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 .
Election/Restrictions
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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.
Claim 1,6,9-10,12,15,18-19,21-22,25,33-38 and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and claim 36 of copending Application No. 18733421 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
The difference is that compounds of the conflicting claims are positional isomers of the instantly claimed compounds.
Thus instant claims are drawn to compounds 1.2-diazole fused compounds
in the conflicting claims are drawn to 1,3-diazole is fused compounds 18733421
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;
Instant
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in an otherwise same formula. Thus the conflicting compounds are positional isomers.
The intended use of the compounds as per the method claims in both cases are same, clearly relying on inherent biological property.
According to MPEP 2144.09 [R-01.2024] are obvious variants of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1,6,9-10,12,15,18-19,21-22,25,33-38 and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and claim 32 of copending Application No. 19283966 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
The difference is that compounds of the conflicting claims are positional isomers of the instantly claimed compounds.
Thus instant claims are drawn to compounds 1.2-diazole fused compounds
in the conflicting claims are drawn to 1,3-diazole is fused compounds Instant
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19283966
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in an otherwise same formula. Thus the conflicting compounds are positional isomers.
In the case of 19283966, the compounds also can be regarded as having species of instant genus.
The intended use of the compounds as per the method claims in both cases are same, clearly relying on inherent biological property.
According to MPEP 2144.09 [R-01.2024] are obvious variants of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1,6,9-10,12,15,18-19,21-22,25,33-38 and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and claim 44 of copending Application No. 19283392 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
The difference is that compounds of the conflicting claims are positional isomers of the instantly claimed compounds.
Thus instant claims are drawn to compounds 1.2-diazole fused compounds
in the conflicting claims are drawn to isomeric 1,2-diazole is fused compounds Instant
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19283392
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in an otherwise same formula. Thus the conflicting compounds are positional isomers.
In the case of 19283966, the compounds also can be regarded as having species of instant genus.
The intended use of the compounds as per the method claims in both cases are same, clearly relying on inherent biological property.
According to MPEP 2144.09 [R-01.2024] are obvious variants of each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Also note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application.
The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are:
1. The disclosure can be used as a dictionary for claim terminology; and
2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804).
The MPEP further notes:
The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”)
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 2, 4-7, 10, 11, 13, 14, 16-18, 21-23, 30, 31, and 35 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 37-55 of copending Application No. 18603755 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1, 2, 4-7, 10, 11, 13, 14, 16-18, 21-23, 30, 31, and 35 provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 37-55 of copending Application No. 19277577 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
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, 4-7, 10, 11, 13, 14, 16-18, 21-23, 30, 31, and 35 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for compounds of formula (I) (hereinafter formula) with limited combination of the R group possibilities , does not reasonably provide enablement for plethora of conceivable compounds of formula. For example, it is not seen where in the specification enabling disclosure is found for any compound wherein R10 or R8 is anything other than H. Similarly, enabling disclosure is not found compounds wherein X3 and X2 are other N
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 and use the invention commensurate in scope with these claims.
The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the relevant factual considerations.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art.
All of the factors have been considered with regard to the claims, with the most relevant factors discussed below:
Formula of base claim 1 contain large number of R groups layered with substituents layered on substituents encompassing wide variety and number of conceivable structures that find little support in the specification. These substituents and hence the compounds of given formula are drawn to species that vary widely in physical and chemical properties such as size, molecular weight, stereochemistry, logP, acidity, basicity, etc. These factors are known in the art (see multiple references cited below) to greatly influence biological properties, for example, binding interaction between target protein and small molecule and art recognized concepts relating to productive small molecule-macromolecule interaction, for example, as needed for the claimed method of claim 40.
There is no guidance on what to choose from these large number of structural moieties or where and how to link these moieties. Enablement is a two prong (make and use) requirement.
Consider the possibilities for R7, R8, R9 and R10. Chemistry for making the compounds of formula rely on the availability of the intermediates such as
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(see page 52), with chirality ultimately derived from alpha-amino acids.
This limits the substituents R8 and R10 to Hs. There is no chemistry scheme on how to convert carbonyls Carbons in the int-D or [0246] to said carbons substituted with
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This is only an example. The disclosed schemes to make the 1-3 diazole part of the formula is also limited such that R4 is always H. Similarly, It is not seen how to make compounds wherein the dotted lines in the formula are single bonds, or X2 and X3 are other N. Similarly, Scheme at page 44 (10 to 11) does teach how to make R2 F compound with Select F, the specification does not teach any and all possibilities of R2 is any halogen
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With respect to use prong of the enablement requirement, is limited to specific R7 and R9 being either methyl or ethyl, with specific stereochemistry (as noted above derived chiral alpha amino acids). Biological data are shown in Table 1 starting at page 195. Very similar compounds show widely different activity. Compare for example, the 6 compounds at page 196. These structurally different compounds have very different activities. Applicant is also encouraged to place on record, what is the difference between the top three compounds here. It is unclear if they are isomeric at the methyl carrying C outside the piperazine ring, or optical isomers. That productive small-molecule-protein interaction requires specific structural including stereochemical and geometrical, features is well taught and art acknowledged, see for example, Sundaresan, Protein Science (2002), 11:1330–1339. Consider for example, compounds of formula I would have additional (stereochemical) complexity when X2 and X3 are CH. These compounds cannot be just willed into existence.
Biological properties are unpredictable and are ultimately tide to the chemical structure, consistent with the wide breadth in IC50 shown in the Table for similar compounds. See “Role of the Development Scientist in Compound Lead Selection and Optimization” by Venkatesh, J. Pharm. Sci. 89, 145-154 (2000) (p. 146, left column). Likewise, J. G. Cannon, Chapter Nineteen in Burger's Medicinal Chemistry and Drug Discovery, Fifth Edition, Volume I: Principles and Practice, Wiley-Interscience 1995, pp. 783-802, 784, teaches many caveats in analog design such as
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Therefore the position taken is that based on the teachings of Sundaresan, Venkatesh and Cannon, the wide breadth of the claims finds little support in the specification.
Note that in University of Rochester v. G.D. Searle & Co., 68 USPQ2d 1424 at 1438, the screening for over 600 compounds was deemed to be undue. Applicant’s scope of the pictured formula far exceeds this number. The specification must teach how to make and use the invention, not teach how to figure out for oneself how to make and use the invention. In re Gardner, 166 USPQ 138 (CCPA 1970). Therefore, one skilled in the art could not make or use the claimed invention without undue experimentation.
There is no structural guidance such as pharmacophore definition disclosed in the specification to guide one of skill in the art to choose from the plethora possibilities recited for the variables.
There is a substantial gap between what is taught in the specification and what is being claimed. For these reasons, one skilled in the art would be faced with undue amount of research. The specification lacks disclosure sufficient to make and use the invention, in predictable manner, commensurate with the scope of the claims.
MPEP 2164.01(a) states, “A conclusion of Iack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557,1562, 27 USPQ 2d 1510, 1513 (Fed. Cir. 1993).'' That conclusion is clearly justified here. Thus, undue experimentation would be required to make and use Applicants' invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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, Andrew Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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