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 .
Final Rejection
The Status of Claims:
Claims 1-4, 6, 26-30, 46-50, 54, and 66-68 are pending.
Claims 1-4, 6, 26-30, 46-50, 54, and 66-68 are rejected.
IDS
The IDS filed on 11/24/2025 were reviewed by the examiner.
Claim Objections
The objection of Claim 6 is withdrawn due to the modification of theclaim.
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.
The rejection of Claims 26-30 and 48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn due to applicant’s convincing arguments and the modification of claim 48.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of Claims 26-30, 54 and 65-68 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn due to the modification of the claims 26 and 54.
Claim Rejections - 35 USC § 103
Applicants’ argument filed 11/21/25 have been fully considered, and are
persuasive.
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 rejection of Claims 1-4, 6, 26-30, 46-50, 54, and 65-68 under 35 U.S.C. 103 as being unpatentable over Rands et al (US 2020/0390746 A1) in view of LaRosa et al (US 2021/0015738 A1) and Strassman (Archives of General Psychiatry March 1994. p. 85-97) has been changed with the rejection of Claims 1-4, 6, 26-30, 46-50, 54, and 65-68 under 35 U.S.C. 103 as being unpatentable over Rands et al (US 2020/0390746 A1) in view of Gaujac et al ( Microchemical Journal 110 (2013) 146–157) and LaRosa et al (US 2021/0015738 A1) and Strassman (Archives of General Psychiatry March 1994. p. 85-97)
However, in view of the revised claims and finding a new prior art, another 103 rejection seems necessary in the followings:
Claims 1-4, 6, 26-30, 46-50, 54, and 65-68 are rejected under 35 U.S.C. 103 as being unpatentable over Rands et al (US 2020/0390746 A1) in view of Gaujac et al ( Microchemical Journal 110 (2013) 146–157), LaRosa et al (US 2021/0015738 A1) and Strassman (Archives of General Psychiatry March 1994. p. 85-97).
Applicant claims the followings:
1. (Currently Amended) A composition comprising a pharmaceutically effective amount of [[an]] amorphous N,N-dimethyltryptamine (DMT) incorporated within a polymeric carrier matrix.
2. (Currently Amended) The composition of claim 1, wherein the amorphous DMT is characterized by a powder x-ray diffractogram free of any discernable peaks.
3. (Currently Amended) The composition of claim 1, wherein the amorphous DMT is characterized by a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT2and/or lacking an indication of phase change, or both.
4. (Currently Amended) The composition of claim 1, wherein the polymeric carrier matrix comprises a mucoadhesive polymer.
6. (Currently Amended) The composition of claim 1, wherein the pharmaceutical composition provides a Tmaxof between 10_min to 90_min upon administration.
26. (Currently Amended) A composition, comprising:about 0.5 % to about 60 % by weight of amorphous N N dimethyltryptamine N,N- dimethyltryptamine (DMT) or a pharmaceutically acceptable salt or prodrug thereof; about 15% to about 80% by weight of a mucoadhesive polymer matrix; and about 0.1% to about 30% by weight of a permeation enhancer.
27. (Currently Amended) The composition of claim 26, wherein the composition comprises about 20% to about 35% by weight of the N N dimethyltryptamine DMT or a pharmaceutically acceptable salt or prodrug thereof.
28. (Currently Amended) The composition of claim 26, wherein the composition comprises about 50% to about 60% by weight of the mucoadhesive polymer matrix.
29. (Currently Amended) The composition of claim 26, wherein the composition comprises about 0.5% to about 20% by weight of a plasticizer.
30. (Currently Amended) The composition of claim [[26]] 29, wherein the composition comprises about 0.5% to about 5% by weight of the plasticizer.
46. (Currently Amended) The composition of claim 1, wherein the amorphous DMT remains in an amorphous form state after storing the composition aging at 25°C and 60% relative humidity for 6 months.
47. (Currently Amended) The composition of claim 46, wherein the amorphous DMT is characterized by a powder x-ray diffractogram free of any discernable peaks.
48. (Currently Amended) The composition of claim 46, wherein the amorphous DMT is characterized by a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm lacking an indication of phase change,_or both..
49. (Currently Amended) The composition of claim 1, wherein the amorphous DMT remains in an amorphous form state after storing the composition at 40°C and 75% relative humidity for 6 months.
50. (Currently Amended) The composition of claim 49, wherein the amorphous DMT is characterized by a powder x-ray diffractogram free of any discernable peaks.
54. (Currently Amended) A method of making a pharmaceutical composition, comprising the steps of:1lcombining N,N-dimethyltryptamine (DMT) or a pharmaceutically acceptable salt or prodrug thereof, and excipients a mucoadhesive polymer in a solvent; and2}removing the solvent to provide a polymeric matrix comprising [[an]] amorphous N N dimethyltryptamine DMT or a pharmaceutically acceptable salt or prodrug thereof.
66. (Currently Amended) The composition method of claim [[65]] 54, wherein the amorphous DMT is capable of remaining remains in an amorphous form state after storing the composition aging at 25°C and 60% relative humidity for 6 months.
67. (Currently Amended) The composition method of claim 66, wherein the amorphous DMT is characterized by a powder x-ray diffractogram free of any discernable peaks.
68. (Currently Amended) The composition method of claim 66, wherein the amorphous DMT is characterized by a differential scanning calorimetry (DSC) spectrum for absence of lacking a sharp melting endotherm of crystalline DMT,and /or lacking indication of phase change, or both.
Determination of the scope and content of the prior art
Rands et al discloses a composition containing N,N-dimethyltryptamine and the method off treating a psychocognitive disorder such as anxiety disorder (see page 6, a paragraph# 91) by administering the composition in the following paragraphs:
Typically, the compositions comprise N,N-dimethyltryptamine. (see page 4, a pargraph#0045) in the amount between 2 % and 90% as in claims 1, 26-27 (see page 4, a paragraph#0034),
The pharmaceutical compositions may be compressed into solid dosage units, such as tablets, or be processed into capsules or suppositories and the use of conventional additivies, such as polymeric binders(and fillers like starch, cellulose and derivatives (see page 5, paragraphs#0057-0058).
Furthermore, it discloses administering the composition to a patient in need thereof for treating the psychocognitive disorders, for example,'anxiety disorder' which includes generalized anxiety disorder, phobia, panic disorder, social anxiety disorder, and post-traumatic stress disorder, 'Generalised anxiety disorder' (GADthat means a chronic disorder characterized by longlasting anxiety that is not focused on any one object or situation. (see page 6, paragraphs#0061, 0091-0092).
The current invention, however, differs from the prior art in that the claimed composition containing amorphous DMT and polymeric carrier characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change and producing Tmax in the time period , the weight % of a mucoadhesive polymer, a plasticizer, an amorphous state after aging at 25*C and 60% relative humidity for 6 months, , and the method of making a pharmaceutical composition, comprising the steps of: -8- combining N-N-dimethyltryptamine or a pharmaceutically acceptable salt and excipients in a solvent; and removing the solvent to provide a polymeric matrix comprising an amorphous N-N- dimethyltryptamine are unspecified.
Gaujac et al teaches that the study was to examine further the potential polymorphism of DMT via XRPD and DSC, including fast scan DSC, in an attempt to
resolve the discrepancies in the melting points described in the literature and to assess the potential of the drug to form amorphous or waxy solids(see page147,left col. Introduction). Also, it indicates that N,N-dimethyltryptamine (DMT) can exhibit both amorphous and crystalline forms during crystallization, as well as distinct polymorphic crystalline forms (different crystal packing structures). The physical state of DMT often depends on factors like solvent choice, cooling rate, and purity.
During analytical characterization, it was found that both layers contained DMT where the bottom layer (yellow in color and minor in abundance with regards to volume) represented an amorphous, high density, and viscous form of pure DMT.
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1124
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(see page 148, table 1)
Furthermore, LaRosa et al teaches that an oral dissolvable film includes: (i) a flowable water-soluble or water swellable film-forming matrix that includes a polymer, and (ii) psychedelic compound selected from the group consisting of psilocybin, psilocin, mescaline, lysergic acid diethylamide (LSD), ketamine, salvinorin A, ibotenic acid, muscimol, N,N-dimethyltryptamine(DMT). (see page 1, a paragraph#0002)
The oral dissolvable film described herein includes a polymeric matrix formed from a film forming agent ( e.g., film-forming polymer), active pharmaceutical ingredient (API), and solvent. Optional additional excipients (alternatively referred to as "additives") used to manufacture the oral film can include one or more of: mucoadhesive polymer, plasticizer, as in claims 4, 29-30 , 65 (partially) binder, filler, bulking agent, saliva stimulating agent, stabilizing and thickening agent, gelling agent, flavoring agent, taste masking agent, coloring agent, pigment, lubricant, release modifier, adjuvant, sweetening agent, solubilizer & emulsifier, fragrance, emulsifier, surfactant, pH adjusting agent, buffering agent, lipid, glidant, stabilizer, antioxidant, anti-tacking agent, humectant, solvent, permeation enhancer, and preservative. (see page 2, a paragraph#0013)
The term "mucoadhesive agent" refers to a substance that, upon contact with a mucosa! surface ( e.g., oral cavity), will adhere therein. The mucoadhesive agent, when placed in the oral cavity in contact with the mucosa therein, will adhere to the mucosa. The mucoadhesive agent permits a close and extended contact of the composition of the oral dissolvable film with the mucosa! surface of the subject, by promoting adherence of the composition to the mucosa, and facilitating the release of the active ingredient from the composition. The mucoadhesive agent can be a polymeric compound, such as a cellulose derivative but it can be also a natural gum, alginate, pectin, or such similar polymer. The concentration of the mucoadhesive agent can be adjusted to vary the length of time that the film adheres to the mucosa or to vary the adhesive forces generated between the film and mucosa. Mucoadhesive agents include, e.g., carboxym-ethyl cellulose (CMC), carboxymethyl cellulose sodium (CMC-Na), polyvinyl alcohol, polyvinyl pyrrolidone (povidone), sodium alginate, methyl cellulose, hydroxyl propyl cellulose, hydroxypropylmethyl cellulose, as in claim 86 (in part)polyethylene glycols, carbopol, polycarbophil, carboxyvinyl copolymers, propylene glycol alginate, alginic acid, methyl methacrylate copolymers, tragacanth gum, guar gum, karaya gum, ethylene vinyl acetate, dimethylpolysiloxanes, polyoxyalkylene block copolymers, pectin, chitosan, carrageenan, xanthan gum, gellan gum, gum Arabic, locust bean gum, and hydroxyethylmethacrylate. (see page 3, a paragraph#0024)
The term "permeation enhancer" as in claim 26 ( in part) refers to a substance employed to increase the delivery the active ingredient, when administered in vivo (e.g., orally), across the desired body surface ( e.g., oral mucosa, such as buccal, sublingual, mucosa, or gingival; or an intestinal surface), resulting in an increased absorption of the active ingredient. copolymers. (see page 5, a pargraph#0044)
The term "transmucosal," as in claim 88 as used herein, refers to any route of administration via a mucosa! membrane or mucosa! surface. Examples include, but are not limited to, buccal, sublingual, nasal, vaginal, and rectal. (see page 6, a paragraph#0067)
In specific embodiments, the oral dissolvable film has a thickness of less than 0.35±0.15 mm. (see page 9, a paragraph#0166)
In specific embodiments, the oral dissolvable film includes: (a) 10±5 wt.% plasticizer, as in claim 83 (b) 8±5 wt.% solvent, ( c) 10±5 wt. % sweetener, ( d) 8±5 wt. % flavoring agent, ( e) 25±10 wt.% binder, (f) 0.0 2±0.0 1 wt.% coloring agent, (g) 0.0 2±0.0 1 wt. % preservative, and (h) 17±16.5 wt. % psychedelic compound selected from the group consisting of psilocybin, psilocin, baeocystin, mescaline, LSD, ketamine, salvinorin A, ibotenic acid, muscimol, DMT, MDMA, MDEA, MDA, and combinations thereof.(see page 9, a paragraph#0188). Furthermore, the psychedelic compound is used for treating anxiety (see page 10 ,a paragraph#0238).
Moreover, Strassman teaches dimethyltryptamine, an endogenous mammalian hallucinogen and drug of abuse, was administered intravenously at 0.05,0.1,0.2, and 0.4 mg/kg to II experienced hallucinogen users, in a double-blind, saline placebo-controlled, randomized design. Treatments were separated by at least 1 week. (see page 85, the left col. , the second paragraph)
Regarding DMT blood levels, plasma levels of DMT peaked at the first blood draw, 2 minutes after the injection was completed, closely corresponding to peak psychological effects. Generally, a doubling of dose resulted in a doubling of A Max values. These data are displayed in Figure 1. (see page 89, the right col., at the last paragraph). As previously described,3' DMT levels varied widely among subjects, peak values ranging from 32 to 204 ng/mL after the 0.4-mg/kg injection.(see page 90 , the left col. , the first paragraph)
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632
602
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Figure 1. Mean dimethyltryptamine (free base) values in 10 subjects after four doses of intravenous dimethyltryptamine fumarate (0.05 mg/kg as in claim 6.
[squares], 0.1 mg/kg [triangles], 0.2 mg/kg [diamonds], and 0.4 mg/kg [closed circles]) and saline placebo (open circles).
(see page 90 ,Fig. 1)
Ascertainment of the difference between the prior art and the claims
The difference between the current application and the applied art is that the applied art do not expressly teach the claimed composition containing DMT and polymeric carrier characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change , an amorphous state after aging at 25*C and 60% relative humidity for 6 months, and the weight % of a mucoadhesive polymer, a plasticizer and an antioxidant.
The difference between the current application and the applied Rands et al art is that the applied art does not expressly teach the claimed composition containing amorphous DMT and polymeric carrier characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change and the producing Tmax in the time period, the weight % of a mucoadhesive polymer, a plasticizer. a buffering agent. and an antioxidant and a permeation enhancer and the film thickness, and the pharmaceutically acceptable salt or prodrug capable of being substantially fully solubilized and released in greater than 1 minute and less than 40 minutes following administration of the composition to a patient in need and an amorphous state after aging at 25*C and 60% relative humidity for 6 months,. The deficiencies of Rands et al are cured partly by Gaujac, LaRosa et al and Strassman.
The difference between the current application and the applied Gaujac et al art is that the applied Gaujac art does not expressly teach the claimed composition containing polymeric carrier characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change and the producing Tmax in the time period, the weight % of a mucoadhesive polymer, a plasticizer. a buffering agent. and an antioxidant and a permeation enhancer and the film thickness, and the pharmaceutically acceptable salt or prodrug capable of being substantially fully solubilized and released in greater than 1 minute and less than 40 minutes following administration of the composition to a patient in need and an amorphous state after aging at 25*C and 60% relative humidity for 6 months,. The deficiencies of Gaujac et al are cured partly by Rands et al, LaRosa et al and Strassman.
The difference between the current application and the applied LaRosa et al art is that the applied art does not expressly teach the claimed composition containing amorphous DMT and polymeric carrier for buccal or sublingual administration characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change , producing Tmax in the time period and the weight % of a mucoadhesive polymer, a plasticizer, and an amorphous state after aging at 25*C and 60% relative humidity for 6 months. . The deficiencies of LaRosa et al are cured partly by Rands et al, Gaujac, and Strassman.
The difference between the current application and the applied Strassman art is that the applied art does not expressly teach the claimed composition containing amorphous DMT and polymeric carrier characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change and the weight % of a mucoadhesive polymer, a plasticizer and a permeation enhancer. The deficiencies of Strassman are cured partly by Rands et al, Gaujac, and LaRosa et al.
Resolving the level of ordinary skill in the pertinent art.
,
Regarding the Claims 1-3, 46-45, 66-68, with respect to the lack of disclosing the claimed composition containing amorphous DMT and polymeric carrier characterized by a powder x-ray diffractogram free of any discernable peaks and a differential scanning calorimetry (DSC) spectrum lacking a sharp melting endotherm of crystalline DMT and/or lacking an indication of phase change, and the amorphous state after aging at 250C and 60% relative humidity for 6 months,, the prior art are silent about them. However, Gaujac et al does teach that N,N-dimethyltryptamine (DMT) can exhibit both amorphous and crystalline forms during crystallization, whereas Rands does disclose the composition containing crystalline N,N-dimethyltryptamine and polymeric binders. Furthermore, it is well-known that the use of a powder x-ray diffractogram and a differential scanning calorimetry (DSC) spectrum during the analysis of the compound containing DMT and the polymeric binder can be resulted in lacking a sharp melting endotherm of crystalline DMT and free of any discernable peaks, not as a patentable distinction over the prior art.
So if the skilled artisan in the art had desired to evaluate the composition containing amorphous N,N-dimethyltryptamine as an alternative to a crystalline N,N-dimethyltryptamine from teaching of Gaujac et al and polymeric binders by means of a powder x-ray diffractogram and a differential scanning calorimetry (DSC), it would have been obvious to the skilled artisan in the art to have observed such characteristics in lacking a sharp melting endotherm of amorphous DMT and free of any discernable peaks and the amorphous state after aging at 250C and 60% relative humidity for 6 months during the process.
Regarding the claim 54, the lack of a teaching of the method of making a pharmaceutical composition, comprising amorphous N-N-dimethyltryptamine and the polymeric matrix by removing the solvent from the pharmaceutical composition, the prior art are silent about the method. However, Gaujac et al does teach that N,N-dimethyltryptamine (DMT) can exhibit both amorphous and crystalline forms during crystallization, while Rands does mention that the pharmaceutical compositions contain N,N-dimethyltryptamine and polymeric binders; this may imply inherently .the method of making its pharmaceutical compositions by removing a solvent. This can be interpreted from the following passages: the pharmaceutical compositions may be compressed into solid dosage units, such as tablets, or be processed into capsules or suppositories and the use of conventional additives, such as polymeric binders and fillers like starch, cellulose and derivatives (see page 5, paragraphs#0057-0058).
Therefore, if the skilled artisan in the art had desired to make a pharmaceutical composition comprising amorphous N-N-dimethyltryptamine and the polymeric matrix by removing the solvent from the pharmaceutical composition, it would have been obvious to the skilled artisan in the art to be motivate to combine Gaujac’s et al amorphous DMT as an alternative in combination with Rands’ method.
Regarding the Claims 26, 28-30, with respect to the lack of disclosing the weight % of a mucoadhesive polymer, a plasticizer and a permeation enhancer, the prior art are silent about them. However, LaRosa et al does teach that optional additional excipients such as mucoadhesive polymer, a plasticizer, (see page 2, a paragraph#0013) and a permeation enhancer(see page 5, a pargraph#0044) are used to manufacture the oral film containing N,N-dimethyltryptamine(DMT). (see page 1, a paragraph#0002).
Furthermore, regarding the percentage of the mucoadhesive polymer, the plasticizer, and the permeation enhancer, the limitation of a composition with respect to the percentage does not impart patentability to the composition when such values are those which would be determined by one of ordinary skill in the art in achieving optimum condition for the particular composition. The percentage range is well-understood by those of ordinary skill in the art to be a result-effective variable, especially when attempting to control the composition by selecting the optimum range of each of mucoadhesive polymer, plasticizer, and the permeation enhancer in the particular composition. Therefore, it would have been obvious to the skilled artisan in the art to be motivated to control and select the optimum range of each of mucoadhesive polymer, plasticizer, and the permeation enhancer in the composition by a routine experimentation . This is because the skilled artisan in the art would expect such a manipulation to be within the purview of the skilled artisan in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Rands expressly discloses the composition containing N,N-dimethyltryptamine and the method off treating a psychocognitive disorder by administering the composition. Furthermore, Gaujac’s et al does teach that N,N-dimethyltryptamine (DMT) can exhibit both amorphous and crystalline forms during crystallization.
Similarly, LaRosa does teach that the oral dissolvable film composition can include mucoadhesive polymer, a plasticizer and a permeation enhancer as additional excipients and one of psychedelic compounds known as DMT, which can be administered by means of buccal or sublingual route. Also, Strassman does mention that Tmax for DMT can be from 2 to 30 or 60 mins as shown in DMT blood levels(see page 90 ,Fig. 1).
Rands and LaRosa and Strassman are commonly related to one another with respect to the composition containing DMT and some polymeric carriers or its pharmacokinetic information about DMT in the blood levels, while Gaujac’s et al does offer guidance that N,N-dimethyltryptamine can have an amorphous form.
Also, Strassman does mention that Tmax for DMT can be from 2 to 30 or 60 mins as shown in DMT blood levels(see page 90 ,Fig. 1).
So, if the skilled artisan in the art had desired to develop a composition containing amorphous DMT and mucoadhesive polymer, plasticizer, and a permeation enhancer for the method of treating anxiety by administering buccally, sublingually, to a subject with anxiety disorder in a release period of d from 2 to 30 mins following administration, it would have been obvious to the skilled artisan in the art to be motivated to incorporate Gaujac’s et al amorphous DMT as an alternative and the teaching of LaRosa’s expedients in combination with Strassman’s Tmax rang for DMT blood levels into the Rands‘ composition and method of treatment. in order to maximize the effect of DMT delivery. This is because the skilled artisan in the art would expect such combined prior art to be successful and feasible as guidance shown the skilled artisan in the art.
Applicants’ Argument
Applicants argue the following issues:
Claims 1-4, 6, 26-30, 46-50, 54, and 65-68 are rejected under 35 U.S.C. §103 as allegedly being unpatentable over Rands9, LaRosa10, and Strassman"1 (collectively, "Cited References"). Applicant traverses.
To establish a prima facie case of obviousness, the Office must show that the prior art discloses or suggests all the limitations of the claimed invention.2 The claims are not prima facie obvious over Rands, LaRosa, and Strassman at least because none of the Cited References teach or suggest a composition comprising amorphous DMT.
Specifically, the Office has provided no basis (or reasoning at all) as to how Rands, LaRosa, or Strassman teach or suggest a composition containing amorphous DMT. None of the Cited References disclose amorphous DMT. In fact, far from teaching the claim-recited amorphous DMT, the only Cited Reference that describes the physical form of its DMT, Rands (the Office's primary reference), discloses crystalline DMT. Rands describes the synthesis of N,N-DMT fumarate, including "[p]reparation of [s]eed [c]rystals of DMT fumarate" and an XRPD pattern consistent with "pattern A", which indicates that Rands' DMT is crystalline, not amorphous.13 No other cited reference remedies Rands' deficiency.
Neither LaRosa nor Strassman provide any teaching with respect to the physical form of the DMT in their disclosure and neither mention amorphous DMT. Accordingly, there is nothing in the Cited References that teaches or suggests the use of amorphous DMT. In contrast, the Cited References would lead one of skill in the art to the use crystalline DMT (as taught by Rands) rather than toward amorphous DMT, as claimed.
For at least the foregoing reasons, Applicant submits that a case of obviousness has not been established, and requests withdrawal of the rejection under 35 U.S.C. § 103.
Regarding applicants’ arguments, the Examiner has noted applicants’ arguments. And they are found to be persuasive. However, as indicated in the above, in view of the revised claims, and finding the new prior art , another 103 rejection seems necessary.
Conclusion
Claims 1-4, 6, 26-30, 46-50, 54, and 65-68 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625