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 .
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 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.
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 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.
DETAILED ACTION
Claims 1, 6, and 8-20 are pending, claims 2-5 and 7 are canceled in this application. This application is a continuation of 17/844,845, filed on 06/21/2022, now abandoned, which is a continuation of 16/743,162, filed on 01/15/2020, now abandoned, which is a division of 15/563,020, filed on 09/29/2017, now abandoned, which is a national stage entry of PCT/US2016/024491, filled on 03/28/2016, which claims priority to provisional application 62/142,045, filed on 04/02/2015.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1, 6, 8-16, and 18-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Brode, II et al. (US 4,663,159) in view of Brode et al. (US 5,407,919).
Brode, II et al. teach a hydrophobic substituted cationic polysaccharide with a desirable combination of properties of enhanced solution viscosity, emulsification, foaming and surface pressure properties combined with the substantivity and desirable cosmetic properties for care cosmetic and non-cosmetic personal applications
including lotion (flowable thus the claimed liquid in the instant claims 1 and 18) or rinses as carriers for active agents in internal drugs (the claimed (b) in the instant claim 1) (column 15, line 67 through column 16, line 20) together in an aqueous solution with NaCl (the claimed liquid aqueous solution in the instant clams 1 and 18 and the claimed inorganic salt in the instant claim 16)) (column 13, line 20-23);
wherein the hydrophobic substituted cationic polysaccharide is
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with Q being -O-, Rsacch being the residue of a polysaccharide repeating unit, z being about 250-4,000 (the claimed structure II in the instant claim 1) (column 8, line 8-14), each R1, R2, and R3 (the claimed Ra, Rb, and Rc in the claimed structure II in the instant claim 1) being hydrogen or
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with R6 being
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(the claimed
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portion in the claimed structure III in the instant claim 1 and the claimed -Rd- being -CH2- in the instant claims 1 and 8) (column 7 line 29 through column 9, line 11); 2 of R9, R10, and R11 being methyl and 1 of R9, R10, and R11 being Rh of Cabout 12-18 alkyl (the instant claims 1 and 8) (column 9, line 19-44) and A being chloride (the instant claim 10) (column 8, line 28-30) and 2 of R1, R2, and R3 being -H and 1 of R1, R2, and R3
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(the instant claim 9) (column 10, line 26-36); and
the hydrophobic substituted cationic polysaccharide having viscosity of 23 cps (mPa.s) measured at 25 °C for a 2% hydrophobic substituted cationic polysaccharide in aqueous solution in table II run 26 (the instant claims 19 and 20) (column 13, line 13-19) and 0.096-0.113 of CS (cationic substitution) (the instant claims 11-13) (claim 2), and
exemplified a lotion comprising 1% by weight of hydrophobic substituted cationic polysaccharide in table IV (the instant claim 6), i.e., < about 25-500,000 cps viscosity.
The molecular weight (MW) of the polysaccharide is calculated to be 45,750-732,000 based on the 250-4000 repeating units (claim 2) and 183 g/mol saccharide repeating unit weight. The hydrophobic cationic substitution is calculated to be 2.62% of the MW of the polysaccharide: 0.1045%x14/351=2.62% based on the cationic substitution of 0.096-0.113 (claim 2) using the midpoint 0.1045 for calculation and 1 nitrogen (14 g/mol) in each of
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(351 g/mol) while CS is a percent nitrogen content (column 11, line 39-45). The MW of the hydrophobic substituted cationic polysaccharide is calculated to be about 46,948-751,178 (45,750 x 102.62% = 46,948 and 732,000 x 102.62% = 751,178).
Brode, II et al. teach selection and optimization of various hydrophobic and/or non-hydrophobic substitutions producing hydrophobe substituted cationic polysaccharides with a wide range of desired viscosity (column 13, line 7-19); thus, non-hydrophobic quaternary ammonium group is not taught by Brode, II et al. as must have substitution (the instant claim 1).
Brode, II et al. do not teach the same MW (about 46,948-751,178 vs the claimed ≥100,000 and 100,000-500,000 in the instant claims 14 and 15).
This deficiency is cures by the rationale that a prima facie case of obviousness typically exists when the ranges of MW lie inside/overlap with the range disclosed in the prior art, such as in the instant rejection.
The claimed range of MW is ≥100,000 and 100,000-500,000 and the range of MW taught in the prior art is about 46,948-751,178 and therefor, includes/overlaps with the claimed ranges.
Brode, II et al. do not teach the lotion being used for nasal application (instant claim 1).
This deficiency is cures by Brode et al. who teach a composition in form of lotion, etc., (column 4, line 42-55) with water as a diluent (column 5, line 1-2) as personal care or a nasal transmucosal system (abstract and column 1, line 57-61) (implies a step of applying to nasal mucosal) comprising active including nonoxynol-9 (column 5, line 68), buffered saline (column 5, line 34-49) (containing NaCl), and from about 0.5-10% by weight (column 5, line 18-23) of water soluble cationic hydrophobic modified cellulose including hydroxyethyl cellulose modified by
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with each R1 and R2 being CH3 or C2H5; R3 being CH2CH2; R4 being a C8-18 alkyl; and A1 being a halide ion (column 2, line 66 through column 3, line 27); wherein cationic substitution is about 0.1-0.25 (column 3, line 61-67) with the MW of the cationic hydrophobic modified cellulose being about 20,000-200,000 and a viscosity of about 10-500 cp (mPa.s) at 25 °C for a 2% solution (column 2, line 25-43).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Brode, II et al. and Brode et al. to specify the personal care lotion and/or interna drugs taught by Brode, II et al. being suitable for nasal application (implies a step of applying to nasal mucosal). A lotion comprising cationic hydrophobic modified cellulose being suitable for personal use also being suitable for nasal application was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Claims 1, 6, and 8-20 rejected under 35 U.S.C. 103(a) as being unpatentable over Brode, II et al. (US 4,663,159) in view of Brode et al. (US 5,407,919) and McCarty (US 2007/0071806 A1).
The teachings of Brode, II et al. and Brode et al. are discussed above and applied in the same manner.
Brode, II et al. do not specify adding a phosphate buffer in the instant claim 17.
This deficiency is cured by Brode et al. who teach the personal care or a nasal transmucosal system comprising cationic hydrophobic modified cellulose and buffered saline and McCarty who teaches transmucosal composition for antiviral actives to nasal or vaginal being buffered with phosphate buffer (abstract, paragraph 6-8).
It would have been prima facie obvious at the time of the invention to a person of ordinary skill in the art to combine the teachings in Brode, II et al., Brode et al., and McCarty to add buffer Brode et al. to the composition taught by Brode, II et al. and specify the buffer in the composition taught by Brode et al. being a phosphate buffer. Buffer being incorporated in personal care and internal drug lotion and a phosphate buffer being suitable in nasal composition were well known to a person of ordinary skill in the art at the time of the invention. The motivation for adding buffer Brode et al. to the composition taught by Brode, II et al. and specifying the buffer in the composition taught by Brode et al. being a phosphate buffer flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG YU/
Primary Examiner, Art Unit 1614