DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ claimed inventions, filed 3 October 2025, in the matter of Application N° 19/349,368. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ Request for Track One consideration filed on 3 October 2025, was GRANTED on 25 November 2025.
No claims have been added, amended, or canceled. The issue of new matter is moot.
Thus, claims 1-30 represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 3 October 2025 is acknowledged and has been considered.
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.
(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.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Qingpo et al. (CN 101322719A; IDS reference of record; machine translation cited).
The limitations of the claimed composition recite a solid, oral dosage form comprising about 1-20 mg of arsenic trioxide, a surfactant (emulsifier), and one or more pharmaceutically acceptable excipients.
Qingpo discloses a solid pharmaceutical composition comprising arsenic trioxide, an emulsifying agent, an optional co-emulsifying agent, and one or more excipients (see e.g., Abstract; claim 1). Paragraph [0049] defines the solid preparations as being a capsule or tablet. Embodiment 1, for instance, discloses a formulation comprising 10 mg of arsenic trioxide.
The foregoing expressly meets the limitations of the claimed composition.
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 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 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 the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-30 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US Pre-Grant Publication Nº 2012/0245156 A1; IDS reference of record), in view of Kwong (US 2008/0089951 A1), and further in view of Zhou et al. (PloS Med; 2005).
The limitations of the claimed composition are discussed above. The limitations of the remaining dependent claims further limit the surfactant (e.g., sodium lauryl sulfate), the excipients (i.e.; mannitol, talc, etc.). Claims 13, 16, 19, 25, and 28 recite a method of treating acute promyelocytic leukemia comprising the daily administration of the recited composition.
Nguyen discloses preparing solid dosage forms comprising at least one active pharmaceutical ingredient (API), at least one homogenising agent, one binding agent and/or one filler (see e.g., Abstract; claims; ¶[0048]).
The homogenising agent is further defined in the claims as representing various ranges of the total dry component of the oral dry composition: about 0.001% to about 10%, about 0.1% to about 5%, and from about 0.1% to about 1% (see e.g., claims 10-12). The homogenising agent is additionally defined as being selected from sodium lauryl sulfate (see e.g., claim 9; ¶[0096]).
The API is taught as being able to be selected as arsenic trioxide (see e.g., claim 16; ¶[0101]). The amount of API used within the solid tablets is disclosed as being as broad as from about 0.001% to about 80% by weight of the total dry weight of the tablet and as narrow as about 0.5% to about 30% by weight of the tablet.
Table 5 provides exemplary batch productions for 200 mg tablets, thus providing the skilled artisan with a target tablet weight off of which to base the amounts of ingredients.
Thus, it would be well within the purview of the ordinarily skilled artisan to calculate the weight of API and homogenising agent within the manufactured oral tablet. Regarding instantly claimed composition, the reference most preferably discloses that the API is present 0.5-30% of the dosage form, which based on a 200-mg tablet, recalculates to a mass ranging most preferably from 1-30 mg of API (i.e., arsenic trioxide). Similarly, the homogenising agent being present in an amount ranging most preferably from 0.1% to about 1%, in a 200-mg tablet, would then possess between about 0.1-1 mg of homogenising agent (e.g., SLS).
Magnesium stearate is disclosed as another species of surfactant that may be used. Mannitol is disclosed as a preferred filler component for the tablets. See e.g., ¶[0096] and ¶[0121].
Thus, the Examiner submits that the reference teaches and suggests the limitations of the instantly claimed compositions recited by claims 1-12 and 22-24.
The reference is acknowledged as possessing two key deficiencies. First, the Examiner submits that arsenic trioxide as the API is one that may be selected from a larger list of APIs, but is nevertheless, taught and suggested. Secondly, the reference does not expressly teach or suggest treating acute promyelocytic leukemia with a composition comprising arsenic trioxide, a surfactant, and at least one excipient.
Kwong is considered to remedy both of these deficiencies disclosing the preparation and administration of oral dosage forms such as tablets and capsules comprising arsenic trioxide as the active ingredient (see e.g., Abstract; claims 1, 10-12), with claim 11 disclosing preferred dose amounts ranging from 5-10 mg. Paragraph [0037] discloses that surfactants such as SLS, Spans, and Tweens are included with the dosage form.
The reference additionally discloses that arsenic trioxide is highly efficacious in the treatment of acute promyelocytic leukemia (APL), and that it is the standard treatment for APL. See ¶[0007], ¶[0024], and ¶[0026].
Wherein Nguyen and Kwong are deficient is with respect to the limitations recited by claims 15, 18, 21, 27, and 30, whereby the respective methods of treating APL further comprising administering retinoic acid.
Zhou is considered to bridge this gap in its disclosure of testing the efficacy of all-trans retinoic acid (ATRA), arsenic trioxide, of a combination of the two, for their respective groups’ ability to degrade the promyelocytic leukemia retinoic acid receptor α (PML-RARα) oncoprotein. Each group was tested, and while all groups demonstrated complete remission (CR) of greater than 90%, the combination of ATRA and arsenic trioxide took the least amount of time to achieve CR (see e.g., pg. 0035, last column).
Thus, while the Examiner acknowledges that Zhou does not disclose administering the instantly claimed composition, it does provide very clear motivation to the skilled artisan to modify the teachings of Nguyen to select arsenic trioxide for the practiced dosage. It further motivates said artisan to treat a patient suffering from APL with a dosage form containing both arsenic trioxide and ATRA.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Nonstatutory 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 1-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-21 of copending Application No. 18/408,664 (reference application).
Claim 2 of the reference application recites:
A solid, oral pharmaceutical composition, comprising:
arsenic trioxide in an amount of from about 1 mg to about 20 mg;
a surfactant;
a bulking agent; and
a lubricant.
Instant claim 1 more generically recites:
A solid, oral pharmaceutical composition, comprising:
arsenic trioxide in an amount of from about 1 mg to about 20 mg;
a surfactant; and
one or more pharmaceutically acceptable excipients.
The limitations of reference claim 3 read directly on instant claim 2.
The limitations of reference claims 5-9 read on instant claims 3, 4, 7, 8, 11, 12, 23, and 24.
The limitations of reference claims 2, 4, and 14 read on instant claim 22.
The limitations of reference claims 2, 10, and 14 read on instant claim 5, 9, and 22.
The limitations of reference claims 3 and 10 read on instant claim 6 and 10.
The method limitations of reference claims 18-20 read on each of the groupings of instant claims 13-21 and 25-30.
Thus, were the ‘664 reference application available as prior art, the Examiner advances that it would render the instantly claimed inventions prima facie obvious where it did not anticipate it.
This is a provisional nonstatutory double patenting rejection.
Claims 1-12 and 22-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 15-18 of Vaddi et al. (USPN 12,364,664 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of claim 1 of the ‘664 patent disclose:
A solid, oral pharmaceutical composition comprising:
a bulking agent;
a lubricant; and
a lyophilized composition comprising arsenic (LCCA) made by a method comprising
combining arsenic trioxide powder, water, and an alkalizing agent to obtain a pH of at least 12, followed by adding an acid to adjust the pH to about 7 to about 8, thereby generating a solution comprising arsenious acid;
adding surfactant to the solution comprising arsenious acid; and
lyophilizing the solution comprising arsenious acid and the surfactant to obtain the LCCA.
The limitations of claims 2 and 3 disclose that the LCCA and the composition comprise about 24-29% of the LCCA and about 69-74% of the bulking agent in the composition.
Claims 15 and 16 disclose that the resulting formulation is a capsule or tablet.
Claim 17 discloses that the capsule will contain between 0.25-50 mg of the LCCA.
Given that the disclosed LCCA ultimately represents 24-29% of the composition, at most, the practiced capsules will contain 12-14.5 mg of LCCA which is composed of arsenic trioxide and surfactant. Claim 7 of the ‘664 patent discloses further that the amount of the surfactant by weight does not exceed 50% the amount of the arsenic trioxide by weight.
Thus, in considering the composition of the LCCA and the portions assigned to its constituents, the ordinarily skilled artisan will understand that the LCCA will, at most contain 6-7.25 mg of arsenic trioxide and surfactant each. Such is considered to teach the limitations of both arsenic trioxide and surfactant (e.g., SLS) as instantly recited.
Claims 5 and 6 disclose sodium lauryl sulfate (SLS) as a surfactant.
Claim 4 discloses mannitol as a bulking agent and talc and/or magnesium stearate as the lubricant.
The Examiner thus submits that a person of ordinary skill in the art in possession of the ‘664 patent would have had a reasonable expectation of successfully producing the instantly claimed composition. Were the ‘664 patent available as prior art, the Examiner advances that it would have rendered the instantly claimed composition prima facie obvious for the reasons discussed above.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. 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 or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615