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 .
Claims 51-70 are pending in this application.
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 65-70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The nature of the instant invention has claims, which embrace substituted hydrozone and hydrazine compounds.
HOW TO USE: Claims 65-70 are drawn to the method of treating a medical condition selected from a medical condition in which activating PERK is beneficial, a medical condition associated with aggregation-prone protein and a medical condition in which upregulating an unfolded protein response. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The scope of claims 65-70 includes diseases and/or conditions not even known at this time, which may be associated with PERK, associated with aggregation-prone protein and upregulating an unfolded protein response. While the treatment of diabetes has been linked with PERK, with aggregation-prone protein or the upregulating an unfolded protein the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced. “Viral infection” or “cancer” cannot be deemed enabled. The notion that a compound could be effective against viral infection or cancer in general is contrary to our current understanding of how pharmacologicals work. All attempts to find a pharmaceutical to treat a viral infection, cancer, etc. generally have thus failed.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others. The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
In addition to the treatment of a magnitude of viral infections, etc., the claims also include the treatment of cancer. Evidence involving a single compound and two types of cancer was not found sufficient to establish the enablement of claims directed to a method of treating seven types of cancer with members of a class of several compounds in re Buting 163 USPQ 689. The remarkable advances in chemotherapy have seen the development of specific compounds to treat specific types of cancer. The great diversity of diseases falling within the “tumor” category means that it is contrary to medical understanding that any agent (let alone a genus of thousands of compounds) could be generally effective against such diseases. The intractability of these disorders is clear evidence that the skill level in this art is low relative to the difficulty of the task.
It is difficult to treat many of the disorders claimed herein. Instant claim language embraces disorders not only for treatment but the prevention, which is not remotely enabled. The specification indicates that “therapeutically effective amount means an amount of active ingredient effective to prevent, alleviate or ameliorate symptoms of a disorder, e.g., a viral infection or a disease or disorder associated with a viral infection. It is presumed in the prevention of the diseases and/or disorders claimed herein there is a way of identifying those people who may develop a tolerance to opiate analgesia, etc. There is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the disorders claimed herein.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
As stated in the MPEP, 2164.08 ''[t]he Federal Circuit has repeatedly held that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). AII that is necessary is that one skilled in the art be able to practice the claimed invention, given the Ievel of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839,166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination.''
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 51-70 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. The following reasons apply:
Claim 51 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “R1-R7 and R10-R14”, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 51 recites the limitation "substituted phenyl" in the definition for R10 and R11 of the proviso. There is insufficient antecedent basis for this limitation in the claim.
Claim 55 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “R1-R6 and R10-R14”, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 51 recites the limitation "substituted phenyl" in the definition for R10 and R11 of the proviso. There is insufficient antecedent basis for this limitation in the claim.
Claim 58 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “R1-R6” with respect to Formula III, IV and V, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 58 and claims dependent thereon are vague and indefinite in that it is not known what is meant by “R2-R4” with respect to Formula V, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 58 recites the limitation "trihaloalkyl" in the definition for R2-R4 of the proviso. There is insufficient antecedent basis for this limitation in the claim.
Claim 59 is vague and indefinite in that it is not known what is meant by “R1-R5” with respect to Formula III, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 61 is vague and indefinite in that it is not known what is meant by “R1-R5 and R2R4” with respect to Formula IV, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 61 is vague and indefinite in that it is not known what is meant by “at least one of R2-R4, is a trihaloalkyl, which is not a limitation of Formula IV.
Claim 62 is vague and indefinite in that it is not known what is meant by “R1-R5” with respect to Formula IV, which is a range which does not particularly point out and distinctly claim the subject matter which applicants regard as the invention, i.e., it fails to indicate that which is embraced by the range. The definitions of each individual variable must be clearly set forth herein.
Claim 64 recites the limitation "substituted phenyl" in the definition for R10 and R11 of Formula V. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 55 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooley et al., U.S. Patent Application No. 2019/0008809. Cooley teaches the compound of Formula I where X is CR12; Y is CR13; R1 is H; R2 is OH; R3 is OH; R4 is H; R5 is H; R6 is H; R10 is H; R11 is H; one of R12 and R13 is H and the other is nitro; R14 is H as set forth in example 289 (Figure 15a) as claimed 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 51-70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-47 of copending Application No. 18/852,465 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds and method of use of the compounds of Formula I, II, III, I and V are embraced by the method of use of the compounds of Formula I wherein Formula I is
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This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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