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
This application filed on 10/20/2023 is a U.S. National Stage filing under 35 U.S.C. Q 371 of International Application No. PCT/EP2022/060579, filed 04/21/2022, which claims the benefit of European Patent Application No. 21382343.8, filed 04/21/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 01/22/2024 and 07/19/2024, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
Status of claims
The preliminary amendment filed on 03/11/2026, that cancelled claims 1-10 and 18-27, is acknowledged. Claims 11-17 and 28-37 are pending.
Election/Restriction
Applicant’s response filed on 03/11/2026 to Restriction/Election Requirement filed on 01/13/2026, is acknowledged. Applicant elected without traverse Group II drawn to a method for treatment and/or prevention of hyperproliferative disorders comprising administering to a subject in need thereof a compound of formula (I). Claims 28-37 read on the elected Group. Claims 11-17 of Group I are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Pursuant to the Election of Species Requirement, Applicant respectively elected without traverse, 2-Imidazo[2,1-b]thiazol-6-vl-N-[4-(2-methyl-1H-indol-3-vl)-thiazol-2-yll-acetamide depicted below for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable:
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Claims 28-35 read on the elected species. Applicant’s elected species was searched, and determined to be free of the art of record. Pursuant to MPEP § 803.02, the search and examination was extended to the non-elected species discussed below, which new search species falls within the scope of instant claims 28-37 (i.e., claims to proper Markush groupings that include both the new search species as well as the originally elected species. MPEP § 803.02(III)(C)(2)). The new search species underlies rejections of these claims pursuant to 35 U.S.C. § 102. As such, the election of species requirement is maintained as provisional, and claims 11-17 are provisionally withdrawn from consideration pursuant to 37 CFR 1.142(b). See, MPEP § 803.02.
Thus, claims 11-37 are pending with claims 11-17 are withdrawn from further consideration, and claims 28-37 are under consideration.
Abstract
The Abstract of the disclosure is objected to because the Abstract recites “the present disclosure relates to …”. Applicant is reminded of the proper language and format for an abstract of the disclosure. 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. 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).
Rejections 35 U.S.C. 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.
Claim 32 is 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.
Pursuant to 35 U.S.C. 112, the claim must apprise one of ordinary skill in the art of its scope so as to provide clear warning to others as to what constitutes infringement. MPEP 2173.02(II); Solomon v. Kimberly-Clark Corp., 216 F.3d 1372, 1379, 55 USPQ2d 1279, 1283 (Fed. Cir. 2000). The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention. MPEP § 2173.05(a).
Claim 32 is rejected pursuant to 35 U.S.C. 112, as indefinite because it is unclear whether this claim is directed to the statutory category of method or composition. Claim 32 is reproduced below.
Claim 32. “The method according to claim 28 wherein Gl is selected from the group consisting of 1H-indol-3-yl, imidazo[2,1-b]thiazol-6-yl, imidazo[1,2-a]pyridin-2-yl, 1H- indol-2-yl, benzo[d]oxazol-2-yl, imidazo[2,1-b]thiazol-3-yl, benzo[b]thiophen-2-yl, thiophen-2- yl, benzo[b]furan-2-yl, and 1H-imidazol-4-yl, all of which may be optionally substituted as defined in claim 11.”
The claim 32 is dependent on claim 28, which is directed to a method of treatment comprising administering a compound of formula (I). However, claim 32 references claim 11 which directed a “a compound of formula (I’). The recitation of “a compound of formula (I)” indicates the statutory category of a composition. Note that claim 11 is directed to formula (I’), whereas claim 28 is directed to formula (I). A single claim which claims both an apparatus/product and the method steps of using the apparatus/product is indefinite under 35 U.S.C. 112(b). MPEP § 2173.05(p) (citing Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990); In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)). Further, the claimed invention must be to one of the four statutory categories, processes, machines, manufactures and compositions of matter. MPEP § 2106(I). Here it is unclear whether claim 1 is directed to the statutory category of composition of matter or process or both.
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 28-37 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 claim(s) contains 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.
The claims do not reasonably provide enablement for the treatment and prevention of cancer. 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.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)”. The “use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc. 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
By way of background, four cases are of particular relevance to the question of enablement of a method of treating cancers broadly or even generally:
In In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, the claim was drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” using 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”.
In Ex parte Jovanovics, 211 USPQ 907 the claims were drawn to “the treatment of certain specified cancers in humans” by the use of a genus of exactly two compounds, the N-formyl or N-desmethyl derivative of leurosine. Applicants submitted “affidavits, publications and data” for one of the compounds, and a dependent claim drawn to the use of that species was allowed. For the other, no data was presented, applicants said only that the other derivative would be expected to be less effective; claims to the genus were refused.
In Ex parte Busse, et al., 1 USPQ2d 1908, claims were drawn to “A therapeutic method for reducing metastasis and neoplastic growth in a mammal” using a single species. The decision notes that such utility “is no longer considered to be “incredible””, but that “the utility in question is sufficiently unusual to justify the examiner's requirement for substantiating evidence.” Note also that there is also a dependent claim 5 which specified “wherein metastasis and neoplastic growth is adenocarcinoma, squamous cell carcinoma, melanoma, cell small lung or glioma.” The decision notes that “even within the specific group recited in claim 5 some of the individual terms used actually encompass a relatively broad class of specific types of cancer, which specific types are known to respond quite differently to various modes of therapy.”
In 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.”
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
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) The breadth of the claims:
The presently claimed invention is directed to a method for the treatment and/or prevention of hyperproliferative disorders characterized in that it comprises the administration to a subject in need thereof of a compound of formula (I).
The instant specification disrobed the term “hyperproliferative” as: “The term "hyperproliferative disorder" refers to a disorder involving undesired and uncontrolled cell proliferation. The hyperproliferative disorder may be benign or malignant (cancer). The term "cancer" thus refers to any malignant growth or tumor caused by abnormal and uncontrolled cell division; it may spread to other parts of the 10 body through the lymphatic system or the blood stream and includes both solid tumors and blood-borne tumors.” [page 15, line 6-11].
Cancer is not a single disease, or a cluster of closely related disorders. There are hundreds of proliferative diseases, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, something seen especially in, for example, the cancers of the breast, brain, and salivary glands. They can occur in every part of the body. Moreover, prevention is a practice of which would require identification of patients that are at risk of developing cancer. The specification and the art of record fail to disclose a validated marker or method for predicting a benefit from the instantly claimed compounds. Therefore, the scope of the diseases covered is deemed very broad, and cannot be considered enabled by the instant specification. In addition, treating a cancer encompasses thousands of anti-cancer/antitumor agents under the classes such as small molecular chemotherapy, antitumor antibiotic substance, a platinum-based agent etc. is deemed very broad, and cannot be considered enabled by the instant specification.
(2) The nature of the invention:
The present claims describe a method for treating and preventing every cancer. That is; in order to be enabled to practice the present invention, the skilled artisan would have to accept that by administering the claimed compound of formula (I) to a cancer patient that such therapeutic objectives could actually be achieved. However, in light of the fact that the specification fails to provide the skilled artisan with any direction or guidance as to how the treatment of cancer in general could be achieved, or how the claimed compound of formula (I) dose or regimen will be selected for treating and preventing any particular kind of cancer, the present specification is viewed as lacking an enabling disclosure of the entire scope of the claimed invention.
(3) The state of the Prior Art:
The instant claims are directed to a method for the treatment and/or prevention of hyperproliferative disorders characterized in that it comprises the administration to a subject in need thereof of a compound of formula (I). However, as taught by Chakraborty (S. Chakraborty, et al. Ecancermedicalscience. 2012, 14;6:ed16. doi: 10.3332/ecancer.2012.ed16), “the cure for cancer is like the Holy Grail since most of the existing treatments are not effective enough to provide full protection from this disease”. Chakraborty teaches that “in recent years the burgeoning of sophisticated genomic, proteomic and bioinformatics techniques has made it possible for us to get a glimpse of the intricate interplay of numerous cellular genes and regulatory genetic elements that are responsible for the manifestation of cancerous phenotypes. With the use of modern genomic technologies, we are now beginning to understand the enormous complexity of cancer, however, there are few success stories as far as the treatment of cancer is concerned, [Abstract]. Chakraborty teaches that the non-specific nature of cancer symptoms makes diagnosis difficult (let alone treatment and prevention). Chakraborty teaches examples of cancer with diagnosis difficulties include esophageal cancer, prostate cancer, and pancreatic cancer. [Page 3-4]. Moreover, Zafar (A. Zafar, et al. Med Res Rev. 2021;41:961–1021, DOI: 10.1002/med.21750), teaches the challenges associated with neuroblastoma treatment. Zafar teaches that standard treatment in children all lead to relatively poor outcomes for NB treatment. It is also important to note that oncology drugs have the lowest LOA (likelihood of approval) from phase I (6.7%) compared with drugs used for other diseases (allergy, dermatology, urology, autoimmune disease, and ophthalmology).45 Complicating matters, the current treatments approved for NB have limited targeted specificity. [Page 964, 1st para.]. Numerous mechanisms have been proposed as methods of treating assorted cancers a selection of which follow. Cytotoxic agents could be applied directly to the tumor’s cells, directly killing them. Immunotherapy to stimulate the patient's immune system to attack cancer cells, either by immunization of the patient, in which case the patient's own immune system is trained to recognize tumor cells as targets, or by the administration of therapeutic antibodies as drugs, so the patient's immune system is recruited to destroy tumor cells by the therapeutic antibodies. Increasing the amount or activity of the body’s tumor suppressor genes, PTEN, APC and CD95, which can, for example, activate DNA repair proteins, suppress the Akt/PKB signaling pathway, or initiate apoptosis of cancer cells. Angiogenesis inhibitor strategies based on cutting off the blood supply that growing tumors need by shutting off the growth of new blood vessels by, for example, suppressing proliferation of endothelial cells or inducing apoptosis of endothelial cells.
A number of these approaches – and others as well – have produced anti-cancer drugs. However, despite high hopes for success, and a plausible theory why these should work for cancers generally, these approaches have yet to produce a drug which can claim such a goal.
Specifically, the prior art demonstrates that there never has been a compound capable of treating cancers generally. “The cancer therapy art remains highly unpredictable, and no example exists for efficacy of a single product against tumors generally.” A similar statement appears at In re Application of Hozumi et al., 226 USPQ 353: “In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way”. There are compounds that treat a modest range of cancers, but no one has ever been able to determine how to get a compound to be effective against cancer generally, or even a majority of cancers.
The attempts to find compounds to treat the various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally, and the existence of such a single treatment for cancer is contrary to our present understanding in oncology. This is because it is now understood that there is no “master switch” for cancers generally; cancers arise from an exceptionally wide variety of differing mechanisms. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, primarily a wide variety of failures of the body's cell growth regulatory mechanisms, but also such external factors such as viruses, exposure to environmental chemicals (e.g. tobacco tars, alcohol, toxins), ionizing radiation, and unknown environment factors.
Accordingly, there is substantive “reason for one skilled in the art to question the objective truth of the statement of utility or its scope” (In re Langer, 183 USPQ 288, 297), specifically, the scope of covering cancer generally.
Similarly, In re Novak, 134 USPQ 335, 337-338, says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case. Likewise, In re Cortright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Moreover, even if applicants’ assertion that cancer in general could be treated with these compounds were plausible, which it is not, that “plausible” would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success.”
(4) The skill of those in the art:
The skill of those in the art is expected to be high, requiring advanced training in chemistry, medicine, or pharmacology.
(5) The level of predictability in the art:
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”. More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
With this in mind the level of predictability in the art is sufficiently low that even with hundreds of successful examples of chemotherapy there has yet to be shown any single method of treating the vast scope of cancers known. The level of unpredictability in the art renders the scope of instant claim to be not enabled.
(6)/(7) The amount of direction provided/ Working examples:
While the treatment of cancer is discussed in broad terms, the necessary specifics, i.e. dosing, therapeutic index, contraindications, interaction between the claimed compound with other antitumor agents, toxicity etc., are completely absent. And while the anti-cancer agent therapy is discussed in board term the, only testing of the effect of the claimed compound in vitro is discussed.
The examples of the treatment of cancer are limited in vitro data regarding binding affinity to TET2 and in vitro cell line testing. The specification discussed antiproliferative activity of the claimed compound on HL60 (leukemia) cell lines, A375 (melanoma) cell lines, T98G (glioblastoma) cell lines, LN229 (glioblastoma) cell lines, Hop62 (lung) cell lines, MCF7 (breast) cell lines, MDA-MD-468 (breast) cell lines and HCTI 16 (colon) cell lines. The specification provides data on the effectiveness of the claimed compound i.e., EC50, on the listed cancer cell lines, wherein the range of EC50 is between 0.063-81.6 µM. The specification stated that: “The results summarized in Tables 6 and 7 show that the compounds of the invention are capable of slowing growth of many different tumoral cell lines.” [page 49-52]. However, the claimed method is directed to a subject (e.g., in vivo). The specification defines the term “subject” as: “The term "subject" refers to a mammal, e.g., a human.” [page 18, line 32]. The translation of in vitro assays data to in vivo described by Atkins as poor and not predictable. Atkins, (J. Atkins et al. British Journal of Cancer 123, 1496–1501 (2020)). Teaches that “it is very difficult to determine toxicity from these in vitro models. The predictability of in vivo models of drug toxicity is also unclear. Historically, it appears unrealistic to expect preclinical models to predict the exact behavior of drugs in humans.” Atkins also teaches that “combinations of in vitro and in vivo studies are conducted according to experience, historical precedence, and governmental requirements, but there is no consensus about the actual predictability of these preclinical studies. Drugs that show efficacy in cell model systems are not always beneficial clinically. [page 1496, col. 1, 1st para.]. Thus, these limited assays do very little to provide the necessary information, and, in light of the immense diversity of types of cancers and their varied reactions to treatment, the guidance provided is very limited. The exceptional diversity of cancers, and the treatment of them, is not well represented by the provided in vitro assays. It is well known that there is no single treatment that works for all kinds of cancers, and in view of the teachings of Atkins, the experimentation required, based on solely limited cell line assays to practice the instant invention would be egregious.
(8) The quantity of experimentation needed:
Given the fact that, historically, the development of new cancer drugs has been difficult and time consuming, and especially in view of the above factors, the quantity of experimentation needed is expected to be great. However, the quantity needed to expand limited cell line assays as a working example provided in the instant specification to a viable treatment for the claimed scope of cancer or tumor is untenable.
MPEP 2164.01(a) states, “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. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
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.
(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 28-35 and 37 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by H. Ng et al. (US Patent No. 8,163,761 B2, 04/24/2012, “Ng” cited in the PTO-892).
Ng discloses a method of treating diseases or disorders, wherein the diseases is liver diseases, proliferative disease, cancer, etc. [col. 57, ln. 40-53], wherein the method comprising administering an effective amount of a compound, [col. 32, ln. 27-30], wherein the compound is compound 21, [col. 37, Table 3, comp. 21]:
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Ng’s compound 21 anticipates claim 28 compound of formula (I) wherein:
n is 0;
G1 is five-membered heteroaromatic ring condensed with other ring;
G2 is s;
R1, R2, R3, and R4 are H;
A1, A2, A3, and A4 are CR, wherein R is H.
Claim 29 is met because R1 is H.
Claim 30 is met because G1 is bicyclic.
Claim 31 is met because G1 contains N.
Claim 33 is met because G2 is s.
Claim 34 is met because R1, R2 and R3 are H.
Claim 35 is met because A2, A3, and A4 are CR, wherein R is H.
Claim 37 is met because Ng discloses a method of treating cancer by administering Ng’s compound 21 above.
Conclusion
Claims 28-37 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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