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. Specifically, the examiner notes that the terminal B group that is bound to the OH in the last repeated monomer unit does not yield an alcohol group which would form the claimed polyol, it yields either a carbonate or a peroxy (technically a peroxyacid group) which are not alcohol groups/thereby yielding a polyol. Thus, the examiner is ensuring applicants realize that in fact their formula (I) does not actually yield a polyester polyol as they have defined them in the specification at pg. 10, ln. 27-28, and in fact broadens their own definition to include these molecules which are not actually polyester polyols, since they only actually contain one alcohol/hydroxyl moiety and a carbonate or peroxyacid moiety on the terminal B portion of the molecule which is bound to the OH group. Thus, clearly claim 16 is only claiming any compounds of their formula which have the HLB values and are capable of solubilizing chlorhexidine at the claimed rates/conditions.
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 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 (polyester polyol), 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, Res-1-Res-4; examples which use Priplast; etc.).
Regarding the 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; etc.).
Regarding the newly added limitation that the composition excludes C2-C22 alkyl 1,2-diols Menon does not require the presence of C2-C22 alkyl 1,2-diols. They teach that in some embodiments
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];).
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, compositions contain little or no hydrophilic vehicle]; [0016];).
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]; 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 does prefer/exemplifies compositions wherein the compositions comprise the excluded monoacylglycerides and C2-C22 alkyl 1,2-diols. However, as discussed above Menon does not limit the hydrophobic vehicle to only the instantly excluded monoacylglycerides and C2-C22 alkyl 1,2-diols, for example claim 1 does not limit the hydrophobic vehicle at all except for the HLB and two proximate hydrogen bonding groups (which does not need to be a 1,2-diol) and the instant claims do not exclude hydrophobic vehicles having these properties, and for instance Menon recites ethyl hexyl glycerin which does not belong to either of the instantly excluded monoacylglycerides or C2-C22 alkyl 1,2-diols which are preferred by Menon. Further, the instant claims use comprising language and do not exclude additional hydrophobic vehicles/solvents for solubilizing the chlorhexidine gluconate, nor does the claimed hydrophobic plasticizer have to be used as a solvent in the instant claims. Especially since the instant claims merely require the hydrophobic plasticizer to be capable of solubilizing chlorhexidine not that the chlorhexidine actually has to be solubilized in the hydrophobic plasticizer. Thus, the resins which are polyester polyols of Menon and which can/do contain the dissolved chlorhexidine gluconate of Menon still read on the claimed compositions, especially since Menon does not require the presence of the excluded monoacylglycerides and/or C2-C22 alkyl 1,2-diols as hydrophobic vehicle/solvent of the chlorhexidine. Thus, whether or not Menon teaches that chlorhexidine is soluble in the polyester polyols of Menon they are the same polyester polyols claimed in the instant claims and which are disclosed in the instant specification and as such this is property of these compounds that they are capable of solubilizing chlorhexidine and their presence in the compositions of Menon with the solubilized CHG would lead to further solubilization of the chlorhexidine/CHG, and as such it would obvious that the polyester polyols can be added in addition to one of the other solvents of Menon that have the HLB of no greater than 10, e.g. ethylhexyl glycerin or dipropylene glycol, etc. in place of the now excluded monoacylglycerides and/or C2-C22 alkyl 1,2-diols 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 and/or C2-C22 alkyl 1,2-diols of Menon’s examples for other hydrophobic vehicles having an HLB of no greater than 10 in which CHG is solubilized, e.g. ethylhexyl glycerin or dipropylene glycol 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. Especially since the instant claims merely require the hydrophobic plasticizer to be capable of solubilizing chlorhexidine not that the chlorhexidine actually has to be solubilized in the hydrophobic plasticizer as is discussed above.
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) 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 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]).
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 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), 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]).
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.
Allowable Subject Matter
Claim 16 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments/Remarks
Applicant’s amendments to the claims have prompted the revised/new grounds of rejection presented herein. Applicant’s amendments to the claims have also overcome/rendered moot the previous claim objections, and previous 102 rejections both of which are hereby withdrawn, and applicant’s specification amendments have also overcome the previous objections to the specification.
Applicant’s arguments with respect to Menon have been fully considered but are not persuasive at this time. Applicants argue that Menon must be considered for all that is taught but that they believe that a reference teaches away if it would have led a person skill in the art in a direction different from that taken by the inventor. The examiner respectfully disagrees that Menon teaches away from the instantly claimed invention for the reasons which are discussed above. Firstly, the examiner respectfully points out that Menon is art for all it teaches and whether or not it prefers to include the instantly excluded C2-C22 alkyl 1,2-diols and monoacylglycerides these compounds are clearly not required by Menon, as Menon teaches using other hydrophobic vehicles, e.g. dipropylene glycol for instance which is expressly claimed in Menon as the hydrophobic vehicle which is not a C2-C22 alkyl 1,2-diols or a monoacylglyceride. Thus, as is discussed above Menon clearly teaches that their hydrophobic vehicles are not in anyway limited to the instantly excluded C2-C22 alkyl 1,2-diols and monoacylglycerides, contrary to applicant’s assertions and arguments otherwise. Thus, the examiner agrees that Menon no longer anticipates the instant claims but the examiner disagrees that Menon does not render obvious the instant claims for the reasons discussed above which are incorporated herein.
As discussed above, Menon is prior art for all it teaches and Menon is not limited to their examples and/or preferred hydrophobic vehicles contrary to applicant’s assertions because it is known, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983). Further contrary to applicant’s arguments above, “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Applicants then argue that Menon does not teach using the polyester polyol as the hydrophobic plasticizer. The examiner respectfully points out that this is the intended purpose of the polyester polyol and that the presence of the polyester polyol in the prior art reads on the instant claims because all that is required of the instant hydrophobic plasticizer is that it be capable of dissolving CHG under the claimed conditions and this is property of the priplasts and/or polyester polyols instantly claimed and which are disclosed and taught by Menon, and it is known that compounds are inseparable from their properties. Thus, because Menon’s compositions contain/can contain the same polyester polyol instantly claimed and/or disclosed as discussed above then obviously these same polyester polyols would have the same properties instantly claimed whether or not the prior art recognizes or calls them hydrophobic plasticizers. Additionally, applicant’s own specification defines "plasticizer" refers to a substance or combination of substances that lowers the glass transition temperature of another substance (e.g., a pressure-sensitive adhesive). Thus, again this is a property of the claimed hydrophobic plasticizers and as Menon teaches/discloses the same polyester polyols which are instantly claimed as discussed above then clearly these same polyester polyols would have the same properties that are instantly claimed because "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. Thus, contrary to applicant’s arguments whether or not Menon recognizes the polyester polyols to solubilize CHG this is a property of the claimed/disclosed PRIPLAST polyester polyols which are taught by Menon. Further, Menon does not have to recognize that the would solubilize the CHG as this is a property of the PRIPLAST polyester polyols when they are mixed with CHG/CHG containing solutions which is taught by Menon. Further, nothing in the instant claims as they are currently written actually requires the CHG to be solubilized in the hydrophobic plasticizer/polyester polyols claimed. The claim only requires that the hydrophobic plasticizer be capable of dissolving the CHG under specific conditions. Thus, contrary to applicant’s arguments Menon does not have to teach solubilizing CHG in the PRIPLAST polyester polyols which are the same as those instantly claimed because these are features which are not actually required of the instant claims as they are currently written. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., hydrophobic plasticizer/polyester polyol as a solubilizer for CHG/having CHG solubilized therein) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Thus, contrary to applicant’s arguments Menon still reads on the instant claims at this time and still renders the instant claims obvious for the reasons discussed above which are incorporated herein.
Applicants then argue that their specification demonstrates unexpected results in view of the prior art because applicant’s example 4 show that compositions comprising vicinal diols had worse geometric mean of lifted area and drape lift frequency results than compositions that did not. The examiner respectfully points out that this data is not commensurate in scope with the instant claims as the claims only exclude 1,2-diols but the data states that it underscores using plasticizers where the hydrogen bonding groups which are not necessarily diols are separated by more than 3 carbon atoms on the molecule where the instant claims only require a separation by greater than 3 atoms not 3 carbon atoms, and further the tested inferior example only contains the monoacyl glyceride and applicants have not demonstrated that other compositions with different combinations of hydrogen bonding groups being 3 or less atoms apart also lead to these inferior results and as discussed above Menon is not limited to compositions using monoacyl glycerides as is clearly discussed above and within the teachings of Menon because for instance Menon clearly claims other hydrophobic solvents which are not within the excluded group of the instant claims which can be used to solubilize CHG and used with the polyester polyol resins of Menon which together still render the instant claims obvious for the reasons discussed above.
The arguments over ‘759 are moot as applicants have amended the claim to exclude the siloxane polymers.
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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin E Hirt whose telephone number is (571)270-1077. The examiner can normally be reached 10:30-7:30 ET M-F.
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/ERIN E HIRT/Primary Examiner, Art Unit 1616
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