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 .
DETAILED ACTION
Status of 18/085,293
Claims 29-48 are currently pending.
Priority
Instant application 18/085,293, filed 12/20/2022, claims priority as follows:
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Provisional application 63/081,016 contains support for the instant claims and thus, claims 29-48 are granted the effective filing date of 9/21/2020.
Information Disclosure Statement
All references from the IDS submitted on 3/20/2023 have been considered unless marked with a strikethrough.
Claim Objections
Claim 29 is objected to for a minor informality. Claim 29 recites, “RL in each instance is independently, hydrogen, halogen…” but should recite, “RL in each instance is independently hydrogen, halogen…” where the comma after independently is omitted. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) – Enablement
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 29 and 33-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The instant specification, while being enabled for decreased production of inflammatory markers and treatment of inflammatory bowel disease, multiple sclerosis, and asthma models in mice, does not reasonably provide enablement for treating all other autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples, and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Nature of the Invention
The invention is drawn to methods of treating conditions in which NLRX1 is implicated with compounds of Formula (I), found on pages 8-11 of the specification and recited in claim 48. The compounds are disclosed as ligands of NLRX1 able to treat conditions in which NLRX1 is implicated, wherein the condition is selected from the group consisting of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases.
Breadth of the Claims
The claims are broadly directed to the use of compounds of Formula (I) for the treatment of all conditions in which NLRX1 is implicated, wherein the condition is selected from the group consisting of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases. The genus of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases is disclosed in the instant specification on pages 31-34, and includes non-limiting examples. The broadest reasonable interpretation of these genera includes a vast number of diseases for which the disclosure does not contain support.
Level of Ordinary Skill in the Art
The artisans using Applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical arts, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
For example, different types of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases affect different organs and have different methods of growth and/or harm to the body, and different vulnerabilities. The skill thus depends on the autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases. There are some diseases where the skill level is high and there are multiple successful therapeutic treatments. The mechanism of action in these situations, however, is not necessarily the same as is alleged for these compounds.
State of the Prior Art and Predictability in the Art
At the time of filing, there were very few compounds known in the art as ligands of NLRX1. None have been shown to have a broad spectrum of treatment of conditions in which NLRX1 is implicated, wherein the condition is selected from the group consisting of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases. Further, there are different types of treatments available for the said conditions in which NLRX1 is implicated, such as cancer, including surgery, chemotherapy, hormonal therapy, biological therapy, and radiation. Not every treatment option is effective for every patient, and for some patients, combinations of the above treatment options are necessary to manage their symptoms. Therefore, the ability to treat conditions in which NLRX1 is implicated, wherein the condition is selected from the group consisting of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases is unpredictable, much less the ability to anticipate which patients are at risk for said conditions and diseases.
For example, Lu (Lu, P. et. al. PLoS One, 2015, 10(12), p. e0145420, cited in the IDS of 3/20/2023) was identified as close prior art, at the time of filing, and discloses compounds as NLRX1 ligands discovered by modeling-enabled characterization (abstract). Ligands identified by docking include punicic acid, eleostearic acid, and docosahexaenoic acid (Figures 1-3), and Lu further discloses the treatment of colitis in mice, using a similar method disclosed in the instant specification, with punicic acid (page 11). No other evidence of treating conditions in which NLRX1 is implicated, wherein the condition is selected from the group consisting of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases is disclosed by Lu.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Furthermore, there is no evidence of record, which would enable the skilled artisan in the identification of the people who have the potential of becoming afflicted with the numerous diseases/disorders or conditions claimed herein. That a single compound or class of compounds can be used to treat or prevent all autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases embraced by the claims is an incredible finding for which Applicant has not provided supporting evidence. Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all the diseases or disorders by administering the instant claimed compounds.
Amount of Direction Provided and Working Examples The only direction or guidance present in the instant specification is the listing of diseases applicant considers as treatable by the claimed compounds and the activity of certain compounds of Formula (I) as modulators of production of inflammatory markers and in the treatment of inflammatory bowel disease, multiple sclerosis, and asthma models in mice. The specification does not show any examples where compounds of the claims were used to treat the full scope of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases as set forth in claims, but merely demonstrates that certain compounds decreased production of inflammatory markers and treated inflammatory bowel disease, multiple sclerosis, and asthma models in mice. (See MPEP § 2164.02 (“Compliance with enablement requirement of 35 USC 112, first paragraph, does not turn on whether an example is disclosed… Lack of a working example, however is a factor to be considered, especially in a case involving an unpredictable and undeveloped art”.)
Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases out of all autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases of the instant claims would be benefited (treated, prevented, or cured) and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment and prevention of the claimed diseases.
A person having ordinary skill in the art at the time the invention was made would be faced with an undue amount of experimentation to use the pharmaceutical compositions for the full scope of the claimed intended uses.
A conclusion of lack 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.
The specification fails to provide enough support of the broad use of the methods of administering compounds of the claims in the treatment of autoimmune diseases, allergic diseases, chronic and/or inflammatory central nervous system diseases, chronic and/or inflammatory respiratory diseases, cancers, and infectious diseases as a result necessitation one of skill to perform an exhaustive search for which diseases can be treated or prevented by what compounds of the invention to practice the claimed invention.
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 “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”.
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 by the compounds encompassed in the instant claims, with no assurance of success.
Claim Rejections - 35 USC § 112(a) – Written Description
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 29-48 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.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) 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 methods of treating conditions in which NLRX1 is implicated with compounds of Formula (I), or a salt or ester thereof. Particularly, the term “ester” recited in claims 29 and 48 invoke the 35 U.S.C. 112(a) rejection, and claims 30-47 depend from the above claims. Even a cursory calculation of the number of compounds embraced in the instant claims would result in thousands of compounds.
Level of skill and knowledge in the art
The level of skill and knowledge in the art is high.
Partial Structure
Compounds of Formula (I) have been disclosed and example compound species that would be within the general formula have been disclosed. However, as to the claimed esters, no specific examples are given that would demonstrate possession or put the public in possession of all the claimed esters of Formula (I). It is generally accepted that esters may vary by chemical formulae and may also differ in properties and the arrangement of atoms in the molecule.
Physical and/or chemical properties/functional characteristics
The compounds of Formula (I), and esters thereof, are compounds which are allegedly useful in treatment of conditions in which NLRX1 is implicated, for example in the treatment of asthma or inflammatory bowel disease. 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 the esters of Formula (I).
A review of the prior art identifies the reference Najjar (Najjar, A. & Karaman, R. Expert Opinion on Drug Discovery, 2018, 14(3), 199-220) discloses successes and failures of prodrugs of known pharmaceuticals, one example of which is also an ester (abstract and page 212, section 3). Najjar teaches hetacillin, an ester prodrug of ampicillin, which was withdrawn since it did not have a superior advantage when compared to ampicillin. In light of Najjar, it is unknown which of the esters of compounds of Formula (I) claimed by Applicant will be active or inactive. Further, one of ordinary skill in the art would not be able to predict which compounds, 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 esters would or would not be active.
Since Applicant has not set forth compounds or substituents on Formula (I) in the specification which Applicant considers esters, it is not clear what compounds fall under Formula (I). Applicant has not described which esters have the ability to treat conditions in which NLRX1 is implicated, and which do not. Stated differently, there is no structure/function correlation and no representative number of specific examples of esters that demonstrate which compounds retain activity. Further, one of ordinary skill in the art would not be able to predict the biological activity of the claimed esters of Formula (I).
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 esters, predicting if a certain claimed compound retains the activity and function of the original drug is filled with experimental uncertainty because esters contain variation by chemical and physical properties of the molecules.
Method of making the claimed invention
Although the specification provides a method for making the compounds of Formula(I), no method for making all of the compounds, including the esters, encompassed by the instant claims has been disclosed. Methods of synthesizing compounds are, in general, known to a person of ordinary skill; however, methods of making the myriad of compounds encompassed by the instant claims is beyond the skill of the artisan, particularly when certain elements, such as esters are merely 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 esters of Formula (I) because the examples illustrated in the experimental section are limited to only compounds of Formula (I).
Substantial and undue experimentation would be needed to practice Applicant’s invention because the specification lacks sufficient detail to show how to use the esters of the instant invention. Further, there is no guarantee that all of the esters embraced by the scope of the claims would be use in treatment conditions in which NLRX1 is implicated.
Even with the undue burden of experimentation, there is no guarantee that one would obtain the product of and ester of an instant compound of Formula (I). Although some functional characteristics are disclosed or would be known to a person 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 esters 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 generic. It is unquestionable that the claim(s) are broad and generic with respect to all possible compounds encompassed by the claims: the possible structural variations are limitless to any esters of Formula (I). In the instant case, however, the specification does not disclose a sufficient variety of species to reflect this variance in the genus. Specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims such as, for example, esters of Formula (I).
The description requirement of the patent statue 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.
Dependent claims 30-47 do not resolve the 112(a) written description rejections raised in claims 29 and 48, since those claims do not further limit or provide further structure of the esters of Formula (I). Accordingly, these claims are also rejected. This rejection would be overcome by amending the claims to remove the term “ester”.
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 29-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,548,885 (herein after the ‘885 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘885 patent recite Formula (I), which is the same as instant Formula (I), and compounds thereof. Claim 29 of the ‘885 patent recites a method of ameliorating or reducing a symptom of a condition in which NLRX1 is implicated in with said compounds. In addition to the method claim 29, the utility disclosed in the specification provides further support for a nonstatutory double patenting rejection by Examples 7-10 (cols 35-38). See MPEP § 804(I)(B)(1) and Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010).
Close Prior Art Not Cited
Close prior art is Merck Sharp & Dohme Corp. (US 2015/0329562 A1, herein after “Merck”). Merck discloses compounds as Factor IXa inhibitors for treating or preventing thromboses, embolisms, hypercoagulation, or fibrotic changes (abstract). Specifically, Merck discloses compounds such as Example 6 (page 28, Table 3):
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Which overlaps with instant Formula (I):
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When A1 is C(RA), where RA is H, A2 is N, A3 is N(RA), where RA is H, A4 is absent, A5 is C(RA), where RA is H, A6 is C(RA), where RA is H, A7 is C(RA), where RA is H, R8 is H, L is C(RL)2, where one RL is hydroxyl and the other is H, A11 is N, A12 is N(RA), where RA is an optionally substituted heteroaryl, A13 is C(RA), where RA is H, A14 is absent, and A15 is C(RA), where RA is H. However, Example 6 of Merck differs from a compound of Formula (I) by the morpholine ring in place of instant ring D. There is no motivation to change the morpholine ring to a 5-membered ring because compounds of Merck are known to treat different diseases by a different mechanism of action. Further, there is no teaching, suggestion, or motivation in Merck, alone or in view of the prior art, to modify the compounds therein to arrive at a compound of the instant claims.
Conclusion
No claims are allowed.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621