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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/10/25 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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(s) 1-5 and 15-18 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Tabuteau (US 2021/0177834 A1 hereafter Tabuteau).
Tabuteau teaches a dosage form comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan hydrobromide and a polymer [abstract, claim 11]. The polymer is a polyacrylic acid copolymer [0124]. One portion of the release is immediate, and the other drug release is sustained [0123]. The dosage is delivered once or twice a day [005-007, 0067]. The dosage form is useful in treating various neurological conditions including Alzheimer’s disease, major depressive disorder, neuropathic pain and anxiety [0028, 0174, 0194]. These disclosures render the claims anticipated.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the disclosures of Tabuteau (US 2021/0177834 A1 hereafter Tabuteau).
As discussed above, Tabuteau discloses a dosage form comprising bupropion hydrochloride and dextromethorphan hydrobromide along with polyacrylic polymers. The formulation can be used to treat alcohol abuse, yet the reference is silent to the specific number of drinks per day the abuser consumes. However, the method requires the treatment of a nervous system condition, and given the broadest reasonable interpretation, zero drinks per day would meet the limitations of the claims in the treatment of other nervous system conditions such as anxiety, or neuropathic pain. As such, in the treatment of other nervous system conditions, the dosage form would also treat alcohol abuse regardless of the number of drinks consumed per day. The Office does not have the facilities for examining and comparing applicants’ product with the product of the prior art in order to establish that the product of the prior art does not possess the same material structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the claimed products are functionally different than those taught by the prior art and to establish patentable differences. See Ex parte Phillips, 28 U.S.P.Q.2d 1302, 1303 (PTO Bd. Pat. App. & Int. 1993), Ex parte Gray, 10 USPQ2d 1922, 1923 (PTO Bd. Pat. App. & Int.) and In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
It would have been obvious to follow the teachings and suggestions of Tabuteau to treat various nervous system conditions including alcohol abuse as the dosage form comprises the same products and components of the instant claims. The alcohol abuse treatment would have been effective even with zero drinks consumed daily as the dosage form treats nervous system conditions. One of ordinary skill in the art would have been motivated to treat various nervous system conditions including alcohol abuse as the prior art discloses this feature.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,717,518 and claims 1-22 of U.S. Patent No. 11,925,636 Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 518 and 636 claims specifically recite the treatment of major depression and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12544345 and claims 1-25 of U.S. Patent No. 12364674 Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 345 and 674 claims specifically recite the treatment of agitation and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,844,797 and claims 1-18 of U.S. Patent No. 11,839,612 Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 797 and 612 claims specifically recite the treatment of major depression and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9-15 and 18-28 of U.S. Patent No. 11,986,444 and claims 1, 2, 5-7 ,10-23 and 31-35-22 of U.S. Patent No. 12,036,191 Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 444 and 191 claims specifically recite the treatment of major depression and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,194,036. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 036 claims specifically recite the treatment of Alzheimer’s disease and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,9 and 12-20 of U.S. Patent No. 12,599,576. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 576 claims specifically recite the treatment of nervous system disorders, and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,239,642 and claims 1-22 of U.S. Patent No. 12,472,174. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 642 and 174 claims specifically recite the treatment of major depression and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,310,961 and claims 1-22 of U.S. Patent No. 12,263,161. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 961 and 161 claims specifically recite the treatment of seizures, and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,239,642 and claims 1-22 of U.S. Patent No. 12,472,174. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 642 and 174 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,478,622 and claims 1-21 of U.S. Patent No. 12,564,587. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 642 and 174 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,433,884 and claims 1-29 of U.S. Patent No. 14,433,884. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 884 and 795 claims specifically recite the treatment of agitation associated with Alzheimer’s disease and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
Claim 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-38 of copending Application No. 18/777,011 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 011 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 and 9-15 of copending Application No. 18/986,390 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 390 claims specifically recite the treatment of disorders of the nervous system, and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-40 of copending Application No. 19/387,351 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 351 claims specifically recite the treatment of depression and anxiety and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19-39 of copending Application No. 19/300,204 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 204 claims specifically recite the treatment of depression where the tablet dosage form is bilayered, while the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/571,930 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 930 claims specifically recite the treatment of Alzheimer’s disease and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21-40 of copending Application No. 19/381,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 686 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23-44 of copending Application No. 19/373,558 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 558 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/464,192 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 192 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of copending Application No. 19/434,619 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to broadly drawn to methods of treating various neurological conditions including anxiety, depression and agitation by the administration of a formulation at least comprising: 105 mg of bupropion hydrochloride and 45 mg of dextromethorphan and a polymer that is an acrylic polymer. The claims differ in that the 619 claims specifically recite the treatment of agitation associated with neurological disorders and the instant claims recite limitations regarding the presence of alcohol in the system of the patient. However, the same conditions are treated with the exact same combination of the same drugs and excipients. The scopes overlap such that the claims would act as prior art over one another and cannot be allowed together.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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, Michael Hartley can be reached at 5712720616. 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.
/MICAH PAUL YOUNG/ Primary Examiner, Art Unit 1618
Prosecution Insights