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 .
Election/Restrictions
Newly submitted claims 46-49 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the product as claimed can be used in the materially different process of using that product; the product can be used in product stability studies.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 46-49 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Status
Applicant’s claim amendments in the response filed 17 March 2026 are acknowledged.
Claims 27, 30 & 33-52 are pending.
Claims 1-26, 28, 29, 31 & 32 are cancelled.
Claims 46-49 are amended.
Claims 36-52 are withdrawn.
Claims 27, 30 & 33-35 are under consideration.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file. The effective filing date of the instant application is 11 June 2020.
Withdrawn Objections/Rejections
The rejection of claims 47 & 48 under 35 U.S.C. 112(d) is withdrawn due to Applicant’s amendments to recite the amount of water and Applicant’s amendments which shift the invention from a composition to a method of using a hand sanitizer.
The rejection of claims 46-49 under 35 U.S.C. 103 over Morley, Pabla, Murty [as evidenced by Hunt] and Bouarfa is withdrawn due to Applicant’s amendments which shift the invention from a composition to a method of using a hand sanitizer.
Maintained Rejections
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.
Claims 27, 30 & 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Morley (US 2011/0158920; Published: 06/30/2011; IDS-filed 12/09/2022; previously cited), Pabla (Published: 2007; previously cited), Murty [(US 6,503,532; Published: 01/07/2003; previously cited); as evidenced by Hunt (GB 2,409,976; Published: 07/20/2005)] and Bouarfa (JP 2017531617; Published: 10/26/2017; previously cited).
All references refer to the English language translation
With regard to claim 27, Morley teaches a bigel comprising an oleogel and aqueous gel (title; abstract). With regard to claim 27, Morley teaches the structure of an oleogel comprising a cellulose polymer to gel an oily agent (abstract). With regard to claims 27 & 30, more broadly, Morley teaches and claims caprylic/capric triglyceride in an amount of 10-30% by weight of the formulation and in the Table 2 & 3 examples teaches inclusion of Labrafac CC (i.e. a mixture of capric/caprylic triglycerides) in an amount of 20% & 21% of the bigel ([0029], [0191[; Morley’s-claim 43). With regard to claim 49, Morley teaches an embodiment in which the oily agent is comprises a mixture of capric/-caprylic triglycerides [0035]. With regard to claim 27, Morley teaches an “embodiment, ethylcellulose is present in a proportion of between about 0.01 and 5% by weight of the bigel produced, more preferably between about 0.05 and 1% by weight. In some embodiments, the amount of ethylcellulose is a low percentage of about 0.05-0.1%, while in other embodiments it can be higher, such as 0.1-0.5%, 0.5-1% or 1-5% by weight of the bigel produced” [0031]. With regard to claims 27 & 34, the cellulose polymer may also be non-sodium carboxymethylcellulose and mixtures of ethylcellulose and non-sodium carboxymethylcellulose (Morley-claim 2). With regard to claim 27, Morley teaches an embodiment in which “ethylcellulose is present in a proportion of between about 0.01 and 5% by weight of the bigel produced, more preferably between about 0.05 and 1% by weight. With regard to claim 27, Morley teaches the gelling agent may be carbomer and “is present in a proportion of between about 0.3 and about 5% by weight of the bigel, for example at about any of the following proportions: 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9%, 1.0%, 1.1%, 1.2%, 1:3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, by weight, or between 2.5-3%, 3-3.5%, 3.5-4%, 4-4.5% or between 4.5-5% by weight of the bigel produced” ([0053], [0054] & [0061]). With regard to claim 27, Morley in the Table 2 & 3 Examples teaches carbomer/Carbopol in an amount of 1.4% of the bigel [0191]. As such, with regard to claim 27, Morley teaches the ethylcellulose and carbomer gelling agents in a combined amount of 0.31-10% and in the Table 2 & 3 Examples teaches the ethylcellulose and carbomer/carbopol gelling agents in a combined amount of 5.4% [0191]. With regard to claim 27, Morley teaches the pH of the bigel varies with application and “suitable bigels have been formed with a pH of between 4.9 and 6, and for some applications, the ideal pH of the bigel is around pH 5” ([0097] & [0098]). With regard to claim 27, Morley teaches the pH adjusting agent may be triethanolamine and if triethanolamine is used, the gel can tolerate high alcohol concentrations [0101]. With regard to claim 27, Morley in the Table 2 & 3 examples teaches inclusion of 3.36% ethanol [0191]. Morley teaches inclusion of sorbic acid in the bigel as an antimicrobial preservation agent in an amount preferably “between about 0.01 to 0.5%, by weight of the final bigel composition, and may suitably be employed at levels of about 0.01 to 0.05%, 0.05 to 0.1%, 0.1 to 0.2%, 0.2 to 0.3%, 0.3 to 0.4% and 0.4 to 0.5% by weight” (i.e. disinfecting ingredient; [0101], [0103] & [0105]). With regard to claim 35, Morley teaches the viscosity of the bigel to be between 1,000-30,000 cP (1-30 Pas), and preferably between 20,000-30,000 cP (20-30 Pas; Morley-claim 25). Morley teaches adding at least one active pharmaceutical ingredient (API) which may be hormones, anti-itch agents (dermatological agents), antimicrobial agents, corticosteroids, anti-inflammatory agents ([0144]; Morley-claims 32-34). Morley in the Table 3 bigel teaches the API is testosterone in an amount of 1.0% [0191]. More broadly, Morley teaches “the bigel will comprise from about 0.01 to about 10%, more preferably from about 0.05% to about 5%, even more preferably 0.1% to about 5%, and most preferably 0.1% to about 2%, by weight of the active agent component” [0134]. Morley teaches the bigel may be used for a transdermal release system [0110].
Morley does not teach the amount of ethanol/alcohol and triethanolamine/pH adjusting agent or that the amount of water is between 5 and 20 wt.%
In the related field testosterone gel formulations, with regard to claim 27, Pabla teaches Androgel is the first-ever testosterone replacement gel to enter the US market and it comprises 67.0% ethanol and Carbopol 980 (i.e. carbomer). Pabla teaches Androgel is an open transdermal system (pg. 389). With regard to claim 27, Pabla examined testosterone T gels comprising 67 % ethanol (Absolute Alcohol) and admixtures isopropanol (IPA) and ethanol in a combined amount of 67% (pg. 390). “The release profiles also show a general trend of increasing drug release with increasing IPA concentration” (pg. 392). Pabla teaches Androgel has a problem with low bioavailability and increasing the bioavailability through use of penetration enhancers, which may be isopropyl alcohol, may be a solution (pg. 394). Pabla teaches IPA creates “a concentration gradient for the drug to permeate. Also, good cosolvent characteristics of IPA are added advantages as it does not affect the consistency and aesthetics of the formulation” (pg. 395). Pabla teaches their “results showed that all the gels were similar to Androgel “ (pg. 395). Pabla teaches ethanol is a solvent and a penetration enhancer (pg. 390, 394 & 395). Pabla teaches their invention is a hydroalcoholic gel formulation (pg. 395).
In the related field of invention, Murty teaches transdermal delivery system for THC comprising a gel (title; abstract). With regard to claim 27, the delivery system comprises carbopol, water, and triethanolamine (abstract). With regard to claim 27, Murty in the Gel Formulation #43 teaches the composition comprises 1.0 % Pemulen (i.e. carbomer; see evidentiary reference Hunt-pg. 4, ll. 20-30), 70.0% ethanol and 0.5% triethanolamine (col. 10). With regard to claim 27 & 33, more broadly, Murty teaches inclusion of triethanolamine in an amount “from greater than 0 to 5 wt% (Murty-claims 1 & 2).
With regard to claim 27, in the same field of invention of gel type compositions, Bouarfa teaches a composition which is embodied as a bigel (pg. 116; title). Bouarfa teaches the composition comprises an “aqueous phase (water, and optionally a water-miscible solvent) is 5% to 95% by weight” (pg. 104). Bouarfa teaches water comprises the aqueous phase (pg. 104).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (F) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the bigel suggested by Morley’s teachings by adjusting the amount of ethanol to be between 67-70% of the bigel, the amount of water to be 5% to 95%, and the amount of the triethanolamine to be greater than 0-5 wt.% as suggested by the combined teachings of Pabla, Bouarfa, and Murty because Morley, Pabla, Bouarfa and Murty are directed to gels comprising ethanol/alcohol, Carbopol/polyacrylic acid, and triethanolamine and known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to modify the penetration and bioavailability of testosterone through modification of the amount of ethanol and adjust the pH of the bigel through adjustment of the triethanolamine while controlling gel stiffness through use of 5-95% water. Use of the triethanolamine permits the gel to tolerate high alcohol concentrations at taught by Morley [0101].
With regard to claims 27, 33 & 35, as it pertains to the recited viscosity, pH range, and amounts of alcohol, water, oil composition/capric/caprylic triglycerides, gelling agent, pH adjusting/triethanolamine, carbomer, cellulose polymer/ethylcellulose, and disinfecting ingredient/active ingredient, the combined teachings of Morley, Bouarfa, Pabla and Murty teach these parameters with values that fall within the recited ranges. 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).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
In the traverse of the rejection of clams 27, 30 & 33-35 under 35 USC 103 over the Morley, Pabla and Murty evidenced by Hunt, Applicant supplies a chart stating the deficiencies of each reference, and argues features from each reference were selected were based using the claims as a roadmap, and compositional context of each feature taught by the references was discarded (reply, pg. 8-9).
This is not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, bigels to deliver testosterone were known and taught by Morley. Morley teaches the use of triethanolamine permits the gel to tolerate high alcohol concentrations [0101]. With regard to the amount of alcohol, Morley teaches inclusion of the poorly soluble compound, testosterone. Pabla teaches testosterone has poor bioavailability and use of ethanol in an amount of 69% in a gel composition to function as a solubilizer and penetration enhancer. In the related field of invention, Murty teaches use of 70% ethanol to solubilize another poorly soluble compound in gels comprising carbomer, triethanolamine and water. It is obvious to use a similar technique (i.e. solubilization of poorly soluble active agents with 70% ethanol) to improve similar devices (i.e. gels) in the same way. With regard to the amount of water, Bouarfa teaches a bigel having an “aqueous phase (water, and optionally a water-miscible solvent) is 5% to 95% by weight”. The ordinary skilled artisan would optimize within that amount of water in order to alter the amount of aqueous phase which impacts gel stiffness. With regard to the amount of oil, Morley teaches a bigel having an amount of oil that is close to Applicant’s recited upper limit (i.e. 7% versus 10%). 10% of an oil composition/triglycerides and 7.0% of an oil/composition/triglycerides are expected to have the qualities of an oily feel to the bigel and formulation of sparingly soluble pharmaceutical ingredients into a composition (Morley-[0003] & [0069]). In the instant case, A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).
Applicant argues the claimed subject matter is not reached by routine optimization. Applicant points to F6 and F7 to argue gels comprising at least 70 weight% ethanol and 7% Labrafac (i.e. triglycerides) did not form a gel (reply, pg. 9; specification-pg. 20). Applicant argues Formulation F8 contains triethanolamine in an amount of 0.5% but it is not homogenous but F9 which used triethanolamine in an amount of 0.056% (“only a very small amount”) yields homogenous hydroalcoholic gels with bi-gel properties (reply, pg. 9-10).
This is not persuasive. Comparison of F6 and F7 formulations to the recited claims show that it is an apples-to-oranges comparison. The F6 and F7 comprise hydrogen peroxide, lack triethanolamine (which provides high alcohol tolerance as taught by Morley), and F7 lacks Carbopol (a known gellant). Compositions F8 and F9 teach triethanolamine is critical to stable formulations (Specification-pg. 20). Morley teaches inclusion of this critical reagent in their bigels and even teaches its function is to provide high alcohol tolerance. With specific regard to the F9 formulation, Murty is in the same field of invention of gels with poorly soluble active agents and teaches inclusion of triethanolamine in an amount “from greater than 0 to 5 wt%”. The “from greater than 0” teaches inclusion of low levels of triethanolamine in gels with poorly soluble active agents. Applicant is just optimizing within amounts taught as suitable by the prior art.
Further, Applicant’s F9 composition is not commensurate with the scope of the claims. Formulation F9 comprises hydrogen peroxide; this reagent is not present in the instant claims. Formulation F9 comprises Labrafac WL 1349 (i.e. medium chain triglycerides); no mono- or di-glycerides are present. However, independent claim 27 is generic and recites the oil composition is selected from mono-, di- and triglycerides. Formulation F9 uses Emulfree P which is an admixture of propylene glycol laurate, ethylcellulose, and propylene glycol isostearate; however independent claim 27 is generic to the cellulose polymer and none of the claims recite inclusion of propylene glycol laurate and propylene glycol isostearate. Further, Formulation F9 is a species, using singular reagents in singular amounts. However, independent claim 27 recites ranges of amounts for the singular reagents and Applicant has not shown criticality over the entirety of these ranges. "[O]bjective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
Applicant argues the amendments to claims 47 and 48 support the hand sanitizer embodiments (reply, pg. 10).
This is not persuasive or germane to the outstanding rejections. Applicant has shifted inventions in claims 47 and 48 from a composition to a method of use. MPEP 819 states “The general policy of the Office is that applicants are not permitted to shift to claim another invention after an election is made and an Office action on the merits is made on the elected invention. Specifically, the applicant may not disaffirm or change their election, as a matter of right, after making an oral election and receiving an Office action based upon that oral election in a pending application. See 37 CFR 1.142(b). In addition, the applicant cannot, as a matter of right, file a request for continued examination (RCE) on claims that are independent and distinct from the claims previously claimed and examined (i.e., applicant cannot switch inventions by way of an RCE as a matter of right)“.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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