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 Status
Claims 1, 5, 9, 14-21, 28, 31, 44, 47, 178, 182, 188-189 and 203 are pending. Claims 1, 5, 9, 14-21, 28, 31, 44, 182, 188-189 and 203 are rejected. Claims 47 and 178 are objected to.
Response to Amendment
Applicant’s amendments have overcome the previously presented 35 USC 102 and 112a rejections as well as the 112d rejections of claims 18-20.
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 17 is 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.
Claim 17 recites compounds where L1-B is broader in scope than independent claim 1 which requires that
PNG
media_image1.png
178
860
media_image1.png
Greyscale
Or
PNG
media_image2.png
292
758
media_image2.png
Greyscale
etc.
Instant claim 17 recites the compound of claim 1 wherein
PNG
media_image3.png
73
705
media_image3.png
Greyscale
.
When L1-B is
PNG
media_image4.png
59
42
media_image4.png
Greyscale
, this definition of X allows for rings other than those specified in claim 1. For instance, claim 17 embraces compounds of this type where X is unsubstituted cyclobutyl whereas claim 1 only provides for one of the following:
PNG
media_image5.png
139
166
media_image5.png
Greyscale
PNG
media_image6.png
118
204
media_image6.png
Greyscale
PNG
media_image7.png
156
394
media_image7.png
Greyscale
PNG
media_image8.png
164
186
media_image8.png
Greyscale
.
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.
To overcome this issue the Examiner recommends that Applicant amend claim 17 to recite:
The compound or salt of claim 1,
wherein
PNG
media_image3.png
73
705
media_image3.png
Greyscale
.
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 203 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2248829-58-3, which entered Registry on November 18th, 2018.
CAS Registry No. 2248829-58-3 is drawn to N-(4-Ethyl-5-methyl-2-thiazolyl)-1-(4-pyridinylmethyl)-1H-pyrrole-2-carboxamide, which has the following structure:
PNG
media_image9.png
200
396
media_image9.png
Greyscale
.
CAS Registry No. 2248829-58-3 is identical to instant compound A82 of claim 203.
Claim 203 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2248870-86-0, which entered Registry on November 18th, 2018.
CAS Registry No. 2248870-86-0 is drawn to N-(5-Cyclopropyl-2-thiazolyl)-1-(4-pyridinylmethyl)-1H-pyrrole-2-carboxamide, which has the following structure:
PNG
media_image10.png
202
406
media_image10.png
Greyscale
.
CAS Registry No. 2248870-86-0 is identical to instant compound A75 of claim 203.
Claim 203 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2248894-89-3, which entered Registry on November 18th, 2018.
CAS Registry No. 2248894-89-3 is drawn to N-Methyl-N-(4-methyl-2-thiazolyl)-1-(4-pyridinylmethyl)-1H-pyrrole-2-carboxamide, which has the following structure:
PNG
media_image11.png
180
374
media_image11.png
Greyscale
.
CAS Registry No. 2248894-89-3 is identical to instant compound A118 of claim 203.
Claim 203 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2248986-96-9, which entered Registry on November 18th, 2018.
CAS Registry No. 2248986-96-9is drawn to N-(6-Methyl-2-benzothiazolyl)-1-(4-pyridinylmethyl)-1H-pyrrole-2-carboxamide, which has the following structure:
PNG
media_image12.png
184
432
media_image12.png
Greyscale
.
CAS Registry No. 2248986-96-9 is identical to instant compound A73 of claim 203.
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, 9, 14-21, 28, 31, 44, 182, 188-189 and 203 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10-11, 17, 21, 26, 39, 43, 45, 47, 49, 51, 62, 64-68, 72, 76, 80, 88, 97 and 196-197 of co-pending Application No. 18/019,885 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 64 discloses the following compound (Table A):
PNG
media_image13.png
191
342
media_image13.png
Greyscale
.
Compound A52 is embraced by instant Formula (III) where R4 is C1 alkyl, m is 1, L2 is C1 alkylene, R2 is H, L1-B is
PNG
media_image14.png
139
157
media_image14.png
Greyscale
and there are 0 instances of G and E (corresponding to instant claims 1, 14-17, 19-21, and 31).
Co-pending claim 97 discloses the following compound (Table B):
PNG
media_image15.png
145
363
media_image15.png
Greyscale
.
Compound B48 is embraced by instant Formula (IIIA) where L1-B is
PNG
media_image16.png
101
198
media_image16.png
Greyscale
and there are 2 instances of G, where G is halo and C1 alkyl (corresponding to instant claims 1, 5, 9, 14-18, 19, 28 and 44).
Regarding instant claim 203, the co-pending application discloses the following compound in claim 64:
PNG
media_image17.png
235
341
media_image17.png
Greyscale
.
Compound A21 is analogous to instant compound A275 depicted below:
PNG
media_image18.png
181
363
media_image18.png
Greyscale
.
Co-pending compound A21 differs from instant compound A275 by the presence of a methyl substituent where the instant compound has a hydrogen. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) 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).” It is well established that the substitution of methyl for hydrogen on a known compound is not a patentable modification absent unexpected or unobvious results. In re Wood, 199 U.S.P.Q. 137 (C.C.P.A. 1978) and In re Lohr, 137 U.S.P.Q. 548, 549 (C.C.P.A. 1963).
The motivation to make a substitution of a hydrogen for an alkyl group stems from the fact that a person having ordinary skill in the art would expect that the compounds would have the same utility as the compounds taught by the co-pending application. In the interest of generating additional compounds that have the same utility as the compounds taught by the co-pending application, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the co-pending application that have been demonstrated to have the desired utility. The replacement of hydrogen for an alkyl group falls under the well-established doctrine of homology, which assumes that homologous compounds are likely to have similar properties. Therefore, the instantly claimed compound which differs by hydrogen/alkyl, over the compound of the co-pending application is unpatentable absent a showing of unexpected results. MPEP 2144.09 (VIII) states “A prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
Regarding instant claim 189, the co-pending application teaches a method of treating cancer by administering the co-pending compounds (claims 196 and 197).
Instant claim 182 recites a method of inhibiting protein secretion in a cell comprising contacting the cell with the instant compounds in an effective amount. A person of ordinary skill would recognize this as a natural consequence of administering the compound to treat a disease where it would be expected to contact the recited proteins in the biological system.
Regarding instant claim 188, with respect to the fact that the claims of the co-pending case are drawn to compounds and compositions while the instant claims are drawn to methods of treating inflammation or an inflammatory disease, Applicant is directed to Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. 95 USPQ2d 1797, Geneva Pharmaceuticals, Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373 [68 USPQ2d 1865] (Fed. Cir. 2003), and Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353 [86 USPQ2d 1001] (Fed. Cir. 2008) for analogous situations. The instantly claimed utility is disclosed in paragraph [0010] of the co-pending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5, 9, 15-19, 21, 28, 31, 44, 182, and 188-189 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 11, 14-17, 20-21, 23, 28, 32, 34, 38-40, 42, and 49-50 of copending Application No. 18/841,805 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because copending claim 38 discloses compounds from Table A or B including the following:
PNG
media_image19.png
162
430
media_image19.png
Greyscale
PNG
media_image20.png
178
432
media_image20.png
Greyscale
.
Regarding instant claims 1, 5, 9, 15-19, 21, 28, 31, 44, 182, and 188-189 are copending compound B18 is embraced by instant formula (III) where R4 is absent (m is 0), L2 is C1alkylene, R2 is H, L1-B is
PNG
media_image21.png
116
184
media_image21.png
Greyscale
, G is N(RN)2, RN is H.
Copending compound B22 reads on instant claims 1, 5, 9, 15, 17-18, 20-21, 31, 182, and 188-189 where R4 is F (m is 1), L2 is C1alkylene, R2 is H, L1-B is
PNG
media_image22.png
122
114
media_image22.png
Greyscale
, and there are 0 instances of G.
Regarding instant claim 182, copending claim 42 recites a method of inhibiting protein secretion in a cell comprising contacting the cell with the copending compound in amount effective to inhibit secretion wherein the protein is PD-1.
Regarding instant claims 188-189, copending claims 49-50 disclose methods of treating inflammation and cancer by administering the copending compounds.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 47 and 178 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626