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 .
Status of the Claims
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/05/2024, have been received and entered into the instant application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98, and MPEP §609.
Priority
This application filed on 07/05/2024, is a 371 of PCT/EP2023/000002, filed on 01/05/2023, which claims benefit of EPO Application No. 22000008.7, filed on 01/07/2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 7-9, 12 and 15-18 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.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate. See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Each of claims 7-9, 12 and 15-18, is directed to directed to a product (a pharmaceutical composition), but each of the claims also recites “composition is applied”, which appears to indicate a process of using the composition.
Claim 13 is directed to directed to a product (a pharmaceutical composition), but claim 13 also recites “wherein a previous treatment with at least one other pharmaceutically active agent was refractory”, which appears to indicate a process of using the composition.
It is unclear to one skilled in the art as to whether the phrase “composition is applied” or “wherein a previous treatment with at least one other pharmaceutically active agent was refractory”, is referring to a process step, because each of claims 7-9, 12-13 and 15-18 recites a product. A person skilled in the art cannot reasonably determine whether each of claims 7-9, 12-13 and 15-18, is a composition or a process claim. This is indefinite because the claim recites both a product (a pharmaceutical composition) and a process of using the product “composition is applied”. Please see MPEP § 2713.05(p)(II).
Accordingly, for the purpose of examination, each of claims 7-9, 12-13 and 15-18, is being interpreted as a pharmaceutical composition. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
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.
Claims 1-10 and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin et al (hereinafter “Martin”, U.S. Pub. No. 20170368063, published 12/28/2017).
Independent claim 1 is directed to a pharmaceutical composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof, for use (intended use) in the treatment of a congenital muscular dystrophy, wherein said congenital muscular dystrophy is Duchenne muscular dystrophy or Becker muscular dystrophy.
Independent claim 4 is drawn to a pharmaceutical composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof, and at least one pharmaceutically acceptable excipient for use (intended use) in the treatment of Duchenne muscular dystrophy or Becker muscular dystrophy.
Regarding claims 1 and 4, Martin (see abstract, ¶s 0001, 003-0031, 0042, Table 1, claims 1, 10, 12 and Example 4, Table 4 on ¶s 0079-0083), teaches a composition comprising crystalline form III of 5-amino-2,3-dihydro-1,4-phthalazinedione sodium salt.
Regarding the intended use of a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof (claims 1-4, 7-9, 12-13 and 15-18), it is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the cited prior art teaches a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof (see discussions above).
Since the prior art teaches the identical chemical structure, the properties Applicants disclose and/or claim are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. Applicants are further requested to note that it is well settled that “intended use” of a composition or product, e.g., a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof, will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161.
Therefore, claims 1-4, 7-9, 12-13 and 15-18 are anticipated by Martin.
Regarding claim 5, Martin discloses that the pharmaceutical compositions are suitable for oral or topical applications (see ¶ 0060).
Regarding claim 6, Martin discloses an excipient selected from the group consisting of a list the includes sweeteners (see ¶ 0148).
Regarding claims 10 and 19, Martin discloses that the compositions can be formulated as retard formulations (see ¶ 0060).
Regarding claim 14, Martin discloses that the compositions can be formulated in the form of suppositories (see ¶ 0124).
Claims 1 and 4-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin et al (hereinafter “Martin2020”, U.S. Pub. No. 20200369623, published 11/26/2020).
Regarding claims 1 and 4, Martin2020 teaches a pharmaceutical composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione and a pharmaceutically acceptable excipient (see claims 8-9).
Regarding the intended use of a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof (claims 1, 4, 7-9, 12-13 and 15-18), it is noted that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the cited prior art teaches a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof (see discussions above).
Since the prior art teaches the identical chemical structure, the properties Applicants disclose and/or claim are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. Applicants are further requested to note that it is well settled that “intended use” of a composition or product, e.g., a composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a pharmaceutically acceptable salt thereof, will not further limit claims drawn to a composition or product. See, e.g., Ex parte Masham, 2 USPQ2d 1647 (1987) and In re Hack 114, USPQ 161.
Therefore, claims 1, 4, 7-9, 12-13 and 15-18 are anticipated by Martin2020.
Regarding claim 5, Martin2020 discloses that the pharmaceutical compositions are suitable for oral, inhalatory or topical applications (see ¶ 0057).
Regarding claim 6, Martin2020 discloses an excipient selected from the group consisting of a list the includes carriers or sweeteners (see ¶ 0059 and claim 9).
Regarding claims 10 and 19, Martin2020 discloses that the compositions can be formulated as retard formulations (see ¶ 0128 and claim 14).
Regarding claim 11 and 20, Martin2020 discloses that the compositions can be formulated as lyophilizates (see ¶s 0080 and 0100).
Regarding claim 14, Martin2020 discloses that the composition can be formulated in the form of suppository (see ¶ 0081).
Non-Statutory Obviousness-Type 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.
Preliminary matter:
Although the Office have cited some of applications and/or patents for the nonstatutory double patenting rejections (see rejections below), it is noted that the instant application is from an enormous family of applications and patents, which are commonly owned, such that it is burdensome for the Office to identify all potential applications and/or patents that can invoke the issue of nonstatutory double patenting. Therefore, applicants are requested to assist the Office in identifying all potential applications and/or patents that raises the issue of nonstatutory double patenting with regard to the claims of the instant application, specifically for instant claims 24-30.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims over claims U.S. Patent Nos:
1) 8.772.294;
2) 9,079,863;
3) 10,258,620;
4) 11,007,192;
5) 11,111,218;
6) 11,203,575;
7) 12,122,753; and
8)12,616,695.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the reference patents are similarly drawn to 5-amino-2,3-dihydro-1,4-phthalazinedione. For example, the claims of the instant invention (e.g., claims 1-3), are drawn to a pharmaceutical composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a salt or a crystalline form thereof, whereas, the claims of U.S. Patent No. 11,111,218 (‘218 patent, e.g., claims 1-3), are drawn to a crystalline form of 5-amino-2,3-dihydro-1,4-phthalazinedione and a pharmaceutical composition comprising the crystalline form.
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference patents’ subject matter.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims over claims U.S. Patent Application Nos:
1) 17/795,360;
2) 17/913,687;
3) 18/717,846;
4) 18/726,854;
5) 18/726,933;
6) 18/850,379;
7) 18/921,655;
8) 19/497422;
9) 19/523,256; and
10) 19/562,758.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the reference patent applications are similarly drawn to 5-amino-2,3-dihydro-1,4-phthalazinedione. For example, the claims of the instant invention (e.g., claims 1-3), are drawn to a pharmaceutical composition comprising 5-amino-2,3-dihydro-1,4-phthalazinedione or a salt or a crystalline form thereof, whereas, the claims of U.S. Patent Application No. 17/795,360 (‘360 application, e.g., claims 1, 3-5), are drawn to a method for using 5-amino-2,3-dihydro-1,4-phthalazinedione or a salt or a crystalline form thereof, in order to treat an inflammatory disease.
The ’360 application claim anticipates claims directed to the claimed 5-amino-2,3-dihydro-1,4-phthalazinedione of the instant application per se because the skilled artisan practicing invention of the instant application must necessarily possess the same 5-amino-2,3-dihydro-1,4-phthalazinedione disclosed therein, in order to practice the invention.
Nonstatutory double patenting includes rejections based on anticipation (see MPEP § 804).
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference patents’ subject matter.
This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. 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.
/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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