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 .
Receipt is acknowledged of Applicant’s Amendment filed on 04/17/2026.
Claims 1 and 26 have been amended.
Claims 1, 4-5, 8-14, 23, 26, 30-31 are pending in the instant application.
Claims 5, 8, 10-11 are withdrawn from further consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112, 1st paragraph
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.
Claims 1, 4-5, 8-9, 12-14, 23, 26, 30-31 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.
Independent claim 1 recites “and the like” does not meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus of “the like” encompassed by the claim, since there is no description of the structural relationship of these “the like” provided in the specification and Applicant has not provided a description as to how the base molecule may be changed while remaining the like. Dependent claims are also rejected as they fail to rectify the issues present in claim 1.
The Examiner suggests deleting “and the like”.
Rejections - 35 USC § 112, 2nd paragraph
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.
Claim 1 is 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.
Regarding claim 1, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
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.
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) 1, 4, 9, 12-14, 23, 26, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over DUFFIELD et al (US 2011/0053866).
Applicant’s independent claim 1 is directed to a composition comprising of: an active substance; about 10-35% of a thermos-responsive and 5-25% of ion-sensitive polymer, such as gellan gum; a lipophilic compound; about 2-20% of poly(ethylene oxide) polymer; about 0.5-5% of polyvinyl alcohol.
Regarding claim 1, DUFFIELD teaches a tablet composition comprised of:
Tetrabenazine (see [0578] at Example 8), which reads on an active substance;
20% of Pluronic F127 (see [0578] at Example 8), which is also known as poloxamer 407 and reads on about 10-35% of a thermos-responsive; and gellan gum (see [0246]), which reads on ion-sensitive polymer, wherein gellan gum is a polysaccharide gum used in the matrix to provide release rate of the drug (see [0248]);
Magnesium stearate (see [0578] at Example 8), which reads on a lipophilic compound (see Applicant’s specification at [0151]);
10% Polyethylene oxide (see [0578] at Example 8), which reads on about 2-20% of poly(ethylene oxide) polymer;
0.44% of polyvinyl alcohol (see [0578] at Example 8), which reads on about 0.5-5% of polyvinyl alcohol.
DUFFIELD further teaches formulating drugs as controlled-release formulations can sometimes reduce the side effects of drugs by smoothing out the Cmax value and can also provide simplified once-a-day administration (see [0009]).
The references do not specifically teach adding the gellan gum in the amounts claimed by Applicant. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, such as drug release rate and smoothing out the Cmax value for optimal therapeutic effect. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Regarding claim 4, DUFFIELD teaches tablet (see [0577]).
Regarding claims 9 and 30, DUFFIELD teaches cholestyramine resin (see 0346]), which reads on bile acid sequestrant.
Regarding claims 12 and 13, DUFFIELD’s tablet composition is capable of the intended use of treatment of the body and oral administration.
Regarding claim 14, DUFFIELD teaches tablet (see [0577]).
Regarding claim 23, as discussed above, DUFFIELD teaches Pluronic F127 (see [0578] at Example 8), which is also known as poloxamer 407.
Regarding claim 26, DUFFIELD teaches behenic acid (see [0211]) can be add for release-resistance or controlled release (see [0211]).
Claim(s) 1, 4, 9, 12-14, 23, 26, 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over DUFFIELD et al (US 2011/0053866) in view of DAVIDSON et al (Colesevelam Hydrochloride (Cholestagel) A New, Potent Bile Acid Sequestrant Associated With a Low Incidence of Gastrointestinal Side Effects. Arch Intern Med. 1999;159;(16):1893-1900.
As discussed above, DUFFIELD teaches Applicant’s invention.
Regarding claim 31, DUFFIELD does not teach using colesevelam as the active ingredient.
DAVIDSON teaches the prior art had known of the drug colesevelam is used for treating hypercholesterolemia with low incidence of gastrointestinal side effects (see title and abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate colesevelam as the active ingredient. The person of ordinary skill in the art would have been motivated to make those modifications, because the incorporation would permit treating patients with other ailments, such as hypercholesterolemia, and decreasing the side effects, and reasonably would have expected success because the primary reference teaches formulating drugs as controlled-release formulations can sometimes reduce the side effects of drugs by smoothing out the Cmax value and can also provide simplified once-a-day administration (see [0009]).
Response to Arguments
Applicant argues that the Examiner considers Example 8 of Duffield to read on the composition of claim 1. However, Example 8 does not include gellan gum, which the Examiner considers to read on the ion-sensitive polymer recited in claim 1. Example 8 of Duffield does not include an ion-sensitive polymer, nor a hydrophilic matrix comprising a combination of at least one thermo-responsive polymer and at least one ion-sensitive polymer. Duffield instead discloses gellan gum only in a list of polysaccharide gums in paragraph 246. There is no teaching in Duffield to suggest that gellan gum can be used in the composition of Example 8 as an ion-sensitive polymer. Duffield does not provide any teaching related to ion-sensitive polymers, nor their selection. The present application distinguishes between thermo-responsive polymers and ion-sensitive polymers. The Examiner is therefore using hindsight to cherry-pick components out of the lists of numerous potential compounds provided in Duffield.
The Examiner finds this argument unpersuasive, because the teaching of DUFFIELD is not limited to the examples, similar to Applicant’s claims are not limited to Applicant’s examples. As discussed in the rejection, DUFFIELD teaches gellan gum is a polysaccharide gum used in the matrix to provide release rate of the drug. Thus, it would have been obvious and add gellan and optimize the amount of gellan, because the amount of a specific ingredient, such as gellan, in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, such as drug release rate and smoothing out the Cmax value for optimal therapeutic effect. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Applicant argues that Duffield simply provides a list of numerous gums. In contrast, claim 1 recites gellan gum as an ion-sensitive polymer and xanthan gum as a bio-adhesive polymer. This grouping is neither taught nor suggested by Duffield. Indeed, Duffield does not mention nor recognize ion-sensitive polymers. The combination of a thermo-responsive polymer and ion-sensitive polymer gives rise to modulated release of an active substance based on the target site of action.
The Examiner finds this argument unpersuasive, because Applicant’s claim 1 does not recite only gellan and xanthan gum, but rather recites a Markush group of ion-sensitive polymers and bio-adhesive polymers. Additionally, DUFFIELD’s motivation to use and optimize gellan gum appears to be the same motivation/reason/desire as Applicant, such as “modulated release of an active substance”, which is the same as “provide release rate of the drug” as taught by DUFFIELD.
Applicant argues that claim 1 as amended recites a very limited subset
of the compounds provided in the application as filed.
The Examiner finds this argument unpersuasive, because the scope of Applicant’s claim 1 encompass every active substance.
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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