidifying the flowable tissue dressing material as recited by claim 23.
Heinrich discloses wound treatment materials, and teaches that such materials may include a combination of adhesives, hemostats, sealants, or any other tissue or wound treating material, such as oxidized regenerated cellulose as a hemostat (paragraph 171), and polymeric materials as sealants such as isocyanate functional macromers along with a photoinitiator that can be cured upon exposure to UV light (paragraphs 168-169).
As to claim 17, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the device of Litinsky, Jurgen Muller, and Henry as combined supra by selecting oxidized regenerated cellulose as the type of cellulose sorbent, because Litinsky expressly teaches that the device may comprise a cellulose material as a sorbent, and Heinrich teaches that oxidized regenerated cellulose is a type of cellulose that is useful in wound treatment materials as a hemostat, such that the skilled artisan reasonably would have expected that it could serve as the cellulose sorbent in the Litinsky device and help to control any bleeding from the wound.
As to claim 23, it further would have been prima facie obvious to incorporate a photoinitiator and UV light source to solidify the flowable dressing material at the wound site, because Heinrich expressly teaches that polymeric materials comprising macromers for use as wound treatments can be cured using a photoinitiator and a UV light source, such that the skilled artisan reasonably would have expected that the Litinsky device comprising macromers as a wound treatment material also could be cured in this manner.
Claim 25 is rejected under 35 U.S.C. 103 as unpatentable over Litinsky (WO 2015/005821) as evidenced by the English translation thereof and in view of Jurgen Muller et al (WO 2002/030480) as evidenced by the English translation thereof and Henry (US Pat. No. 5,589,156) as applied to claims 14 and 24 above, and further in view of Jaehnigen et al. (US Pat. Pub. 2020/0339735; filed 12.20.2018) and Pigg et al. (US Pat. Pub. 2012/0078154).
The teachings of Litinsky, Jurgen Muller, and Henry are relied upon as discussed above, but they do not further expressly disclose that the molecular weight of the open cell foam is greater than or equal to about 100,000 as recited by claim 25 or that it has a moisture vapor transmission rate within the range of claim 25.
Jaehnigen discloses polyurethane foams that can be used as wound dressings (paragraphs 1-6), and teaches that the foams preferably have a molecular weight of at least 80,000, which encompasses the range of claim 25 (paragraph 99).
Pigg is directed to open cell foams suitable for use in wound dressings (Abstract and paragraph 14). Pigg teaches that selection of an appropriate moisture vapor transmission rate allows the wound to heal under moist conditions without causing the skin around the wound to macerate, and that a suitable rate for a backing sheet for the dressing is 500 to 2000 g/m2/24 hours, which substantially overlaps the range of claim 25 (paragraph 35).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the device of Litinsky, Jurgen Muller, and Henry as combined supra by selecting a molecular weight for the open cell foam that is within the recited range with a reasonable expectation of success, because Jaehnigen teaches that polyurethane foams having molecular weights within said range are suitable for use as wound dressings. Additionally, discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It further would have been prima facie obvious to select a polyurethane foam having a moisture vapor transmission rate within the recited range, because Pigg expressly teaches that the moisture vapor transmission rate of is a result effective variable that will affect the ability of the wound to heal under moist conditions, and the skilled artisan would have had a reasonable expectation of success in arriving at the claimed range because Pigg teaches that a suitable moisture vapor transmission rate for a component of a wound dressing is within the claimed range. Discovering optimum or working ranges involves only routine skill in the art in cases where the general conditions of a claim are disclosed in the prior art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Applicant’s Arguments
Applicant argues that Litinshy states that foams that are pre-obtained are disadvantageous because they do not ensure self-sterilization of the foam at the time of application or disinfect the wound surface, and instead discloses a foam that is formed in situ, thereby teaching away from a flowable tissue dressing material comprising a reacted polymer as required by claim 14.
In response, this argument is not persuasive because once a portion of the isocyanate and polyol components are mixed in the device, a reacted polymer in the carrier will be present as recited by the claims. The timing of when the mixing step occurs (e.g., pre-formed versus forming in situ) does not patentably distinguish the claimed invention from Litinsky, at least because the present claims are not method claims but rather device claims, the patentability of which is determined by its structure and not the manner in which it is used, and the structure of the Litinsky device is the same as the structure recited by the present claims.
Additionally, Litinsky’s teaching that forming the foam in situ is superior to pre-forming the foam would not render a pre-formed foam nonobvious. "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant's argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." 27 F.3d at 554, 31 USPQ2d at 1132.).
Applicant argues that the skilled artisan would not have had a reasonable expectation of success in including the water soluble pore forming particles of Jurgen Muller into the polyurethane foam coating of Litinksy because Litinsky allegedly requires the use of water to mix the components used to form the foam, such that the particles would dissolve in the water prior to contact with a tissue site, and therefore would not form pores. Applicant also claims that the skilled artisan would understand that the initial component mixture of Litinsky would have a low viscosity and thus would not be highly viscous as required by Muller, such that the water soluble pore forming particles of Muller would not remain suspended in the initial component mixture of Litinsky during formation of the foam, and thus would not form pores upon contact with water.
In response, this argument is not persuasive because the present specification discloses the same the process steps recited by Litinsky for formation of the foam, i.e., mixing the polyol and isocyanate together in the presence of water (paragraph 24). rejection proposes to incorporate the water soluble particles. Therefore, the use of water when mixing the polyol and isocyanate together does not result in the particles dissolving before tissue contact and therefore unable to form pores, based upon the evidence of record. There is no evidence of record that the Litinsky process of mixing the polyol and isocyanate together would require such a large amount of water that the water soluble particles would dissolve. In fact, paragraph 24 of the present specification further states that the water that is present may be merely ambient water, which would be a minimal amount of water. The skilled artisan wishing to use water soluble particles to generate pores in the Litinshy foam similarly would be motivated to use only a minimal amount of water that would not interfere with the pore-forming function of the water soluble particles. Additionally, while Jurgen Muller does disclose that its suspension is highly viscous which prevents the organic and suspended aqueous phases from separating during the casting process (page 9, 2nd to last paragraph), there is no evidence of record that this teaching would be relevant to the Litinsky process of forming a foam from polyol and isocyanate components, and which does not involve the creation of organic and aqueous phases nor a casting process.
New Rejections
Claims 66-67 and 69-70 are rejected under 35 U.S.C. 103 as unpatentable over Litinsky (WO 2015/005821) as evidenced by the English translation thereof and in view of Jurgen Muller et al (WO 2002/030480) as evidenced by the English translation thereof and Henry (US Pat. No. 5,589,156) as applied to claims 14 and 24 above, and further in view of Krueger et al. (US Pat. Pub. 2006/0030632).
The teachings of Litinsky, Jurgen Muller, and Henry are relied upon as discussed above. Litinsky further teaches that the device comprises two separated sections (“first zone” and “second zone” of claim 69) disposed within a container comprising first and second reactants (i.e., the polyol and isocyanate), and a partition between the sections that is at least partially removable to allow for mixing of the first and second reactants (paragraphs 48-51) but they do not further expressly disclose that the flowable tissue dressing material further comprises a cell open configured to promote rupturing of cell walls and formation of an open cell structure comprising clay, silica, or calcium carbonate as recited by claim 66.
Kreuger discloses open cell polyurethane foams for use in a wound dressing, wherein the foam comprises clay, silica, or calcium carbonate as a nucleant to improve foam gas bubble formation (i.e., rupturing of the cell wall to promote formation of an open cell structure)(paragraphs 54, 87 and claims 1 and 4 of Krueger).
As to claims 66-67 and 69-70, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the device of Litinsky, Jurgen Muller, and Henry as combined supra by incorporating clay, silica, or calcium carbonate as a nucleant, because Kreuger teaches that doing so will improve formation of gas bubbles during formation of a polyurethane foam to be used as a wound dressing.
Claim 68 is rejected under 35 U.S.C. 103 as unpatentable over Litinsky (WO 2015/005821) as evidenced by the English translation thereof and in view of Jurgen Muller et al (WO 2002/030480) as evidenced by the English translation thereof, Henry (US Pat. No. 5,589,156), and Krueger et al. (US Pat. Pub. 2006/0030632) as applied to claims 66-67 and 69-70 above, and further in view of Azzi (US Pat. Pub. 2009/0096121).
The teachings of Litinsky, Jurgen Muller, Henry, and Krueger are relied upon as discussed above, but they do not further expressly disclose that the water soluble particles comprise polyvinyl alcohol (PVA).
Azzi discloses a method of producing open cell foams (Abstract), the method comprising incorporating water soluble space-filler particles such as sodium chloride particles or polyvinyl alcohol particles, which help to form pores in the form (paragraphs 62 and 65-68).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the device of Litinsky, Jurgen Muller, Henry, and Krueger as combined supra by selecting polyvinyl alcohol particles instead of, or in addition to, the sodium chloride water soluble particles taught by Jurgen Muller, because Azzi teaches that sodium chloride particles and polyvinyl alcohol particles are functionally equivalent for the purpose of serving as pore formers in open cell foams, such that the skilled artisan reasonably would have expected that polyvinyl alcohol particles could be used as the type of water soluble pore forming particles for forming the open cell foam of Litinsky. An express suggestion to substitute a specific known equivalent over other known equivalents is not necessary to render such substitution obvious. MPEP 2144.06 (citing In re Fout, 213 USPA 532 (CCPA 1982)).
Claim 71 is rejected under 35 U.S.C. 103 as unpatentable over Litinsky (WO 2015/005821) as evidenced by the English translation thereof and in view of Jurgen Muller et al (WO 2002/030480) as evidenced by the English translation thereof, Henry (US Pat. No. 5,589,156), and Krueger et al. (US Pat. Pub. 2006/0030632) as applied to claims 66-67 and 69-70 above, and further in view of Von Wolff et al. (US Pat. Pub. 2014/0236112).
The teachings of Litinsky, Jurgen Muller, Henry, and Krueger are relied upon as discussed above, but they do not further expressly disclose that the dressing material further comprises polyhexamethylene biguanide (PHMB).
Van Wolff discloses wound dressings (paragraph 1) comprising polyurethane foams (paragraphs 39, 46-47), wherein the dressing further may comprise polyhexamethylene biguanide (PHMB) as an antimicrobial against pathogenic microbial colonization of a wound (paragraph 86).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the device of Litinsky, Jurgen Muller, Henry, and Krueger as combined supra by incorporating polyhexamethylene biguanide (PHMB) into the flowable tissue dressing material, because Van Wolff teaches that this compound advantageously helps protect against microbial colonization of a wound when incorporated into a wound dressing comprising a polyurethane foam.
Conclusion
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 GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/BENNETT M CELSA/ Primary Examiner, Art Unit 1600
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