Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 1-13 and 15-21 are pending in the application. Claims 1-7, 9, 10, 12, 13, 15-18 and 21 are rejected. Claim 13 is objected to. Claims 8, 11, 19 and 20 are withdrawn.
Restriction/Election of Species
Applicant’s election without traverse of “compound 6” (structure reproduced below) in the reply filed on June 9, 2026 is acknowledged.
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The absence of any statement indicating whether the requirement to restrict is traversed or the failure to provide reasons for traverse will be treated as an election without traverse. See MPEP § 818.01.
Pursuant to MPEP § 803.02, the Markush claims that read on the elected species were examined fully with respect to the elected species. Upon examination, the elected species were found to be anticipated or rendered obvious by prior art; therefore, the Markush claim and claims to the elected species will be rejected. The claim(s) and subject matter that do not read on the elected species have NOT been examined and searched and are withdrawn from further consideration by the examiner. Any subject matter addressed under, for instance, 35 U.S.C. § 103 was discovered incidental to the examination of the elected species. Rejections addressing such subject matter is presented solely in the interest of compact prosecution. Consequently, the prior art search was expanded to include the following prior art compound:
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Claims 8, 11, 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 9, 2026.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/EP2022/077910, filed on October 7, 2022, which claims priority to EPO Application No. EP21306418.1, filed on October 8, 2021.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on April 5, 2024 and February 10, 2025 are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claim 13 should be amended to include the word “and” before the last recited chemical structure (i.e., Compound 26) for proper Markush language.
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 1-7, 9, 10, 12, 13, 15-18 and 21 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 treating a histiocytosis or a craniopharyngioma comprising the administration of the instantly claimed compound of formula (I), does not reasonably provide enablement for the prevention of a histiocytosis or a craniopharyngioma in a subject. 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 use the invention commensurate in scope with this claim.
As a general rule, enablement must be commensurate in scope with the claim language. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and 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). MPEP § 2164.08. That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is “undue.” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
Breadth of the Claim – The breadth of the claims is drawn to a method for treating or preventing a histiocytosis or a craniopharyngioma comprising administering to a subject a compound of formula (I) or a pharmaceutically acceptable salt thereof. Accordingly, the instant claims are drawn to methods of preventing (i.e., keeping from happening) a histiocytosis or a craniopharyngioma in a subject.
Nature of the Invention – The nature of the invention pertains to methods of treating a histiocytosis or a craniopharyngioma in a subject comprising administering benzimidazole derivatives [e.g., formula (I)] and pharmaceutical compositions comprising such benzimidazole derivatives to a subject, wherein the benzimidazole derivatives function as inhibitors of ERK/MyD88 interactions. See e.g., pages 1 and 6.
State of the Prior Art and Predictability in the Art – Even in view of the seemingly high level of skill in the art, there is no absolute predictability when determining the physiological effects of a compound of formula (I) with respect to preventing a histiocytosis or a craniopharyngioma in a subject. 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. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). In fact, with respect to Langerhans cell histiocytosis, BJC HealthCare (Langerhans Cell Histiocytosis, <www.stlouischildrens.org/conditions-treatments/langerhans-cell-histiocytosis>, archived via Wayback Machine on December 14, 2018) teaches that “[b]ecause the cause of Langerhans cell histiocytosis is unknown, there is no known way to prevent the condition.” See page 3. Regarding craniopharyngiomas, Zoicas et al. (Front. Endocrin., 2012, 3:46) teach “[t]he molecular pathogenesis of craniopharyngiomas remain widely unknown...[and] [b]ecause of their infiltrative growth behavior and their high tendency for recurrence, the treatment is often challenging.” See e.g., page 1. Zoicas et al. also teach that “[t]here are no evidence-based guidelines or a clear consensus for best treatment of primary or recurrent craniopharyngiomas in adults...and [r]ecurrence of craniopharyngiomas remains a problem which highly impacts on the long-term prognosis of the patients.” See e.g., pages 3 and 4.
Relative Skill of Those in the Art – The artisan making and using applicant’s pharmaceutical compound would be a synthetic chemist and/or a health practitioner, possessing a commensurate degree level and/or skill in the art, as well as several years of professional experience. Due to the unpredictability in the pharmaceutical art, it is difficult to assess the potential pharmacological activity of the instantly claimed compound of formula (I) against preventing a histiocytosis or a craniopharyngioma in a subject. Considering that the prior art teaches that 1) the prevention of Langerhans cell histiocytosis is not possible and 2) the treatment- let alone prevention- of craniopharyngiomas is challenging as “[s]ystemic chemotherapy is generally regarded as ineffective” (see e.g., page 4 of Zoicas et al.), the prevention of histiocytosis or craniopharyngioma appears to be currently beyond the capabilities of modern medical science.
Amount of Direction/Guidance Provided and Existence/Absence of Working Examples – The specification provides a general overview of the biological factors contributing to the progression of histiocytosis and craniopharyngioma. See e.g., pages 1-6. The specification also provides in vitro data assessing the ERK/MYD88 inhibitory activity of the instantly claimed compound of formula (I) in histiocytosis cells. See pages 28-30. However, there is no actual evidence of the effectiveness of the instantly claimed compound of formula (I) in preventing (i.e., keeping from happening) a histiocytosis or a craniopharyngioma in a patient. Accordingly, the instant claims are not deemed enabled when considering the lack of evidence in the instant disclosure and the prior art with respect to such claimed methods. Quantity of Experimentation Necessary – The quantity of experimentation needed to use the invention based on the content of the disclosure is undue. Using the full scope of the instant claims seems especially unfeasible when considering that the prevention of histiocytosis or craniopharyngioma is not even supported by the prior art. Therefore, the claimed invention would require a person having ordinary skill to invest an indefinite amount of experimentation clearly beyond what can be considered as routine.
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). The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976).
In view of the Wands factors and In re Fisher (CCPA 1970) discussed above, a person of skill in the art would have to engage in undue experimentation to test the instantly claimed compound of formula (I) in methods of preventing a histiocytosis or a craniopharyngioma from occurring in a patient, with no assurance of success. Dependent claims 2-7, 9, 10, 12, 13, 15-18 and 21 do not correct the issue of lack of enablement and are likewise rejected. It is suggested that Applicant amend instant claim 1 to cancel the expression “or preventing” to overcome this issue of lack of enablement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. § 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
(1 of 3) Claims 1-7, 9, 10, 13, 16-18 and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Renno et al. (PCT Publication No. WO 2018/054989 A1; March 29, 2018) in view of Apps et al. (Acta Neuropathologica, 2018, 135:757–777).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Renno et al. teach Example 1 which corresponds to the following chemical structure (see e.g., page 39):
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Regarding instant claims 1-7, 9, 10, 13 and 18, the above prior art Example 1 is encompassed by variable definitions of the instantly claimed compound of formula (I), wherein X1 is CR2 and R2 is CONR11R12, further wherein R11 is H and R12 is aryl substituted with O(C1)alkyl; R1 and R3 are each H; R7 is H; R4 and R6 are each H; and X2 is CR5 and R5 is NR13R14, further wherein R13 and R14 are each (C1)alkyl. The above prior art Example 1 also corresponds to Compound 1 as recited in instant claim 13. Renno et al. further teach that the prior art compounds (e.g., Example 1) “are able to firstly inhibit the protein/protein interactions of the MAP Kinase Erk, leading to inhibition of proliferation, and secondly to induce apoptosis of cancer cells...[and] are able to inhibit Erk1/2 interaction with MyD88.” See e.g., page 1.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 1, 16 and 17, although Renno et al. teach Example 1 as an anticancer drug/ MAP Kinase Erk (i.e., MAPK/ERK) inhibitor (see e.g., the abstract and page 39), Renno et al. does not specifically teach methods of treating a histiocytosis or a craniopharyngioma, as instantly required, by administering Example 1 to a subject. However, Apps et al. teach that “MAPK/ERK pathway inhibition...is associated with decreased proliferation and increased apoptosis in both mouse and human [adamantinomatous craniopharyngiomas].” See e.g., page 773.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1, 16 and 17, it would, therefore, have been obvious to a person of ordinary skill in the art to utilize the MAPK/ERK inhibitor compound (i.e., Example 1) taught by Renno et al. in treatment methods known to benefit from MAPK/ERK inhibition. Considering that Apps et al. “identify the MAPK/ERK pathway and inflammasome signal[]ing as potentially targetable pathways” in human adamantinomatous craniopharyngioma (ACP) (see e.g., page 758), a skilled artisan would be motivated to administer Example 1 (i.e, a MAPK/ERK inhibitor) to patients suffering from ACP and, thereby, employ the instantly claimed methods.
(2 of 3) Claims 1 and 12 are rejected under 35 U.S.C. § 103 as being unpatentable over Renno et al. (PCT Publication No. WO 2018/054989 A1; March 29, 2018) in view of Wermuth (The Practice of Medicinal Chemistry, 1996, 203-237).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claim 1, Renno et al. teach Example 1 which corresponds to the following chemical structure (see e.g., page 39):
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The above prior art Example 1 is encompassed by variable definitions of the instantly claimed compound of formula (I), wherein X1 is CR2 and R2 is CONR11R12, further wherein R11 is H and R12 is aryl substituted with O(C1)alkyl; R1 and R3 are each H; R7 is H; R4 and R6 are each H; and X2 is CR5 and R5 is NR13R14, further wherein R13 and R14 are each (C1)alkyl.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claim 12, Renno et al. does not teach Applicant’s elected species of Compound 6 (reproduced below) which is also representative of a species encompassed by instant claim 12.
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However, Renno et al. does teach the aforementioned Example 1 compound. The prior art Example 1 does not read on Applicant’s elected species (i.e., Compound 6) because of a -C= vs -N= difference on a phenyl ring in the position corresponding to instant variable “R12.” Renno et al., however, teach the following genus which encompasses both the prior art Example 1 compound and Applicant’s elected species (see e.g., page 20):
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With respect to the above prior art genus of formula (A), Renno et al. teach “X1 represents N or CR2, preferably CR2” and “R2 represents...an aryl or heteroaryl group optionally substituted...” (regarding positions, the prior art variable X1 corresponds to instant variable X1). See e.g., pages 20 and 21.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 12, it would, therefore, have been obvious for a person of ordinary skill in the art to arrive at instant Compound 6 (i.e., Applicant’s elected species) by replacing the phenyl substituent of the prior art Example 1 compound (where indicated below) with a 3-pyridyl moiety.
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Wermuth teach that the “substitution of -CH= by -N= […] in aromatic rings has been one of the most successful applications of classical isosterism.” See e.g., page 211. Therefore, recognizing that phenyl/pyridyl are considered to be bioisosteres, a person of ordinary skill in the art would have been motivated to substitute one for the other and reasonably expect the resulting compound to maintain the same biological utility (e.g., MAPK/ERK inhibition).
(3 of 3) Claims 1, 15 and 21 are rejected under 35 U.S.C. § 103 as being unpatentable over Renno et al. (PCT Publication No. WO 2018/054989 A1; March 29, 2018) in view of Roth et al. (Neurooncol Pract., 2015, 2(1):6-12).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Regarding instant claim 1, Renno et al. teach Example 1 which corresponds to the following chemical structure (see e.g., page 39):
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The above prior art Example 1 is encompassed by variable definitions of the instantly claimed compound of formula (I), wherein X1 is CR2 and R2 is CONR11R12, further wherein R11 is H and R12 is aryl substituted with O(C1)alkyl; R1 and R3 are each H; R7 is H; R4 and R6 are each H; and X2 is CR5 and R5 is NR13R14, further wherein R13 and R14 are each (C1)alkyl.
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 15 and 21, Renno et al. does not teach at least one other active ingredient being, for instance, a corticosteroid (i.e., prednisone or dexamethasone) administered simultaneously, separately or sequentially. However, Roth et al. teach inter alia the glucocorticoid (i.e., a corticosteroid subclass) dexamethasone is “by far the most frequently used” corticosteroid administered to “[t]he vast majority of patients suffering from brain tumors...during the course of their disease.” See e.g., page 8.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 15 and 21, it would, therefore, have been obvious to a person of ordinary skill in the art to simultaneously administer Example 1, taught by Renno et al., and dexamethasone to a patient suffering from a brain tumor, such as craniopharyngioma. Roth et al. teach that corticosteroids, such as dexamethasone, “are administered to brain tumor patients mainly to (i) reduce the tumor-surrounding edema and thereby the mass effect in the brain; (ii) target lymphomas in the CNS; and (iii) prevent or treat chemotherapy-induced nausea and vomiting.” See e.g., page 6. Therefore, at least in the interest of providing these beneficial properties to a patient suffering from a brain tumor, a person of ordinary skill in the art would have been motivated to employ the instantly claimed methods.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
(1 of 2) Claims 1-7, 9, 10, 12, 13, 15-18 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-15 of U.S. Patent No. 11,384,081 (“the ‘081 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to methods of treatment of cancer comprising administering the instantly claimed compound of formula (I). For instance, the first compound recited in claims 3 and 10 of the ‘081 patent corresponds to the first compound as recited in instant claim 13. In addition, claim 14 of the ‘081 patent lists “thalidomide” as another drug for administration which correlates to “thalidomide” as recited in instant claim 15. Accordingly, it would have been obvious to arrive at the instantly claimed methods based on claims 1 and 4-15 of the ‘081 patent. A person of ordinary skill in the art would be reasonably expected to recognize that a person in need of the ‘081 patent method of treatment of cancer could also be considered to be in need of the instantly claimed method of preventing a histiocytosis or a craniopharyngioma (i.e., preventing a condition does not indicate with certainty that a person would have later developed the condition if left untreated). Therefore, at least in the interest of treating a larger number of individuals present within the patient population encompassed by the claims of the ‘081 patent, a person of ordinary skill would be motivated to employ the instantly claimed methods.
(2 of 2) Claim 1-7, 9, 10, 12, 13, 15-18 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,509,465 B2 (“the ‘465 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to compounds and pharmaceutical compositions thereof that read on the instantly claimed compound of formula (I). For instance, the first compound as recited in claim 8 of the ‘465 patent corresponds to the first compound as recited in instant claim 13. In addition, the specification of the ‘465 teach a “method of treatment of cancer” comprising administering the instantly claimed compound of formula (I). See e.g., column 13, lines 43-45. It would, therefore, have been obvious for a person of ordinary skill in the art to arrive at the instantly claimed method of preventing a histiocytosis or a craniopharyngioma based on the fact that the ‘465 patent discloses a “method of treatment of cancer.” See e.g., column 13, lines 43-45. A person of ordinary skill in the art would reasonably be expected to recognize that any application of the ‘465 patent’s disclosed “method of treatment of cancer” would effectively embrace the instantly claimed method of preventing a histiocytosis or a craniopharyngioma in a subject since the subject would not definitively have either a histiocytosis or a craniopharyngioma. With respect to the fact that the claims of the patent are drawn to compounds and compositions while the instant claims are drawn to a method of treating or preventing a histiocytosis or a craniopharyngioma, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. “[T]he specification of an earlier patent may be used in the obviousness-type double patenting analysis.” See In re Basell, 547 F.3d 1378.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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