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 .
Election/Restrictions
Applicant's election with traverse of Group I, drawn to a compound of formula (I); and a compound having the structure of:
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, which is “(5-{(3R)-1-[(1-fluorocyclopropyl)(1H-imidazol-2-yl)methyl]-5',6'-dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b]pyrazol]-2'-yl}-3-(trifluoromethyl)pyridin-2-amine (diastereomer 1 and diastereomer 2)” in claim 9 and described in Example 948 of instant application, as the elected species of compound of formula (I) in the reply filed on May 12, 2026 is acknowledged. The traversal is on the ground(s) that the claimed invention is drawn to a specific compound rather than a generic formula, the compound of formula (I) is considered structurally distinct as it requires structure features in addition to the compound 27 of Cashman cited by the Examiner. Applicant further argues the exemplary claimed compound demonstrates unexpected results. This is not found persuasive because of the following reasons: First, the lack of unity of invention is based solely on whether the claims share a single general inventive concept by possessing the same or corresponding specifical technical features rather than in light of the unexpected results. Second, although applicant argues the claimed invention is drawn to a specific compound species rather than a generic formula, it is respectfully noted that instant claim(s) recites a compound of formula (I), and the technical feature shared between the groups of inventions lies on the pyrazole ring of formula (I) circled as follows
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, which is also indicated in the previous Office Action mailed on December 12, 2025, and that common technical feature shared between the groups of inventions is clearly taught by Cashman to be useful for treating cancer as a disease or disorder. In other words, the technical feature these groups of inventions shared in common is not a special technical feature in view of Cashman. Additionally, the group of species are lacking a priori without the need to consult prior arts.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 8 and 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 12, 2026.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner
discover a prior art by LÜCKING et al. that renders obvious the claimed invention. In light of this discovery, the search is expanded to the subject matter of the compound of formula (I) to include the expanded compound species having the structure of:
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(“2'-[6-amino-5-(trifluoromethyl)pyridin-3-yl]-N-ethyl-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide”), in addition to the elected compound species (“Example 948”), such that it does not encompass the full scope of the claims.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on May 12, 2026, wherein claims 1-9 and 12-19 are unchanged; and claims 10-11 are cancelled.
Claims 1-9 and 12-19 are pending.
Claims 6, 8 and 13-19 are withdrawn.
Claims 1-5, 7, 9, and 12 are under examination in accordance with the elected species along with the expanded compound species set forth in the Expansion of Election of Species Requirement section above.
Priority
The instant application 18/275,978 filed on August 4, 2023 is a 371 of PCT/EP2022/052794 filed
on February 4, 2022, which claims priority to, and the benefits of Foreign Application No.
PCT/CN2021/075566 filed on February 5, 2021; and Foreign Application No. PCT/CN2021/086946 filed on April 13, 2021.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on February 5, 2021 and April 13, 2021. It is noted, however, that applicant has not filed a certified copy of the PCT/CN2021/075566 and PCT/CN2021/086946 applications as required by 37 CFR 1.55.
Therefore, claims 1-9 and 12-19 under examination are not entitled to the benefits of Foreign Application No. PCT/CN2021/075566 and PCT/CN2021/075566, and will receive an effective filing date of February 4, 2022, which is the filing date of 371 of PCT/EP2022/052794.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 12, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Please note that foreign references without an English translation but have an English translation of the abstract will only have the abstract considered by the Examiner.
Specification
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The disclosure is objected to because of the following informalities:
The specification does not have a proper arrangement, the first two paragraph on page 2 appears to be a brief summary of the invention, and that should be after the “background of the invention”; and the section(s) described there in are not in upper case. Some section(s) are missing proper section title, for example, “DETAILED DESCRIPTION OF THE INVENTION”. Please see MPEP sections noted above for proper format(s).
Page 4, line 16, the recitation of “In WO In WO2016/205942” contains typographical error, “In WO” should be deleted.
It contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms “Screener™”, “Viewlux”, “Pherastar”, which are trade names or a marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. While the Examiner has made every attempt to check the specification for trade name or mark compliance, Applicant is required to carefully check the entire specification for any and all issues regarding trade name or mark.
the specification is repleted with the phrase “(diastereometric mixture)”, and the “diastereometric” in said phrase appears to contain typographical error and should read – diastereomeric--, for example, see p. 547, Example 47.
Appropriate correction is required.
Claim Interpretation
The claimed term “alkinyl” (e.g., “C1-3-alkinyl”) is reasonably construed by the Examiner to be referring to “alkynyl”.
Claim Objections
Claims 1, 2 and 9 are objected to because of the following informalities:
Regarding claims 1-2,
the claim repeatedly recites “tert. butyl” that contains a period (.) therein, and that appears to be a typographical error. A single sentence should only end with one terminal period, thus, said period should be deleted from the claim language;
The claim language is not being consistent with the use of comma. The claim repeatedly missing a comma (,) before the term “wherein” and “optionally”. For example, “-(C=O)-NRbRc wherein” at R1 is missing a comma; and -O-CHRa-6 membered heteroaryl optionally” at R1 is missing a comma.
the claim is repeatedly missing a coordinating conjunction (e.g., “and” or “or”) before the very last item in the list of alternated usable members, such coordinating conjunction should be added to indicate the end of series. For example, the 5th line from the bottom of claim 1 is missing a coordinating conjunction;
The phrase “G is –(CH2)- and with the condition, that” includes a comma (,) that appears to be a typographical error and should be deleted.
the claim language repeatedly recites a coordinating conjunction (e.g., “and” or “or”) in the list other than right before the very last item in the list of alternated usable members, and that should be deleted. For example, the recitation of “
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” contains the term “or” before the second listed item rather than before the last listed item “-CH2F”, and that appears to be a typographical error. Same logic applies to other sentence.
The claim language is not being consistent with the use of comma (,) and semicolon (;), for examples,
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The list of alternated usable members are sometimes separated with comma, space or semicolon. Such inconsistency can cause issues, and should be amended for the sake of clarity.
The “
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” appears to be missing an asterix (*) like other listed variables (e.g., “
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”) to indicate the bond is attached to the core of the compound.
While the Examiner has made every attempt to check the typographical errors and punctuations, Applicant is required to carefully check the entire claims for any and all issues noted above.
Regarding claim 9,
the claim is repleted with the phrase “(diastereometric mixture)”. The “diastereometric” in said phrase appears to contain typographical error and should read – diastereomeric--;
the claim recites semicolon (;) twice after the phrase “2'-{6-amino-5-[(1R)-1-(2,6-dichloro-3-fluorophenyl)ethoxy]pyridin-3-yl}-N-ethyl-5',6'dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b ]pyrazole]-1-carboxamide (isomer 2)”, and one of them should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 9, and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim broadly recites “an N-oxide, a hydrate, a solvate… a mixture of same”, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the genus N-oxide, hydrate, solvate and a mixture of same at the time of filing.
First, the disclosure fails to identify any particular species of N-oxide, hydrate, solvate of compound of Formula (I), synthetic preparation, or representative examples thereof, aside from a broad recitation that any nitrogen of formula (I) can be oxidized, and any possible hydrate and solvate are contemplate for use in the claimed invention. No guidance identifying which position of nitrogen may be oxidize while retaining the same activity, no representative N-oxide spanning across the claimed genus, no demonstrated possession of N-oxide embodiments across varying the combinations of variables presented in formula (I). Same logic applies to hydrate and solvate of compound of Formula (I).
Second, the disclosure fails to describe “mixture of same”. The specification fails to identify any particular species of “mixture of same”, synthetic preparation, or representative examples thereof. The mere boiler plate reference to “mixture of same” does not provide adequate blaze marks to the vast genus encompassed by the claims.
Therefore, in view of the foregoing, applicant is not in the possession of the entire scope of N-oxide, a hydrate, a solvate and mixture of same of the compound of formula (I).
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7, 9, and 12 are 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.
Regarding claims 1-2,
“4 to 6 membered heterocycloalkyl or heterocycloalkenyl, both with 1-2 nitrogen atoms, but always linked via a carbon to the phenyl group of compounds of formula (I)” at R1 renders the claim indefinite. The compound of formula (I) does not have a phenyl group drawn; it is not clear what is the “phenyl group” referring by the Applicant. In addition, it is not clear what are the “compounds of formula (I)” referred by the Applicant. Therefore, one skilled in the art would not reasonably be apprised of the metes and bounds of the claimed compound.
the term “same” in the phrase of “a mixture of same” is a relative term which renders the claim indefinite. The term “same” requires a reference to establish a baseline for comparison, said term is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree. In addition, when the term “same” is used in the context of mixture, it is also not clear what is being referred to as “a mixture of same”, the metes and bounds for the ingredients contains therein cannot be determined. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
the claim is repleted with the coordinating conjunction “or” and “and” more than once in the same sentence and that renders the claim indefinite as it can leads to various interpretations. The phrase “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same” can be interpreted in numerous ways, for example, (i) or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or (a salt thereof, or a mixture of same); (ii) or (a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof), or (a mixture of same); (iii) or (a stereoisomer), (a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof), or (a mixture of same). Same logic applies to other sentences, e.g.,
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. The lack of clarity renders the claim indefinite, because one cannot reasonably determine which interpretation applies.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites
the broad recitation “a mixture of same”, and the claim also recites “a compound of formula (I)”, which is the narrower statement of the range/limitation. It is not clear if the claimed invention is drawn to a singular compound of formula (I), or a mixture of compounds of formula (I);
the broad recitation “C1-4-alkyl optionally substituted with one or more halogen”, and the claim also recites “-CF3, CHF2, -CH2F”, see e.g.,
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,
which is the narrower statement of the range/limitation.
The broad recitation “optionally substituted one or more times with halogen”, and the claim also recites “all optionally substituted by one or two halogen”, which is the narrower statement of the range/limitation. See e.g., in –C(=O)-NRbRc.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
With respect to the phrase “the cyclic substructure comprising E-N-G is a 4 to 5 membered hetercycloalkyl” in variable G, the claim is circular. That means the definition of “the cyclic substructure comprising E-N-G is a 4 to 5 membered hetercycloalkyl” loops back onto the “E is –(CH2)n with n = 1 or 2; G is -(CH2)-” set forth before, but the later definition “4 to 5 membered hetercycloalkyl” is a broad range or limitation that allows the presence of more than one heteroatoms. Therefore, it is like defining a word with a word. In another word, the claim leaves the reader unsure of what the boundaries of that cyclic substructure is. Additionally, said phrase contains the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," that is inclusive or open-ended and does not exclude additional, unrecited elements. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004); therefore, it is not clear what is being referred to as “the cyclic substructure comprising E-N-G”.
The “C1” alkinyl in the phrase “C1-3-alkinyl” renders the claim indefinite, because the claim appears to encompass chemically impossible or undefined structure in which a single carbon is forming a triple bond by itself. The specification does not clearly redefine the term. Therefore, one skilled in the art would not reasonably be apprised of the metes and bounds of the claimed compound.
The recitation of “-C(=O)-NRbRc…Rb is selected from -H…and Rc is selected from -H…all optionally substituted by one or two halogen…optionally substituted one or more times with halogen” renders the claim indefinite, because the claim appears to encompass chemically impossible or undefined structure in which a hydrogen not only binds to the core, it is also forming a bond with the claimed subsistent(s) such as halogen(s). Additionally, said phrase further recites “optionally substituted one or more times with halogen” after the list of substituents, to the extent that said phrase is intending to further substituted the claimed substituent(s) (e.g., halogen), it also encompasses chemically impossible or undefined structure. In short, a halogen cannot be substituted on another halogen that already has a bond with the core. The specification does not clearly redefine the term. Therefore, one skilled in the art would not reasonably be apprised of the metes and bounds of the claimed compound.
Accordingly, claims 3-5, 7, 9, and 12 are rejected based on their dependency on a rejected base claim.
Regarding claims 3-5 and 7,
the recitation of “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same” of the claimed variable(s) renders the claim indefinite. For example, claim 3 recites “A is selected from a single bond or -O- or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same”; However, it is not clear what is the “stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same” of a single bond or -O- for that instance. The specification does not clearly redefine the term. Therefore, one skilled in the art would not reasonably be apprised of the metes and bounds of the claimed compound. Same logic applies to other variables.
the claim is repleted with the coordinating conjunction “or” and “and” more than once in the same sentence and that renders the claim indefinite as it can leads to various interpretations. The phrase “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same” can be interpreted in numerous ways, for example, (i) or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or (a salt thereof, or a mixture of same); or (ii) or (a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof), or (a mixture of same). The lack of clarity renders the claim indefinite, because one cannot reasonably determine which interpretation applies.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-5, 7 and 9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3-5 and 7, the recitation of “or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same” fails to further limit the variable of formula (I) set forth in claim 1. For example, claim 3 recites “A is selected from a single bond or -O- or a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same”; and it fails to further limit variable A of formula (I) set forth in claim 1, because variable A in claim 1 does not include “a stereoisomer, a tautomer, an N-oxide, a hydrate, a solvate, or a salt thereof, or a mixture of same” as an alternated variable A.
Regarding claim 9, the claim recites several compounds with deuterium(s), for example,
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, and they fail to further limit the compound of formula (I) set forth in claim 1, because said formula (I) does not include deuterium. Additionally, the claim recites mixture, for example, racemic mixture, diastereometric mixture of compounds of formula (I), and that fails to further limit the compound of formula (I) set forth in claim 1, because claim 1 is drawn to “a” compound of formula (I) and that is not a mixture of compounds of formula (I).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 1-5, 7, 9, and 12 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The Markush grouping of the compound of formula (I) is improper, because the alternatives defined by the Markush grouping do not share a substantial feature and/or a common use that flows
from the substantial structural feature for the following reasons:
Instant claim 1 broadly recites a compound of formula (I)
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, encompassing vast variety of A, E, G, Q, R1 and R4 that do not belong to the same chemical or physical class. For example, phenyl, 4 to 6 membered heterocycloalkyl and cyclopropyl are not known in the art to belong to the same chemical or physical class. The claim(s) promise a broad genus of compounds of formula (I). However, these alternated compound species do not share a substantial structural feature in common, and they also do not share a common use that flows from the substantial structural feature. In the instant case, the pyrazole ring circled as follows:
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is the only structure feature that is shared among the Markush grouping of compound of Formula (I), and that does not constitute a substantial portion of the compound as a whole. According to Cui et al. (US 2006/0128724 A1), compounds of formula 3
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(see e.g., [0034]), including compound of Example 76 having the structure of:
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(see e.g., [0606]), are potent inhibitors of the c-Met protein kinase (see e.g., abstract). Although the compounds of formula (I) of Cui et al. (e.g., Example 76) shares the pyrazole ring in common, and also shares the circled structure:
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(see instant formula (Ia)) in common, said compound is taught to inhibit c-Met protein kinase rather than MAP4K1. Therefore, it is not apparent that this common structure feature alone, i.e., pyrazole or
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, shared among all the compound species of Formula (I) contributes to the substantial feature essential for the compound of formula (I) to have the desired property of inhibiting MAP4K1.
Additionally, the Markush grouping of compound of formula (I) includes wide variety of
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that do not belong to the same chemical or physical class. Said ring can be fused with the pyridine ring to form structures, such as
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and
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. According to McComas et al. (WO 2013/033901 A1), compound 97 having the structure of:
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(see e.g., p. 66, “97”) is an exemplary compound of formula (I) useful for inhibiting hepatitis C virus NS5B polymerase (see e.g., abstract); and according to Xi et al. (WO 2014/089324 A1), compound of Example 26 having the structure of:
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inhibits the protein kinase activity such as ALK and c-Met receptor (see e.g., p. 115, “Example 26”; [019]). Although compound 96 of McComas et al. and the compound of Example 26 of Xi et al. both share the “pyrazole” in common and are each fused to a
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ring, it is noted that these compounds are taught to have different property, and they are not known to be capable of inhibiting MAP4K1. Therefore, it is also not apparent that the presence of pyrazole ring fused with any alternated members of
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constitutes a substantial structure feature for the compound of formula (I) as a whole for the desired property of inhibiting MAP4K1.
The Markush grouping of compound of formula (I) includes wide variety of
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that forms spiro ring with the core, such as
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. According to Liu et al. (WO 2010/094242 A1), Example 386 having the structure of:
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is an exemplary compound of formula (I) and an inhibitor of the beta-secretase enzyme (see e.g., abstract; p. 155, Ex No. 386). Although said compound shares the same pyrazole, and
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, and
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, said compound is taught to have different property, i.e., beta-secretase enzyme inhibitor rather than MAP4K1 inhibitor; and therefore, it is also not apparent that the presence of pyrazole ring fused with any combination of
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, and
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, constitutes a substantial structure feature for the compound of formula (I) as a whole for the desired property of inhibiting MAP4K1.
Furthermore, based upon Table 1 of the instant specification, compound of Example 772 has a MAP4K1 IC50 of “9,52E-10” and Compound of Example 533 has a MAP4K IC50 of “! 2.00E-05”. In other words, there is roughly a 21,008 fold difference between these two compounds of formula (I). Please note according to page 1127 of the specification, Compound of Example 772, (3R)-2'-[6-amino-5-(trifluoromethyl)pyridin-3-yl]-N-[1-(3-chloropyridin-4-yl)cyclobutyl]-5', 6'dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide, has the structure of:
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; and according to p. 909-910 of the specification, compound of Example 533, 2'-{6-amino-5-[(1R)-1-(2-chlorophenyl)ethoxy]pyridin-3-yl}-N-ethyl-5',6'-dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide (mixture of stereoisomers), having the structure of
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. It is noted that these compounds are in claim 9 and in light of the specification, it is also not apparent that the Markush grouping of compound of formula (I) share the same common use.
Each of these findings demonstrates that not all members recited in this Markush grouping belong to the same recognized chemical class; i.e., the species fail to share a single structural similarity or any substantial structural feature. Additionally, the alternated compound species of formula (I) embraced by the instant claim(s) fail to share a single structural similarity or a common use that flows from the substantial structural feature for the reasons set forth above.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. 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.
Claims 1-3, 5, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over LÜCKING et al. (WO 2021/249913 A1; cited in the IDS filed on May 12, 2026).
The applied reference has a common Applicant with the instant application. The applied reference is published on December 16, 2021, which is before the effective filing date of the instant application (see Priority section above), it constitutes prior art under 35 U.S.C. 102(a)(1). Based upon the earlier effectively filed date of the reference, it also constitutes prior art under 35 U.S.C. 102(a)(2).
LÜCKING et al. teaches compound of Example 132, 2'-(6-aminopyridin-3-yl)-N-ethyl-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide, having the structure of:
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(referred to herein as “Compound 132”)(see e.g., claim 9; p. 289, line 1-2; p. 206, Example 132) is an exemplary compound of formula (I) capable of inhibiting MAP4K1 (HPK1) (see e.g., Table 1, Example 132). LÜCKING et al. further teaches compound of Example 9, tert-butyl 2'-[5-(trifluoromethyl)pyridin-3-yl]-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxylate, having the structure of:
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(referred to herein as “Compound 9”)(see e.g., p. 139, Example 9; claim 9) is also an exemplary compound of formula (I) capable of inhibiting MAP4K1 (HPK1) (see e.g., Table 1, Example 9). LÜCKING et al. further teaches a pharmaceutical composition comprising the compound of general formula (I), including 2'-(6-aminopyridin-3-yl)-N-ethyl-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide (see e.g., claim 9), and one or more pharmaceutically acceptable excipients (see e.g., claims 9 and 12). LÜCKING et al. further teaches diastereomeric mixtures are contemplated for use (see e.g., p. 28, line 35 to p. 29, line 5). LÜCKING et al. further teaches compounds of formula (I)
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, wherein R2 represents, inter alia,
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, where R4 represents, inter alia, -H, C1-C6 alkyl optionally substitute with halogen; -NRiRj, in which R1 represents -H and Rj represents -H (see e.g., p. 6, line 22-25; p. 10, line 31 to p. 11, line 3; p. 12, line 5-6); and the term "halogen atom" means particularly, inter alia, fluorine (see e.g., p. 22, line 35-36); and examples of the term “C1-C6-alkyl” includes methyl (see e.g., p. 23, line 1-10).
According to MPEP 2144.09, “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. ‘An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.’ In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)”; and “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)”. In the instant case, the compound of formula (I) of LÜCKING et al. and the claimed compound of formula (I) have very close structural similarities/same chemical core, the difference between the compound 132 of LÜCKING et al. and the claimed compound is that the prior art compound does not have a trifluoromethyl substituted on the pyridine ring, and the position of nitrogen atom in the pyridine ring is different as indicated below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting compound 132 of LÜCKING et al. and then modify said compound by substituting the hydrogen atom of the pyridine ring with a trifluoromethyl, and then changing the position of nitrogen atom in the pyridine ring as taught by LÜCKING et al. One would have been motivated to do so, because it is known in the art that positions isomers (compounds having the same radicals in physically different positions on the same nucleus) with sufficiently close structural similarity possess similar properties; and LÜCKING et al. teaches compound 9 as another exemplary compound of formula (I), i.e.,
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, in which it changes the position of nitrogen atom in the pyridine ring and substituted said pyridine ring with a trifluoromethyl, also exhibits MAP4K1 (HPK1) inhibiting effect; and further teaches the compound of formula (I) with the same chemical core can contains R2 moiety substituted with two R4 groups, e.g.,
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, including -H; C1-C6 alkyl optionally substitute with halogen; and -NRiRj, in which R1 and Rj are both -H. One would have reasonably expectation of success to arrive at the claimed invention with a reasonable expectation of success, because one would have reasonably expected that by changing the position of nitrogen atom in the pyridine ring of compound 132 of LÜCKING et al. and further substituting the hydrogen at the 5th position of the pyridine ring (see shaded position:
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) with a trifluoromethyl would successfully arrive at a compound that exhibits the same or substantially similar MAP4K1 inhibiting effect; therefore, said modified compound 132 can successfully combine with one or more pharmaceutically acceptable excipients to arrive at a pharmaceutical composition. Please note the modified compound 132 of LÜCKING et al. renders obvious the “2'-[6-amino-5-(trifluoromethyl)pyridin-3-yl]-N-ethyl-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide” in claim 9.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-5, 7, 9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over LÜCKING et al. (WO 2021/074279 A1; referred to herein as “LÜCKING#2”; cited in the IDS filed on May 12, 2026), in view of LÜCKING et al. (WO 2021/249913 A1; cited in the IDS filed on May 12, 2026).
To the extent that the claims are drawn to the elected compound species of formula (I), the following 35 U.S.C. 103 rejection applies.
The applied reference “LÜCKING#2” has a common Applicant with the instant application. The applied reference is published on April 22, 2021, which is before the effective filing date of the instant application (see Priority section above), it constitutes prior art under 35 U.S.C. 102(a)(1). Based upon the earlier effectively filed date of the reference, it also constitutes prior art under 35 U.S.C. 102(a)(2).
LÜCKING#2 teaches Example 314, (rac)-1-[(rac)-cyclopropyl(1H-imidazol-2-yl)methyl]-2'-(quinolin-3-yl)-5',6'-dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b]pyrazole] (mixture of diastereomers), having the structure of:
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(referred to herein as “Compound 314”) is an exemplary compounds of formula (I) capable of inhibiting MAP4K1 (see e.g., p. 563, “Example 314”; p. 636, Example 314). LÜCKING#2 further teaches a pharmaceutical composition comprising the compound of general formula (I) and one or more pharmaceutically acceptable excipients (see e.g., claim 12). LÜCKING#2 further teaches the compounds of formula (I)
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, in which R1 represents a group *-A-B, in which *-A represents *-CRaH; Ra represents, inter alia, C3-C7-cycloalkyl all optionally substituted with halogen; B represents
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; R2 is
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, R4 represents, inter alia, -H, C1-C6-alkyl optionally substituted with halogen, NRiRj, in which Ri represents hydrogen and Rj represents hydrogen (see e.g., claims 1 and 3). LÜCKING#2 further teaches the term “halogen atom” means particularly, inter alia, a fluorine (see e.g., p. 22, line 21-22); and examples of the term “C1-C6-alkyl” includes methyl (see e.g., p. 22, line 24-32).
LÜCKING#2 does not teach the elected species of compound of formula (I) as claimed in claim 9.
LÜCKING et al. teaches compound of Example 132, 2'-(6-aminopyridin-3-yl)-N-ethyl-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide, having the structure of:
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(referred to herein as “Compound 132”)(see e.g., claim 9; p. 289, line 1-2; p. 206, Example 132) is an exemplary compound of formula (I) capable of inhibiting MAP4K1 (HPK1) (see e.g., Table 1, Example 132). LÜCKING et al. further teaches compound of Example 9, tert-butyl 2'-[5-(trifluoromethyl)pyridin-3-yl]-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxylate, having the structure of:
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(referred to herein as “Compound 9”)(see e.g., p. 139, Example 9; claim 9) is also an exemplary compound of formula (I) capable of inhibiting MAP4K1 (HPK1) (see e.g., Table 1, Example 9). LÜCKING et al. further teaches a pharmaceutical composition comprising the compound of general formula (I), including 2'-(6-aminopyridin-3-yl)-N-ethyl-5',6'-dihydrospiro[azetidine-3,4'-pyrrolo[1,2-b]pyrazole]-1-carboxamide (see e.g., claim 9), and one or more pharmaceutically acceptable excipients (see e.g., claims 9 and 12). LÜCKING et al. further teaches diastereomeric mixtures are contemplated for use (see e.g., p. 28, line 35 to p. 29, line 5).
According to MPEP 2144.09, “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. ‘An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.’ In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)”. In the instant case, the compound of formula (I) of LÜCKING#2 and the claimed compound of formula (I) have very close structural similarities/same chemical core, the difference between the Example 314 of LÜCKING#2 and the claimed compound is that the prior art compound contains unsubstituted cyclopropyl rather than fluoro-substituted cyclopropyl; contains unsubstituted R2 moiety rather than amino- and trifluoromethyl-substituted R2, and contains quinolin-3-yl rather than pyridin-3-yl as R2 shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting compound 314 of LÜCKING#2 and then modify said compound by substituting the hydrogen atom of the cyclopropyl (
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) with a fluorine as the halogen atom, and then selecting pyridine ring taught by LÜCKING et al. as R2 and substituted said R2 with amino (-NH2) and trifluoromethyl (-CF3). One would have been motivated to do so, because LÜCKING#2 teaches the C3-C7-cycloalkyl at R2 can optionally substituted with halogen, particularly fluorine, and further teaches R2 can substituted with two R4, including -H, -NH2, and C1-C6-alkyl optionally substituted with halogen, e.g., C1-C6-alkyl includes methyl, and halogen is particularly fluorine to arrive at a compound of formula (I) capable of inhibiting MAP4K1 (HPK1); and LÜCKING et al. teaches Compound 132, which contains 6-aminopyridin-3-yl at R2, and Compound 9, which contains 5-(trifluoromethyl)pyridin-3-yl at R2, with very close structural similarity are both capable of inhibiting capable of inhibiting MAP4K1 (HPK1). One would have reasonably expectation of success to arrive at the claimed invention with a reasonable expectation of success, because one would have reasonably expected that by modifying the Example 314 of LÜCKING#2 in accordance with the formula (I), specifically, substituting the hydrogen atom of the cyclopropyl with a fluorine; and then selectively choose to replace R2 of Example 314 of LÜCKING#2 (i.e.,
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) with a pyridine ring taught by LÜCKING#2 substituted with -NH2 and trifluoromethyl similar to Compound 132 and Compound 9 of LÜCKING et al. would have successfully arrive at a compound that exhibits the same or substantially similar MAP4K1 inhibiting effect; therefore, said modified compound 314 of LÜCKING#2 in view of LÜCKING et al. can successfully combine with one or more pharmaceutically acceptable excipients to arrive at a pharmaceutical composition. Please note the modified compound 314 of LÜCKING#2 in view of LÜCKING et al. renders obvious the “(5-{(3R)-1-[(1-fluorocyclopropyl)(1H-imidazol-2-yl)methyl]-5',6'-dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b]pyrazol]-2'-yl}-3-(trifluoromethyl)pyridin-2-amine (diastereomer 1 and diastereomer 2)” in claim 9.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
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.
Claims 1-5, 7, 9, and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-12, and 22-23 of copending Application No. 19/505,651 (reference application).
The claims of reference application lies within the scope of the claimed invention, specifically, the reference application is drawn to a compound having the structure of:
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or a stereoisomer, a tautomer, a salt, a solvate, a hydrate or a mixture thereof; and a pharmaceutical composition comprising the compound and one or more pharmaceutically acceptable excipients useful for treating disorder associated with aberrant Map4K1 signaling; reading on the compound of formula (I) instantly claimed.
Regarding “(5-{(3R)-1-[(1-fluorocyclopropyl)(1H-imidazol-2-yl)methyl]-5',6'-dihydrospiro[pyrrolidine-3,4'-pyrrolo[1,2-b]pyrazol]-2'-yl}-3-(trifluoromethyl)pyridin-2-amine (diastereomer 1 and diastereomer 2)”, which is the elected species of compound of formula (I), as claimed in claim 9, according to MPEP 2144.09, “[a] prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. ‘An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.’ In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)”; and “[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)”. In the instant case, the claimed compound have very close structural similarities. The difference between the compound of reference application and the claimed compound is that the reference compound contains two fluorine substituents added to cyclopropyl rather than one fluorine, the position where the fluorine atoms(s) are substituted on the cyclopropyl is different, and contains three nitrogen atoms to form the 5-membered heteroaryl ring rather than two nitrogen as indicated below (see shaded):
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254
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by modifying the numbers of nitrogen atom present in the 5-memebred heteroaryl ring and the numbers of fluorine atom substituted on the cyclopropyl, and further modify the position of said fluorine substitution, because one would have been motivated to arrive at compounds similar in structure that are capable of treating disorder associated with aberrant Map4K1 signaling. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that compound that changes the position of fluorine substituted on the cyclopropyl, and changes the number of nitrogen atom present in the 5-memebred heteroaryl ring and the numbers of fluorine atom substituted on the cyclopropyl is sufficiently close in structural, and would have successfully treating disorder associated with aberrant Map4K1 signaling.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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