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 .
Claims 1-2, 5-7,9-10, 12-14, and 17-26 are pending.
Claims 2,5, 7,17,20-21 and 25 are withdrawn.
Claims 1, 6, 10, 12-14, 18-19, 22-24, and 26 are under current examination.
Applicants' arguments filed on 04/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
New Rejections necessitated by amendments
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 10, 12-14, 18-19, 22-24, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Lacoutiere (USPgPub 2005/0089541A1) in view of Magallon et al. (WO2007/130982), Ramakanth et al. (Novel Two component gels of cetylpyridinium chloride and the bola-amphibile 6-amino caproic acid: phase evolution and mechanism of gel formation), Dieter et al. (WO2019/036770-filed 8/2018), Menon et al. (WO2014/035981), Edmiston (Reducing the risk of Surgical Site Infections: Does Chlorhexidine Gluconate Provide a Risk Reduction Benefit?) and as evidenced by Schreiber et al. (USPgPub 2005/0124705)
The instant claims are being examined to the extent of the species elections in which the lipophilic component is: emollient oil of isopropyl myristate and lipophilic surfactant of glyceryl monocaprylate (also known as monocaprylin or glyceryl caprylate); chlorhexidine gluconate as the amphiphilic component; water as the hydrophilic component and FD&C yellow # 5 dye as the fluorescent material.
Lacoutiere teaches pH stable topical o/w compositions comprising water, chlorhexidine salt (a chlorhexidine compound) in an amount from 0.05-3% by weight and an emulsifier having an HLB anywhere from 9-18, see claim 1 and paragraph [0015]. The composition can comprise the emulsifier from 0.05-30% by weight, see claim 9. The oily phase can further comprise isopropyl myristate (emollient oil), see paragraph [0034]. The chlorhexidine compound includes chlorhexidine gluconate, see paragraph [0031]. Adjuvants including dyes can further be present in an amount anywhere from 0.01-20% by weight, see paragraph [0066]. The composition can be free of lower monohydric solvents given these are optional, and furthermore they can be present in the alternative to polyhydric alcohols, see paragraphs [0112] and [0051]. The particle size of the droplets can comprise from 70-350nm which overlaps and renders obvious the claimed particle size range of from about 5-400nm at room temperature, and can comprise microemulsions, see paragraphs [0030] and [00120]. The aqueous phase comprises 50-98% by weight and comprises water, see claim 6 and paragraphs [0051]-[0052]. The surfactant of Lacoutiere comprises lipophilic properties and can comprise an HLB anywhere from 9-18, see paragraph [0012] and [0056]. Lacoutiere teaches that the emulsion can comprise one emulsifying surfactant with the co-emulsifier only being an optional component, see paragraph [0055] and [0112]. Therefore, the emulsifier surfactant can consist of only one emulsifier and thus makes up 100 wt.% of the emulsifying surfactant. In one embodiment the lipophilic oily phase is present from 2-50% by weight, see paragraph [0052]. Given the oily phase can comprise one oil which is inclusive of isopropyl myristate in an amount of 2-50% by weight (paragraphs [0034] and [0052]) and that the emulsifier surfactant can be in an amount from 0.05-30% by weight then Lacoutiere suggests embodiments where the emollient oil (i.e. isopropyl myristate) can be equal to or greater than the surfactant. Lacoutiere teaches that the amount of chlorhexidine is sufficient to produce the desired stability, see paragraph [0032].
Lacoutiere not expressly teach that the dye comprises a fluorescent material including FD&C yellow no. 5 dye (the elected fluorescent material).
However, Magallon et al. teach aqueous compositions which comprise chlorhexidine gluconate and anionic dye sufficient to stain a patient’s skin, see abstract and page 2, lines 5-8. The formulation is stabilized by a cationic excipient compound including cetylpyridinium chloride which is the alternative to benzalkonium chloride see page 7, lines 5-6. Magallon et al. teach no alcohol because alcohol based compositions pose flammable properties, see page 2, lines 14-16. Magallon teaches that aqueous compositions with chlorhexidine and dye are stable with no precipitant, see page 3, lines 17-20. Examples of anionic dyes which are added to chlorhexidine are FD&C dyes such as yellow No. 5, see page 5, line 30 and page 6, line 25-28 and example 2. Ramakanth et al. teach that an amphiphilic compound includes cetylpyridinium chloride, see page 4. Thus, the cetylpyridinium chloride of Magallon is considered an amphiphilic component of which instant claim 1 comprises. Magallon et al. teach that the solutions are stable at room temperate for three months and are stable for at least three months.
It would have been prima facie obvious to provide the antimicrobial composition of Lacoutiere with FD&C yellow no. 5 dye.
A person of ordinary skill in the art would have been motivated to do so in order to visualize where the stain has been applied to a patient’s skin for treating skin surfaces. There would have been a reasonable expectation of success because Lacoutiere taches chlorhexidine gluconate and Magallon et al. teach that chlorhexidine gluconate can be mixed with anionic dyes including FD&C no. 5 to help visualize the application of chlorhexidine compositions, and Lacoutiere teaches that their compositions further contains a dye.
The modified Lacoutiere does not expressly teach that the lipophilic surfactant emulsifier is all of glyceryl monocaprylate (aka monocaprylin) thereby providing an HLB of less than 10.
Dieter et al. teach that glyceryl monocaprylate (also known as Imwitor 988) potentiates the activity of antimicrobial agents, see abstract. The glycerolipid which is Imwitor 988 acts synergistically with antiseptics, see paragraph [0135]. Dieter teaches that the antiseptic is chlorhexidine, see paragraph [0022], [0041], and claims 69-60 and 93. The glycerolipid Imwitor 988 is taught in Dieter to be glycerol monocaprylate, see paragraph [0277]. The composition is formulated for topical use including o/w emulsions, see paragraphs [0143]-[0145].
Menon et al. teach that surprisingly it was discovered that chlorhexidine gluconate can be solubilized in hydrophobic vehicles having an HLB of less than 10, see paragraph [0010]. Examples of the hydrophobic vehicle include glyceryl monocaprylate, see claims 1 and 6.The HLB of glyceryl monocaprylate emulsifier is about 8 which is less than 10 (see table 4). A combination with glyceryl monocaprylate and chlorhexidine gluconate results in high antimicrobial log reduction, see paragraph [0051]. As evidenced by Schreiber, glyceryl monocaprylate is an emulsifier, see claim 16.
It would have been prima facie obvious to substitute the nonionic emulsifier surfactant of Lacoutiere for glyceryl monocaprylate as the emulsifier wherein the emulsifier surfactant has an HLB of less than 10.
One of ordinary skill in the art would have been motivated do so because glyceryl monocaprylate is an emulsifier, and is taught by Dieter glyceryl monocaprylate provides synergistic properties with antimicrobial compounds including chlorhexidine. Furthermore, per the teachings of Menon, glyceryl monocaprylate acts as an excellent solubilizer for chlorhexidine gluconate and provides an HLB of less than 10.
There would have been a reasonable expectation of success because the antimicrobial composition of Lacoutiere contains chlorhexidine salts with emulsifier surfactant, and Dieter teaches that antimicrobials are advantageously combined with glyceryl monocaprylate for synergistic antimicrobial properties. Given that glyceryl monocaprylate comprises an HLB of about 8 as suggested by Menon, the substitution would necessarily provide the surfactant as having an HLB of less than 10 as a composition and its properties are inseparable.
With regards to the claim limitation that the composition has no closed cup flash point at temperatures of 70 degrees Fahrenheit to 200 degrees Fahrenheit as measured according to ATM D-3279-96-e-1, and provides at least 1.5 log microbial reduction on mammalian skin following ten minutes contact as measured by ASTM E1874-09, as the composition of the modified Lacoutiere are stable, provides antimicrobial activity, and do not require volatile materials, and the composition of the modified Lacoutiere renders obvious the instantly claimed composition having a lipophilic surfactant system comprising glyceryl caprylate, an amphiphilic component comprising chlorhexidine gluconate, water as a hydrophilic component and FD&C yellow no. 5 dye, the composition would necessarily provide the properties of no closed cup flash point and the 1.5 log microbial reduction on mammalian skin following 10 minutes contact, absent evidence to the contrary. Furthermore, Edmiston et al. teaches that chlorhexidine gluconate at 0.05% provides a greater than 5-log reduction against microbial pathogens after a one-minute exposure time, see abstract. Therefore, it would have been obvious that the composition of the modified Lacoutiere which contains chlorhexidine gluconate in amounts inclusive of 0.05% would necessarily provide for at least 1.5 log microbial reduction after ten minutes of contact absent evidence to the contrary as a composition and its properties are inseparable.
With regards to the amount of FD&C Yellow no. 5, water, lipophilic component, glyceryl monocaprylate, isopropyl myristate (emollient oil) and chlorhexidine gluconate, the modified Lacoutiere teaches overlapping ranges MPEP 2144.05 discloses “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).”
With regards to the stability of the composition, since the composition of the modified Lacoutiere arrives at a topical antimicrobial composition comprising emollient, glyceryl monocaprylate, water, fluorescent dye in the form of a microemulsion with overlapping droplet sizes and is free of monohydric alcohols, the storage stability would be the natural result of the combination of prior art elements. Furthermore, the composition of Magallon is stable for at least 3 months with overlaps a range of 6 since at least 3 is inclusive of longer than three months.
Furthermore, the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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.
Claim(s) 1, 6 10, 12-14, 18-19 and 22-24 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 15-16 and 19-23 of copending Application No. 17298060 in view of Magallon et al. (WO2007/130982) and Ramakanth et al. (Novel Two component gels of cetylpyridinium chloride and the bola-amphibile 6-amino caproic acid: phase evolution and mechanism of gel formation.
Claim(s) 1, 6,9-10, 12-14, 18-19 and 22-24 and 26 are directed to an invention not patentably distinct from claim 15-16 and 19-23 of commonly assigned of copending Application No. 17298060. Specifically, both the instant claims and that of copending Application ‘060 claim topical antimicrobial compositions comprising: emollient oil, a surfactant system with an HLB value of less than about 10, the surfactant system containing acylglycerols, wherein caprylic acid is present in the acylglycerols an amount of at least 80% by weight, an amphiphilic component including a chlorhexidine or polyhexamethylene biguanide, water, wherein the composition has less than 10% of lower monohydric alcohols, wherein the composition is a microemulsion having droplets with a particle size of 5nm to 400nm. Both Applications can comprise isopropyl myristate and glycerol monocaprylate.
The difference between the instant claims and that of Application ‘060 is that the instant claims further fluorescent dye (in particular, the elected species of: FD&C yellow No. 5)
However, Magallon et al. teach aqueous compositions which comprise chlorhexidine gluconate and anionic dye sufficient to stain a patient’s skin, see abstract and page 2, lines 5-8. . The formulation is stabilized by compounds including cetylpyridinium chloride, see page 7, lines 5-6. Magallon et al. teach no alcohol because alcohol based compositions pose flammable properties, see page 2, lines 14-16. Magallon teaches that aqueous compositions with chlorhexidine and dye are stable with no precipitant, see page 3, lines 17-20. Examples of anionic dyes which are added to chlorhexidine are FD&C dyes such as yellow No. 5, see page 5, line 30 and page 6, line 25-28 and example 2. Ramakanth et al. teach that an amphiphilic compound includes cetylpyridinium chloride, see page 4. Thus, the cetylpyridinium chloride of Magallon is considered an amphiphilic component of which instant claim 1 comprises.
It would have been prima facie obvious to provide the antimicrobial composition of Application ‘060 with FD&C yellow no. 5 dye.
A person of ordinary skill in the art would have been motivated to do so in order to visualize where the stain has been applied to a patient’s skin for treating skin surfaces. There would have been a reasonable expectation of success because both the instant claims and that of Application ‘060 taches chlorhexidine compounds and Magallon teaches that chlorhexidine gluconate can be mixed with anionic dyes including FD&C no. 5 to help visualize the application of chlorhexidine compositions.
This is a provisional nonstatutory double patenting rejection.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned Application 17298060 discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
With regards to the stability of the composition, since the composition of the 982 Application in view of Magallon arrives at a topical antimicrobial composition comprising emollient, glyceryl monocaprylate, water, fluorescent dye in the form of a microemulsion with overlapping droplet sizes and is free of monohydric alcohols, the storage stability would be the natural result of the combination of prior art elements. Furthermore, the composition of Magallon is stable for at least 3 months with overlaps a range of 6 since at least 3 is inclusive of longer than three months
Response to Remarks
Applicants argue that the Double Patenting rejection be held in abeyance. Applicants point to MPEP 804.I.B.1 for procedure.
Examiner respectfully submits that from MPEP 804:
i) Application under examination has the same patent term filing date
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome. Provisional nonstatutory double patenting rejections are subject to the requirements of 37 CFR 1.111(b). Thus, applicant can overcome a provisional nonstatutory double patenting rejection by filing a reply that either shows that the claims subject to the rejection are patentably distinct from the claims of the reference application, or includes a compliant terminal disclaimer under 37 CFR 1.321 that obviates the rejection. If the reply is sufficient, the examiner will withdraw the nonstatutory double patenting rejection in the application in which it was submitted
As both Applicants have the same filing date, the rejection is maintained.
Regarding holding a rejection abeyance, Examiner respectfully submits that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejections of record have been maintained as no action regarding these rejections has been taken by applicants at this time.
Applicants argue that Magallon explicitly teaches aqueous compositions which are only precipitant free if they include the cationic excipient of benzalkonium chloride which claim 1 excludes. Applicants argue that the cationic surfactant only extends the stability to about 72 hours.
Examiner respectfully submits that the instant claims do not limit the amphiphilic component and Magallon teaches in the alternative to benzalkonium chloride, a cationic excipient such as cetylpyridinium chloride can be used. Thus, the reference is not limited to the use of benzalkonium chloride as the cationic excipient. Furthermore, Magallon teaches that the solutions are stored for three months at room temperature and that the they are stable for at least three months using a concentration of 0.05% w/v cationic excipient, see page 13, lines 5-12 at example 7.
With regards to the stability of the composition, since the composition of the modified Lacoutiere arrives at a topical antimicrobial composition comprising emollient, glyceryl monocaprylate, water, fluorescent dye in the form of a microemulsion with overlapping droplet sizes and is free of monohydric alcohols, the storage stability would be the natural result of the combination of prior art elements. Furthermore, the composition of Magallon is stable for at least 3 months with overlaps a range of 6 since at least 3 is inclusive of longer than three months.
Furthermore, the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Conclusion
Currently, no claims are allowed and all claims rejected.
The amendment to the claims necessitated new grounds of rejections. 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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