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
Applicant’s claim for the benefit of a prior-filed application (371 of PCT/GB2021/051965, filed 07/29/2021) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority (GB2011836.0, filed 07/30/2020) under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group 3, Claims 15, 18, 20, 22, 28, 31, 32, and 40, and Species 2, wherein the supersaturation of the liquid is controlled by antisolvent precipitation after it has passed through the membrane, in the reply filed on 17 September 2025 is acknowledged.
Claims 1-6, 9, 12, 24, 78, 81-83, and 90 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 September 2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 15 is objected to because of the following informalities:
“or said first liquid phase comprises an antisolvent phase and said second liquid phase…”;
“each of the inlet end and the [[an ]]outlet end being provided with a chamfered region…”; and
“and controlling provision of the [[a ]]second liquid phase to the tubular membrane…”.
Claim 40 is objected to because of the following informalities:
“wherein the crossflow emulsification apparatus includes an insert.”
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.
Claims 22, 28, 31, and 32 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.
Regarding Claim 22, the phrase "and the like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "and the like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Claims 28, 31, and 32 are also rejected due to their dependence on Claim 22.
Regarding Claim 28, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Please note that there are multiple instances where the phrase “such as” is used in this claim. Claims 31 and 32 are also rejected due to their dependence on Claim 28.
Regarding Claim 28, the phrase "for example" or “e.g.” (in the phrase, “HMG-CoA reductase inhibitors, e.g. statins”) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding Claim 31, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding Claim 32, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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 (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 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.
Claim(s) 15, 18, 20, 22, 28, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over BAKKER et al. (US 2006/0182808 A1) in view of WILLIAMS et al. (WO 2019/092461 A1, published 16 May 2019).
Regarding Claim 15, BAKKER discloses an antisolvent solidification process (abstract) to produce solid particles of pharmaceutical compounds in amorphous form (p0025). The process entails a first liquid medium comprising at least one dissolved organic or inorganic compound being forced through a membrane into antisolvents (or vice versa) to yield the desired solid particles (i.e., dispersing a first liquid phase in a second liquid phase; said first liquid phase comprises a solution of the compound and said second liquid phase comprises an antisolvent phase; or said first liquid phase comprises an antisolvent and said second liquid phase comprises a solution of the compound; p0068).
BAKKER further discloses the membrane is preferably in tubular shape (p0045) and is positioned inside a membrane module between one or more inlets for the liquid medium comprising the at least one dissolved organic or inorganic compound and one or more inlets for the antisolvents and further comprises an outlet for the produced solid particles (i.e., a crossflow emulsification apparatus; an outer tubular sleeve provided with a first inlet at a first end; a particle outlet; and a second inlet, distal from… the first inlet; p0046). The membrane is further porous so as to allow for the liquid medium to form droplets (i.e., a tubular membrane provided with a plurality of pores and adapted to be positioned inside the tubular sleeve; p0047). BAKKER further discloses that among other factors, the size of the droplets is dependent on the liquid medium flow rate and the antisolvent flowrate (i.e., controlling provision of the first liquid phase to the tubular membrane; and controlling provision of a second liquid phase to the tubular membrane via the plurality of pores to form solid particles of the compound.; p0048).
However, BAKKER is deficient in disclosing further specifics of the membrane module, i.e., wherein the second inlet of the outer tubular sleeve is distal from and inclined relative to the first inlet, an optional insert adapted to be located inside the tubular membrane, said insert comprising an inlet end and an outlet end, each of the inlet end and an outlet end being provided with chamfered region; the chamfered region is provided with a plurality of orifices and a furcation plate.
WILLIAMS discloses a cross-flow apparatus for producing an emulsion or dispersion by dispersing a first phase in a second phase (abstract) for pharmaceutical products (pg. 1, lines 24-25). The apparatus comprises an outer tubular sleeve 2 provided with a first inlet 3 at a first end 4; an emulsion outlet 5; and second inlet 7, distal from and inclined relative to the first inlet (i.e., a second inlet, distal from and inclined relative to the first inlet; pg. 5, lines 1-5; FIG. 1(a)). The apparatus further optionally includes an insert 10 adapted to be located inside a tubular membrane that is provided inside the tubular sleeve, said insert comprising an inlet end and an outlet end, each of the inlet end and an outlet end being provided with a chamfered region 12 and 13; the chamfered region is provided with a plurality of orifices 17a, b and a furcation plate (i.e., optionally an insert adapted to be located inside the tubular membrane, said insert comprising an inlet end and an outlet end, each of the inlet end and an outlet end being provided with chamfered region; the chamfered region is provided with a plurality of orifices and a furcation plate; pg. 5, lines 8-11; FIGs. 2-4). Advantageously, the positioning of the second inlet at an incline relative to the first inlet in that at the start of injection, the dispersed phase can steadily displace the continuous phase rather than mix due to density differences (pg. 8, lines 6-15). Advantageously, the optional insert allows for a variance in the spacing between the insert and the tubular membrane to control the desired size of the droplets formed (pg. 6, lines 9-11). Thus, prior to the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to position the second inlet inclined from the first inlet and to provide an optional insert as taught by WILLIAMS for the antisolvent solidification process of pharmaceutical compounds disclosed by BAKKER.
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Regarding Claims 18 and 20, modified BAKKER makes obvious the method of Claim 15. BAKKER further discloses the method prepares solid particles of pharmaceutical compounds in amorphous form (p0025).
Regarding Claims 22 and 28, modified BAKKER makes obvious the method of Claim 15. BAKKER further discloses the method prepares pharmaceutical compounds including pharmaceutically active compounds (p0075), including, e.g., steroid hormones (p0027).
Regarding Claim 40, modified BAKKER makes obvious the method of Claim 15. As noted in the rejection of Claim 15, WILLIAMS further teaches an insert for the cross-flow apparatus.
Claim(s) 31 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over BAKKER et al. (US 2006/0182808 A1) in view of WILLIAMS et al. (WO 2019/092461 A1), as applied to Claim 28 above, and further in view of KOILKONDA et al. (US 2006/0111417 A1).
Regarding Claims 31 and 32, modified BAKKER makes obvious the method of Claim 28. Modified BAKKER is deficient in disclosing the pharmaceutically active compound is an antihypertensive agent, e.g., telmisartan, or that the antihypertensive agent is in amorphous form.
KOILKONDA discloses a process for preparing amorphous telmisartan (abstract; p0013-0014). The process involves dissolving a solution of telmisartan in a suitable organic solvent (p0027) such that the telmisartan is uniformly admixed and shaped into a desired form (p0038). While KOILKONDA discloses other methods of preparing amorphous telmisartan, one of ordinary skill in the art prior to the effective filing date of the claimed invention would have found it obvious to apply the method of modified BAKKER for preparing amorphous pharmaceutical active ingredients to the preparation of amorphous telmisartan as disclosed by KOILKONDA. All claimed elements were known in the prior art and one of ordinary skill in the art could have combined the elements as claimed by known methods with no change in their respective, individual functions, and the combination would have yielded nothing more than predictable results (MPEP §2143.01 A). Even further, as noted by BAKKER, the disclosed antisolvent solidification process advantageously addresses morphological instabilities commonly observed in conventional methods of precipitation taught by KOILKONDA (p0003); thus, BAKKER discloses a solidification process that improves on the preparation of amorphous pharmaceutical active ingredients (p0025), such as telmisartan disclosed by KOILKONDA. The claim would have been obvious because a particular known technique was recognized as part of the capabilities of one of ordinary skill in the art (MPEP §2143.01 D).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN B HUANG whose telephone number is (571)270-0327. The examiner can normally be reached 9 am-5 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vickie Kim can be reached at (571)272-0579. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ryan B Huang/Primary Examiner, Art Unit 1777