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 of the drug particle compositions of Claims 1-11 in the reply filed on 31 October 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
The instant application is a National Stage entry of International application PCT/JP2021/044592 filed 4 December 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to Japanese National application 2020-203797 filed 8 December 2020.
Status of the Claims
Claims 1-15 are pending.
Claims 12-15 are withdrawn from examination as directed to non-elected inventions.
Claims 1-11 are presented for examination and rejected as set forth in greater detail below.
Claim Interpretation
Applicants claims are directed to drug containing particles containing a “drug of a salt with an acid,” which by referring to applicants specification, and more particularly the examples (see, e.g., [0017]), the Examiner has determined is more accurately described as “a salt of a drug with an acid” and will be interpreted as such, combined with a carbonate and a coating of a water-insoluble polymer. Dependent claims limit the identity of the carbonate to being a water-soluble carbonate, which the specification indicates may be represented by either a sodium or sodium hydrogen carbonate, or define the concentration of carbonate in the particles, either relative to the total weight of the particle or the amount of drug agent within the particle. Additional dependent claims define the concentration of coating present in the particle, or indicate the particle is “a uniform particle containing the drug…and containing the carbonate.” The Examiner considers this the equivalent of a particle in which the drug and carbonate are homogeneously distributed, or mixed to uniformity. Alternative claims indicate the drug portion of the particle is separate from the carbonate portion, such as by Claim 8 requiring the core be the drug provided with a carbonate coating, or the core is a carbonate provided with a drug coating layer. Claim 9 places an additional layer between the core and coating. Claim 10 incorporates a disintegrant into the particle, and Claim 11 a binder, fluidizer, or lubricant in either or both of the separating or coating layer.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Shah (U.S. PGPub. 2020/0179267).
Shah describes particles having a drug-containing core having a gas-generating agent surrounded with a flexible membrane. (Abs.). Shah indicates the gas-generating agent may be, for example, a sodium hydrogen carbonate such as that required by Claim 2. [0031; 0150]. Shah indicates these particles may be represented by a form combining a core having a combination of an active pharmaceutical agent, an acid, and a gas-generating agent, surrounded by a permeable elastic membrane. [0041]. In one particular exemplary embodiment, this combination is provided by blending the active with the carbonate and additional excipients. [0247-49]. While not described using the same language as that of Claim 6, by indicating that the drug and carbonate components of the core have been “blended,” the skilled artisan would conclude that the resultant mixture is uniform. Shah indicates this permeable membrane may be made from an insoluble or sparingly soluble polymer, addressing the “water-insoluble polymer” requirement of the instant claims. Shah [0119; 0162; 0174], see Specification [0054] (indicating that “the ‘water-insoluble polymer’ includes polymers poorly soluble in water”). Shah indicates the core may contain between 5-50% of the gas-generating agent, addressing the limitations of Claim 3. [0150]. Exemplary active agents capable of being incorporated into the core include a variety of hydrochloric acid salts of active agents, addressing the active agent limitations of the present claims. [0188](listing each of hydroxyzine, buspirone, trifluoperazine, and thiothixene hydrochloride salts as suitable active agents). In an exemplary embodiment, the carbonate is present in the composition in a ratio of 0.4 parts carbonate to the weight of the drug containing particles, addressing the limitations of Claim 4. [0246](Table 1, “Tablet 1”). In a similar manner, this embodiment demonstrations a ratio of coating to the total particle weight of 0.17, addressing the limitations of Claim 5. Id.
The specific combination of features claimed is disclosed within the broad teachings of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of a water-soluble carbonate combined with a hydrochloric acid salt of an active agent within a water impermeable polymer coating in the concentrations and ratios claimed, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of a water-soluble carbonate combined with a hydrochloric acid salt of an active agent within a water impermeable polymer coating in the concentrations and ratios claimed from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1-5 and 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida (EP1787640)(of record).
Yoshida describes drug particles containing a drug at the core, a layer containing an insolubilizer and insolubilizing substance, and a water-insoluble coating atop the insolubilizing layer. (Abs.), [0012; 0026-28; 0049-50]. In particular embodiments the core is provided with multiple layers providing different properties to the compositions, including configurations where the core is provided with a coating layer, onto which is then placed the coating containing the insolubilizers. [0012; 0027]. In one particular embodiment the insolubilizer present atop the drug containing core is sodium carbonate. [0018 (#5); 0031]. Yoshida indicates that the amount of insolubilizer in the coating is not particularly limited, but may represent up to 95% of the coating, which itself may be present as between 1-300% of the weight of the drug core. [0047-48]. Yoshida indicates that the core may be present as a drug only, addressing limitations of Claim 8, and that the drug may be present in the composition in concentrations falling within the range of 0.5-90% by weight. [0026; 0055]. By the teachings of these ranges of drug and insolubilizer present in the coating, the ranges of concentration of carbonate to drug recited by Claim 4 is overlapped, rendering it obvious. See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Yoshida indicates that the water-insoluble substance present in the outer coating may represent up to 100% of the total weight of the coating, which may be provided in the amount of between 1-100% of the weight of the core particle containing the drug, again reciting a range of ratio of coating to drug-core overlapping and therefore rendering obvious that of instant Claim 5. [0052-53]. Yoshida indicates that there are not particular limitations placed on the identity of the drug to be included, and recited a number of hydrochloride salts of active drugs (bardnidipine, niucardipine, odansetron, and azasetron hydrochlorides, to name a few) suitable for inclusion. [0054]. Yoshida indicates that there are no particular restrictions on the pharmaceutical additives includable in the compositions, with each of the disintegrants, binders, fluidizers, and lubricants recited by Claims 10 and 11 identified as suitable for including in the core or coating layers. [0057; 0074]. Yoshida additionally indicates that the drug particles may possess a layer between the core and the insolubilizer layer, addressing limitations of Claim 9. [0027].
The specific combination of features claimed is disclosed within the broad teachings of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of a drug core containing a hydrochloric acid salt of an active agent, covered by an intermediate coating, then a coating of a water-soluble carbonate such as sodium carbonate which is then coated by a water impermeable polymer layer in the concentrations and ratios claimed, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of a drug core containing a hydrochloric acid salt of an active agent, covered by an intermediate coating, then a coating of a water-soluble carbonate such as sodium carbonate which is then coated by a water impermeable polymer layer in the concentrations and ratios claimed from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
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 1-5 and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 12,090,233 in view of Yoshida, discussed in greater detail above. Although the claims at issue are not identical, they are not patentably distinct from each other because the Independent Claim 1 of the ‘233 patent mirror those of Claim 8 of the present application requiring a drug containing core provided with an intermediate layer, a carbonate layer, and then a water-insoluble layer incorporating various concentrations of each as well as additional excipients as are recited in the present claims, without specifying that the drug in question is an acid salt of an active drug. This is cured by the teachings of Yoshida, indicating that acid salts of active agents may suitably be provided in similar taste-masking coated drug cores.
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614