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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8, in the reply filed on 05/27/2026 is acknowledged.
Accordingly, claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
The preliminary amendment of 05/29/2024 is acknowledged. Claim 9 is amended. Claims 9-13 are withdrawn as set forth above. Claims 1-8 are examined on the merits herein.
Priority
The instant application filed 05/29/2024, is a 371 filing of PCT/KR2022/019656, filed 12/06/2022, which claims foreign priority to KR10-2021-0186751, filed 12/24/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/29/2024 and 12/01/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Niecestro, R, et al. (US 20040166162 A1, 08/26/2004, IDS dated 12/01/2025), hereinafter Niecestro, in view of Wen, X, et al. (US 20230210779 A1, 07/06/2023, effectively filed 09/08/2020, PTO-892), hereinafter Wen.
Niecestro discloses a multi layer pharmaceutical dosage form comprising at least two layers whereby a proton pump inhibitor is in one distinct layer and an aluminum, magnesium or calcium antacid salt is in a second distinct layer (abstract).
Regarding claim 1: The antacid and the proton pump inhibitor are separately granulated. The antacid granules will comprise at least the antacid and a binder (i.e., excipient) ([0059]; Examples), thereby reading on preparing the second granule of (2). The proton pump inhibitor (PPI) granules will comprise at least the proton pump inhibitor, a binder (i.e., excipient) and an alkaline agent ([0059]; Examples), thereby reading on preparing the first granule of (1). The granules are prepared by dry granulation techniques in a specific embodiment ([0059]; claim 21). Once the antacid granules and the proton pump inhibitor granules are prepared, they are then further mixed with additional excipients to form an antacid laying mixture and a proton pump layering mixture ([0063]). The proton pump inhibitor layering mixture is fed into a tablet press to form the proton pump inhibitor layer, then the antacid layering mixture is fed into the tablet press to form the antacid layer of the multi-layer tablet ([0064], which reads on filling the first and second granules into a tablet press as generally defined in (3) and (4). It should be appreciated that the order in which the proton pump inhibitor layer and antacid layer are fed into the tablet press can be reversed ([0064]). The proton pump inhibitor layering mixture and the antacid layering mixture are individually processed on a tablet press and manually compressed to produce a bilayer chewable tablet ([0076]; [0089]; [0093]; [0097]), which reads on compressing the layers as generally defined in (3) and (4).
Regarding claim 2: Specific proton pump inhibitors used in the tablets of Niecestro include esomeprazole ([0042]; [0049]; [0056]), omeprazole ([0027]; [0038]; [0045]; [0052]; Examples; claim 10), lansoprazole ([0027]; [0039]; [0046]; [0053]; claim 10), rabeprazole ([[0040]; [0047]; [0054]), and pantoprazole ([0027]; [0041]; [0048]; [0055]; claim 10).
Regarding claim 3: A preferred antacid salt is magnesium hydroxide ([0028]).
Regarding claims 4 and 5: The binders used in the PPI and antacid granules of Niecestro may be selected from hydroxypropyl cellulose, starch and pregelatinized starch, and sodium carboxymethyl cellulose ([0030]). Additional fillers include dibasic calcium phosphate (i.e., dicalcium phosphate), mannitol, and microcrystalline cellulose ([0031]). Disintegrants such as crospovidone ([0032]) and conventional processing aids such as tablet lubricants (magnesium stearate) and glidants (colloidal silicon dioxide) may also be used ([0035]).
Regarding claim 6: Granules are prepared using pharmaceutically acceptable methods commonly known in the art, such as roller compaction ([0026]; [0059]; Ex. 7; claim 22).
The teachings of Niecestro differ from that of the instant invention in that Niecestro does not explicitly teach using a double-layer tablet press to first compress the lower layer at a specific pre-pressure and then to secondly compress the upper later at a specific main pressure, as defined in claims 1 and 7-8, nor a specific embodiment comprising the antacid of claim 3 or the excipients of claims 4 and 5.
Wen discloses an ibuprofen controlled-release tablet and a method for preparing it. The controlled-release tablet is composed of a drug-containing immediate-release layer and a drug-containing sustained-release layer (abstract). A method for preparing an ibuprofen controlled-release tablet, comprises the steps: a. performing wet granulation among other steps to prepare a drug-containing immediate-release layer particle for later use; b. performing wet granulation among other steps to prepare a drug-containing sustained-release layer particle for later use; d. placing a formulation amount of the drug-containing sustained-release layer particle into a punching die of a tablet machine for pre-pressing; and then placing a formulation amount of the drug-containing immediate-release layer particle into the punching die to be pressed into a tablet ([0045]-[0048]). Such a method reads on filling a second granule (i.e., sustained-release layer particle) into a container (i.e., punching die) using a double-layer tablet press (i.e., tablet machine is used to make double layer tablet) and first compressing the lower layer by applying a pre-pressure (i.e., pre-pressing), and filling the first granule (i.e., immediate-release layer particle) on the lower layer and then second compressing the upper layer by applying a main pressure (i.e., pressed into a tablet), as recited in claim 1. In step d, a pre-pressure is preferably 0.1-0.5 KN; and a main pressure is preferably 10-50 KN ([0055]; [0020]). Such a pre-pressure reads on the instantly claimed pre-pressure of 1 kN or less, as recited in claim 1, while such a main pressure encompasses the main pressure of 25 to 35 kN, as recited in claim 1. Wen further teaches that the pre-pressure has an important effect on hardness and fragility of the tablet. Too small pre-pressure leads to an insufficient filling amount and thus a target tablet weight cannot be reached. Too large pre-pressure leads to cracking of the tablet. An optimal range of the pre-pressure is 0.1-0.5 KN. The main pressure will also affect the hardness and fragility of the tablet. Too small main pressure may lead to a failure to reach a target hardness and a non-conformity fragility. Too large pre-pressure may lead to cracking or hardness exceeding a limit. An optimal range of the main pressure is 10-50 KN ([0055]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of claimed invention, to compress the antacid and PPI granules of Niecestro according to the compression method of Wen since such a compression method is known and routine in the art of bi-layer tablets as taught by Wen. Wen teaches the effect of the compression step and pressure levels on the hardness and fragility of the final tablet. Therefore, one of ordinary skill in the art could have applied the known compression technique of Wen to the known method of Niecestro to predictably yield the instant invention. One of ordinary skill in the art would have been motivated to use the compression method of Wen in order to improve the hardness and fragility of the tablets, as reasonably suggested by Wen. The compression technique of Wen uses a pre-pressure of 0.1-0.5 kN which reads on the pre-pressure of claims 1 and 7, and a main pressure of 10-50 kN, which encompasses the range of claims 1 and 8. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. It would have also been well within the abilities of an ordinary artisan to optimize the main pressure since such a pressure is a results effective parameter as taught by Wen. The optimization of a result effective parameter is considered within the skill of the artisan. See, In re Boesch and Slaney (CCPA) 204 USPQ 215. This is what research chemists do, optimization of result-effective variables through routine experimentation (MPEP 2144.05 IIA and B). One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since both Niecestro and Wen teach methods of compressing a bi-layer tablet starting from granulated forms of their respective actives.
Regarding the order of the compression steps and therefore which active becomes incorporated in the lower versus upper layer, Niecestro teaches that the order in which the proton pump inhibitor layer and antacid layer are fed into the tablet press can be reversed. As such, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to fill the antacid granule first to form the lower layer and the PPI granule second to form the upper layer, since reversing the order is known and routine in the art as taught by Niecestro. One of ordinary skill in the art could have easily switched the order depending on which active is desired in the lower vs upper layer. Furthermore, changes in sequence of adding ingredients is considered prima facie obvious. See Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959).
Regarding claim 3, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to select the magnesium hydroxide of Niecestro as the antacid since it is a known and routine antacid in the art. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. One of ordinary skill in the art could have replaced any of the antacids in the specific embodiments of Niecestro with magnesium hydroxide through no more than simple substitution of one known element for another to yield predictable results. One of ordinary skill in the art would have had a reasonable expectation of success in doing so since magnesium hydroxide is a preferred antacid taught by Niecestro.
Regarding the excipients of claims 4 and 5, it is discussed above that various binders, fillers, disintegrants, and processing aids may be used in preparing the granules and tablets of Niecestro. It would have therefore been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention to select and combine any of these excipients with the PPI and antacid granules, since such excipients are known and routine in the art. One of ordinary skill in the art could have selected and combined any of these known excipients with the PPI and antacid granules via known methods. Given their established function and routine use in the art such a combination would have yielded predictable results. One of ordinary skill in the art would have had a reasonable expectation of success in doing so since all of these excipients are generally taught by Niecestro.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10 and 14 of copending Application No. 18/004,317 in view of Niecestro and Wen. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Niecestro and Wen.
Copending claim 14 recites a method of preparing the pharmaceutical composite formulation comprising: preparing a first layer mixed part comprising, as an active ingredient, a proton pump inhibitor or a pharmaceutically acceptable salt thereof, and a lubricant, and a binder (i.e., excipient); and preparing a second layer mixed part comprising, as an active ingredient, an antacid that is magnesium hydroxide; and tableting the first layer mixed part and the second layer mixed part, wherein the preparing of the first layer mixed part comprises a granulation process. The second layer may further comprise any selected form the group consisting of a diluent, a disintegrant, a fluidizing agent, a lubricant, and any mixtures thereof (i.e., excipients) (copending claim 10).
The copending claims differ from the instant claims in that they do not explicitly recite dry granulating the PPI or the antacid mixtures nor the compression method of steps (3) and (4).
Niecestro discloses a multi layer pharmaceutical dosage form comprising at least two layers whereby a proton pump inhibitor is in one distinct layer and an antacid salt is in a second distinct layer (abstract). The antacid and the proton pump inhibitor are separately granulated with their respective excipients ([0059]; Examples). The granules are prepared by dry granulation techniques in a specific embodiment ([0059]; claim 21), which reads on the dry granulation of the PPI and anatcid mixtures as defined in step (1) and (2). The proton pump inhibitor layering mixture is fed into a tablet press to form the proton pump inhibitor layer, then the antacid layering mixture is fed into the tablet press to form the antacid layer of the multi-layer tablet ([0064], which reads on filling the first and second granules into a tablet press as generally defined in (3) and (4). The proton pump inhibitor layering mixture and the antacid layering mixture are individually processed on a tablet press and manually compressed to produce a bilayer chewable tablet ([0076]; [0089]; [0093]; [0097]), which reads on compressing the layers as generally defined in (3) and (4).
Wen discloses an ibuprofen controlled-release tablet and a method for preparing it. The controlled-release tablet is composed of a drug-containing immediate-release layer and a drug-containing sustained-release layer (abstract). A method for preparing two distinct layers and placing a formulation amount of one layer particle into a punching die of a tablet machine for pre-pressing; and then placing a formulation amount of the other layer particle into the punching die to be pressed into a tablet ([0045]-[0048]). Such a method reads on filling a second granule (i.e., sustained-release layer particle) into a container (i.e., punching die) using a double-layer tablet press (i.e., tablet machine is used to make double layer tablet) and first compressing the lower layer by applying a pre-pressure (i.e., pre-pressing), and filling the first granule (i.e., immediate-release layer particle) on the lower layer and then second compressing the upper layer by applying a main pressure (i.e., pressed into a tablet), as recited in (3) and (4). In this step a pre-pressure is preferably 0.1-0.5 KN; and a main pressure is preferably 10-50 KN ([0055]; [0020]). Such a pre-pressure reads on the instantly claimed pre-pressure of 1 kN or less, as recited in (3), while such a main pressure encompasses the main pressure of 25 to 35 kN, as recited in (4). Wen further teaches that the pre-pressure has an important effect on hardness and fragility of the tablet. Too small pre-pressure leads to an insufficient filling amount and thus a target tablet weight cannot be reached. Too large pre-pressure leads to cracking of the tablet. An optimal range of the pre-pressure is 0.1-0.5 KN. The main pressure will also affect the hardness and fragility of the tablet. Too small main pressure may lead to a failure to reach a target hardness and a non-conformity fragility. Too large pre-pressure may lead to cracking or hardness exceeding a limit. An optimal range of the main pressure is 10-50 KN ([0055]).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of claimed invention, to perform dry granulation of the PPI/excipient mixture and antacid/excipient mixture of the copending claims individually, since such a process is known and routine in the art as taught by Niecestro. One of ordinary skill in the art could have applied the known technique of dry granulation to the known method of the copending claims to predictably generate the instantly claimed method. One of ordinary skill in the art would have had a reasonable expectation of success in doing so since the copending claims generally teach a granulation step.
It would have been further prima facie obvious to one of ordinary skill in the art to compress the antacid and PPI granules of the combined method according to the compression method of Wen since such a compression method is known and routine in the art as taught by Wen. Wen teaches the effect of the compression step and pressure levels on the hardness and fragility of the final tablet. Therefore, one of ordinary skill in the art could have applied the known compression technique of Wen to the method above to predictably yield the instant invention. One of ordinary skill in the art would have been motivated to use the compression method of Wen in order to improve the hardness and fragility of the tablets, as reasonably suggested by Wen. The compression technique of Wen uses a pre-pressure of 0.1-0.5 kN which reads on the pre-pressure of (3), and a main pressure of 10-50 kN, which encompasses the range of (4). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since the copending claims, Niecestro, and Wen all teach methods of forming a bi-layer tablet.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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