DETAILED ACTION
Claims 1-2, 4, 6-8 and 11-24 are currently pending. Claims 1-2, 4, 6-8, 11-16 and 23-24 are currently under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Examiner’s Note
Applicant's amendments and arguments filed 04/29/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04/29/2026, it is noted that claims 1-2 and 13 have been amended and no new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 4, 6-8, 11-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2 contains the limitation “one or more solubilizer comprising:..” and “a solubilizer selected from…” and newly added limitation of “wherein the solubilizer is present in an amount of about 5 wt% to about 10 wt%”. It is unclear if the amount claims limits only the “a solubilizer selected from ethylene glycol monoheptanoate and propylene glycol monoheptanoate” or if the amount of solubilizer is mean to limit both the ”one or more solubilizer” group and the “a solubilize” groups, as both groups are directed to solubilizers. For examination purposes the amount will only be deemed to limit the group of “a solubilizer selected from ethylene glycol monoheptanoate and propylene glycol monoheptanoate” as it does not properly refer back to the “one or more solubilizer” grouping. Claims 4, 6-8, 11-16 are additionally rejected as not clearing out the ambiguity of claim 2 in regards to the use of “one or more solubilizer” and “a solubilizer” in multiple instances and the amounts of such.
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) 1-2, 4, 6-8, 11-16 and 23-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0296678 (previously applied) in view of US 2014/261454 (IDS dated 10/25/2022), US 2008/0254084 and Krishna (Krishna, B.V.S. et al, Journal of Hospital Infection (2010) 74, pgs. 199-203).
Regarding claim 1, the limitation of a composition comprising a homogenous solution comprising a solublizer comprising a pair of vicinal hydrogen bonding groups, wherein at least one hydrogen bonding group is a hydrogen bond donor and a saturated or unsaturated C7-C22 hydrocarbon group; an active agent at greater than 0 wt% and up to about 20 wt% with respect to the weight of the solublizer; wherein the homogeneous solution is free of water and hydrophilic vehicle present in an amount in mols of less than about 2:1 with respect to the amount of octenidine salt is met by the ‘678 publication teaching compositions containing chlorhexidine gluconate solubilized in hydrophobic vehicles. The composition including adhesives and articles including medical articles such as drapes (abstract). The CHG can be solubilized in a wide variety of hydrophobic vehicles [0011]. All methods taught may leave small amounts of water, which are e.g., less than 1 wt% [0013]. The composition is taught to have 2 parts by weight hydrophilic vehicle per 1 part by weight CHG [0014]. CHG is taught to be at least 5% by weight of the vehicle [0019]. The hydrophobic vehicles contain Formula I and II [0018], wherein glycerol monostearate is specifically taught, wherein the composition is homogenous (Table 2a). The instant specification teaches “free of water” to mean less than 0.001 wt% [0053], thus free of water allows for some water to be present and overlaps with the ‘678 publication teaching less than 0.01 wt% water [0013]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, the limitation of a composition comprising a homogenous solution comprising a solublizer comprising a pair of vicinal hydrogen bonding groups, wherein at least one hydrogen bonding group is a hydrogen bond donor and a saturated or unsaturated C7-C22 hydrocarbon group; an active agent in an amount up to about 1.5 wt%; water present in an amount less than 5 wt% with respect to the weight of the solubilizer and octenidine salt combined and hydrophilic vehicle present in an amount in mols of less than about 2:1 with respect to the amount of octenidine salt, a pressure sensitive adhesive and plasticiser is met by the ‘678 publication teaching compositions containing chlorhexidine gluconate solubilized in hydrophobic vehicles. The composition including adhesives and articles including medical articles such as drapes (abstract). The CHG can be solubilized in a wide variety of hydrophobic vehicles [0011]. All methods taught may leave small amounts of water, which are e.g., less than 1 wt% [0013]. The composition is taught to have 2 parts by weight hydrophilic vehicle per 1 part by weight CHG [0014]. CHG is taught to be at least 5% by weight of the vehicle [0019]. The hydrophobic vehicles contain Formula I and II [0018], wherein glycerol monostearate is specifically taught, wherein the composition is homogenous (Table 2a). The solution is taught to have a pressure sensitive adhesive ([0022], [0045]) and a plasticizer [0050] and the resin system includes the elected polyester polyols [0022]. The limitation of “wherein the solubilizer is present in an amount of about 5wt% to about 10 wt%” is directed to only the ethylene glycol monoheptanoate and propylene glycol monoheptanoate, wherein the ‘678 publication teaches glycerol monostearate.
The ‘678 publication teaching the active agent present at 1 wt%, glycerol monoleate at 10.7%, PSA at 74%, RES-4 at 10.7% (Table 14A) wherein the plasticizer is amorphous polyester polyol (Table 6a). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding the limitation of wherein the composition, at a wet thickness of 1 mil , has a time to kill acclivity of about 1.0 to about 5.0 average log reduction in CF after an incubation time of 15 minutes is met by the ‘678 publication teaching the direct time to kill analysis with an incubation period of 5 minutes is a log reduction of 3.5-3.6 (Table 7).
Regarding claim 4, the limitation of wherein one hydrogen-bonding group is a hydrogen-bond acceptor or wherein both hydrogen-bonding groups are hydrogen bond doners is met by the ‘678 publication teaching two hydroxyl groups [0018].
Regarding claims 6-8 and 23, the ‘678 publication teaches glycerol monostearate (Table 2a).
Regarding claims 12 and 24, the limitation of wherein the hydrophilic vehicle is selected from the group which includes glycerol is met by the ‘678 publication teaches composition including glycerol (Table 14a).
Regarding claims 13 and 15, the limitation of wherein the solublizer is glycol fatty monoester, the pressure sensitive adhesive is present in an amount of about 65 wt% to about 75% and the plasticizer is present in an amount of about 15-25 wt% is met by the ‘678 publication teaching the active agent present at 1 wt%, glycerol monoleate at 10.7%, PSA at 74%, RES-4 at 10.7% (Table 14A) wherein the plasticizer is amorphous polyester polyol (Table 6a). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claim 14, the limitation of the pressure-sensitive adhesive comprising an aliphatic (meth)acrylate polymer and an N-vinylpyrrolidone polymer is met by the ‘678 publication teaching isooctyl acrylate/N-vinylpyrrolidone (Table 6a).
Regarding claim 16, the limitation of further comprising a second solubilizer present in an amount of about 5 wt% to about 10 wt%, wherein the second solubilizer is a glycerol fatty monoester is met by the ‘678 publication teaching combinations of hydrophobic vehicles (claims 2-4) wherein the vehicle is present at 10.7% (Table 14a). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
The ’678 publication does not specifically teach octenidine salt, wherein the octenidine salt is solubilized in the solubilizer to provide the homogenous solution at a temperature of about 20 to 25 degrees C, or at a temperature equivalent to the melting point temperature of the solublizer (claims 1-2), specifically octenidine hydrochloride (claim 11).
The ‘454 publication teaches cationic antiseptic agents, a film forming polymer and a solvent, wherein the cationic antiseptic agent remains solubilized within the solution. The antiseptic agents is preferably octenidine dihydrochloride or chlorhexidine gluconate and the film forming polymer is an acrylate being applied to a drape (abstract).
The ’084 publication teaches antimicrobial preparations which comprise octenidine dihydrochloride in liposomes (abstract). The preferred form of the compositions includes solutions and creams [0008]. Cream compositions are taught to include glycerol monoester particularly glycerol monostearate and octenidine dihydrochloride [0024]. A composition containing octenidine dihydrochloride and glycerol monostearate is taught to be homogenized [0053].
Krishna teaches octenidine is a biguanide compound with structural similarity to chlorhexidine (page 200, 4th paragraph).
It would have been obvious to one of ordinary skill in the art to substitute a first active agent, chlorohexidine, as taught by the ‘678 publication with a second active agent, octenidine, as taught by the ‘454 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, 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). M.P.E.P. §2144.06.
One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success as the ‘678 publication teaches chlorohexidine for use on a drape and the ‘454 publication teaches the interchangeably of antiseptics of chlorohexidine and octenidine on medical drapes. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Kreshna teaches octenidine and chlorhexidine to be biguanide compounds with structural similarity which are both known to be used as topical antimicrobial agents.
Regarding the limitation of octenidine salt is solubilized in the solubilizer provide the homogeneous solution at the claimed temperature, the ‘678 publication teaches the claimed solublizer with the desire for a homogenous clear composition and the ‘454 publication teaches the claimed active agent of octenidine hydrochloride wherein clear solutions are desired. Thus, the combination of references teaches both the claimed ingredients and the desire for a homogenous solution. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘678 publication teaches the desire for a homogenous composition wherein glycerol monostearate is used with the active agent and the ‘084 publication teaches a homogenized composition comprising glycerol monostearate and octenidine dihydrochloride, thus providing an expectation of success in using glycerol monostearate in a homogenous composition comprising octenidine dihydrochloride.
Claim(s) 1-2, 6-8 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0296678, US 2014/261454, US 2008/0254084 and Krishna as applied to claims 1-2, 4, 6-8, 11-16 and 23-24 above, and further in view of US 2010/0282409 (previously applied) and Manning (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-2, 4, 6-8, 11-16 and 23-24 are taught by the combination of the ‘678 publication, the ‘454 publication, the ‘084 publication and Krishna.
The ‘678 publication teaching the active agent present at 1 wt%, glycerol monoleate at 10.7%, PSA at 74%, RES-4 at 10.7% (Table 14A) wherein the plasticizer is amorphous polyester polyol (Table 6a). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
The combination of references does not teach the elected solublizer, propylene glycol monoheptanoate.
The ‘409 publication teaches antimicrobial composition that include hydroalcoholic solvent system comprising a lower c2-c5 alcohol and water, cationic antimicrobial agent such as chlorohexidine gluconate and an emollient (abstract). The emollient may be C2-C18 alkyl esters of propylene glycol [0070].
Manning teaches certain food grade esters have antimicrobial properties and are selected for person care emulsion formulations (abstract). Food-grade monoesters are taught to have antimicrobial efficacy against yeast, mold and two bacteria (page 63, first column, second paragraph). Monoesters of propylene glycol were used (page 63, second column, first paragraph). Three esters having exceptional activity were propylene glycol heptanoate, propylene glycol caprylate and glyceryl caprylate (page 63, third column, second paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include propylene glycol monoheptanoate in the hydrophobic vehicle taught by the ‘678 publication because the ‘678 publication teaches the fatty vehicle to include glycerol monostearate wherein the composition is for treatment of bacteria [0054] and Manning teaches propylene glycol to be used for antimicrobial activity. One of ordinary skill in the art before the effective filing date of the claimed invention would have an expectation of success in using propylene glycol monoheptanote in the compristion taught by the ‘678 publication containing chlorhexidine as the ‘409 publication teaches the combination of chlorohexidine and C2-C18 alkyl esters of propylene glycol [0070] wherein propylene glycol heptanoate taught by Manning falls within the esters taught. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a fatty vehicle that is known to be used as an antibacterial in a fatty vehicle compristion that is used for the treatment of bacterial.
Claim(s) 1-2, 12 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0296678, US 2014/261454, US 2008/0254084 and Krishna as applied to claims 1-2, 4, 6-8, 11-16 and 23-24 above, and further in view of JP 2003-081709 (previously applied).
As mentioned in the above 103(a) rejection, all the limitations of claims 1-2, 4, 6-8, 11-16 and 23-24 are taught by the combination of the ‘678 publication and the ‘454 publication.
The combination of references does not specifically teach the elected methoxy isopropanol.
The ‘709 publication teaches bactericidal disinfectant composition (title). The composition is taught to be excellent bactericidal effect and have high safety to human body [0001]. The water-soluble alcohol having 1-4 carbon atoms include methanol, ethanol, isopropanol and 2-methoxyisorporanol, glycerin and the like [0025].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use methoxyisopropanol for the hydrophilic vehicle taught by the ‘678 publication because the ‘678 publication teaches hydrophilic vehicles include propane diols and glycerol (Table 6b) and the ‘709 publication teaches water-soluble alcohols include e.g., methoxy isopropanol, propane diols and glycerol [0025]. Thus one of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success in using one known water-soluble alcohol in place of another water soluble alcohol for a hydrophilic vehicle in a bactericidal disinfectant.
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.
9,713,659:
Claims 1-2, 4, 6-8, 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,713,659 in view of US 2016/0296678 and US 2014/261454. The instant application and the ‘659 patent are directed to compositions that are solubilized in hydrophobic vehicle comprising glycerol monostearate, wherein water is not taught as present and comprise a small quantity of hydrophilic vehicle. The instant claims differ in that the active agent is octenidine hydrochloride at 1.5wt% or less and additionally contains a plasticizer.
The ‘678 publication teaching compositions containing chlorhexidine gluconate solubilized in hydrophobic vehicles. The composition including adhesives and articles including medical articles such as drapes (abstract). The CHG can be solubilized in a wide variety of hydrophobic vehicles [0011]. All methods taught may leave small amounts of water, which are e.g., less than 1 wt% [0013]. The composition is taught to have 2 parts by weight hydrophilic vehicle per 1 part by weight CHG [0014]. CHG is taught to be at least 5% by weight of the vehicle [0019]. The hydrophobic vehicles contain Formula I and II [0018], wherein glycerol monolaurate is specifically taught, wherein the composition is homogenous (Table 2a). The solution is taught to have a pressure sensitive adhesive ([0022], [0045]) and a plasticizer [0050] and the resin system includes the elected polyester polyols [0022].
The ‘454 publication teaches cationic antiseptic agents, a film forming polymer and a solvent, wherein the cationic antiseptic agent remains solubilized within the solution. The antiseptic agents is preferably octenidine dihydrochloride or chlorhexidine gluconate and the film forming polymer is an acrylate being applied to a drape (abstract).
It would have been obvious to one of ordinary skill in the art to substitute a first active agent, chlorohexidine, as taught by the ‘659 patent with a second active agent, octenidine, as taught by the ‘454 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, 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). M.P.E.P. §2144.06. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success as the ‘678 publication teaches chlorohexidine for use on a drape and the ‘454 publication teaches the interchangeably of antiseptics of chlorohexidine and octenidine on medical drapes wherein known concentrations are taught. It would have been obvious to one of ordinary skill in the art to include a plasticizer as the ’648 publication teaches that it is known to include plasticizers in antiseptic containing compositions comprising pressure sensitive adhesives and the ‘659 patent is an antiseptic containing comprising which includes pressure sensitive adhesives.
10,016,537:
Claims 1-2, 4, 6-8, 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,016,537 in view of US 2016/0296678 and US 2014/261454. The instant application and the ‘537 patent are directed to compositions that are solubilized in hydrophobic vehicle comprising glycerol monostearate, wherein water is not taught as present and comprise a small quantity of hydrophilic vehicle. The instant claims differ in that the active agent is octenidine hydrochloride at 0-20 wt% and additionally contains a plasticizer.
The ‘678 publication teaching compositions containing chlorhexidine gluconate solubilized in hydrophobic vehicles. The composition including adhesives and articles including medical articles such as drapes (abstract). The CHG can be solubilized in a wide variety of hydrophobic vehicles [0011]. All methods taught may leave small amounts of water, which are e.g., less than 1 wt% [0013]. The composition is taught to have 2 parts by weight hydrophilic vehicle per 1 part by weight CHG [0014]. CHG is taught to be at least 5% by weight of the vehicle [0019]. The hydrophobic vehicles contain Formula I and II [0018], wherein glycerol monolaurate is specifically taught, wherein the composition is homogenous (Table 2a). The solution is taught to have a pressure sensitive adhesive ([0022], [0045]) and a plasticizer [0050] and the resin system includes the elected polyester polyols [0022].
The ‘454 publication teaches cationic antiseptic agents, a film forming polymer and a solvent, wherein the cationic antiseptic agent remains solubilized within the solution. The antiseptic agents is preferably octenidine dihydrochloride or chlorhexidine gluconate and the film forming polymer is an acrylate being applied to a drape (abstract).
It would have been obvious to one of ordinary skill in the art to substitute a first active agent, chlorohexidine, as taught by the ‘537 patent with a second active agent, octenidine, as taught by the ‘454 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, 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). M.P.E.P. §2144.06. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success as the ‘678 publication teaches chlorohexidine for use on a drape and the ‘454 publication teaches the interchangeably of antiseptics of chlorohexidine and octenidine on medical drapes wherein known concentrations are taught. It would have been obvious to one of ordinary skill in the art to include a plasticizer as the ’648 publication teaches that it is known to include plasticizers in antiseptic containing compositions comprising pressure sensitive adhesives and the ‘537 patent is an antiseptic containing comprising which includes pressure sensitive adhesives.
10,456,509:
Claims 1-2, 4, 6-8, 11-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,456,509 in view of US 2016/0296678 and US 2014/261454. The instant application and the ‘509 patent are directed to compositions that are solubilized in hydrophobic vehicle comprising glycerol monostearate, wherein water is not taught as present and comprise a small quantity of hydrophilic vehicle. The instant claims differ in that the active agent is octenidine hydrochloride at 0-20 wt% and additionally contains a plasticizer.
The ‘678 publication teaching compositions containing chlorhexidine gluconate solubilized in hydrophobic vehicles. The composition including adhesives and articles including medical articles such as drapes (abstract). The CHG can be solubilized in a wide variety of hydrophobic vehicles [0011]. All methods taught may leave small amounts of water, which are e.g., less than 1 wt% [0013]. The composition is taught to have 2 parts by weight hydrophilic vehicle per 1 part by weight CHG [0014]. CHG is taught to be at least 5% by weight of the vehicle [0019]. The hydrophobic vehicles contain Formula I and II [0018], wherein glycerol monolaurate is specifically taught, wherein the composition is homogenous (Table 2a). The solution is taught to have a pressure sensitive adhesive ([0022], [0045]) and a plasticizer [0050] and the resin system includes the elected polyester polyols [0022].
The ‘454 publication teaches cationic antiseptic agents, a film forming polymer and a solvent, wherein the cationic antiseptic agent remains solubilized within the solution. The antiseptic agents is preferably octenidine dihydrochloride or chlorhexidine gluconate and the film forming polymer is an acrylate being applied to a drape (abstract).
It would have been obvious to one of ordinary skill in the art to substitute a first active agent, chlorohexidine, as taught by the ‘509 patent with a second active agent, octenidine, as taught by the ‘454 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, 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). M.P.E.P. §2144.06. One of ordinary skill in the art before the effective filing date of the claimed invention would have a reasonable expectation of success as the ‘678 publication teaches chlorohexidine for use on a drape and the ‘454 publication teaches the interchangeably of antiseptics of chlorohexidine and octenidine on medical drapes wherein known concentrations are taught. It would have been obvious to one of ordinary skill in the art to include a plasticizer as the ’648 publication teaches that it is known to include plasticizers in antiseptic containing compositions comprising pressure sensitive adhesives and the ‘509 patent is an antiseptic containing comprising which includes pressure sensitive adhesives.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Double Patenting:
Applicant requests the double patenting rejection be held in abeyance.
In response, Applicant has presented no substantive arguments and thus the rejections are maintained for reasons of record.
103: the ‘678 publication (Menon) in view of the ‘454 publication (Dokken), the ‘084 publication (Behrends) and Krishna.
Applicant argues amended independent claim 1 requires a homogenous solution free of water [0053] in the instant specification. The ‘678 publication teaches non-aqueous to encompass compositions that contains small amounts of water and is silent to entirely free from water.
In response, the instant specification teaches “free of water” to mean less than 0.001 wt% [0053], thus free of water allows for some water to be present and overlaps with the ‘678 publication teaching less than 0.01 wt% water [0013]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Applicant argues the ‘678 publication teaches the solubilizer system exceeds 10 wt%, for instances teaching up to 33 wt% or up to 43 wt% (Examples C3 and CE-4). Appropriate vehicle selection and loading is required to fully solubilize the CHG and afford surface activity. High loading of solubilizer may contribute to the activity of the CHG.
In response, Applicant is referred to the 112(b) rejection above, wherein the amount of solubilizer is only limiting to ethylene glycol monoheptanoate and propylene glycol monoheptanoate, and not the claimed “one or more solubilizers” as a whole.
Applicant argues, in contrast the present application reports that composition comprising octenidine HCl and low (5-10 wt%) solubilize have much greater antimicrobial effectiveness than compositions comprising CHG at the same solubilizer content. Applicant points to the instant specification Table 2 and 3. Even double the concentration, 2% compared to 1.0% octenidine HCl, the octenidine HCl kills 1580 times as many CFU. These results were observed from composition comprising equal amounts of the same solubilizer 10% glycerol monoisosteate (GMIS).
In response, the results pointed to in the instant specification are not commensurate in scope with the instant claims. As discussed above, the limitations regarding the solubilize amount only limits ethylene glycol monoheptanoate and propylene glycol monoheptanoate. Thus the instant claims are thus broad in both the claimed solubilizer and in the amounts of solubilizer being undefined, except in regards to ethylene glycol monoheptanoate and propylene glycol monoheptanoate which are not the tested compound. Thus the results are not commensurate in scope with the instant claims.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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