DETAILED ACTION
The receipt is acknowledged of applicant’s amendment and IDS both filed 12/18/2025.
Claims 1-19, 22, 27, 30-32, 35-44. 59, 68-69 are pending.
Claims 1-7, 10-15, 30-32, 35-37, had been elected without traverse in the reply filed on 09/10/2025.
Claims 8-9, 16-19, 22, 27, 38-44. 59, 68-69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and species. Election was made without traverse in the reply filed on 09/10/2025.
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 .
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 (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 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 1-7, 10-15, 32 and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Caldwell (US 2016/0015628, IDS filed 03/14/2023) as evidenced by the article by Sheffield™ (“Spray dried Fast Flo 316”, previously provided), combined with the article by Aleksovski et al. (“Mini tablets: a contemporary system for oral drug delivery in targeted patient groups”, previously provided).
The applied reference “Caldwell” has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant Claims
Claim 1 is directed to a tablet formulation comprising:
a core comprising
omecamtiv mecarbil, a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable hydrate of a pharmaceutically acceptable salt thereof;
a filler;
a binder;
a glidant; and
a lubricant; and
a film coating on the core, the film coating comprising
a modified-release polymer and a pore former,
wherein the tablet formulation has a diameter of 5 mm or less.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Caldwell teaches pharmaceutical formulations comprising omecamtiv mecarbil dihydrochloride salt that can be monohydrate of the salt (abstract; ¶¶ 0002, 0007-0008, 0031-0032, 0035). The formulations are tablets comprising core (drug layer) and coating. The core comprises the drug (omecamtiv mecarbil), hydroxypropyl cellulose (claimed as binder) (¶ 0111). The core comprises microcrystalline cellulose (MCC) and FASTFLOW Lactose (¶¶ 0135-0137). FASTFLOW Lactose is lactose monohydrate, as evidenced by the article by Sheffield. Both MCC and lactose monohydrate are claimed as fillers. The reference teaches the core comprises lubricants comprising magnesium stearate and colloidal silica which is silicon dioxide claimed as glidant, or mixture thereof (¶¶ 0091-0092, 0099, 0103, 0117). The composition comprises more excipients in the core (0119). The coating comprises insoluble polymers, e.g. cellulose acetate (CA) and ethyl cellulose (EC), and pore forming agent including polyethylene glycol 3350 (PEG 3350) (¶¶ 0144-0150). The drug release profile is: less than 30% at one hour, less than 30% at 2 hours, 30-75% at 3 hours, 30-75% at 6 hours and more than 80% at 16 hours (¶¶ 0044-0051; claims 9-10). Figure 4 shows Cmax 269 ng/mL (138-449).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Caldwell teaches the tablet comprising core and coating as claimed, the reference however does not teach the diameter of the tablet of 5 mm or less as claimed by claim 1. While Caldwell teaches all the claimed ingredients of the core as claimed by claim 1, the reference does not teach a single embodiment with all the claimed ingredients.
Aleksovski teaches minitablets having diameter of less than 3 mm. The minitablets are patient friendly and have improved swallowing and flexible dosing (see the entire document, and in particular page 65).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide tablet comprising omecamtiv mecarbil as taught by Caldwell evidenced by the article by Sheffield, and formulate the tablet as minitablets having diameter less than 3 mm as taught by Aleksovski. One would have been motivated to do so because Aleksovski teaches mini-tablets are patient friendly and have improved swallowing and flexible dosing. One would reasonably expect formulating minitablets comprising omecamtiv mecarbil having the claimed diameter of less than 3 mm that are patient friendly, easy to swallow, and provide flexible dosing.
Regarding the claimed diameter of the tablet of 5 mm or less as claimed by claim 1 and up to 3 mm as claimed by claim 37, Aleksovski teaches less than 3 mm that overlaps with the claimed diameters. 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 [R-5].
Caldwell teaches all the claimed ingredients of the core, the reference does not teach a single embodiment with all the claimed ingredients. As such, the instant prior art does not appear to provide sufficient specificity, i.e., involves some “picking and choosing” to give rise to anticipation. See, Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, it must be remembered that “[w]hen 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.... the combination is obvious”. KSRv. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have obvious to have selected the various combinations of features claimed from within the prior art disclosure, specifically MCC, lactose, HPC, and sodium stearate based on their suitability for a drug core comprising omecamtiv mecarbil, wherein the core is coated with film comprising CA or CE and pore forming agent as claimed.
Regarding omecamtiv mecarbil dihydrochloride monohydrate as claimed by claim 2, it is taught by Caldwell.
Regarding MCC and lactose monohydrate claimed by claims 3 and 4, both are taught by Caldwell.
Regarding HPC claimed by claim 5, it is taught by Caldwell.
Regarding silicone dioxide claimed by claim 6, it is taught by Caldwell.
Regarding magnesium stearate claimed by claim 7, it is taught by Caldwell.
Regarding the pore former is a plasticizer as claimed by claim 10, Caldwell teaches PEG which is a plasticizer.
Regarding the modified release polymers of the coating as claimed by claims 11-12, Caldwell teaches CA and EC.
Regarding the film former claimed by claims 13-15, Caldwell teaches PEG 3350.
Regarding the release profiles claimed by claim 32, Caldwell teaches release profiles overlapping with the claimed release profiles. 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 [R-5].
Regarding claim 35, Caldwell teaches Cmax 269 (138-449) that falls within the claimed Cmax of 100-1000 ng/mL. 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 [R-5].
Regarding claim 36 that the formulation is free of pH modifying agent, Caldwell does not teach pH modifying agent.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Caldwell as evidenced by the article by Sheffield, and combined with Aleksovski as applied to claims 1-7, 10-15, 32, 35-37 above, and further in view of WO 2019/006235 (hereinafter WO 235, previously cited on PTO 892 and copy is provided).
The applied reference “WO ‘235” has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant Claims
Claims 30 recites the formulation comprises 1-3 mg omecamtiv mecarbil and claim 31 comprising recites the formulation comprises 1 mg omecamtiv mecarbil.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of Caldwell, as evidenced by the article by Sheffield, and combined with Aleksovski are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Caldwell however does not teach the dose of omecamtiv mecarbil as claimed by claims 30 and 31.
WO ‘235 teaches method of treating heart failure by administering an oral formulation comprising omecamtiv mecarbil in a dose from about 0.001 mg to about 100 mg. The dose is based on individual patient condition, e.g. severity of the of the condition, ejection fraction of the patient receiving the treatment, age, body weight, general health, diet, sex, route of administration, etc. (¶¶ 0043, 0044, 0062).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide oral formulation comprising omecamtiv mecarbil as taught by Caldwell as evidenced by the article by Sheffield, and combined with Aleksovski and adjust the dose to between 0.001 mg and 100 mg as taught by WO ‘235. One would have been motivated to do so because WO ‘235 teaches dose within this range treats heart failure based on individual patient condition, e.g. severity of the of the condition, ejection fraction on the patient receiving the treatment, age, body weight, general health, diet, sex, route of administration, etc. One would reasonably expect formulating oral dose comprising 0.001-100 mg of omecamtiv mecarbil based on individual patient needs to effectively treat heart failure.
Regarding the claimed dose of the omecamtiv mecarbil of between 1-3 mg or 3 mg as claimed by claims 30 and 31, respectively, WO ‘235 teaches doses embracing the claimed doses. 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 [R-5].
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 12/18/2025have been fully considered but they are not persuasive.
Request for Rejoinder
Applicants argue that each of claims 8-9, 16-19, 22, and 27 depend, directly or indirectly, from claim 1 and, claim 1 is believed to recite allowable subject matter. Rejoinder of claims 8-9, 16-19, 22, and 27 is thus requested.
As will be discussed infra, no claims are allowable at this time. Rejoinder will be considered upon indication of allowable subject matter.
Claim Rejections - 35 U.S.C. § 103
A prima facie case of obviousness has not been established for the claimed subject matter
I-A. The cited references alone do not teach or suggest each and every element of the claims as amended
Caldwell
Applicants argue that Caldwell relates to pharmaceutical formulations of OM, and discloses formulations comprising "a drug layer comprising omecamtiv mecarbil (OM); a sweller layer; and a semipermeable membrane coating having at least one delivery port". Caldwell does not disclose a tablet that is 5 mm or less in diameter, and in fact is silent regarding the size of the formulations disclosed therein.
In response to this argument, it is argued that if Caldwell was to teach all the elements of the invention as claimed, the reference would have been an anticipatory references. In the instant case, the rejection is based on combination of the cited references. All the elements of the claims are taught by and would have been obvious over the combination of the cited references as set forth in this office action. All the ingredients of the claimed tablet formulation is taught by Caldwell and the claimed size is taught by Aleksovski.
WO '235
Applicants argue that WO'235 relates to methods of treating heart failure with cardiac sarcomere activators, including OM. WO'235 does not disclose a tablet that is 5 mm or less in diameter, and in fact is silent regarding the size of the formulations disclosed therein.
In response to this argument, it is argued that WO ‘237 is relied upon for solely teaching the dose of OM as claimed by claims 30 and 31 that is suitable to treat heart failure, as applicants had done. The reference does not need to teach the limitations already taught by Caldwell. The reference satisfies the purpose for which it was applied.
Sheffield
Applicants argue that Sheffield is a product page relating to a single product, namely, Sheffieldᵀ Spray Dried Fast Flo 316. Sheffield does not disclose any specific formulations and is silent with respect to OM. Sheffield is also silent with respect to tablet formulations comprising a film coating and tablet formulations that are 5 mm or less in diameter.
In response to this argument, it is pointed out that the reference is only an evidentiary reference and does not need to teach any limitation of the claims. The reference is relied upon to show that FASTFLOW Lactose taught by Caldwell is the same claimed lactose monohydrate. The reference satisfies the purpose for which it was applied.
Aleksovski
Applicants argue that Aleksovski is a general reference related to "mini-tablets", which it defines as "tablets with a diameter of ≤ 3 mm". Aleksovski is silent regarding OM. Nor does Aleksovski teach or suggest a mini-tablet comprising a film coating with a modified-release polymer and a pore former, much less formulating OM in such a tablet.
In response to this argument, as applicants themselves noted, the reference teaches the claimed tablet size. The reference does not need to teach the drug or any other limitations of the claims that are taught by Caldwell. The reference satisfies the purpose for which it was applied.
I-B. A person of ordinary skill in the art would not have been motivated to modify or combine the cited references with any reasonable expectation of success
Applicants argue that neither Caldwell, WO'235, nor Sheffield teach or suggest a tablet with a diameter of 5 mm or less. The Office contends that "Aleksovski teaches minitablets having diameter of less than 3 mm" and that "it would have been obvious to formulate the tablet [of Caldwell] as minitablets as taught by Aleksovski". OM is an activator of cardiac myosin that directly targets the contractile mechanisms of cardiac myocytes intended to enhance efficiency of myocardial contraction in patients suffering from a cardiovascular condition, such as heart failure. OM has a narrow therapeutic window, meaning that the maximum safe dose of OM is relatively close to the minimum effective dose of OM. For this reason, it is important for formulations comprising OM be able to deliver OM at a controlled rate, since an overly rapid OM dissolution rate can lead to an undesirable higher Cₘₐₓ, which can lead to increased adverse events. See Instant Application at [0022].
In response to this argument, it is argued that Caldwell teaches release profile of OM overlapping with the claimed release profile as claimed by claim 32, and teaches Cmax 269 (138-449) that falls within the claimed Cmax of 100-1000 ng/mL. Caldwell further teaches slow release at paragraph [0042]. Therefore, the tablet taught by Caldwell deliver OM at controlled or modified rate as claimed, and not immediate release tablet that provides increased adverse events. The secondary references provided the elements missing from the primary reference, e.g. size of the tablet. Motivation to combine the references exists, and reasonable expectation to achieve the present invention has been provided, as set forth in this office action.
Applicants argue that a person of ordinary skill in the art, without hindsight, (1) would have no motivation to modify the OM formulations disclosed by Caldwell, (2) would have no motivation to specifically combine Caldwell with Aleksovski, a generic reference that is silent with respect to OM, and (3) would have no reasonable expectation of success in formulating OM (which, as noted above, has a narrow therapeutic window) as a mini-tablet with a diameter of less than or equal to 5 mm.
In response to applicant's argument that (1) the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, motivation to combine the references exist, even if different from what applicant would have done. (2) Further, there is 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, motivation to combine the references are drawn from the cited references themselves, even if motivation is different from what applicant would have done, and one would have achieved the claimed tablet having the claimed size. (3) There would be reasonable expectation of success. Applicants attention is directed to the scope of the claims that are directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references. The size of the claimed tablet was known before the effective filing date of the present invention. It has been decided by the Courts that even in a case where the reference does not teach the same use of the composition, the two different intended uses are not distinguishable in terms of the composition, see In re Thuau, 57 USPQ 324; Ex parte Douros, 163 USPQ 667; and In re Craige, 89 USPQ 393.
Applicants argue that, to the contrary, Aleksovski actually teaches away from the formulation of dose-sensitive drugs in mini-tablet formulations, cautioning that "formulation factors may have a significant influence on the drug release profile [of mini-tablets]" and that "decreasing the tablet size tends to provide faster drug release due to increased surface-to-volume ratio and decreased diffusion pathway." Aleksovski at pgs. 75, 76. Going further, Aleksovski notes that "in some cases, when highly soluble active compounds were used, immediate drug release occurred even when 60% polymer (HPMC K15M) was used in the mini-tablet formulation." Aleksovski at pg. 76 (emphasis added). A person of ordinary skill in the art seeking to develop formulations of OM, a drug for which an overly rapid dissolution rate is undesirable, would thus have been dissuaded by Aleksovski from developing mini-tablet formulations of OM.
In response to this argument, applicants attention is directed to the scope of the claim that are directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references. Aleksovski teaches easier swallowable minitablet, as applicants achieved in paragraphs [0130]-[0132] of the current published application. Aleksovski does not teach away from the present invention, rather suggests small tablets for easiness of swallowing, as applicants had desired in the present specification paragraph [0022]. "A reference may be said to teach away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken by the applicant. The degree of teaching away will of course depend on the particular facts; in general, a reference will teach away if it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant." In re Gurley, 27 F.3d 551,553 (Fed. Cir. 1994). In the instant case, Aleksovski does not deter person of ordinary skill in the art from using small tablets with diameter less than 3 mm.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
The claimed subject matter exhibits unexpected results
Applicants argue that even if a prima facie case of obviousness were established, which Applicant does not concede, the nonobviousness of the claimed tablet formulations is reinforced by the fact that these formulations exhibit unexpected results. The claimed tablet formulation achieves the unexpected result of providing a tablet formulation of OM that is more suitable for patients with difficulty swallowing, while also achieving a suitable controlled release profile.
In response to this argument, as discussed supra, the controlled release profile of tablet comprising OM is taught by Caldwell. Further, Aleksovski teaches the advantage applicants achieved by the small size of the tablet, that is having easy to swallow tablet. Therefore, achieving the claimed size of the tablet was know in the art before the effective filing date of the present invention for the same reason used the small size of the claimed tablet.
Applicant initially sought to develop tablets having a reduced size by simply scaling down the physical size and dose of an omecamtiv mecarbil modified release tablet. However, when the release profile of the scaled-down tablet was evaluated, it was observed that just a 50% reduction in dose and size (e.g., from 50 mg to 25 mg) resulted in a significant undesirable increase in the dissolution rate of omecamtiv mecarbil. See Instant Application at [0022]; Figure 1. An increase in the dissolution rate can lead to an undesirable higher Cₘₐₓ, which can lead to increased adverse events. Id. at [0022]. In view of these findings, Applicant next sought to develop new tablet formulations for omecamtiv mecarbil that, while small enough to be suitable for patients with difficulty swallowing, would also be capable of achieving a desirable controlled release profile. In pursuit of this goal, and in view of the undesirably high release rate previously observed for scaled-down tablets, Applicant developed reduced-size tablets comprising both a core and a modified-release film coating. The modified-release film coating comprises both a modified-release polymer and a pore former, each of which plays a distinct role in the function of the coating. For example, the modified-release polymer facilitates the release of omecamtiv mecarbil from the core in a controlled fashion. See Instant Application at [0084]. On the other hand, the pore former serves to increases the porosity of the modified-release polymer by dissolving upon exposure to water or biological fluid, thus forming drug release channels. Id. at [0092].
In response to this argument, it is argued that combination of the cited references teaches tablet having the claimed ingredients and overlapping release profile and size. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done. Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 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.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
Applicants argue that, as demonstrated in Examples 5 and 7, Applicant surprisingly and unexpectedly observed that the mini-tablet formulations of claim 1 achieved a desired release profile of omecamtiv mecarbil. Notably, Example 7 demonstrates that when the claimed tablet formulations were dosed in human subjects at 6 mg (6 X 1 mg) and 25 mg (25 X 1 mg), no serious adverse events were observed, nor any treatment-emergent adverse events leading to discontinuation of the study. See Instant Application at [0161]-[0180].
In response to this argument regarding applicant's arguments of unexpected superior results in the instant specification, it is the examiner's position that the data in the specification regarding the claimed tablet, are not unexpected results and therefore cannot rebut prima facie obviousness. The examiner directs applicant's attention to MPEP 716.02 (a). "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness...of the claims at issue." In re Corkhill, 711 F.2d 1496, 266 USPQ 1006 (Fed.Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. Furthermore, the MPEP states, "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
It is further argued that the objective evidence of nonobviousness must be commensurate in scope with claims that evidence is offered to support. See in Greenfield and DuPont 197 USPQ 227 (CCPA 1978); In re Boesch and Slaney 205 USPQ 215 (CCPA 1980); and In re Tiffin and Erdman 170 USPQ 88 (CCP 1971). Claim 1 does not recite the amount of each ingredient and dose used by applicant in examples 5 and 7.
Conclusion
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 (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 Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/Isis A Ghali/Primary Examiner, Art Unit 1611 /I.G./