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 .
Priority
The instant application, filed 05/11/2023, is a 371 filing of PCT/EP2021/081795, filed 11/16/2021, which claims foreign priority to NO20201253, filed 17/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR § 1.55.
Amendments and Claim Status
The following amendment filed on 04/09/2026 is acknowledged and entered.
Claims 1 are amended;
Claims 2 4-7, and 13 are cancelled;
Claims 1, 3, 8-12, and 14-18 are pending and are under prosecution.
Response to arguments
Applicant’s arguments filed 04/09/2026 with respect to the objection to the specification and claim rejections under 35 U.S.C. § 112(a) have been fully considered.
With respect to the objection to the specification, Applicant’s explanation for the intentional use of capsaicin is sufficient to overcome the objection. As such, the objection is hereby withdrawn.
With respect to the rejection of claims 1-12 and 14-18 under U.S.C. § 112(a), the cancellation of claims 2, 4-7, and 13 is sufficient to render the rejection against said claims moot. The arguments made by applicant are herein addressed.
The following section of the MPEP is relied upon for the response to Applicant’s arguments. According to MPEP § 2163.02, the standard for determining compliance with the written description requirement is as follows,
Whenever the issue 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, inventor 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 that the inventor was in 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). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
Applicant asserts that the amendment reciting “by inhibiting bacterial quorum sensing” now satisfies the written description requirement.
Applicant’s argument is found unpersuasive, because written description requires possession of the claimed compounds and the claimed method.. The written description requirement is satisfied only when the specification reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. There are no substituted phenyl substituents at position R, and the specification only conveys one singular compound. The specification fails to provide representative species, working examples, or structural features that correlate with the full scope of the claimed method.
Applicant further argues that the instant application does not concern the synthesis of the compounds, but rather the use of said compounds in a method for the treatment of leaky gut, leaky gut syndrome, and increased intestinal permeability by inhibiting bacterial quorum sensing.
Applicant’s argument is unconvincing, because in order to demonstrate possession of the instantly claimed compounds used in a method of treatment, a person of ordinary skill in the art would need to be guided on how to synthesize and characterize said compounds. Providing evidence of synthesis of characterization would demonstrate adequate written description of the claimed invention, which the instant application lacks completely.
The cited examples and figures in the prior art do not map to the claims in a manner that would demonstrate possession of compounds encompassing the claimed substituents at position R. The specification does not describe the claimed compounds with sufficient specificity to distinguish them from the universe of possible conjugates and substitutions that can be theoretically made.
Genentech, 108 F.3d at 1366, 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”.
Accordingly, applicant has not demonstrated the possession of the claimed compounds as required under 35 U.S.C. § 112 (a). The rejection is therefore maintained. Applicant is invited to amend the claims to correspond to subject matter that is adequately supported by the specification, or to provide persuasive evidence demonstrating possession of the claimed compounds used within a method of treating as of the effective filing date.
With respect to the rejection of claims 1-12 and 14-18 under U.S.C. § 112(a), the cancellation of claims 2, 4-7, and 13 is sufficient to render the rejection against said claims moot. The arguments made by applicant are herein addressed.
Applicant argues that the claims have been amended to indicate that the methods works by way of inhibiting bacterial quorum sensing.
Applicant’s argument is unconvincing because the specification continues to lack any examples of the administration of the compounds to treat any of the claimed diseases. Simple experiments of in vitro bacterial assays do not extrapolate to a method of treatment without undue experimentation.
Applicant argues that the method should not be limited by the in vitro experiments of examples 1-6, as these cannot be fairly extrapolated to humans and clinical experiments.
Applicant’s argument is unconvincing, because the person of ordinary skill in the art would be subject to undue experimentation in order to convert the findings presented within the instant specification to a workable treatment regimen.
Finally, applicant argues that the claimed method is not unpredictable, because it is drawn to a synthetic substance, and not a plant extract as cited in MPEP § 2163.03
Applicant’s argument is unconvincing because a citation to MPEP § 2163.03 was not made. Instead, the previous office action cited MPEP § 2164.03 which deals with the relationship of predictability in the art and the enablement requirement. Further, no mention of a plant extract was made, rendering the argument which distinguishes the instantly claimed method utilizing a synthetic compound moot. To reiterate, a highly detailed disclosure would render the claimed method predictable. However, the specification lacks a detailed disclosure, and provides no instruction with respect to a method of treatment.
Accordingly, applicant has enabled a person of ordinary skill in the art to practice the claimed method as required under 35 U.S.C. § 112 (a). The rejection is therefore maintained. Applicant is invited to amend the claims to correspond to subject matter that is adequately supported by the specification, or to provide persuasive evidence demonstrating possession of the claimed compounds in a method of treating as of the effective filing date.
Thus, all arguments presented by Applicants have been addressed and are found unpersuasive for the reasons presented herein and in the previous non-final rejection. Applicants are reminded that “attorney argument [is] not the kind of factual evidence that is required to rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Claim Rejections - 35 U.S.C. § 112
The following is a quotation of the first paragraph of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. § 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 8-12, and 14-18 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.
Claims 1-12 and 14-18 of the instant application are drawn to a method of administering a compound having following substituents:
R is selected from the group comprising phenyl and substituted phenyl, wherein said substituted phenyl is substituted in any one or more positions with 1-5 identical or different substituents selected from the group comprising fluoro; chloro; bromo; iodo, cyano, nitro, trifluoromethyl, C1-C6 straight chain and branched alkoxy, C1-C6 sulfoxy, —S—C1-C6 alkyl, C1-C6 straight chain and branched alkyl, alkenyl, and alkynyl C2-C6 straight chain and branched alkenyl, C2-C6 straight chain and branched alkynyl, C1-C6 fluoroalkyl, chloroalkyl, bromoalkyl, and iodoalkyl, COO—C1-C6 alkyl, O(CO)—C1-C6 alkyl, NH—C1-C6 alkyl, N(C1-C6 alkyl)2, CON(C1-C6 alkyl)2, and NH(CO)—C1-C6 alkyl,
35 U.S.C. § 112(a) and the first paragraph of pre-AIA 35 U.S.C. § 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). 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.
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); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
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. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of any working example of the invention as claimed, and the lack of predictability in the art.
In the instant specification, there is no disclosure of compounds having the following claimed substituents:
R as substituted phenyl
The instant specification (pages in 33-44) teaches a method utilizing a singular compound (compound V) which is characterized as having only the following substituent:
R is phenyl
Therefore, the methods and compounds described in the instant specification detail only none of the total substituents claimed (see substituent list 1, above). All working examples presented in the instant specification are related to the compounds containing only a phenyl at position R. There is no further substitution of the phenyl reflected in the instant specification.
There are no working examples in the instant specification for the wide range of substituents claimed at position R, but for which evidence of possession has not been provided. Thus the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held 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(1997); In re Gosteli, 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 invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 1-12 and 14-18 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Claims 1, 3, 8-12, and 14-18 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 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 make and/or use the invention. subject matter. More specifically, the specification does not describe any methods for the treatment of leaky gut, leaky gut syndrome, or increased intestinal permeability, nor does it describe a method to a medicinal dose of the compounds make the medicinal dose and administer said compounds for a therapeutic use.
The following factors are considered in determining whether undue experimentation is required to practice the invention:
(1) Nature of the invention;
(2) Breadth of the claims;
(3) State of prior art;
(4) Level of ordinary skill in the art;
(5) Level of predictability in the art;
(6) Amount of direction provided;
(7) Presence of working examples; and
(8) Quantity of experimentation required to make or use the invention.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Nature of the invention: Independent claim one recites therapeutic methods targeting leaky gut, leaky gut syndrome, or increased intestinal permeability comprising administering a therapeutically effective amount of at least one compound claimed to a subject in need thereof.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that the broad genus of the claimed compounds can be used to treat a leaky gut, leaky gut syndrome, or increased intestinal permeability. Thus, the cited claims are deemed very broad since these claims read on the common treatment of leaky gut, leaky gut syndrome, or increased intestinal permeability by a range of distinct compounds characterized by substituents with much variability (e.g., R) i.e. large Markush group/genus scope. Furthermore, the claims are deemed very broad with respect to patient group (i.e., newly diagnosed or remission, cytogenetic risk, transplant eligibility), biomarker status, disease stage, duration of treatment, and dosing schedules of a compound of Formula (I).
State of the Prior Art: The current state of the art recognizes that capsaicin and related capsaicinoids can influence gut microbiota composition and bacterial pathogenicity (Abstract). Rosca et al. (Molecules, Volume 25, Issue 23, 5681, published December 2, 2020), hereinafter Rosca reports that capsaicin has been observed to modulate bacterial populations, reduce virulence related behaviors such as biofilm formation, and alter inflammatory markers in experimental systems (pages 3-6). Rosca hypothesizes that such effects may indirectly impact gut health. Rosca further hypothesizes that capsaicin-mediated changes in microbiota and inflammatory signaling could be associated with intestinal barrier function in certain animal models (page 13).
Although the disclosure widely reviews the use of capsaicin in a number of contexts, there is no mention of treatment of intestinal permeability or leaky gut syndrome in reference to capsaicyn. The reference neither teaches nor suggests such a use for capsaicyn. Rather, the authors of this manuscript repeatedly characterize that the available data is largely experimental, caution against extrapolation to human treatment, and acknowledge that further studies are required before any therapeutic conclusions can be drawn (pages 13 and 14). As such, the current state-of-the-art does not appear to recognize leaky gut, leaky gut syndrome, or increased intestinal permeability therapy via the administration of capsaicyns.
Predictability/Unpredictability in the Art: The level of ordinary skill in producing a medicinal dose from a bioactive compound requires sufficient experience in pharmaceutical formulations and is considered to be sophisticated. Regardless, the level of skill cannot overcome the extreme unpredictability in the field of gastrointestinal disease and intestinal permeability therapy. With regard to the relationship of predictability of the art and the enablement requirement, the MPEP § 2164.03 states,
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938).
In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). A need for greater disclosure derives from the fact it is not obvious from the disclosure of one species, what other species will work.
Generally speaking, then, the Courts recognize that predictability in chemical related arts is low enough to require a highly detailed disclosure. Unpredictability arises in chemical related arts because subtle changes in molecular structure may greatly impact a compound's structure-activity relationship, pharmacologic activity, and/or biologic profile. In drug development, the skilled artisan would not be able to easily extrapolate treatment for a medical use from a single example or limited disclosure without more instruction. These considerations support a requirement for a disclosure with a high level of detail. Predictability with regard to the claimed method of producing a medicinal dose from a raw plant is considered to be extremely low due to the lack of specificity regarding the type of plant, type of medicinal dose, and type of medical use. Considered in light of the general unpredictability of pharmacology, the predictability of practicing the claimed methods of is extremely low.
In support of the claimed method, the specification provides no examples of a medicinal dose of a compound of Formula (I) or any capsaicyn in the treatment of leaky gut, leaky gut syndrome, or increased intestinal permeability. Rather, the specification provides evidence, by way of existing scientific literature and examples within the specification, that capsaicin compounds can affect gut microbiota. Like the prior art, the specification provides no evidence that a compound of Formula (I) or any capsaicyn may find success in treating leaky gut, leaky gut syndrome, or increased intestinal permeability.
The lack of evidentiary support tends to lead to a conclusion of lack of enablement. (See, e.g., In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, claim drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” administering a small genus of compounds. The Court decided that human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed.”; Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.”).
Guidance of the Specification/Working Examples: The MPEP at § 2164.02 states that a single working example in the specification for a claimed invention is enough to preclude a rejection stating nothing is enabled, since at least that embodiment would be enabled. However, in these cases a rejection stating that enablement is limited to a particular scope may continue to be appropriate. The Court in In re Brana is instructive with regard to working examples in the pharmaceutical setting. In essence, the Court found a pharmaceutical invention enabled where the animal model (in vitro or in vivo) correlates to the claimed use and the claimed compounds compared favorably with compounds known to have the same therapeutic effect. In re Brana, 51 F.3d 1560, 1566; 34 USPQ2d 1436, 1441 (Fed. Cir. 1995).
The MPEP at § 2164.02 is instructive regarding animal models and states that an in vitro or in vivo animal model example in the specification constitutes a "working example" if that example "correlates" with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute "working examples." In this regard, the issue of "correlation" is also dependent on the state of the prior art. If the art is such that a particular model is recognized as correlating to a specific condition, it should be accepted as correlating unless the examiner has evidence that the model does not correlate. In re Brana at 51 F.3d 1566; 34 USPQ2d 1441 (Fed. Cir. 1995).
Patent applications claiming new methods of treatment usually find support in test results, however, human trials cannot be required for a therapeutic invention to be patentable. Janssen Pharmaceutica N.V. v. Teva Pharms. USA, Inc., 583 F.3d 1317, 1324 [92 USPQ2d 1385] (Fed. Cir. 2009). Results from animal tests or in vitro experiments may suffice to satisfy the utility requirement. Id. Under the appropriate circumstances, in vitro testing alone may establish a practical utility for the compound in question. For example, in Janssen Pharmaceutica, the Federal Circuit noted its own previous findings with regard to in vitro test results,
We noted in Cross v. Iizuka that “[w]e perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the [pharmaceutical] compound in question” in order for a patent to issue. 753 F.2d 1040, 1051 [224 USPQ 739] (Fed. Cir. 1985). We concluded that in vitro test results for a claimed pharmaceutical compound, combined with animal test results for a structurally similar compound, showed “a reasonable correlation between the disclosed in vitro utility and an in vivo activity. Id. at 1327.
In this case, no working examples are presented demonstrating the claimed process in any subject. Rather, the specification discloses in vitro biological assays evaluating phenylcapsaicyn for their ability to inhibit bacterial quorum sensing and biofilm formation. Specifically, the examples described quorum sensing inhibition in Chromobacterium Violaceum CV026 reporter assay, and biofilm inhibition assays using crystal violet staining against pathogenic bacterial strains including Pseudomonas aeruginosa, E. coli O157:H7, and Salmonella enterica. The studies demonstrate that phenylcapsaicyn is capable of reducing bacterial pathogenicity (pages 34-44).
These teachings are not commensurate in scope with the instant claims. The disclosed examples are limited to in vitro bacterial assays, and did not assess intestinal permeability, gastrointestinal inflammation, or therapeutic treatment and any subject whatsoever. There are no in vivo studies, animal models, clinical data, or measurements relevant to gut barrier function provided. Nor is there any disclosure of administering the compounds to a subject to treat leaky gut. Assertions that quorum sensing or biofilm inhibition may lead to improvement in gastrointestinal inflammatory conditions are simply speculative, and appear only as conclusory statements unsupported by experimental evidence.
The Quantitation of Experimentation Required: A great deal of experimentation is necessary to take molecule from the bench to the clinic. For example, Hörig and Pullman, (J. Translational Med. Volume 2, Article Number 44, published December 20, 2004) note that the path to successfully utilizing a compound as treatment: “requires satisfying a matrix of domains from relevance to the disease and the drug-ability of the target through feasibility and convenience of drug delivery, demonstration of favorable benefit-risk profile in order to achieve a drug label that reflects physician and patient acceptance” (page 44). Hörig and Pullman further suggest that the complexity of determining whether a molecule may be used as treatment of diseases requires collaborative research, where success is determined by: “identification and validation of novel drug targets, development of robust and validated assays to screen drug leads for safety and potential efficacy in humans, and the identification of suitable patients for expedited but informative trials (page 45).
Each step involved in determining whether a compound may be used to treat a disease presents a need for rigorous experimentation. Years of research may be required in determining whether a compound may be used to treat a disease.
The claims encompass a broad method of treatment of leaky gut, leaky get syndrome, or increased intestinal permeability comprising the administration of a compound of Formula (I). While the art recognizes a link between capsaicin and got microbiota, there is a lack of evidence regarding leaky gut, leaky gut syndrome, or increased intestinal permeability treatment via capsaicyns. This lack of evidentiary support is lacking especially in a compound of Formula (I), which differs from traditional capsaicin compounds in the inclusion of a triple bond in the place of the double bond found in traditional capsaicin compounds. The specification provides no evidence that the claimed capsaicyns are capable of their claimed use. The specification provides no working examples practicing the claimed method of administration of the compounds claimed to a patient for a medical use. In addition, while the level of skill in the art is high, it cannot overcome a lack of evidentiary support found in the art or the specification. Without such evidence, in light of the unpredictability found in the chemical and pharmaceutical arts, the amount of experimentation required to practice the invention is considered to be undue.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR § 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR § 1.17(a)) pursuant to 37 CFR § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call +1 (800) 786-9199 (IN USA OR CANADA) or +1 (571) 272-1000.
/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
Prosecution Insights