DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.1
Status of the Claims
Claims 5-7 are pending in this application.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/19/2025 has been entered.
Terminal Disclaimer
The terminal disclaimer filed on June 12, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of
US 8846744 B2;
US 8598152 B2;
US 9012440 B2;
US 10245276 B2;
has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant’s arguments, filed 9/19/2025, with respect to the provisional rejections of claim 5-7 for nonstatutory obviousness double patenting (ODP) over App. No. 17/609,452, have been fully considered but are not persuasive.
The Attorney response states that the presently pending claims of the ‘452 application are directed to a method for the treatment of pain, while reducing the abuse liability of tramadol, in a patient with an addiction to tramadol (Emphasis added by the response).
The Attorney response argues that the target patient population of the ‘452 application is limited to “patients addicted to tramadol.”
The Attorney response states that the patient population recited in the instantly
claimed method is clearly distinct from the patient population recited in the presently
pending claims of the '452 application, thus necessitating the withdrawal of the provisional nonstatutory double patenting rejection.
In response, the Examiner notes as examined claim 5’s patient population (those in need of the treatment of pain) are NOT patentably distinct from those of the earlier filed 17/609,452 claimed patient population.
The claimed subject of treatment of pain in subjects also includes those at risk of addiction, as generally recognized in the field/art of pain management.
As noted by the Rehabs UK (https://rehabsuk.com/addictions/drug/tramadol-addiction/)
Drugs, like tramadol, affect the brain's reward system by creating dopamine-induced feelings of euphoria. Surges of dopamine reinforce pleasurable behaviours and encourage repetition, even if the activity is unhealthy. Over time, the brain adapts and the reward system becomes less responsive. This effect is
known as tolerance. The high felt initially becomes much less intense with repeated drug use. To recreate it, increasing quantities of tramadol need to be consumed. Someone in this stage of addiction will need to undergo detox from Tramadol. Once someone becomes addicted to tramadol getting hold of it becomes all-consuming." See page 2, What to understand about Tramadol Addiction, from the Rehabs UK webpage, copy included previously with the Advisory Action mailed June 25 2025.
A PHOSITA would have found it prima facie obvious to treat the claimed patient population, those in need of treatment of pain, as per the claimed population of 17/609 ,452, those patients in need of treatment of pain, while reducing tramadol abuse liability in patients either with a tramadol addiction OR THE RISK of TRAMADOL ADDICTION (emphasis added), as it is generally known in the art that patients who take tramadol for the treatment of pain, as claimed, are at risk of developing an abuse liability for it.
Maintained Double Patenting Rejections
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 5-7 remain provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over currently pending claims 14, 21 and 24-25 of copending Application No. 17/609,452.
Examined reference patent claim 5 is directed to
A method of treating pain comprising administering to a patient in need thereof an effective amount of a co-crystal comprising (rac)-tramadol•HCI and celecoxib in a molecular ratio of 1: 1, wherein the co-crystal exhibits an increased exposure of celecoxib in the blood after oral administration compared to the exposure which would be observed after oral administration of an equivalent amount of celecoxib in combination with tramadol, and wherein the co-crystal shows a Fourier Transform Infra-Red pattern with absorption bands at 3481.6 (m), 3133.5 (m), 2923.0 (m), 2667.7 (m), 1596.0 (m), 1472.4 (m), 1458.0 (m), 1335.1 (m), 1288.7 (m), 1271.8 (m), 1168.7 (s), 1237.3 (m), 1168.7 (s), 1122.6 (s), 1100.9 (m), 1042.2 (m), 976.8 (m), 844.6 (m), 820.1 (m), 786.5 (m) 625.9 (m) cm-1.
Claim 6 recites different species of pain being treated (acute, chronic, neuropathic, etc.); claim 7 is recites acute pain only.
Reference application claim 14 discloses a methods treating pain with the co-crystal as detailed below.
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Reference claim 21 recites the claimed Fourier Transform Infra-Red Pattern.
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Claims 24-25 recite treatment of overlapping types of pain, including acute pain.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion and Correspondence
In conclusion, no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can be reached M-F.
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, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 This application is a CON of 16/720,574 filed 12/19/2019, issued as US PAT 11478488. App. No. 16/720,574 is a CON of filed 16/275,437 02/14/2019 US PAT 10548909. App. No. 16/275,437 is a CON of filed 15/231,915 08/09/2016 US PAT 10245276. App. No. 15/231,915 is a CON of filed 14/665,055 03/23/2015 ABN. App. No. 14/665,055 is a CON of 14/066,127 filed 10/29/2013 US PAT 9012440. App. No. 14/066,127 is a CON of 13/395,021 filed 03/08/2012 US PAT 8598152. App. No. 13/395,021 is a 371 of PCT/EP2010/002385 filed 04/19/2010. This application claims earliest priority to PCTEP2009007451 filed 10/16/2009.