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 .
Priority
The instant application is a continuation of US 19/442,876, filed January 7, 2026, which is a continuation of US 19/095,971 (filed January 11, 2023, now abandoned), which is a continuation of US Application 16/473,748 (filed June 26, 2019, now US Patent 11,576,898), which is a 35 USC 371 National Stage filing of international application PCT/KR2017/015489, which claims priority under 35 USC 119(a)-(d) from Korean Application KR10-2016-0179334, filed December 26, 2016.
Information Disclosure Statement
The information disclosure statements (IDS) dated January 9, 2026 and July 13, 2026 were in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and signed copies of the 1449 forms are attached.
Election/Restrictions
Applicant's election without traverse of croscarmellose sodium as a specific disintegrant in the reply filed July 13, 2026 is acknowledged.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Scope of the Elected Invention
Applicant’s species election reads on claims 10-16. Examination of the elected invention was conducted in accordance with the MPEP 803.02:
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious. See, e.g., Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298, 92 USPQ2d 1163, 1171 (Fed. Cir. 2009)(the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art).
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If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration. As an example, in the case of an application with a Markush claim drawn to the compound X-R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, XA, XB, XC, XD, or XE. The Markush claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species.
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If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush claim and claims to the elected species will be rejected, and claims to the nonelected species will be held withdrawn from further consideration.
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If the examiner determines that the elected species is allowable over the prior art, the examination of the Markush claim will be extended. If prior art is then found that anticipates or renders obvious the Markush claim with respect to a nonelected species, the Markush claim shall be rejected; claims to the nonelected species would still be held withdrawn from further consideration. The prior art search will not be extended unnecessarily to cover all nonelected species, and need not be extended beyond a proper Markush grouping. See subsection IV.B, below, for additional guidance.
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Should applicant, in response to a rejection of a Markush claim, overcome the rejection by amending the Markush claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush claim will be examined again. The examination will be extended to the extent necessary to determine patentability of the Markush claim. In the event prior art is found during this examination that anticipates or renders obvious the amended Markush claim, the claim will be rejected and the action can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a).
The elected species is not allowable in view of the prior art; therefore, examination of the Markush-type claim has not been extended to include other species. Since art was found on the elected species, subject matter not embraced by the elected embodiment is therefore withdrawn from further consideration.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10-11 and 13-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 10,512,635 (“the ‘635 patent”).
The instant claims are drawn to a formulation for oral administration, which is further defined as a tablet which is stable at pH 4.0, comprising a compound of Formula I or a salt thereof
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. Notably, the elected species requires the addition of croscarmellose sodium as a disintegrant.
The ‘635 patent teaches the compound of formula
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or a salt thereof formulated for the treatment of GERD, and in particular nocturnal acid breakthrough (col. 2, ll. 1-24). The prior art teaches the preparation of anticipatory tablets of the Compound of Formula I. Examples 1 and 2 (col. 5, l.51 – col. 6, l. 49) detail the tableting process for either 50 mg (Example 1) or 100 mg (Example 2) of active ingredient. Mannitol, microcrystalline cellulose, and sodium croscarmellose were mixed with the active compound, as required, followed by the addition of a binding solution of hydroxypropyl cellulose (6 mg or 12 mg, respectively) and purified water. The mixture is granulated and dried/milled, and mixed with microcrystalline cellulose, sodium croscarmellose, colloidal silicon dioxide (2 mg or 4 mg, respectively, as a diluent) and magnesium stearate (2 mg or 4 mg respectively, as a lubricant). With respect to instant claim 11, the prior art specifies in each example that the disintegrant was used within a range of 1% to 20% by weight of the final formulation, exemplifying 10 mg in Example 1 and 20 mg in Example 2. The formulation is then compressed to form a tablet.
With respect to the limitation: “wherein the formulation is stable at pH 4.0,” “Products of identical chemical composition can not have mutually exclusive properties" (MPEP 2112.01(II)). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure as that recited in the claim, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)). Even if that property (i.e. particle size, hydrophobicity, injectability) is not disclosed in the prior art, if the chemical structure is identical, the art need not recognize every property of the compound in order to render it unpatentable. In accordance with MPEP 2112, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Since the prior art teaches all required limitations of the claimed product, the claims are anticipated.
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 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.
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.
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 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 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 10-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al. US 2007/0142448 (“the ‘448 publication”).
The instant claims are drawn to a formulation for oral administration, which is further defined as a tablet which is stable at pH 4.0, comprising a compound of Formula I or a salt thereof
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. Notably, the elected species requires the addition of croscarmellose sodium as a disintegrant.
Determining the scope and contents of the prior art
The ‘448 publication teaches the compound (S)-4((5,7-difluorochroman-4-yl)oxy)-N,N-2-trimethyl-1H-benzo[d]imidazole-6-carboxamide as Example 2 (paragraph [0400]):
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. The art further discloses that the compounds therein may be administered orally (paragraph [0251]-[0270]) and notes that for tablet dosage forms, a disintegrant is generally used in the formulation, with croscarmellose sodium, sodium starch glycolate and lower alkyl-substituted hydroxypropylcellulose specifically disclosed as 3 of only 11 possible disintegrants. The art explicitly teaches that the amount of the disintegrant is from 1 to 25 wt%, preferably 5 to 20 wt%, which falls completely inside the range recited in instant claim11. The prior art additionally teaches additional ingredients for oral formulations such as tablets and capsules, which are binders, fillers or lubricants. “Binders are generally used to impart cohesive qualities to a tablet formulation. Suitable binders include microcrystalline cellulose, gelatin, sugars, polyethylene glycol, natural and synthetic gums, polyvinylpyrrolidone, pregelatinized starch, hydroxypropyl cellulose and hydroxypropyl methylcellulose. Tablets may also contain diluents, such as lactose (monohydrate, spray-dried monohydrate, anhydrous and the like), mannitol, xylitol, dextrose, sucrose, sorbitol, microcrystalline cellulose, starch and dibasic calcium phosphate dehydrate (see paragraph [0257]) (pertaining to instant claims 13 and 14). Further, “tablets also generally contain lubricants such as magnesium stearate, calcium stearate, zinc stearate, sodium stearyl fumarate, and mixtures of magnesium stearate with sodium lauryl sulphate” (see paragraph [0259]). Thus, the prior art recites the particular excipients
Ascertaining the differences between the prior art and the claims at issue
There is no specific example where a formulation contains both the claimed compound and a disintegrant as claimed.
Resolving the level of ordinary skill in the pertinent art
It would have been prima facie obvious for the skilled artisan to select from the compounds described as being particularly preferable for the purpose describe in the prior art, as well as using those preferable exemplified compounds to treat include in the formulations described therein. The prior art provides a finite list of predictable solutions, where there would have been a reasonable expectation of success in using the compounds of the prior art for the utility disclosed therein.
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Accordingly, it would not have been considered inventive for the skilled artisan to follow the explicit suggestion of the prior art to formulate exemplary compounds with disintegrants, binders, fillers, and/or lubricants as described when such are taught as being commonly used components for oral formulations of the anticipatory compounds, and combining the ingredients to arrive at the instantly claimed product. The ingredients are used for their well-known purposes described in the prior art. The skilled artisan would have reasonably expected success in preparing these oral formulations since the prior art teaches that such preparations are within the scope of the contemplated invention.
As such, the optimizations made in the instant claims are obvious in view of the prior art teachings. In the absence of showing unobvious results, it would have been obvious to one of ordinary skill in the art at the time of the invention when faced with the prior art that to conduct the methods of the instant claims with a reasonable expectation of success in doing so.
Claim Rejections – 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 10-11 and 13-16 are rejected on the ground of nonstatutory double patenting over Claims 1-7 of US Patent 11,576,898.
Claims 10-11 and 13-16 are provisionally rejected on the ground of nonstatutory double patenting over Claims 10-18 of US Patent Application 19/442,876.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented and copending claims are drawn to a tablet for oral administration comprising the same active ingredient as instant Formula 1, and at least one disintegrant selected from croscarmellose sodium, sodium starch glycolate and low-substituted hydroxypropylcellulose. The patented claims go on to recite particular amounts of the disintegrant, as well as particular binders, fillers and lubricants where are identical in scope to those of the instant claims. Further, the patented and copending claims which recite a tablet having the same components as the instant claims, with the added property of
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, the patented and copending claims anticipate the products recited in the instant claims. Therefore, a double patenting rejection is appropriate.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. 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.
/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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