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 11/07/2023, is a U.S. national stage application under 35 U.S.C. § 371 of Patent Cooperation Treaty Application No. PCT/KR2022/005144, filed on 04/08/2022, which claims the priority benefit of Korean Patent Application No. KR 10-2021-0059327, filed on 05/07/2021.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 11/14/2023, 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
Claims 1-11 are pending.
Abstract
The Abstract of the disclosure is objected to because the Abstract recites “the present invention 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).
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 9-11 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 treating breast cancer, does not reasonably provide enablement for the treatment and prevention of the claimed scope of every type 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 (claims 9-11) is directed to a pharmaceutical composition for preventing or treating cancer, comprising the compound of Formula 1, wherein cancer includes all types of cancers listed in claim 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 pharmaceutical composition 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 a compound of Formula 1 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, how to specifically select an active agent of the broad genus of Formula 1, and how 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 pharmaceutical composition for treating or preventing a cancer by compound of Formula 1. However, as taught by Chakraborty (S. Chakraborty, et al. Ecancer medical science. 2012, 14;6: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]. 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) The amount of direction provided:
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 few species of the claimed genus of Formula 1 on SK-BR-3 and BT-474 cancer cells (breast cancer cells) is discussed. The 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.
(7) Working examples:
The examples of the treatment of cancer are limited in vitro data regarding inhibition of cell growth related to cancer such as SK-BR-3 and BT-474 cancer cells, in cell line assays. For example, the specification provides evaluation test of inhibitory activity of the species of Formula 1 against proliferation of SK-BR-3 and BT-474 cancer cells, as shown in Table 2 and 3, Example 1. These tests are directed to breast cancer cells using the few species of the claimed compound. The exceptional diversity of cancers, and the treatment of them, is not well represented by these examples. It is well known that there is no single treatment that works for all kinds of cancers, so 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
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6 and 8-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Y. Lee et al. (WO 2020/190119 A1, 09/24/2020, “Lee” cited in the PTO-892).
Prior Art Effect of Lee
The earliest possible effective filing date of the subject claims is that of priority document KR 10-2021-0059327, filed on 05/07/2021. Lee is effective prior art under 35 USC § 102(a)(2) respecting the subject matter cited in this rejection as of the filing date of Lee priority document KR2020/095044 (03/19/2020) because: (1) Lee is U.S. patent application publication; (2) names another inventor; and (3) the subject matter of Lee relied upon in this rejection is disclosed in Lee’s priority document KR2020/095044 (03/19/2020). See MPEP § 2154.01; 35 USC § 102(d). Thus, the effective filing date of the subject matter relied upon in this rejection is 03/19/2020, which is before the claims’ earlies possible effective filing date of 05/07/2021. See MPEP § 2154.01; 35 USC § 102(d).
Joint Inventorship
This application currently names joint inventors and Assignee. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Lee discloses 6-(isooxazolidin-2-yl)-N-phenylpyrimidin-4-amine derivative of Formula 1, and a pharmaceutical composition for treating cancer, [Abstract]. Lee discloses species of Formula 1, for example, compound 654, [Table 1, pg. 194, original patent]:
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Compound 654 anticipates claims 1, 2, and 3 Formula 1, wherein:
Z1 is N;
Z2 is CH;
Z3 is CH;
R1 is C1 alkoxy;
R2 is NR7R8 wherein R7 and R8 linked together with N to form 6-membered heterocycloalkyl substituted with R9 and R9 is 3-membered cycloalkyl (cyclopropyl);
R3 is -NH(C=O)R11C=CR12R13, wherein R11, R12, and R13are H;
R4 is phenyl;
L1 is a
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; and
R5 is H.
Claim 4 is met because R2 is NR7R8 wherein R7 and R8 linked together with N to form piperazine substituted with R9 and R9 is cyclopropyl.
Claim 5 is met because R4 is phenyl; L1 is a
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; and R5 is H.
Claim 6 is met because R3 is -NH(C=O)R11C=CR12R13, wherein R11, R12, and R13are H.
With regard to claim 8, Lee discloses a process of preparing compound of Formula 1by preparing compound of formula 5, from formula 4, and preparing compound if formula 6 for formula 5, and then preparing compound of formula 1 from formula 6 [Google patent translated document, page 17]:
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With regard to claims 9, 10, and 11, Lee discloses 6-(isooxazolidin-2-yl)-N-phenylpyrimidin-4-amine derivative of Formula 1, and a pharmaceutical composition for treating cancer comprising the compound of Formula 1 as an effective component, wherein cancer is lung cancer, wherein the compound of Formula 1 inhibits wild-type or variants of one or more of ErbB2 and ErbB4, [Abstract], wherein the pharmaceutical composition contains a pharmaceutically acceptable carrier. The pharmaceutically acceptable carrier includes diluents or excipients such as fillers, extenders, binders, wetting agents, disintegrants, and surfactants, [Google patent translated document, page 36, 2nd para.].
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.
Non-statutory Double Patenting over US Patent No. 11466000B2
Claims 1-6 and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent No. 11,466,000 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-6, and 9-11 recite a compound of Formula 1, a composition comprising the compound of Formula 1 and pharmaceutically acceptable carrier, a preparation process for the compound of Formula 1, and using the composition for treating cancer and inhibiting a wild-type or mutant kinase of one or more of ErbB2 and ErbB4:
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US Patent No. 11,466,000 B2 recites in claim 1 a compound of Formula 1, wherein claims 2-8 defines R1-6, claim 9 recites species of Formula 1, for example compound 654, and claim 10 recites a pharmaceutical composition comprising a compound of claim 1, or a stereoisomer, hydrate, or pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carriers:
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US Patent No. 11,466,000 B2 compound 654 anticipates instant claimed compound of Formula 1, wherein: Z1 is N; Z2 is CH; Z3 is CH; R1 is C1 alkoxy; R2 is NR7R8 wherein R7 and R8 linked together with N to form 6-membered heterocycloalkyl substituted with R9 and R9 is 3-membered cycloalkyl (cyclopropyl); R3 is -NH(C=O)R11C=CR12R13, wherein R11, R12, and R13 are H; R4 is phenyl; L1 is a
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; and R5 is H.
Claims 10 and 11 are met by US Patent No. 11,466,000 B2 because US Patent No. 11,466,000 B2 specification teaches a method of using the above compound in inhibition activity against wild type or mutants of at least one of ERBB2 and ERBB4, and therefore can be usefully used in the treatment of cancer including pseudomyxoma, intrahepatic cholangiocarcinoma, hepatoblastoma, etc. [Col. 27, ln. 11-25]. MPEP 804 states: The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Non-statutory Double Patenting over US Patent No. 11,466,000,B2 in view of Lee
Claim 8 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US Patent No. 11,466,000 B2 in view of Y. Lee et al. (WO2020/190119A1, 09/24/2020, “Lee” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 8 is directed to a process of preparing compound of Formula 1.
As discussed above, US Patent No. 11,466,000 B2 recites a compound anticipates instant claimed compound of Formula 1, however, US Patent No. 11,466,000 B2 does not recite a process of preparing compound of Formula 1.
Lee teaches as discussed above and incorporated herein by reference. Lee teaches compound 654 (same as US Patent No. 11,466,000 B2 compound 654), and teaches a process of preparing compound of Formula 1by preparing compound of formula 5, from formula 4, and preparing compound if formula 6 for formula 5, and then preparing compound of formula 1 from formula 6 [Google patent translated document, page 17]:
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to utilize Lee’s process of preparing compound of Formula 1, i.e., compound 654 in preparing the US Patent No. 11,466,000 B2, compound 654. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Lee’s teaches preparation process of the same compound 654 with high preparation yield ranging from 74-96 for Formula 4- formula 1 steps, [see Lee’s preparation example 2, Google translation document], which would motivate skilled artisan to use the process to prepare instant claimed compound in high yield.
Non-statutory Double Patenting over US Patent No. 12157730B2
Claims 1-6, and 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 38-43 of US Patent No. 12,157,730 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-6, and 9-11 recite a compound of Formula 1, a composition comprising the compound of Formula 1 and pharmaceutically acceptable carrier, a preparation process for the compound of Formula 1, and using the composition for treating cancer and inhibiting a wild-type or mutant kinase of one or more of ErbB2 and ErbB4:
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US Patent No. 12,157,730 B2 recites in claim 1-8 A method of treating cancer in a patient in need thereof, wherein the cancer in the patient comprises one or more mutations in EGFR or HER2, comprising administering to the patient an effective amount of a compound of Formula 1 and 2 and define R1-6, claim 9 recites species of Formula 1, for example compound 654, and claims 38-43 recite that the cancer is selected from the group consisting of pseudomyxoma, intrahepatic biliary tract cancer, hepatoblastoma, etc.:
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US Patent No. 12,157,730 B2 compound 654 anticipates instant claimed compound of Formula 1, wherein: Z1 is N; Z2 is CH; Z3 is CH; R1 is C1 alkoxy; R2 is NR7R8 wherein R7 and R8 linked together with N to form 6-membered heterocycloalkyl substituted with R9 and R9 is 3-membered cycloalkyl (cyclopropyl); R3 is -NH(C=O)R11C=CR12R13, wherein R11, R12, and R13 are H; R4 is phenyl; L1 is a
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; and R5 is H.
Non-statutory Double Patenting over US Patent No. 12,157,730 B2 in view of Lee
Claims 8 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, and 38-43 of US Patent No. 12,157,730 B2 in view of Y. Lee et al. (WO 2020/190119 A1, 09/24/2020, “Lee” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 8 is directed to a process of preparing compound of Formula 1, and claim 9 is directed a pharmaceutical composition for treating cancer comprising compound of Formula 1 and pharmaceutically acceptable carrier.
As discussed above, US Patent No. 12,157,730 B2 recites a compound anticipates instant claimed compound of Formula 1, however, US Patent No. 12,157,730 B2 does not recite a process of preparing compound of Formula 1. Also, US Patent No. 12,157,730 B2 recites a method of treating cancer by compound of Formula 1, however, US Patent No. 12,157,730 B2 does not recites that the compound is formulated in a composition with a carrier.
Lee teaches as discussed above and incorporated herein by reference, page 18.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to utilize Lee’s process of preparing compound of Formula 1, i.e., compound 654 in preparing the US Patent No. 12,157,730 B2, compound 654. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Lee’s teaches preparation process of the same compound 654 with high preparation yield ranging from 74-96 for Formula 4- formula 1 steps, [see Lee’s preparation example 2, Google translation document], which would motivate skilled artisan to use the process to prepare instant claimed compound in high yield. One of ordinary skill in the art would have been motivated with reasonable expectation of success to formulate US Patent No. 12,157,730 B2 compound of Formula 1 i.e., 654 in a pharmaceutical composition with a carrier for treating cancer because Lee teaches a method of treating cancer by administering compound 654 with pharmaceutically acceptable carrier to form tablets, pills, etc. [Google patent translated document, page 36, 2nd para.].
Non-statutory Double Patenting over Copending Application No. 18/474,027
Claims 1-6, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-19, 24, and 41-48 of copending Application No. 18/474,027 (US PG-PUB 2024/0150337A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 1-6, and 9-11 recite a compound of Formula 1, a composition comprising the compound of Formula 1 and pharmaceutically acceptable carrier, a preparation process for the compound of Formula 1, and using the composition for treating cancer and inhibiting a wild-type or mutant kinase of one or more of ErbB2 and ErbB4:
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Copending Application No. 18/474,027 recites in claim 16 a compound of Formula 1, and in claim 24 a subgenus of Formula 1:
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, wherein R3 is
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etc.; R5 is
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etc.; and R6 is H.
Copending Application No. 18/474,027 subgenus above reads on instant claimed compound of Formula 1, wherein: Z1 is N; Z2 is CH; Z3 is CH; R1 is -OCH3; R2 is NR7R8 wherein R7 and R8 linked together with N to form 6-membered heterocycloalkyl substituted with R9 and R9 is 3-membered cycloalkyl (cyclopropyl); R3 is -NH(C=O)R11C=CR12R13, wherein R11, R12, and R13 are H; R4 is phenyl; L1 is a
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; and R5 is H.
Skilled artisan would be motivated to combine independent claim 16 of Copending Application No. 18/474,027 with dependent claim 24 to arrive at the instantly claimed compounds because the subgenus of claim 24 defines R1-6 of Copending Application No. 18/474,027 Formula 1. Therefore, combining the independent claim 1 with the dependent claims render the instant claims obvious.
Claim 9 is met because Copending Application No. 18/474,027 recites in claim 41 a pharmaceutical composition comprising a compound of claim 16, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carriers.
Claims 10 and 11 are met by Copending Application No. 18/474,027 because claims 42-48 recites a method of treating cancer in a patient in need thereof, wherein the cancer in the patient comprises one or more mutations in EGFR or HER2, comprising administering to the patient an effective amount of a compound of claim 16, or a pharmaceutically acceptable salt thereof, wherein cancer is selected from pseudomyxoma, intrahepatic biliary tract cancer, etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Non-statutory Double Patenting over Copending Application No. 18/474,027 in view of Lee
Claim 8 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-6, and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-19, 24, and 41-48 of copending Application No. 18/474,027 (US PG-PUB 2024/0150337A1). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 8 is directed to a process of preparing compound of Formula 1.
As discussed above, copending Application No. 18/474,027 recites a compound reads on instant claimed compound of Formula 1, however, copending Application No. 18/474,027 does not recite a process of preparing compound of Formula 1.
Lee teaches as discussed above and incorporated herein by reference, page 18.
The obviousness rational is the same as the rationale of the Non-statutory Double Patenting of US Patent No. 11466000B2, page 18.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting Rejection Consideration
A non-statutory double patenting rejection over US application No. 18/026,793 (published as US PG-PUB 2023/0322753A1) was considered but not applied because US application No. 18/026,793 defines R4 and R5 as: R4 and R5 are each independently selected from the group consisting of hydrogen, halogen, and haloalkyl, or R4 and R5 form, together with a benzene, a 7 to 12 atom heteroaryl that includes one or more heteroatoms, wherein each heteroatom of the one or more heteroatoms is selected from the group consisting of N, O and S, and wherein the 7 to 12 atom heteroaryl is substituted or unsubstituted by a Ci-s straight chain or branched chain alkyl.
Reasons for Allowance
Claim 7 is allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is considered to be Y. Lee et al. (WO2020/190119A1, 09/24/2020, “Lee” cited in the PTO-892), prior art effect of Lee, above.
Lee discloses 6-(isooxazolidin-2-yl)-N-phenylpyrimidin-4-amine derivative of Formula 1, and a pharmaceutical composition for treating cancer, [Abstract]. Lee discloses compound 654 as species of Formula 1, [Table 1, pg. 194, original patent]. Lee’s compound 654 differs from a compound of claim 7, for example, compound 3 in the relevant region highlighted with the ova, as depicted in the below table for facile comparison:
Lee’s compound 654
Claim 7, compound 3
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In In order to arrive at a compound falling within the instant claim 7, e.g., compound 3, one of ordinary skill in the art would have to modify Lee’s above compound 654 to replace the highlighted the ethynyl moiety with phenoxy to arrive at a compound of claim 7. However, Lee’s disclosure does not provide sufficient guidance and motivation to one of ordinary skill in the art to perform the functional modifications to arrive at the instantly claimed compounds. Therefore, the claims are neither anticipated nor rendered obvious by Lee.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1-6 and 8-11 are rejected. Claim 7 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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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622