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 .
This is a Non-Final Office Action.
Claims 14 and 18-29 are pending and under examination. Claim 29 is a new claim.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 3, 2025 has been entered.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102/103
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14 and 18-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ranzani et al. (US 8846744).
The ‘744 patent teaches a method of treating pain comprising a co-crystal of (rac)-tramadol.HCl-celecoxib (1:1) and at least a solubility enhancer polymer of copovidone, see column 12, Example 1 and column 11, lines 23-29. The definition of pain is found in column 10. The properties of the co-crystal is found in columns 3-4, and more specifically column 3, lines 50-67, and column 4, lines 1-13. The phrase, “reducing the abuse liability of tramadol, in a patient with an addiction to tramadol” in claim 14, is based on the properties of the known cocrystal, and therefore, inherent.
The specification states, “While investigating the potential of E-58425 in the treatment of pain, the applicant has highlighted that it lends itself to decrease the abuse liability of tramadol by modification of its pharmacokinetics properties,” see page 3, penultimate paragraph. MPEP 2112 states, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Furthermore, MPEP 2112.01 states, “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Assuming, arguendo, that the phrase, “reducing the abuse liability of tramadol, in a patient with an addiction to tramadol” in claim 14, is not inherent, the phrase is based on a result effective variable of the concentration, and therefore, would be obvious to one of ordinary skill in the art. The daily dosages are taught in column 11, lines 9-22.
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited reference), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, this type of modification would have been well within the purview of the skilled artisan and is no more than an effort to optimize results.
Thus, claims 14 and 18-29 are rejected.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 14 and 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over Ranzani et al. (US 8846744) and further in view of Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
The present application claims a method for the treatment of pain, while reducing the abuse liability of tramadol, in a patient with an addiction to tramadol, comprising administration of an effective amount of a co-crystal of (rac)- tramadol-HCI and celecoxib, wherein the co-crystal is administered alone or in combination with one or more pharmaceutically acceptable excipients, and wherein the molecular ratio between the (rac)-tramadol-HCI and celecoxib is 1:1, characterized in that the co-crystal shows a Powder X-Ray Diffraction pattern with peaks [2θ] at 14.1, 16.8, 19.0 and 22.7º,with the 2θ values being obtained using copper radiation (CuKα1 1.54060Å).
The phrase, “in a patient with an addiction to tramadol” in claim 1, provides the patient population.
The ‘744 patent teaches a method of treating pain comprising a co-crystal of (rac)-tramadol.HCl-celecoxib (1:1) and at least a solubility enhancer polymer of copovidone, see column 12, Example 1 and column 11, lines 23-29. The definition of pain is found in column 10. The properties of the co-crystal is found in columns 3-4, and more specifically column 3, lines 50-67, and column 4, lines 1-13.
The phrase, “reducing the abuse liability of tramadol” is a property of the cocrystal. Moreover, the ‘744 reference teaches a synergistic effect of the 1:1 crystalline tramadol celecoxib cocrystal. Furthermore, said phrase is based on a result effective variable of the concentration, and therefore, would be obvious to one of ordinary skill in the art. The daily dosages are taught in column 11, lines 9-22.
The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited reference), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Accordingly, this type of modification would have been well within the purview of the skilled artisan and is no more than an effort to optimize results.
Carpenter et al. teach the “Use of celecoxib after head and neck surgery and reconstruction with fee tissue transfer was associated with a decrease in oral, IV, and total opioid requirements…,” see Conclusion and Relevance on page 3/23. Moreover, Table 4 on page 12/23 provides data that shows treatment with celecoxib after HNC surgery with free tissue reconstruction was associated with significantly decreased mean use of intravenous and total (IV plus oral) opioids in patients who received celecoxib.” The article concludes, “The decrease in opioid use in these patients with HNC was clinically significant, suggesting that celecoxib should be considered as an adjust pain medication after head and neck cancer surgery,” see page 16/23.
Frampton et al. teach celecoxib as a COX-2 selective inhibitor effective to treat acute or chronic musculoskeletal pain, e.g., arthritis, see page 2434, first two paragraphs.
Thus, it would be obvious to administer the co-crystal of (rac)-tramadol.HCl-celecoxib (1:1) to treat pain in patients with an addiction or at risk of it based on the ‘744 patent and the Carpenter and Frampton teachings.
Thus, claims 14 and 18-29 are rejected.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8598152 in view of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘152 patent are drawn to the same co-crystal of (rac)-tramadol.HCl-celecoxib. Moreover, the ‘152 patent discloses the treatment of pain with said co-crystal. There is no patentable distinction between products and methods of intended use of said products. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘744 patent are drawn to a pharmaceutical composition comprising the same co-crystal of (rac)-tramadol.HCl-celecoxib. Moreover, the ‘744 patent discloses the treatment of pain with said co-crystal. There is no patentable distinction between products and methods of intended use of said products. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 9012440 in view of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘440 patent are drawn to the same co-crystal of (rac)-tramadol.HCl-celecoxib. Moreover, the ‘440 patent discloses the treatment of pain with said co-crystal. There is no patentable distinction between products and methods of intended use of said products. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10238668 in view of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘668 patent are drawn to the same co-crystal of (rac)-tramadol.HCl-celecoxib. Moreover, the ‘668 patent claims a method of treating pain with said co-crystal. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10245276 in view of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘276 patent are drawn to the same co-crystal of (rac)-tramadol.HCl-celecoxib. Moreover, the ‘276 patent discloses the treatment of pain with said co-crystal. There is no patentable distinction between products and methods of intended use of said products. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10548909 in view of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘909 patent are drawn to a method of treating pain with the same co-crystal of (rac)-tramadol.HCl-celecoxib. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Claims 14 and 18-29 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11478488 in view of U.S. Patent No. 8846744, Carpenter et al. (JAMA Otolaryngology-Head & Neck Surgery, 2018, 144(12), 988–994) and Frampton et al. (Drugs, 2007, 67 (16), 2433-2474).
. Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claims are drawn to the treatment of pain, while reducing the abuse liability of tramadol, with a specific co-crystal of (rac)-tramadol.HCl-celecoxib. The claims in the ‘488 patent are drawn to a method of treating pain with the same co-crystal of (rac)-tramadol.HCl-celecoxib. The same rationale provided for the 102 and 103 rejections above is equally applicable here.
Conclusion
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624