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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/30/2026 has been entered.
Status of Claims
Amendments filed on 06/05/2026 is acknowledged.
Claims 3-4, 6-7, 10, 15 and 19-20 remain cancelled. Claim 27 is now cancelled.
Claim 1 is amended.
Claims 1-2, 5, 8-9, 11-14, 16-18, 21-26 and 28 are pending and being examined on the merits herein.
Priority
This instant application, filed on 06/16/2022, is a 371 of PCT/GB2020/053256, filed on 12/17/2020, claiming foreign priority to GB1918617.0, filed on 12/17/2019.
Claim Interpretation
Claims are interpreted as following.
Claim 1, the components of the thixotropic agent is interpreted as “comprises a combination of: one or more alkali metal carboxyalkylcelluloses, and one or more other celluloses, wherein the one or more other celluloses is not cellulose ether or a cellulose ester”.
Phrases of “sprayable personal lubricant” (in claim 1 and all other claims), and “wherein the composition has an osmolality from 1000 mOsm/kg to less than 1,200 mOsm/kg and a viscosity of at least 800 mPa.s at a temperature of 25 C and a shear rate of 10 S-1; and wherein the sprayable personal lubricant composition is a non-Newtonian thixotropic fluid” (in claim 1, and similar phrases shown in claim 12) are interpreted as the property, “intended use”, or “process of making” of the composition, because they do not materially contribute to the subject matter of the composition.
Claims 13-14 and 16 are interpreted as “intended use” or “process of using” of the composition, because spray device or method of dispensing does not structurally contribute limitations to the composition.
Claims 21-22 and 24-26 are interpreted as property, “intended use”, “process of using”, or “process of making” of the composition, because viscosity and shear rate does not provide structural limitations to the composition.
Claim 28 is interpreted as “the thixotropic agent comprises from 5 wt% to 15 wt% of the one or more alkali metal carboxyalkylcelluloses and from 85 wt% to 95 wt% of the one or more other celluloses not as cellulose ether cellulose ester”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5, 8-9, 11, 13, 17-18, 21-26 and 28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “one or more celluloses, wherein the one or more celluloses is not a cellulose ether or a cellulose ester” and the claim also recites “one or more alkali metal carboxyalkylcelluloses” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by the narrower limitation, e.g., alkali metal carboxyalkylcelluloses, which belongs to the broad scope as “one or more celluloses” since it is a specific cellulose ether as a matter of fact, however, then there is a question and doubt how the broad limitation of “the one or more celluloses is not a cellulose ether or a cellulose ester” does not apply to alkali metal carboxyalkylcelluloses. If it is meant to be that “one or more alkali metal carboxyalkylcelluloses” are required in the composition along with other not-ether or ester celluloses, it is suggested to overcome the rejection by revising the claim language like “… a combination of: one or more alkali metal carboxyalkyl celluloses; and one or more other celluloses that is not a cellulose ether or a cellulose ester”.
Claim 12 recites “one or more celluloses, and one or more alkali metal carboxyalkylcelluloses”. Similar to the issue discussed above in claim 1, the broad scope of “the one or more celluloses” and the narrower scope of “the one or more alkali metal carboxyalkylcelluloses” render the claim indefinite. In order to overcome the rejection, it is recommended to rephrase as “one or more metal carboxyalkylcelluloses, and one or more other celluloses”.
Claim 28 recites “one or more celluloses and … one or more alkali metal carboxyalkylcelluloses”. Similar to the issue discussed above in claim 1, the broad scope of “the one or more celluloses” and the narrower scope of “the one or more alkali metal carboxyalkylcelluloses” render the claim indefinite. In order to overcome the rejection, it is recommended to rephrase as “…the one or more alkali metal carboxyalkylcelluloses and the one or more other celluloses”.
Claims 2, 5, 8-9, 11, 13, 17-18, and 21-22 are rejected accordingly because they are directly or indirectly depending on claim 1, and they do not further clarify the issues as addressed above in claim 1.
Claims 23-26 are rejected accordingly because they are directly or indirectly depending on claim 12, and they do not further clarify the issues as addressed above in claim 12.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 5, 8-9, 11-14, 16-18 and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Schaub (WO2006050951, 05/18/2006, in record of 08/26/2025), in view of Lichter et al. (WO2010011609, 01/28/2010, PTO-892) and Kottayil et al. (US20170296485, 10/19/2017, IDS of 06/16/2022).
Schaub throughout the refence teaches a lubricating formulation comprising humectant (e.g., [0015]) having thixotropic and/or shear-thinning properties (e.g., [0031] to facilitate human child birth (e.g., [0001]).
Regarding instant claims 1-2, 8, 12, 17-18, 21, and 23-25, Schaub teaches a lubricating formulation comprising (a) a polyacrylic acid, (b) a water-soluble thickener, (c) a humectant, and (d) optionally water [0015]. Schaub teaches that humectant of the composition is a humectant or a mixture of several humectants, preferred examples as pharmaceutically acceptable polyalcohols, such as propylene glycol, in particular 1,2-propylene glycol, glycerol (or glycerin) and/or polyethylene glycol, in particular liquid polyethylene glycol [0021], typically present in a weight proportion of 0.1-30%, preferably 10-30%, more preferably 15-25% and most preferably 18-22% based on the total weight of the composition [0022] (corresponding to humectant in instant claims 1-2, 8, 12, 17-18, and 23; overlapping with amounts of less than 25% in instant claim 1, or 5 to 15 % in instant claim 12, or up to 15% in instant claim 17, or from 2% to 15% in instant claim 18, or of 7% to 9% in instant claim 23).
Schaub indicates that the composition advantageously has thixotropic and/or shear-thinning properties, with the viscosity decreasing influence of increasing shear stress and/or shear rate (e.g., [0031]). Therefore Schaub teaches the lubricating composition is a non-Newtonian thixotropic fluid (corresponding to non-Newtonian thixotropic fluid in instant claims 1 and 12).
Schaub teaches water-soluble thickener used in the composition are preferred cellulose derivatives, in particular hydrophilically modified cellulose derivatives, such as hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, or/and hydroxypropylmethylcellulose [0020], typically present in proportion of 0.1-30%, preferably 1-10%, more preferably 2.5-7.5% and most preferably 4-6% based on the total weight of the composition [0020]. Although Schaub does not explicitly teach celluloses are thixotropic agents, MPEP 2112.01.II. states "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, celluloses in the composition are inherent as thixotropic agents, overlapping with thixotropic agent cellulose amount from 1% to 10% in instant claim 1, or 2 to 5% in instant claim 12, though they are ether or ester-celluloses.
Schaub emphasizes that the composition has a substantially isotonic osmolarity for example salts such as sodium chloride in a proportion by weight of typically 0.1-5%, preferably 0.3-0.6% based on the total weight of composition (Claim 12;[0026]), indicating the composition has the same osmolarity as body fluids, which would be typically around 300 mOsm/kg as known in the field, corresponding to osmolality in instant claim 1, overlapping with less than 1,200 mOsm/kg in instant claim 12. Schaub indicates the composition is gel or gel-like mixture and is transferred to a sterile filling machine to fill syringes and dispense the composition from syringes to target areas after heating for administration in human [0101-0103], implying it can be squeezed through a syringe (bottle or tube) with pumping pressure.
Schaub specifies that the viscosity of the composition is preferably in the range of 1-40 Pa.s (or 1,000 -40,000 mPa.s). The viscosity is preferably determined using a rotational viscometer, speed series N, level 4, sensor SV DIN, time 60 s, 20 revolutions at 20 °C. Alternatively, the viscosity can be determined using a Brookfield RVT viscometer at a spindle rotation speed of 0.05 to 100 revolutions per minute [0028] (overlapping with viscosity of at least 800 mPa.s in instant claims 1 and 24, or 800 to 1500 mPa.s in instant claims 21 and 25).
Regarding instant claims 11-12, Schaub indicates the pH of the composition is preferably adjusted to a range of 4-7 [0027] (overlapping with pH from 4.0-5.0 in instant claims 11 and 12).
Schaub does not teach the lubricant composition comprises one or more alkali metal carboxyalkylcelluloses, or other celluloses not being ether or ester in the composition as interpreted in instant claims 1 and 12. Schaub does not teach using microcrystalline cellulose and sodium carboxymethyl-cellulose as recited in instant claim 5. Schaub does not directly teach the composition is sprayable as recited in instant claims, and does not teach the composition osmolality is from 1000 mOsm/kg to less than 1200 mOsm/kg as recited in instant claim 1. Schaub fails to teach using the spraying method or spray apparatus as recited in instant claims 13-14 and 16. Schaub also does not teach ratios of glycerin and propylene glycol as recited in instant claims 9 and 12, or viscosity after spraying percentage compared to viscosity before spraying as recited in instant claims 22 and 26.
Lichter throughout the reference teaches sprayable compositions (e.g., nasal spray [00199]) for the treatment of otic diseases or conditions with antimicrobial agent compositions and formulations (e.g., Abstract).
Lichter teaches that the composition can comprise solubilizers such as polyethylene glycol, propylene glycol (e.g., [00114]), carrier materials including, e.g., binders, suspending agents, disintegration agents, filling agents, surfactants, solubilizers, stabilizers, lubricants, wetting agents, diluents, and the like, such as glycerine (e.g., [0095]), penetration enhancers such as glycerol, propanediol (e.g., [00406]), dispersing, suspending, and/or viscosity modulating agents can include polyethylene glycol, sodium carboxymethylcellulose (as a species of alkali metal carboxyalkyl-celluloses) (e.g., [0097]; [00346]), and specifies that microcrystalline cellulose and sodium carboxymethylcellulose as proper viscosity enhancing agents (e.g., [00337]). All these components correspond to ingredients in instant claims 1 and 12, and the claims depending on them. MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot 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, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."). For this instance, being humectant of glycerine, propylene glycol, propanediol, or polyethylene glycol is property of the compound, which has been taught by prior art, and the property would necessarily present in prior art. Similarly, microcrystalline cellulose and sodium carboxymethylcellulose being thixotropic agents are inherent properties taught by prior art.
Lichter teaches that the viscosity of the composition can be from about 100 to about 100,000 cP (1 cP= 1 mPa.s), about 100 cP to about 1,000 cP, and other ranges (e.g., [00338]) (overlapping with viscosity ranges in instant claims 1, 21 and 24-25). Lichter specifies that the practical osmolality of the composition is from about 100 mOsm/kg to about 1000 mOsm/kg (e.g., [00272]), with conventional interpretation of “about” as +/-10%, about 1000 mOsm/kg would result in range 900-1100 mOsm/kg, correspondingly overlapping with osmolality from 1000 mOsm/kg to less than 1200 mOsm/kg in instant claim 1.
Lichter exemplifies the water/propylene glycol/glycerin (same as glycerine) solvent system containing propylene glycol at 30 mg and glycerine 20 mg of per gram formulation in Example 6 ([00451]-[00455]), exhibiting a glycerine and propylene glycol weight ratio of 2:3 (overlapping with the ratio ranges in instant claims 9 and 12).
Kottayil teaches a sprayable composition that can comprise propylene glycol, polyethylene glycol, or in combination (e.g., [0050]; [0093]) (corresponding to humectants in instant claims), film forming polymers which can provide thixotropic behavior (corresponding to thixotropic agents in claims), such as, microcrystalline cellulose (not a cellulose ether or ester) and carboxymethylcellulose sodium (a species of alkali metal carboxyalkylcelluloses: sodium as alkali metal, alkyl as methyl) (e.g., [0077]; [0131]) (corresponding to instant claims 1, 5, and 12). Kottayil emphasizes that the topical spray of the composition sets as a microporous, breathable and bioadhesive microporous film (e.g., Claims 1, 12; [0010]) droplets (e.g., [0012]), and that the film does not interfere with perspiration, respiration and other metabolic activities of the skin, and the film is preferably non-greasy and non-sticky, preferably non-transferable(e.g., [0049]). Kottayil teaches the viscosity from about 10 to about 2,000,000 centipoise (mPa.s), preferably from about 0.3 to 1000 centipoise (mPa.s) (corresponding to viscosity at least 800 mPa.s in instant claim 1), and more preferably from about 0.5 to about 100 centipoise (mPa.s), at 37° C [0094].
Kottayil teaches that the composition can be stored in glass vials sealed tightly with a cap or spray pump [0128] and describes the composition has “shear-thinning” property [0080] that can be sprayed using a metered dose mechanical pump (e.g., [0148]. This directs to the sprayable composition dispensing apparatus in Kottayil can be a well-known squeeze-type spray bottle or a pump spray device known in the art, and the method of providing the personal lubrication of dispensing the composition by spraying onto a target area, which correspond to instant claims 13-14 and 16.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date to combine teachings of Lichter, Kottayil and Schaub to achieve the current invention, because all compositions share common categories of ingredients, e.g., humectant and thixotropic agents, and Schaub teaches that celluloses are suitable, while both Lichter and Kottayil teach specific celluloses in the sprayable composition with favorable properties, such as Lichter indicating multiple functions of the specific celluloses as suitable ingredients in the composition, e.g., functioning as dispersing or suspending agent in addition to viscosity adjusting agent, and Kottayil specifies that the resulted sprayable composition being breathable, non-sticky, and shear-thinning, an artisan would have the motivation swapping out the cellulose ether or ester from Schaub with Lichter or Kottayil’s specified other suitable celluloses with reasonable expectation of success for implementing the teaching from Lichter and Kottayil to make the Schaub application more convenient and feasible. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D). Moreover, It is prima facie obvious to select a known material, e.g., cellulose species or humectants, for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “[a] prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See 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). For this instance, all the amount ranges of humectant, osmolality, pH, viscosity ranges, weight ratio of glycerine and propylene glycol, overlap with those taught by prior art as presented above in detail. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
In light of claim interpretation as presented above, osmolality, viscosity and shear rate of the composition, and “sprayable personal lubricant”, are interpreted as property, or “intended use”, or “process of making”, or “process of using” of the composition. The agents in the compositions are the structural building blocks for the composition, and the properties, or intended use, or process of making, or process of using, would necessarily be capable of achieving the same intended use, or possess the same inherent property as the claimed composition. In this case, the combination of Schaub, Lichter and Kottayil teaches a composition with the same ingredients (i.e. chemical components) in the same concentrations as the instant claimed lubricant composition as discussed above. Regarding instant claims 22 and 26, as evidenced by the instant specification, when the composition is made up of the same chemical compounds with the same amount in same osmolality and viscosity range, the composition would be capable of performing the intended use as being sprayable, and would be capable of achieving the osmolality, viscosity and shear rate as claimed, such as, the composition having claimed viscosity after spraying as in instant claims 22 and 26. Especially Kottayil indicates that the desired viscosity for any given formulation or use may vary, for example, according to the preference of the physician, the manner of application and type of applicator used, the amount of formulation needed, the area to which the formulation is to be applied, and similar considerations [0094]. Therefore, it would be obvious for artisans in the field to optimize the viscosity of the composition to achieve the claimed properties because it is a routine experimentation to optimize and achieve the desired viscosity. Further, if viscosity, osmolality, and shear rate are interpreted as “process of making”, MPEP 2113. I. states "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claims 28 is rejected under 35 U.S.C. 103 as being unpatentable over Schaub (WO2006050951, 05/18/2006, in record of 08/26/2025), in view of Lichter et al. (WO2010011609, 01/28/2010, PTO-892) and Kottayil et al. (US20170296485, 10/19/2017, IDS of 06/16/2022), as applied to claims 1-2, 5, 8-9, 11-14, 16-18 and 21-26 above, further evidenced by IMCD (Avicel RC591, 03/04/2026, in record of 03/09/2026).
Schaub, Lichter and Kottayil combined teaching teaches a composition that can comprise less than 25% humectants, e.g., glycerine, propylene glycol, polyethylene glycol, or in combination thereof, and thixotropic agent such as microcrystalline cellulose (not cellulose ether or ester), and sodium carboxymethylcellulose, which can present preferably 1-10% in the composition, and the composition can be in desirable forms, e.g., lubricant and/or sprayable, with desirable osmolality, viscosity and shear rate, as discussed above in great detail and incorporated herein.
Regarding instant claim 28, Kottayil teaches using Avicel RC591 (microcrystalline cellulose and carboxymethylcellulose sodium) in the formulation (e.g., [0131]), forming a gel like consistency and producing a larger droplet size upon spraying with a mechanical pump [0133].
The combination of Schaub, Lichter and Kottayil does not explicitly teach the thixotropic agent comprising from 5 wt% to 15 wt% of the one or more alkali metal carboxyalkylcelluloses and from 85 wt% to 95 wt% of the one or more other celluloses which are not cellulose ether or ester as interpreted instant claim 28.
As evidenced by IMCD, Avicel RC591 is a modified microcrystalline cellulose (corresponding to the cellulose not as cellulose ether or ester) product comprising 82-89% microcrystalline and 11-18% sodium carboxymethylcellulose (corresponding to alkali metal carboxyalkylcellulose) based on dry weight of Avicel RC591 composition, overlapping with the claimed ranges of 85 wt% to 95 wt% of the one or more celluloses (not as ether or ester as in claim 1), and from 5 wt% to 15 wt% of the one or more alkali metal carboxyalkylcellulose in instant claim 28. MPEP 2112.01.II. states "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). The cellulose and alkali metal carboxyalkylcellulose species taught by Kottayil would be thixotropic agents as instantly claimed, because being thixotropic in inherent property of the compounds.
It would have been prima facie obvious for a person with ordinary skills to incorporate the specific thixotropic agent having the relevant weight ranges taught by Kottayil as evidenced by IMCD into the composition taught by Schaub, Lichter and Kottayil to arrive at current invention. Because Schaub, Lichter and Kottayil combined teaching teaches celluloses are suitable, while Kottayil teaches the agent at specific percentage combination of the two cellulose species in the sprayable composition with favorable properties, e.g., breathable, non-sticky, and shear-thinning, with gel-like consistency and producing large droplet size, it would have motivated an artisan in the field to experiment and would have provided reasonable expectation of success to make the application more convenient and feasible. It is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (MPEP §2144.07). See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
No claim is allowed.
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/DX.Z./Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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