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 .
Election/Restrictions
Applicant’s election without traverse of Group I, directed to tablets comprising lysergic acid diethylamide or a salt thereof, in the reply filed on 01/16/2026 is acknowledged.
Claims 1-22, 33, and 40 are cancelled.
Claims 23-32 and 34-39 are pending and under current examination.
Priority
This application is a Continuation of Application No. 18/077,085 (patented as US 12,521385, B2), filed 12/07/2022, and a Continuation of Application No. 17/890,133 (patented as US 12,527,785 B2), filed 08/17/2022. Application No. 18/077,085 is also a Continuation of U.S. Application No. 17/890,133. Application No. 17/890, 133 claims priority to US PRO, 63/234,773, filed 08/19/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/22/2025, 10/22/2025, 10/31/2025, and 01/16/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Claim Objections
Claim 35 is objected to because of the following informalities: it is suggested that “wherein tablet comprises” should read “wherein the tablet comprises” in line 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 26 and 34-39 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The terms “low molecular weight dextrans” and “low to intermediate molecular weight cellulose gums” in claim 26 are relative terms which render the claim indefinite. The terms “low molecular weight dextrans” and “low to intermediate molecular weight cellulose gums” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what molecular weights satisfy being “low” or “low to intermediate”, and the metes and bounds of the claim are uncertain.
Claim 34 recites the limitation “wherein the relative amounts (by weight) of LSD, or a salt thereof, maltodextrin, hydroxypropyl methylcellulose, and mannitol are <1 :2-10: 1-5:2-10, respectively” in lines 6-7. As all components in the recited ratio are ranges, and no component serves as a fixed reference point, the relationship between the amounts of the components is unclear.
Additionally, claim 34 recites the limitation “(by weight)” in parentheses, rendering the claim indefinite as to whether this limitation is a required feature of the claim. If Applicant intends for this to be a required limitation, it is recommended that the parentheses be removed.
Claims 35-39 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 34 and failure to cure the deficiencies noted above.
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.
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 23-26 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Raz (US 2018/0036303 A1, published February 8, 2018; included on IDS submitted 07/22/2025) as evidenced by Sigma (“Product Information D-Lysergic Acid Diethylamide Tartrate”, https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/224/330/l114dat.pdf?srsltid=AfmBOop-ayfQzGxOk5YWXm0duxZtKiet6pG8ahnL1FoOptRMk9kBnNal).
Regarding instant claims 23, 26, and 28-31, Raz teaches a pharmaceutical composition for the treatment of Alzheimer’s disease comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (abstract, claim 1). The composition may be provided in the form of tablets in a mixture with non-toxic pharmaceutically acceptable excipients (paragraphs [0038] and [0043]-[0047]). These excipients include: non-gelling matrix formers consistent with claim 26 (including pregelatinized (modified) starch); binders consistent with claim 28 (including methylcellulose, hydroxypropyl methylcellulose, and polyvinylpyrrolidone) which include the hydroxypropyl methylcellulose of claim 29; and fillers consistent with claim 30 (including lactose, mannitol, calcium sulfate, starch, sodium chloride, and sorbitol) which include the mannitol of claim 31.
Regarding instant claim 24-25, Raz exemplifies pharmaceutical compositions comprising D-lysergic acid diethylamide tartrate (Examples 1-2, paragraphs [0071]-[0074]), indicating that D-LSD tartrate is a pharmaceutically acceptable salt of LSD useful in the compositions for treating Alzheimer’s disease of Raz. As evidenced by Sigma, D-lysergic acid diethylamide tartrate comprises the D-tartrate form of tartrate (“Chemical Name”).
Raz does not teach the combination of lysergic acid diethylamide or a salt thereof and excipients with sufficient specificity to anticipate, but rather renders obvious the instant claims. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to combine the prior art elements taught by Raz according to known methods to yield predictable results. Here, as described above, Raz teaches pharmaceutical compositions in the form of tablets comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (exemplifying D-LSD d-tartrate as a pharmaceutically acceptable salt) for the treatment of Alzheimer’s Disease. Raz further teaches that compositions may be formulated according to conventional pharmaceutical practice (paragraph [0038]), and provides the above excipients as examples of non-toxic pharmaceutically acceptable excipients that can be used in tablet formulations.
Rearrangement of the prior art elements taught by Raz to reach the tablet of the instant claims is within the purview of a person of ordinary skill in the art who is not an automaton and would predictably result in a pharmaceutically acceptable tablet that can be used to treat Alzheimer’s disease. From MPEP 2141 I., "[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417, 82 USPQ2d at 1395-96 (Internal quotations omitted.)”.
Claims 27 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Raz, as evidenced by Sigma, as applied to claims 23-26 and 28-31 above, and further in view of Gandhi et al. (US 2009/0208576 A1, published August 20, 2009), hereafter “Gandhi”.
The teachings of Raz are set forth above. Raz further teaches that the pharmaceutical composition can be formulated for immediate release, including by oral or sublingual administration (paragraphs [0007], [0039]-[0040]; claim 33), and that tablets can comprise non-toxic pharmaceutically acceptable excipient such as granulating and disintegrating agents (e.g., cellulose derivatives including microcrystalline cellulose, starches including potato starch, croscarmellose sodium, alginates, or alginic acid) (paragraph [0044]). Raz further teaches that compositions may be formulated according to conventional pharmaceutical practice (paragraph [0038]).
Raz does not explicitly teach an orally disintegrating tablet (instant claim 32) and does not teach the inclusion of a non-gelling matrix former of maltodextrin (instant claim 27).
Gandhi teaches orally disintegrating tablets which disintegrate within 60 seconds in the oral cavity which are prepared form a co-processed composite (abstract, claims 1 and 20). The tablet comprises an active ingredient selected from those including a drug for Alzheimer’s disease (claim 21), and at least one water-soluble excipient including polysaccharides of maltodextrins (claims 1-3 and 7; paragraph [0033]-[0034]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the tablet of Raz to be an orally disintegrating tablet, as suggested by Gandhi. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success as Gandhi teaches that orally disintegrating tablets provide the convenience of a tablet formulation while allowing the ease of swallowing provide by a liquid formulation, encourage adherence to daily medication requirements in patients who have difficulty swallowing, and offer more accurate dosing than oral liquids (paragraph [0026]). There is a reasonable expectation of success as Gandhi teaches that orally disintegrating tablets can comprise a drug for Alzheimer’s disease, and the compositions of Raz are used in the treatment of Alzheimer’s; Raz further indicates that patients suffering from Alzheimer’s have difficulty carrying out even simple tasks (paragraph [0002]). Additionally, as noted above, Raz contemplates compositions formulated for immediate release, including by oral or sublingual administration (paragraphs [0007], [0039]-[0040]; claim 33), and that compositions may be formulated according to conventional pharmaceutical practice (paragraph [0038]).
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the tablet of Raz to comprise the maltodextrins suggested by Gandhi. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to incorporate a water-soluble excipient that contributes to the rapid disintegration of pharmaceutical tablets known to be used with drugs for Alzheimer’s disease, as suggested by Gandhi. There is a reasonable expectation of success the compositions of Raz are used in the treatment of Alzheimer’s, and Raz contemplates compositions formulated for immediate release, including by oral or sublingual administration (paragraphs [0007], [0039]-[0040]; claim 33) formulated according to conventional pharmaceutical practice (paragraph [0038]). Additionally, as noted above, Raz teaches the inclusion of disintegrants as an example of pharmaceutically acceptable excipients for use in tablets (paragraph [0044]).
Claims 34-39 are rejected under 35 U.S.C. 103 as being unpatentable over Raz (US 2018/0036303 A1, published February 8, 2018; included on IDS submitted 07/22/2025) as evidenced by Sigma (“Product Information D-Lysergic Acid Diethylamide Tartrate”, https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/224/330/l114dat.pdf?srsltid=AfmBOop-ayfQzGxOk5YWXm0duxZtKiet6pG8ahnL1FoOptRMk9kBnNal) in view of Gandhi et al. (US 2009/0208576 A1, published August 20, 2009), hereafter “Gandhi”.
Regarding instant claim 34, Raz teaches a pharmaceutical composition for the treatment of Alzheimer’s disease comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (abstract, claim 1). The composition may be provided in the form of tablets in a mixture with non-toxic pharmaceutically acceptable excipients (paragraphs [0038] and [0043]-[0047]). These excipients include hydroxypropyl methylcellulose and mannitol, and can include granulating and disintegrating agents (paragraph [0044]). Raz further teaches that compositions may be formulated according to conventional pharmaceutical practice (paragraph [0038]).
Regarding instant claims 35-36, Raz exemplifies pharmaceutical compositions comprising D-lysergic acid diethylamide tartrate (Examples 1-2, paragraphs [0071]-[0074]), indicating that D-LSD tartrate is a pharmaceutically acceptable salt of LSD useful in the compositions for treating Alzheimer’s disease. As evidenced by Sigma, D-lysergic acid diethylamide tartrate comprises the D-tartrate form of tartrate (“Chemical Name”).
Regarding instant claims 37-39, Raz further teaches that the pharmaceutical composition can be formulated for immediate release, including by oral or sublingual administration (paragraphs [0007], [0039]-[0040]; claim 33).
Raz does not explicitly teach an orally disintegrating tablet (instant claims 37-39) and does not teach the inclusion of maltodextrin (instant claim 34).
Gandhi teaches orally disintegrating tablets which disintegrate within 60 seconds in the oral cavity which are prepared form a co-processed composite (abstract, claims 1 and 20). The tablet comprises an active ingredient selected from those including a drug for Alzheimer’s disease (claim 21), and at least one water-soluble excipient including polysaccharides of maltodextrins (claims 1-3 and 7; paragraph [0033]-[0034]). Gandhi further teaches that orally disintegrating tablets can comprise a binder of hydroxypropyl methylcellulose (claim 26) and comprise mannitol (claim 35).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the tablet of Raz to be an orally disintegrating tablet, as suggested by Gandhi. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success as Gandhi teaches that orally disintegrating tablets provide the convenience of a tablet formulation while allowing the ease of swallowing provide by a liquid formulation, encourage adherence to daily medication requirements in patients who have difficulty swallowing, and offer more accurate dosing than oral liquids (paragraph [0026]). There is a reasonable expectation of success as Gandhi teaches that orally disintegrating tablets can comprise a drug for Alzheimer’s disease, and the compositions of Raz are used in the treatment of Alzheimer’s; Raz further indicates that patients suffering from Alzheimer’s have difficulty carrying out even simple tasks (paragraph [0002]). Additionally, as noted above, Raz contemplates compositions formulated for immediate release, including by oral or sublingual administration (paragraphs [0007], [0039]-[0040]; claim 33), and that compositions may be formulated according to conventional pharmaceutical practice (paragraph [0038]).
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the tablet of Raz to comprise the maltodextrins suggested by Gandhi. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to incorporate a water-soluble excipient that contributes to the rapid disintegration of pharmaceutical tablets known to be used with drugs for Alzheimer’s disease, as suggested by Gandhi. There is a reasonable expectation of success the compositions of Raz are used in the treatment of Alzheimer’s, and Raz contemplates compositions formulated for immediate release, including by oral or sublingual administration (paragraphs [0007], [0039]-[0040]; claim 33) formulated according to conventional pharmaceutical practice (paragraph [0038]). Additionally, as noted above, Raz teaches the inclusion of disintegrants as an example of pharmaceutically acceptable excipients for use in tablets (paragraph [0044]).
Regarding the relative amounts of the components of claim 34, as set forth in the above rejections under 35 USC § 112(b), the relationship between the amounts of components is unclear as no component serves as a fixed reference point. However, Raz teaches that LSD or a pharmaceutically acceptable salt thereof can be included in an amount sufficient to treat Alzheimer’s disease (claim 1). Gandhi suggests that excipients in orally disintegrating tablets can be included in amounts that result in a desired disintegration time while avoiding a chalky or dry feel in the mouth (paragraphs [0005]-[0011]), and further suggests adjusting the ratio of excipients (paragraph [0036]). The prior art therefore suggests that the amounts and corresponding ratios of LSD or salt thereof and excipients can be routinely optimized to achieve a tablet that contains LSD or salt thereof in an amount sufficient to treat Alzheimer’s disease, achieves a desired disintegration time, and avoids unpleasant mouthfeel. Per MPEP 2144.05 II. A. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”
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 23-32 and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-9 of U.S. Patent No. 12,527,786 B2 in view of Raz (US 2018/0036303 A1, published February 8, 2018; included on IDS submitted 07/22/2025) as evidenced by Sigma (“Product Information D-Lysergic Acid Diethylamide Tartrate”, https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/224/330/l114dat.pdf?srsltid=AfmBOop-ayfQzGxOk5YWXm0duxZtKiet6pG8ahnL1FoOptRMk9kBnNal) and Gandhi et al. (US 2009/0208576 A1, published August 20, 2009), hereafter “Gandhi”.
Both the instant claims and those of U.S. Patent No. 12,527,786 B2 recite orally disintegrating tablets containing LSD or a salt thereof, particularly tartrate salt, a non-gelling matrix former of maltodextrin, a filler of mannitol, and a binder of hydroxypropyl methylcellulose. The claims of U.S. Patent No. 12,527,786 B2 recite a ratio of LSD or salt thereof to hydroxypropyl methylcellulose of <1% to 1-5% by weight.
The claims of U.S. Patent No. 12,527,786 B2 do not recite that the tartrate salt of LSD is specifically d-LSD D-tartrate, as required by instant claims 25 and 36.
Raz teaches a pharmaceutical composition for the treatment of Alzheimer’s disease comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (abstract, claim 1); Alzheimer’s disease is the most common cause of dementia (paragraph [0002]). The composition may be provided in the form of tablets in a mixture with non-toxic pharmaceutically acceptable excipients (paragraphs [0038] and [0043]-[0047]). Raz exemplifies pharmaceutical compositions comprising D-lysergic acid diethylamide tartrate (Examples 1-2, paragraphs [0071]-[0074]), indicating that D-LSD tartrate is a pharmaceutically acceptable salt of LSD useful in the compositions for treating Alzheimer’s disease. As evidenced by Sigma, D-lysergic acid diethylamide tartrate comprises the D-tartrate form of tartrate (“Chemical Name”).
It would have been prima facie obvious to one of ordinary skill in the art to use the d-LSD tartrate suggested by Raz as the LSD tartrate salt in the tablet recited by the claims of U.S. Patent No. 12,527,786 B2. One of ordinary skill in the art would be motivated to use a tartrate salt form of LSD known to be useful in treating Alzheimer’s disease, particularly as the claims of U.S. Patent No. 12,527,786 B2 recite that LSD tablets are used in methods of treating dementia.
Regarding the relative amounts of the components of claim 34, as set forth in the above rejections under 35 USC § 112(b), the relationship between the amounts of components is unclear as no component serves as a fixed reference point. However, the prior art of Gandhi teaches orally disintegrating tablets which disintegrate within 60 seconds in the oral cavity which are prepared form a co-processed composite (abstract, claims 1 and 20). The tablet comprises an active ingredient selected from those including a drug for Alzheimer’s disease (claim 21), and at least one water-soluble excipient including polysaccharides of maltodextrins (claims 1-3 and 7; paragraph [0033]-[0034]). Gandhi further teaches that orally disintegrating tablets can comprise a binder of hydroxypropyl methylcellulose (claim 26) and comprise mannitol (claim 35). Gandhi further suggests that excipients in orally disintegrating tablets can be included in amounts that result in a desired disintegration time while avoiding a chalky or dry feel in the mouth (paragraphs [0005]-[0011]), and suggests adjusting the ratio of excipients (paragraph [0036]). The prior art therefore suggests that the amounts and corresponding ratio of excipients in orally disintegrating tablets can be routinely optimized to achieve a tablet that achieves a desired disintegration time, and avoids unpleasant mouthfeel. Per MPEP 2144.05 II. A. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of U.S. Patent No. 12,527,786 B2, the instant claims are rejected on the ground of nonstatutory double patenting.
Claims 23-32 and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-9 of U.S. Patent No. 12,521,385 B2 in view of Raz (US 2018/0036303 A1, published February 8, 2018; included on IDS submitted 07/22/2025) as evidenced by Sigma (“Product Information D-Lysergic Acid Diethylamide Tartrate”, https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/224/330/l114dat.pdf?srsltid=AfmBOop-ayfQzGxOk5YWXm0duxZtKiet6pG8ahnL1FoOptRMk9kBnNal) and Gandhi et al. (US 2009/0208576 A1, published August 20, 2009), hereafter “Gandhi”.
Both the instant claims and those of U.S. Patent No. 12,521,385 B2 recite orally disintegrating tablets containing LSD or a salt thereof, particularly tartrate salt, a non-gelling matrix former of maltodextrin, a filler of mannitol, and a binder of hydroxypropyl methylcellulose. The claims of U.S. Patent No. 12,5271,385 B2 recite a ratio of LSD or salt thereof to hydroxypropyl methylcellulose of <1% to 1-5% by weight.
The claims of U.S. Patent No. 12,521,385 B2 do not recite that the tartrate salt of LSD is specifically d-LSD D-tartrate, as required by instant claims 25 and 36.
Raz teaches a pharmaceutical composition for the treatment of Alzheimer’s disease comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (abstract, claim 1); Alzheimer’s disease is the most common cause of dementia (paragraph [0002]). The composition may be provided in the form of tablets in a mixture with non-toxic pharmaceutically acceptable excipients (paragraphs [0038] and [0043]-[0047]). Raz exemplifies pharmaceutical compositions comprising D-lysergic acid diethylamide tartrate (Examples 1-2, paragraphs [0071]-[0074]), indicating that D-LSD tartrate is a pharmaceutically acceptable salt of LSD useful in the compositions for treating Alzheimer’s disease. As evidenced by Sigma, D-lysergic acid diethylamide tartrate comprises the D-tartrate form of tartrate (“Chemical Name”).
It would have been prima facie obvious to one of ordinary skill in the art to use the d-LSD tartrate suggested by Raz as the LSD tartrate salt in the tablet recited by the claims of U.S. Patent No. 12,521,385 B2. One of ordinary skill in the art would be motivated to use a tartrate salt form of LSD known to be useful in treating Alzheimer’s disease, particularly as the claims of U.S. Patent No. 12,521,385 B2 recite that LSD tablets are used in methods of treating dementia.
Regarding the relative amounts of the components of claim 34, as set forth in the above rejections under 35 USC § 112(b), the relationship between the amounts of components is unclear as no component serves as a fixed reference point. However, the prior art of Gandhi teaches orally disintegrating tablets which disintegrate within 60 seconds in the oral cavity which are prepared form a co-processed composite (abstract, claims 1 and 20). The tablet comprises an active ingredient selected from those including a drug for Alzheimer’s disease (claim 21), and at least one water-soluble excipient including polysaccharides of maltodextrins (claims 1-3 and 7; paragraph [0033]-[0034]). Gandhi further teaches that orally disintegrating tablets can comprise a binder of hydroxypropyl methylcellulose (claim 26) and comprise mannitol (claim 35). Gandhi further suggests that excipients in orally disintegrating tablets can be included in amounts that result in a desired disintegration time while avoiding a chalky or dry feel in the mouth (paragraphs [0005]-[0011]), and suggests adjusting the ratio of excipients (paragraph [0036]). The prior art therefore suggests that the amounts and corresponding ratio of excipients in orally disintegrating tablets can be routinely optimized to achieve a tablet that achieves a desired disintegration time, and avoids unpleasant mouthfeel. Per MPEP 2144.05 II. A. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of U.S. Patent No. 12,521,385 B2, the instant claims are rejected on the ground of nonstatutory double patenting.
Claims 23-32 and 34-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-6 of U.S. Patent No. 12,036,220 B2 in view of Raz (US 2018/0036303 A1, published February 8, 2018; included on IDS submitted 07/22/2025) as evidenced by Sigma (“Product Information D-Lysergic Acid Diethylamide Tartrate”, https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/224/330/l114dat.pdf?srsltid=AfmBOop-ayfQzGxOk5YWXm0duxZtKiet6pG8ahnL1FoOptRMk9kBnNal).
Both the instant claims and those of U.S. Patent No. 12,036,220 B2 recite orally disintegrating tablets containing LSD tartrate, a non-gelling matrix former of maltodextrin, a filler of mannitol, and a binder of hydroxypropyl methylcellulose. The claims of U.S. Patent No. 12,036,220 B2 recite these components present in weight % interpreted to be consistent with the ratio recited in instant claim 34.
The claims of U.S. Patent No. 12,036,220 B2 do not recite that the tartrate salt of LSD is specifically d-LSD D-tartrate, as required by instant claims 25 and 36.
Raz teaches a pharmaceutical composition for the treatment of Alzheimer’s disease comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (abstract, claim 1); Alzheimer’s disease is the most common cause of dementia (paragraph [0002]). The composition may be provided in the form of tablets in a mixture with non-toxic pharmaceutically acceptable excipients (paragraphs [0038] and [0043]-[0047]). Raz exemplifies pharmaceutical compositions comprising D-lysergic acid diethylamide tartrate (Examples 1-2, paragraphs [0071]-[0074]), indicating that D-LSD tartrate is a pharmaceutically acceptable salt of LSD useful in the compositions for treating Alzheimer’s disease. As evidenced by Sigma, D-lysergic acid diethylamide tartrate comprises the D-tartrate form of tartrate (“Chemical Name”).
It would have been prima facie obvious to one of ordinary skill in the art to use the d-LSD tartrate suggested by Raz as the LSD tartrate salt in the tablet recited by the claims of U.S. Patent No. 12,036,220 B2. One of ordinary skill in the art would be motivated to use a tartrate salt form of LSD known to be useful in treating Alzheimer’s disease, particularly as the claims of U.S. Patent No. 12,036,220 B2 recite that LSD tablets are used in methods of treating dementia.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of U.S. Patent No. 12,036,220 B2, the instant claims are rejected on the ground of nonstatutory double patenting.
Claims 23-32 and 34-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 8 of copending Application No. 18/199,244 in view of Raz (US 2018/0036303 A1, published February 8, 2018; included on IDS submitted 07/22/2025) as evidenced by Sigma (“Product Information D-Lysergic Acid Diethylamide Tartrate”, https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/product/documents/224/330/l114dat.pdf?srsltid=AfmBOop-ayfQzGxOk5YWXm0duxZtKiet6pG8ahnL1FoOptRMk9kBnNal), and Gandhi et al. (US 2009/0208576 A1, published August 20, 2009), hereafter “Gandhi”.
Both the instant claims and those of copending Application No. 18/199,244 recite orally disintegrating tablets comprising LSD, particularly LSD tartrate salt, a filler of mannitol, and a binder of hydroxypropyl methylcellulose.
The claims of copending Application No. 18/199,244 do not recite that the tartrate salt of LSD is specifically d-LSD D-tartrate, as required by instant claims 25 and 36. The claims of copending Application No. 18/199,244 further do not recite a non-gelling matrix former of maltodextrin as required by the instant claims.
Raz teaches a pharmaceutical composition for the treatment of Alzheimer’s disease comprising lysergic acid diethylamide or a pharmaceutically acceptable salt thereof (abstract, claim 1); Alzheimer’s disease is the most common cause of dementia (paragraph [0002]). The composition may be provided in the form of tablets in a mixture with non-toxic pharmaceutically acceptable excipients (paragraphs [0038] and [0043]-[0047]). Raz exemplifies pharmaceutical compositions comprising D-lysergic acid diethylamide tartrate (Examples 1-2, paragraphs [0071]-[0074]), indicating that D-LSD tartrate is a pharmaceutically acceptable salt of LSD useful in the compositions for treating Alzheimer’s disease. As evidenced by Sigma, D-lysergic acid diethylamide tartrate comprises the D-tartrate form of tartrate (“Chemical Name”).
Gandhi teaches orally disintegrating tablets which disintegrate within 60 seconds in the oral cavity which are prepared form a co-processed composite (abstract, claims 1 and 20). The tablet comprises an active ingredient selected from those including a drug for Alzheimer’s disease (claim 21), and at least one water-soluble excipient including polysaccharides of maltodextrins (claims 1-3 and 7; paragraph [0033]-[0034]).
It would have been prima facie obvious to one of ordinary skill in the art to use the d-LSD tartrate suggested by Raz as the LSD tartrate salt in the tablet recited by the claims of copending Application No. 18/199,244. One of ordinary skill in the art would be motivated to use a tartrate salt form of LSD known to be useful in tablets for treating Alzheimer’s disease.
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to modify the orally disintegrating tablet of copending Application No. 18/199,244 to comprise the maltodextrins suggested by Gandhi. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success to incorporate a water-soluble excipient that contributes to the rapid disintegration of pharmaceutical tablets known to be used with drugs for Alzheimer’s disease, as suggested by Gandhi.
Regarding the relative amounts of the components of claim 34, as set forth in the above rejections under 35 USC § 112(b), the relationship between the amounts of components is unclear as no component serves as a fixed reference point. However, the prior art of Gandhi teaches orally disintegrating tablets which disintegrate within 60 seconds in the oral cavity which are prepared form a co-processed composite (abstract, claims 1 and 20). The tablet comprises an active ingredient selected from those including a drug for Alzheimer’s disease (claim 21), and at least one water-soluble excipient including polysaccharides of maltodextrins (claims 1-3 and 7; paragraph [0033]-[0034]). Gandhi further teaches that orally disintegrating tablets can comprise a binder of hydroxypropyl methylcellulose (claim 26) and comprise mannitol (claim 35). Gandhi further suggests that excipients in orally disintegrating tablets can be included in amounts that result in a desired disintegration time while avoiding a chalky or dry feel in the mouth (paragraphs [0005]-[0011]), and suggests adjusting the ratio of excipients (paragraph [0036]). The prior art therefore suggests that the amounts and corresponding ratio of excipients in orally disintegrating tablets can be routinely optimized to achieve a tablet that achieves a desired disintegration time, and avoids unpleasant mouthfeel. Per MPEP 2144.05 II. A. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”.
Given the subject matter of the instant claims is obvious and substantially overlaps the subject matter of copending Application No. 18/199,244, the instant claims are rejected on the ground of nonstatutory double patenting. This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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, Bethany Barham can be reached at (571)272-6175. 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.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611