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 1-19 are currently pending and under examination.
Priority
The present application claims priority to U.S. Provisional Patent Application No. 63/388,241, filed on July 11, 2022.
Claim Objections
Claim 4 is objected to because of the following informalities: the items "…directly compressible starches modified starches.." are missing a comma in between. The claim should read “…directly compressible starches, modified starches…”.
Claim 16 is objected to because of the following informalities: the phrase “the method of claim 14 wherein” is missing a comma between ‘14’ and ‘wherein’.
Claim 17 is objected to because of the following informalities: the phrase “the method of claim 15 wherein” is missing a comma between ‘15’ and ‘wherein’.
Claim 18 is objected to because of the following informalities: the phrase “the method of claim 14 wherein” is missing a comma between ‘14’ and ‘wherein’.
Claim 19 is objected to because of the following informalities: the phrase “the method of claim 15 wherein” is missing a comma between ‘15’ and ‘wherein’.
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.
(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, 3-5, 7-9, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2012171065 A1 (herein Ogru), cited in the IDS dated 04/05/2024.
Regarding claim 1, Ogru teaches a pharmaceutical composition comprising 3,5-diiodothyropropionic acid (herein abbreviated DITPA) and one or more conventional ingredients (claim 1), which includes pharmaceutically acceptable excipients (pg. 11, lines 7-15).
Regarding claim 3, Ogru teaches that the excipients can include disintegrants, binders, fillers, lubricants, surfactants (pg. 7, lines 9-14), sweeteners, and flavoring agents (pg. 11, lines 7-8).
Regarding claim 4, Ogru teaches that the disintegrants can include starches, sodium alginate, crosslinked polymers, and microcrystalline cellulose.
Regarding claim 5, Ogru (pg. 7, lines 9-14) teaches that the binders can include polyethylene glycol, hydroxyalkyl celluloses (“cellulosic polymers”) polyvinylpyrrolidone, gelatin, and natural gums.
Regarding claim 7, Ogru teaches that the surfactant may be a lauryl sulfate salt (pg. 13, line 5).
Regarding claim 8, Ogru teaches that the composition does not contain a preservative (pg. 11, lines 7-15, preservative is optional).
Regarding claim 9, Ogru teaches that the composition may be a tablet (pg. 6, lines 28-29).
Regarding claim 14, Ogru teaches a method for treating Allan-Herndon-Dudley syndrome comprising administering a composition comprising DITPA (claim 5).
Regarding claim 15, Ogru teaches a method for treating one or more symptoms of Allan-Herndon-Dudley syndrome comprising administering a composition comprising DITPA (claim 5; see also definition of treatment, pg. 4, lines 6-11: “The terms “treatment”, treating, and the like, as used herein refers to…ameliorating the effects of the syndrome…including the prevention or elimination of the occurrence of one or more symptoms”).
Regarding claim 16, Ogru further teaches a method for treating Allan-Herndon-Dudley syndrome comprising administering a composition comprising DITPA, wherein the composition is administered at a dosage from about 0.1 to about 10 mg/kg/day (pg. 5, lines 5-10, “Preferably, the amount of DITPA is within the range from about 1 to about 5 mg/kg body weight/day”).
Regarding claim 17, Ogru further teaches a method for treating one or symptoms of Allan-Herndon-Dudley syndrome comprising administering a composition comprising DITPA, wherein the composition is administered at a dosage from about 1 to about 5 mg/kg/day (see above rejections for claims 15 and 16).
Regarding claim 18, Ogru further teaches a method for treating Allan-Herndon-Dudley syndrome comprising administering a composition comprising DITPA, wherein the composition is administered at a dosage of about 2.5 mg/kg/day (pg. 5, lines 5-10, “In some embodiments, the amount of DITPA is…about 2.7 mg/kg bodyweight/day”; 2.7 is within 10% of 2.5 and thus about 2.5 as per the instant specification).
Regarding claim 19, Ogru further teaches a method for treating one or more symptoms of Allan-Herndon-Dudley syndrome comprising administering a composition comprising DITPA, wherein the composition is administered three times a day (pg. 2, lines 16-18, “A fourth aspect of the present invention provides a dosage regime for the treatment of a patient with Allan-Herndon-Dudley syndrome, wherein a daily dosage of DITPA is divided into three equal portions and each portion is administered to the patient with about 8 hours apart”).
Therefore, the reference anticipates the instantly claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0362191 A1 (herein Tengler), with an effective filing date of May 12th, 2021.
Regarding claim 1, Tengler teaches a pharmaceutical composition comprising DITPA and one or more pharmaceutically acceptable excipients (claim 9).
Regarding claim 2, Tengler teaches a composition comprising DITPA and one or more pharmaceutically acceptable excipients, wherein the DITPA is present at a concentration from about 0.001% to 10% w/w. The concentration of DITPA in Tengler is less than 10% w/w of the micro-multi-particulate, which is in turn at most 1/5 of the tablet weight. Thus, Tengler teaches a composition wherein the concentration of DITPA is less than 2%.
Therefore, the reference anticipates the instantly claimed invention.
Claims 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Verge et al. (“Diiodothyropropionic Acid (DITPA) in the Treatment of MCT8 Deficiency”, cited in the IDS dated 04/05/2024).
Regarding claim 14, Verge et al. teaches the use of a pharmaceutical composition comprising DITPA and one or more excipients (pg. 2, col. 2, para. 6, “capsule formulation”) to treat Allan-Herndon-Dudley syndrome (abstract, “DITPA almost completely normalizes thyroid tests and reduces the hypermetabolism and the tendency for weight loss”).
Regarding claim 15, Verge et al. teaches the use of a pharmaceutical composition comprising DITPA to treat one or more symptoms of Allan-Herndon-Dudley syndrome (abstract, “DITPA almost completely normalizes thyroid tests and reduces the hypermetabolism and the tendency for weight loss”).
Regarding claim 16, Verge et al. further teaches the use of a pharmaceutical composition comprising DITPA to treat Allan-Herndon-Dudley syndrome, wherein the composition is administered at a dosage of from about 0.1 to about 10 mg/kg/day (abstract, “Treatment was initiated at ages 8.5–25 months, beginning with a small dose of 1.8 mg, increasing to a maximal 30 mg/d (2.1–2.4 mg/kg/d), given in three divided doses…. DITPA almost completely normalizes thyroid tests and reduces the hypermetabolism and the tendency for weight loss”).
Regarding claim 17, Verge et al. further teaches the use of a pharmaceutical composition comprising DITPA to treat one or more symptoms of Allan-Herndon-Dudley syndrome, wherein the composition is administered at a dosage of from about 1 to about 5 mg/kg/day.
Regarding claim 18, Verge et al. teaches the use of a pharmaceutical composition comprising DITPA to treat Allan-Herndon-Dudley syndrome, wherein the composition is administered at a dosage of about 2.5 mg/kg/day. The taught dosage of 2.4 mg/kg/day is within 10% of 2.5 and therefore is about 2.5 as per the instant specification.
Regarding claim 19, Verge et al. teaches the use of a pharmaceutical composition comprising DITPA to treat one or more symptoms of Allan-Herndon-Dudley syndrome, wherein an amount of the composition to be administered is split in three parts, with one part administered to the subject each of three times a day.
Therefore, the reference anticipates the instantly claimed invention.
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.
Claims 1, 3-9, and 14-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ogru in view of Aungst (“Intestinal Permeation Enhancers”). The teachings of Ogru as applied to claims 1, 3-5, 7-9, and 14-19 are set forth earlier in this Office action in the section “Claim Rejections - 35 USC § 102”, and these claims are thereby rejected.
Regarding claim 6, Ogru teaches a composition comprising DITPA and one or more pharmaceutically acceptable excipients, as in claim 3 (pg. 11, lines 5-7, “The pharmaceutical composition comprising DITPA as the therapeutically active ingredient, may optionally further comprise one or more conventional ingredients. Examples of conventional ingredients include, but are not limited to…”). Ogru does not teach a composition with permeation enhancers.
Aungst teaches that permeation enhancers (abstract, “excipients that increase intestinal membrane permeability”) can be used to increase the bioavailability of drugs in pharmaceutical compositions. Aungst further teaches that permeation enhancers include sodium lauryl sulfate, sodium caprate, and sodium caprylate (Table 1; also see section “Fatty Acids”).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date to use the pharmaceutical composition as clearly taught by Ogru with the permeation enhancers as clearly taught by Aungst. One would have been motivated to modify the teachings of Ogru to increase the bioavailability of DITPA in the composition by adding permeation enhancers and would have had a reasonable expectation of success in doing so based on the beneficial teachings of Aungst.
Claims 1, 3-5, and 7-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ogru in view of FDA Guidance for Industry: Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (herein FDA). The teachings of Ogru as applied to claims 1, 3-5, 7-9, and 14-19 are set forth earlier in this Office action in the section “Claim Rejections - 35 USC § 102”, and these claims are thereby rejected. The rejection of claim 9 is reiterated below for reference.
Regarding claim 9, Ogru teaches a composition comprising DITPA and one or more pharmaceutically acceptable excipients, wherein the composition is a tablet (pg. 6, lines 28-29).
Regarding claim 10, Ogru teaches the tablet composition of claim 9, wherein the DITPA can be formulated to provide sustained release, usually within a hydrolyzable matrix (pg. 7, lines 32-36). Ogru teaches that the matrix can consist of hydrophilic polymers such as polyvinylpyrrolidones and hydroxyalkyl celluloses (pg. 8, lines 1-8), which are claimed by the instant application (claim 5).
The prior art does not explicitly teach the disclosed composition disperses in water, nor gives any dispersal times. However, the above water dispersion properties depend, among other things, from the specific components, relative amounts, type of formulation, and pH of the formulation etc., all of which seem to be the same or very similar to the composition made obvious by the prior art.
The Office does not have the facilities and resources to provide the factual evidence needed in order to establish that the pharmaceutical composition comprising DITPA that will result from the teachings of the prior art does not possess the same material, structural and functional characteristics of the formulation claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the formulation used in the instantly claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). Thus, claims 10, 12, and 13 are rejected.
Regarding claim 11, Ogru teaches a pharmaceutical composition comprising DITPA, where in the composition is a water-dispersible tablet (see above rejection for claim 10). Ogru does not teach that the tablet is scored such that the tablet is dividable into four equal parts.
FDA teaches that a tablet dosage form can be scored into equal parts to allow the patient to adjust the dosage (pg. 3, para. 1, “One characteristic of a tablet dosage form is that it may be manufactured with a score or scores. This characteristic is useful because the score can be used to facilitate the splitting of the tablet into fractions when less than a full tablet is desired for a dose”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to use the tablet taught by Ogru with the scoring as taught by FDA. One would have been motivated to modify the tablet of Ogru to allow the patient to adjust the dosage, and would have had a reasonable expectation of success in doing so based on the beneficial teaching of FDA. Thus, claim 11 is 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 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 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. US 12,390,432 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of claims 14-19 of the instant application are obvious over the methods and dosages of US 12,390,432 B2.
US 12,390,432 B2 claims a method of treating Allan-Herndon-Dudley syndrome comprising administering DITPA to a subject in need thereof. US 12,390,432 B2 further claims the dosage of 2.5 mg/kg/day, as well as the administration of DITPA in three divided dosages daily. US 12,390,432 B2 does not claim the administration of a pharmaceutical composition comprising DITPA to treat Allan-Herndon-Dudley syndrome. However, the specification teaches that DITPA may be formulated in a composition comprising DITPA comprising one or more pharmaceutically acceptable excipients (col. 4, lines 19-21). Thus, it would have been prima facie obvious to administer DITPA as a pharmaceutical composition according to the methods and dosages claimed in US 12,390,432 B2, and one would have had a reasonable expectation of success in doing so. In doing so, one would arrive at the inventions of claims 14-19 of the instant application.
Claims 1-3, 14, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11, 16, 17, and 19 of copending Application No. 18/350,089 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 16, 17, and 19 of the reference application respectively anticipate claims 1, 2, and 3, of the instant application, and claims 14 and 19 of the instant application are obvious over claims 1-8 and 11 of the reference application.
Claims 16, 17, and 19 of the reference application recite a pharmaceutical composition comprising DITPA to treat Allan-Herndon-Dudley syndrome in a prenatal subject in need of such treatment. Claims 1-3 of the instant application recite the same pharmaceutical composition without the limitation of the prenatal subject. Thus, reference claims 16, 17, and 19 are “species” of the “generic” claims 1-3 of the instant application. It has been held that a generic invention is anticipated by a species within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Claims 1-8 of the reference application recite a method of treating Allan-Herndon-Dudley syndrome comprising administering DITPA or a salt thereof to a subject. Claim 11 further recites that the daily dose is divided into three parts. The claims do not recite the use of DITPA in a composition comprising one or more pharmaceutically acceptable excipients. However, the specification teaches that DITPA may be formulated in a composition comprising DITPA comprising one or more pharmaceutically acceptable excipients (para. 0028). Thus, it would have been prima facie obvious to administer DITPA as a pharmaceutical composition according to the methods and dosages recited in claims 1-8 and 11 of the reference application, and one would have had a reasonable expectation of success in doing so. In doing so, one would arrive at the inventions of claims 14 and 19 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 18/350,077 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 14 of the instant application is obvious over claim 3 of the reference application.
Claim 3 of the reference application recites a method of treating Allan-Herndon-Dudley syndrome in a subject, the method comprising administration of DITPA to the subject. The claim does not recite the use of DITPA in a composition comprising one or more pharmaceutically acceptable excipients. However, the specification teaches that DITPA may be formulated in a composition comprising DITPA comprising one or more pharmaceutically acceptable excipients (para. 0146). Thus, it would have been prima facie obvious to administer DITPA as a pharmaceutical composition according to the method recited in claims 3 of the reference application, and one would have had a reasonable expectation of success in doing so. In doing so, one would arrive at claim 14 of the instant application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2017/024282 A1 teaches a pharmaceutical composition comprising a therapeutic agent and a permeation enhancer or combination of permeation enhancers. Claims 42-49 in particular claim a composition with many of the permeation enhancers in instant application claim 6.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVER D. HEES whose telephone number is (571)272-9840. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, AMY L. CLARK can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVER D HEES/ Examiner, Art Unit 1628
/AMY L CLARK/ Supervisory Patent Examiner, Art Unit 1628