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 1-13, 15-18, and 23 are pending and examined.
Suggestions for Allowance:
Claims 12 and 13 comprise allowable subject matter. Once the §112 rejections are addressed (i.e., changing “the” to “a” in these claims to address antecedent basis concerns will place them in condition for allowance.
Claim Rejections - 35 USC § 112
Claims 1-11 and 15-18 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection. The following reasons apply:
Claims 1-11 are directed to structural formulas I, II or III, or a pharmaceutically acceptable form or an isotope derivative thereof. The claims encompass various constituents for the ring formations and R groups. Thus, the claims encompass countless potential compounds. In other words, it is not clear that Applicant contemplated the extent and/or specificity of all the potential compounds claimed. As such, the language monopolizes the countless pharmaceutical composition embodied in the claims.
The instant specification only tests the effects of 103 potential compounds on the relative mRNA of INFβ/GAPDH in a THP1 cell line. The specification does not describe nor test nor contemplate the countless other compounds that are encompassed within claims 1-11.
Claim 15-17 are directed to a pharmaceutical composition comprising a compound effective to treat or reduce one or more diseases or disorders. Claim 18 is directed to a method for treating or reducing a disease or disorder mediated by or associated with STING.
It is not entirely clear which diseases or disorders, and thus the patient population, for which the pharmaceutical composition is effective. In other words, it is not clear that Applicant contemplated the extent and/or specificity of diseases or disorders claimed. As such, the language to treat or reduce one or more diseases monopolizes the entirety of patients that could be administered the pharmaceutical composition.
The instant Specification tests the effects of 103 compounds on the relative mRNA of INFβ/GAPDH in a THP1 cell line. The Specification does not describe nor test nor contemplate the effects of any compound on a particular disease or disorder.
The claimed invention is not fully described in the specification. The written description requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technological knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the claimed invention.
Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and to demonstrate that by disclosure in the specification of the patent.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003).
Written description requirement, serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the claimed invention that is claimed. A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void.
See MPEP 2163.01-02 for general principles governing compliance with the written description requirement applications. 35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 that require that the “specification shall contain a written description of the invention. The written description requirement has several policy objectives. “[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed.” In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). “The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.” Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “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.”
Whenever the issue of written description arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-cath, Inc. V. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). MPEP 2163.02.
Whether the written description requirement is satisfied is a fact-based inquiry that will depend on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed. The written description requirement is not satisfied by the appearance of mere indistinct words in a specification or a claim, even an original claim. A description of what a material does, rather than of what it is, usually does not suffice.” Enzo, 323 F.3d at 968 (citing Eli Lilly, 119 F.3d at 1568); See Rochester, 358 F.3d at 926 (“[G]eneralized language may not suffice if it does not convey the detailed identity of an invention”).
The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him. See Genentech, 108 F.3d 1461, 1365 (Fed. Cir. At 1366, 78, 1999).
However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2022). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claim has adequate written support.
Regardless of whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods. Where the specification provides only constructive examples in lieu of working examples, it must still “describe the claimed subject matter in terms that establish that the applicant was in possession of the claimed invention, including all elements and limitations.”
It is suggested to amend the claims to represent the embodiments in the Specification that were possessed at the time of filing.
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 1-4, and 6-12 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 1 and 8, claim 1 recites the limitation, “the structural formula I or formula II.” Claim 8 recites, “the structural formula III.”. There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor 8 refer to “a structural formula,” and it is unclear what structural formulas the applicant is referring to. Claim 1 and claim 8 further recite, “the group consisting of halo, oxo, OH, CN, OR, CF3, C1-6 alkyl, 3- to 6-membered heterocycloalkyl, 5- to 6- membered aryl or heteroaryl, 6- to 10-membered fused, spiro or bridged bicyclic ring, NRR’, N(R)S(O)2R, S(O)2R and S(O)2NRR’.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor claim 8 refer to “a group consisting of halo, oxo, OH, CN, OR, CF3, C1-6 alkyl, 3- to 6-membered heterocycloalkyl, 5- to 6- membered aryl or heteroaryl, 6- to 10-membered fused, spiro or bridged bicyclic ring, NRR’, N(R)S(O)2R, S(O)2R and S(O)2NRR’,” and it is unclear what group the applicant is referring to. Claim 1 and claim 8 further recite, “the group consisting of halo, oxo, OH, CN, OR, CF3 and C1-6 alkyl.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor claim 8 refer to “a group consisting of halo, oxo, OH, CN, OR, CF3 and C1-6 alkyl,” and it is unclear what group the applicant is referring to. Claim 1 and claim 8 further recite, “the aforementioned aromatic carbocyclic or heterocylic rings.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor claim 8 refer to “an aforementioned aromatic carbocyclic or heterocyclic rings,” and it is unclear which aromatic carbocyclic or heterocyclic rings the applicant is referring to. Claim 1 and claim 8 further recite, “the nitrogen to which they are attached.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor claim 8 refer to “a nitrogen to which they are attached,” and it is unclear what nitrogen the applicant is referring to. Claim 1 and claim 8 further recites, “the group consisting of C1-3 alkyl, C3-6 cycloalkyl or heterocyclic, halo, OH, OC1-3 alkyl, and CN.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor claim 8 refer to “a group consisting of C1-3 alkyl, C3-6 cycloalkyl or heterocyclic, halo, OH, OC1-3 alkyl, and CN,” and it is unclear which group the applicant is referring to. Claim 1 and claim 8 further recite, “the carbon atom to which they are bonded.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Neither claim 1 nor claim 8 refer to “a carbon atom to which they are bonded,” and it unclear what carbon atom the applicant is referring to. Claim 1 and claim 8 further recite, “the aforementioned alkyl, R, R’, aromatic carbocyclylic or heterocyclylic rings.” There is insufficient antecedent basis for these limitations in claims 1 and 8. Claim 1 does not refer to “an aforementioned alkyl, R, R’, aromatic carbocyclylic or heterocyclylic rings,” and it is unclear what aforementioned alkyl, R, R’, aromatic carbocyclylic or heterocyclylic rings the applicant is referring to.
Further, claim 1 and claim 8 recite “carbocyclylic or hetercyclylic rings.” The terms “carbocyclylic” and “heterocyclylic” are indefinite. It is unclear to the examiner what the applicant means by either carbocyclylic or heterocyclylic. The meaning of every term used in a claim should be apparent from the prior art or from the specification and the drawings at the time the applicant is filed. Claim language may not be “ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention.” In re Packard, 75 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014).
Claims 3, 4, 6, 7, 9, 11, and 12 recite, “the group.” There is insufficient antecedent basis for these limitations in claims 3, 4, 6, 7, 9, 11 and 12. Claims 1-12 do not refer “a group,” and it is unclear what groups the applicant is referring to.
Claim 2, which is dependent on claim 1, is similarly rejected under 35 U.S.C. 112(b). Claim 10, which is dependent on claim 9, is similarly rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112
Claims 1-11, 15-18 and 23 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 the elected compound species and those embodied by the instant Specification, does not reasonably provide enablement for the other compound species encompassed by formula I, formula II and formula II and is not enabled for any pharmaceutically acceptable form or isotope derivative thereof. Additionally, the specification, while enabling the elected disease and disorder species and those embodied by the instant Specification, does not reasonably provide enablement to treat or reduce any disease or disorder, any disease or disorder mediated by or associated with STING or the effects of aging. 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 or use the invention commensurate in scope with these claims.
The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261(1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below.
Nature of the Invention
As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the instant case, the claimed invention pertains to compounds of formulas I, II and III, which are alleged by the Specification to act as STING agonists. Further the claimed invention pertains to a method to treat or reduce any disease or disorder, including diseases or disorder mediated by or associated with STING and aging.
The State of the Prior Art and the Relative Skill of those in the Art
As stated in the MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
As discussed above, the instantly claimed invention pertains to compounds of formula I, II, and III, which are alleged by the Specification to act as STING agonists and to treat or reduce diseases or disorders, including aging and diseases or disorders mediated by or associated with STING. Thus, the state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit pharmacological efficacy. Further, the state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which subject populations would therapeutically benefit from administration of the claimed compounds (i.e., which diseases or disorders and which diseases or disorders mediated by or associated with STING would the administration of the claimed compounds be appropriate and/or efficacious for). There is no absolute predictability even in the view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of the ordinary skills in the art from accepting the administration of any of the claimed compounds embodied by formulas I, II or III for the treatment of any disease or disorder, or any disease or disorder mediated or associated with STING or aging on its face.
According to Gulen et al., “cGAS–STING drives ageing-related inflammation and neurodegeneration,” Nature | Vol 620 | 10 August 2023, “the cGAS–STING signalling pathway, which mediates immune sensing of DNA3, is a critical driver of chronic inflammation and functional decline during ageing.” Abstract. Gulen explains that cGAS–STING pathway as a driver of ageing-related inflammation in peripheral organs and the brain, and reveal blockade of cGAS–STING signaling as a potential strategy to halt neurodegenerative processes during old age. Thus, Gulen appears to limit age related benefits to the cGAS-STING pathway and in chronic conditions associated with neurodegenerative processes.
According to and as evidenced by: Lindsey Valich, University of Rochester, “Removing an inflammation-linked protein makes aging worse,” September 8, 2026, https://www.rochester.edu/newscenter/protein-cgas-sting-pathway-inflammation-aging-718912/, while cGAS has been known to play a role in inflammation, this is thought to activate a cGAS-STING pathway that can reduced age-related chronic inflammation in some instances. Further, the description includes chronic inflammation secondary to specific conditions, including diseases that are more common with age. Thus, it does not appear that even aging or even age related inflammation in a healthy subject is recognized as being mitigated with the agents that target the cGAS-STING pathway.
This would appear to mean that any compound capable of impacting chronic inflammation in the brain and CNS must also be capable of crossing the blood brain barrier at a concentration that provides a therapeutic efficacy. Pharmacokinetic data may be required to show that administration of any concentration at any dosage will have such impact on a neurodegenerative conditions associated with chronic inflammation. This appears to be corroborated by:
Alarcon-Esposito et al., “Identification and development of cGAS inhibitors and their uses to treat Alzheimer's disease,” Neurotherapeutics 22 (2025) explains: “However, only those inhibitors that can penetrate the blood-brain barrier (BBB) are suitable for treating the central nervous system, such as AD.” See p4, 4th full par.
The Level of Predictability in the Art
The instantly claimed invention is highly unpredictable as discussed below: It is noted that the pharmacological and pathophysiological art is unpredictable, requiring each embodiment of compounds and each embodiment of diseases or disorders to be individually assessed for pharmacological and physiological activity.
At the time of the instant application was filed, it would have been known by those of ordinary skill in the art that – due in large part to the strict requirement of complementarity between a compound and its corresponding binding site on a target receptor or enzyme – compounds, in the vast majority of cases, demonstrate a remarkably high correlation between their structure, specificity and ability to produce a pharmacological effect. At the same time, it would have been generally assumed that two compounds with similar chemical properties would exhibit similar biological effects. Thus, given a series of compounds that are shown to exert an activity of interest (or given a target of interest), the ordinarily skilled artisan would have expected that a limited genus of related compounds (e.g., compounds exhibiting near equal molecular shapes and volumes, approximately the same distribution of electrons, and similar physical properties such as hydrophobicity, etc.) would interact with the given target to elicit a related biological response.
Once a compound has been identified by ligand based and/or structure-based drug design methods as potentially binding to the target molecule, it must be evaluated. Usually, several molecules which scored well during the docking run are evaluated in further tests since even the top scoring molecule would fail in vitro assays. Finally, leads are brought into the wet lab for biochemical evaluation. A low level of predictability is not surprising considering that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific target enzyme. Indeed, modifying even a single atom in a compound can dramatically change the compound’s overall structure and, even though complementarity in one portion of the compound might be improved by the chemical revision, the overall binding or activity might be severely compromised. Indeed, in the instant specification, Table 1 of biological data exemplifies the wide variability in the relative activity of mRNA INFβ/GAPDH between the 103 proposed compounds (i.e., ranging from 0.7-9547.9 THP1).
Further, it is noted that pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regard to the efficacy of the instantly claimed compounds on the treatment of reduction of one or more diseases, including aging and those mediated by or associated with STING (e.g., whether any disease or disorder, aging and/or diseases or disorder associated with STING can be reduced or treated).
With regard to pharmaceutical compositions for and methods of treating and preventing one or more diseases or disorders, including aging and diseases or disorders associated with STING, there are various conditions and pathophysiology that can ultimately cause diseases or disorders, including aging and diseases or disorders associated with STING. Further, a broad range of individuals are affected by one or more diseases or disorders including aging and disease or disorders associated with STING. No medications are disclosed in the art as being useful for the treatment of any one or more diseases or disorders, especially aging.
The Amount of Direction/Guidance Present and the Presence or Absence of Working Examples
The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, the Specification discloses approximately 103 compound species encompassed by Formula I-III. See Table 1 starting on page 306 of the instant Specification. There are no examples for the remaining compounds encompassed by the claimed Formulas I-III that are not disclosed in Table 1. Additionally, the use of the compounds are also listed in Table 1 on the activity of mRNA INFβ and GAPDH. There are no examples for the treatment or reduction of any one or more diseases or disorders, STING associated diseases or disorders, nor aging.
Scope of Breadth of the Claims
As stated in MPEP 2164.01(c), “when a compound or composition claim is not limited by a recited use, any enabled use that would reasonably correlate with the entire scope of that claim is sufficient to preclude rejection for non-enablement based on how to use”. Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled”. Indeed, the 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’.” In re Wright, 999 F.2d 1557 (Fed. Circ. 1993).
Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims.” Amgen, Inc., v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. See also Ak Steel Corp. v. Solla, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation.
As to the first inquiry, as discussed above, the claims are drawn to compounds of Formula I-III, which are alleged by the Specification to act at STING to treat or reduce any one or more diseases or disorders, including aging and diseases or disorders associated with STING. Considering that Formulas I-III encompasses thousands of compound species and that any one or more diseases or disorders encompasses countless diseases or disorders, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses approximately 103 similarly structured compound species encompassed by Formulas I-III as recited by the claims. Further, the Specification does not disclose any particular specific diseases or disorders except aging and STING associated diseases or disorders. STING associated diseases or disorders encompasses various diseases or disorders, including those which have not been discovered yet. As such, the claims are extremely broad with respect to the disclosure. The second inquiry is discussed in detail below. For example, compounds 1-46 in Table 1, and encompassed by claim 1, have the same ring structure for Ring A. However, Ring A could be any “5-, 6- or 7-membered substituted or unsubstituted heterocycle.” The variability in the Specification for potential Ring A and Ring B should be limited to the examples disclosed in the Specification.
The quantity of experimentation needed
In view of the all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed. As discussed above, the claims are drawn to compounds of Formula I-III, which are alleged by the Specification to act at STING for the treatment or reduction of any one or more diseases or disorders. Since identifying any compound which is capable of treating or reducing any disease or disorder is extremely complex, the nature of the instant invention is considered to be one of extreme complexity. In the instant case, the complexity is exacerbated by the broadness of Formulas I-III with respect to the disclosure since Formulas I-III encompasses many thousands of compound species, whereas the instant Specification discloses only 103 such compound species exerting the disclosed activity with structural similarities not reflected in Formulas I-III. The complexity is additionally exacerbated with the broadness of treating or reducing one or more diseases or disorders since one or more diseases or disorders encompasses countless disease or disorder species. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan (armed with screening technologies including computer assisted virtual screening techniques such as ligand-based and structure-based design methods) could not reasonably predict which of the thousands of compounds encompassed by Formulas I-III would exert the alleged activity based on the limited disclosure of 103 similarly structured compounds with a high degree of variability. Although the skilled artisan would have known that certain chemical modifications to the disclosed compounds may predictability provide structurally related compounds having similar activity, the skilled artisan would have also known that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme.
Thus, factors such as “sufficient working examples,” “the level of skill in the art,” and “predictability,” etc. have been demonstrated to be sufficiently lacking in the instantly claimed compositions and methods. In view of the breath of the claim, the chemical and pathophysiological nature of the invention, and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention in scope with the claims.
The court in Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001, states that “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.”
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which diseases can be treated or prevented by the compound encompassed in the instant claims, with no assurance of success.
As such, no claim is allowed.
Conclusion
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/JARED BARSKY/Primary Examiner, Art Unit 1628
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