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 .
Benefit of Earlier Filing Date
The instant application, filed 03 November 2023, is a national stage application of PCT/US2021/030896, filed 05 May 2021. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Requirement for Restriction/Election was mailed 22 May 2026.
Applicant’s Response to Requirement for Restriction/Election was received 13 July 2026.
Applicant’s provisional election without traverse of Group I (Claims 1, 4, 7, 9, 15, 18, 25, 41-42, and 46-47) and SACC-0064443, shown below, in the Response filed 13 July 2026 is acknowledged. The claims in Group II (Claims 10-13) and Group III (Claims 19, 21, 23, 29, and 32) are withdrawn.
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In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine the patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected species does not make a contribution over the prior art of record.
Status of the Claims
The listing of claims filed 13 July 2026 has been examined.
Claims 1, 4, 7, 9-13, 15, 18-19, 21, 23, 25, 29, 32, 41-42, and 46-47 are pending.
Claims 10-13, 19, 21, 23, 29, and 32 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species.
Claims 2-3, 5-6, 8, 14, 16-17, 20, 22, 24, 26-28, 30-31, 33-40, and 43-45 are cancelled.
Claims 1, 4, 7, 9, 15, 18, 25, 41-42, and 46-47 are examined on the merits.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 06 February 2024 is acknowledged and has been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it uses phrases which can be implied, such as, “Applicants have developed novel…” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(a)
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, 4, 7, 9, 15, 18, 25, 41-42, and 46-47 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 claims contain 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”) Thus, an applicant complies with the written description requirement “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, 107 F.3d at 1572, 41 USPQ2d at 1966,” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims of the instant application embrace, “…a small molecule as disclosed in Tables 2-7 with one or more substitutions; a small molecule having a structural similarity of about 50% or greater to the small molecules disclosed in Tables 2-7; and a small molecule analog of an arthropod kinin…” (Claim 1). Particularly, the phrases “one or more substitutions” and “analog of an arthropod kinin”, recited in claim 1, invoke the 35 U.S.C. 112(a) rejection. Even a cursory calculation of the number of compounds embraced in the instant claims would result in thousands of compounds.
Level of Skill & Knowledge in the Art
The level of skill and knowledge in the art is high.
Partial Structure
Claims 1 and 18 recite the claimed small molecule has “one or more substitutions” and Tables 2-7 discloses exemplary small molecule species. This is a broad genus and, according to its broadest reasonable interpretation, includes any possible substitutions. While some possible substitutions are disclosed for compounds which share SACC-0064443’s backbone (Drawings, Fig. 6), no exemplary compounds which have an additional substitution have been disclosed for the other compounds presented in Tables 2-7. The recited compounds have widely varied structures, lacking any unifying structural element, and the disclosure lacks any specific guidance regarding which positions may have a substitution, except for SACC-006443’s aryl group (Fig. 6). The Specification broadly discusses possible substitutions of alkyl groups (p. 10, Lines 29-33), cycloalkyl groups (p. 11, Lines 17-19), aryl groups (p. 11, Lines 24-25), heteroaryl groups (p. 12, Lines 9-10), heterocyclyl groups (p. 13, Lines 24-27), aralkyl (p. 14, Lines 2-5) and provides some examples (p. 16, Lines 15-29). However, based on the limited number of exemplary structures having an additional substitution provided, a representative number of examples to support any substitution on all instantly recited compounds is lacking, and one or ordinary skill in the art would conclude that Applicant is not in possession of the claimed invention, as currently recited.
For example, Talley (WO 2004/092123 A2) presents a compound (Drawings, p. 25/79, Fig. 1A) which corresponds to instantly recited SACC-0039590 as well as a similar compound (Drawings, p. 27/79, Fig. 1A), shown below:
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Besides generically suggesting a methyl substitution, the Specification provides no example structures showing SACC-0039590 having an additional methyl substitution. Thus, Talley’s disclosure fails to suggest or draw a clear line as to where and/or which substitutions can be made on any other instantly recited compounds aside from SACC-0039590. Accordingly, a person having ordinary skill in the art (PHOSITA) is not in possession of the knowledge of which instantly recited structures should have a substitution or where said substitution should be made.
Furthermore, the Specification discloses some structural analogs, such as SACC-0412062 and SACC-0412060 (p. 5, Line 33 – p. 6, Line 21). However, as to the claimed small molecules having one or more substitutions and analogs, examples which would demonstrate possession or put the public in possession of all claimed small molecules having one or more substitutions and analogs is lacking. Furthermore, a person having ordinary skill in the art would recognize analogs include structural analogs as well as functional analogs.
Physical and/or Chemical Properties/Functional Characteristics
The instantly claimed small molecules, and analogs thereof, are compounds which allegedly function as arthropod kinin receptor agonists or antagonists. Although the art recognizes generally accepted definitions, the terms are not explicitly defined by the Specification in such a way as to demonstrate that the inventor had possession of all claimed small molecules having one or more substitutions and all analogs.
A review of the prior art identifies NUS (National University of Singapore, 15 January 2018, “Subtle changes in chemical structure can affect drug toxicity”, PhysOrg, 4 pages), which discloses minor changes in chemical structure can lead to significant functional changes (p. 2, ¶ 3). NUS teaches diclofenac, a widely used painkiller, and lumiracoxib, which is no longer in use due to causing severe liver toxicity, have minimal structural differences (p. 3). In light of NUS, it is unknown which of the analogs and small molecules having one or more substitutions claimed by Applicant will be active or inactive. Further, one of ordinary skill in the art would not be able to predict which small molecules, of the vast number that are claimed, will be active or inactive absent evidence. There is no structure/function correlation in the Specification showing which analogs and small molecules having one or more substitutions would or would not be active.
Since Applicant has only set forth analogs and small molecules having one or more substitutions in the Specification for a few claimed small molecules, it is not clear which other small molecules would be considered analogs or which substitutions on other small molecules would be acceptable. Applicant has not sufficiently described which analogs or small molecules having one or more substitutions have the ability to function as kinin receptor agonists or antagonists, and which do not. Stated differently, there is no structure/function correlation and no representative number of specific examples of small molecules having one or more substitutions, aside from SACC-006443, and analogs that demonstrate which compounds retain activity. Further, one of ordinary skill in the art would not be able to predict the biological activity of all the claimed analogs and small molecules with one or more substitution.
Predictability of the Art
Medicinal chemistry is an experimental science with a low predictability level. Small changes in the structure of a compound can lead to large differences in their pharmacological activity. Regarding analogs and substitutions, predicting if a certain claimed compound retains the activity and function of the original compound is filled with experimental uncertainty because analogs contain and substitutions can lead to variation by chemical and physical properties of the molecules.
Method of Making the Claimed Invention
The Specification states, “Small molecules utilized for this study were part of a Texas AgriLife Research compound library in the laboratory of James Sacchettini, designated the SAC-2 library. This library is composed of randomly selected small molecules purchased from commercial vendors...” (p. 63, Lines 14-17). No exemplary methods for making the claimed small molecules are provided in the Specification. Methods of synthesizing compounds are, in general, known to a person of ordinary skill; however methods of making the myriad of small molecules encompassed by the instant claims is beyond the skill of the artisan particularly when certain elements, such as analogs and substitutions, are only described partially.
As such, the instant Specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the analogs and small molecules having one or more substitutions because the examples are limited to a relatively small subset of the instantly claimed small molecules which, as discussed previously, share no unifying structural element.
Substantial and undue experimentation would be needed to practice Applicant’s invention because the Specification lacks sufficient detail to show how to use the analogs and small molecules having one or more substitutions of the instant invention. Further, there is no guarantee that all of the analogs and small molecules having one or more substitutions embraced by the scope of the claims would be useful arthropod kinin receptor agonists or antagonists.
Even with the undue burden of experimentation, there is no guarantee that one would obtain the product of a desired analog or small molecule having one or more substitutions of an instantly claimed small molecule. Although some functional characteristics are disclosed or would be known to one of ordinary skill in the art, in the absence of a disclosed structure, there can be no correlation between the function and structure of the claimed analogs and small molecules having one or more substitutions in the instant application.
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims, as the possible structural variations are limitless to any analogs and small molecules having one or more substitutions of the genus. In the instant case, however, the Specification does not disclose a sufficient variety of species to reflect this variance in the genus. The Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims, such as analogs and small molecules having one or more substitutions of the disclosed small molecules.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222, USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the Specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. This rejection would be overcome by amending the claims recite only small molecules which are supported by the disclosure and to remove the phrases related to “one or more substitutions” and “analog of an arthropod kinin”.
Claims 4, 7, 9, 15, 25, 41-42, and 46-47 fail to remedy the issue in claim 1 and, consequently, are included in this rejection.
Claim Rejections - 35 USC § 112(b)
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, 7, 9, 15, 18, 25, 41-42, and 46-47 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.
Claims 1 and 4 recite, “…the small molecules disclosed in Tables 2-7.” MPEP 2173.05(s) states, “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).” Note there is no limit to the length of a claim. Examiner suggests copying the small molecule structures depicted in Tables 2-7 into the claims.
Claim 1 recites, “…having a normalized percent activation of greater than about 40% as defined by Equation (II) or inhibitory activity greater than about 40% as defined by Equation (III).” Claims 7 and 9 recite “Equation (III)” and “Equation (II),” respectively. MPEP 2173.05(s) states, “Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table ‘is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.’ Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).” Examiner suggests copying Equations (II) and/or (III) into the claims where appropriate.
Claims 1, 4, 7, and 9 recite the word “about,” which is defined by the Specification as, referring “…to variation in the numerical quantity that can occur, for example, through typical measuring and liquid handling procedures used for making concentrates or use solutions in the real world; through inadvertent error in these procedures; through differences in the manufacture, source, or purity of the ingredients used to make the compositions or carry out the methods; and the like. The term ‘about’ also encompasses amounts that differ due to different equilibrium conditions for a composition resulting from a particular mixture.” (p. 8, Lines 6-13). In claims 1, 4, 7, 9, “about” is used in relation to structural similarity and/or pharmacodynamic activity. Thus, the provided definition fails to provide any guidance on which numerical ranges are encompassed by the word “about” as it is used in the context of claims 1, 4, 7, and 9, and, accordingly, the claims’ metes and bounds are unclear. For example, the compounds which would be encompassed by the phrase “a structural similarity of about 50% or greater” (Claim 1) is indefinite.
Claim 1 recites, “An arthropod kinin receptor agonist or antagonist comprising a small molecule selected from:
a small molecule as disclosed in Tables 2-7 with one or more substitutions;
a small molecule having a structural similarity of about 50% or greater to the small molecules disclosed in Tables 2-7; and
a small molecule analog of an arthropod kinin having a normalized percent activation of greater than about 40% as defined by Equation (II) or an inhibitory activity greater than about 40% as defined by equation (III).”
The above claim language renders claim 1 indefinite because a small molecule having “one or more substitutions,” “a structural similarity of about 50% or greater”, and/or “a normalized percent activation of greater than about 40% as defined by Equation (II) or an inhibitory activity greater than about 40% as defined by equation (III)” could each include innumerable additional compounds, including those lacking substantial structural similarity to the starting small molecule. Furthermore, it is unclear how much structural variance is permitted by the aforementioned phrases. Examiner recommends claiming compounds having structures supported by the disclosure and according to Applicant’s intention.
Claim 1 recites, “…a small molecule analog of an arthropod kinin…” The Specification states, “In some embodiments, additional molecules may be created/identified. Any arthropod kinin may be used as a control kinin to elucidate the small molecule analogs, which can be determined through a dual-addition calcium fluorescence assay.” (p. 3, Lines 26-28). An “analog” could include innumerable additional compounds, including those lacking substantial structural and/or functional similarity to the starting molecule. Furthermore, based on the Specification, it is unclear how much structural variance is permitted by the word “analog.” Accordingly, the metes and bounds of how different an “analog” can be from the compounds presented in Tables 2-7, either structurally or functionally, is unclear.
Claims 15, 18, 25, 41-42, and 46-47 fail to remedy the issue in claim 1 and, consequently, are included in this rejection.
Claims 1, 4, 7, 9, 15, 18, 25, 41-42, and 46-47 are rejected on the basis that claim 1contains 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
While the Specification discloses the instantly recited small molecules function as either arthropod kinin receptor agonists or antagonists, said small molecules lack both a substantial structural similarity and a shared, art-recognized class. Additionally, a compound which acts as an agonist would not be considered “functionally equivalent” to a compound which acts as an antagonist. For example, instantly recited compounds include SACC-0129990, SACC-0115325, and SACC-0064443 (p. 87-88, Table 2), shown below:
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Due to their differing structures, a skilled artisan would not consider SACC-0129990, SACC-0115325, and SACC-0064443 to have a single structural similarity, nor would a skilled artisan predict SACC-0129990, SACC-0115325, and SACC-0064443 to be functional equivalents.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claims 4, 7, 9, 15, 18, 25, 41-42, and 46-47 fail to remedy the issue in claim 1 and, consequently, are included in this rejection.
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.
Claims 1, 4, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS RN: 303028-29-7, shown below, which entered STN 16 November 2000:
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Regarding claims 1, 4, and 7, CAS RN: 303028-29-7 is structurally identical to SACC-0064443 (Specification, p. 22, Lines 6-7; p. 88, Table 2; p. 91, Table 3).
A compound, which, meeting all the structural limitations required by claim 1 would be expected to exhibit the same pharmacodynamic properties as recited in claim 7. Claim 7 recites, “The arthropod kinin receptor antagonist of claim 1 having an inhibitory activity greater than about 60% as defined by Equation (III).” Inhibitory activity is a pharmacodynamic property. An identical compound must inherently have the same pharmacodynamic effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, CAS RN: 303028-29-7 would inherently fulfill the limitations regarding parameters of pharmacodynamic properties recited by claim 7.
Claims 1, 4, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS RN: 909862-25-5, shown below, which entered STN 08 October 2006:
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Regarding claims 1, 4, and 9, CAS RN: 909862-25-5 is structurally identical to SACC-0072619 except CAS RN: 909862-25-5 lacks defined stereochemistry (Specification, p. 21, Line 9-p. 22, Line 1; p. 87, Table 2; p. 91, Table 3). Thus, CAS RN: 909862-25-5 has a structural similarity of about 90% or greater to the instantly recited small molecules.
A compound, which, meeting all the structural limitations required by claim 1 would be expected to exhibit the same pharmacodynamic properties as recited in claim 9. Claim 9 recites, “The arthropod kinin receptor antagonist of claim 1 having a normalized percent activation of greater than about 60% as defined by Equation (II).” Percent activation is a pharmacodynamic property. An identical compound must inherently have the same pharmacodynamic effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, CAS RN: 909862-25-5 would inherently fulfill the limitations regarding parameters of pharmacodynamic properties recited by claim 9.
Claims 1, 4, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Talley (WO 2004/092123 A2).
Regarding claims 1, 4, and 7 Talley teaches the following compound (Drawings p. 25/79, Fig. 1A), which is structurally identical to instantly claimed SACC-0039590 except in Talley’s compound the central alkylamine is unprotonated (Specification, p. 32 Lines 6-7; p. 97, Table 6):
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Thus, Talley’s compound has a structural similarity of about 90% or greater to the instantly recited small molecules.
A compound, which, meeting all the structural limitations required by claim 1 would be expected to exhibit the same pharmacodynamic properties as recited in claim 7. Claim 7 recites, “The arthropod kinin receptor antagonist of claim 1 having an inhibitory activity greater than about 60% as defined by Equation (III).” Inhibitory activity is a pharmacodynamic property. An identical compound must inherently have the same pharmacodynamic effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, Talley’s compound would inherently fulfill the limitations regarding parameters of pharmacodynamic properties recited by claim 7.
Claims 1, 4, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guenther (US 2014/0163037).
Regarding claims 1, 4, and 9, Guenther teaches the following compound (p. 31, Claim 19, Compound 3), shown below, which is has a structural similarity of about 50% or greater to instantly recited SACC-0027895:
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A compound, which, meeting all the structural limitations required by claim 1 would be expected to exhibit the same pharmacodynamic properties as recited in claim 9. Claim 9 recites, “The arthropod kinin receptor antagonist of claim 1 having a normalized percent activation of greater than about 60% as defined by Equation (II).” Percent activation is a pharmacodynamic property. An identical compound must inherently have the same pharmacodynamic effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, Guenther’s compound would inherently fulfill the limitations regarding parameters of pharmacodynamic properties recited by claim 7.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 7, 15, 25, 41-42, and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Talley (WO 2004/092123 A2).
Regarding claims 1, 4, 7, 15, 25, 41-42, and 46-47, Talley teaches the following compound (Drawings p. 25/79, Fig. 1A), which is structurally identical to instantly claimed SACC-0039590 except in Talley’s compound the central alkylamine is unprotonated (Specification, p. 32 Lines 6-7; p. 97, Table 6):
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Talley’s disclosed compounds are fungal invasion inhibitors (p. 2, Lines 11-13), indicating said inhibitors may be administered to a subject having a fungal infection (p. 12, Lines 17-23). Pharmaceutical compositions comprising said fungal invasion inhibitors may include pharmaceutically acceptable carriers, antimicrobial agents, and/or fungicidal agents (p. 12, Lines 24-26; p. 28, Lines 6-11). Additionally, Talley discloses compositions comprising such inhibitors have agricultural applications and may be applied on plants as sprays or dusts, in irrigation systems, or on soil (p. 42, Lines 20-28). Furthermore, Talley states the composition may contain additional components like preservatives, sweetening agents, colorants, flavors glucose, fructose, and/or galactose (p. 36, Lines 12-19).
Talley does not explicitly teach a specific, exemplary composition containing an instantly recited compound.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Talley would have found it prima facie obvious to prepare a composition comprising a small molecule recited by claim 1 because Talley suggests including an instantly recited small molecule in various compositions. Furthermore, Talley suggests such compositions are appropriate for pharmaceutical and agricultural use. Talley indicates agricultural compositions can be sprayed or dusted on foliage, which implies the composition would be either liquid or solid, respectively. Furthermore, a compound which meeting all instantly recited structural limitations would be expected to exhibit either antifeedant or feeding enhancer activity (Claim 46). An identical compound must inherently have the same activity, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01.
Note the preambles in claims 15, 25, and 41 which indicate the claimed compositions are a pharmaceutical composition, an agricultural composition, or an animal bait are interpreted as intended uses. MPEP § 2111.02(II) states, “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference… between the claimed invention and the prior art. If so, the recitation serves to limit the claim… To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim.” Currently, based on the claim language interpreted under its broadest reasonable interpretation, whether the claimed composition is used as a medicament, in agriculture, or as an animal bait results in no structural difference between the claimed invention and the prior art.
Note claims 15, 25, and 41 recite the pharmaceutical composition, agricultural composition, and animal bait, respectively, comprise an instantly recited small molecule and “optionally” include an additional component. Accordingly, said additional components remain optional and are not required.
Regarding claim 18, Talley teaches all of the claimed elements as stated above. Furthermore, Talley discloses the compound shown below (Drawings, p. 27/29, Fig. 1A):
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This compound has a structural similarity of about 50% or greater to SACC-0039590 and has an additional methyl substitution on the five-membered ring.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Talley would have found it prima facie obvious to prepare a pharmaceutical composition wherein the instantly claimed small molecule has one or more substitutions because Talley discloses a structurally similar compound having a substitution. Thus, a PHOSITA would have had a reasonable expectation of success in using SACC-0039590 having at least one substitution in a composition.
Non-Statutory 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, 4, 7, 15, 18, 25, 41-42, and 46-47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/380,514 in view of Talley (WO 2004/092123 A2).
Application ‘514 claims a small molecule arthropod kinin receptor antagonist having a structure according to any one of formulas I-XV, or a structural similarity of about 60% or greater (Claim 1) as well as compositions containing a compound of formula I-XV (Claims 9-15). For example, one compound claimed by ‘514 is a compound of formula XIV, shown below:
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Application ‘514 does not claim all of the instantly recited small molecules.
Talley teaches the following compound (Drawings p. 25/79, Fig. 1A), which is structurally identical to a compound of formula XIV, except in Talley’s compound the central alkylamine is unprotonated and the five-membered ring has a methyl substitution (Specification, p. 32 Lines 6-7; p. 97, Table 6):
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Talley’s disclosed compounds are fungal invasion inhibitors (p. 2, Lines 11-13), indicating said inhibitors may be administered to a subject having a fungal infection (p. 12, Lines 17-23). Pharmaceutical compositions comprising said fungal invasion inhibitors may include pharmaceutically acceptable carriers, antimicrobial agents, and/or fungicidal agents (p. 12, Lines 24-26; p. 28, Lines 6-11). Additionally, Talley discloses compositions comprising such inhibitors have agricultural applications and may be applied on plants as sprays or dusts, in irrigation systems, or on soil (p. 42, Lines 20-28). Furthermore, Talley states the composition may contain additional components like preservatives, sweetening agents, colorants, flavors glucose, fructose, and/or galactose (p. 36, Lines 12-19).
Talley does not explicitly teach a specific, exemplary composition containing a compound of formula XIV.
Prior to the filing of the instant application, a person having ordinary skill in the art (PHOSITA) following the teachings of Talley would have found it prima facie obvious to prepare a composition a compound of formula XIV because Talley suggests including a compound of formula XIV in various compositions. Furthermore, Talley suggests such compositions are appropriate for pharmaceutical and agricultural use. Talley indicates agricultural compositions can be sprayed or dusted on foliage, which implies the composition would be either liquid or solid, respectively. Furthermore, a compound which meeting all instantly recited structural limitations would be expected to exhibit either antifeedant or feeding enhancer activity (Claim 46). An identical compound must inherently have the same activity, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01.
Because claims 1, 4, 7, 15, 18, 25, 41-42, and 46-47 in the instant application would have been obvious over claims 1-15 of copending Application No. 19/380,514 in view of Talley (WO 2004/092123 A2), claims 1, 4, 7, 15, 18, 25, 41-42, and 46-47 in the instant application are not patentably distinct from claims of copending Application No. 19/380,514.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
Prosecution Insights