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 Interpretation
Applicant’s specification states that formula (I) in claim 16 is for polyester polyols. However, formula I as written does not lead to polyester polyols because with repeat (A-B) units and B being C(O)O would lead to peroxy compounds not polyols in the final A-B repeat unit as the compound would only contain 1 OH group or if B is OC(O) when bound to the OH as written would lead to a carbonate group again not a polyol because the compound only contains 1 OH group as written. As applicants explicitly state in the specification that their claims can include polyester polyols of formula (I) the examiner is interpreting polyester polyols to include these moieties of formula (I) which are not actually within the scope of polyester polyols as would be recognized by one of ordinary skill in the art of organic chemistry.
Specification
The use of the terms PRIPLAST 3186, 3190, etc., Poly-BD R-45HT, Polvest HT, KRASOL LBH 2000, KRASOL LBH 3000, etc. and X-21-5841, KF-6000, etc. which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Election/Restrictions
Applicant's election with traverse of group I, claims 1, 3, 5, 7-8, 16, 20-21, 26, 32, 34, 36, 39 in the reply filed on 01/26/26 is acknowledged and the species shown in applicant’s response. The examiner has broadened applicant’s search because formula (I) in claim 16 was not found (See claim interpretation above). The traversal is on the ground(s) that they have amended the claims to exclude the monoacyl glycerides. This is not found persuasive in light of the 102 rejection below which demonstrates that the previously cited Menon et al. (US20190160209) still anticipates the instant claims. Based on the examiner’s search she is also including claims 41, 43, and 45 with the elected group. Thus, the claims being examined in this office action are 1, 3, 5, 7-8, 16, 20-21, 26, 32, 34, 36, 39, 41, 43, and 45.
The requirement is still deemed proper and is therefore made FINAL.
Claims 49-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/26/26.
Claim Objections
Claim 8 is objected to because of the following informalities: the hydroxyl value number appears to missing the units for the number. Based on the definition of “hydroxyl value” in the specification, the number is to be expressed in units of mass of potassium hydroxide in milligrams equivalent to the hydroxyl content of one gram of the chemical substance. Thus, applicants should add these units to the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 5, 7-8, 20-21, 26, 32, 34, 41, and 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Menon et al. (US20190160209 from IDS), as evidenced by Priplast information slides from presentations found via bing image search(es), and WO2020129009 (From IDS).
Menon exemplifies J4, which contains Priplast 3197 (Res-4) in 15 wt% (as evidenced by Croda and some slides disclosing Priplast properties found on the internet and WO2020129009 PRIPLAST 3197— dimer acid and dimer diol and has a molecular weight of 2000 and hydroxyl value of greater than 20), and chlorhexidine in 1 wt% which anticipates claims 1, 3, 5, 7, 8, 26, 32 and as the example does not contain water it also anticipates claim 34. This example in Menon also contains PSA2 in 64 wt% and PSA2 is a pressure sensitive adhesive, specifically isooctyl acrylate/acrylamide which is an acrylic copolymer, and as such this composition also anticipates claims 41 and 43. (See table 6a; Table 14b; [0083])
Menon also exemplifies CE-3 ([0060-table B] which contains 2 wt% chlorhexidine gluconate, 50% PSA-2 (and PSA2 is a pressure sensitive adhesive, specifically isooctyl acrylate/acrylamide which is an acrylic copolymer), 24 wt% Priplast 3193 (Res-1) (as evidenced by WO2020129009 PRIPLAST 3193-- dimer acid and ethylene glycol) which is derived from ethylene glycol, 24 wt% propanediol, which anticipates claims 1, 3, 5, 7, 20-21, 26, 32, 41, 43, and as the example does not contain water it also anticipates claim 34.
Menon teaches all limitations of the claims and anticipates the claims. The examiner notes that Menon is art for all it teaches including comparative/non-preferred embodiments such as these which anticipate the instant claims.
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, 3, 5, 7-8, 20-21, 26, 32, 34, 36, 39, 41, 43, and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US20190160209 from IDS), as evidenced by WO2020129009 (from IDS) and several Priplast property slides found via bing image search.
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 3, 5, 8, 20-21, 26, 32, the disclosure of Menon also broadly teaches compositions which comprise chlorhexidine gluconate present in about 0.2 wt% up to 5 wt% based on the total weight of the composition and in an amount of about 0.1 wt% to about 20 wt% with respect to the weight of the hydrophobic plasticizer/Priplast, and wherein the composition further comprises hydrophobic plasticizers specifically the instantly disclosed polyester polyols: Priplast 3192 (molecular weight 2000, derived from dimer acid, adipic acid, and 1,6-hexane diol as evidenced by WO2020129009 (see pg. 10, ln. 1), Priplast 3196 (molecular weight 3000 and has a hydroxyl value greater than 20 as claimed as evidenced by slides found via bing image search, and derived from 1,6-hexanediol which is a C2-C10 alkyl diol as evidenced by WO2020129009 (see pg. 10, ln. 3)), and/or other claimed Priplasts which are specifically exemplified in applicant’s specification and would therefore obviously have the properties claimed, e.g. hydroxyl value, HLB of less than 5, etc. (See entire document; claim 1; [0002-0003]; [0010-0011]; [0013-0014]; [0016]; [0019-0023]; [0029-0030]; [0045-0046]; Table 6a, specifically Res-1-Res-4; examples which use Priplast; claims; etc.).
Regarding the newly added limitation that the composition excludes monoacylglycerides Menon does not actually require the presence of monoacylglycerides as Menon states in some embodiments the hydrophobic vehicle comprises an ester group, e.g., a monoacylglycerol, which means that in other embodiments the hydrophobic vehicle does not contain monoacylglycerol, further at paragraph [0011] Menon states that the present inventors have discovered that CHG (chlorhexidine gluconate) can be solubilized in a wide variety of hydrophobic vehicles. Consistent with typical usage, as used herein, a “hydrophobic vehicle” is one having a hydrophile/lipophile balance (“HLB”) of no greater than 10 which in no way limits the hydrophobic vehicles to monoacylglycerides even if they are exemplified as being examples of these hydrophobic vehicles because the specification is not limited to the examples as the prior art is art for all it teaches (See entire document; claim 1; [0002-0003]; [0010-0011]; [0013-0014]; [0016]; [0019-0023]; [0029-0030]; [0045-0046]; Table 6a, specifically Res-1-Res-4; examples which use Priplast; claims; etc.).
Regarding claim 7, Menon teaches wherein the claimed Priplasts, e.g. Priplast 3196, etc. are used in amounts of about 10 wt% to about 50% wt based on the total weight of the composition (Table 6a, specifically Res-1-Res-4; Table 8, Table 9, example tables showing amounts of Priplast used).
Regarding claims 34, Menon teaches wherein their compositions contain less than about 1 wt% water with respect to the weight of the composition ([0004]; [0013-0014]; claims).
Regarding claims 36 and 39, Menon teaches wherein the composition further comprises a hydrophilic vehicle in amounts of no greater than 1 part by weight hydrophilic vehicle per 1 part by weight chlorhexidine gluconate, specifically no greater than 0.1 parts by weight hydrophilic vehicle per 1 part by weight chlorhexidine gluconate. In some embodiments, the composition comprises no greater than 0.1 parts by weight water per 1 In part by weight chlorhexidine gluconate and as defined by Menon a “hydrophilic vehicle ” is one having a hydrophile / lipophile balance ( “ HLB ” ) of greater than 10 ([0004]; [0010]; [0014]; [0016]; claims).
Regarding claims 41 and 43, Menon teaches wherein their compositions can be used to form an antimicrobial adhesive with pressure sensitive adhesives, and can specifically comprise an acrylic polymer as claimed (See [0007]; [0002]; [0022-0029]).
Regarding claim 45, Menon teaches wherein their compositions, including their adhesives can be placed on medical articles, e.g. adhesive drapes which would have a first surface and second surface opposite the first surface and wherein the antimicrobial adhesive is on one surface, e.g. the first surface ([0064]; Claims; abstract; [0002]; [0007]; [0052]; [0079-0081]; [0084]; [0086-0088]).
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)/ Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
Menon prefers compositions wherein the compositions comprise the excluded monoacylglycerides as the examples which anticipate the instant claims and are rejected via the 102 rejection above are directed to comparative examples not examples of Menon’s invention. However, as discussed above Menon does not limit the hydrophobic vehicle to only monoacylglycerides, for example in Table 4, 1,2-octanediol has a HLB less than 10 and chlorhexidine is soluble in it and as such it would obvious to substitute this solvent or one of the other solvents of Menon that have the HLB of no greater than 10 for the monoacylglycerides in the Examples of Menon in order to form effective compositions for delivering/utilizing chlorhexidine gluconate as Menon clearly teaches that they have found that CHG (chlorhexidine gluconate) can be solubilized in a wide variety of hydrophobic vehicles having an HLB of no greater than 10 and it would have been obvious for one of ordinary skill in the art to determine other solvents in which CHG can be solubilized as was done by Menon. Thus, it would be obvious to substitute the monoacylglycerides of Menon’s examples for other hydrophobic vehicles having an HLB of no greater than 10 in which CHG is solubilized, e.g. 1,2-octanediol and combine that with the Priplast resins/hydrophobic plasticizers instantly claimed which are used in the examples of Menon in order to develop the instantly claimed compositions because simple substitution of one known element, specifically one known hydrophobic vehicle having an HLB of no greater than 10 in which CHG is solubilized, for another to obtain predictable results would have been obvious to one of ordinary skill in the art.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US20190160209), as evidenced by WO2020129009 and Priplast information slides found via Bing image search as applied to claims 1, 3, 5, 7-8, 20-21, 26, 32, 34, 36, 39, 41, 43, and 45 above and further in view of AU2013223759 (‘759).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Menon and the evidentiary references together teach the composition of claims 1, 3, 5, 7-8, 20-21, 26, 32, 34, 36, 39, 41, 43, and 45 as discussed above and incorporated herein.
Ascertainment of the difference between prior art and the claims
(MPEP 2141.02)
Menon and the evidentiary references do not teach wherein the hydrophobic plasticizer has one of the claimed formulae of claim 16. However, this deficiency in Menon and the evidentiary references is addressed by ‘759.
‘759 teaches liquid antimicrobial compositions for use in adhesives which can comprise chlorhexidine, and which is also a biocide containing halogen atoms of part (a) in ‘759 and the claimed siloxane polymers of applicant’s formula III as claimed in instant claim 16, specifically dimethyl polysiloxane (CH3[Si(CH3)2O]nSi(CH3)3), or other linear siloxanes or silanols of applicant’s formula:
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(See pg. 17, ln. 23-25, ln. 27; pg. 18, ln. 2-11; pg. 15, ln. 26-pg. 16, ln. 32 (various types of liquid formulations); pg. 11, ln. 4; pt. 13, pg. 9, and pt. 29, pg. 10; pg. 51, ln. 22-24; pg. 27, ln. 33-36, pg. 27, ln. 8-pg. 28, ln. 4; pg. 28, ln. 22-pg. 29, ln. 5). It would be obvious to optimize the number of repeat units in the polymers of ‘759 to read on those instantly claimed, specifically from 10-200, as since these polymers were known to be effective for formulating compositions containing chlorhexidine it would be obvious to optimize the repeat units to find the most effective linear siloxanes and/or silanols for forming effective chlorhexidine compositions especially since these compounds, e.g. linear siloxanes of applicant’s formula and the formula taught by ‘759 are known to be non-polar liquids with a broad range of viscosity and as they are of applicant’s formula they have the claimed HLB value of no greater than 10 and other properties instantly claimed since it is of applicant’s formula in claim 16 which depends from claim 1.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art at the time of the instant filing to have determined what other plasticizers can solubilize chlorhexidine for formulating the claimed compositions because Menon teaches forming compositions comprising the same plasticizers instantly claimed/disclosed with the same amounts of chlorhexidine and it would have been obvious to substitute other plasticizers, e.g. the claimed siloxanes and/or silanols as taught by ‘759 in order to form the claimed composition because these lipophilic oils were known in the art to be useful for forming liquid formulations comprising chlorhexidine and other antimicrobials as these were known lipid liquids which were effective for forming antimicrobial compositions comprising chlorhexidine.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the above claims would have been obvious to one of ordinary skill in the art within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claims 1, 3, 5, 7-8, 20-21, 26, 32, 34, 36, 39, 41, 43, 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10016537 (‘537) in view of Menon et al. (US20190160209), AU2013223759 (‘759), and as evidenced by WO2020129009 and Priplast information slides found via Bing image search.
‘537 teaches compositions comprising chlorhexidine gluconate solubilized in hydrophobic vehicle having an HLB of no greater than 10, wherein the hydrophobic vehicle is alcohol having proximate hydroxyl groups and wherein the composition can further comprise a resin which together with the hydrophobic vehicle plasticizes the hydrophobic phase of the resin. ‘537 further teaches wherein their compositions can be used to form a pressure sensitive adhesives with the claimed acrylate polymers/acrylic copolymers and medical articles, and wherein the composition comprises the same amounts of chlorhexidine, and hydrophilic vehicle, and water that are instantly claimed. ‘537 does not teach/claim wherein the resins are the claimed hydrophobic plasticizers having the claimed properties or the claimed formula or are present in the claimed amounts, etc. The examiner notes that ‘537 uses comprising language and does not exclude the claimed resins in the claimed amounts. However, these deficiencies in ‘537 are addressed by Menon and (‘759), and as evidenced by WO2020129009 and Priplast information slides found via Bing image search.
Regarding claims 1, 3, 8, 20-21, 26, 32, Menon also broadly teaches compositions which comprise chlorhexidine gluconate present in about 0.2 wt% up to 5 wt% based on the total weight of the composition, and wherein the composition further comprises hydrophobic plasticizers specifically the instantly disclosed polyester polyols: Priplast 3192 (molecular weight 2000, derived from dimer acid, adipic acid, and 1,6-hexane diol as evidenced by WO2020129009 (see pg. 10, ln. 1), Priplast 3196 (molecular weight 3000 and has a hydroxyl value greater than 20 as claimed as evidenced by slides found via bing image search, and derived from 1,6-hexanediol which is a C2-C10 alkyl diol as evidenced by WO2020129009 (see pg. 10, ln. 3)), and/or other claimed Priplasts which are specifically exemplified in applicant’s specification and would therefore obviously have the properties claimed, e.g. hydroxyl value, HLB of less than 5, etc. (See entire document; claim 1; [0002-0003]; [0010-0011]; [0013-0014]; [0016]; [0019-0023]; [0029-0030]; [0045-0046]; Table 6a, specifically Res-1-Res-4; examples which use Priplast; claims; etc.).
Regarding the newly added limitation that the composition excludes monoacylglycerides Menon does not actually require the presence of monoacylglycerides as Menon states in some embodiments the hydrophobic vehicle comprises an ester group, e.g., a monoacylglycerol, which means that in other embodiments the hydrophobic vehicle does not contain monoacylglycerol, further at paragraph [0011] Menon states that the present inventors have discovered that CHG (chlorhexidine gluconate) can be solubilized in a wide variety of hydrophobic vehicles. Consistent with typical usage, as used herein, a “hydrophobic vehicle” is one having a hydrophile/lipophile balance (“HLB”) of no greater than 10 which in no way limits the hydrophobic vehicles to monoacylglycerides even if they are exemplified as being examples of these hydrophobic vehicles because the specification is not limited to the examples as the prior art is art for all it teaches (See entire document; claim 1; [0002-0003]; [0010-0011]; [0013-0014]; [0016]; [0019-0023]; [0029-0030]; [0045-0046]; Table 6a, specifically Res-1-Res-4; examples which use Priplast; claims; etc.).
Regarding claim 7, Menon teaches wherein the claimed Priplasts, e.g. Priplast 3196, etc. are used in amounts of about 10 wt% to about 50% wt based on the total weight of the composition (Table 6a, specifically Res-1-Res-4; Table 8, Table 9, example tables showing amounts of Priplast used).
Regarding claims 34, Menon teaches wherein their compositions contain less than about 1 wt% water with respect to the weight of the composition ([0004]; [0013-0014]; claims).
Regarding claims 36 and 39, Menon teaches wherein the composition further comprises a hydrophilic vehicle in amounts of no greater than 1 part by weight hydrophilic vehicle per 1 part by weight chlorhexidine gluconate, specifically no greater than 0.1 parts by weight hydrophilic vehicle per 1 part by weight chlorhexidine gluconate. In some embodiments, the composition comprises no greater than 0.1 parts by weight water per 1 In part by weight chlorhexidine gluconate and as defined by Menon a “hydrophilic vehicle ” is one having a hydrophile / lipophile balance ( “ HLB ” ) of greater than 10 ([0004]; [0010]; [0014]; [0016]; claims).
Regarding claims 41 and 43, Menon teaches wherein their compositions can be used to form an antimicrobial adhesive with pressure sensitive adhesives, and can specifically comprise an acrylic polymer as claimed (See [0007]; [0002]; [0022-0029]).
Regarding claim 45, Menon teaches wherein their compositions, including their adhesives can be placed on medical articles, e.g. adhesive drapes which would have a first surface and second surface opposite the first surface and wherein the antimicrobial adhesive is on one surface, e.g. the first surface ([0064]; Claims; abstract; [0002]; [0007]; [0079-0080]; [0086-0088]).
Regarding claim 16, ‘759 teaches liquid antimicrobial compositions for use in adhesives which can comprise chlorhexidine, and which is also a biocide containing halogen atoms of part (a) in ‘759 and the claimed siloxane polymers of applicant’s formula III as claimed in instant claim 16, specifically dimethyl polysiloxane (CH3[Si(CH3)2O]nSi(CH3)3), or other linear siloxanes or silanols of applicant’s formula
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(See pg. 17, ln. 23-25, ln. 27; pg. 18, ln. 2-11; pg. 15, ln. 26-pg. 16, ln. 32 (various types of liquid formulations); pg. 11, ln. 4; pt. 13, pg. 9, and pt. 29, pg. 10; pg. 51, ln. 22-24; pg. 27, ln. 33-36, pg. 27, ln. 8-pg. 28, ln. 4; pg. 28, ln. 22-pg. 29, ln. 5). It would be obvious to optimize the number of repeat units in the polymers of ‘759 to read on those instantly claimed, specifically from 10-200, as since these polymers were known to be effective for formulating compositions containing chlorhexidine it would be obvious to optimize the repeat units to find the most effective linear siloxanes and/or silanols for forming effective chlorhexidine compositions especially since these compounds, e.g. linear siloxanes of applicant’s formula and the formula taught by ‘759 are known to be non-polar liquids with a broad range of viscosity and as they are of applicant’s formula they have the claimed HLB value of no greater than 10 and other properties instantly claimed since it is of applicant’s formula in claim 16 which depends from claim 1.
It would have been obvious to form the claimed composition by adding the claimed polyester polyols/plasticizers in the claimed amounts as taught by Menon for formulating effective adhesives/devices comprising chlorhexidine as claimed into the compositions and devices of ‘537 and/or the claimed siloxanes of ‘759 in the amounts of Menon which are the same as the instantly claimed amounts into the formulations of ‘537 as the resins/plasticizers because these allow for effective formulation of different medical adhesives comprising chlorhexidine which can be very useful as antimicrobials. Thus, one would conclude that the instantly claimed composition is rendered obvious when taken in view of US ‘537 and the combined references because both ‘537 and the instant application use comprising language which is open-ended and does not exclude the solvents of ‘537 from the instant composition and does not exclude the plasticizers instantly claimed, etc. from the composition of ‘537.
Claims 1, 3, 5, 7-8, 20-21, 26, 32, 34, 36, 39, 41, 43, 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10232093 (‘093) in view of Menon et al. (US20190160209), AU2013223759 (‘759), and as evidenced by WO2020129009 and Priplast information slides found via Bing image search.
‘093 teaches compositions comprising chlorhexidine gluconate solubilized in hydrophobic vehicle having an HLB of no greater than 10, wherein the hydrophobic vehicle is ether having 2 proximate hydrogen groups and wherein the composition can further comprise a resin which together with the hydrophobic vehicle plasticizes the hydrophobic phase of the resin. ‘093 further teaches wherein their compositions can be used to form a pressure sensitive adhesives with the claimed acrylate polymers/acrylic copolymers and medical articles, and wherein the composition comprises the same amounts of chlorhexidine, and hydrophilic vehicle, and water that are instantly claimed. ‘093 does not teach/claim wherein the resins are the claimed hydrophobic plasticizers having the claimed properties or the claimed formula or are present in the claimed amounts, etc. The examiner notes that ‘093 uses comprising language and does not exclude the claimed resins in the claimed amounts. However, these deficiencies in ‘093 are addressed by Menon and ‘759, and as evidenced by WO2020129009 and Priplast information slides found via Bing image search.
Regarding claims 1, 3, 8, 20-21, 26, 32, Menon also broadly teaches compositions which comprise chlorhexidine gluconate present in about 0.2 wt% up to 5 wt% based on the total weight of the composition, and wherein the composition further comprises hydrophobic plasticizers specifically the instantly disclosed polyester polyols: Priplast 3192 (molecular weight 2000, derived from dimer acid, adipic acid, and 1,6-hexane diol as evidenced by WO2020129009 (see pg. 10, ln. 1), Priplast 3196 (molecular weight 3000 and has a hydroxyl value greater than 20 as claimed as evidenced by slides found via bing image search, and derived from 1,6-hexanediol which is a C2-C10 alkyl diol as evidenced by WO2020129009 (see pg. 10, ln. 3)), and/or other claimed Priplasts which are specifically exemplified in applicant’s specification and would therefore obviously have the properties claimed, e.g. hydroxyl value, HLB of less than 5, etc. (See entire document; claim 1; [0002-0003]; [0010-0011]; [0013-0014]; [0016]; [0019-0023]; [0029-0030]; [0045-0046]; Table 6a, specifically Res-1-Res-4; examples which use Priplast; claims; etc.).
Regarding the newly added limitation that the composition excludes monoacylglycerides Menon does not actually require the presence of monoacylglycerides as Menon states in some embodiments the hydrophobic vehicle comprises an ester group, e.g., a monoacylglycerol, which means that in other embodiments the hydrophobic vehicle does not contain monoacylglycerol, further at paragraph [0011] Menon states that the present inventors have discovered that CHG (chlorhexidine gluconate) can be solubilized in a wide variety of hydrophobic vehicles. Consistent with typical usage, as used herein, a “hydrophobic vehicle” is one having a hydrophile/lipophile balance (“HLB”) of no greater than 10 which in no way limits the hydrophobic vehicles to monoacylglycerides even if they are exemplified as being examples of these hydrophobic vehicles because the specification is not limited to the examples as the prior art is art for all it teaches (See entire document; claim 1; [0002-0003]; [0010-0011]; [0013-0014]; [0016]; [0019-0023]; [0029-0030]; [0045-0046]; Table 6a, specifically Res-1-Res-4; examples which use Priplast; claims; etc.).
Regarding claim 7, Menon teaches wherein the claimed Priplasts, e.g. Priplast 3196, etc. are used in amounts of about 10 wt% to about 50% wt based on the total weight of the composition (Table 6a, specifically Res-1-Res-4; Table 8, Table 9, example tables showing amounts of Priplast used).
Regarding claims 34, Menon teaches wherein their compositions contain less than about 1 wt% water with respect to the weight of the composition ([0004]; [0013-0014]; claims).
Regarding claims 36 and 39, Menon teaches wherein the composition further comprises a hydrophilic vehicle in amounts of no greater than 1 part by weight hydrophilic vehicle per 1 part by weight chlorhexidine gluconate, specifically no greater than 0.1 parts by weight hydrophilic vehicle per 1 part by weight chlorhexidine gluconate. In some embodiments, the composition comprises no greater than 0.1 parts by weight water per 1 In part by weight chlorhexidine gluconate and as defined by Menon a “hydrophilic vehicle ” is one having a hydrophile / lipophile balance ( “ HLB ” ) of greater than 10 ([0004]; [0010]; [0014]; [0016]; claims).
Regarding claims 41 and 43, Menon teaches wherein their compositions can be used to form an antimicrobial adhesive with pressure sensitive adhesives, and can specifically comprise an acrylic polymer as claimed (See [0007]; [0002]; [0022-0029]).
Regarding claim 45, Menon teaches wherein their compositions, including their adhesives can be placed on medical articles, e.g. adhesive drapes which would have a first surface and second surface opposite the first surface and wherein the antimicrobial adhesive is on one surface, e.g. the first surface ([0064-0066]; Claims; abstract; [0002]; [0007]; [0079-0080]; [0086-0088]).
Regarding claim 16, ‘759 teaches liquid antimicrobial compositions for use in adhesives which can comprise chlorhexidine, and which is also a biocide containing halogen atoms of part (a) in ‘759 and the claimed siloxane polymers of applicant’s formula III as claimed in instant claim 16, specifically dimethyl polysiloxane (CH3[Si(CH3)2O]nSi(CH3)3), or other linear siloxanes or silanols of applicant’s formula
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(See pg. 17, ln. 23-25, ln. 27; pg. 18, ln. 2-11; pg. 15, ln. 26-pg. 16, ln. 32 (various types of liquid formulations); pg. 11, ln. 4; pt. 13, pg. 9, and pt. 29, pg. 10; pg. 51, ln. 22-24; pg. 27, ln. 33-36, pg. 27, ln. 8-pg. 28, ln. 4; pg. 28, ln. 22-pg. 29, ln. 5). It would be obvious to optimize the number of repeat units in the polymers of ‘759 to read on those instantly claimed, specifically from 10-200, as since these polymers were known to be effective for formulating compositions containing chlorhexidine it would be obvious to optimize the repeat units to find the most effective linear siloxanes and/or silanols for forming effective chlorhexidine compositions especially since these compounds, e.g. linear siloxanes of applicant’s formula and the formula taught by ‘759 are known to be non-polar liquids with a broad range of viscosity and as they are of applicant’s formula they have the claimed HLB value of no greater than 10 and other properties instantly claimed since it is of applicant’s formula in claim 16 which depends from claim 1.
It would have been obvious to form the claimed composition by adding the claimed polyester polyols/plasticizers in the claimed amounts as taught by Menon for formulating effective adhesives/devices comprising chlorhexidine as claimed into the compositions and devices of ‘093 and/or the claimed siloxanes of ‘759 in the amounts of Menon which are the same as the instantly claimed amounts into the formulations of ‘093 as the resins/plasticizers because these allow for effective formulation of different medical adhesives comprising chlorhexidine which can be very useful as antimicrobials. Thus, one would conclude that the instantly claimed composition is rendered obvious when taken in view of US ‘093 and the combined references because both ‘093 and the instant application use comprising language which is open-ended and does not exclude the solvents of ‘093 from the instant composition and does not exclude the plasticizers instantly claimed, etc. from the composition of ‘093.
Conclusion
No claims are allowed.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616
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