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 .
Status of the Claims
Claims 1-3, 5, 6, 12, 13, 15, 16, and 18-23 are pending.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Instant application is a U.S. National Stage Entry of PCT/EP2022/061705, filed 05/02/2022. PCT/EP2022/061705 claims priority of foreign application, EP21171865.5, filed 05/03/2021. Therefore, the effective filing date is 05/03/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/02/2023 and 11/16/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restriction Requirement
Applicant’s election without traverse of Group I, claims 1-3, 5, 6, 12, and 13, in the reply filed on 05/20/2026 is acknowledged. Applicant further elected the IMT compound 2-[(3R)-1-[(2R)-2-[4-(2-chloro-4-fluoro-phenyl)-2-oxo-chromen-7-yl]oxypropanoyl]-3-piperidyl] acetic acid, shown below, and a Bcl-2 inhibitor as the anti-cancer drug.
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The elected species read on claims 1-3, 5, 12, and 13. The search has been limited to the elected species.
Claims 6, 15, 16, and 18-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/20/2026.
Objections – Drawings
37 C.F.R. 1.84:
(u) Numbering of views.
(1) The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.
(2) Numbers and letters identifying the views must be simple and clear and must not be used in association with brackets, circles, or inverted commas. The view numbers must be larger than the numbers used for reference characters.
The drawings are objected to because some views contain partial views that are not identified by the view number followed by a capital letter (e.g., figures 2-4), some views contain descriptions after the view number (e.g., figures 5A-D), the “FIG.” is not capitalized in the views, and the view numbers are not larger than reference characters in some views (e.g., figures 1-3).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 2 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). For the sake of compact prosecution, claim 2 is being interpreted as being dependent upon claim 1.
Claim 5 is objected to because of the following informalities:
Claim 5 reads “B-celllymphocyte” and should read “B-cell lymphocyte”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 5, 12, and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a composition wherein the IMT compound is an unsubstituted compound of formula (I), (II), or (III), or wherein the substituents comprise those defined in claim 3, does not reasonably provide enablement for a composition comprising any “IMT” compound, or compounds of formula (I), (II), and (III) with undefined optional substituents. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The nature of the invention
The nature of the invention relates to a composition comprising IMT inhibitor compounds, including compounds of formulas (I), (II), and (III) in claim 2. Such compounds are useful as inhibitors of mitochondrial transcription. This invention is also directed to methods comprising said compounds.
Predictability of the art
The hypothetical compounds in claims 1 and 2 would be unpredictable in terms of one skilled in the art being able to synthesize every possible compound claimed in instant claims 1 and 2. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is a reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of skill in the art
An ordinary artisan in the area of drug development would have experience in synthesizing and screening chemical compounds for particular activities, such as a medical doctor or chemist. Screening of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target, (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can often be employed, developing a therapeutic method, as claimed, is generally not well-known or routine, given the complexity of certain biological systems.
4. The breadth of the claims
The scope of the claims involves compounds of formulas (I), (II), and (III), shown below.
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Claim 1 is very broad in the compounds to be used in the composition. Claim 2 is very broad in the number of variables and the options of substituents for each variable. There is an indefinite amount of hypothetical compounds included in claims 1 and 2.
5. The amount of direction provided, the presence or absence of working examples, and the quantity of experimentation necessary
The specification only provides 99 IMT inhibitor compounds. Synthesis methods are not taught in the specification to provide for the aforementioned undefined IMT inhibitor compounds of claim 1 or the undefined optional substituents in claim 2. It would be expected that the undefined optional substituents in formula (I), (II), and (III) would change the reactivity of the compounds, and therefore would require alternate synthesis methods. It would also be expected that some combinations of hypothetical compounds would not be able to be synthesized due to their instability (e.g., steric hindrance). It would require one skilled in the art, such as a chemist, to perform thousands of reactions to determine which compounds are IMT inhibitors and which compounds of formulas (I), (II), and (III) can be prepared. This would require synthesis and biological methods other than those provided in the specification. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the instant claims do not comply with the enablement requirement of 35 U.S.C. 112(a), since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 12, and 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the phrases "preferably" and “in particular” render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. There is a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See MPEP § 2173.05(d).
Regarding claim 1, the phrase "including but not limited to" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. There is a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See MPEP § 2173.05(d). Claims 2, 3, 5, 12, and 13 are rejected as being dependent upon a rejected claim and failing to specify the inhibitor.
Regarding claim 2, the phrase "substituted" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "substituted"), thereby rendering the scope of the claim unascertainable. The specification describes “substituted”, on page 36, as one or more substituents commonly known in the art. Therefore, neither the claims or the specification limit the structure of the optional substituents, resulting in an indefinite number of compounds falling under Formula (I). See MPEP § 2173.05(d).
The inventor or joint inventor should note that claim 1 is a reach-through claim. The claim attempts to obtain protection for subject matter that is prophetic and/or has yet to be invented. The IMT compounds and anti-cancer compounds are defined by their desired activity, rather than their structure, which would include those IMT compounds and anti-cancer compounds that have not yet been invented. Similarly, the metes and bounds of the IMT compounds and anti-cancer compounds are not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. Neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the composition comprising an IMT compound and anti-cancer compound has been rendered indefinite by the use of the reach-through protocol. Claims 2, 3, 5, 12, and 13 are rejected as being dependent upon a rejected claim and failing to specify both the IMT and anti-cancer drug.
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.
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 1-3, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Di Lucrezia et al. (WO 2019057821 A1), hereinafter referred to as Reference ‘821, cited by Applicant in the IDS.
Reference ‘821 teaches, in claims 10 and 13, a pharmaceutical composition comprising the elected species 2-[(3R)-1-[(2R)-2-[4-(2-chloro-4-fluoro-phenyl)-2-oxo-chromen-7-yl]oxypropanoyl]-3- piperidyl]acetic acid. The composition is taught in claim 14 to be used in the treatment of specific cancers. The composition is taught in claim 15 to be used in combination with another cancer therapy.
Reference ‘821 teaches, on page 51, that the compounds are inhibitors of mitochondrial transcription and trigger the death of AML cells. Reference ‘821 teaches, on page 52, that the standard of care for hepatocellular carcinoma and melanoma comprises the administration of MEK inhibitors. Additionally, it is taught on page 53 that the activity of the inhibitor compounds, inclusive of the elected species, “on tumor cells can be further enhanced by combining the treatment with the respective standard of care in order to get improved/additive treatment results”.
Reference ‘821 fails to teach a specific embodiment combining the MEK inhibitors with the composition comprising the elected species described above.
However, it is expressly suggested that the composition should be combined with the “standard of care”. As shown above, the standard of care for hepatocellular carcinoma and melanoma is defined as the administration of MEK inhibitors. Therefore, it would be prima facie obvious to combine the standard of care MEK inhibitors with the invention of Reference ‘821, since it is explicitly stated to do so in order to “get improved/additive treatment results”. One would have a reasonable expectation of success in combining two treatments that are known to be used for the same purpose, since the idea of combining them flows logically from their having been individually taught in the prior art. The addition of an MEK inhibitor would not be expected to reduce the efficacy of the composition described in Reference ‘821.
Regarding the “kit” of claim 13, when the composition is taught in the prior art, the “kit” containing the same components taught in the prior art is not patentably new. There is not a functional relationship between the kit and the IMT inhibitor and anti-cancer drug as defined in claim 1. See MPEP 2111.05.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Reference ‘821 (cited above), as applied to claims 1-3, 12, and 13 above, further in view of Fischer et al. (US 20100278921 A1).
Reference ‘821 teaches a composition comprising the elected species 2-[(3R)-1-[(2R)-2-[4-(2-chloro-4-fluoro-phenyl)-2-oxo-chromen-7-yl]oxypropanoyl]-3- piperidyl]acetic acid and an additional anti-cancer agent. Reference ‘821 teaches that the above composition should be combined with “standard of care” compounds in order to get improved/additive treatment results. Reference ‘821 teaches, in claim 14, a method of treating lymphoma comprising administering the above composition.
Reference ‘821 fails to teach combination with the Bcl-2 inhibitors Venetoclax, Navitoclax, or Oblimersen, as required in instant claim 5.
However, Fischer et al. teaches, in claim 30, the compound ABT-263 (Navitoclax) and a method of treating non-Hodgkin’s lymphoma comprising administering said compound.
MPEP 2144.06 I states: "It 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)”.
Therefore, instant claim 5 is rendered prima facie obvious in view of the prior art, since it comprises combining two prior art compositions, taught by Reference ‘821 and Fischer et al., which are taught to be used for the same purpose, treating lymphoma. Additionally, one would be motivated to do so since Reference ‘821 teaches the combination with an additional standard of care anti-cancer treatment, such as that taught by Fischer et al.
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).
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 1-3, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 12,281,079 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘079 teaches, in claim 1, compounds of formula (I), shown below. The compounds of claim 12 read on the compounds of instant claims 2 and 3.
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In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Patent ‘079 teaches, in the disclosure in columns 50 and 51, the combination with MEK inhibitors in order to get improved/additive treatment results, as in instant claim 1.
Regarding the “kit” of claim 13, when the composition is taught in the prior art, the “kit” containing the same components taught in the prior art is not patentably new. There is not a functional relationship between the kit and the IMT inhibitor and anti-cancer drug as defined in claim 1. See MPEP 2111.05.
Claims 1-3, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 14, and 18 of U.S. Patent No. 11,111,238 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘238 teaches, in claims 1 and 13, compounds of formula (I) which read on the compounds of instant claims 2 and 3. A pharmaceutical composition comprising said compounds is taught in claim 14. Claim 18 teaches the combination of said pharmaceutical composition with an additional cancer therapy.
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In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Patent ‘238 teaches, in the disclosure in columns 46 and 47, the combination with MEK inhibitors in order to get improved/additive treatment results, as in instant claim 1. Regarding the “kit” of claim 13, see above rejection.
Claims 1-3, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 11, and 13 of U.S. Patent No. 10,703,735 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patent ‘735 teaches, in claims 1 and 10, compounds and methods of inhibiting POLRMT comprising compounds of formula (I). The compounds of formula (I) differ from the instant compounds in that they contain an -H rather than -Me for variable R2.
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However, it is generally noted that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Lincoln, 126 U.S.P.Q. 477, 53 U.S. P.Q. 40 (C.C.P.A. 1942); In re Druey, 319 F.2d 237, 138 U.S.P.Q. 39 (C.C. P.A. 1963); In re Lohr, 317 F.2d 388, 137 U.S.P.Q. 548 (C.C.P.A. 1963); In re Hoehsema, 399 F.2d 269, 158 U.S.P.Q. 598 (C.C.P.A. 1968); In re Wood, 582 F.2d 638, 199 U.S. P.Q. 137 (C.C.P.A. 1978); In re Hoke, 560 F.2d 436, 195 U.S.P.Q. 148 (C.C.PA.A. 1977); Ex parte Fauque, 121 U.S.P.Q. 425 (P.O.B.A. 1954); Ex parte Henkel, 130 U.S.P.Q. 474, (P.O.B.A. 1960). Given that applicant did not provide unexpected or unobvious results of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to substitute the “methyl” group to a hydrogen.
Patent ‘735 teaches, in claims 11 and 13, the combination of the pharmaceutical composition with a second cancer therapy.
In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See also Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Patent ‘735 teaches, in the disclosure in columns 27 and 28, the combination with MEK inhibitors in order to get improved/additive treatment results, as in instant claim 1. Regarding the “kit” of claim 13, see above rejection.
Conclusion
Claims 1-3, 5, 12, and 13 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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