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 .
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 102 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a disease or condition associated with an aberrant glutaminyl-peptide cyclotransferase-like protein (QPCTL) activity in a subject in need thereof comprising administering a therapeutically effective amount of a compound of Formula (I), or a pharmaceutically acceptable salt or stereoisomer thereof, does not reasonably provide enablement for such a method where the term treating encompasses the concept of prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
With regard to rejections under 35 USC 112(a) or 35 USC 112, first paragraph, the following factors are considered (MPEP 2164.01(a)): a) Breadth of claims; b) Nature of invention; c) State of the prior art; d) Level of ordinary skill in the art; e) Level of predictability in the art; f) Amount of direction and guidance provided by the inventor; g) Working examples and; h) Level of experimentation needed to make or use the invention based on the content of the disclosure.
a) The claim is extraordinarily broad: A method of treating a disease or condition associated with an aberrant glutaminyl-peptide cyclotransferase-like (QPCTL) activity in a subject in need thereof, comprising administering a therapeutically effective amount of a compound of Formula (I).
The examiner notes that the specification explicitly teaches that the term treating includes “…preventing the underlying causes [emphasis added] of symptoms…” (page 25, [0073]). That is, the specification explicitly teaches that the term treating encompasses the prevention of a disease or condition associated with an aberrant glutaminyl-peptide cyclotransferase-like protein (QPCTL) activity. Such diseases or conditions are, for instance, cancers, schizophrenia, infertility, psoriasis, multiple sclerosis, Alzheimer’s disease, Familial British Dementia, Familial Danish Dementia, Hunting’s disease, rheumatoid arthritis, etc. (beginning page 11, [0031]-[0034]).
b,c) The nature of the invention is determined in part by the state of the prior art.
As even a cursory perusal of the medicinal arts reveals, they have not advanced to the point where complex diseases with a significant genetic component, such as, for instance, cancers, schizophrenia, infertility, psoriasis, multiple sclerosis, Alzheimer’s disease, Familial British Dementia, Familial Danish Dementia, Hunting’s disease, rheumatoid arthritis, etc. can be said to be prevented.
d) The level of skill in the art is considered to be relatively high.
e) The level of predictability in the art is considered to be relatively low.
The basis of all modern medicine and biology is, of course, chemistry. Yet even under the best of circumstances, and more than two hundred years after Lavoisier laid the foundations of its modern practice, chemistry remains an experimental science. Neither the medicinal/biological arts nor the chemical arts upon which they are based have advanced to the point where certainty has replaced the need for clinical and/or laboratory experimentation.
Cancer, for instance, is neither a simple disease, nor a single disease. While some cancers can be treated in some hosts using specific compounds, the effective treatment - let alone prevention - of various forms of cancer remains highly unpredictable in the art.
Note that the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art (MPEP 2164.03).
f,g) The amount of direction provided by the inventor is considered to be determined by the specification and the working examples. Inventor’s data do not demonstrate that the instant method prevents, for instance, cancers, schizophrenia, infertility, psoriasis, multiple sclerosis, Alzheimer’s disease, Familial British Dementia, Familial Danish Dementia, Hunting’s disease, rheumatoid arthritis, etc.
h) It would clearly require an extraordinary - and thus undue - amount of experimentation (clinical trials, etc.) in order to determine if, in fact, the instant method is actually efficacious in the prevention of cancers, schizophrenia, infertility, psoriasis, multiple sclerosis, Alzheimer’s disease, Familial British Dementia, Familial Danish Dementia, Hunting’s disease, rheumatoid arthritis, etc.
Claim Rejections - 35 USC § 112(d)
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.
Claim 28 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth 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.
In the present instance, the claim fails to further limit the subject matter of the claim upon which it depends (claim 1). Dependent claim 28 merely repeats the definition of variable R1 of the claim upon which it immediately depends, 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.
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, 28, 30, 42, 50 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of (parent) U.S. Patent No. 11,834,440 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claim teaches a Markush set of compounds of Formula (I). The instant claims teach a broader Markush set of compounds, also labeled Formula (I), which fully encompasses the patented compounds. Thus, the patented claim and the instant claims are related in a species/genus fashion. That is, the patent is a narrower teaching of the broader teaching of the instant application. Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 5 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-16 of (parent) U.S. Patent No. 11,834,440 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other.
The patented claims teaches a set of, or individual, diagramed compounds which are members of the set of compounds of Formula (I). The instant claim teaches a broader Markush set of compounds, labeled Formula (Iaa), which fully encompasses the patented compounds. Thus, the patented claims and the instant claim are related in a species/genus fashion. That is, the patent is a narrower teaching of the broader teaching of the instant application. Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 102 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-19 of (parent) U.S. Patent No. 11,834,440 B2, cited in the IDS. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claim 17 teaches a method of treating cancer comprising administering the set of diagramed compounds of Formula (I) of claim 8. Patented claims 18 and 19 further define the cancer. The patent specification explicitly teaches that cancer is a disease or condition associated with aberrant QPCTL activity (column 12, line 15).
Instant claim 102 teaches a method of treating a disease or condition associated with aberrant QPCTL activity comprising administering a compound of Formula (I).
As pointed out in the preceding rejection, patented claim 8 teaches a set of diagramed compounds which are members of the set of compounds of Formula (I). The instant claim, drawn to the compounds of instant Formula (I), teaches a broader Markush set of compounds which fully encompasses the compounds of patented claim 8. Thus, the patented claims and the instant claim are essentially related in a species/genus fashion. That is, the patent is a narrower teaching of the broader teaching of the instant application (both with respect to the compounds as well as the disease or condition). Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Claim 102 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of (parent) U.S. Patent No. 12,162,862 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Patented claim 1 teaches a method of treating a disease or condition associated with an aberrant QPCTL activity comprising administering a pharmaceutical composition comprising a compound of Formula (I). Instant claim 102 teaches a method of treating a disease or condition associated with an aberrant QPCTL activity comprising administering a compound of Formula (I).
The patented claim is predicated upon a Markush set of compounds of Formula (I). The instant claim is predicated upon a broader Markush set of compounds, also labeled Formula (I), which fully encompasses the compounds of the patent. Thus, the patented claim and the instant claim are related in a species/genus fashion. That is, the patent is a narrower teaching of the broader teaching of the instant application. Note, however, that if a generic claim is presented in a separate application after the issuance of a patent claiming one or more species within the scope of the generic claim, the generic claim may be rejected on the grounds of nonstatutory double patenting. (MPEP 806.04(i).)
Allowable Subject Matter
Claims 3, 8, 12, 15, 18, 22, 24, 44-47 and 100 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 7/23/2026
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