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 .
Priority
The instant application, filed July 24, 2023, is a continuation of US Application 17/212,623 (filed March 25, 2021, now US Patent 11,752,161), which claims priority under 39 USC 1192(a)-(d) from Chinese Application CN 2020102271770, filed March 27, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) dated July 24, 2023 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS was considered and a signed copy of the 1449 form is attached.
Election/Restrictions
Applicant’s election with traverse of Group I (claims 21-30 and 35-40, drawn to pharmaceutical compositions) in the reply filed on June 21, 2024 is acknowledged. Further, Applicant’s election with traverse of the species of hydroxypropyl methylcellulose in the same reply is also acknowledged. The elected species reads on claims 35-40 within Group I.
Applicant traverses the restriction and election requirement on the grounds that there would not be a serious burden to search the inventions together. This was not found to be persuasive. because in the present case (MPEP § 808.02): First, separate classification of identified inventions shows that each invention has attained recognition in the art as a separate subject for inventive effort, and also required a separate field of search (searching different classes/subclasses and employing different search queries). Second, the inventions have acquired a separate status in the art due to their recognized divergent subject matter and the search for each innovation is not co-extensive particularly with regard to the literature search. Reference that would anticipate the invention of one group would not anticipate or even make obvious another group. Third, the burden also resides in the examination of independent claim sets for clarity, enablement and double patenting issues. The inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph. Accordingly, the requirement was still found to be proper and is made final.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the examiner searched the compound based on the elected species above, wherein: the elected species was not found to be free of the prior art. Accordingly, the scope of the search and examination was limited to the claimed compositions comprising the elected species of hydroxypropyl methylcellulose.
Status of Claims
Currently, claims 21-42 are pending in the instant application. Claims 21-34 and 41-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention and/or species.
Claims 35-40 read on the elected invention and species and are therefore under consideration in the instant application.
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary. The abstract submitted with the application refers to formula (I) but does not show or describe the particular compound(s) being referenced. Appropriate correction is required.
Claim Rejections – 35 USC § 112
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 36-38 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims are indefinite because they are drawn to a product, but at the same time require an active step. It is not clear which statutory class of invention Applicants intend. For example, claim may be drawn to a method of making a pharmaceutical composition, and properly contain the required active step of mixing components (a) and (b), followed by hot melt extrusion. Alternatively, the claim could be redrafted as a product-by-process claim, replacing the “wherein components (a) and (b) are mixed and undergo hot melt extrusion” with “wherein the composition is obtained by mixing components (a) and (b), followed by hot melt extrusion.” Claims 5, 14 and 16 contain the same issue. Further, no dependent claim corrects the issue, so all are included as indefinite.
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.
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.
Claims 35-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/226604 (“the ‘604 publication”), in view of Huang and Gupta.
The instant claims are drawn to a pharmaceutical composition comprising one part of the compound of Formula (I) and 6 to 20 parts of hydroxypropyl methyl cellulose (HPMC) with a glass transition temperature of 90C to 130C. It is noted that for the purposes of interpreting the claims for comparison with the prior art that a product claim cannot require an active step. Thus, although the active step of mixing and hot melt extrusion is not interpreted as a necessary part of the claim construction, the phrase will be treated as a product-by-process limitation.
Determining the scope and contents of the prior art
The ‘604 publication teaches the compound
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as compound 2 (paragraph [0005]) for the treatment of fibrotic conditions (paragraph [0006]). Pharmaceutical compositions of the prior art compounds are described beginning at paragraph [0055] where the art notes that standard formulation techniques are used. With regard to the tablet or capsule required by claim 18, the particular oral dosage forms are described at paragraph [0061]. The prior art also teaches hydroxypropyl methyl cellulose as a solubilizer to be used in tablets of the composition (paragraph [0062]). The prior art also teaches several different weak acids as carriers or excipients to be used in the compositions (paragraph [0062]).
Ascertaining the differences between the prior art and the claims at issue
The difference between the instant claims and the prior art is that the instantly claimed composition is generically encompassed by the prior art, rather than specifically exemplified.
Resolving the level of ordinary skill in the pertinent art
In addition to the fact that there is a suggestion in the prior art to use each of the required substances of the claimed composition, there was evidence in the art at the time of the present invention of the use of low glass transition temperature HPMC (Affinisol) (see Huang, abstract). The AFFINISOL taught by Huang and also by Gupta necessarily have the properties recited by the instant claims, since a substance and its properties are inseparable. The use of this low glass transition temperature excipient was shown to have many benefits, including allowing for hot melt extrusion processing, as well as creating dispersions of poorly water soluble drugs and rapidly and significantly improving their solubility. Gupta teaches that poor aqueous solubility of drugs has emerged as a major challenge in formulating oral drugs, which leads to slow dissolution rate, incomplete absorption and low bioavailability (see Introduction). The use of low glass transition temperature HPMC in the formulation with such drugs is expected to improve solubility and thus bioavailability of the active ingredient in the formulation.
In summary, the instantly claimed compositions represent a selection of particular exemplified components, already well-characterized in the art for preparing oral formulations of formula (I) for oral administration and immediate release. It would have been obvious for a person of ordinary skill in the art to have optimized within the ranges disclosed in the ‘604 publication for said substances. Such optimization would not have been considered inventive as the combination of prior art references would have provided both the motivation and reasonable expectation of success necessary to prepare the claimed solid formulations of formula (I).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699