DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Amendments to the Claims and Arguments/Remarks filed 26 February 2026, in response to the Office Correspondence dated 26 November 2025, are acknowledged.
The listing of Claims filed 26 February 2026, have been examined. Claims 1, 3, 4, 6-13, 15 and 16 are pending. Claim 1 is amended and is supported by the originally-filed disclosure. Claims 2, 5, and 14 are canceled and no new claims have been added.
Response to Amendment
The applicant traverses the obviousness rejections over Kweon, Ahn, Kamali, and Matsumoto, arguing that the prior art does not teach the claimed formulation structure. Based on the amendment to the base claim 1, requiring the additional limitation that the lubricant be on the inside and outside of the granules, a new ground of rejection under 35 U.S.C. § 103 are made to address the new limitation.
The applicant requests that the provisional double patenting rejection be held in abeyance or withdrawn under MPEP 804.I.B.1(b)(i) because the reference application has a later filing date. The applicant’s request is denied. The provisional nonstatutory double patenting rejection is maintained.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 26 November 2025, since the art which was previously cited continues to read on the amended/newly cited limitations.
Claim Rejections – Nonstatutory 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).
Claims 1, 3, 4, 6-13, 15 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, and 8-14 of co-pending US Application No. 18/015,278 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims teach the same limitations, with one of the three key differences being the concentration range of 1-5 wt % sodium stearyl fumarate, based on the total weight of the composite formulation, versus the 3-8% range of the instant claim 1. The claimed ranges overlap (i.e., 3-5%) and are adjacent, suggesting that one of ordinary skill in the art would recognize these ranges as interchangeable without requiring an inventive step (see MPEP § 2144.05, Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions). Further, in the absence of evidence demonstrating a critical difference in a 3-8% range, providing unexpected and materially different properties compared to a 1-5%, the adjustment is merely an obvious optimization within a predictable range.
In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990) supports that minor range adjustments are obvious where the prior art suggests a general range and no unexpected results are shown and In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003) supports that overlapping ranges create a presumption of obviousness unless the applicant proves criticality.
The second difference being the specification of a composite formulation with a form of about 5-15 mm width and length and a thickness of about 3-8 mm, per the limitation of instant claim 9. Wherein, reference claim 8 discloses composite formulations in the form of a tablet and it is known in the art that tablets can encompass compressed pharmaceutical dosage formulations of all shapes and sizes (evidentiary reference: Kamali as cited above on page 5, column 7, second to last paragraph) and further, that the instant claimed dimensions are within a common dimensional range for oral tablets. Thus, in the absence of evidence demonstrating the criticality of the claimed dimensions (see In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366, Fed. Cir. 1997), it would be obvious to one of ordinary skill to use common dimensional range for oral tablets.
The third and final difference being that of instant claim 14 to that of reference claim 12 in which the two active ingredients are prepared and separately granulated followed by mixing rather than being mixed and granulated together. The change in the sequence of adding ingredients and making a step separable, without providing evidence of criticality of this change or any change in outcome is rendered obvious.
In reBurhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) established that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In reGibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) teaches that the selection of any order of mixing ingredients is prima facie obvious. Further, regarding making separable processing steps, under KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007) and In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), separating a manufacturing process into modular or distinct steps as a matter or predictable and routine modification (e.g., for efficiency, scalability, or ease of implementation) and is considered obvious.
Thus, in summary, the claims of the instant application are not patentably distinct from the claims of the reference application. The differences, including the specific 3-8 wt% lubricant range versus a 1-5 wt% range in the reference, and the specific tablet dimensions, are considered obvious variations given the overlap and lack of patentably distinct significance of the adjustments in minor lubricant range change, specification of a format dimensional range, and separation of parts in the method of making, the claims are not separately patentable.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. To overcome this rejection, the applicant may file a Terminal Disclaimer to obviate double patenting concerns, where applicable, demonstrate criticality by providing comparative data showing unexpected results (i.e., 3-8% range compared to 1-5% and tablet dimensions), or amend the claims to recite a non-overlapping range and provide evidence of non-obviousness.
New Rejections
The following new rejections are made from the previous Office Correspondence dated 26 November 2025, as the Applicant's amendment necessitated the new grounds of rejection presented below based on the amended/newly cited limitations.
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-AlA 35 U.S.C. § 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AlA) 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, 4, 6-13, 15 and 16 are rejected under 35 U.S.C. § 103 as being unpatentable over Kweon (WO-2018124497-A1; published 05 July 2018) in view of Ahn (KR-20190130432-A; published 22 November 2019), Kamali (US-8414921-B2; published 09 April 2013), Thakur and Qiu (US-20130090344-A1; published 11 April 2013, hereinafter referred to as “Thakur”), Gerteis (US-20170173911-A1; published 22 June 2017), and Louw (M.Sc. Thesis, North-West University; published 2003).
Regarding instant claim 1, Kweon teaches a composite pharmaceutical formulation comprising a DPP-4 inhibitor (citagliptin [sitagliptin]; claim 4) and an SGLT2 inhibitor (dapagliflozin; claim 1) prepared as dry granules (page 15, ¶[0050]; exemplified dry granule mixing of SGLT2 inhibitor dapagliflozin and DPP-4 inhibitor in Examples 4-7 ¶[0061]-[0063]), which was ultimately tableted but, wherein the composite preparation may be formulated as granules (page 13, ¶[0040]). Kweon further teaches the use of lubricants, including magnesium stearate, in its formulations (page 9, ¶[0022]), and exemplifies formulations with a total lubricant amount of 3 and 6 wt% (Table 2, ¶[0065]), which falls within the claimed range of 3-8 wt%. However, Kweon does not explicitly teach the use of sodium stearyl fumarate as the lubricant and wherein the lubricant is on the inside and the outside of the dry granules.
Thakur teaches a solid pharmaceutical composition prepared by dry granulation (roller compaction). The process explicitly includes adding a lubricant (magnesium stearate) both before roller compaction (intragranular) and after roller compaction (extragranular; Process B, ¶[0034]-[0048] and Examples 1–5). Thakur teaches a lubricant amount of 0.1 to 10 wt% (claim 1), which encompasses the instant claimed 3-8 wt% range. Thakur also teaches that dry granulation overcomes sticking during manufacturing (¶[0024]).
Gerteis is directed to external lubrication of press rolls in a roller compaction device to prevent sticking/caking of powder/ribbon residues (Abstract; ¶[0010]. Gerteis teaches that reducing internal lubricant (e.g., magnesium stearate) below 0.3% causes sticking, but that external roll coating with magnesium stearate prevents sticking while allowing internal lubricant to be drastically reduced (¶[0011], ¶[0021]-[0027]). Gerteis thus provides a direct solution to the roller sticking problem that the applicant alleges is solved by the claimed instant invention.
Louw teaches that sodium stearyl fumarate (Pruv®) is a suitable lubricant and does not have the disadvantages of magnesium stearate regarding tablet strength, disintegration, and dissolution (Abstract). Critically, Louw demonstrates that sodium stearyl fumarate increased tablet strength with continuous mixing (opposite of magnesium stearate) and that formulations with sodium stearyl fumarate showed an average 50% increase in drug release compared to magnesium stearate (Summary/Conclusions). Thus, Louw provides an affirmative teaching of sodium stearyl fumarate’s superior properties and a strong motivation to substitute sodium stearyl fumarate for magnesium stearate.
Ahn teaches a composite formulation of a DPP-4 inhibitor (linagliptin) and an SGLT2 inhibitor (dapagliflozin). Ahn explicitly identifies sodium stearyl fumarate as a suitable lubricant (glidant) for such formulations in the alternative to magnesium stearate (pages 13-14, ¶[0053]-[0054]). Ahn thus provides the motivation to substitute the lubricant in a similar dual-agent antidiabetic formulation.
Further, Kamali teaches a composite formulation comprising sitagliptin and metformin and explicitly discloses dry granulation as a method of preparation (page 2, column 3, lines 7-11; column 4, lines 63-67; processing steps described on page 4, column 8, lines 32-51). Kamali also teaches the use of lubricant/glidants in the composite formulations, including sodium stearyl fumarate in the alternative to magnesium stearate (page 3, column 5, lines 4-9) in a range of "about 0.1 to 10% by weight" (claim 1 and 21), which encompasses the claimed 3-8 wt% range.
Regarding instant claims 4, 6, 7, 10, 11, and 12, Kweon explicitly discloses the use of dapagliflozin L-proline (claim 1), various excipients such as low-substituted hydroxypropyl cellulose (claim 11), formulation also as a tablet or capsule (claim 19), specific weight percentages for sitagliptin and dapagliflozin that fall within the claimed ranges (Table 2, ¶[0065]), and the inclusion of metformin (claim 2). Therefore, these dependent claims do not add patentable weight over the combination applied to claim 1.
Regarding instant claim 8, Kweon teaches granules comprising active ingredients as described above for instant claim 1. Kamali teaches dry granulation, which inherently produces "compacted granules" when a roller compactor is used. It would have been obvious to use the dry granulation technique of Kamali to produce the granules of Kweon.
Regarding instant claim 9, Kweon teaches tablets (page 9; ¶[0025]). Kamali defines a "tablet" as encompassing "compressed pharmaceutical dosage formulations of all shapes and sizes" (page 4, column 7, lines 58-60). The claimed dimensions of 5-15 mm width/length (diameter for a round tablet is also 5-15 mm) and 3-8 mm thickness, represent a common and conventional size range for oral tablets (see evidentiary reference Hummler et al., Influence of Solid Oral Dosage Form Characteristics on Swallowability, Visual Perception, and Handling in Older Adults. Pharmaceutics. 2023 Apr 21;15(4):1315; page 3, Table 1 dimensions). In the absence of evidence demonstrating the criticality of these specific dimensions, their selection is considered an obvious, routine design choice (see In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366, Fed. Cir. 1997).
Regarding instant claims 13, 15, and 16, Kweon teaches a composite formulation of sitagliptin and dapagliflozin. Kamali provides a detailed dry granulation method comprising blending actives and excipients and lubricants, dry granulating with a roller compactor, adding a lubricant to the granules, and then tableting the mixture (page 4, column 8, lines 32-53). It would have been obvious to apply this established dry granulation method to the active ingredients disclosed in Kweon, wherein the choice of lubricant as sodium stearyl fumarate as a substitute for the magnesium stearate lubricant used by Kweon is taught by Ahn and Kamali with use of an about 0.1-10 wt% range (as described above), in which the specific choice of the instant claim of 3-8 wt% is encompassed within and arriving at such would be a matter of routine experimentation.
The claimed invention is a dry granule composite of sitagliptin and dapagliflozin with sodium stearyl fumarate as a lubricant inside and outside the granules in an amount of 3-8 wt%. Thakur teaches every element of the claimed invention except the specific APIs (sitagliptin/dapagliflozin) and the specific lubricant of sodium stearyl fumarate instead of magnesium stearate. Thakur teaches, dry granulation (roller compaction), split lubrication as lubricant added before roller compaction (intragranular) and after roller compaction (extragranular), lubricant amount of 0.1-10 wt%, which encompasses 3-8 wt% and that dry granulation overcomes sticking problems.
Kweon supplies the missing APIs of sitagliptin and dapagliflozin in a dry granule formulation (¶ [0061]-[0063]; Table 2). Kweon also teaches a lubricant amount of 3-6 wt%, which falls within the instant claimed range. Ahn and Kamali teach that sodium stearyl fumarate is a suitable lubricant for DPP-4/SGLT2 inhibitor combinations and for sitagliptin formulations, respectively.
Louw provides a powerful, specific motivation to substitute sodium stearyl fumarate for magnesium stearate. Louw explicitly teaches that stearyl fumarate for magnesium stearate is superior to magnesium stearate in terms of tablet strength and drug dissolution (average 50% increase). A person of ordinary skill in the art seeking to improve Thakur’s formulation would have been strongly motivated to use sodium stearyl fumarate based on Louw’s clear comparative data. Gerteis teaches that external roll lubrication prevents sticking/caking and improves manufacturability. A person od ordinary skill in the art would have been motivated to combine Gerteis’s external roll coating with Thakur’s split-addition process to address the very roller sticking problem identified by the applicant.
Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to take Thakur’s dry granulation split-lubrication process and substitute the APIs with sitagliptin and dapagliflozin as taught by Kweon and substitute magnesium stearate with sodium stearyl fumarate based on Louw’s teaching of sodium stearyl fumarate’s superior properties, and Ahn/Kamali’s teaching that sodium stearyl fumarate is suitable for such combinations. In addition to applying Gerteis’s external roll lubrication to further prevent sticking. Optimizing the specific amount of lubricant to the lubricant amount to 3-8% within Thakur’s 0.1-10 wt% range would be a matter of routine experimentation.
The instant dependent claims (4, 6-13, 15, 16) recite routine variations or features explicitly disclosed in the prior art wherein Kweon teaches dapagliflozin L-proline (claim 1), Thakur teaches microcrystalline cellulose, mannitol, crospovidone and cellulose binders (¶[0017]-[0019]) and Kweon teaches croscarmellose. Thakur teaches tablets and capsules (Examples 1-5), Thakur’s dry granulation inherently produces compacted granules, Kweon teaches sitagliptin and dapagliflozin amounts falling within the instant claim 10 and 11 ranges (Table 2), Kweon teaches a three-drug combination including metformin (claim 2), and Thakur’s Process B explicitly teaches instant claim 13, 15 and 16 method steps (a), (b), and (c) with roller compaction and tableting. Wherein, applying standard tablet dimensions would be a matter of routine optimization well within the ability of one of ordinary skill in the art.
Claims 1 and 3 are rejected under 35 U.S.C. § 103 as being obvious over Kweon (WO-2018124497-A1; published 05 July 2018) in view of Ahn (KR-20190130432-A; published 22 November 2019), Kamali (US-8414921-B2; published 09 April 2013), Thakur and Qiu (US-20130090344-A1; published 11 April 2013, hereinafter referred to as “Thakur”), Gerteis (US-20170173911-A1; published 22 June 2017), and Louw (M.Sc. Thesis, North-West University; published 2003), in further view of Matsumoto (WO2017126524A1; publication date 27 July 2017).
The limitations of instant claim 1 are taught by Kweon in view of Ahn, Kamali, Thakur, Gerteis, and Louw, as outlined above, however they do not explicitly disclose the use of sitagliptin phosphate hydrate as per the limitation of instant claim 3, which depends from instant claim 1.
Regarding instant claim 3, the combination of Kweon, Ahn, Kamali, Thakur, Gerteis, and Louw is applied as in the new rejection above. Matsumoto teaches the use of sitagliptin phosphate hydrate as a dipeptidyl peptidase 4 inhibitor in a combination diabetes pharmaceutical formulation (see claim 8). Thus, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to use the phosphate hydrate form of sitaglptin in to the composite formulation of the invention by Kweon because sitagliptin phosphate hydrate was known in the art at the time of the invention as a commercially relevant phosphate hydrate form of sitagliptin, as taught by Matsumoto, and used for similar pharmaceutical composite preparations for oral administration combining active ingredients for the treatment of type 2 diabetes.
Response to Arguments
Applicant Arguments/Remarks of the reply, filed 26 February 2026, have been fully considered. The applicant traverses the obviousness rejections over Kweon, Ahn, Kamali, and Matsumoto, arguing that the prior art does not teach the claimed formulation structure. Based on the amendment to claim 1, requiring the additional limitation that the lubricant be on the inside and outside of the granules, the examiner has issued new 35 U.S.C. § 103 rejections to address the new claim limitation.
The applicant argues that Kweon does not teach both APIs inside granules and lubricant inside/outside. Kweon explicitly teaches dry granulation of both active ingredients together. In Kweon, Examples 4-7 describe mixing dapagliflozin and sitagliptin with excipients, followed by roller compaction (dry granulation) (¶[0061]-[0063]). The fact that Kweon’s preferred embodiment places dapagliflozin outside does not negate that Kweon fully enables and suggests dry granulating both APIs together.
Also, the applicant’s own alleged unexpected results are discussed, but it bears noting that the comparison in the applicant’s new data is between a formulation with no internal lubricant (Comparative Example A) and formulations with internal lubricant (Examples A-F). The prior art Kamali already teaches internal lubrication. Thus, the comparison is not against the closest prior art, but against a less optimal embodiment.
However, Thakur explicitly teaches the split-lubrication structure of lubricant inside and outside. A person of ordinary skill in the art would have been motivated to combine Thakur’s process with Kweon’s APIs. The combination of Thakur and Kweon directly teaches the claimed structure.
The applicant argues that Ahn and Kamali merely list sodium stearyl fumarate as an option without using it in working examples.
And that structural differences between linagliptin (Ahn) and sitagliptin (Kweon) would discourage substitution of sodium stearyl fumarate. This argument ignores settled case law. The fact that two compounds belong to the same pharmacological class provides strong motivation to combine teachings (see, e.g., In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012), wherein structural similarity between chemical compounds is not required where they share a common utility). Ahn teaches sodium stearyl fumarate as a suitable lubricant for a DPP-4 inhibitor/SGLT2 inhibitor combination. Sitagliptin is a DPP-4 inhibitor. A person of ordinary skill in the art seeking to improve Kweon’s formulation would logically turn to Ahn’s teaching on lubricants for the exact same class of drug combination.
Further, the applicant’s assertion that structural differences create unpredictability is unsupported by evidence. The applicant has provided no data showing that sitagliptin and linagliptin behave differently with respect to sodium stearyl fumarate compatibility. Without such evidence, the argument is mere attorney speculation, which cannot overcome a prima facie case of obviousness (see In re De Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)).
Kamali further supplies motivation because it teaches sodium stearyl fumarate specifically with sitagliptin, the exact API used by the applicant. Even if the applicant disputes the relevance of metformin as a co-ingredient, Kamali’s teaching that sodium stearyl fumarate is compatible with sitagliptin is directly on point. A person of ordinary skill in the art would reasonably expect that what works for sitagliptin in a metformin combination would also work for sitagliptin in a dapagliflozin combination, absent evidence of a specific incompatibility, which the applicant has not provided.
Moreover, Louw provides actual comparative data showing sodium stearyl fumarate’s superiority over magnesium stearate (e.g., 50% increase in drug release). A person of ordinary skill in the art seeking to optimize a dry granulation formulation would be strongly motivated to select sodium stearyl fumarate based on Louw’s teachings.
The fact that Louw relates to direct compression, not dry granulation, is not dispositive. A person of ordinary skill in the art would reasonably expect sodium stearyl fumarate’s advantageous properties (e.g., hydrophilicity, less impact on dissolution) to translate across different manufacturing methods (see In re Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012), wherein teachings from one art area can be applied to another where reasonably pertinent).
The applicant has submitted additional experimental data (Table A, Table B, Figure A) purporting to show that including sodium stearyl fumarate inside dry granules dramatically improves granule yield (from 75.6% to >95%). This evidence fails to overcome the obviousness rejection because the comparison is flawed. Comparative Example A uses no internal sodium stearyl fumarate. But the prior art already teaches internal lubrication. Thus, the applicant is not comparing the claimed invention to the closest prior art, yet is comparing it to a deliberately deficient formulation. The applicant has not compared the claimed invention to a formulation representing the combined teachings of the prior art (see In re Baxter-Travenol, 952 F.2d 388 (Fed. Cir. 1991).
Moreover, the improvement in granule yield (75.6% to >95%) is exactly what a person of ordinary skill in the art would expect from adding an internal lubricant. The mere fact that a claimed composition works better than an inferior formulation does not make it non-obvious. Gerteis explicitly teaches that internal lubricant prevents sticking. This is a predictable result, not an unexpected one.
In addition, the applicant has not submitted the promised Declaration under 37 C.F.R. § 1.132. The Office cannot consider evidence that has not been filed. The applicant’s statement that a declaration is “in the process of being obtained” does not constitute evidence. The record currently contains only the applicant’s own unsupported assertions regarding the experimental data.
Yet, even if the data were properly submitted, they would not demonstrate criticality of the 3-8 wt% range because the data include Examples A-F with internal sodium stearyl fumarate ranging from 1-5% (Table B). Example A, for instance, uses only 1% internal sodium stearyl fumarate (4 mg in a 400 mg tablet) and still achieves 96.8% yield. Thus, the data actually suggest that any amount of internal sodium stearyl fumarate, even as low as 1%, improves yield, and undermines any assertion that the claimed 3-8 wt% total sodium stearyl fumarate (including both internal and external) is critical. In addition, Table B shows that formulations with 1% internal sodium stearyl fumarate, which, when combined with 8% external sodium stearyl fumarate, totals 9% overall, which is outside the claimed range and still achieves a high granule yield.
In addition, regarding the applicant’s assertion that that the 3-8 wt% range is critical, Thakur teaches a lubricant range of 0.1-10 wt%, fully encompassing the claimed 3-8 wt% range and Kamali strongly overlaps with the claimed range. Under In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), overlapping ranges create a presumption of obviousness. The specification’s Comparative Examples show that at <3 wt%, tableting defects occur (e.g., sticking), and at >8 wt%, dissolution decreases. But these are precisely the types of routine optimization that a person of ordinary skill in the art would expect. Every formulation has an optimal lubricant concentration, wherein too little causes sticking and too much causes dissolution problems. Finding the optimal range within a known range is obvious, not invention (see In re Boesch, 617 F.2d 272, 276 (CCPA 1980), wherein optimization of a known range is prima facie obvious).
The applicant has not provided comparative data showing that 3-8 wt% produces unexpected results compared to amounts just outside the range (e.g., 2.5 wt% or 8.5 wt%). The specification’s Comparative Examples 5-8 show results at the extremes but do not demonstrate a discontinuous threshold at exactly 3 wt% or 8 wt%. Without such data, the range is merely an optimization. The alleged deficiencies outside the range (e.g., dissolution, stability) are typical optimization trade-offs, not evidence of criticality. Accordingly, the claimed range is considered the result of routine optimization of a known variable.
The applicant argues unpredictability due to dual-API dry granulation. The relevant inquiry is reasonable expectation of success, not certainty. The prior art collectively teaches dual API systems (Kweon, Ahn), dry granulation (Kamali), sodium stearyl fumarate lubricant substitution (Ahn, Kamali, Louw). Thus, the claimed invention represents combination of known elements yielding predictable results.
The new §103 rejection based on Thakur, Gerteis, Louw, Kweon, Ahn, and Kamali is well-founded. The prior art collectively teaches every limitation of the claims, and a person of ordinary skill in the art would have had a reasonable expectation of success in combining these teachings. The applicant’s arguments regarding unexpected results and criticality are not supported by evidence commensurate with the scope of the claims. For the reasons set forth herein and in the previous Office Action, claims 1, 3, 4, 6-13, 15, and 16 remain rejected under 35 U.S.C. § 103.
The provisional double patenting rejection is maintained. As stated in the previous Office Action, MPEP 804.I.B.1(b)(i) provides that a terminal disclaimer is unnecessary only after all other rejections are overcome and examination is otherwise in condition for allowance. The present application still contains outstanding rejections under 35 U.S.C. § 103. Therefore, it is not yet in condition for allowance, and the provisional double patenting rejection remains proper and is maintained.
The applicant is advised that a terminal disclaimer over the reference application will be required before allowance, unless the applicant amends the claims to be patentably distinct or demonstrates criticality.
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 nonprovisional extension fee (87 CFR 1.17(a)) 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.
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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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