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 .
DETAILED ACTION
Claims 1-13, 16, and 18-23 are pending in the instant application.
Claims 1-13, 16, and 18-23 are examined herein.
Priority
The instant application claims benefit of foreign priority to IN202041048559, filed on 06 November 2020, and the benefit of priority to PCT/IB2021/060148, filed on 03 November 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 06 November 2020.
Information Disclosure Statement
No information disclosure statement (IDS) submitted by applicant.
Claim Interpretation
Claims 1, 6, 7, 13, 16, and 18-21 recite the term “about,” though considered a relative term, “about” is clearly defined on page 13, line 4, of the specification. Therefore no 112(b) rejection was written.
Claims 1, 5, 20, and 23 are directed to a composition; as such, the intended use (i.e. for treating acute pain) does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2111.02.II:
[S]tatements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.
Claim 23 is directed to a composition; as such, the method of making does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2113 I:
[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.
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.
Claims 1-13, 16, and 18-23 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 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.
Claims 1, 6, 7, 20, 22, and 23 recite the pharmaceutical salt or ester of meloxicam. Ester is not described, defined, nor are any examples given, in the specification. As the dependent claims do not remedy the issue they are subject to the rejection as well.
One of ordinary skill in the art would not be able to practice the instant invention without undue
experimentation to determine the scope of functional esters of meloxicam, which under broadest reasonable interpretation includes functional ester prodrugs. Formulation of an ester prodrug would require significantly more experimentation. Strickley et al. (Formulation Challenges of Prodrugs. Prodrugs. 2007. Chapter 4.1.2. 383-410) discuss several formulation challenges presented with prodrugs, namely; chemical stability, reactive by-products, solubility, and polymorphism. Experimentation is required to make a successful ester prodrug. The specification does not provide any structure-function correlation to support the bounds of a functional ester of meloxicam; nor are any examples presented in the instant specification, which suggests the applicant is not in possession of a functional ester of meloxicam.
In conclusion, there is no structure-function correlation between what is and what is not a functional ester in the specification. Without the correlation between structure and function or an adequate representation of species functioning as an ester of meloxicam, the instant invention fails to comply with the written description requirement.
Claim Rejections - 35 USC § 112
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.
Claims 5 and 23 are 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 5 recites the intended use of a compound of claim 1, which does not alter the composition and therefore provide no further limit to claim 1.
Claim 23 recites the method of making a composition of claim 22, which does not alter the composition and therefore provide no further limit to claim 22.
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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13, 16, 18-19, and 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosch (US9526734B2).
Regarding claim 1, Bosch discloses a pharmaceutical composition comprising meloxicam and one or more excipients (column 2, line 30) wherein the Tmax is 1-3 hours in a subject under fasting conditions (claim 3).
Regarding claim 2, Bosch discloses a formulation with rapid drug release and increased rate of absorption shown by the high dissolution rate, low Tmax, and high Cmax. Cyclodextrin is not included in the formulation.
Regarding claim 3, Bosch discloses a pharmaceutical composition wherein the dissolution rate is such that 90% of the meloxicam dissolves in less than 8 minutes (claim 2).
Regarding claim 4, Bosch discloses the composition as a capsule (claim 1).
Regarding claim 5, Bosch discloses the composition for the treatment of osteoarthritis pain (claim 1).
Regarding claim 6, Bosch discloses a composition comprising 5-10 mg of meloxicam (column 2, line 8).
Regarding claim 7, Bosch discloses a composition comprising 10 mg of meloxicam, which is about 7.5-15 mg (claim 5).
Regarding claim 8, Bosch discloses the composition can comprise surfactants, polymers, binding agents, filling agents, lubricating agents, sweeteners, flavoring agents, preservatives, buffers, diluents, wetting agents, disintegrants, and/or, effervescent agents (column 18, line 35)
Regarding claims 9 and 10, Bosch discloses a the composition can comprise the polymer of vinyl pyrrolidone and vinyl acetate (copovidone), polyvinylpyrrolidone (povidone), and/ or hydroxypropyl cellulose.
Regarding claims 11 and 12, Bosch discloses the composition can comprise sodium carbonate, sodium bicarbonate, and/or calcium carbonate (column 9, line 17, and column 18).
Regarding claims 13 and 16, Bosch discloses the total amount of meloxicam to excipient to have a mass percentage of 5-99% w/w, which covers the instant 100- 400 mg of sodium bicarbonate (column 9).
Regarding claims 18 and 19, Bosch discloses a Tmax of 1-3 hours in a fasted state (claim 3).
Regarding claims 20 and 21, Bosch discloses a Cmax of 700-1900 ng/ml (claim 5). Which overlaps with the recited range of about 2000 - 3500 ng/ml. The specification gives a definition of “about” to be a range up to 20% of a value. Therefore about 2000 ng/ml includes values from 1600 ng/ml – 2000 ng/ml. And the recited Cmax in claim 21 of about 2200 ng/ml includes values from 1760 ng/ml - 2200 ng/ml.
Regarding claim 22, Bosch discloses a pharmaceutical composition comprising meloxicam and one or more excipients (column 2, line 30) wherein the excipients can be polymers and/or effervescent agents (column 18, line 35)
Regarding claim 23, Bosch discloses a the method of co-milling meloxicam with excipients, including alkaline agents, which can result in the meloxicam being embedded in an alkaline surrounding (column 9).
Conclusion
Claims 1-13, 16, and 18-23 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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