DETAILED ACTION
Claims 1-8 and 10-21 are pending in the present application.
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 without traverse of Group I (claims 1-8 and 10-17) along with an election of species of compound 163 in the reply filed on July 6, 2026 is acknowledged. Claims 18-21 are withdrawn from further consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
The Applicant has made an election of species in the present application. As the elected species has been found to be free of the art, the scope of searched subject matter has expanded to encompass the proper Markush grouping of the core structure of present claim 3:
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Priority
The claim to priority as a 371 filing of PCT/EP2022/082355 filed on November 17, 2022, which claims benefit of EP 21208821.5 filed on November 17, 2021 is acknowledged in the present application file.
Improper Markush Grouping Rejections
Claims 1, 2, 4-6, 8, 10-17 are rejected on the 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). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of Formula (I) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: while the genus of Formula I contains the structure:
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, each X can be selected from any chemically possible C, N, O, and S and is optionally substituted. This leads to many various core structures as there are 9 X substitutions with 4 possibilities each. Therefore, the genus as claimed does not share a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1-6, 8, and 10-17 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 present claims are drawn to compounds of Formula I:
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, where each X can be selected from any chemically possible C, N, O, and S and is optionally substituted. This leads to many various core structures as there are 9 X substitutions with 4 possibilities each.
Pages 60-117 of the specification identifies various compounds of formula I. However, the vast majority of the structures contain the formula of claim 3 with aromatic rings for R1, which is not allowed by independent claim 1. Additionally, there are no compounds where all X are C or where all X are heteroatoms.
With respect to claim 11, the compound is for the prevention and treatment of any disease in a mammalian subject. However, the compounds are only described as autophagy inducers, which are limited in the diseases and disorders that can be treated or prevented.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the genus is described by a generic formula, the generic formula is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention at the time of filing. Namely, that the definitions described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described. MPEP 2163 goes on to describe what a "representative number of species" is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification do not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus. Therefore, the claims lack written description and are properly rejected under 35 U.S.C. 112(a).
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, 8, and 10-17 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.
With respect to claims 1-5, 8, and 10-17, R1, R2, and R3 are defined that some groups may be “optionally comprising chemically possible N, O, and S.” Additionally, each X is independently selected from “chemically possible combinations of C, N, O, and S. There is no clear definition in the claims or the present specification as to what is meant by chemically possible, and what bonds or additional elements may also be present with the C, N, O, or S atom.
With respect to claim 7, the last three compounds contain blank spaces such that it is not known if the “4-“ and “yl” are supposed to be next to each other or if there should be additional text in place of the blank.
Regarding claims 12 and 17, the term "preferably" renders the claim indefinite because it is unclear whether the limitations following the term are part of the claimed invention. See MPEP § 2173.05(d).
With respect to claims 4-6, functional groups are defined to include “a physiologically acceptable salts of the groups, solvates of the groups, hydrates of the groups, enantiomers of the groups, and polymorphs of the groups.” The conventional definition of a solvate, hydrate, and polymorph is of a complete compound and not for just a substituent. It is not known if the claim is meant to be a solvate, hydrate, or polymorph of just a functional group or of the complete compound. For purposes of art, the claims have been interpreted as if the terms for the compound as a whole.
Claim 15 recites the limitation "the autophagy-related disease or condition" in line 3. There is insufficient antecedent basis for this limitation in the claim.
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 4-6, 8, 11-14, 16, and 17 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.
With respect to claims 4 and 6, R1 is defined to include aromatic rings, which are not embraced by the definition of parent claim 1 where R1 is selected from C5 or C6 alkyl, which implies no double bonds in the ring.
With respect to claims 5 and 6, R2 and R3 include groups that do not comprise an NH2 or NH as required by parent claim 1.
With respect to claims 8, 11-14, 16, and 17, the claims reference functions of the claimed compounds, but do not further limit the structure of the compounds of claim 1. Therefore, the claims do not further limit parent claim 1.
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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 1568631-86-6 (2014).
CAS Registry No. 1568631-86-6 is the compound
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, which reads on claim 4 where R1 is
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, R2 and R3 combine to form a 6-membered ring substituted by C2 alkyl substituted by NH2. See the hitstructure.
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 1-8 and 10-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 12-19 of copending Application No. 18/711,519 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claim 6 of the ’519 application details compounds of the formula
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where R2 is
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and R3 is isopropyl which anticipates present claim 6 and compound 163 of present claim 7. Additionally, claims 1-6 and claims 12-19 of the ‘519 application map to present claims 1-6 and 10-17 respectively. Even though the ‘519 application requires that R2 or R3 or the combination thereof includes at least one saturated/fully substituted nitrogen, there are overlap in groups that have both nitrogen groups that are fully substituted and those with NH or NH2. Additionally, the compound formed above for present claim 7 contains a fully substituted nitrogen attached to R2 and R3. Therefore, claims 1-6 and 10-17 are anticipated.
With respect to present claim 8, claim 1 of the ‘519 application anticipates present claim 1 and there is no difference in the scope of compositions of present claims 1 and 8. Therefore, present claim 8 is also anticipated.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-8 and 10-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH R KOSACK/Primary Examiner, Art Unit 3991
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