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 .
Claim Objections
Claims 30 and 80 are objected to because of the following informalities:
Clam 30 recites “a dissolution solution” in line 2 of the claim and should be “the dissolution solution”.
Clam 80 recites “providone k-90” in line 2 of the claim and should be “povidone K-90”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 30-31, 37-38, 60-67, and 69-79 are rejected under 35 U.S.C. 102(a as being anticipated by Salamone et al. (US 20170151314 A1), hereinafter referred to as “Salamone”.
Regarding Claim 38, Salamone teaches a dissolution solution comprising up to about 8.25% sodium hypochlorite (debridement enzyme for necrotic tissue comprising: a “antimicrobial agent” including sodium hypochlorite, see Abstract; Paragraph [0085]; the debridement composition can include a biological agent, i.e. antimicrobial agent such as hypochlorite in an amount sufficient to hinder or eradicate microorganisms; 0.1 to 99.5 wt % of an amylase component, see Paragraph [0057] and Claim 1).
Regarding Claim 30, Salamone teaches a method for treating pancreatic necrosis (debridement enzyme for necrotic tissue that specifically attacks nucleoprotein components of purulent exudates, see Paragraph [0004), the method comprising administering a dissolution solution of claim 38 to one or more pancreatic necrotic collections in a subject in need of treatment thereof (that specifically attacks nucleoprotein components of purulent exudates, see Paragraph [0004]).
Regarding Claim 31, Salamone teaches all of the limitations of claim 30 and Salamone further teaches one or more of:
(a) dissolving one or more solid necrosomes of the one or more pancreatic necrotic collections;
(b) decreasing a viscosity of a liquid collection of the one or more pancreatic necrotic collections;
(c) lavaging the one or more pancreatic necrotic collections; and
(d) draining the one or more pancreatic necrotic collections with a stent or a pigtail drain (methods to debride necrotic tissue include surgical debridement, enzymatic debridement, autolytic debridement, biological debridement, and mechanical debridement, with surgical and enzymatic debridement being most prevalent, see Paragraph [0004]).
Regarding Claim 37, Salamone teaches all of the limitations of claim 30 and Salamone further teaches wherein the treatment is conducted over one treatment session (contacting the debridement composition with an area of skin in need of debridement in regular intervals which can be at least once a day, see Paragraph [0105]).
Regarding Claim 60, Salamone teaches all of the limitations of claim 38 and Salamone further teaches the dissolution solution comprising 1%,2%,4%, 5.25 %, 5.8%, 6%, or 8.25% sodium hypochlorite (0.1 to 99.5 wt % of an amylase component, see Claim 1).
Regarding Claim 61, Salamone teaches all of the limitations of claim 38 and Salamone further teaches comprising between about 0.5% to about 5% sodium hypochlorite (hypochlorite in an amount sufficient to hinder or eradicate microorganisms; 0.1 to 99.5 wt % of an amylase component, see Claim 1; Paragraphs [0057] and [0087[).
Regarding Claim 62, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the dissolution solution further comprises one or more dissolution compounds selected from chlorine dioxide, hydrogen peroxide, eusol (chlorinated lime in boric acid), ethylenediaminetetraacetic acid (EDTA), formcresol (formaldehyde, cresol, glycerin), glutaraldehyde, one or more proteolytic enzymes, peracetic acid, chlorhexidine, Ca hypochlorite, and papain gel; optionally wherein the one or more proteolytic enzymes include a collagenase (the debridement agent can comprise proteolytic enzymes including collagenase, see Paragraph [0004]).
Regarding Claim 63, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the dissolution solution comprises one or more components selected from an alginic acid, a cellulosic-based compound, a lectin-like cytoadhesive, gellan gum, polycarbophil, carbomer, chitosan, xanthan gum, cyclomethicone, a poloxamer, polyethylene oxide, carrageenan, carboxymethylcellulose, ammonium alginate, sodium alginate, potassium alginate, calcium alginate, poly(methyl vinyl ether/maleic anhydride) ethyl cellulose, propylene glycol, sodium hyaluronate, agar, dextran hydroxypropyl cellulose, croscarmellose sodium, dimethyl-beta-cyclodextrin, povidone, methylcellulose, potassium alginate, pectin, an aliphatic polyester, ceresin, a polyoxyethylene alkyl ester, ceratonia, gelatin, propylene glycol alginate, polyvinyl alcohol, hydroxyethyl methyl cellulose polyoxyl hydroxystearate, and guar gum (debridement composition can also include gelling agents such as gellan gum, see Paragraphs [0042] and [0045]).
Regarding Claim 64, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the dissolution solution further comprises an excipient selected from glyceryl monooleate, lecithin, oleic acid, a dibutyl sebacate salt, sodium chloride, one or more preservatives, glycerin, chlorhexidine, dimethyl sulfoxide, glyceryl behenate, sodium stearate, glyceryl palmitostearate, olive oil, and sucrose stearate (penetration enhancers that can be used in the debridement compositions described herein include oleic acid, see Paragraph [0056]).
Regarding Claim 65, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the dissolution solution comprises one or more of a pharmaceutically acceptable vehicle, a surfactant, a stabilizing polymer, and a buffer (the debridement composition can include one or more pharmaceutically or cosmetically acceptable carrier that is compatible with the enzymatic debridement composition or a surfactant or a stabilizing polymer, or a buffer, see Paragraphs [0036], [0041], and [0042]).
Regarding Claim 66, Salamone teaches all of the limitations of claim 65 and Salamone further teaches wherein the pharmaceutically acceptable vehicle comprises propylene glycol and water (examples of pharmaceutically or cosmetically acceptable carriers include propylene glycol and water, see Paragraph [0041]).
Regarding Claim 67, Salamone teaches all of the limitations of claim 65 and Salamone further teaches wherein the surfactant is a polysorbate or a sorbitan ester (neutral surfactants may be added, such as polysorbate, see Paragraph [0097]).
Regarding Claim 69, Salamone teaches all of the limitations of claim 65 and Salamone further teaches wherein the stabilizing polymer is a poloxamer (poloxamers can be used, see Paragraph [0096]).
Regarding Claim 70, Salamone teaches all of the limitations of claim 65 and Salamone further teaches wherein the buffer is a phosphate or a citrate buffer (phosphate buffered saline (PBS), see Paragraph [0041])
Regarding Claim 71, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the dissolution solution comprises one or more components selected from a solvent, a foaming agent (the debridement compositions described herein can be formulated as a liquid or a foam, see Paragraph [0041]), a foam stabilizer (water-soluble viscosity builders, see Paragraph [0045]), a hydrophobic component and/or emollient (hydrophobic compounds, see Paragraph [0093]), an absorption promoter (penetration enhancer may also be utilized to enhance transdermal delivery, see Paragraph [0056]), a foam breaker (fatty alcohols including foam breakers, see Paragraph [0056]), and an antifoaming agent (monoglycerides, hence including antifoaming agents, see Paragraph [0042]).
Regarding Claim 72, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the solvent is selected from distilled water, ethanol, isopropanol, glycerin, propylene glycol, dimethyl isosorbide, and dimethyl sulfoxide (DMSO) (the debridement composition can include one or more pharmaceutically or cosmetically acceptable carrier including glycerin, see Paragraph [0041]).
Regarding Claim 73, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the foaming agent is selected from cetyl alcohol, cetyl stearyl alcohol, sodium docecyl sulfate, sodium oleate, sodium stearate, stearic acid, and polysorbate 20 (polysorbate 20, see Paragraph [0097]).
Regarding Claim 74, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the foam stabilizer is selected from xanthan gum, guar gum, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose methyl cellulose, agar- agar, alginates, sodium lauryl sulfate, lauryl acid, palmitic acid, stearic acid, coconut oil, tragacanth gum, gelatin, and glycerin (xanthan gum, see Paragraph [0045]).
Regarding Claim 75, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the hydrophobic component and/or emollient is selected from a mineral oil, a plant oil, an ester, an essential oils, petrolatum, omega-3 polyunsaturated oil, and silicon oil (hydrophobic hydrocarbons of mineral oil, see Paragraph [0167]).
Regarding Claim 76, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the absorption promoter is selected from ethanol, a fatty acid, and a fatty alcohol (fatty acids, see Paragraph [0056]).
Regarding Claim 77, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the foam breaker is selected from an alkyl polysiloxane, an oil, an alcohol, a fatty alcohol, and acetone (fatty alcohols, see Paragraph [0056]).
Regarding Claim 78, Salamone teaches all of the limitations of claim 71 and Salamone further teaches wherein the antifoaming agent is selected from silicone oil, a glyceride, and polyamide (monoglycerides, hence including antifoaming agents, see Paragraph [0042]).
Regarding Claim 79, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the dissolution solution comprises one or more components selected from cetyl alcohol, a polysorbate, glycerin, a polyvinylpyrrolidone, a hydroxypropyl methylcellulose (HPMC), and water (the amylase powder can be admixed with other powders that function as excipients including polyvinylpyrrolidone, see Paragraph [0170]).
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 36 is rejected under 35 U.S.C. 103 as being unpatentable over Salamone (US 20170151314 A1) in view of Faure et al. (US 20180187131 A1), hereinafter referred to as “Faure”.
Regarding Claim 36, Salamone teaches all of the limitations of claim 30. However, Salamone does not explicitly disclose administering the dissolution solution over a period of time having a range from about 1 minute to about 10 minutes.
Faure teaches a dissolution solution (controlled-moisture aqueous foam and method for treating and disinfecting contaminated surfaces, see Paragraph [0034]) and administering the dissolution solution over a period of time having a range from about 1 minute to about 10 minutes (foam/contamination contact times of 30 s, 5 min, 7 min, 10 min, see Paragraph [0145]; administering the foam may be generated at the time of contacting (spraying) or, on the other hand, prior to this contacting (floating), in open or closed spaces, see Paragraph [0113]; therefore administering can be in the range of 1 minute to about 10 minutes).
Salamone and Faure are analogous art because both teach a controlled-moisture aqueous foam and method for treating and disinfecting contaminated surfaces.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of administering the dissolution solution of Salamone and further include wherein administering the dissolution solution over a period of time having a range from about 1 minute to about 10 minutes, as taught by Faure. Faure teaches it is beneficial to administer the foam to allow for contacting time ranges from a few minutes to the complete drying of the disinfecting aqueous foam which is the time suitable for biological decontamination and use (see Paragraph [0115]).
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Salamone (US 20170151314 A1) in view Freasier et al. (US 20180110735 A1), hereinafter referred to as “Freasier”.
Regarding Claim 68, Salamone teaches all of the limitations of claim 67. However, Salamone does not explicitly disclose wherein the polysorbate is polysorbate 80.
Freasier teaches a foamable composition including: an antibiotic agent; at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, an organic polar solvent, an emollient and mixtures thereof (see Abstract) wherein the foam solution comprises a surface-active agents (also termed “surfactants”) include any agent linking oil and water in the composition, in the form of emulsion comprising polysorbate (see Paragraph [0132]-[0134]), wherein the polysorbate is polysorbate 80 (see Paragraph [0194]; Table 3).
Salamone and Freasier are analogous art because both teach a controlled-moisture aqueous foam and method for treating and disinfecting contaminated surfaces.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the polysorbate surfactant of Salamone and further include wherein the polysorbate surfactant is polysorbate 80, as taught by Freasier. Freasier teaches non-ionic surfactants are preferred in applications including sensitive tissue such as found in most mucosal tissues, especially when they are infected or inflamed. We have surprisingly found that non-ionic surfactants alone provide foams of excellent quality (see Paragraph [0135]).
Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over Salamone (US 20170151314 A1) in view Liu et al. (WO 2018200885 A1), hereinafter referred to as “Liu”.
Regarding Claim 80, Salamone teaches all of the limitations of claim 79. However, Salamone does not explicitly disclose wherein the polyvinylpyrrolidone is povidone K-90.
Liu teaches microencapsulated units contains cross-sectionally substantially homogenous cores containing particles of a sparingly soluble active substance, the cores being coated with a coating that is substantially resistant to gastric conditions but which is erodable under the conditions prevailing in the gastrointestinal tract (see Paragraph [0109]) wherein coating said one or more pills with a polymer coating comprising one or more of polyvinylpyrrolidone (see Paragraph [0108]) wherein the polyvinylpyrrolidone is povidone K-90 (povidone K-90 as binder, see Table 2).
Salamone and Liu are analogous art because both teach a polyvinylpyrrolidone material in a dissolvable solution.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the dissolution solution of Salamone and further include wherein the polyvinylpyrrolidone is povidone K-90, as taught by Liu. Liu teaches polyvinylpyrrolidone is povidone K-90 can be a rapidly disintegrating or dissolving coat for aesthetic, handling, or stability purposes (see Paragraph [0126]).
Claims 35 and 81-82 are rejected under 35 U.S.C. 103 as being unpatentable over Salamone (US 20170151314 A1).
Regarding Claim 35, Salamone teaches all of the limitations of claim 30. However, Salamone does not explicitly disclose wherein a volume of the dissolution solution administered has a range from about 10 mL to about 100 mL.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Salamone to have a volume of the dissolution solution administered in a range from about 10 mL to about 100 mL since it has been held that “where the only difference between the prior art and the claims was a recitation of relative period of time of administration of the claimed dissolution solution and a dissolution solution having the claimed period of time of administration would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Salamone would not operate differently with the claimed volume of the dissolution solution and since the volume of the dissolution solution is intended to be in contact with the devitalized tissue for about 1 to 48 hours, the device would function appropriately having the claimed volume of the dissolution solution. Further, applicant places no criticality on the range claimed, indicating simply that the volume of the dissolution solution “range from about 10 mL to about 100 mL” be within the claimed ranges (specification pg. 6 lines 7-8).
Regarding Claim 81, Salamone teaches all of the limitations of claim 38 and Salamone further teaches wherein the foam formulation comprises NaClO (see Paragraph [0085], cetyl alcohol (see Paragraph [0170]), a polysorbate (see Paragraph [0097]), glycerin (see Paragraph [0041]), a polyvinylpyrrolidone (see Paragraph [0170]), a hydroxypropyl methylcellulose (see Paragraph [0045]), and water (see Paragraph [0041]). However, Salamone not explicitly disclose the claimed percentages.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the dissolution solution of Salamone wherein the dissolution solution comprises between about 0.5% to about 5% NaClO, between about 0.1% to about 3.0% cetyl alcohol, between about 0.1% to about 2.5% of a polysorbate, between about 2.0% to about 6.0% glycerin, between about 0.0% to about 3.0% of a polyvinylpyrrolidone, between about 0.0% to about 3.0% of a hydroxypropyl methylcellulose (HPMC), and water be within the claimed range, as it involves only adjusting the percentages of a components in order to provide desired foaming characteristics to the dissolution solution. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the foam formulation such that it between about 0.5% to about 5% NaClO, between about 0.1% to about 3.0% cetyl alcohol, between about 0.1% to about 2.5% of a polysorbate, between about 2.0% to about 6.0% glycerin, between about 0.0% to about 3.0% of a polyvinylpyrrolidone, between about 0.0% to about 3.0% of a hydroxypropyl methylcellulose (HPMC), and water as a matter of routine optimization since it has been held that “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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 82, Salamone teaches all of the limitations of claim 81 and Salamone further teaches wherein the foam formulation comprises NaClO (see Paragraph [0085], cetyl alcohol (see Paragraph [0170]), a polysorbate (see Paragraph [0097]), glycerin (see Paragraph [0041]), a polyvinylpyrrolidone (see Paragraph [0170]), a hydroxypropyl methylcellulose (see Paragraph [0045]), and water (see Paragraph [0041]). However, Salamone not explicitly disclose the claimed percentages.
It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the dissolution solution of Salamone wherein the dissolution solution comprises about 3.5% NaClO, about 0.5% cetyl alcohol, about 0.5% of a polysorbate, about 5.0% glycerin, between about 0.0% to about 3.0% of a polyvinylpyrrolidone, between about 0.0% to about 0.3% of a hydroxypropyl methylcellulose (HPMC), and water be within the claimed range, as it involves only adjusting the percentages of a components in order to provide desired foaming characteristics to the dissolution solution. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the foam formulation such that it comprises about 3.5% NaClO, about 0.5% cetyl alcohol, about 0.5% of a polysorbate, about 5.0% glycerin, between about 0.0% to about 3.0% of a polyvinylpyrrolidone, between about 0.0% to about 0.3% of a hydroxypropyl methylcellulose (HPMC), and water as a matter of routine optimization since it has been held that “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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 83 is rejected under 35 U.S.C. 103 as being unpatentable over Salamone (US 20170151314 A1) in view Weitzner et al. (US 20180206864 A1), hereinafter referred to as “Weitzner”.
Regarding Claim 83, Salamone teaches all of the limitations of claim 79. However, Salamone does not explicitly disclose wherein the pancreatic necrosis comprises walled-off pancreatic necrosis (WON).
Weitzner teaches a minimally invasive catheter-based devices and procedures for the removal of pancreatic necrotic debris (see Abstract; Paragraph [0003]) wherein the pancreatic necrosis comprises walled-off pancreatic necrosis (WON) (see Paragraph [0003]).
Salamone and Weitzner are analogous art because both disclose procedures for the removal of pancreatic necrotic debris.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of for treating pancreatic necrosis of Salamone and further include wherein the pancreatic necrosis comprises walled-off pancreatic necrosis (WON), as taught by Weitzner. Weitzner teaches is beneficial to treat walled-off pancreatic necrosis (WON) which allows efficient removal of necrotic debris, e.g., of varying consistency from a WOPN without disrupting or damaging the tissue wall and/or blood vessels therein (see Paragraph [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (8/5/2026)Examiner, Art Unit 3781
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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