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/Restriction
Applicant’s election without traverse of Group I, drawn to a formulation for transdermal delivery; and election of species: 1) sodium bicarbonate as the medicament species; and Phosphatidylcholine, Isopropyl Palmitate, Poloxamer 407, Benzyl Alcohol, and Polyglyceryl-4 laurate as the penetration excipient species, comprising, respectively, a phospholipid, fatty acid ester, viscosity-improving agent, penetration enhancer, and emulsifier, in the reply filed on 11/24/2025 is acknowledged. It’s construed the penetration excipient species as phosphatidylcholine ( phospholipid), isopropyl palmitate( fatty acid ester) , poloxamer 407 (viscosity-improving agent), benzyl alcohol( penetration enhancer) and polyglyceryl-4 laurate (emulsifier).
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 67, 68, and 78 read on the elected invention of formulation.
Claim 69 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Status of Claims
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 67, 68, 69 and 78 are pending.
Claim 69 is withdrawn.
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 67, 68 and 78 are under examination in this office action.
Priority
Instant application 18/351,192 filed 07/12/2023 is a continuation of International Application No. PCT/US2022/012330, filed January 13, 2022; and claims the benefit of U.S. Provisional Application No. 63/137,127, filed January 13, 2021; U.S. Provisional Application No. 63/218,983, filed July 7, 2021; U.S. Provisional Application No. 63/219,280, filed July 7, 2021; U.S. Provisional Application No. 63/227,330, filed July 29, 2021; U.S. Provisional Application No. 63/261,510, filed September 22, 2021; U.S. Provisional Application No. 63/271,014, filed October 22, 2021; and U.S. Provisional Application No. 63/287,492, filed December 8, 2021.
Information Disclosure Statement
The information disclosure statement filed 07/09/2024 and 02/12/2025 are in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the Examiner. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent by examiner.
Claim Objections
Claim 65 and 67 are objected to because of the following informalities:
Claims 65 and 67 recite medicament with trademark without symbol ®, e.g. Inlyta, Stivaga, Sutent, etc.
Claim 65 recites vast variety of medicament wherein some medicament are repetitive, e.g.
PNG
media_image1.png
33
144
media_image1.png
Greyscale
PNG
media_image2.png
20
285
media_image2.png
Greyscale
PNG
media_image3.png
23
273
media_image3.png
Greyscale
PNG
media_image4.png
26
423
media_image4.png
Greyscale
PNG
media_image5.png
27
119
media_image5.png
Greyscale
PNG
media_image6.png
25
496
media_image6.png
Greyscale
PNG
media_image7.png
51
741
media_image7.png
Greyscale
Claim 67 recites vast variety of medicament combination wherein some medicament combination are repetitive, e.g.
PNG
media_image8.png
26
360
media_image8.png
Greyscale
These are only exemplary repetitive medicaments. Applicant is required to correct typo and any other repetitive recitation of medicaments.
It’s also noted the medicaments in claims 65 and 67 are written in mixed lower case and/or with first letter capitalized. The recitation of medicaments should be in uniform style.
Specification
The disclosure is objected to because of the following informalities: instant specification recites repetitive medicaments in the same embodiments, e.g.
Page 38, [0104], Table 1,
PNG
media_image9.png
72
812
media_image9.png
Greyscale
Page 116, [0423], Embodiment 53, trametinib and dabrafenib; Trametinib and dabrafenib.
page 117, [0426], Embodiment 55,
PNG
media_image10.png
31
314
media_image10.png
Greyscale
Drawings
The drawings are objected to because Figures 1-26 should be designated by a legend describing topical formulation comprising the medicament.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Claim 1 recites a formulation for transdermal delivery of a medicament through the skin of a subject, the formulation comprising a therapeutically effective amount of a medicament and a penetrant portion, wherein the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids, and, optionally, one or more of a viscosity-improving agent, a penetration enhancer, and an emulsifier; wherein the formulation lacks a natural lecithin and lacks glucose.
It's noted the natural lecithin is construed as the source of phospholipid which does not necessarily contribute to structural limitation of phospholipid. The function/property of phospholipid (e.g. phosphatidylcholine, etc.) is construed as the same or at least equivalent whether it’s natural lecithin or from synthetic source. If the prior art is silent about the source of phospholipid, it’s construed as encompassing embodiments lacks natural lecithin. If the prior art is silent about glucose, it’s construed as encompassing embodiments comprising no glucose.
Claim Rejections - 35 USC § 112
Claims 65 and 67 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of medicament is improper because the alternatives defined by the Markush grouping do not share structural similarity and/or a common use. For example, claim 65 recites inorganic salt, e.g. sodium bicarbonate as medicament which has nothing common with antiviral medicament ( e.g. abacavir, etc.). Claim 67 recites medicaments combination that do not share common use, e.g. adapalene and benzoyl peroxide (for acne vulgaris) , Metformin and Sitagliptin (for diabetes), etc.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
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.
Written Description Rejection
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 67, 68 and 78 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. Instant claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention in full scope. This is a matter of written description, not a question of what one of ordinary skill in the art would or would not have known. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Claim 1 recites formulation for transdermal delivery of a medicament comprising a therapeutically effective amount of a medicament and a penetrant portion, wherein the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids, wherein the formulation lacks a natural lecithin. Claim 1 is construed as directed to formulation of any medicament in combination with a penetrant portion comprising any phospholipid, any long-chain fatty acid and fatty acid ester, which is extremely broad. Claims 65 and 67 refer to transdermal delivery of improper Markush grouping of medicament genus, or combination genus. The vast variety of medicament recited in claim 65 have different chemicals structures, different chemical/physical properties and pharmaceutical activities.
MPEP 2163 II states; “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above)”. While applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. “A representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” See MPEP 2163 II.
Instant specification discloses embodiments comprising some instantly claimed medicament(See Examples 1-31, Table 1) . The instant specification does not provide working example of the medicament combination as recited in claim 67 in combination with the transdermal formulation comprising phospholipid, fatty acid ester and long-chain fatty acid. A "laundry list" disclosure of possible medicament species does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species. MPEP 2163.1.A. and Fujikawa v. Wattanasin, 93 ”.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed.Cir. 1996).
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 1, 2, 5, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 67, 68 and 78 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites a formulation for transdermal delivery of a medicament through the skin of a subject, the formulation comprising a therapeutically effective amount of a medicament and a penetrant portion, wherein the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids, and, optionally, one or more of a viscosity-improving agent, a penetration enhancer, and an emulsifier; wherein the formulation lacks a natural lecithin and lacks glucose. The limitation “a low molecular weight alcohol” is vague and indefinite. It’s not clear what range of molecular weight is considered as low. Methanol, ethanol, propanol and butanol are considered as low molecular weight alcohol. Is C5-C8 alcohol considered as low molecular weight alcohol? The lack of clarity regarding the low molecular weight alcohol render claim 1 indefinite.
Claims 2, 5, 11, 12, 17-19, 26, 27, 34, 36, 39, 47, 49, 65, 67, 68 and 78 are rejected due to dependency on claim 1.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claim 36 recites trademark/tradename "span" used to identify/describe polysorbate emulsifier. Accordingly, the identification/description is indefinite.
Claim 44 uses the phrase “e.g.” is equivalent to "for example" and this renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 65 and 67 recite vast variety of medicament or combination thereof that could be included in the formulation of claim 1, wherein the medicament is recited as short acronym, e.g. TAF, TDF. It’s not clear what TAF or TDF mean for what medicament. Claim 65 also recites “ branched chain amino acids” (page 50) which is also indefinite. It’s not clear what branched chain amino acids are encompassed by this limitation. The lack of clarity of medicament or combination thereof render claims 65 and 67 indefinite.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 36, 39, 47, 49, 65 and 78 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Glonek et al. (WO 2019/182969 A1, Applicant’s IDS dated 07/09/2024).
Glonek teaches topical phospholipid formulation comprising a phospholipid component for transdermal delivery of active agents ( See abstract, page 2, lines 1-21; Example 1-2, claims 13-20).
Regarding the phospholipid component of claim 2, Glonek teaches phospholipid molecules selected from the group consisting of lysophosphatidic acid, lysodiphosphatidylglycerol, phosphatidylglycerol, lysophosphatidylethanolamine, phosphatidic acid, diphosphatidylglycerol, ethanolamine plasmalogen, phosphatidylethanolamine, phosphatidylserine, lysophosphatidylcholine, phosphatidylinositol, and phosphatidylcholine (See page 3, lines 14-19; page 6, lines 5-10).
Regarding the amount of phospholipid of claim 5, Glonek teaches phospholipid component is present in a concentration of from about 0.1 % w/w to about 10% w/w based on the total weight of the formulation (See page 3, lines 12-13; page 5, lines 21-35; Example 1-2).
Regarding limitation of fatty acid ester of claim 8, 11, and long-chain fatty acid of claim 12, 17-18, Glonek teaches oil phase comprising two or more components selected from the group consisting of cetyl alcohol, beeswax, isopropyl palmitate, oleic acid, sorbitan stearate, stearyl alcohol, stearic acid, glyceryl stearate, and an ester (See page 2, lines 17-21; Example 1-2, Table 1-2). Glonek teaches topical formulations include one or more thickening agent, emulsion stabilizer, rheology modifier, or viscosity modifier in an amount of from about 0.1 % w/w to about 10% w/w based on the total weight of the final formulation, e.g. long-chain fatty acid, saturated or unsaturated fatty acids, hydrogenated fatty acids, fatty acid glyceride, glycerol mono-oleate esters, glycerol mono-caprate, glyceryl monocaprylate, fatty alcohols, cetyl alcohol, isopropyl myristate, isopropyl palmitate, stearic acid, stearyl alcohol or any combination thereof, etc. (See page 10, lines 1-35).
Regarding claims 19 and 26, Glonek teaches gelling agents (poloxamers, carboxymethylcellulose etc.), in an amount from 0.01% to 5% w/w (See page 15, lines 1-5). Glonek teaches viscosity-increasing agent (e.g. carbomer, carboxymethylcellulose etc.) ( See page 15, lines 28).
Regarding claim 27, Glonek teaches topical carriers, e.g. liquid alcohols, liquid glycols, ethanol, isopropanol, glycerol, propylene glycol, etc. ( See page 12, lines 18-25).
Regarding claim 36, Glonek teaches cetyl alcohol as emulsifier and used in the oil base with isopropyl palmitate, oleic acid, etc. (See page 10, line 24; page 17, line 21; Example 1-2). Glonek also teaches other emulsifier, e.g. Tween® 60 (See Example 1).
Regarding claim 44, Glonek teaches embodiments comprising phospholipid component (5%), isopropyl palmitate (5%), oleic acid (2% ), stearic acid (1%) , benzyl alcohol (1%), water (50%), cetyl alcohol (emulsifier, 1%), sorbitan stearate emulsifier (e.g. Arlacel™ 60), etc. (See Examples 1-2, Table 1-2).
Regarding active agents/medicaments, Glonek teaches nutraceuticals (e.g. carnitine, minerals) in an amount of 0.01% w/w -5% w/w, pharmacologically active agents or drugs from major therapeutic areas e.g. steroids (e.g., corticosteroids), anti-inflammatory agents, anti-infectives such as antibiotics and antiviral agents, analgesics and analgesic combinations, anorexics, antiarthritics, anti-asthmatic agents, anticonvulsants, antihistamines, antiseptics, antimigraine preparations, anti-motion sickness agents, antinauseants, diagnostics, hormones, hypnotics, immunosuppressives, muscle relaxants, parasympatholytics, psychostimulants, sedatives, tranquilizers, anesthetics, vitamins (e.g. Vitamin D), etc. (See page 12, lines 30-35; page 13, lines 1-32; page 16, lines 1-10).
As elaborated, Glonek collectively teaches topical phospholipid formulation comprising a phospholipid component, fatty acid ester (e.g. isopropyl palmitate) and fatty acid (oleic acid, steric acid, etc.) for transdermal delivery of active agents. Glonek is silent about natural lecithin and glucose. As such, Glonek anticipates instantly claimed invention.
Claims 1, 2, 5, 8, 11, 12, 17-18, 27, 34, 47, 49, 65, and 78 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Perricone (US 9597401B2, hereafter “Perricone’401” ).
Perricone’401 teaches transdermal composition comprising a phosphatidylcholine carrier and other penetration enhancers (e.g. fatty acid ester, fatty acids and alcohols, surfactant, etc.) for transdermal delivery of active ingredient, e.g. nitric oxide/ peptide (See abstract, Col. 1,lines 59-65, Examples 2, 6-8, claims 1-17). Please note nitric oxide read on the medicament of claim 65.
Regarding claims 2 and 5, Perricone’401 teaches various amount of phosphatidylcholine from about at least about 1 wt. %, to at least about 10 wt. %, etc. (See Col 13, lines 32-50; Examples 6-8; claim 12 and14).
Regarding claims 8 and 11, Perricone’401 teaches embodiments further comprising a fatty acid ester, e.g. isopropyl palmitate, at amount from 1% w/w to about 50% w/w (See Col. 11. lines 28-45; Example 7).
Regarding claims 12 and 17-18, Perricone’401 teaches embodiments comprising one or more transdermal penetration enhancers, e.g. cationic, anionic, or nonionic surfactants (e.g., sodium dodecyl sulfate, poloxamers, etc.); fatty acids and alcohols (e.g., ethanol, oleic acid, lauric acid, liposomes, etc.), or other agents wherein the transdermal penetration enhancers are present in amount from 10 wt. %, at least about 20 % w/w, at least about 30% w/w, etc. (See Col. 15, lines 7-32).
Regarding claims 27 and 34 , Perricone’401 teaches embodiments comprising polyglycol, polyethylene glycol, etc. at various amount from 1 wt.% to 30 wt.% ( See Col. 13, lines 5-30). Perricone’401 also teaches embodiments comprising benzyl alcohol, ethyl alcohol, isopropyl palmitate, etc. ( See Col.13, lines 32-50; Example 7).
Regarding water limitation of claim 47, Perricone’401 teaches embodiments comprising water, e.g.. 78.3% (See Example 7).
Regarding claim 49, Perricone’401 teaches the amount of active medicament(e.g. nitric oxide) from 0.3 wt. % to at least 10 wt. %( See Col. 8, lines 30-40).
Perricone’401 collectively teaches transdermal composition comprising a phosphatidylcholine carrier and other penetration enhancers (e.g. fatty acid ester, fatty acids and alcohols, surfactant, etc.) for transdermal delivery of active ingredient (nitric oxide/peptide). Further exploration of excipients/penetration enhancer and concentration thereof for improved drug permeation is within the general knowledge of an ordinary skilled in the art. Thus, Perricone’401 anticipates instant claimed invention.
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65 and 78 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fitzsimmons et al. (US10842758B1, hereafter “Fitzsimmons’ 758”, Applicant’s IDS dated 02/12/2025).
The applied reference has a common/joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Fitzsimmons’ 758 disclosed a transdermal delivery formulation for an active agent ( e.g. cannabidiol, CBD) with improved penetration, wherein the formulation comprises one or more phosphatides, and one or more fatty acids (See abstract, Col. 2, lines 10-57; Examples/ Tables 1-7; claims 1-16).
PNG
media_image11.png
291
534
media_image11.png
Greyscale
Regarding the phospholipid recited in claims 2 and 5, Fitzsimmons’ 758 teaches transdermal delivery formulation comprises phosphatidylcholine, hydrogenated phosphatidyl choline, phosphatidylserine, phosphatidylethanolamine, phosphatidylinositol, one or more phosphatides, one or more Inositol phosphatides, or combinations thereof, in amount less than 30% w/w or in amount less than 12% w/w of the formulation (See Col. 12, lines 1-9, 28-34; Col. 29, lines 59-67; claim ).
Regarding claims 8 and 12, Fitzsimmons’ 758 teaches fatty alcohols, fatty acids, fatty esters are bilayer fluidizers that may be used in some embodiments, e. g. isopropyl linoleate, isopropyl myristate, isopropyl myristate/fatty acid, isopropyl palmitate, linoelaidic acid, linoleic acid, linolenic acid, neodecanoic acid, oleic acid, palmitic acid, etc. (See Col. 15, lines 10-40).
Regarding claim 11, Fitzsimmons’ 758 teaches various embodiments comprising isopropyl palmitate at various amount from 5%-30%, e.g. 13% (See claim 1, 16; Example 2/ Table 7)
Regarding fatty acid limitation of claims 12 and 17-18, Fitzsimmons’ 758 teaches embodiments comprising one or more fatty acid, e.g. oleic acid, linoleic acid, at about 1-35% w/w of the formulation.(See Col.30, lines 5-18)
Regarding limitation of claims 19 and 26, Fitzsimmons’ 758 teaches embodiments comprising nonionic detergent, e.g. a poloxamer, Pluronic® in an amount between about 2-12% w/w of a transdermal
delivery formulation, preferably between about 5-25% w/w (See Col. 13, lines 5-7, 20-26). Fitzsimmons’ 758 explicitly teaches poloxamer(407) (See Table 7).
Regarding limitation of claims 27 and 34, Fitzsimmons’ 758 teaches embodiments comprising combinations of an alcohol, such as benzyl alcohol at a concentration of 0.5-20% w/w of the final
formulation (See Col. 20, lines 26-29; Col. 29, lines 39-40; Table 7 ).
Regarding limitation of claims 36 and 39, Fitzsimmons’ 758 teaches embodiments comprising cetyl alcohol in various amount less than 2% w/w to less than 10 %w/w of the formulation(See Col 12. , lines 19-20; Col. 31, lines 24-27; claim 9).
Regarding claim 44, Fitzsimmons’ 758 explicitly teaches lecithin-free formulation (See Table 7) comprising no glucose.
PNG
media_image12.png
402
528
media_image12.png
Greyscale
Regarding water limitation of claims 47, Fitzsimmons’ 758 teaches embodiments comprising water in an amount at 10-50% w/w (See claims 1 and 10, Table 1-7)
PNG
media_image13.png
254
565
media_image13.png
Greyscale
Regarding claims 65 and 67, Fitzsimmons’ 758 teaches variety of additional active drugs and combination thereof for treating variety of disease, e.g. anticancer agent (See Fig 9A-S), adalimumab, infliximab, a steroid, immunosuppressants, antivirals ( e.g. Abacavir, Didanosine, Emtricitabine, Lamivudine, Elvitegravir plus TDF plus FTC plus cobicistat, Dolutegravir plus abacavir plus lamivudine), and Parkinson’s disease (e.g. Larodopa, Levodopa and carbidopa, etc.) (See Col.18, lines 1-48).
Fitzsimmons’ 758 teaches lecithin-free transdermal formulation comprising phospholipid, isopropyl palmitate, oleic acid, linoleic acid, poloxamer (407), water, etc.. Thus, Fitzsimmons’ 758 anticipates instantly claimed invention.
Claim Rejections - 35 USC§ 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 68 and 78 are rejected under 35 U.S.C. 103 as unpatentable over Sand et al. (US 20180271983 A1, hereafter “Sand’ 983”).
Sand’ 983 teaches transdermal delivery and/or systemic delivery of an active agent (e.g. lidocaine) through skin, nails or hair follicles, wherein the formulation comprises an effective amount of active agent along with multiple-component penetration enhancers, e.g. benzyl alcohol at 0.5 - 20 % w / w, lecithin organogel at 25- 70 % w / w, detergents (e.g. nonionic detergents), bile salts, polar solvents, etc. (See abstract, [0007]-[0009], [0045]-[0047], Examples 1-22, claims 1-16). Sand ‘983 teaches lecithin organogel is clear, thermodynamically stable, viscoelastic, and biocompatible jelly- like permeation agent, chiefly composed hydrated phospholipids and appropriate organic liquid, e.g. lecithin isopropyl palmitate, which is formed when isopropyl palmitate is used to dissolve lecithin and the ratio of lecithin to isopropyl palmitate is 50: 50 (See [0048]).
Regarding the phospholipid- based permeation enhancer of claims 2 and 5, Sand ‘983 teaches micro- emulsion based organic gel in liquid phase characterized by 1, 2- diacyl-sn- glycero- 3- phosphatidyl choline, and an organic solvent (e.g. isopropyl palmitate, etc.) (See [0049]) and the lecithin organogel is present in the final formulation in the range of 25 - 70 % w / w (See [0048], claims 1-2) (which reads on the elected PC and fatty acid ester species). Sand ‘983 teaches other lecithin such as synthetic lecithin could also be used (See [0048])(which reads on instant negative limitation of natural lecithin and claim 78). Sand ‘983 teaches embodiments comprising 0.8% w/w of phosphatidylcholine, 1 % w/w caffeine, 2% w/w benzyl alcohol, 30% w/w lecithin isopropyl palmitate, 22% w/w deoxycholic acid, 30% poloxamer(See Example 7). Sand ‘983 teaches embodiments that lacks glucose (See Examples 1-22).
Regarding fatty acid ester of claims 8 and 11, Sand teaches an effective amount of anesthetic along with 25% - 70% w / w or 30 %- 60 % w / w or 30 % - 40 % w / w of lecithin organogel wherein the lecithin organogel comprises soy lecithin in combination with isopropyl palmitate or isopropyl myristate and benzyl alcohol (See [0181]). Sand ‘983 teaches organogel is typically amphiphilic permeation agent wherein suitable gelling components, e.g. isopropyl palmitate , ethyl laurate, ethyl myristate and isopropyl myristate, etc. can be used (See [0048], Examples 1-22).
Regarding the long-chain fatty acid recited in claim 12 and 17-18, Sand ‘983 teaches formulation components further comprise fatty acids, lipids, terpenes, cationic and anionic detergents, wherein the exemplary fatty acid include linoelaidic acid, linoleic acid, oleic acid, etc. (See [0048], [0060]-[0062]).
Regarding the viscosity-improving agent of claims 19 and 26, Sand ‘983 teaches nonionic detergent (e.g. poloxamer, Pluronic® F68, Pluronic® F127, etc. ) provides gel-like or creams properties and is present from 10% w/w to 40%w/w (See [0054]-[0056], Examples 1-22). Sand ‘983 explicitly teaches embodiments comprising poloxamer 407 (See Example 6)
Regarding other penetration agent of claims 27 and 34, Sand ‘983 teaches alcohol as additional components (e.g. benzyl alcohol, PEG/propylene glycol, etc.) at concentration of 0.15-20% w/w along with lecithin isopropyl palmitate (See [0051], [0084]-[0094], Examples 1-22).
Regarding emulsifier of claim 36 and 39, Sand ‘983 teaches surfactants/ detergents e.g. Tween® 60, Tween® 80, Span® 80, in the range of 1 % w/w-15% w/w formation of miscellas for superior penetration (See [0035], [0050], [0056]).
Regarding claim 44, Sand ‘983 explicitly teaches embodiments comprising instant elected penetration enhancer species (See Example 6, [0258]): Example 6: a formulation containing 65 % w / w of Pluronic® lecithin organic gel made up of 33.17 % poloxamer 407 powder , 33.17 % soy lecithin granules , and 33.17 % isopropyl palmitate syrup was mixed with 2 % w / w benzyl alcohol and buffer to pH 10-11 wherein the buffer comprises 10 g sodium bicarbonate and 12.6 g of sodium carbonate, etc.
Regarding water in claim 47, Sand ‘983 teaches aqueous form of embodiments comprising water, glycerol, etc. (See [0050], [0057], [0109] ).
Regarding the amount of active ingredients recited in claim 49, Sand ‘983 teaches the amount of active ingredients from 0.01 to 50% w/w, 0.25% w/w to 30% w/w (See [0040], [0110], Examples 1-22).
Regarding claim 68, Sand ‘983 teaches transdermal or systemic delivery of active ingredients (See abstract, [0007], [0073], [0137], etc.)
Regarding the active ingredients recited in claim 65, Sand ‘983 teaches variety of medicament/active ingredients, e.g. anesthetic (e.g. lidocaine, etc.), antivirals (e.g. acyclovir, penciclovir, etc.) , fat-dissolving agent, a nutrient or nutrient combination, a tissue volume enhancer, a vaccine component, a hair growth modulator, an antifungal agent, an agent to promote smoking cessation, and/or a cannabinoid, etc. (See Examples 1-22, [0084]-0095], [0130]- [0184], claims 14-17). Sand ‘983 teaches antivirals as the medicament, e.g. acyclovir, penciclovir, etc. (See [0173]-0175]). Sand ‘983 explicitly teaches sodium bicarbonate as the active ingredients for athletic performance (See [0131], Examples 9)(which reads on instant elected medicament).
Regarding claim 67, Sand ‘983 teaches additional active ingredients and combination of active ingredients, e.g. benzocaine + lidocaine + tetracaine ( BLT) (See [0090]-[0092], Example 25).
Sand ‘983 collectively teaches multiple-component penetration formulation comprising phospholipid(e.g. phosphatidylcholine, etc.), fatty acid ester (e.g. isopropyl palmitate ), alcohol (e.g. benzyl alcohol), detergent/surfactant (e.g. poloxamer, etc.) for transdermal delivery and/or systemic delivery of an active agent, wherein the formulation synergistically induce skin permeation enhancements better than that induced by the individual components (See [0047]).
It’s noted the function/property of phospholipid (e.g. phosphatidylcholine, etc.) is construed as the same or at least equivalent whether it’s natural lecithin or from synthetic source. Sand ‘983 teaches other lecithin such as synthetic lecithin could also be used (See [0048]). It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore different source of phospholipid ( natural lecithin or synthetic ) in search for alternative transdermal delivery of active medicament, based on the collectively teaching of Sand ‘983, together with experimentation/ optimization of penetrant component based on general knowledge of transdermal delivery formulation, and arrive at instant invention with reasonable expectation of success. Further exploration of excipients/penetration enhancer and concentration thereof for improved drug permeation is within the general knowledge of an ordinary skilled in 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. MPEP 2144.05.
A skilled artisan would be motivated to further explore the penetration formulation for different medicament since Sand ‘983 collectively teaches multiple-component penetration formulation synergistically induce skin permeation enhancements better than that induced by the individual components (See [0047]). One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is 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.
Claim 67 is rejected under 35 U.S.C. 103 as unpatentable over Sand et al. (US 20180271983 A1, hereafter “Sand’ 983”) , in view of EPIDUO® (adapalene and benzoyl peroxide)( 2013).
The collective teachings of Sand’ 983 is elaborated in preceding 103 rejection and applied as before. Sand ‘983 collectively teaches multiple-component penetration formulation comprising phospholipid(e.g. phosphatidylcholine, etc.), fatty acid ester (e.g. isopropyl palmitate ), alcohol (e.g. benzyl alcohol), detergent/surfactant (e.g. poloxamer, etc.) for transdermal delivery and/or systemic delivery of an active agent.
Sand ‘983 is silent about the medicament combination recited in claim 67, e.g. adapalene and benzoyl peroxide.
EPIDUO® (adapalene and benzoyl peroxide) is combination of adapalene, a retinoid, and benzoyl peroxide, indicated for the topical treatment of acne vulgaris.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to incorporate the penetration formulation taught by Sand ‘983 for transdermal delivery of different medicament or combination thereof, e.g. adapalene and benzoyl peroxide taught by Epiduo label, together with experimentation/ optimization of penetrant component based on general knowledge of transdermal delivery formulation, and arrive at instant invention with reasonable expectation of success. A skilled artisan would be motivated to explore penetration formulation taught by Sand ‘983 for transdermal delivery of different medicament combination, e.g. adapalene and benzoyl peroxide, because multiple-component penetration formulation synergistically induce skin permeation enhancements better than that induced by the individual components as taught by Sand ‘983. One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is 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.
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, 2, 5, 8, 11, 12, 17-18, 27, 34, 47, 49, and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US patent No. 10842758B1.
Reference claims are directed to a transdermal delivery formulation comprising the following components:
a. Cannabidiol (CBD) at a concentration from 1% to 7%;
b. a phosphatidylcholine at a concentration from 4% to 15%;
c. glucose at a concentration from 0% to 3%;
d. benzyl alcohol at a concentration from 0.25% to 5%;
e. deionized water at a concentration from 10% to 75%;
f. safflower oil at a concentration from 1% to 20%;
g. oleic acid at a concentration from 0.2% to 7.5%;
h. stearic acid at a concentration from 0.1% to 7%; and
i. isopropyl palmitate at a concentration from 5% to 30%.
It’s noted the phosphatidylcholine, isopropyl palmitate, benzyl alcohol read on instant elected penetration excipient species. Oleic acid and stearic acid read on the long-chain fatty acid (instant claim 12, 17-18), and CBD read on medicament recited in claim 65.
Reference claims comprising glucose at a concentration of 0% read on instant negative limitation of glucose. Reference claims are silent about natural lecithin and construed as encompassing embodiments that lacks natural lecithin.
It’s noted the function/property of phospholipid (e.g. phosphatidylcholine, etc.) is construed as the same or at least equivalent whether it’s natural lecithin or from synthetic source. It would have been prima facie obvious to one of the ordinary skilled in the art to explore different source of phospholipid ( natural lecithin or synthetic ) in search for alternative transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 5, 8, 11, 12, 17-18, 27, 34, 47, 49, and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US patent No. 11026896 B2.
Reference claims are directed to a method of treating a patient with an ailment by applying a transdermal formulation to the skin of the patient, the transdermal formulation comprising the following components:
a. Cannabidiol at a concentration from 1% to 7%;
b. a phosphatidylcholine at a concentration from 4% to 15%;
c. glucose at a concentration from 0% to 3%;
d. benzyl alcohol at a concentration from 0.25% to 5%;
e. deionized water at a concentration from 10% to 75%;
f. safflower oil at a concentration from 1% to 20%;
g. oleic acid at a concentration from 0.2% to 7.5%;
h. stearic acid at a concentration from 0.1% to 7%; and
i. isopropyl palmitate at a concentration from 5% to 30%,
It’s noted the phosphatidylcholine, isopropyl palmitate, benzyl alcohol read on instant elected penetration excipient species. Oleic acid and stearic acid read on the long-chain fatty acid (instant claim 12, 17-18), and CBD read on medicament recited in claim 65.
Reference claims comprising glucose at a concentration of 0% read on instant negative limitation of glucose. Reference claims are silent about natural lecithin and construed as encompassing embodiments that lacks natural lecithin.
It’s noted the function/property of phospholipid (e.g. phosphatidylcholine, etc.) is construed as the same or at least equivalent whether it’s natural lecithin or from synthetic source. It would have been prima facie obvious to one of the ordinary skilled in the art to explore different source of phospholipid ( natural lecithin or synthetic ) in search for alternative transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 5, 8, 11, 12, 17-19, 27, 34, 49, 65 and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US patent No. 11052152 B2, in view of Glonek et al. (WO 2019/182969 A1, Applicant’s IDS dated 07/09/2024).
Reference claims are directed to a method of treating an individual to impede lactic acidosis, wherein the individual is administered a topical formulation for transdermal delivery of an active agent through the skin of a subject, wherein said active agent comprises sodium bicarbonate,
wherein said formulation comprises a penetrant that provides a lecithin at 5%-15% w/w of said formulation and sodium bicarbonate at 20%-40% w/w of the formulation, wherein said formulation further comprises an isopropyl palmitate, benzyl alcohol at 0.5%-20% w/w of the formulation, propylene glycol at about 1%-5% w/w of the formulation, poloxamer 407 at 1%-15% w/w of the formulation.
Reference claims are silent about glucose and “natural” lecithin. It’s noted the function/property of phospholipid (e.g. phosphatidylcholine, etc.) is construed as the same or at least equivalent whether it’s natural lecithin or from synthetic source.
Reference claims are silent about fatty acids.
The collective teachings of Glonek is elaborated in preceding 102 rejection and applied as before. Glonek collectively teaches topical phospholipid formulation comprising a phospholipid component, fatty acid ester (e.g. isopropyl palmitate) and fatty acid (oleic acid, steric acid, etc.) for transdermal delivery of active agents.
It would have been prima facie obvious to one of the ordinary skilled in the art to explore more penetrant portion(e.g. fatty acid) based on the combined teaching of reference claims and Glonek, together with experimentation/ optimization based on general knowledge of transdermal delivery formulation, and arrive at instant claims with reasonable expectation of success. A skilled artisan would be motivated to combine reference claims and Glonek because Glonek teaches fatty acid could be combined with phospholipid component for delivering active agent. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 8, 12, 17-19, 27, 34, 36, 49, 65 and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US patent No. 11357792B2.
Reference claims are directed to a formulation suitable for transdermal delivery of active agents, wherein the active agents consist of a buffering agent and tranexamic acid, and the formulation further comprises a long chain fatty acid, a phosphatidylcholine (Phospholipon® 90G), and a fatty acid ester; and wherein the buffering agent comprises sodium carbonate and/or sodium bicarbonate. tranexamic acid read on active medicament of claim 65.
Reference claim 2 recites the long chain-fatty acid that read on instant claim 12. Reference claim 19 recites the lecithin is selected from synthetic lecithin, further comprises benzyl alcohol, isopropyl palmitate (IPP), and one or more of water, a poloxamer, and a polyglyceryl-4 Laurate (Durosoft®).
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore different penetrant and combination thereof for transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 8, 12, 27, 49, 65 and 78 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US patent No. 11389472B2.
Reference claims are directed to a method for treating gout or reducing a symptom of gout, comprising topically administering to a subject in need thereof a transdermal formulation comprising a buffering agent and menthol, wherein the buffering agent comprises sodium bicarbonate or sodium carbonate.
Reference claim 16 recites transdermal formulation further comprises a penetrant or a penetration enhancer comprising one or more of benzyl alcohol, cetyl alcohol, isododecane, isopropyl palmitate (IPP), isopropyl stearate, menthol, phosphatidyl choline, undecane, and lecithin, wherein the lecithin is selected from an egg lecithin, a soy lecithin, and a synthetic lecithin.
Reference claim 16 recites fatty acids comprising one or more of an alkanoic acid, caprid acid, diacid, ethyloctadecanoic acid, hexanoic acid, lactic acid, lauric acid, a lecithin, linoelaidic acid, linoleic acid, linolenic acid, neodecanoic acid, oleic acid, palmitic acid, etc.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore different penetrant and combination thereof for transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 8, 12 , 27, 36, 49 and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-16 of US patent No. 11793830 B2.
Reference claims are directed to a method treating melasma or reducing a sign or a symptom of melasma comprising topically administering to a subject in need thereof a transdermal formulation having two active agents, wherein the two active agents consist of a buffering agent and tranexamic acid; wherein the buffering agent is selected from the group consisting of sodium carbonate, sodium bicarbonate.
Reference claims 13-16 further recite limitation of transdermal formulation.
Reference 13 recites wherein the transdermal formulation further comprises a penetrant or penetration enhancer comprising one or more of benzyl alcohol, cetyl alcohol, isododecane, isopropyl palmitate (IPP), isopropyl stearate, menthol, phosphatidyl choline, undecane, and/or a lecithin, wherein the lecithin is selected from an egg lecithin, a soy lecithin, and a synthetic lecithin.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore different penetrant and combination thereof for transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
Claims 1, 2, 8, 12 , 19, 27 and 65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of US patent No. 12070503B2.
Reference claims are directed to a method for impeding lactic acidosis in an individual, the method comprising administering to the individual a topical formulation for transdermal delivery of an active agent through the skin of a subject, wherein the active agent comprises sodium bicarbonate,
wherein the topical formulation comprises: a lecithin at about 5%-15% w/w of the formulation, sodium bicarbonate at about 20%-40% w/w of the formulation, a poloxamer at about 1%-15% w/w of the formulation or an aqueous solution comprising about 15% -50% w/w poloxamer, an isopropyl palmitate, and menthol.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore different penetrant and combination thereof for transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 5, 8, 11, 12, 19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 68 and 78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-66 of copending US patent application No 18/350468. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a formulation for transdermal delivery of a phosphodiesterase-5 (PDE5) inhibitor through the skin of a subject, the formulation comprising a therapeutically effective amount of a PDE5 inhibitor and a penetrant portion, wherein the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids, and, optionally, one or more of a viscosity-improving agent, a penetration enhancer, and an emulsifier. Reference claims are silent about glucose which is considered as comprising embodiments lacks glucose.
It’s noted the function/property of phospholipid (e.g. phosphatidylcholine, etc.) is construed as the same or at least equivalent whether it’s natural lecithin or from synthetic source. It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instant invention to explore different source of phospholipid ( natural lecithin or synthetic ) in search for alternative transdermal delivery of active medicament, based on the collectively teaching of reference claims together with experimentation/ optimization of penetration enhancer based on general knowledge of transdermal delivery formulation. 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. MPEP 2144.05.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 65, 68, and 78 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49, 68 and 69 of copending US application No. 18/796.818. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a formulation for transdermal delivery of a medicament through the skin of a subject, the formulation comprising a therapeutically effective amount of a medicament and a penetrant portion, wherein the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids, and, optionally, one or more of a viscosity-improving agent, a penetration enhancer, and an emulsifier; wherein the formulation lacks a natural lecithin.
Reference claims 2, 5, 8, 11, 12, 17-19, 26, 27, 34, 36, 39, 44, 47, 49 recite the same or similar limitation that read on instant claims.
Reference claim 68 recite narrow scope of medicament that read on instant claim 65.
The scope of reference application is narrower than instant claim.
The instant application shares at least one common inventor and applicant with the reference patent. Further, the instant application is not related to the reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Conclusion
No claim is allowed.
The reference made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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, Amy L Clark can be reached on (571)272-1310. 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.
/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628