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 .
Change of Examiner
Applicant is advised that the Examiner assigned to the prosecution of the instant application has changed.
Status of the Claims
This action is in response to papers filed 1/21/2026 in which claim 76 was withdrawn; claims 20 and 78 were cancelled; and claim 14 was amended. All the amendments have been thoroughly reviewed and entered. Claims 14-19, 21-22, 25-31, 53-60, 71 and 79-80 are under examination.
Response to Amendment
The Applicant's amendments and/or arguments filed 1/21/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered but they are not persuasive.
All 103 rejections are maintained/modified in light of amendment.
The non-statutory double patenting rejections over US Patent No. 11963947 are withdrawn.
The non-statutory double patenting rejections over the following patents are maintained/modified in light of amendment:
US Patent No. 11963947 in view of Lopez
US Patent No. 11266630 in view of Lopez and Agneta
US Patent No. 11666556 in view of Lopez and Agneta
103 rejections over Chen in view of Lopez and Agneta
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Applicant argues that the focus of Lopez is one specific glucokinase (GK) activator, and that the cited references fail to suggest that any DPP-IV inhibitor can be combined with any GK activator. This is not persuasive. In the Office Action dated 10/22/2015, the Examiner pointed out that Lopez teaches pharmaceutical compositions comprising GK activators in combination with other diabetic treating compounds, including DPP-IV inhibitors, such as such as sitagliptin, vildagliptin, saxagliptin, linagliptin, etc. [pg. 11 of OA]. The Examiner cited to the Abstract and columns 1-2 of Lopez, wherein Lopez teaches compositions comprising one or more GK activators and anti-diabetic drugs, including DPP-IV inhibitors, for the treatment of type 2 diabetes and related disorders [col. 1 lines 58-60]. Lopez states that exemplary GK activators include FRI-1 or those disclosed in WO 05/066145 [col. 3 line 41]. Chen similarly teaches a GK activator, HMS5552, for the treatment of diabetes, and discusses the role of GK activators in treating type 2 diabetes and related disorders such as hyperglycemia [col. 2 line 7-30]. Lopez further teaches that DPP-IV inhibitors are diabetic drugs that inhibit the action of dipeptidyl peptidase IV from cleaving dipeptides located at N-terminal portions of proteins having either an N-terminal praline or alanine residue, which serves to enhance the production of insulin [col. 1-2]. One of ordinary skill in the art would understand that classes of compounds with the same mechanism of action and same resulting function could predictably be substituted for one another for the same purpose. Taken together, a skilled artisan would have combined a known GK activator such as HMS5552 with the DPP-IV inhibitors taught in Lopez, including saxagliptin, with a reasonable expectation of success, because the prior art teaches that these compounds are useful for treating type 2 diabetes and related disorders. Accordingly, even though the individual references do not explicitly teach the specifically claimed combination of HMS5552 and saxagliptin, a skilled artisan would recognize that a combination of a GK activator and DPP-IV inhibitor would predictably be able to treat type 2 diabetes are related disorders. Substitution of equivalents known for the same purpose is prima facie obvious, thus the combined teachings of Chen and Lopez would prompt a skilled artisan to select a known GK activator such as HMS5552 and a known DPP-IV inhibitor such as saxagliptin to arrive at the instantly claimed combination. See MPEP 2144.06.
Furthermore, "[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Both GK activators and DPP-IV activators are known in the art for the treatment of diabetes and disorders relating to glucose regulation such as hyperglycemia and impaired glucose tolerance, thus it would be obvious to one or ordinary skill to combine these compounds for the same purpose. Applicant’s argument that that Chen in view of Lopez does not make obvious the use of GK activators, as a class of compounds, with diabetic drugs such as DPP-IV inhibitors, is therefore not persuasive.
Applicant also argues that the Office has not established that the result of combining HMS5552 with DPP-IV inhibitors would have been predictable to those skilled in the art. This is not persuasive. In the Office Action dated 10/22/2015, the Examiner cited to Lopez, columns 6-7, wherein they discuss the unexpected finding of synergistic effects between GK activators and DPP-IV inhibitors in modifying glucose metabolism and controlling body weight in subjects with impaired glucose metabolism [col. 6-7]. The OA dated 10/22/2025 also cites to columns 7-9 wherein Lopez discusses the dosages of GK activator and sitagliptin. Lopez teaches that sitagliptin, in amounts that would be suboptimal if administered alone, can still confer a therapeutic benefit when combined with a GK activator [col. 8-9]. As discussed above, the teachings of Chen in view of Lopez are sufficient to motivate a skilled artisan to select the instantly claimed combination of compounds as functional equivalents, and substitution of equivalents for the same purpose is prima facie obvious. Thus, the result of combining HMS5522 with DDP-IV to yield synergistic effects would have been predictable to a skilled artisan in light of the prior art.
Finally, Applicant has submitted data purportedly demonstrating unexpected results. This is not persuasive. An applicant bears the burden of proving unexpectedly good results. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). When unexpected results are used as evidence of non-obviousness, the results must be shown to be unexpected compared with the closest prior art. In re Baxter Travenol Labs, 952 F.2d 388, 392, 21 USPQ2d 1281, 1285 (Fed. Cir. 1991); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196, (Fed. Cir. 1984). In order for the comparison to be valid, the closest prior art and the claimed invention must be tested under substantially the same conditions, and test results must include results of the test performed on the invention as claimed an on the closest prior art. Here, applicant has not provided this comparison. Furthermore, the data presented is not commensurate in scope with the instant claims. The data presents only a 1:1 ratio of HMS5552 to saxagliptin whereas the instant claims recite, for example, weight ratios of glucokinase activator to DPP-IV activator of about 1:10 to 100:1, about 1:4 to 40:1, and about 1:4, about 1:2, about 1:1, about 1.5:1, about 1.5:2, about 2:1, about 5:1, about 10:1, about 15:1, about 20:1 or about 40:1. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the " objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. See MPEP 716.02(d). Thus, the data provided by applicant is not sufficient to demonstrate unexpected results.
Non-statutory double patenting rejections
Applicant reiterates the arguments set forth in their remarks regarding the 103 rejection. As the same rationale (as above) is applicable, the discussion will not be repeated herein.
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 14-19, 21-22, 25-31, 53-60, 71, and 79-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11963947 in view of US 10004782 to Lopez et al.
The above patented claims do not recite the specific DPP-IV inhibitor, saxagliptin, of the instant claims 14-19, 21-22, 25-31, 53-60, 71, and 79-80.
Lopez teaches pharmaceutical compositions comprising glucokinase activator for treating diabetes, in combination with other diabetic treating compounds such as DPP- IV inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin etc.), metformin, or exenatide [Abstract, col. 1-2]. Lopez teaches glucokinase activator such as FRI-1 [col. 3, line 33-49], and DPP-IV inhibitors such as those listed in the instant claims [col.3, line 64-67]. Lopez also teaches different excipients such as those claimed in the instant application and also taught by Chen [col. 6]. Lopez teaches synergistic effects with a combination of glucokinase activator and other diabetic medications such as DPP-IV inhibitors, metformin, etc. [col. 6-7].
Therefore, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to employ saxagliptin as a DPP-IV inhibitor in combination with the GK inhibitor HMS5552 because Lopez teaches saxagliptin and sitagliptin as equivalent in their DPP-IV inhibition effect and suggests synergistic effects of a combination of GK activator and DPP-IV inhibitor. Therefore, one of an ordinary skill in the art would have expected that substitution of sitagliptin with saxagliptin or further including saxagliptin along with sitagliptin still provides DPP-IV inhibitory effect along with the GK activator.
Claims 14-19, 21-22, 25-31, 53-60, 71, and 79-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11266630 in view of US 10004782 to Lopez et al. and WO 2011060290 to Agneta et al. (cited on IDS).
US ‘630 patent claims are directed to a solid dispersion comprising glucokinase activator, HMS5552 (of instant claims), in combination with a polymer carrier, which is Eudragit. Patented claims recite the glucokinase activator and polymer ratio that is within the claimed ranges. Further, patented claims recite the excipients such as disintegrants, lubricants etc., which are also claimed in the instant application.
Patented claims do not recite instant DPP-IV inhibitors and the exact amounts of excipients of instant dependent claims.
Lopez teaches pharmaceutical compositions comprising glucokinase activator for treating diabetes, in combination with other diabetic treating compounds such as DPP- IV inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin etc.), metformin, or exenatide [Abstract, col. 1-2]. Lopez teaches glucokinase activator such as FRI-1 [col. 3, line 33-49], and DPP-IV inhibitors such as those listed in the instant claims [col.3, line 64-67]. Lopez also teaches different excipients such as those claimed in the instant application and also taught by Chen [col. 6]. Lopez teaches synergistic effects with a combination of glucokinase activator and other diabetic medications such as DPP-IV inhibitors, metformin, etc. [col. 6-7].
Agneta teaches pharmaceutical formulation comprises: a sodium dependent glucose transporter 2 (SGLT2) inhibitor or its salt or solvate; metformin or its salt or solvate; and optionally a coating, where the pharmaceutical formulation is an immediate release formulation and is in the form of a tablet, stock granulation, or capsule, for treating type II [Abstract, page 1]. The active agents in the composition includes SGLT2 inhibitor [page 2], metformin [page 4, line 29-31], and further teaches combining glucokinase activator as an anti-diabetic [page 30, line 15-16] with the sodium dependent glucose transporter 2 (SGLT2) inhibitor and metformin. Agneta also teaches excipients such as those claimed including Opadry® coating (see page 5, line 24 and throughout the reference).
Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to further modify the solid dispersions of the above patent (‘630) by including DPP-IV inhibitors, in the amounts taught by Lopez, and further choose the suitable amounts of excipients taught by Lopez and Agneta so as to arrive at the instant claims. One of an ordinary skill in the art would have been motivated to arrive at the instant combination of HMS5552 and DPP-IV inhibitors because Lopez teaches synergistic effects in diabetic treatment by combining glucokinase activator with other anti-diabetic drug such as DPP-IV inhibitor for lowering blood glucose, reducing fasting blood glucose levels, reducing HbA1C etc., particularly with a combination of DPP-IV inhibitor [col. 2, line 34-col. 3, line 3]. Further, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to further modify the claims of the above ‘630 patent (modified by Lopez) by optimizing the amounts of claimed excipients in such a way to achieve the desired effect such as tableting properties such as disintegration, lubrication, binding effect. One of an ordinary skill in the art would have looked to the analogous teachings of Agneta because Agneta suggests pharmaceutical compositions for providing a diabetes treatment, and in this regard, Lopez teaches synergistic effects with glucokinase activator and other diabetic treating drugs such as metformin, DPP-IV inhibitor.
Claims 14-22, 25-31, 53-60, 71 and 78-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11666556 in view of US 10004782 to Lopez et al. and WO 2011060290 to Agneta et al.
Patent ‘556 recites a fixed dose combination formulation, comprising: (a) a glucokinase activator (GK activator) i.e., HMS5552, and repaglinide [claim 15]. The patented claims further recite the excipients such as disintegrants, lubricants, polymer carrier (Eudragit L100) etc., which are also claimed in the instant application. Patented claims lack the instant claimed DPP-IV inhibitor and the amounts of the same. The teachings of Lopez and Agneta are incorporated herewith.
Lopez teaches pharmaceutical compositions comprising glucokinase activator for treating diabetes, in combination with other diabetic treating compounds such as DPP- IV inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin etc.), metformin, or exenatide [Abstract, col. 1-col. 2]. Lopez teaches glucokinase activator such as FRI-1 [col. 3, line 33-49], and DPP-IV inhibitors such as those listed in the instant claims [col.3, line 64-67]. Lopez also teaches different excipients such as those claimed in the instant application and also taught by Chen [col. 6]. Lopez teaches synergistic effects with a combination of glucokinase activator and other diabetic medications such as DPP-IV inhibitors, metformin, etc. [col. 6-7].
Agneta teaches pharmaceutical formulation comprises: a sodium dependent glucose transporter 2 (SGLT2) inhibitor or its salt or solvate; metformin or its salt or solvate; and optionally a coating, where the pharmaceutical formulation is an immediate release formulation and is in the form of a tablet, stock granulation, or capsule, for treating type II [Abstract, page 1]. The active agents in the composition includes SGLT2 inhibitor [page 2], metformin [page 4, line 29-31], and further teaches combining glucokinase activator as an anti-diabetic [page 30, line 15-16] with the sodium dependent glucose transporter 2 (SGLT2) inhibitor and metformin. Agneta also teaches excipients such as those claimed including Opadry® coating (see page 5, l 24 and throughout the reference).
Hence, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to further modify the patented (‘556 patent) fixed dose combination by including DPP-IV inhibitors, in the amounts taught by Lopez, and further choose the suitable amounts of excipients taught by Lopez and Agneta so as to arrive at the instant claims. One of an ordinary skill in the art would have been motivated to arrive at the instant combination of HMS5552 and DPP-IV inhibitors because Lopez teaches synergistic effects in diabetic treatment by combining glucokinase activator with other anti-diabetic drug such as DPP-IV inhibitor for lowering blood glucose, reducing fasting blood glucose levels, reducing HbA1C etc., particularly with a combination of DPP-IV inhibitor [col. 2, line 34-col. 3, line 3]. Further, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to further modify the claims of the above ‘556 patent (modified by Lopez) by optimizing the amounts of claimed excipients in such a way to achieve the desired effect such as tableting properties such as disintegration, lubrication, binding effect. One of an ordinary skill in the art would have looked to the analogous teachings of Agneta because Agneta suggests pharmaceutical compositions for providing a diabetes treatment, and in this regard, Lopez teaches synergistic effects with glucokinase activator and other diabetic treating drugs such as metformin, DPP-IV inhibitor.
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.
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.
Claim(s) 14-19, 21-22, 25-31, 53-60, 71, and 79-80 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/108128 to Chen et al (equivalent to US 11266630 as evidenced from the Bib data of US 11266630) (cited on IDS) in view of US 10004782 to Lopez et al. (Lopez) and WO 2011060290 to Agneta et al. (Agneta).
(US 11266630 has been relied upon as an English translation of WO 2018/108128 to Chen et al.)
Chen teaches an oral solid dispersion and a preparation method containing a glucokinase activator, an isotopic label thereof, or a medical salt thereof and a polymer support, and an excipient [Abstract]. The composition is in the form of a tablet or a capsule, powders etc. [Abstract, col. 2, line 59-67]. Fig. 1 shows absorption of HMS5552 tablet in different sites of intestinal tract of human. Chen teaches that glucokinase plays an important role in blood glucose in balance in human body, and an activated glucokinase is important in treating diabetic patients [col. 2, line 7-30].
Chen particularly teaches instant claimed a glucokinase activators of instant claim 14, including HMS5552 in [col. 10-11] in amount of 10-90% by weight [col.17, line 21-28; col. 32-33], and teaches 1 mg to 200 mg amount [col. 18, line 57-64].
Chen teaches the solid dispersion includes polymer carrier such as Eudragit polymers, in the same ratios of HMS55552 to polymer (of instant claims 18, 19) [col. 15-16]. Chen further teaches the instant excipients such as diluent, sweetener, binders, disintegrants etc., such as those listed in the instant claim 25 [col. 15-16 & col. 34-37]. In particular, Chen teaches instant claimed specific excipients of instant claim 26, coated with the same polymers of instant claims 28-30 [see col. 17, line 29-58]. Further, Chen teaches the amounts of excipients that generally falls within the ranges that falls within the instant claim 31 [col. 18, line 9-35, col. 28].
Chen does not teach the claimed combination of DPP-IV inhibitors such as those listed in claims 14 and 20; and the specific saxagliptin of independent claim 14 and its dependents. Chen also does not teach the exact claimed amounts of excipients of claims 57-60.
Lopez teaches pharmaceutical compositions comprising glucokinase activator for treating diabetes, in combination with other diabetic treating compounds such as DPP- IV inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin etc.), metformin, or exenatide [Abstract, col. 1-col. 2]. Lopez teaches glucokinase activator such as FRI-1 [col. 3, line 33-49], and DPP-IV inhibitors such as those listed in the instant claims [col.3, line 64-67]. Lopez also teaches different excipients such as those claimed in the instant application and also taught by Chen [col. 6]. Lopez teaches synergistic effects with a combination of glucokinase activator and other diabetic medications such as DPP-IV inhibitors, metformin, etc. [col. 6-7]. Lopez discusses the dosages of glucokinase activator, sitagliptin, metformin in columns 7 to 9.
It would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to combine the DPP-IV inhibitors such as sitagliptin, linagliptin, saxagliptin etc., in suitable amounts such as suggested by Lopez, with the glucokinase activator of Chen so as to arrive at the instant combination of HMS5552 and DPP-IV inhibitors because Lopez teaches synergistic effects in diabetic treatment by combining glucokinase activator with other anti-diabetic drug such as DPP- IV inhibitor for lowering blood glucose, reducing fasting blood glucose levels, reducing Hb AIC etc., particularly with a combination of DPP-IV inhibitor [col. 2, line 34-col. 3, line 3].
With respect to the specific amounts of excipients of claims 31 and 53-60, the rejection relies on Agneta et al.
Agneta teaches pharmaceutical formulation comprises: a sodium dependent glucose transporter 2 (SGLT2) inhibitor or its salt or solvate; metformin or its salt or solvate; and optionally a coating, where the pharmaceutical formulation is an immediate release formulation and is in the form of a tablet, stock granulation, or capsule, for treating type II [Abstract, page 1]. The active agents in the composition includes SGLT2 inhibitor [page 2], metformin [page 4, line 29-31], and further teaches combining glucokinase activator as an anti-diabetic [page 30, line 15-16] with the sodium dependent glucose transporter 2 (SGLT2) inhibitor and metformin.
Agneta also teaches excipients such as those claimed including Opadry® coating (see page 5, line 24 and throughout the reference). Thus, it would have been obvious for one of an ordinary skill in the art before the effective filing date of the instant invention to further modify the teachings of Chen (as modified by Lopez) by optimizing the amounts of claimed excipients in such a way to achieve the desired effect such as tableting properties such as disintegration, lubrication, binding effect. One of an ordinary skill in the art would have looked to the teachings of Agneta because of the analogous teachings i.e., Agneta also teaches pharmaceutical compositions for providing a diabetes treatment, and in this regard, Lopez teaches synergistic effects with glucokinase activator and other diabetic treating drugs such as metformin, DPP-IV inhibitor. Hence one of an ordinary skill in the art would have expected to prepare an effective oral composition comprising the doses of GK activators and one of the DPP-IV inhibitors, in the amounts taught by Chen and Lopez respectively, and further suitable amounts of polymeric carrier (Eudragit L100) for providing an effective treatment for diabetes.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 (37 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
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