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 .
Claims 19-34 are pending in the instant application. Claims 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected subject matter. The withdrawn subject matter is patentably distinct from the elected subject matter as it differs in structure and element and would require separate search considerations. In addition, a reference which anticipates one group would not render obvious the other. Claims 22-34 are rejected.
Information Disclosure Statements
The information disclosure statements filed on August 19, 2025 and February 10, 2025 have been considered and signed copies of form 1449 are enclosed herewith.
Election/Restrictions
Applicant’s election of Group III, claims 22-34, and the species capsazepine (claim 26) and menthol (claim 27) in the response filed on July 13, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The restriction requirement between inventions is still deemed proper and is hereby made final. Upon further search and consideration, however, the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 22-34 has been searched and examined in its entirety).
Claim Rejections - 35 USC § 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 22-31 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of ameliorating or treating a subject afflicted with inflammation or epithelial cancer wherein the cancer is a tissue selected from the group consisting of: breast, such as triple negative metastatic adenocarcinoma, lung, pancreas, colon, and any combination thereof, or a symptom associated therewith, does not reasonably provide enablement for a method of ameliorating or treating a subject afflicted with any known (in the art) cell proliferation related disease or any known (in the art) type of cancer, or a symptom associated therewith. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include: nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e., what compounds can treat which specific disease by what mechanism). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statue. In the instant case, the claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects, whether or not the disease, or the symptom associated therewith, is affected by the administration of a combination of a cannabinoid and a TRP ligand would make a difference.
With regards to ameliorating or treating a cell proliferation related disease, or a symptom associated therewith, this could include many unrelated diseases or conditions (i.e., many of which have a different cause and, therefore, require a different treatment). There is not one class of compounds, let alone one compound, which can treat all of the possible diseases, or symptoms associated therewith, which could be included under a cell proliferation related disease, or a symptom associated therewith. The same reasoning applies to the treatment of cancer, or a symptom associated therewith.
With regards to the treatment of cancer, for example, the state of the prior art is that cancer therapy remains highly unpredictable. There are many known (in the art) types of cancer. The various types of cancers have different causative agents, involve different cellular mechanisms, and consequently, differ in treatment protocol. Symptoms and treatment depend on the cancer type and how advanced it is (see URL: http://www.nlm.nih.gov/medlineplus/cancer.html). It is known that the challenge of cancer treatment has been to target specific therapies to pathogenetically distinct tumor types, that cancer classification has been based primarily on morphological appearance of the tumor and that tumors with similar histopathological appearance can follow significantly different clinical courses and show different responses to therapy (Golub et al., page 531). Furthermore, it is known that chemotherapy is most effective against tumors with rapidly dividing cells and that cells of solid tumors divide relatively slowly and chemotherapy is often less effective against them. It is also known in the prior art (Lala et al., page 91) that the role of NO in tumor biology remains incompletely understood with both the promotion and inhibition of NO mentioned for the treatment of tumor progression and only certain human cancers may be treated by selected NO-blocking drugs. These examples show that there are different cellular mechanisms, the unpredictability in the art and the different treatment protocols.
Also, with specific reference to cancer, Ex parte Kranz, 19 USPQ2d 1216, 1219 notes the "general unpredictability of the field [of] ...anti-cancer treatment." In re Application of Hozumi et al., 226 USPQ 353 notes the "fact that the art of cancer chemotherapy is highly unpredictable".
Hence, in the absence of a showing of correlation between all the various cell proliferation related diseases, or the symptoms associated therewith, claimed as capable of treatment through the administration of a combination of a cannabinoid and a TRP ligand, one of skill in the art is unable to fully predict possible results from the administration due to the unpredictability.
The amount of direction or guidance present and the presence or absence of working examples
A disclosure should contain representative examples which provide reasonable assurance to one skilled in the art that the compounds which fall within the scope of a claim will possess the alleged activity. The only direction or guidance present in the instant specification is the listing of diseases, or symptoms associated therewith, Applicant considers as treatable by the administration of a combination of a cannabinoid and a TRP ligand and assays involving the cell lines MCF7, MDA-MB-231, MDA-MB-468, T47D, H1975, Panc 1, BxPc3, Hs578T, B16, and LS174t (i.e., drawn to the treatment of breast cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, melanoma, and colon epithelial adenocarcinoma) and drawn to the reduction of swelling, pain and inflammation (see pages 23-30). However, the disclosure does not provide how the examples correlate to the treatment of the assorted cell proliferation related diseases, or symptoms associated therewith. In other words, the specification does not contain any evidentiary support that the administration of a combination of a cannabinoid and a TRP ligand would be able to treat the many various diseases, or symptoms associated therewith, listed besides inflammation or epithelial cancer wherein the cancer is a tissue selected from the group consisting of: breast, such as triple negative metastatic adenocarcinoma, lung, pancreas, colon, and any combination thereof, or a symptom associated therewith.
Applicant has not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds and 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).
The level of skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which diseases, or symptoms associated therewith, would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the administration of a combination of a cannabinoid and a TRP ligand for the amelioration or treatment of a subject afflicted with a cell proliferation related disease, or a symptom associated therewith, as a result necessitating one of skill to perform an exhaustive search for which diseases, or symptoms associated therewith, can be ameliorated or treated by the administration of a combination of a cannabinoid and a TRP ligand in order to practice the claimed invention.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what specific diseases, or symptoms associated therewith, are benefited by the administration of a combination of a cannabinoid and a TRP ligand.
Factors such as "sufficient working examples", "the level of skill in the art" and "predictability", etc. have been demonstrated to be sufficiently lacking in the instantly claimed formulation and method. In view of the chemical nature of the invention and the lack of working examples regarding the activity of the claimed compounds, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate in scope with the claims.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that "a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion" and ”[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable".
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation to test which specific diseases, or symptoms associated therewith, can be ameliorated or treated by the administration of a combination of a cannabinoid and a TRP ligand.
This rejection can be overcome, for example, by amending the claims to be drawn to a method of ameliorating or treating a subject afflicted with inflammation or epithelial cancer wherein the cancer is a tissue selected from the group consisting of: breast, lung, pancreas, colon, and any combination thereof, or a symptom associated therewith.
Claims 22-25 and 28-34 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.
Specifically, claim 22 recites the limitation: administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising a cannabinoid and a “TRP ligand” for which the specification does not provide an adequate written description to convey that the inventors where in possession of the full scope of the claimed invention.
Regarding the requirement for adequate written description of chemical entities,
Applicant's attention is directed to the MPEP §2163. In particular, Regents of the
University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert.
denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written
description requires a precise definition, such as by structure, formula, chemical name,
or physical properties, "not a mere wish or plain for obtaining the claimed chemical
invention.” Eli Lilly, 119 F.3d at 1566. The Federal Circuit has adopted the standard set
forth in the Patent and Trademark Office ("PTO") Guidelines for Examination of Patent
Applications under the 35 U.S.C. 112.1 "Written Description" Requirement
("Guidelines"), 66 Fed. Reg. 1099 (Jan. 5, 2001), which state that the written description
requirement can be met by "showing that an invention is complete by disclosure of
sufficiently detailed, relevant identifying characteristics," including, inter aria, "functional
characteristics when coupled with a known or disclosed correlation between function
and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed.
Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106 (emphasis added)). Moreover,
although Eli Lilly and Enzo were decided within the factual context of DNA sequences,
this does not preclude extending the reasoning of those cases to chemical structures in
general. Univ. of Rochester v. G.D. Searle & Co., 249 Supp. 2d 216, 225 (W.D.N.Y.
2003).
Medicinal chemistry and pharmacology are unpredictable areas. Even carefully designed inhibitors do not always function as expected. It is generally unpredictable whether any TRP ligand combined with a cannabinoid would possess the ability to ameliorate or treat a subject afflicted with a cell proliferation related disease, or a symptom associated therewith. For strong inhibitors of TRPV1 or TRPA1, for example, some structure-activity-relationship may be ascertained from structurally similar derivatives; however, the degree of structural similar must be high in order to expect similar properties. For new or untested compounds, TRP inhibition is largely unpredictable.
The only examples of TRP antagonists disclosed in the specification are the TRPV1 antagonists capsazepine, capsaicin and thapsigargin and the TRPA1 antagonists menthol, camphor and carvacrol. However, Applicant has not described the genus in a manner that would allow one skilled in the art to immediately envisage all the compounds contemplated for use. As such, the claims lack adequate written description for the many compounds embraced by the claimed TRP ligands.
It is also noted that the examples in the specification involve capsazepine thapsigargin, capsaicin, camphor, menthol, and carvacrol (see pages 23-30).
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.
Although the prior art discloses a number of different classes of inhibitors of TRP (e.g., TRPV1 or TRPA1), a person of ordinary skill in the art could not reasonably predict whether an untested compound would be able to function as a TRP inhibitor or specifically a TRPV1 or TRPA1 inhibitor because definitive structure-function correlations have not been established in the prior art. It is even more difficult to be able to predict whether an untested generic TRP inhibitor would be able to be used to ameliorate or treat a subject afflicted with a cell proliferation related disease, or a symptom associated therewith. Some exceptions may extend to compounds that share a high degree of structural similarity to known TRPV1 or TRPA1 inhibitors, for example, in the prior art. However, the claim encompasses both known and unknown compounds that are structurally divergent from known TRP ligands. The examples in the specification (i.e., capsazepine, thapsigargin, capsaicin, camphor, menthol, and carvacrol) and the prior art do not sufficiently represent the vast structural diversity of small molecules and biomolecules embraced by the claims. Due to the high degree of unpredictability generally associated with inhibition and the lack of structure-function correlation, a person of ordinary skill in the art would reasonably conclude that the inventors did not possess all of the TRP ligands claimed. Because the specification does not provide sufficient structural information to distinguish the claimed inhibitors from other entities, the claims lack written description.
This rejection can be overcome by amending the claims to be limited to the use of the specific TRPV1 antagonists capsazepine, capsaicin and thapsigargin and the TRPA1 antagonists menthol, camphor and carvacrol.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 22, 24-26 and 30-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20219/374501 A1.
US 20219/374501 A1 discloses a pharmaceutical composition comprising at least one cannabinoid, such as CBD, and/or terpene and/or capsaicin, for use in modulating the activation of the TRPV1 ion channel, thereby treating diseases, such as chronic inflammatory pain (see abstract, [0004], [0080]-[0081] and [0087]). In addition, said composition can further comprise a pharmaceutically acceptable carrier (see [0089]). Therefore, a method for ameliorating or treating a subject afflicted with a cell proliferation related disease, or a symptom associated therewith (i.e., inflammation and/or resulting pain thereof), the method comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising CBD and capsaicin of the instant claims is anticipated by the reference.
Claims 22-25, 27, and 29-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/051055 A2.
WO 2020/051055 A2 discloses a gum or lozenge composition comprising a cannabinoid, such as CBD or THC, menthol, which is known in the art to be a TRP ligand, and a pharmaceutically acceptable carrier for use in the treatment of pain and/or inflammation in the oral cavities. Said cannabinoid can be derived from plants (phytocannabinoids) or synthetically produced (see [0027]). The amount of cannabinoid in the composition is in the range of 2-60 mg, and the amount of menthol in the composition is in the range of 1-20 mg, meaning a molar ratio of 1:1-1:500 (see [0022] and [0028]). It is also disclosed in the reference that menthol is effective as an anesthetic, pain reducing (e.g., analgesic) or anti-inflammatory compound (see [0032]). Therefore, a method for ameliorating or treating a subject afflicted with a cell proliferation related disease, or a symptom associated therewith (i.e., inflammation and/or pain), the method comprising administering to said subject a therapeutically effective amount of a pharmaceutical composition comprising CBD or THC and menthol of the instant claims is anticipated by the reference.
Conclusion
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/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
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