DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 09/22/2025 has been entered.
Prosecution Reopened
The action is made NON-FINAL.
Prosecution on the merits of this application is reopened on claims 19-20, 22-27, 29, 38-43, 45-46, 48-49 and 51 considered unpatentable for the reasons indicated below:
The claimed composition rather than embodying any inventive concept merely appends a well-known pharmaceutical product with broadly recited conventional pharmacological additives in ratios already described within the same field of endeavor and recites a functional condition which adds little meaning to the claim and in itself is obvious in light of the prior art as dissolution tests are conventionally performed on compounded pharmaceuticals and there is no requisite information within the Specification to demonstrate that the dissolution functional language as claimed, is anything but the inclusion of conventional, predictable scientific principles, materials and methods which are ubiquitously utilized in the art during bioavailability testing of compounded pharmaceuticals and appears merely to be a means to patent an obvious variation of Compound A, previously patented. Thus, absent any showing of an unexpected result, the claims are obvious.
Applicant is advised that the Notice of Allowance mailed 11/10/2025 is vacated. If the issue fee has already been paid, applicant may request a refund or request that the fee be credited to a deposit account. However, applicant may wait until the application is either found allowable or held abandoned. If allowed, upon receipt of a new Notice of Allowance, applicant may request that the previously submitted issue fee be applied. If abandoned, applicant may request refund or credit to a specified Deposit Account.
The indicated allowability of claims 19-20, 22-27, 29, 38-43, 45-46, 48-49 and 51 is withdrawn in view of the newly discovered reference to Azarmi et al. (“Current Perspectives in Dissolution Testing of Conventional and Novel Dosage Forms”, 10/06/2006) (hereinafter Azarmi). Rejections based on the newly cited reference follow.
Status of Claims
Applicant’s elected, without traverse, Group I, claims 1-16, 19-29, 33, 35 and 37 in the reply filed on 06/24/2024. The claims of Groups II-V, as well as claims 1-16, 21, 28, 33, 35, and 37 have been cancelled by Applicants. Therefore, claims 19-20, 22-27, 29, 38-43, 45-46, 48-49 and 51 are pending and examined.
Claim Objections
Claims 24 and 40 are objected to because of the following informalities: “of the of claim 19” in line 1 of each table should be recited as --- of claim 19 ---. Appropriate correction is required.
Claims 24 and 40 are objected to because of the following informalities: immediately prior to “one or more binders” in line 3 of each table and “one of more disintegrants” in line 4 of each table there should be recited --- the ---. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: immediately prior to “more” in the last line there should be recited --- or ---. Appropriate correction is required.
Claim 43 is objected to because of the following informalities: immediately prior to “comprises” in line 2 of the claim there should be recited --- further ---. Appropriate correction is required.
Claim Rejections – 35 U.S.C. § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 19-29, 39, and 41-45 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 2008/0234367 (Washburn et al., 09/25/2008, hereinafter Washburn) in view of US 2007/0249544 Himmelsbach et al., 10/25/2007, hereinafter Himmelsbach), further in view of Azarmi et al. (“Current Perspectives in Dissolution Testing of Conventional and Novel Dosage Forms”, 10/06/2006) (hereinafter Azarmi).
Washburn teaches a tablet formulation for administering SGLT2 inhibitors (¶¶0147-0152). The formulation includes 1-350mg SGLT2 inhibitor; a filler (diluent), such as lactose or mannitol, at about 0% to 90% (¶0150); a binder, such as wax, at less than 500 microns at about 0% to 35% (¶0151); disintegrants at 0%-20% (¶0157); tableting lubricants at about 0.2% to 8% (¶0152); glidants (¶0152); a coating at 0%-15% comprising one or more film-formers or binders and plasticizers (¶0153). Washburn teaches formulating the tablets by using e.g. wet granulation to form granules, blending the granules with further excipients (¶0166). In one embodiment, the ratio of the SGLT2 inhibitor to other anti-obesity agent or antidiabetic agent may be about 0.2:1 (¶0035). The lubricant may be magnesium stearate at 0.2-8% (¶0152), the binder may include hydrophilic polymers such as HPMC (¶0153) or lactose (¶0151), the plasticizer may include polyethylene glycol (¶0153), the glidant may be Syloid brand silicon dioxide (i.e. colloidal silicon dioxide) (¶0152), fillers include microcrystalline cellulose at 1-80% (¶0150) and disintegrants include croscarmellose sodium (table 1). The coating may also include titanium dioxide, talc, and colorant (¶0158).
Washburn does not teach that the active ingredient is crystalline 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, also known as empagliflozin, or the use of HPC as the binder.
Himmelsbach teaches a pharmaceutical composition comprising 1mg-100mg of crystalline 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene (i.e. Compound A, which is the same compound as instantly claimed as evidenced by the instant specification at page 11, first row on the table) and one or more conventional carriers and/or diluents (¶¶3 and 61 and Figs 1-2 demonstrating same crystalline structure as instant drawings). Compound A is taught as a SGLT2 inhibitor (¶¶3-4). The composition may be formulated as conventional galenic preparations such as plain or coated tablets, capsules, powders suspensions or suppositories (¶61). The crystalline form allows for high purity of the active ingredient (¶¶5 and 56). Uniform distribution of the medicament in the formulation is a critical factor, particularly when the medicament has to be given in low doses (¶6). To ensure uniform distribution, the particle size of the active substance can be reduced to a suitable level, e.g. by grinding (or micronizing) (¶61).
Washburn and Himmelsbach differ from the instant claims insofar as not disclosing a specific dissolution condition as instantly claimed.
Azarmi demonstrates that pharmaceutical formulations are conventionally modified to optimize dissolution profiles “[n]ovel dosage forms present unique problems in the development of in vitro release technologies simply because of the physiochemical properties of the formulations and the unique physiological environment in which they should release their content” (see entire document, especially ¶ 1-3). Moreover, Azarmi indicates that “..it is necessary to further develop in vitro assays for novel dosage forms and to establish standard protocols for their drug release tests including the use of biorelevant dissolution media…for quality control purposes of certain dosage forms…” (p. 19), such as conventional release tablets, immediate release tablets, extended release tablets, powders, sublingual and buccal tablets, chewing gums and chewable tablets, encapsulated formulations, transdermal delivery systems and suppositories in order to evaluate the release properties of the chemical compounds under various conditions (Id., pp. 13-17). Azarmi further indicates that “… dissolution testing should be a sensitive and a reliable predictor of bioavailability [but] a predictive tool for the in vitro and in vivo dissolution behavior of a dosage form…” (p. 13). Azarmi teaches that conventional approaches for media utilization in typical dissolution profiles include: dilute hydrochloric acid, buffers in the physiologic pH range of 1.2–7.5, simulated gastric fluid (with or without enzymes), simulated intestinal fluid (with or without enzymes), water, and surfactants solutions such as polysorbate 80, and sodium lauryl sulfate (General Chapter (1092), USP 29, Suppl. 2). Table 1 shows examples of different USP dissolution media used for dissolution testing of tablets and capsules. (p. 13, col. 1).
Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have conducted many dissolution tests, producing varying results depending upon the type of pharmaceutical composition and the dissolution test conditions, such as utilizing a multitude of solvents under varying conditions, and arrived at the claimed dissolution profile through routine experimentation based on the dissolution time desired. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP § 2144.05(II)(A). Moreover, in any case, Himmelsbach teaches the same composition as instantly claimed, disclosing that the compound, Compound A, is an SGLT2 inhibitor (Id., pp. 7-8), teaches conventional carriers and/or diluents, and wherein ‘[u]niform distribution of the medicament in the formulation is a critical factor, to ensure uniform distribution, the particle size of the active substance can be reduced to a suitable level, e.g., by grinding…or micronizing, and demonstrate the same crystalline structure as within the Drawings as instantly disclosed (Id., p. 8). As such, regarding the claimed dissolution profile, where the structure of the composition (i.e. a composition comprising a SGLT2 inhibitor with specified ratio of disintegrant to binder) is taught by the prior art, there is a reasonable expectation that the functional recitations regarding such a composition are also met, given that the function of compositions are a product of the compositions structure. See MPEP 2112.01(II).
Himmelsbach does not teach specific excipients for a formulating the crystalline 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to use the crystalline form of 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene when formulating the composition of Washburn, given Himmelsbach teaches that the crystalline form of the compound is highly pure. MPEP 2144.06.
Further, it would have been prima facie obvious to one of ordinary skill in the art to reduce the particle size of the active agent via grinding or micronizing in order to optimize the distribution of the medicament in the formulation, as taught by Himmelsbach. See MPEP 2144.05.
In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05. Here, the ranges of SGLT2 inhibitor (1-350mg), a filler/diluent (0% to 90%), a binder (0% to 35% and <500[Symbol font/0x6D]m) and disintegrant (0%-20%) overlap with the instantly recited ranges of active (0.5-25%), diluent (65-93%), binder (1-5% and <250[Symbol font/0x6D]m), disintegrant (1-4%), and disintegrant to binder ratio (1.5:3.5 to 1:1).
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections have been made.
Claims 38, 40, and 46-51 are rejected under 35 U.S.C. 103(a) as being unpatentable over US 2008/0234367 (Washburn et al., 09/25/2008, hereinafter Washburn) in view of US 2007/0249544 Himmelsbach et al., 10/25/2007, hereinafter Himmelsbach), further in view of Azarmi et al. (“Current Perspectives in Dissolution Testing of Conventional and Novel Dosage Forms”, 10/06/2006) (hereinafter Azarmi), and further in view of US 5,516,530 (Lo et al., 05/14/1996, hereinafter Lo).
The combined teachings of Washburn, Himmelsbach and Azarmi are discussed above and differ from the instant claims insofar as they do not explicitly teach hydroxypropyl cellulose (HPC).
However, Lo teaches HPC is a water-soluble polymer, like HPMC, which acts as a binder in pharmaceutical dosage forms (col.3).
It would have been obvious to one of ordinary skill in the art, following the teaching of Washburn and Himmelsbach, would have been motivated to select HPC as a binder, particularly given the teaching of Lo. See MPEP 2144.06.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections have been made.
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 19-29 and 38-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 1-5 of U.S. Patent No. 7,713,938;
Claims 1-12 of U.S. Patent No. 7,723,309;
Claims 1-4 and 11-12 of U.S. Patent No. 8,283,326;
Claims 1-7 of U.S. Patent No. 8,507,450;
Claims 1-5, 20-23, and 31-40 of U.S. Patent No. 8,551,957;
Claims 1-5 of U.S. Patent No. 10,406,172;
Claims 1-11 and 14-22 of U.S. Patent No. 10,596,120;
Claims 1-29 of U.S. Patent No. 10,610,489,
each taken in view of US 2008/0234367 (Washburn et al., 09/25/2008, hereinafter Washburn), US 5,516,530 (Lo et al., 05/14/1996, hereinafter Lo), and “Current Perspectives in Dissolution Testing of Conventional and Novel Dosage Forms” (Azarmi et al., 10/06/2006) (hereinafter Azarmi). The patented claims teach crystalline forms of or pharmaceutical compositions of 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene (i.e. instantly claimed compound). However, the claims do not teach the instantly recited excipients in tablet form.
Washburn is discussed above, but does not teach use of the crystalline form of 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene as the SLGT2 inhibitor.
Azarmi is discussed above as teaching performing various dissolutions tests in various dissolution conditions.
Lo is discussed above as teaching HPC is a tablet binder like HPMC.
It would have been prima facie obvious to one of ordinary skill in the art formulating the composition claimed in the cited patents, each of which recites the SLGT2 inhibitor 1-chloro-4-(beta-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, to choose excipients such as those taught by Washburn and Lo, given that Washburn teaches a composition for formulating SGLT2 inhibitors.
Response to Arguments
Applicant’s arguments have been considered but are moot because new rejections have been made.
Examiner’s Comment
Regarding the Remarks filed 30 April 2025, Applicant argues that one must “pick and choose among the various excipients described in Washburn, and select the type and amount of each excipient and thereby arrive at the dissolution profile recited in the claims”; however, the scope of the functional language must be taken into account and must be given its broadest, reasonable interpretation (MPEP § 2173.01 (I)). In this instant case, the functional language of the instant claims does not require any particular excipients, any specific binders, or any specific disintegrants. As such, the pharmaceutical composition as-claimed in light of the functional language contained therein, may contain a myriad of various conventional binders, excipients, and disintegrants, and may be of any hardness, density, or ground to any granulation size arrive at the claimed functional language dependent upon the type of dissolution test is administered. Essentially, Applicants are claiming a functional limitation so broadly that it reads on a result achieved with no indication of what is contained within the pharmaceutical or how it is compounded. It is clear from the teachings of Azarmi et al. that dissolution tests are known to be carried out under many various testing conditions utilizing a multitude of solvents under varying conditions.
Moreover, there further exists no amounts of any ingredients within the composition of claim 19; and moreover, the claim states ‘comprising’ language which allows for the incorporation of unclaimed and even undisclosed ingredients. Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” See MPEP § 2111.01 (II). Thus, even if a particular embodiment exists within Applicants’ Specification which teaches a specific composition having defined amounts of the chemical compound, particular amounts of specific excipients, binders, and disintegrants, compounded in a very specific way, the functional language as-claimed far-exceeds the boundaries of scope compared to such an example and therefore one could not, consonant with current patent laws and guidance, read such a particular example into at least claim 19. Thus, considering the broad breadth of the functional language as-claimed, a myriad of compositions could fit the claimed dissolution profile and subsequently, the functional language is merely a result achieved which adds no meaningful substance to the claimed invention.
Nonetheless, and notwithstanding the above, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). See MPEP § 2144.05 part II A. In view of Azarmi et al., dissolution testing for drugs is paramount to determining the in vitro and in vivo release characteristics of any given pharmaceutical preparation prior to manufacturing the pharmaceutical. Moreover, considering the breadth of the claimed dissolution test, one of ordinary skill in the art would be motivated to conduct many dissolution tests, and such tests produce varying results dependent upon the type of pharmaceutical composition and the dissolution test conditions and Applicants have demonstrated no particular unexpected result or any new and unobvious benefit with such a broadly-claimed dissolution functional requirement as-claimed.
Applicants have claimed a pharmaceutical composition comprising a known chemical compound which is a known SGLT2 inhibitor, whereby the prior art recognizes the need to add excipients, disintegrants and binders which are conventionally added to pharmaceutical compositions containing SGLT2 inhibitors and added obvious ratios which are already taught by the prior art. The claim ends with a functional limitation which adds little meaning to the claimed invention due to the enormous breadth of the functional language set forth therein as discussed above; without demonstrating any new, meaningful, inventive concept or modification of Compound A to result in a beneficial improvement in bioavailability for example.
In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)) (Emphasis added). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). (emphasis added)
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable varition.103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
Therefore, the composition as-claimed, including the functional limitation, is rendered obvious over the combinations of the above-cited references and Applicant’s argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY TIEN at (571)272-8267. The examiner can normally be reached on Monday - Thursday 8:30 AM - 6:30 PM EST.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612