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 .
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This application, filed July 31, 2024, is a reissue of U.S. Patent 11,401,294 (hereafter the '294 patent), which issued from U.S. application Serial No. 16/894,461 (the ‘461 application) with claims 1-19 on August 2, 2022.
Information Disclosure Statement (IDS)
The second-listed non-patent literature document on sheet 9 of the IDS filed 12/16/2024, i.e., the document to Hirayama, has been crossed out, i.e., not considered, because it is in Japanese and no concise explanation of relevance was provided.
Statement Under 37 CFR 3.73(c)
The Statement Under 3.73(c) filed 07/31/2024 is improper because it does not state the patent number, i.e., 11,401,294, and issue date, i.e., Aug. 2, 2022, at the top of the form. A new Statement Under 3.73(c) stating the patent number and issue date is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 1 at each of lines 4 and 9, the term “(1:2)” renders the claim indefinite because it is not clear what the 1:2 is referring to or on what basis the 1:2 is measured. Also, the 1:2 should not be in parenthesis. The same applies to dependent claims 2-7.
Similarly, in claim 8, the “(1:1)” at each of lines 6 and 31, the “(1:2)” at each of lines 11 and 21, and the “(1:1:1)” at line 16 render the claim indefinite because it is not clear what they are referring to, or on what basis they are measured. Also, they should not be in parenthesis. The same applies to dependent claims 9-19.
Claim 6 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.
The weight ratio range of Form B to Form D of from about 0.2:1 to about 1:0.2 in claim 6 is broader than, and thus, does not further limit, the weight ratio range of from about 0.5:1 to about 1:0.5 in claim 5.
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 1-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-43 of U.S. Patent No. 10,717,755 (the ‘755 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
With respect to instant claims 8-19, claims 1, 6, 16, 11, 20 and 25 of the ‘755 patent are directed to the co-crystal compound of instant Form B, Form D, Form C, Form G, the co-crystal in section (f) of instant claim 8, and Material A, respectively. Claims 1, 6, 16, 11, 20 and 25 of the ‘755 patent do not teach treating a neurological disorder with the co-crystals.
However, the claimed method of treating a neurological disorder, including treating the neurological disorders in instant claims 12-19, is taught in the ‘755 patent specification as a use of the co-crystals (see col. 14, lines 30-48). As noted in MPEP 804.II.B.1 (emphasis added), “when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”
It would have been obvious to one of ordinary skill in the art to have used the co-crystals in claims 1, 6, 16, 11, 20 and 25 of the ‘755 patent for treatment of the claimed neurological disorders because such is taught in the ‘755 patent specification as a use of the co-crystals. Accordingly, instant claims 8-10 and 12-19 are rendered obvious by the claims of the ‘755 patent.
Further with respect to instant claim 11, and also with respect to instant claims 1-7, the pharmaceutical composition in claim 31 of the ‘755 patent contains any one of Forms B and D, i.e., any one of the co-crystals in instant claims 1 and 6 of the ‘755 patent, along with a pharmaceutically acceptable solid carrier. Thus, the use of each of Forms B and D in the pharmaceutical composition would have been obvious. In particular, using mixtures of compositions having the same use/function, i.e., for treating a neurological disorder, would have been obvious. See, e.g., MPEP 2144.06.I. Further with respect to instant claims 4-6, the determination of an appropriate weight ratio of Form B to Form D in the pharmaceutical composition, such as the ratio here claimed, would have been obvious with the goal of preparing a pharmaceutical composition suitable for treating a neurological disorder.
The co-crystal in instant claim 20 is clearly anticipated by the co-crystal in any of claims 1, 6, 11, 16, 20 or 25 of the ‘755 patent.
The co-crystal in instant claim 21 is clearly anticipated by the co-crystal in any of claims 1, 6, 11, 16 or 25 of the ‘755 patent.
The co-crystal in instant claim 22 is clearly anticipated by the co-crystal in claim 20 of the ‘755 patent.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 11,401,294 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached at 571-272-6660. 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.
Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991