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 Application
The Preliminary Amendment filed on 09/03/24 is acknowledged.
Claims 8-9, 11-12, 16-18, 20-21, 28, 32, 34, 36-52, and 54-56 were cancelled.
Claims 1, 3, 5-7, 10, 13-15, 19, 22-25, 27, 29-31, 33, 35, and 57 were amended.
Claims 1-7, 10, 13-15, 19, 22-27, 29-31, 33, 35, 53, and 57 are pending and are included in the prosecution.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 11/21/23; 03/28/24; 09/03/24; 02/03/25; and 05/27/25 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statements. Please see the attached copies of PTO-1449.
Claim Objections
Claims 24-25 and 33 are objected to because of the following informalities:
In claim 24, line 2 and claim 25, line 2, the term “gastrorentive” should be corrected to recite “gastroretentive.”
In claim 33, the preamble “An oral composition of zolmitriptan …” should be corrected to recite “An oral composition comprising zolmitriptan …” in order to positively recite the inclusion of the active agent.
Appropriate correction 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.
Claim 27 is 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 pre-AIA the applicant regards as the invention.
Claim 27 recites both a broad limitation together with narrow limitations.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 27 recites the broad recitation “polyalkylene oxides,” and the claim also recites “high molecular weight polyethylene oxide” which is the narrower statement of the range/limitation.
Claim 27 also recites the broad recitation “cellulose polymers,” and the claim also recites “hydroxyalkyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, carboxymethylcellulose, microcrystalline cellulose” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Notice for all US Patent Applications filed on or after March 16, 2013
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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. Applicant is 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 1-2, 13-15, 19, 33, 35, 53, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Baraban (US 2018/0028499 A1).
Instant claim 1 is drawn to an oral composition for treating the symptoms of autism spectrum disorder (ASD), wherein the composition comprises from about 7.5 mg to about 90 mg of zolmitriptan, or a pharmaceutical acceptable salt thereof, and the oral administration of the composition provides a therapeutically effective plasma concentration of zolmitriptan for a period of about 8 hours to about 24 hours.
Baraban teaches a pharmaceutical composition that includes a therapeutically effective amount of a 5HT receptor agonist ([0005]) which includes zolmitriptan ([0031], [0063], [0216], [0227], [0265], claims 1, 11, 33, and 49) for the treatment of ASD ([0101] and [0112]). The pharmaceutical composition may be formulated as a tablet, capsule, pill, cachet, or lozenge for oral administration ([0140]). The 5HT receptor agonist is administered to a subject at an amount of about 0.1 mg to about 1000 mg per kg body weight ([0023]-[0024] and claims 24-25). The dosage of such compounds preferably lies within a range of plasma concentrations that include the ED50 with little or no toxicity ([0177]). The pharmaceutical compositions may additionally include components to provide sustained release and/or comfort ([0160]). The 5-HT receptor agonist may be administered in the dosage at least once a day ([0134]).
Baraban does not expressly teach that the oral administration of the composition provides a therapeutically effective plasma concentration of zolmitriptan for a period of about 8 hours to about 24 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a pharmaceutical composition formulated as a tablet, capsule, pill, cachet, or lozenge for oral administration comprising zolmitriptan for the treatment of ASD wherein the zolmitriptan is administered to a subject at an amount of about 0.1 mg to about 1000 mg per kg body weight, as taught by Baraban, in view of the administration of the zolmitriptan once a day, also as taught by Baraban, and produce the instant invention.
One of ordinary skill in the art would have found that the oral administration of the composition taught by Baraban provides a therapeutically effective plasma concentration of zolmitriptan for a period of about 8 hours to about 24 hours since this reference teaches the same composition with the same active agent which is administered in the same way, i.e., orally, there is sustained release ([0160]) and the 5-HT receptor agonist may be administered in the dosage at least once a day ([0134]), i.e., having a release and effective plasma concentration over 24 hours.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. 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, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1, 33, and 53, the limitation of an oral composition would have been obvious over the pharmaceutical composition which may be formulated as a tablet, capsule, pill, cachet, or lozenge for oral administration ([0140]), as taught by Baraban.
Regarding instant claims 1, 33, 53, and 57, the limitations of treating the symptoms of ASD would have been obvious over the treatment of ASD ([0101] and [0112]), as taught by Baraban.
Regarding instant claims 1, 2, and 35, the limitations of the composition comprising from about 7.5 mg to about 90 mg and about 10 mg to about 30 mg of zolmitriptan, or a pharmaceutical acceptable salt thereof, respectively, would have been obvious over the pharmaceutical composition that includes a therapeutically effective amount of a 5HT receptor agonist ([0005]) which includes zolmitriptan ([0031], [0063], [0216], [0227], [0265], claims 1, 11, 33, and 49), wherein the 5HT receptor agonist is administered to a subject at an amount of about 0.1 mg to about 1000 mg per kg body weight ([0023]-[0024] and claims 24-25), as taught by Baraban. One of ordinary skill in the art would have found it obvious to administer the zolmitriptan dosage based on the target patient and the specific disease symptom, and the recited ranges would have been obvious variants over the range taught by Baraban.
Regarding instant claims 1, 13-15, 19, 33, and 53, the limitations of the oral administration of the composition providing a therapeutically effective plasma concentration of zolmitriptan for a period of about 8 hours to about 24 hours and the pharmacokinetic characteristics would have been obvious over the oral administration of the pharmaceutical composition comprising zolmitriptan ([0031], [0063], [0216], [0227], [0265], claims 1, 11, 33, and 49), the dosage of the active agents which preferably lies within a range of plasma concentrations that include the ED50 with little or no toxicity ([0177]), the sustained release ([0160]), and the administration of the 5-HT receptor agonist at least once a day ([0134]), as taught by Baraban.
Claims 3-7, 10, 22-27, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Baraban (US 2018/0028499 A1), as applied to claims 1-2, 13-15, 19, 33, 35, 53, and 57 above, in view of Badul (US 2008/0280975 A1).
Instant claim 3 is drawn to the composition of claim 1, wherein the composition comprises an immediate release (IR) portion and an extended release (ER) portion.
The teaching of Baraban is discussed above.
Baraban does not expressly teach an IR portion and an ER portion.
Badul teaches orally administrable dosage forms which are multiparticulate and preferably packaged in capsules or press-molded into tablets ([0087]). The dosage forms include the drug zolmitriptan ([0616]). Oral pharmaceutical dosage forms including tablets, capsules, lozenges, oral gastroretentive tablets and capsules, etc. are taught ([0284]). The dosage form includes an outer capsule which may be an enteric coated capsule or a capsule containing an IR formulation to provide rapid plasma concentrations or a rapid onset of effect or a loading dose and the inner capsule containing an ER formulation ([0104]). Dosage forms in both IR and ER forms are taught ([0232] and [0262]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a pharmaceutical composition formulated as a tablet, capsule, pill, cachet, or lozenge for oral administration comprising zolmitriptan for the treatment of ASD wherein the zolmitriptan is administered to a subject at an amount of about 0.1 mg to about 1000 mg per kg body weight once a day, as taught by Baraban, in view of the oral dosage forms such as tablets and capsules containing zolmitriptan and both IR and ER formulations, as taught by Badul, and produce the instant invention.
One of ordinary skill in the art would have found it obvious to combine the teachings of Baraban and Badul because both the references are drawn to oral compositions comprising zolmitriptan. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Moreover, one of ordinary skill in the art would have had a reasonable expectation of success in producing a functional dosage form comprising both IR and ER formulations of zolmitriptan by combining the teachings of Badul with those of Baraban in order to control the release of the active agent and achieve optimal release and pharmacokinetic (PK) characteristics.
Regarding instant claim 3, the limitation of an IR portion and an ER portion would have been obvious over the dosage forms including both IR and ER forms ([0104], [0232] and [0262]), as taught by Badul.
Regarding instant claims 4, 5, and 6, the limitations of the IR portion containing about 20% - 40% by weight of the zolmitriptan, the ER portion containing about 60%-80% by weight of the zolmitriptan, and the IR portion containing about 25% of the total zolmitriptan and the ER portion containing about 75% of the total zolmitriptan, respectively, would have been obvious over the tablets that preferably contain from 5% to 70% of the active compound ([0147]), as taught by Baraban and the dosage forms including both IR and ER forms ([0104], [0232] and [0262]), as taught by Badul. One of ordinary skill in the art would have found it obvious to distribute the active component in the IR and ER portions based on the desired immediate release and extended release. The recited % ranges would have been obvious over the ranges taught by Baraban unless there is evidence of criticality or unexpected results. Also, according to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 7 and 10, the limitations of the IR portion comprising about 1 mg to about 10 mg of zolmitriptan and the ER portion comprising about 5 mg to about 25 mg of zolmitriptan, respectively, would have been obvious over the zolmitriptan ([0031], [0063], [0216], [0227], [0265], claims 1, 11, 33, and 49), which is administered to a subject at an amount of about 0.1 mg to about 1000 mg per kg body weight ([0023]-[0024] and claims 24-25), the tablets that preferably contain from 5% to 70% of the active compound ([0147]), as taught by Baraban, and the dosage forms including both IR and ER forms ([0104], [0232] and [0262]), as taught by Badul. One of ordinary skill in the art would have found it obvious to distribute the active component in the IR and ER portions based on the desired immediate release and extended release. The recited dosage ranges would have been obvious over the ranges taught by Baraban unless there is evidence of criticality or unexpected results. Also, according to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claim 22, the limitation of a multiparticulate formulation would have been obvious over the multiparticulate dosage forms ([0087]), as taught by Badul.
Regarding instant claim 23, the limitation of a drug-containing particles coated with an ER coating would have been obvious over the multiparticulate dosage forms ([0087]) and the application of delayed release coatings ([0097]), controlled release coatings ([0262]), as taught by Badul.
Regarding instant claims 24 and 25, the limitations of a gastroretentive tablet and a gastroretentive layer would have been obvious over the oral gastroretentive tablets ([0284]) and the delayed release coatings ([0097]), controlled release coatings ([0262]), as taught by Badul. One of ordinary skill in the art would have found it obvious to include a gastroretentive layer as taught by Badul in order to produce a gastroretentive dosage form.
Regarding instant claims 26, 27, and 29, the limitations of the gastroretentive layer comprising a water-swellable polymer would have been obvious over the polyethylene oxide (PEO), polyvinyl alcohol, hydroxypropyl methyl cellulose, xanthan [gum] ([0024]), polyvinylpyrrolidone, starch, pregelatinized starch, and maltodextrin ([0376]), as taught by Badul. One of ordinary skill in the art would have found it obvious to include the preceding components in various portions of the dosage form, including the gastroretentive layer as taught by Badul, in order to produce a gastroretentive dosage form.
Regarding instant claim 30, the limitation of about 35-55% by weight of PEO would have been obvious over the PEO and gels or gums such as xanthan [gum] ([0024]) and the total amount of gel forming agent of about 2 to about 80 percent on a dry weight basis of the composition ([0059]), as taught by Badul. One of ordinary skill in the art would have found it obvious to include the preceding components as gel forming agents in various amounts based on the range taught by Badul, in order to produce an optimal gastroretentive dosage form.
Regarding instant claim 31, the limitation of the composition which is gastroretained for at least 2 h following oral administration would have been obvious over the oral gastroretentive tablets ([0284]), as taught by Badul since this is a future intended effect after the gastroretentive tablet is orally administered. One of ordinary skill in the art would have found it obvious to prepare a gastroretentive tablet as taught by Badul and modify the gastroretentive portion as well as the IR and ER portions in order to produce the desired time for gastroretention.
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 1-7, 10, 13-15, 19, 22-27, 29-31, 33, 35, 53, and 57 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 33-53 of copending Application No. 17/770,535 (“the ‘535 Application”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to an oral composition for treating the symptoms of ASD, wherein the composition comprises from about 7.5 mg to about 90 mg of zolmitriptan, or a pharmaceutical acceptable salt thereof, and the oral administration of the composition provides a therapeutically effective plasma concentration of zolmitriptan for a period of about 8 hours to about 24 hours, and therefore, encompass overlapping or coextensive subject matter.
The differences are that claims 34-36 of the ‘535 Application recite a specific patient population and claims 41- 53 of the ‘535 Application recite results after administration of zolmitriptan whereas instant claims are silent with respect to these limitations.
However, the patient population covered by instant claim 57 includes the patient population outlined in claims of the ‘535 Application. Also, the results after administration recited in claims of the ‘535 Application would have been expected results after the method of instant claim 57 using the composition of instant claims is administered to a subject in need of treatment of ASD.
Therefore, instant claims are obvious over claims of the ‘535 Application, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615