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 – Improper Markush Group
The nonstatutory Markush grouping rejection is based on a judicially approved “improper Markush grouping” doctrine. Claims 1, 5, 9, 11, 15, 16, 23, 35, 37, 44, 52, 54, 56-58, 61, 63, 65 and 79 is rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if:
(1) the species of the Markush group do not share a single structural similarity,”
OR
(2) the species do not share a common use.
Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
This rejection applies to the definition of the multiple moieties in the claimed monomer. These moieties are broad and divergent in nature.
The compounds do not even belong to a recognized class of compounds because every variable varies having complex meanings and endless permutations and combinations. The members of the recited Markush group are so disparate chemically as not to be members of a recognized chemical class of compounds. Further the point of attachment and how these are linked to each render the conceivable compounds structurally different and uncommon. In view of these claimed elements and the divergent substitutions on the above groups, the physical and chemical properties of claimed compounds are going to be different. Applicants’ may have to establish the core structure for their claimed compound. It cannot be said that all members of the Markush group have a single structural similarity, based on the above described structural differences. Specifically, the species of the Markush group do not share a “single structural similarity” because there are no required structural features within each variable definition such that each member of the group would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds, in common. In addition alternatively usable member of the Markush group for example, the inhibitors or binders of different enzymes, does not share a common use, absent evidence to the contrary.
The question of whether the lack of a specific statutory basis is a fatal flaw against a holding of an Improper Markush group was decided in In re Harnish, 206 USPQ 300, 305, where the court said, “…we think it should be clear from our actions in Weber and Haas II that we there recognized the possibility of such a thing as an "improper Markush grouping." We were and are aware that it does not have a specific statutory basis …” The court went on to reverse the rejection, (which had been made by the Board under Rule 196(b)) but not on the lack of a specific statutory basis but rather, “Clearly, they are all coumarin compounds which the board admitted to be "a single structural similarity." We hold, therefore, that the claimed compounds all belong to a subgenus, as defined by appellant, which is not repugnant to scientific classification. Under these circumstances we consider the claimed compounds to be part of a single invention so that there is unity of invention…” Thus, the rejection was overturned not because of any lack of a specific statutory basis, but because of the specific facts in the case. The Markush group was held proper in that case, as was the case also in Ex parte Price 150 USPQ 467, Ex parte Beck and Taylor, 119 USPQ 100, and Ex parte Della Bella and Chiarino 7 USPQ2d 1669. Cases where the Markush group was held improper include Ex Parte Palmer, 7 USPQ 11, In re Winnek, 73 USPQ 225, In re Ruzicka, 66 USPQ 226, Ex parte Hentrich, 57 USPQ 419, Ex parte Barnard, 135 USPQ 109, Ex parte Reid, 105 USPQ 251, Ex parte Sun and Huggins, 85 USPQ 516, In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371. Note In re Milas 71 USPQ 212 in which the structural difference between vitamin A and D was sufficient to uphold the improper Markush rejection. Also see In re Winnek 73 USPQ 225 and In re Ruzicka 66 USPQ 226 in which structural differences were small and yet a similar holding was maintained. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive. Of particular interest is Ex Parte Hozumi, 3 USPQ2d 1059, which reversed an improper Markush rejection “in view of the relatively large proportion of the structure of the compounds in the claimed class which is common to the entire class”. Here, by contrast, the amount in common is none.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 112
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, 5, 9, 11, 15, 16, 23, 35, 37, 44, 52, 54, 56-58, 61, 63, 65 and 79 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.
With R1 not being H as recited in base claim 1, pictured formulae in dependent claims 9 and 11 lack antecedent basis.
Note that Applicant has pointed out commercial availability of compounds in IDS such as
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Claim 11 depends on claim 1 which does not include R4 = H possibility. As such claim 11 lacks antecedent basis.
Interpretation of the variables such as X, Y, Z all are O or all or CO or all are NR1c in the context of specification renders a meaningful patent search for the whole scope of the claim impossible. So many documents were retrieved on initial search that it is impossible to determine which parts of claim 1 may be said to define subject-matter for which protection might legitimately be sought. More on this in section under 112-1 below.
Claim Rejections - 35 USC § 112
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, 5, 9, 11, 15, 16, 23, 35, 37, 44, 52, 54, 56-58, 61, 63, 65 and 79 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for making few compounds, does not reasonably provide enablement for plethora of conceivable macromonomers. For example, it is not seen where in the specification, enabling disclosure is found for compounds having X, Y, Z all are O or all are CO or all are NR1c. 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 method claims.
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 for example, the possibility that the last of the possibilities recited for for X, Y and Z, that is, all of these being O. There is no disclosure to any such compounds. Similarly, consider the second to last of the possibilities recited for X, Y and Z, that is, all of these being CO. There is no disclosure to any such compounds. These are only examples with respect to the core of the claimed formulae. These structures contradict commonsense chemistry, as no such compounds are found in the prior art. The specification does not teach where to procure starting materials to make such compounds. According to the U.S. Court of Customs and Patent Appeals in In re Argoudelis , De Boer, Eble, and Herr 168 USPQ 99 at 101, "[o]rdinarily no problem in this regard arises since the method of preparing almost all starting materials can be set forth in writing if the materials are not already known and available to the workers in the art, and when this is done the specification is enabling to the public". In re Argoudelis , De Boer, Eble, and Herr 168 USPQ 99 at 104, "it is essential that there be no question that, at the time an application for patent is filed, (emphasis in original) the invention claimed therein is fully capable of being reduced to practice (i.e., that no technological problems, the resolution of which would require more than ordinary skill and reasonable time, remain in order to obtain an operative, useful embodiment)." . Organic chemistry is unpredictable and capricious as taught by Dorwald F. A. Side Reactions in Organic Synthesis, 2005, Wiley: VCH, Weinheim pg. IX of Preface pg. 1-15 which teaches that ” …as will be shown throughout this book, the outcome of organic reactions is highly dependent on all structural features of a given starting material, and unexpected products may readily be formed. [8]……...Even the most experienced chemist will not be able to foresee all potential pitfalls of a synthesis, especially so if multifunctional, structurally complex intermediates must be prepared.…..” Substituents such as all X, Y and Z being NR1c also raise ‘impossible substituents’, for example structural possibilities of having displaceable (basic nitrogen) halogens on adjacent atoms, in view of definition of R1c which includes H and halogen. Such compounds just cannot be willed into existence. If a substituent is impossible, the claim can properly be rejected under 35 USC 112 paragraph 1 or 2. A compound with an impossible substituent clearly cannot be made, and hence a paragraph 1 rejection is proper. Alternatively, if it is impossible, then it is not correct. Similarly, there is no chemistry scheme to make any and all possible deuterated compound(s). While replacing H with D from a OH or NH to make OD or ND respectively, the replacement of D in C-H requires of de novo synthesis. Organic chemistry is unpredictable and capricious as taught by Dorwald F. A. Side Reactions in Organic Synthesis, 2005, Wiley: VCH, Weinheim pg. IX of Preface pg. 1-15. Dorwald teaches that ” …as will be shown throughout this book, the outcome of organic reactions is highly dependent on all structural features of a given starting material, and unexpected products may readily be formed. [8]……...Even the most experienced chemist will not be able to foresee all potential pitfalls of a synthesis, especially so if multifunctional, structurally complex intermediates must be prepared.…..”
As to ‘use’ prong’ of the 112-1 requirement:
Biological properties are unpredictable and are ultimately tide to the chemical structure. 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, teaches many caveats in analog design such as the following at page 799 column B:
Alteration of distances between portions of the pharmacophore of a molecule (or even' between other portions). may produce profound qualitative and/or quantitative changes in pharmacological actions.
Consistent with the above noted unpredictability is the disclosed (see page 294 of specification), the tested compounds show a wide range of activities (+ to +++). 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. 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, for predictable activity. 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.
According to Friedman, Annu. Rev. Physiol. 2020. 82:323–42, see page 337, “Many advances have set the stage for progress in understanding APOL1 kidney disease. Genetic data from enormous studies seem likely to help identify genetic modifiers, environmental risk factors, and more- versus less-effective therapies, all of which have the potential to teach us about mechanism and inform efforts to prevent or treat disease. New technologies such as CRISPR allow for rapid generation of cell lines and animal models that would have been out of reach only a few years ago. We may even see technologies such as nucleic acid–based therapies or screening of huge DNA encoded compound libraries leading to therapies before we fully understand the mechanism of disease. Thus, there is reason for optimism that these advances in understanding the biology of APOL1 and its genetic variants will ultimately lead to a reduction in the major racial disparities in kidney disease”. Similarly, according to Jagannathan International Journal of Nephrology and Renovascular Disease 2021:14 97–104, at page 103, that there is a modest association between high-risk APOL1 geno-type with progression to CKD and from CKD to ESRD progression. Currently, there is not sufficient straight forward evidence for guidance, and it may be prudent to conduct APOL1 genotype testing only in high-risk individuals such as in patients with the presence of CKD or HIV who wish to pursue genetic testing after being informed of all advantages and trade-off that are associated with it. Likewise, Lin, Oncogene APOL1 promotes proliferation and inhibits apoptosis via activating NOTCH1 signaling pathway in pancreatic cancer in Cell Death Dis 12, 760 (2021, strongly suggest the regulatory role of APOL1 and NOTCH1 signaling pathway in PC cell proliferation and apoptosis, which may provide a basis for future screening of PC biomarkers and selection of drug therapy targets. “Reason for optimism”, “modest evidence” and ‘suggestion” and ‘basis for future work’ are not tantamount to supportive of enabling disclosure. Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent 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”. There are no working examples present showing efficacy of instant compounds in animal models of any disease condition. In absence of such teachings, guidance, prior art and working examples, it would require undue experimentation to demonstrate efficacy of instant compounds in animal models of every disease condition mediated either by hyperactivity or hypoactivity of APOL1 and hence their utility for treating these disease conditions.
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.
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.
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.
Claims 1, 5, 9, 11, 15, 16, 23, 35, 37, 44, 52, 54, 56-58, 61, 63, 65, 78, 79 are rejected under 35 U.S.C. 103 as being unpatentable over US11976067 (provisional priority 01/18/2022).
US11976067 teaches claims column 1362-1524 compounds similar to the instant formula as explained below:
Compare US11976067 claim 1 formula:
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Entry 1, 6, 13 and 26
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of independent claim 78 (which does fall under the scope of base claim 1 Z = CO; R1c of NR1c is H and Z is bond) are similar to the compounds of formula of claims of US11976067 (see dependent claims species in US11976067). Also compare bottom of instant claim 9 at claim page 10.
The difference is the presence of L2 in formula of claim 1 US11976067. In US11976067 is
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. That is the R4 CH2 in instant formula is linked to the B ring. Otherwise, there is extensive overlap in the claims.
As per MPEP 2144.09 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) [R-01.2024]; A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). Further the above pointed out difference, CH2 replacement for O can be argued as ‘bioisosteric replacement’. See for example, Foye’s Principles of Medicinal Chemistry, 7th Edition, page 53 column B.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for their beneficial properties. Again, the invention is a selective combination of the inventions by the prior arts done in a manner obvious to one of ordinary skill in the art. Patent for the combination of known elements wherein their functions remain the same withdraws “what is already known into field of its monopoly and diminishes resources available to skilled men”. Sakraida v. Ag Pro, Inc.189 USPQ 449, 425 US 273, (1976).
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 10618897.
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, 5, 9, 11, 15, 16, 23, 35, 37, 44, 52, 54, 56-58, 61, 63, 65, 78, 79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,4,6-7,10-11,18,22-24,29,33 and 35 and method claims 36, 37, 44-49 of copending Application No. 18714031 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims contain overlapping subject matter.
The difference is the presence of R4 in the instant claims in the place of H of 18714031 in the claimed formulae. However, the R4 in the instant claims is positioned in the claims of 18714031 as R2. As such the compounds in the conflicting product claims and the method claims 36, 37, 44-49 of 18714031. Also note that the intended use of the products here are the same with underlying same biochemical mechanism. The latter implies the above difference just does not contribute to APOL1 activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The difference is the presence of R4 in the instant claims in the place of H of 18714031 in the claimed formulae. However, the R4 in the instant claims is positioned in the claims of 18714031 as R2. As such the compounds in the conflicting product claims and the method claims 36, 37, 44-49 of 18714031. Also note that the intended use of the products here are the same with underlying same biochemical mechanism. The latter implies the above difference just does not contribute to APOL1 activity.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9 and 11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-55 of U.S. Patent No. 11866446. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
With X = 0 and Y=Z=CH2 as in instant claims 9 and 11 formulae
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the differences are replacement of thiophene moiety in 1866446 with benzene in the instant case and the instant B appearing as A in 1866446. According to MPEP2144.09 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) [R-01.2024]. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). Further the replacement of benzene by a thiophene ring as ring equivalents is known in the art., 2013 See for example, Foye’s Principles of Medicinal Chemistry, 7th Edition, page 53 bottom of column B.
Claims 9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12421249 . Although the claims at issue are not identical, they are not patentably distinct from each other as explained below:
With X = 0 and Y=Z=CH2 as in instant claims 9 and 11 formulae
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the differences are replacement of thiophene moiety in 1866446 with benzene in the instant case and the instant B appearing as A in 1866446. According to MPEP2144.09 Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) [R-01.2024]. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.). Further the replacement of benzene by a thiophene ring as ring equivalents is known in the art. See for example, Foye’s Principles of Medicinal Chemistry, 7th Edition, Chapter, 2, 2013. page 53 bottom of column B.
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.
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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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