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 .
Status of Claims
Applicants’ Amendments and Remarks, filed on 08/08/2025 is acknowledged.
Claims 1, 13, and 16 are amended.
Claims 3-4, 6-7, 10, and 15 remain cancelled; Claims 19-20 are now cancelled.
Claims 27-28 are new.
Claims 1-2, 5, 8-9, 11-14, 16-18, and 21-28 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.
Withdrawn Objections/Rejections
All previous claim Objection(s) / Rejection(s) as set forth in the previous Office action (mailed 08/26/2025) that are not repeated and/or maintained in the instant Office action are withdrawn, in light of applicant’s amendment and remark filed on 11/26/2025.
Claim Interpretation
Claims are interpreted as following.
Claim 1 is interpreted as following:
A composition comprising:
a humectant present in an amount of less than 25% by weight of the composition, wherein the humectant is selected from the group consisting of glycerine, propylene glycol, 1,3-propanediol, polyethylene glycol, and combinations of two or more thereof;
a thixotropic agent present in an amount of from 1% to 10% by weight of the composition, wherein the thixotropic agent comprises a combination of: one or more celluloses, wherein the one or more celluloses is not a cellulose ether or a cellulose ester; and one or more alkali metal carboxyalkylcellulose.
Phrases of “sprayable personal lubricant” (in claim 1 and all other claims), and “wherein the composition has an osmolality of 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 or “intended use” or “process of making” of the composition, because they do not contribute structural limitations to the composition.
Claims 13-16 are interpreted as “intended use” or “process of using” of the composition, because spray device or method of dispensing do not structurally contribute limitations to the composition.
Claims 21-22 and 24-26 are interpreted as property or “intended use” or “process of using” or “process of making” of the composition, because viscosity and shear rate does not provide structural limitations to the composition.
Claim 27 is interpreted as property or “process of making” of the composition, because osmolality does not provide structural limitations to the composition.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter Rejection
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 27 has been added as part of an amendment filed on 11/26/2025. However, the instant specification does not provide support for the claimed osmolality range “1000 mOsm/kg-1200 mOsm/kg” recited in Claim 27. The instant specification and claims as originally filed only recite “less than 1200 mOsm/kg”, while the new range includes 1200 mOsm/kg.
If Applicant believes this rejection is in error, applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, Claim 27 represents new matter.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 27 recites “1000 mOsm/kg-1200 mOsm/kg”, while claim 1, which claim 27 depends upon, recites “less than 1200 mOsm/kg”, which excludes 1200 mOsm/kg. Therefore, claim 27 extends the high end amount range and fails to further limit the subject matter of the claim 1 which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 21-27 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 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 less than 1,200 mOsm/kg in instant claims 1 and 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 neither one or more alkali metal carboxyalkylcelluloses nor not-ether or ester celluloses in the composition as recited in instant claims 1 and 12, or 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 1 and 12, and 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, viscosity after spraying percentage compared to viscosity before spraying as recited in instant claims 22 and 26, osmolality from 1000 mOsm/kg to 1200 mOsm/kg in instant claim 27.
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 carboxyalkylcellulose: 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 Kottayil and Schaub to achieve the current invention, because both compositions share common categories of ingredients, e.g., humectant and thixotropic agents, and Schaub teaches that celluloses are suitable, while Kottayil teaches specific celluloses in the sprayable composition with favorable properties, e.g., breathable, non-sticky, and shear-thinning, swapping out the cellulose ether or ester from Schaub with Kottayil’s specified celluloses is easy to experiment, an artisan in the field would have reasonable expectation of success for implementing the teaching from 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 in instant claims 1, 11-12, 17-21, 23-25 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).
Regarding glycerin and propylene glycol ingredients and amount in instant claims 9 and 12, since both Schaub and Kottayil teaches that glycerin, propylene glycol, polyethylene glycol, or in combination are suitable for the composition, it would have been prima facie obvious to adjust the weight amount of ingredients to reach optimal ratio of glycerin and propylene glycol when these two are chosen as the optional ingredients, or to choose and combine any other suitable humectants and adjust their ratios in the composition based upon the total amount taught by prior art. It would have been prima facie obvious for one of ordinary skill in the art to optimize the numbers through nothing more than “routine experimentation” (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382.
Regarding instant claims 22 and 26-27, 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 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. Thus, as evidenced by the instant specification, when the composition is made up of the same chemical compounds with the same amount, it would necessarily have the same osmolality, and 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; or the osmolality from 1000 mOsm/kg to 1200 mOsm/kg in instant claim 27. 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 1-2, 5, 8-9, 11-14, 16-18 and 21-28 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 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 21-27 above, further evidenced by IMCD (Avicel RC591, 03/04/2026, PTO-892).
Schaub and Kottayil 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 celluloses, e.g., hydroxyethylcellulose, hydroxypropylcellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, microcrystalline cellulose, carboxymethylcellulose sodium, 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 and Kottayil does not explicitly teach the thixotropic agent comprising from 85 wt% to 95 wt% of the one or more celluloses and from 5 wt% to 15 wt% of the one or more alkali metal carboxyalkylcellulose as recited in instant claim 28.
As evidenced by IMCD, Avicel RC591 is a modified microcrystalline cellulose (corresponding to the cellulose not as an 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 into Schaub to arrive at current invention. Because both Schaub and Kottayil 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 Schaub 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).
Response to Arguments
Applicant’s remarks/arguments filed on 11/26/2025 have been fully considered, but the arguments regarding art rejections are not persuasive.
Applicant asserts that a person skilled in the art would not combine the teaching of Schaub and Kottayil because Kottayil does not teach the product as a lubricant with osmolality.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Schaub and Kottayil both teach personal compositions comprising humectants and thixotropic agents. In addition, the instant application is a composition invention, as interpreted in claim interpretation presented above in this office action, the phrases of “sprayable personal lubricant” (in claim 1 and all other claims), and “wherein the composition has an osmolality of 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 or “intended use” or “process of making” of the composition, because they do not contribute structural limitations to 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 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. Thus, as evidenced by the instant specification, when the composition is made up of the same chemical compounds with the same amount, it would necessarily have the same osmolality, and would be capable of performing the intended use as being sprayable.
Moreover, properties can be latent if they are not recognized by prior art, that is said, Kottayil composition still may present or be capable of achieving the right osmolality or being lubricant. MPEP 2145 II. states that “prima facie obviousness is not rebutted by merely recognizing additional advantages or latent properties present but not recognized in the prior art”, see In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Appellant argued that the presence of DEHP as the plasticizer in a blood collection bag unexpectedly suppressed hemolysis and therefore rebutted any prima facie showing of obviousness. However, the closest prior art utilizing a DEHP plasticized blood collection bag inherently achieved same result, although this fact was unknown in the prior art.).
Applicant asserts that cited art does not teach limitations in new claims 27-28.
In response, these two additional new claims are examined thoroughly as presented above. As claim interpretation shows that osmolality of the composition is interpreted as property, or intended use, or process of making, or process of using, which would necessarily be capable of achieving, or inherently present as long as the agents are present in the composition which are taught by prior art, in this case, Schaub and Kottayil teaches the composition. Claim 28 is rejected with new evidence as presented above in office action.
In summary, prior art teaches the current invention. Please refer to the entire office action as presented above as the complete response to remarks/arguments.
Conclusion
No claim is 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 DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616