The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 4-5, are pending in this application.
Claims 1-3, are deleted.
Non-Elected Claims
Claims 1-5, were originally filed, 9/6/21. The claims were subject to restriction for election species in the office action mailed 12/25/23. In the Paper filed 4/8/24, Applicant elects
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, which was found allowable. The search was expanded to include
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, wherein X is N, Y is C, Z is NR6, and R4 is limited to alkyl (optionally substituted). R5-R8 are as defined in claim 4. See page 6 of the NF.
The general policy of the Office is that applicants are not permitted to shift to claim another invention after an election is made and an Office Action on the merits is made on the elected invention. The applicant cannot, as a matter of right, file a request for continued examination (RCE) on claims that are independent and distinct from the claims previously claimed or lack unity of invention with the claims previously elected and examined (i.e., applicant cannot switch inventions by way of an RCE as a matter of right). See MPEP § 706.07(h), subsection VI(B).
Since applicant has received office actions (4/19/24, 1/8/25) on the merits for the originally presented invention, the election made 4/8/24 has been constructively elected by original presentation for prosecution on the merits. Accordingly,
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etc., that are not searched must be deleted as being directed to non-elected inventions. See 37 CFR 1.142(b) and MPEP § 821.03.
The elected compound is independent and distinct from the non-elected compounds. The non-elected compounds are withdrawn from further consideration.
If the elected species is found allowable, the search will be expanded by the Examiner to other species and sub-generic compounds within the elected group until:
All the compounds of the elected group are searched “if the members are sufficiently few in numbers” or “to the extent necessary to determine patentability.” “The prior art search will not be extended unnecessarily to cover all nonelected species.” MPEP 803.02.
In accordance with the decisions in In re Weber, 198 USPQ 328 (CCPA 1978) and In re Haas, 198 USPQ 334 (CCPA, 1978), it is improper for the Office to refuse to examine that which, applicants regard as their invention, unless the subject matter lacks unity of invention.
The searched was stopped because prior arts of record anticipate or render obvious the invention as set forth in the NF mailed 4/19/24, and FR mailed 1/8/25.
Response
Applicant's arguments filed 7/8/25 have been fully considered but they are not persuasive. Applicant contends a species “would certainly not make obvious the entire . . . genus.” This is not correct. Under the US patent practice, to anticipate or render obvious a genus, a prior art must teach at least one species within the genus. Other contentions not addressed herewith is because the rejections and contentions thereof are now obviated. The amendment filed 7/8/25, obviates the previous 102 and 103 rejections.
Proviso
Claim 4 has the proviso set forth below, which obviates anticipatory rejection with respect to the compounds. The proviso is deemed applicant’s admission that the compounds are not applicant’s inventions. However, their known equivalents, e.g. isomers, bioisosteres, etc. should have been included in the proviso. They are within the scope of claim 4 and are claimed in claim 5. Therefore the claims are subject to obviousness rejection.
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“A statement by an applicant in the specification or made during prosecution [including interview] identifying the work of another as ‘prior art’ is an admission which can be relied upon for both anticipatory and obviousness determinations.” MPEP 2129 (I). In the instant case, applicant proviso compounds are deemed invention by another. “In the absence of another credible explanation, examiner should treat such subject matter as the work of another.” In re Riverwood Int. Corp. 66 USPQ2d 1331, 324 F3d 1346 (CCPA 2003). See also the MPEP 2129 (I)-(II). “Valid prior art may be created by the admission of the parties. Admission of knowledge of prior art’s invention of another constitutes an admission that the invention was prior art to the applicant.” In re Fout, 213 USPQ 532 (CCPA, 1982), cited in In re Riverwood Int. Corp. See also In re Nomiya, 184 USPQ 607 (CCPA, 1975).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 4-5, are rejected under 35 U.S.C. 103(a) as being unpatentable over Applicant’s admission alone, or in view of King, Med. Chem, Principle and Practice (1994) 206-208.
Applicant proviso
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. Applicant claims
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. The compound is embraced by claim 4 and cited in claim 5. Applicant replaces H with methyl at position R6.
Hydrogen and alkyl are art recognized equivalents. In re Lincoln, 126 USPQ 477, 53 USPQ 40 (CCPA, 1942); In re Druey, 319 F.2d 237, 138 USPQ 39 (CCPA, 1963); In re Lohr, 317 F.2d 388, 137 USPQ 548 (CCPA, 1963); In re Hoehsema, 399 F.2d 269, 158 USPQ 598 (CCPA, 1968); In re Wood, 582 F.2d 638, 199 USPQ 137 (CCPA, 1978); In re Hoke, 560 F.2d 436, 195 USPQ 148 (CCPA, 1977); Ex parte Fauque, 121 USPQ 425 (POBA, 1954); Ex parte Henkel, 130 USPQ 474, (POBA, 1960).
Applicant also claimed H and alkyl as equivalents in the instant, e.g. at R6. Having known the compounds are equivalents, are expected to have similar biological and chemical properties, and the substitution is a routine practice in the art, a POSA would have known and be motivated to make the substitutions at the time the invention was made, with reasonable expectation of success.
Applicant proviso
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. Applicant claims
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. The compound is embraced by claim 4 and cited in claim 5. Applicant replaces H with methyl at position Z (20 v 3o amine). 20 and 3o amines are obvious variants, Ex parte Bluestone, 135 USPQ 199 (1961). Having known that they are obvious variants, are expected to have similar activities and is a routine practice in the art to claim them, a POSA would have known and be motivated to replace one for the other, at the time the invention was made, with reasonable expectation of success.
2a) Applicant also claims
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, a position isomer of the proviso compound above.
The isomer is embraced by claim 4 and cited in claim 5. When a compound is known, a POSA knows its isomers. A novel and useful compound, which is an isomer of a compound by a prior art, is prima facie obvious. Isomers are general class of compounds made by the same general process and the claimed compound could have been made by the process of making the compound by the prior art. In re Norris, 84 USPQ 458 (CCPA, 1950). Having known that isomers often have similar biological and chemical activities, a POSA with reasonable expectation of success, would have known and be motivated to claim the isomer, at the time the invention was made.
2b) Applicant claims these amino protected variants of the above proviso compound,
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. The variants are embraced by claim 4 and cited in claim 5. The combination of unpatentable inventions is not patentable. Applicant cannot claim the combination of a known compound and a well-known protecting group, under the US patent practice. Having known that Boc, Ts and Bn, are well-known amino protecting groups, and how to perform the protections are well-known in the art, e.g. Green’s Protective groups in Organic Synthesis, Wiley-Interscience Publications, 2006, Chapt. 7. Therefore, a POSA would have known and be motivated, with reasonable expectation of success, to claim the protected variants, at the time the invention was made.
2c) Applicant claims
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. The compounds are embraced by claim 4 and cited in claim 5. Applicant replaces NH with O or S at position Z. They are bioisosteres equivalents. See King, ring equivalents, table 1, pp. 208. See also Ex parte Engelhardt, 208 USPQ 343, In re Merck, 231 USPQ 375.
Applicant also claimed them as equivalents in the instant, at Z. Having known the compounds are equivalents, and expected to have similar biological and chemical activities, a POSA, with reasonable expectation of success, would have known and be motivated to replace NH with O or S, and vice versa, at the time the invention was made.
Applicant proviso
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and
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. Applicant claims
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. The compound is embraced by claim 4 and cited in claim 5. Applicant replaces H with Ph at position R4. From the proviso compounds, it is clear H and Ph are equivalents. Having known the compounds are equivalents, and are expected to have similar biological and chemical activities, a POSA, with reasonable expectation of success, would have known and be motivated to replace H with Ph, and vice versa, at the time the invention was made.
As held in KSR Int. Co. v. Teleflex Inc, 550 U.S. 82 USPQ2d 1385 (2007), “when a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation, 103 likely bars its patentability. For the same reason if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
In the instant, it is not beyond the ordinary skill of a Scientist to use conventional technique in making the protected variants, isomer, or the equivalents, at the time the invention was made. They are deemed inventions of reasoning, not of creativity, KSR, supra.
A showing of sufficiently close structural relationship is enough to create an expectation of similar properties, in light of the totality of prior arts, that the new compound will have "similar properties" to the old. Motivation is found in the expectation that similar compounds would have similar properties. A disclosure of new property does not defeat such expectation. Dillon, 16 USPQ2d, 1897 (Fed Cir, 1990). Applicant must show the prior art’s compound does not have the new property. Dillon, 16 USPQ2d, 1897 (Fed Cir, 1990), In re Shetty, 195 USPQ 753 (CCPA, 1977).
Applicant who claims a compound, which is structurally similar to a prior art’s compound must rebut the presumed expectation that structurally similar compounds have similar properties. In re Wilder, 195 USPQ 426 (CCPA, 1977). In the instant, the claimed compounds and the proviso compounds have the same utilities.
Therefore, the claims are not allowable over the combination of the proviso compounds and knowledge well-known in the art. Deleting claim 4 and the rejected species from claim 5, will obviate the rejection.
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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 4-5, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, of U.S. Patent No. 11,117,893. Although the claims at issue are not identical, they are not patentably distinct from each other because, the instant compounds are within the scope of the compounds made in the patent, and are inherent in the process.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Andy Kosar, can be reached on (571) 272-0913. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/ Primary Examiner, Art Unit 1625
November 5, 2025