Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Request for continued examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2024 has been entered.
DETAILED ACTION
As filed, claims 12, 15, 17, 18, 20, 43-45 are pending of which claim 12 is amended. Claims 44-46 are newly added. Claims 1-11, 13, 14, 16, 19, 21-42 are cancelled.
Response to Remarks
Applicant’s amendments have been fully considered and are entered. The status for each rejection and/or objection in the previous Office Action is set out below.
The rejection of claims 12, 15, 17, 18, 20, and 43 under 35 U.S.C. §103(a) over US 20070129282,by Ahlem, 6/7/2007 is withdrawn in view of claim amendments to specify the characterization data of the claimed crystalline solvate of
PNG
media_image1.png
200
400
media_image1.png
Greyscale
.
The NSDP rejections of are maintained/modified in view of the amendments to claims. The requisite Terminal Disclaimers were not submitted by Applicants. The examiner had a telephone conversation with Applicant's Representative regarding submission of terminal disclaimer. It was noted that the Applicants prefer an office action to be issued at this time.
Claim Objections
1.Claims 15, 17, 18, 20, 43-45 are objected to because of the following informalities: the recitation in said claims “Claim” should be changed to lower case.
2.The recitation in claim 12 “essentially” should be change to avoid potential indefiniteness issues.
3. Claims 44 and 46 are objected to because of the following informalities: the recitation “10° C./min”; “20° C. to 100° C. “ contains extra punctuation.
Appropriate correction is required.
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.
1.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,995,112 in view of US 2008/0153792 by Frinke et al June 2008. Claims 1-8 of the patent teach a solid form of 17a-ethynylandrost-5-ene-3b,7b,17b -triol but do not teach the use of such for the treatment of conditions. However, the patent discuss treatment of such conditions with same crystalline solvates as claimed with the same characterization data as shown on Figures 1-6 of the ‘112 patent. Furthermore, the ‘792 publication teaches on [0062]-[0063] and [0044] the treatment of inflammatory condition such as inflammatory bowel, lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol (instant claims 12). Regarding instant claims 25 and 26, the ‘792 publication teaches on [0002], [0023] and [0044] the treatment of condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol. Thus, it would have been obvious for one of ordinary skill in the art to have employed the solid compound of the patent in the method of the ‘792 publication. There would have been a reasonable expectation of success given the similar purposes of the references.
2.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8,518, 922 in view of US 2008/0153792-A1 06-2008.
Claims 1-8 of the patent teach a crystalline forms of 17a-ethynylandrost-5-ene-3b,7b,17b -triol with characterization data as shown in the figures but do not teach the use of such for the treatment of lung conditions. However, the ‘792 publication teaches on [0062]-[0063] and [0044] the treatment of inflammatory condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol (instant claims 12,13). Regarding instant claims 25 and 26, the ‘792 publication teaches on [0002], [0023] and [0044] the treatment of condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol
There would have been a reasonable expectation of success given the similar purposes of the references.
3.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,555,046 in view of US 2008/0153792-A1 06-2008. Claim 1 of the patent teaches a solid form of 17a-ethynylandrost-5-ene-3b,7b,17b -triol, wherein the solid form has similar characterization data as claimed compound the same characterization data as shown on Figures 1-19 of the ‘046 patent the but does not teach the use of such for the treatment of inflammation or metabolic, inflammatory associated with a hyperproliferation conditions or autoimmune conditions, impaired glucose tolerance or a hyperglycemia conditions. However, the ‘792 publication teaches on [0062]-[0063] and [0044] the treatment of inflammatory condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol (instant claims 12,13). Regarding instant claims 25 and 26, the ‘792 publication teaches on [0002], [0023] and [0044] the treatment of condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol
There would have been a reasonable expectation of success given the similar purposes of the references.
4.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,314,471 in view of US 2008/0153792-A1. Claim 1 of the patent teaches a method of making a solid form of 17a-ethynylandrost-5-ene-3b, 7b, 17b -triol, the solid form has similar characterization data as claimed compound the same characterization data as shown on Figures 1-8 but does not teach the use of such for the treatment of inflammation or metabolic, inflammatory associated with a hyperproliferation conditions or autoimmune conditions, impaired glucose tolerance or a hyperglycemia conditions. However, the ‘792 publication teaches on [0062]-[0063] and [0044] the treatment of inflammatory condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol (instant claims 12,13). Regarding instant claims 25 and 26, the ‘792 publication teaches on [0002], [0023] and [0044] the treatment of condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol
There would have been a reasonable expectation of success given the similar purposes of the references.
5.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8,252,947 in view of US 2008/0153792-A1 06-2008. Claims 1-6 of the patent teach solid forms including the Form III hydrate of 17a-ethynylandrost-5-ene-3b,7b,17b -triol with similar characterization data as claimed compound the same characterization data as shown on Figures 1-19 but do not teach the use of such for the treatment of inflammation or metabolic, inflammatory associated with a hyperproliferation conditions or autoimmune conditions, impaired glucose tolerance or a hyperglycemia conditions. However, the ‘792 publication teaches on [0062]-[0063] and [0044] the treatment of inflammatory condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol (instant claims 12,13). Regarding instant claims 25 and 26, the ‘792 publication teaches on [0002], [0023] and [0044] the treatment of condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol
There would have been a reasonable expectation of success given the similar purposes of the references.
6.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,850,271 in view of US 2008/0153792-A1 by Frinke et al 06-2008. Claims 1-4 of the patent teach solid forms including the Form III hydrate of 17a-ethynylandrost-5-ene-3b,7b,17b -triol which has similar characterization data as claimed compound the same characterization data as shown on Figures 1-18 but do not teach the use of such for the treatment of inflammation or metabolic, inflammatory associated with a hyperproliferation conditions or autoimmune conditions, impaired glucose tolerance or a hyperglycemia conditions. However, the ‘792 publication teaches on [0062]-[0063] and [0044] the treatment of inflammatory condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol (instant claims 12,13). Regarding instant claims 25 and 26, the ‘792 publication teaches on [0002], [0023] and [0044] the treatment of condition such as lung conditions, cystic fibrosis, acute asthma, chronic asthma with 17α-ethynylandrost-5-ene-3β,7β,17β -triol
There would have been a reasonable expectation of success given the similar purposes of the references.
7.Claims 12, 15, 17, 18, 20, 43-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,877,972. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent teach treatment of disease with solid forms of 17a-ethynylandrost-5-ene-3b,7b,17b -triol including the Form III hydrate which has similar characterization data as claimed compound the same characterization data as shown on Figures 1-19B of the ‘972 patent.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to:
Ana Muresan
(571) 270-7587
Ana.Muresan@uspto.gov
The examiner can normally be reached Monday - Friday (9:00AM - 5:30PM).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANA Z MURESAN/Primary Examiner, Art Unit 1692
Prosecution Insights