DETAILED ACTION
Status of Application
Claims 1-12 are pending in this action. Claims 1-12 are currently under consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation-in-part of U.S. Patent Application No. 17/711,602, filed Apryl 1, 2022 and now abandoned, which claims benefit of foreign priority to CA3119012, filed May 18, 2021.
Inventorship
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.
Specification
The specification is objected to because of the following informalities:
The specification comprises reference on a publication (e.g., Para. 00042). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises typographic errors, e.g., “between Hydroxypropylmethylcellulose” (Para. 00056), “and Methacrylate” (Para. 00057, 00058) that need to be corrected to “between hydroxypropylmethylcellulose”, “and methacrylate”, respectively.
The use of the trademarks/trade names has been noted in this application (e.g., Examples 5-12, 00063). It should be capitalized wherever it appears and be accompanied by generic terminology. Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
Information Disclosure Statement
No information disclosure statement is associated with this application/submission.
Claim Objections
Claims 1, 4-12 are objected to because of the following informalities:
Claim 1 recites the limitation “to neutralize a bulk amount of an acid insoluble polymer dispersion” should be corrected to “to neutralize a bulk amount of the acid insoluble polymer dispersion” or clarified.
It is suggested in claim 4 the limitation “polymer is selected from at least one of: a gelatin, a non-gelatin gelling agent” should be corrected to “polymer is a gelatin and/or a non-gelatin gelling agent” or clarified. Similar is applied to claim 7.
Claim 4 comprises the typographic error “The method of claim 1 wherein” that needs to be corrected to “The method of claim 1, wherein”. Similar is applied to claims 6, 7.
Claim 5 comprises the typographic error “agent is selected from the group consisting of: tapioca, pullulan, hydroxypropyl methylcellulose” that needs to be corrected to “agent is selected from the group consisting of tapioca, pullulan and hydroxypropyl methylcellulose” for clarity. Similar is applied to claim 6.
Claim 8 comprises the typographic error “in the range of 25% wt. to” that needs to be corrected to “in the range of from 25% wt. to”. Similar is applied to claims 9-12.
The acronym “HPMCP” recited in claim 8 should be removed, because said acronym is not used in subsequent claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(1)
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 1-12 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The present claims are directed to a method of manufacturing an enteric soft gel capsule comprising a gelling polymer, a plasticizer, an acidic insoluble polymer and an alkali agent, wherein the preparation of said enteric/acid resistant soft gel capsules does not require a coating step, i.e., are made in a single step.
In the present case, the instant specification provides a substantial teaching on how to choose a specific combination of alkali agent and acid insoluble polymer (i.e., a specific stoichiometric amount) to be used in the preparation of enteric soft gel capsules, but does not teach what relative concentrations/amounts of a gelling polymer and a plasticizer should be used in a combination with said alkali agent and acid insoluble polymer for providing a gelatin mass containing an acid-insoluble polymer along with the other additives that make clear enteric soft gel capsules with intrinsic acid-resistance properties residing in the capsule shell and do not require a coating.
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for claim limitations must arise from either an explicit or implicit suggestion by the disclosure to show that such a concept as claimed was actually in possession of applicant at the time of the invention. For the reasons provided supra, applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the entire genus of drugs.
Claim Rejections - 35 USC § 112(b)
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 1-12 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “titrating a sample of an acid insoluble polymer in an aqueous dispersion with an alkali agent” that is not reasonably clear. Does this limitation imply the use of an acid insoluble polymer and an alkali agent in water (pH 7)? Clarification is required.
Claim 1 recites the limitation “a stoichiometric amount of alkali agent needed to neutralize a bulk amount of an acid insoluble polymer dispersion to become translucent” that is not reasonably clear. In the present case, it is noted that the term “translucent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim 1 recites the limitation “adding the bulk amount of the translucent acid insoluble polymer dispersion to the polymer mixture” that is not reasonably clear. In the present case, it is unclear at what concentrations said recited components should be mixed/combined to obtain enteric soft gel capsules.
Claim 8 (dependent on claims 5, 4, 1) recites the limitation “wherein the enteric soft gel capsule contains HPMC” that is unclear. In the present case, it is unclear if HPMC is an additional compound to be used in the claimed compositions, or it is a gelling polymer. This limitation was interpreted as best understood as “An enteric soft gel capsule manufactured according to the method of claim 5, wherein the gelling polymer is HPMC present in an amount of from 25 %wt to 27 wt%”. Similar is applied to claim 9-12. Clarification is required.
Claims 2-7 are rejected as being dependent on rejected claim 18 and failing to cure the defect.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
