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 1-9 are cancelled.
Claims 10-19 are newly added and are currently under consideration.
Withdrawn Rejections
The rejections directed to all of the previously pending claims (claims 1-9) are withdrawn in view of Applicant’s cancellation of said claims.
New Grounds of Rejection
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.
Claim(s) 10-19 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Effing et al (US 2008/0152698) and Varges et al (Fluids)(IDS Reference) as evidenced by both Lubrizol (Carbopol® 980 NF polymer) and Liu et al (CN109054778).
Effing teaches a hydrogel composition comprising polyacrylate (specifically Carbopol 980®) at 70g, glycerin at 2000g, the polyol hydroxyethyl cellulose at 300g, the pH adjuster sodium hydroxide at 750g, and Ringer’s Solution which comprises water (see entire document, for instance, [0056], hydrogel 1). It is noted that Carbopol® 980 NF has a carboxylic acid content of 56.0-68.0 (see as evidence Lubrizol, Carbopol® 980 NF polymer). It is noted that the ratio of Carbopol® to glycerin is 3.5:100. Effing further teaches that the hydrogel can comprise a polyol that is selected from the group including glycerin, wherein said glycerin is present in an amount of 5-30% (see entire document, for instance, [0043] and [0044]). Effing exemplifies the presence of the polyol hydroxyethyl cellulose (see entire document, for instance, [0056], and Liu, claim 1, as evidence that hydroxyethyl cellulose is a polyol). Effing further teaches that the glycerin component could be glycerin or polyethylene glycol or their compounds (see entire document, for instance, [0043]).
Effing, while teaching the instantly claimed components, and while teaching 5-30% of the component that can be glycerin, only exemplifies the glycerin at 20%.
Varges teaches hydrogels comprising glycerol and water, wherein when they are used as the continuous phase, the glycerol is present as 60% and the water is present at 40% (see entire document, for instance, page 3, first paragraph under section 2.2). Vargas further teaches that Carbopol® 980 NF is a synthetic homopolymer, polyacrylic acid crosslinked with allyl sucrose or allyl pentaerythritol (see entire document, for instance, page 1, last paragraph).
With regard to the ratio of the glycerin to water, it is noted that Varges motivates one of ordinary skill in the art to optimize the amount of glycerin and water. One would have been motivated to do so since Varges teaches the use of up to 60% glycerin. There would be a reasonable expectation of success since optimizing the water excipients in a composition is well within the skill of one of ordinary skill in the art. It is noted that MPEP 2144.05 states: "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).”
With regard to the composition comprising polyethylene glycol, it is noted that while Effing exemplifies glycerin, the glycerin component is taught as being able to be glycerin, polyethylene glycol, or their compounds. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize both glycerin and polyethylene glycol. It is noted that MPEP 2144.06 states: ““It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
It is noted that with regard to the method of making the composition, Applicant has not established the essential nature of the composition that is affected by the suspension of the homopolymer in water and glycerin. As such, since method of the instant claims and the method of the prior art both result in hydrogel composition, it is deemed that any additional components that may or may not be present do not affect the essential nature of the method. Further, it is noted that with regard to the product, that the mass of the hydrogel in comparison with the amount of water is dependent on the level of hydration. When fully hydrated, the water or solvent comprises a larger percentage, wherein when dehydrated, the amount of the hydrogel is greater. In the course of use, the product achieves different amounts of hydration. It is further noted that the composition is being deemed capable of nasal administration.
Response to Arguments
It is noted that none of the previous grounds of rejection have been maintained in light of Applicant’s cancellation of all the pending claims and the newly added claims. Therefore, Applicant’s arguments directed to grounds of rejection no longer pending are deemed moot.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
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