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 .
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.
DETAILED ACTION
Status of claims
The amendment filed on 12/18/2026 is acknowledged. Claims 2 and 5 have been canceled. Claims 1, 3, 4, and 6-40 are under examination in the instant office action.
Rejections withdrawn
Applicant’s amendments and arguments filed on 12/18/2025 are acknowledged and have been fully considered. Any rejection and/or objection not specifically addressed below is herein withdrawn. Applicant’s amendments have overcome the 35 U.S.C. 103(a) rejection of claims 1-3 over Tian et al. (US 2022/0087958 A1), of claims 1-3 over Faour et al. (US 2005/0008702 A1), and of claims 1-3 over Kositprapa et al. (US 2004/0106660 A1) and nonstatutory obviousness-type double patenting rejection of claims 1-3 over claims 1-25 of U.S. Patent No. 11,684,596 B2 from the previous Office Action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
New ground of rejections necessitated by Applicant’s amendment
The amendments necessitate the following new ground of rejections.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3, 4, and 6-40 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 introduces new matter as the claim recites the limitation "32%-42%” of metformin being released at 8 hours. There is no support in the specification for this limitation. The limitations of “32%" and “42%” were not described in the specification as filed, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. The specification discloses 35% and 45% (paragraph 15), 42.4%, 42.5%, 36.6%, 42.3%, 45.1%, 42.5%, and 41.9% (table 6), 39.7%, 41.3$, 37.2%, 39.4% (table 10), 37.4%, 38.9%, 40.0%, 41.6%, 36.0%, 39.6%, 38.9% (table 14), 38.8%, 38.1%, 39.0%, 38.6% (table 18), 31.2%, 33.8%, 32.5% (table 22), 47.2%, 44.5%, 49.4%, 46.6%, 49.2%, 40.3%, 46.2% (table 26), 41.9%, 39.4%, 38.9%, 38.6%, 32.5%, 46.2% (table 27) in specification as filed but does not describe the instantly claimed limitation. There is no guidance in the specification to select “32%" and “42%” and from MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application. Claims 3, 4, and 6-40 are rejected as dependent claims of a rejected claim.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of the second paragraph 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.
Claim 3 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 3 depends on either claim 1 or claim 2 while claim 2 is a cancelled claim. Hence, one of ordinary skill could not ascertain and interpret the metes and bounds of the patent protection desired as to claim 3.
To expedite the prosecution the dependency of claim 3 is given its broadest reasonable interpretations by the examiner in light of the specification in the 103 rejections as only depending on claim 1.
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.
This application currently names joint inventors. In considering patentability of the claims under 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 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 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.
Claims 1, 3, 4, 6-16, 18-29, 31-36, and 38-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Faour et al. (US 2005/0008702 A1).
Faour et al. teach a simple and improved osmotic device that is capable of providing a controlled release of an active agent contained in the core through a preformed passageway and a second passageway in a multilayered wall (the instant claim 1) (abstract, paragraph 49, 46, and 64, figure 6, and claim 1); comprising,
a core comprising 0.1-99.9% by weight (includes the claimed 50-98% in the instant claim 1) relative to the weight of core of active agents including antidiabetics such as 30-100 mg nifedipine or metformin hydrochloric salt (the instant claims 25 and 26) (paragraph 21, 83, 110, 111, 124, and 150), swellable polymer including polyvinyl pyrrolidone with molecular weight (MW) of 10,000-360,000 (the claimed binder in the instant claims 1, 28, and 29, and overlaps with the claimed 25,000-3,000,000 MW in the instant claim 31) (paragraph 86), surfactant including sodium lauryl sulfate (the claimed absorption enhancer in the instant claims 1 and 32-34) (paragraph 105 and 107), tablet lubricant including magnesium stearate (the instant claims 1, 35, and 36) and other materials known to one of ordinary skill in the art (paragraph 88 and 99),
a wall comprising a semipermeable coating (the claimed controlled membrane film) comprising cellulose acetate (the claimed water-insoluble polymer in the instant claims 1, 15, and 16) and polyethylene glycol (PEG) 400 (>0% PEG, overlaps with the claimed 0-40% pore-forming agent in the instant claims 1, 18, and 19) (paragraph 82), and plasticizer (the instant claim 1) (paragraph 24, 65, an d82) and
two passageways spaced away from the preformed passageway (the claimed opposing side of the dosage form in the instant claims 21-22) (claims 1 and 2); and
exemplified in example 1 a tablet with 99 mg nifedipine (obvious to be replaced with metformin, within the claimed X being about 100-1000 in the instant claim 13 → 95-1050 mg based on ±5% deviation according to the instant specification paragraph 91, within the claimed Y being about 100-1000 in the instant claim 14 → 95-1050 mg based on ±5% deviation, and within the claimed about 100-1000 mg metformin in the instant claim 27 → 95-1050 mg based on ±5% deviation), and, taking the mid-point of the amounts: 1008.95 mg core, 75 mg coating A (semipermeable coating), 40 mg coating B (finish coating), and the total tablet 1123.95 mg: the weight percentage of binder in the core is calculated to be 8.9% (90/1008.95, within the claimed 0-40% in the instant claim 1), absorption enhancer (surfactant) in the core is calculated to be 0.39% (3.9/1008.95, within the claimed 0-20% in the instant claim 1), and lubricant in the core is calculated to be 0.91% (9.15/1008.95, within the claimed 0-10% in the instant claim 1); the weight percentage of water-insoluble polymer (cellulose ester 1 and 2) in coating A is calculated to be 95% (71.25/75, within the claimed 50-99% in the instant claim 1) and plasticizer in coating A is calculated to be 5% (3.75/75, within the claimed 0-25% in the instant claim 1); the weight percentage of coating A relative to the whole tablet (core + coating A + coating B) is calculated to be 6.7% (75/1123.95, very close to the claimed 1.8-6.0% in the instant claim 20); and the weight percentage of coating B relative to the whole tablet (core + coating A + coating B) is calculated to be 3.6% (40/1123.95) (within the claimed about 0.4-40% in the instant claim 40);
wherein the release of the active, with ±5 standard deviation (the instant claims 7-10) (paragraph 53), is: 2-25% at 4 hours (the instant claim 1 and includes the claimed about 18-21% in the instant claim 4), 18-51% at 8 hours (includes the claimed 32-42% in the instant claim 1), 38-92% at 12 hours (includes the claimed about 45-70% in the instant claim 3 and about 50-65% in the instant claim 6), and 74-100% at 24 hours (overlaps with the claimed <92% in the instant claim 1) and the release profile may vary based on core materials used and the semipermeable covering the core, as well as the method used to form the passageway (figure 3 and paragraph 50-52) and nifedipine Cmax of 40.4 ng/mL at about 13 hours (obvious to replace nifedipine with metformin and replace 60 mg strength with 90 mg strength which contains 99 mg of active as discussed above, within the claimed about 8-24 hours in the instant claim 11 and about 13.5 hour → 12.85-14.18 hours based on ±5% deviation in the instant claim 12) for a 60 mg nifedipine (as active) tablet (40.4 / 60 = 0.673, within the claimed X of about 0.6-0.9 in the instant claim 13) (paragraph 54 and 56 and figure 4) and AUCt of 917.6 h*ng/mL for a 60 mg nifedipine (as active) tablet (917.6 / 60 = 15.3, obvious to replace nifedipine with metformin and replace 60 mg strength with 90 mg strength which contains 99 mg of active as discussed above, within the claimed Y of about 7-16 in the instant claim 14) (paragraph 54).
Faour et al. also teach passageways being a 0.5 mm hole (within the claimed 0.30-2.00 mm in the instant claim 23) (paragraph 165). The depth of the passageways in figure 6 is similar to the diameter, i.e., a passageway depth of 0.5 mm (within the claimed 0.10-2.00 mm in the instant claim 24); the wall comprising a semipermeable membrane (23) and a polymer coat (26) (the instant claim 38) (figure 6) with the polymer coat including hydroxypropyl cellulose (paragraph 61) (the instant claim 39); and materials that dissolve in fluids having a pH of 7-8 (paragraph 46), i.e., the pH for dissolving the polymer coating is 7-8 (→ 6.65-8.4 based on ±5% deviation, overlaps with the claimed about 6.8 → 6.46-7.14 based on ±5% deviation the instant claims 1, 3, 4, and 6-10) and the environment of use including intestinal (paragraph 60). Since the dissolution is mimicking intestinal environment, the temperature would be 37 °C (the instant claims 1, 3, 4, and 6-10).
With regard to the overlapping and inclusion ranges discussed above (0.1-99.9% by weight active agents including metformin vs 50-98% in the instant claim 1, 10,000-360,000 MW of polyvinyl pyrrolidone vs 25,000-3,000,000 MW in the instant claim 31, >0% PEG vs 0-40% pore-forming agent in the instant claims 1, 18, and 19, 2-25% at 4 hours vs about 18-21% in the instant claim 4, 18-51% at 8 hours vs 32-42% in the instant claim 1), 38-92% at 12 hours vs about 45-70% in the instant claim 3 and about 50-65% in the instant claim 6, and 74-100% at 24 hours vs <92% in the instant claim 1, and 6.65-8.4 pH vs 6.46-7.14 in the instant claims 1, 3, 4, and 6-10), a prima facie case of obviousness typically exists when the range of a claimed composition overlaps/lies inside the range disclosed in the prior art, such as in the instant rejection. With regard to the very close value discussed above (6.7% semipermeable coating vs 1.8- 6.0% controlled membrane film in the instant claim 20), a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties of a controlled release coating. Please refer to MPEP 2144.05.I:
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.
Claims 1, 3, 4, 6-29, 31-36, and 38-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Faour et al. (US 2005/0008702 A1) in view of Wong et al. (US 4,612,008).
The teachings of Faour et al. are discussed above and applied in the same manner.
Faour et al. do not specify the acetyl content of the cellulose acetate in the instant claim 17.
The deficiency is cure by Wong et al. who teach a semipermeable wall surrounding a core in an osmotic system comprising cellulose acetate having an acetyl content of 35-44.8% (abstract and column 9, line 20-39).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Faour et al. and Wong et al. to specify the acetyl content of the cellulose acetate in the semipermeable wall taught by Faour et al. being 35-44.8%. A semipermeable wall surrounding a core in an osmotic system comprising cellulose acetate having an acetyl content of 35-44.8% was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose. The acetyl content taught by Wong et al. includes that of claimed (35-44.8% vs 39.3-40.3%), a prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Please refer to MPEP 2144.05.I discussed above.
Claims 1, 3, 4, 6-16, 18-36, and 38-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Faour et al. (US 2005/0008702 A1) as evidenced by Ayer (US 4,609,374).
The teachings of Faour et al. are discussed above and applied in the same manner. Faour et al. teach swellable polymer including those in US 4,609,374 (paragraph 86). According to US 4,609,374 (Ayer) typical materials for forming core including hydroxypropyl cellulose (column 5, line 34-43) the instant claim 30.
Claims 1, 3, 4, 6-16, 18-29, and 31-40 are rejected under 35 U.S.C. 103(a) as being unpatentable over Faour et al. (US 2005/0008702 A1) in view of Johannsson (US 2006/0246132 A1).
The teachings of Faour et al. are discussed above and applied in the same manner.
The teachings of Faour et al. are discussed above and applied in the same manner.
Faour et al. do not specify the acetyl content of the cellulose acetate in the instant claim 37.
The deficiency is cure by Johannsson who teaches a lubricant in a sustained release tablet including magnesium stearate, glyceryl dibehenate, etc., (claim 5).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Faour et al. and Johannsson to replace tablet lubricant magnesium stearate in the semipermeable wall taught by Faour et al. with glyceryl dibehenate. Both magnesium stearate and glyceryl dibehenate being suitable tablet lubricant was well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for replacing tablet lubricant magnesium stearate in the semipermeable wall taught by Faour et al. with glyceryl dibehenate flows from both having been used in the prior art, and from both being recognized in the prior art as useful for the same purpose.
Response to Applicants’ arguments:
Applicant’s arguments, filed on 12/18/2025, have been fully considered but they are moot in view of new ground of rejections.
Rejections maintained
The following rejection of the claims is remained for reasons of record and the following. The claims 4 and 6-40, previously not examined on the merit, are included and the rejection is modified based on the amendments and the inclusion of claims 4 and 6-40.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 3, 4, and 6-40 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claimed functional properties are achieved from a specific formulation (embodiments 3-6 being based on embodiments 1 and 2, with various dose amounts of metformin and the same release control coating film CA-398-10 and same seal coating Opadry clear YS-1-7006, two different coating for granules: HPC-EF for embodiment 1 and PVP-K90 for embodiment 2) thus the specific ingredients and amounts that make up the formulation must be positively specified in order to place one of ordinary skill in the art in possession of the claimed dosage with the desired properties. While applicants have shown possession of the embodiments 1-6 having the claimed release profiles (except the amended dissolution profile at 8 hours in claim 1 which is rejected above), they have failed to show possession of the claimed release profiles for all dosage forms containing metformin as recited in the generic claims. Thus, the requirement of written description is not satisfied.
Response to Applicants’ arguments:
Applicants argue that the amendments of claim 1 overcome the rejection.
However, this argument is not deemed persuasive. the scope of claim 1 is much broader than the scope of the compositions achieving the recited release profile.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 3, 4, and 6-40 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 4, 11, and 14-20 (dated 10/01/2025) of copending Application No. 18/195,920 (notice of allowance 11/20/2025). Although the patent and instant claims are not identical, they are not patentably distinct from each other
Although the patent and instant claims are not identical, they are not patentably distinct from each other because claims in both applications are drawn to the same composition.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments:
Applicants argue that the both applications are filed on the same day and thus the nonstatutory obviousness-type double patenting rejection is inappropriate.
However, this argument is not deemed persuasive. MPEP 804 I.B.1.b.(ii):
If both the application under examination and the reference application have the same patent term filing date, the provisional nonstatutory double patenting rejection made in each application should be maintained until it is overcome.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached on 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG YU/
Primary Examiner, Art Unit 1614