DETAILED ACTION
STATUS OF THE APPLICATION
Receipt is acknowledged of Applicants claimed invention, filed 13 September, 2022, in the matter of Application N 17/911,329. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after September 13, 2022, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the originally filed claims. The issue of new matter is moot.
Thus, claims 1-16 represent all claims currently under consideration.
Information Disclosure Statement
Three Information Disclosure Statements (IDS) filed 13 September 2022, 27 October 2023, and 15 November 2023, are acknowledged and have been considered.
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.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Masatoshi et al. (US20090137530) in view of Jones et al. (WO2019246312) and Masaki et al. (JP2016155777) and Shidara et al (JP2002284679).
Masatoshi et al. teach 2-amino-2-[2-(4-heptyloxy-3-trifluoromethylphenyl)-ethyl] propane-1,3-diol as a pharmaceutical agent. The compound of any of 1 to 4, wherein the compound of the formula (I) is any of the following a-e, or a pharmaceutically acceptable acid addition salt thereof, or a hydrate thereof, or a solvate thereof. 2-amino-2-[2-(4-heptyloxy-3-trifluoromethylphenyl)-ethyl] propane-1,3-diol, or a pharmaceutically acceptable acid addition salt thereof, or a hydrate thereof, or a solvate thereof (See 11a). The chemical or its hydrochloride is described in claim 13, 2-amino-2-[2-(4-heptyloxy-3-trifluoromethylphenyl)-ethyl] propane-1,3-diol. Furthermore, claim 14 states that the compound and a carrier are combined to create a pharmaceutical composition. Masatoshi et al. do not discuss the use of excipients like sodium and calcium hydrogen phosphate (See structure IIa and claims 13 and 14).
Regarding claims 1 and 9, Jones et al. teach an S1P modulator serves as the extra agent. The S1P inhibitor is chosen in certain forms from the group that includes fingolimod, KRP203, Siponimod, ponesimod, cenerimod, and amiselimod, as well as their pharmaceutically acceptable salts. Ozanimod, estrasimod, amiselimod, or a pharmaceutically approved salt of these are the S1P modulators in certain formulations (See page 16, lines 29-34 and claims 84 and 85). one or more excipients selected from dibasic calcium phosphate, calcium dihydrogen phosphate, dibasic sodium phosphate and sodium dihydrogen phosphate (See formulations and pharmaceutical formulations paragraph 6, Exemplary formulations paragraph 4 and 5, Aqueous/liquid formulations paragraph 1).
It would have been obvious to one of ordinary skill in the art before the instant effective filing date to use the compound of Masatoshi et al. with the excipients of Jones et al. with the expectation of arriving at a useful pharmaceutical composition.
Regarding claims 1, 2, 3, 4, Masaki et al. teach the ingredients sugar alcohol, dibasic calcium phosphate, and montelukast or its salt (See abstract). The action of light, temperature, or preparation-based additives can change montelukast sodium into a similar compound. The purpose of this invention is to prevent the creation of the aforementioned linked material in the composition that contains sodium montelukast after it has been manufactured or preserved (See paragraph 8). The current invention offers a mixture of calcium hydrogen phosphate or sugar alcohol and montelukast or a salt of it. Mannitol is preferred above erythritol, xylitol, maltitol, sorbitol, lactitol, and erythritol when choosing a sugar alcohol (See paragraph 5).
Regarding claims 1 and 6, Shidara et al. teach thyroid hormone-containing solid preparation composition that contains 0.1 to 5.0% by weight of an inorganic stabilizer and is mostly made up of crystalline cellulose. At least one inorganic stabilizer is chosen from the group that includes sodium hydrogen phosphate, sodium carbonate, and other substances. The above-described solid pharmaceutical composition includes excipients by weight. Lactose, D-mannitol, or anhydrous calcium hydrogen phosphate are examples of excipients (See abstract).
Regarding claims 5, 15, and 16, Masaki et al. teach the content ratio of calcium hydrogen phosphate or sugar alcohol is, for instance, 75 to 97% by mass, preferably 80% based on the total mass of the composition in order to inhibit the development of the substance related to montelukast sodium. 95% by weight is possible, while 85-93% by weight is preferable (See paragraph 8).
Regarding claim 7, Masaki et al. teach under light-shielding conditions, the following procedure was carried out. Iron trioxide, titanium oxide, talc, and yellow ferric oxide are the colorants (See paragraph 44).
Regarding claims 8 and 12, Masaki et al. teach the current invention’s solid preparation can be made using a technique that is well-known to experts in the field. A tablet, for instance, would be made by mixing montelukast or a salt of it with sugar alcohol and any additional ingredients, then adding a binder to create granules, which would then be compacted into tablets. It is also possible to produce tablets, powders, tiny granules, granules, and capsules using techniques that are well-known to experts in the field (See paragraph 20).
Regarding claims 13, and 14, Masaki et al. teach severe test at 60 degrees Celsius, 20 or more tablets of example 1 were kept in a desiccator with a saturated aqueous sodium chloride solution and another desiccator without any saturated aqueous sodium chloride. 60 degrees Celsius and 75% relative humidity for seven days. Following storage, HPLC was used to determine the sample’s fraction of related compounds. From the solvent peak to 35 minutes post-injection, the associated substance’s peak region is a peak area distinct from the montelukast peak. The region of the montelukast peak plus the associated substance peak from the solvent peak to thirty-five minutes post-injection is known as the total peak area (See test example 1, and paragraph 29).
Regarding claims 10 and 11, Masaki et al. teach the sugar alcohol is mannitol, or more specifically D-mannitol, to prevent the production of an analog of montelukast sodium (See paragraph 8). The content ratio of calcium hydrogen phosphate or sugar alcohol in the present invention is 75 to 97% by mass, ideally 80%, based on the composition’s total mass. This is done to inhibit the production of a substance related to montelukast sodium. 95% by weight is possible, while 85-93% by weight is preferable (See paragraph 9). One embodiment’s composition consists of montelukast sodium and a sugar alcohol, ideally mannitol, regarding the overall mass of the composition, the content ratio of each component is, for instance, 3 to 8% by mass for montelukast sodium, ideally 4 to 6% by mass, and 85 to 95% by mass for sugar alcohol, ideally 87 to 93% by mass (See paragraph 15).
Masaki et al. teach a mixture that contains calcium hydrogen phosphate, sugar alcohol, or montelukast or a salt of it. Masaki et al. goes on to say that calcium hydrogen phosphate inhibits the production of a montelukast-related compound (See abstract, paragraph 8 and paragraph 5).
Shidara et al. teach a solid preparation composition that contains thyroid hormone and an inorganic stabilizer. Shidara et al. goes on to say that sodium hydrogen phosphate or something similar could be the inorganic stabilizer and that the inorganic stabilizer stabilizes the complex (See abstract).
A person skilled in the art who encountered Masaki et al., Shidara et al., and Masatoshi et al. would find it challenging to configure the invention of the current application because neither author indicates or suggests that calcium hydrogen phosphate and sodium hydrogen phosphate stabilize the compound described in Masaki et al. as described above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kimberly Barber whose telephone number is (703) 756-5302. The examiner can normally be reached on Monday through Friday from 6:30 AM to 3:30 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax, can be reached at telephone number (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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/KIMBERLY BARBER/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615