DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 08/05/2025 and 09/12/2025 (corrected status of claims), is acknowledged.
Claims 1-20 are pending in this action. Claims 1, 5, 18-20 have been amended. Claims 1-20 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application, filed November 10, 2023, claims benefit of provisional U.S. Application No. 63/383,171, filed November 10, 2022.
Claim Objections
Claim 1 is objected to because of the following informalities: Newly amended claim 1 comprises the typographic error “the formulation a homogeneous mixture that dissolves” that needs to be corrected to “the formulation is a homogeneous mixture that dissolves” or clarified. 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.
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.
Claims 1-20 are 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.
Newly amended claim 1 recites the limitation “a film formulation, …, wherein the formulation is a homogeneous mixture” that is not reasonably clear. In the present case, it is unclear what is homogeneous – a composition for preparation of said film, OR a film. Further, it is noted that neither the claim nor the instant specification provides a definition for the term “homogeneous mixture”. The specification does not provide a standard for ascertaining the requisite degree. Therefore, the metes and bounds of the claim is not reasonably clear. Clarification is required.
Newly amended claim 1 recites the limitation “the formulation is a homogeneous mixture that dissolves in the oral cavity to result in absorption of the pharmaceutical agent by the oral mucosa” that is unclear and indefinite. In the present case, it is noted that said claim discloses film formulations comprising a hydrophilic elastomeric polymer, an enzymatic absorption enhancer, a pharmaceutical agent, i.e., may include other compounds/components even in large amounts (i.e., comprising). The instant specification teaches/discloses that the same compound, e.g., pullulan, can be used as hydrophilic elastomeric polymer or as a film forming agent. To this point, it is noted that “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation”. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Clarification is required.
Claims 2-20 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Modi US 2022/0023224A1 (pub.date 01/27/2022), in view of LaRosa et al., US 2021/0015738A1 (hereinafter referred to as LaRose), and Kucuksen et al., US 2019/0350949 A1 (hereinafter referred to as Kucuksen).
Modi teaches film-based oral dosage forms that dissolve in oral cavity (Title; Abstract; Para. 0001, 0008, 0073) and may include:
(i) film forming hydrophilic agent(s), e.g., hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinylpyrrolidone, polyacrylic acid, acrylic acid copolymers, polyvinyl alcohol, polyethylene glycol, polysaccharides such as pullulan, alginate, amylose, high amylose starch, hydroxypropylated high amylose starch, dextrin, pectin, chitin, chitosan, levan, elsinan and mixtures thereof (Claim 14; Para. 0022 as applied to claims 1-3, 18-20);
(ii) secondary film forming agents, e.g., xanthan gum, tragacanth gum, guar gum, acacia/arabic gum, soy protein isolate, whey protein isolate, casein, zein, gelatin, collagen, carrageenan, and mixtures thereof (Claim 15; Para. 0022, 0023 as applied to claim 4);
(iii) lipases, e.g., pancreatic lipase (PL), pancreatic lipase-related protein 1 or 2 (PLRP1/PLRP2), hepatic lipase, endothelial lipase, lipoprotein lipase, lysosomal lipase, gastric lipase and lingual lipase (identified in the instant specification and claims as enzymatic absorbance enhancers) that can be use in a combination with bile acids (Claim 8; Para. 0042 as applied to claims 5, 6);
(iv) bile acids, e.g., cholic acid, deoxycholic acid, glycocholic acid, chenodeoxycholic acid, taurocholic acid, glycodeoxycholic acid, taurodeoxycholic acid, or salts thereof; lecithin, lactic acid, oleic acid, sorbitan monooleate, sorbitan monolaurate, menthol (Para. 0030, 0033, 0038 0039, 0045, 0059 as applied to claims 6-9) identified in the instant specification and claimed as non-enzymatic absorbance enhancers; and
(v) pharmaceutical agents (here as target molecules), e.g., anti-inflammatory drugs, opioid analgesics, cannabinoids (e.g., cannabidiol (CBD); tetrahydrocannabinol (THC)), terpene (Claims 2-4; Para. 0062 as applied to claims 10, 15, 16).
Modi teaches that said films may comprise two or more target molecules that exhibit complementary activity, and which do not interact in any adverse manner (Para. 0062 as applied to claims 11-13).
Modi also teaches that said films may include 10-80 wt% of film forming agent, including primary and secondary film forming agent; 30-70 wt% of glycerin as a plasticizer, 0.01-10 wt% of lipases and/or bile acids/salts (Para. 0024, 0029, 0043 as applied to claims 19, 20).
Modi does not teach the use of such pharmaceutical agents as psilocybin (Claims 14, 17, 19-20).
LaRosa teaches oral dissolvable films comprising up to 35 wt% of a psychedelic compound, e.g., psilocybin (Claim 1; Abstract; Para. 0075-0076, 0080-0082) that also may include: (i) hydroxypropyl methylcellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinylpyrrolidone, polyvinyl alcohol, pullulan, alginate and mixture thereof (Para. 0023, 0187); (ii) xanthan gum, acacia/arabic gum, guar gum, tragacanth gum, etc. (Para. 0024); (iii) glycerin (Para. 0032, 0035, 0187), and (iv) other additives, e.g., permeation enhancers (Para. 0045). LaRosa teaches that said films can be used for treatment of a large spectrum of psychological or neurological disorders (Para. 0004-0006, 0009).
Kucuksen teaches the use of psilocybin in combination with at least one cannabinoid and/or at least terpene for the prevention or treatment of psychological and brain disorders, wherein the cannabinoid(s) and/or the terpene(s) are administered separately, sequentially or simultaneously to the psilocybin (Abstract; Pars. 0002, 0034, 0053). Kucuksen also teaches that terpene and/or psilocybin have a potential to enhance the effects of cannabinoids (Para. 0197).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include psilocybin as taught by LaRosa and Kucuksen into film-based oral dosage forms that dissolve in oral cavity as taught by Modi. One would do so with expectation of beneficial results, because LaRosa and Kucuksen, teach that psilocybin can be used for treatment various psychological or neurological disorders, and also can be used to enhance the effect of cannabinoids, and Modi teaches film-based dosage forms that allow increasing bioavailability of the target molecule on administration.
With regard to the concentrations as instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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.
Regarding the properties of the disclosed formulations, it is noted that the cited prior art teaches formulations that are substantially the same as the film formulations recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Response to Arguments
Applicant's arguments, filed 08/05/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and rejections have been added to the record to address newly introduced amendments and/or to clarify position of the examiner. Additional examiner’s comments are set forth next.
In response to applicant's arguments against the references individually, it is noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
It has been held that a prior art reference must either be in the field of applicant’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the applicant was concerned, in order to be relied upon as a basis for rejection of the claimed invention. In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). To this point, it should be noted that the Supreme Court decided (KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007)) that:
the obviousness analysis needs not seek out precise teachings directed to the subject matter of the challenged claim and can take into account the inferences and creative steps that one of ordinary skill in the art would employ.
the obviousness analysis cannot be confined by a formalistic conception of the words teaching, suggestion and motivation, or by overemphasis on the importance of published articles and the explicit content of issued patents.
it is error to look only the problem the patentee was trying to solve. Any need or problem known in the field of endeavor at the time of invention and addressed by the prior art can provide a reason for combining the elements in the manner claimed.
it is error to assume that one of ordinary skill in the art in attempting to solve a problem will be led only to those elements of prior art designed to solve the same problem. Common sense teaches that familiar items may have obvious uses beyond their primary purposes, and in many cases one of ordinary skill in the art will be able to fit the teachings of multiple patents together like pieces of a puzzle (one of ordinary skill in the art is not automaton).
it is error to assume that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been collectively taught by the combined teachings of the references. Applicant is advised to clarify the claim language, the structure of the claimed film formulation/product, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615