DETAILED ACTION
Formal Matters
Claims 17, 32, and 48 are cancelled. Claims 1-16, 18-31, 33-47, and 49-61 are pending. Claims 2-13, 18-31, 33-47, 49-60 are withdrawn. Claims 1, 14-16 and 61 are under examination.
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 national stage entry of PCT/IB2022/056309 filed on 7/8/2022, which claims priority to AU2021902100 filed on 7/9/2021.
Election/Restrictions
Applicant’s election without traverse of Group I and species A) HPMC (reads on claims 1, (Claims 1, 14-16 and 61 in the reply filed on 7/21/2026 is acknowledged.
Claims 2-13, 18-31, 33-47, 49-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/21/2026.
It is noted that applicants would like claim 58 considered for rejoinder upon recognition of allowable subject matter for the elected group/species. The examiner notes this for later consideration.
Claim Objections
Claim 15 is objected to for “180 minutes after dissolution test”, which is better worded as “180 minutes after the start of dissolution”
Appropriate correction is required.
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, 14-16 and 61 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.
Claim 1 recites the limitation "wherein the COX-2 inhibitor and…" in the claim where the introduction is “cyclooxygenase (COX-2) inhibitors…” which is in plural form. There does not seem to be antecedent basis for the singular “inhibitor” when starting from plural “inhibitors”. There is insufficient antecedent basis for this limitation in the claim. Application may change the first recitation of “inhibitors” to “inhibitor” as one way to correct this issue. However, if applicant decides to amend to use “one or more COX-2 inhibitors” or “at least one COX-2 inhibitor”, then subsequent recitations would need to refer to “the one or more COX-2 inhibitors” or “the at least one COX-2 inhibitor” to for antecedent basis for those phrasings.
Claims 14-16 and 61 are rejected as being dependent on an indefinite claim.
Claim 14 is indefinite for “sugar or mannitol and hydroxypropyl methylcellulose” as it is unclear if applicant means to provide for “one or both of sugar and mannitol, and hydroxypropyl methylcellulose” or if this phrase refers to choosing sugar or the other option of mannitol and hydroxypropyl methylcellulose. For the purpose of compact prosecution and based on the species election, the examiner will consider the claim as “, one or both of sugar and mannitol, and hydroxypropyl methylcellulose”.
Claim 14 is indefinite for use of “an organic acid comprising…” after the first recitation in claim 1, on which claim 14, uses “an organic acid selected from the group consisting of…”. There are no new organic acids to those present in claim 1, but the switch from closed group to open group language makes it unclear if applicant now means to reopen this group to other organic acids when it was presented as closed in claim 1. For the purpose of compact prosecution if the prior art teaches one of the organic acids listed, it will read on the claim.
Claim 15 is indefinite for use of “part” and “parts” without saying what that part or parts refers to. The parts could be based on weight, volume, moles, etc. and each would provide different amounts of substance. For the purpose of compact prosecution, the examiner will consider these recitations as “part by weight”.
Claim 61 recites the limitation "the pellet comprising sugar or mannitol" in the claim without a previous recitation of “a pellet comprising sugar or mannitol” in claim 1, on which it depends. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delmas US 20040265380.
Delmas teaches coated granules of celecoxib, precipitated silica (has ability to act as filler), ethylcellulose (has ability to swell/expand), and hydroxypropyl methylcellulose that are combined with ingredients such as mannitol, more precipitated silica, and crospovidone to form tablets (example 2 of Delmas, paragraphs 143-149).
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
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 pre-AIA 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 15, and 61 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over CN108524527A (9-14-2018) and Zhong CN 105343030 A (2-24-2016).
CN ‘527 teaches celecoxib pharmaceutical preparations (abstract). CN ‘527 teaches embodiments 35, 36 and 37 which include HPMC and celecoxib to form dispersions. In these embodiments, 5 g of celecoxib and 10g of HPMC are used. Claims 8 and 11 of CN ‘527 provides for forms of granules, tablet, capsule or powder. CN ‘527 provides for a pharmaceutical composition where oral absorption is fast (abstract). The English translation provides that CN ‘527 teaches “the pharmaceutically acceptable auxiliary material can be filled out Fill agent, adhesive, disintegrant, lubricant, glidant etc” or other pharmaceutically acceptable auxiliary materials of the art.
CN ‘527 does not provide for an expander (e.g. a substance such as crosslinked polyvinylpyrrolidone or crosslinked carboxymethylcellulose or similar) or pellet with sugar or mannitol.
Zhong teaches a celecoxib capsule so the celecoxib releases and absorbs in the body (abstract). Zhong teaches mannitol and sugars like lactose and glucose as suitable filling agents (English translation and claim 5 of Zhong). Zhong teaches pelletizing of the formulation, and thus, allows pellet formation (claims 7-9 of Zhong). Zhong teaches disintegrating agents including crosslinked sodium carboxymethylcellulose and polyvinylpyrrolidone (claims 5-7 of Zhong). Zhong provides the action of celecoxib is to suppress COX-2 and reduce inflammation (Background of Zhong). Zhong teaches that dissolution rate is increased to more than 98% and dissolution effect is improved (abstract). In embodiment 1, dehydrated alcohol is sued with a mixture of celecoxib, lactose (sugar and filler in Zhong), crosslinked carboxymethylcellulose and polyvinyl pyrrolidone to make granules (also see embodiment 2).
One of ordinary skill in the art before the time of filing would have included ingredients such as the fillers mannitol and sugars like lactose as well as ingredients such as crosslinked carboxymethylcellulose or polyvinylpyrrolidone to make a suitable pharmaceutical formulation for fast dissolution of celecoxib (a COX-2 inhibitor for treating inflammation) into formulations of CN ‘527 which are also to fast dissolution celecoxib formulations that have celecoxib and HPMC as an ingredient in claimed ratios. Thus, there was a reasonable expectation of success in combining the teachings of the references to produce pharmaceutical formulations of celecoxib using known ingredients for these formulations and also providing increased dissolution rates for delivery of celecoxib to a subject.
Claim 16 in addition to Claims 1, 15, and 61 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over CN108524527A (9-14-2018), Zhong CN 105343030 A (2-24-2016) and CN104193664A.
CN ‘527 and Zhong teach the claims as discussed above.
CN ‘527 and Zhong do not teach imrecoxib. However, they teach the COX-2 inhibitor celecoxib.
CN ‘664 teaches imrecoxib and its function as a COX-2 inhibitor and anti-inflammatory agent (abstract and background technology). CN ‘664 teaches that its prepared form of imrecoxib makes the compound with reduced toxicity (summary of the invention).
One of ordinary skill in the art before the time of filing would have included imrecoxib of CN ‘664 as the COX-2 inhibitor/anti-inflammatory agent in formulations of CN ‘527 and Zhong as they also recognize formulations for a COX-2 inhibitor. As CN ‘664 recognizes its imrecoxib as being made for reduced toxicity and as a COX-2 inhibitor, it would have been a suitable option of COX-2 inhibitor for the pharmaceutical formulations taught by CN ‘527 and Zhong.
Claim 14 in addition to Claims 1, 15, and 61 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over CN108524527A (9-14-2018), Zhong CN 105343030 A (2-24-2016) and CN104721169A (2015).
CN ‘527 and Zhong teach the claims as discussed above.
CN ‘527 and Zhong do not teach an organic acid in the formulation.
CN ‘169 teaches a celecoxib capsule with organic acid, lactose and other adjuvants (abstract and summary of invention). CN ‘169 teaches organic acids including citric acid and tartaric acid (claims 1 and 2 of CN ‘169). CN ‘169 teaches its capsules having high dissolution rate and good stability (abstract).
One of ordinary skill in the art before the time of filing would have included organic acids such as citric acid and tartaric acid into capsule formulations of celecoxib as such a formulation was also seen to cause fast dissolution and had good stability. Therefore, there was a reasonable expectation of success in adding organic acids to formulations of celecoxib for obtaining fast release and stable formulations by teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached on M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/
Examiner, Art Unit 1613
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