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 .
Status of Claims
The amendments to the claims filed July 13, 2023 are acknowledged and entered. Claims 196-215 are pending.
Priority
This application is a 371 of PCT/CA2022/050038, filed January 12, 2022, which claims the benefit of 63/136,782, filed January 13, 2021, and 63/262,040 filed October 4, 2021.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on July 13, 2023 and July 15, 2025. All references have been considered except where marked with a strikethrough.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Claim Rejections - 35 USC § 112a
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 202 and 203-209 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 Formula V wherein R27 is a natural amino acid corresponding to
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when W1 is H, R2 is ,
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, and Z1 and Z2 are each halogen, does not reasonably provide enablement for generic Formula V wherein R27 is a natural amino acid.
The specification is not adequately enabling for the scope of the compounds claimed. The only useful compounds are those embodiments disclosed at Table A of specification and which are included in the subgenus of Formula V indicated above. This narrow scope of compounds does not give a reasonable assurance that all, or substantially all of the compounds within the scope of the claims wherein R27 is an amino acid are useful. The claims are not drawn in terms of a recognized genus but are directed to a more or less artificial selection of compounds. There is no reason why a claim drawn in this way should not be limited to those compounds which are shown to be useful. An Applicant is not entitled to a claim for a large group of compounds merely on the basis of a showing that a selected few are useful and a general suggestion of a similar utility in the others. There is no statement of utility beyond that for inhibition of SGK1 (see Table B). Ex parte Lanham, 108 USPQ at 135 states “It was never intended that a patent be granted upon a product, or a process producing a product, unless such product be useful.”
The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation. (United States v. Teletronics Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is needed is not based on a single factor, but rather a conclusion reached by weighing many factors (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). These factors include the following:
1) Amount of guidance provided by applicant. The Applicant has demonstrated Formula V wherein R27 is a natural amino acid corresponding to
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when W1 is H, R2 is ,
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, and Z1 and Z2 are each halogen is an inhibitor of SGK1 (see Table B). However, there is no evidence to show the full scope Formula V wherein R27 is a natural amino acid which includes thousands of structurally diverse compounds have any use.
2) The nature of the invention and predictability in the art.
The nature of the invention is a compound of Formula V which is reportedly useful for inhibiting SGK1 (Table B). Claim 202 recites a compound of Formula V wherein R27 is a natural amino acid. Claims 203-209 recite limitations to Formula V and therefore are regarded as including the limitation of R27.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
3) Number of working examples. Applicant has prepared one embodiment of Formula V wherein R27 is a natural amino acid corresponding to
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when W1 is H, R2 is ,
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, and Z1 and Z2 are each halogen (see Compound 81). This embodiment represents a narrow subgenus for which applicant has provided sufficient guidance regarding how to use. However, this disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the compounds instantly claimed. Applicant has provided no working examples of any compounds, compositions, or pharmaceutically acceptable salts of Formula V wherein R27 is a natural amino acid beyond the narrow subgenus indicated above.
Within the specification, “specific operative embodiments or examples of the invention must be set forth, Examples and description should be of sufficient scope as to justify the scope of the claims, Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP 608.01(p).
4) Scope of the claims. The scope of the claims involves all of the thousands of compounds of the
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wherein R33 is
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and R27 is an natural amino acid.
The specification provides no definition or description otherwise of what Applicant regards as a “natural amino acid”. Moreira (Biomimetic Technologies, 2015, CH 1.2.1 Amino Acids) teaches amino acids are natural compounds composed of amine (–NH2) and carboxylic acid (–COOH) functional groups, linked to the same carbon atom. Different amino acids have a different and specific side chain linked to this exact carbon. There are more than 500 amino acids identified (See Abstract of CH 1.2.1).
The scope of the claims is thus incredibly broad as the term “natural amino acid” includes at least 500 distinct compounds.
5) Level of skill in the art. The artisan using applicant' s invention would be a scientist with a Ph.D. degree and having several years of research experience.
6) Undue experimentation. 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)."
The conclusion is clearly justified here that applicant is not enabled for using the full scope of compounds claimed.
Claims 202 and 203-209 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.
The claim requires wherein R27 is a natural amino acid; however, the claims do not require wherein the amino acid has any particular structure. Nor does the specification define what Applicant intends by a “natural amino acid”.
Applicant has only provided a single embodiment (Compounds 81) which teaches wherein R27 is a natural amino acid corresponding to
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. As noted above, there are more than 500 known naturally occurring amino acids. In the present case, R27 corresponding to
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is not representative of the full scope of compounds claimed, and given the direction provided by Applicant a person skilled in the art would not recognize that Applicant was in possession of the invention as broadly claimed at the time the application was filed.
Claim Rejections - 35 USC § 112b
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 202-215 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. [A] claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear (MPEP 2173.04). The following terms and/or phrases render the scope of the claims unclear because the specification does not provide a scope limiting definition of the phrase or term, or any direction for ascertaining the scope of the limitation indicated by the term or phrase. Accordingly, one skilled in the art could not ascertain the metes and bounds of the claimed invention.
Claim 202 recites the limitation “natural amino acid”. This limitation renders the scope of claims indefinite because the scope of the limitation is not defined. Applicant provides a single embodiment (compound 81) wherein R27 is an amino acid corresponding to
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; however, an amino acid corresponding
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does not clarify the metes and bounds of the term. Appropriate clarification is required.
Claims 203-215 are indefinite for improperly depending from claim 201 which is drawn to compounds of Formula Vb. Claims 203-213 are genus claims which recite additional limitations that are not supported by the compounds recited in claim 201. The limitations of the claims therefore lack proper antecedent basis. Claims 214-215 are drawn compounds of Formula V which are supported by claim 201. The claims should be amended to depend from a broader claim (e.g. claim 202) which provides support for the limitations.
Claim 208 recites the limitation “Z3”. There is insufficient antecedent basis in the claim for Z3 because the claim depends from claim 206 which does not recite Z3.
Claim Rejections - 35 USC § 112d
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 203-215 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. The claims depend directly or indirectly from claim 201 and are drawn to limitations not supported by base claim 201. The claims are broader in scope that claim 201 and therefor rejected for failing to 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.
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.
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 196-206, 208 and 213-214 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 58-71 of copending Application No. 19/017,207 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the reference application.
A non-statutory obviousness-type 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); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985).
Obviousness-type double patenting requires rejection of an application claim when the claimed subject matter is not patentably distinct from the subject matter claimed in a commonly owned patent, or a non-commonly owned patent but subject to a joint research agreement as set forth in 35 U.S.C. 103 (c)(2) and (3), when the issuance of a second patent would provide unjustified extension of the term of the right to exclude granted by a patent. See Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 58 USPQ2d 1869 (Fed. Cir. 2001); Ex parte Davis, 56 USPQ2d 1434, 1435-36 (Bd. Pat. App. & Inter. 2000).
One having ordinary skill in the art at the time of the invention would have noted that subject matter exists in both the instant invention and the copending application that is not patentably distinct from each other. It has also been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).
In the present case, the reference claims are drawn to a crystalline compound of Formula (II).
Formula (II) of the reference claims corresponds to instant Formula Vb wherein W1, Z1 and Z2 are each halogen; or Formula V wherein R2 is
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; W1, Z1 and Z2 are halogen, and R33 is CH3 The reference claims teach the instant claims and therefore anticipate the claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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January 13, 2026
/K.S.M./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624