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 .
Priority
The present application, filed September 22, 2023, is a national stage application of PCT/US2022/021650, filed March 24, 2022, and claims the benefit of U.S. provisional application 63/165594, filed March 24, 2021.
Status of the Application
Claims 1-12, 16-22, and 24 are pending in this application and examined on the merits herein.
Specification
The disclosure is objected to because of the following informalities:
The specification recites both Bioxome and BioxomeTM, which indicates Bioxome as a registered trademark (for example, see line 6 of p. 44). However, a trademark search did not reveal Bioxome as a registered trademark. Please amend the specification to consistently and correctly reflect Bioxome’s trademark status.
The examiner notes that if bioxome is a registered trademark, its recitation in claims to define or describe a product is not permitted. See MPEP 2173.05(u).
Appropriate correction is required.
Claim Interpretation
The present claims recite the terms bioxome and redoxome. These terms are interpreted consistent with the specification and their definition in the art.
The specification states that bioxomes may refer to artificial, submicron nano-particles having resemblance to natural extracellular vesicles (EV) and may be carrying one or more active molecules as cargo (p. 4, [0025]).
The specification states that redoxomes may refer to bioxome particles carrying a cargo comprising at least one redox active, free radical scavenging compound (p. 6, [0026]).
In addition, Glozman (Publication no. WO 2019198068 A1; cited in PTO-892) discloses bioxome particles as particles comprising a cell membrane component and designed to undergo fusion with a target cell (p. 3, lines 28-30). Glozman discloses redoxomes as bioxome particles carrying a cargo comprising at least one redox active, free radical scavenging compound (p. 12, 18-21).
Therefore, bioxomes and redoxomes are interpreted herein consistent with the specification and their definition in the art.
In addition, claim 8 recites: “The composition of claim 1, further comprising an additional therapeutic agent for healing inflammatory condition of the skin.”
Claim 9 depends from claim 8 and further limits the additional therapeutic agent, reciting drugs having anti-inflammatory activity.
Claim 8 is interpreted as requiring that the additional therapeutic agent is a therapeutic agent used for healing inflammatory condition for the skin, not that the composition of claim 8 is used for healing an inflammatory condition of the skin.
If claim 8 is intended to require the composition is used for healing an inflammatory condition of the skin, then this limitation would be interpreted as an intended use of the composition of claim 8.
MPEP 2111.02 (at II) states: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. …To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim.”
In this instance, if claim 8 is intended to limit the use of the composition to treating an inflammatory condition of the skin, then claim 8 would be considered satisfied by a composition that satisfies the requirements of claim 1 and further comprises any additional therapeutic agent.
However, as stated above, claim 8 is interpreted as requiring the additional therapeutic agent is a therapeutic agent used for healing inflammatory condition for the skin, which the examiner believes is the intended meaning of the limitation.
Claim Objections
Claims 2, 7-9, 16, 21, and 24 are objected to because of the following informalities:
Claim 2 recites: “The composition of claim 1, comprising topiramate and a bioxome.” Because claim 1 recites “bioxome” and not “a bioxome”, please amend claim 2 to recite: “The composition of claim 1, comprising topiramate and bioxome.”
Claim 16 recites: “The method of claim 10, wherein said composition comprises topiramate and a bioxome.” Because claim 10 recites “bioxome” and not “a bioxome”, please amend claim 16 to recite: “The method of claim 10, wherein said composition comprises topiramate and bioxome.”
Claim 8 recites: “The composition of claim 1, further comprising an additional therapeutic agent for healing inflammatory condition of the skin.” Please amend claim 8 to recite: “The composition of claim 1, further comprising an additional therapeutic agent for healing an inflammatory condition of the skin.
Claims 7 and 21 recite C12-C15 and C10-30. Each of these recitations requires a specific number of carbon groups. Consistent with nomenclature for chemical formulas, please amend these terms such that the numbers are subscripts (i.e., C12-C15 and C10-30).
Claims 7 and 21 recite hydroxyethilcellulose. The examiner believes this to be a typographical error and should recite hydroxyethylcellulose.
Claims 9 and 24 recite anti TNFalpha drug. Please amend this to recite anti-TNF-alpha drugs.
Appropriate correction is required.
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.
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.
Claims 10, 16-22 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a dermatological condition, wherein the dermatological condition is an inflammatory condition, does not reasonably provide enablement for treating any dermatological condition by administering to a subject in need a composition recited in claims 10, 16-22, or 24.
The Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) The nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Nature of the invention: The present invention is drawn to a method for treating a dermatological condition comprising a step of administering to a subject in need thereof a composition comprising topiramate and bioxome, redoxome, HA, extracellular vesicles (EV), or PRP extracellular vesicles, or any combination thereof.
The state of the prior art: The state of the art does not provide an expectation that administration of a composition comprising topiramate with one of the additional composition components recited in claim 10 would be effective in treating any dermatological condition.
Shapira (U.S. pre-grant publication no. US 20110257257 A1; cited in PTO-892) teaches compositions for treating disorders associated with epithelial tissue, specifically topiramate compositions which are formulated for topical treatment of wounds and scars (p. 1, [0002], lines 1-4). Shapira suggests that topical topiramate formulations were also found effective in other skin conditions, including improving the state of scarring, mature dermatological scarring, atrophic dermatological diseases, skin barrier diseases, autoimmune skin diseases, steroid-induced skin atrophy, and skin-aging related disorders (p. 1, [0010]). Therefore, in view of Shapira, one of ordinary skill in the art would have recognized topiramate compositions as effective in treating conditions of the skin, including scarring and autoimmune diseases, each of which are associated with an inflammatory response.
However, Bello-Hernández (Bello-Hernández, Y.; et al. Skin Appendage Disorders 2017, vol. 4, pp. 25-28; cited in PTO-892 teaches acneiform rash caused by topiramate (p. 25, Title). Bello-Hernández teaches the case of a 35-year-old man with a disseminated rash of the trunk and extremities after treatment with 25 mg of topiramate daily as a prophylactic migraine treatment. Bello-Hernández teaches this patient was not polymedicated and had a score of 7 on the Naranjo Adverse Drug Reaction Probability Scale. The patient was diagnosed as atypical DRESS syndrome and resolved satisfactorily with symptomatic treatment and topiramate withdrawal, and slowly, the lesions regressed (p. 425, Abstract, lines 5-13).
Regarding the use of topiramate, Bello-Hernández further teaches topiramate is associated with dermatological complaints including urticaria and angioedema as well as photosensitivity and pigmentary changes that return to normal after the discontinuation of the drug (p. 26, Conclusions section, lines 11-14). Bello-Hernández teaches that topiramate use causes or related to localized or generalized nonscarring alopecia, exanthema, pruritus, fixed drug eruption, acneiform eruptions, and hyperhidrosis (p. 27, left column, lines 1-6).
Therefore, in view of the prior art, one of ordinary skill in the art would have recognized topiramate as effective against inflammatory skin conditions. However, one of ordinary skill in the art would have further recognized the occurrence of certain topiramate-induced dermatological conditions, and one of ordinary skill in the art would have found treatment of these topiramate-induced skin conditions to be unpredictable.
The relative skill of those in the art: The relative skill of those in the art is high.
The predictability or unpredictability of the art: The lack of prior art disclosing a single treatment for any dermatological condition means that one skill in the art cannot predict the usefulness of a product or method to make these conditions possible.
In addition, in view of Bello-Hernández teaching the association of topiramate use with specific dermatological conditions, one of ordinary skill in the art would have found a claim that topical administration of a composition comprising topiramate is effective for treating any dermatological condition to be unpredictable.
Therefore the invention of claim 10 is unpredictable.
The breadth of the claims: The scope of the claims includes a method for treating any dermatological condition comprising a step of administering to a subject in need thereof a composition comprising topiramate and bioxome, redoxome, HA, extracellular vesicles (EV), or PRP extracellular vesicles, or any combination thereof.
The amount of direction or guidance presented: Regarding skin aging, the specification provides that skin aging is a part of a natural human "aging mosaic" which follows different trajectories in different organs, tissues and cells with time. While the aging signs of internal organs are masked from the ambient "eyes," the skin provides first obvious marks of the passing time. The specification further provides that different models are proposed to explain the molecular basis for skin aging, including the theory of cellular senescence, decrease in cellular DNA repair capacity and loss of telomeres, point mutations of extranuclear mitochondrial DNA, oxidative stress, increased frequency of chromosomal abnormalities, single-gene mutations, reduced sugar, and chronic inflammation (p. 1, [001]).
Regarding psoriasis, the specification provides that psoriasis is a chronic inflammatory skin condition characterized by clearly defined, red and scaly plaques (thickened skin), and affects 2-4% of males and females. The specification provides that psoriasis can start at any age including childhood, with peaks of onset at 15-25 years and 50-60 years, and it tends to persist lifelong, fluctuating in extent and severity (p. 2, [004]).
Finally, the specification provides that the composition comprising topiramate and bioxome, redoxome, hyaluronic acid (HA), extracellular vesicles (EV), or platelet-derived (PRP) extracellular vesicles, or any combination thereof, as recited in the claims, is useful in the treatment of dermatological compositions including akin aging and psoriasis (p. 2, [007]).
The specification does not provide guidance regarding treatment of the full scope of inflammatory conditions encompassed by claim 10.
The presence or absence of working examples: The specification provides working examples evaluating the epidermal viability of ex vivo cultures of human skin challenged with lipopolysaccharide and treated with topiramate with and without bioxome (p. 44, Example 1), the anti-inflammatory effect of bioxome-encapsulated topiramate in an ex vivo human skin inflammation model (pp. 44-45, Example 2), the effect of topiramate with and without bioxome on the secretion of several anti-inflammatory markers in macrophage RAW 264.7 cells (p. 45, Example 3), the effect of Topiramate with and without bioxome on cell proliferation (p. 45, Example 4), histological evaluation of topiramate with and without bioxome on inflammation-induced hyperproliferation and skin morphology in ex vivo human skin (pp. 45-46, Example 5), the effect of topiramate with and without bioxome on the secretion of PGE2, IL-6, IL-8 in keratinocytes HaCaT cells (p. 46, Example 6), and the effect of Topiramate with and without bioxome on MMP-1 (collagenase) activity (p. 46, Example 7), and ex vivo histological evaluation on human skin treated with Topiramate with or without bioxome following UV radiation (p. 47, Example 8).
The specification does not provide working examples that provide evidence of treating dermatological conditions beyond the scope of treating inflammatory dermatological conditions using the composition recited in claim 10.
Note that a lack of working examples is a critical factor to be considered, especially in a case involving an unpredictable and undeveloped art such as the treatment of the full scope of dermatological conditions encompassed by claim 10. See MPEP 2164.
The quantity of experimentation required: In order to practice the invention of treating the full scope of dermatological conditions using the presently claimed composition, one of ordinary skill in the art would be required to undertake a novel and extensive research program to demonstrate the presently claimed composition is effective for treating any dermatological condition. Because this research would need to be exhaustive, because it would involve a wide scope of dermatological conditions for which there is no single cause or mechanism of disease, it would constitute an undue and unpredictable search burden.
Genentech, 108 F.3d at 1366, sates that, “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion.” And “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims and the nature of the invention, Applicants fail to provide information sufficient to practice the claimed invention for treating the full scope of dermatological conditions by administering to a subject in need the composition recited in the present claims.
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 7, 9, 21, and 24 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.
Claims 7, 9, 21, and 24 recite a Markush group using the open or inclusive term comprising. This is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See MPEP 2173.05(h) at I states: “A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.”
This rejection may be overcome by amending each of these claims to recite “selected from the group consisting of.” In this instance, the claims should be amended to recite “and” between the final members of the Markush group to properly convey the closed Markush group.
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:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 10-11, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Shapira (U.S. pre-grant publication no. US 20110257257 A1; cited in PTO-892) in view of Glozman (Publication no. WO 2019198068 A1; cited in PTO-892).
Claim 1 is drawn to a composition comprising topiramate and bioxome, redoxome,
Hyaluronic acid (HA), extracellular vesicles (EV), or platelet rich derived (PRP) extracellular vesicles, or any combination thereof. Claim 2 requires topiramate and a bioxome, claim 3 requires topiramate is encapsulated by said bioxome, claim 4 requires the composition requires the composition further comprises an excipient, claim 5 requires the excipient or topiramate are encapsulated in said bioxome, claim 6 requires the composition is formulated for topical delivery, and claim 7 requires an additional excipient selected from the group listed.
Claim 10 claims a method for treating a dermatological condition comprising a
step of administering to a subject in need thereof a composition comprising topiramate
and bioxome, redoxome, HA, extracellular vesicles (EV), or PRP extracellular vesicles,
or any combination thereof. Claim 11 requires the dermatological is an inflammatory condition. Claim 16 depends from claim 10 and requires said composition comprises topiramate and a bioxome, claim 17 requires topiramate is encapsulated by said bioxome, claim 18 requires the composition of claim 10 further comprises an excipient, claim 19 requires the at least one excipient, or topiramate, or any combination thereof is encapsulated in said bioxome, in said redoxome, in said HA, in said extracellular vesicles (EV), or in said PRP extracellular vesicles, claim 20 requires the composition is administered is administered topically, and claim 21 requires an additional excipient selected from the group listed.
Shapira teaches a composition for treating disorders associated with epithelial tissue, specifically topiramate compositions which are formulated for topical treatment of wounds and scars (p. 1, [0002], lines 1-4). Shapira teaches and claims formulations comprising a GABA agonist and an oil-in-water carrier, and specifies the GABA agonist is topiramate (p. 17, claims 1 and 2).
Shapira teaches their topiramate composition is effective for providing beneficial outcomes in accelerated wound healing, fresh and mature scarring, atrophic skin disorders, autoimmune skin disorders associated with interrupted skin barrier, and inflammatory skin disorders associated with interrupted skin barrier (pp. 4-5, [0087], lines 1-7).
Shapira teaches that characterization data of topiramate showed that this drug has some water solubility and also potential affinity to lipids (p. 9, [0128], lines 8-10). In addition, Shapira teaches topiramate is suitable for incorporation into oil-in-water based formulations due to its partial aqueous solubility, and, also into fatty ointments due to its hydrophobic properties and potential affinity to lipids (p. 9, [0134]). Shapira further recognizes that topiramate is unstable in aqueous environments and thus must be formulated as a dry composition or as a pure oily/fatty composition (p. 4, [0076, lines 12-14).
Finally, Shapira teaches their composition may be administered as a cream comprising additional excipients including water, dimethicone, stearic acid, isopropyl myristate, mineral oil, glycerin, glyceryl stearate, cetyl alcohol, pentenol and TEA (p. 1, [0017], lines 1-4).
Shapira does not teach a composition comprising topiramate and bioxome, redoxome, hyaluronic acid (HA), extracellular vesicles (EV), or platelet rich derived (PRP) extracellular vesicles, or any combination thereof, as required by independent claim 1. In addition, Shapira does not teach a method of treating a dermatological condition by administering to a subject in need a composition comprising topiramate and bioxome, redoxome, HA, extracellular vesicles (EV), or PRP extracellular vesicles, or any combination thereof, as required by independent claim 10.
Glozman teaches artificial bioxome particles comprising a cell membrane component and designed to undergo fusion with a target cell, wherein said bioxome particle is engineered to carry a cargo comprising at least one predetermined active molecule; and wherein said cargo can be released into the target cell after the fusion of the bioxome particle with the target cell (cover page, Abstract, lines 1-6).
Glozman teaches that based on its membrane fusion and intracellular targeting features, exosomes holds promise to apply as a drug delivery system in order to overcome unsolved need in currently used in the state of the art DDS (p. 2, lines 25-28), which includes improving the poor bioavailability of active natural and therapeutic drugs which are hydrophobic in nature.
Glozman further teaches their invention provides a method of improving a skin condition in a subject in need comprising administering to the subject the composition comprising an
artificial bioxome particle comprising a cell membrane component and designed to undergo fusion with a target cell, wherein said bioxome particle is engineered to carry a cargo comprising at least one predetermined active molecule and wherein said cargo can be released into the target cell after the fusion of the bioxome particle with the target cell (p. 5, lines 17-26) (emphasis added). Glozman specifies that a group of disorders that may be treated include inflammatory disorders such as a chronic or acute inflammatory skin disorder (p. 26, line 30 to p. 27, line 1). Glozman teaching the bioxome is engineered to carry a cargo comprising an active molecule is interpreted as the active molecule being encapsulated by the bioxome.
Therefore, one of ordinary skill in the art would have considered a bioxome formulation disclosed by Glozman for delivering a therapeutic agent to epithelial tissue for the purposes of improving a skin condition, including inflammatory skin conditions.
Glozman further teaches the bioxome particles are formulated with suitable excipients and carriers (p. 18, lines 19-21), and that the bioxome particles can be formulated can be administered as topical creams, pastes, ointments, gels, lotions and the like (p. 27, lines 24-26). These formulations are interpreted as further comprising an excipient, as required by claims 4 and 18.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to formulate topiramate with bioxomes for the purposes of treating a skin condition. One of ordinary skill in the art would have been motivated to formulate topiramate with bioxomes for the purposes of treating a skin condition because Shapira teaches topiramate for treating disorders of epithelial tissue, including inflammatory-related diseases, and because Glozman teaches that bioxomes are useful for delivering drugs for treating skin conditions, enabling delivery of a drug cargo to a cell by undergoing fusion with said cell. In addition, in view of Shapira teaching that topiramate has some water solubility but also an affinity for lipids, and that it should be formulated as a dry composition (e.g. tablets) or as a pure oily/fatty composition because it unstable in aqueous environments, one of ordinary skill in the art would have considered formulation of topiramate with bioxomes, because Glozman teaches bioxomes may improve the bioavailability of hydrophobic therapeutic agents.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because Shapira recognizes topical topiramate for inflammatory disorders of the skin and Glozman teaches improved bioavailability of hydrophobic drugs using bioxomes and teaches bioxome formulations for treating an inflammatory condition of the skin, one of ordinary skill in the art would have contemplated formulation of topiramate in bioxomes, because such a formulation may improve the bioavailability of topiramate and improve its effectiveness in treating skin disorders compared with administration of topiramate alone.
Regarding the method of claims 10-11, because Shapira teaches topiramate for the purposes of treating dermatological conditions, including inflammatory dermatological conditions, and Glozman teaches bioxomes useful for delivering therapeutic agents to the skin for the purposes of treating skin disorders, including inflammatory skin disorders, the method of claims 10 and 11 is also Shapira in view of Glozman.
Regarding the additional excipients required by the composition of claim 7 and the method of claim 21, because Shapira teaches that topiramate may be administered as a cream in a formulation that comprises excipients such as dimethicone and mineral oil, and because Glozman teaches that bioxome particles may be incorporated into a broad range of topical dosage forms including topical creams, one of ordinary skill in the art would have reasonably contemplated formulation of the bioxome-encapsulated topiramate as the cream disclosed by Shapira, because each of Shapira and Glozman teach their inventions formulated as creams, and thus such a formulation would be expected to be effective for topically delivering topiramate and bioxome to the skin.
Therefore the invention taken as a whole is prima facie obvious.
Claims 8-9, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Shapira (U.S. pre-grant publication no. US 20110257257 A1; cited in PTO-892) in view of Glozman (Publication no. WO 2019198068 A1; cited in PTO-892) as applied to claims 1-7, 10-11, and 16-21 above, and further in view of Falk (Publication no. WO 1993016732 A1; cited in PTO-892).
Claim 8 depends from claim 1 and requires the composition further comprises an additional therapeutic agent for healing inflammatory condition of the skin, and claim 9 requires said additional therapeutic agent is selected from the group recited in the claim.
Claim 22 depends from claim 10 and requires the composition used in the method of claim 10 further comprises an additional therapeutic agent for healing inflammatory condition of the skin, and claim 24 requires said additional therapeutic agent is selected from the group recited in the claim.
Shapira and Glozman teach as described in the above rejection under 35 U.S.C. 103.
Shapira and Glozman do not teach the additional therapeutic agent recited in claims 8-9, 22, and 24.
Falk teaches combinations of NSAIDs and hyaluronic acid for clinical use treating neoplastic disease and other conditions where excessive prostaglandin synthesis represents the basis of the pathogenesis of this disease state, which includes arthritis and various others of the so-called tissue inflammatory disorders and/or auto-aggressive diseases (p. 10, lines 19-26).
Specifically, Falk teaches topical treatments for psoriasis and other conditions of the skin which include a drug, that, for example, inhibits prostaglandin synthesis. Falk teaches the drug is preferably a nonsteroidal anti-inflammatory drug (NSAID) (e.g., diclofenac, indomethacin, naproxen) (p. 13, line 34-p. 14, line 1).
Therefore, in view of Falk, one of ordinary skill would have considered administration of a topical composition comprising an NSAID for the purposes of a treating an inflammatory disorder with excessive prostaglandin synthesis.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the composition obvious over Shapira in view of Glozman with an NSAID. One of ordinary skill in the art before the effective filing date of the present application to modify the composition obvious over Shapira in view of Glozman with an NSAID because Shapira teaches topical topiramate compositions for treating skin disease, including those associated with inflammation, Glozman teaches the benefits of bioxome-mediated drug delivery to epithelial tissue, and because Falk teaches NSAIDS for treating conditions associated with increased prostaglandin synthesis, such as inflammatory conditions of the skin, one of ordinary skill in the art would have contemplated the addition of an NSAID to the composition obvious over Shapira in view of Glozman, because addition of an NSAID may be a more effective treatment for the inflammatory condition than the topiramate formulation obvious over Shapira in view of Glozman lacking the NSAID.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because Shapira and Glozman render obvious a composition comprising topiramate and bioxome for treating an inflammatory condition of the skin, and because Falk recognizes NSAIDS for treating inflammatory conditions associated with the skin that have elevated prostaglandin synthesis, one of ordinary skill in the art would have contemplated a composition comprising topiramate, bioxome, and NSAID, as well as administration of this composition for treating inflammatory conditions of the skin, because this combination may be a more effective treatment than administering the composition comprising topiramate and bioxome without the NSAID.
Therefore the invention taken as a whole is prima facie obvious.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Shapira (U.S. pre-grant publication no. US 20110257257 A1; cited in PTO-892) in view of Glozman (Publication no. WO 2019198068 A1; cited in PTO-892) as applied to claims 1-7, 10-11, and 16-21 above, and further in view of Ryback (U.S. pre-grant publication no. U.S. 20040014681 A1; cited in PTO-892).
The examiner believes claim 11 is obvious over Shapira in view of Glozman, as described in the above rejection under 35 U.S.C. 103. However, claim 11 is also obvious over Shapira in view of Glozman and Ryback, because psoriasis is considered an inflammatory dermatological condition.
Claim 11 depends from claim 10 and requires the dermatological condition is an inflammatory condition, and claim 12 depends from claim 111 and requires said inflammatory condition is a TNF-mediated inflammatory disease, selected from skin aging or psoriasis.
Shapira and Glozman teach as described in the above rejection under 35 U.S.C. 103.
Shapira and Glozman do not teach expressly teach the method of treating an inflammatory condition of the skin, as required by claim 11, such as skin aging or psoriasis, as required by claim 12.
Ryback teaches and claims a method for treating a patient suffering from dermatoses
or tissue damage or both which comprises topically applying a therapeutically effective amount of a compound of the formula (I) as shown in the claim (p. 7, claim 1), wherein the compound of formula (I) is topiramate (p. 7, claim 4), and wherein the wherein the dermatoses is from psoriasis (p. 7, claim 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to administer the composition comprising topiramate and bioxomes obvious over Shapira in view of Glozman to a patient for the purposes of treating psoriasis because Shapira and Glozman each acknowledge their respective components of the composition as useful for treating inflammatory disorders of the skin, and because Ryback further teaches that a topical formulation of topiramate is effective for treating psoriasis. Accordingly, one of ordinary skill in the art would have considered administering the composition obvious over Shapira in view of Glozman for the purposes of treating psoriasis.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 4-12, 18-22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Falk (Publication no. WO 1993016732 A1; cited in PTO-892) in view of Ryback (U.S. pre-grant publication no. U.S. 20040014681 A1; cited in PTO-892).
Falk teaches as described in the above rejection under 35 U.S.C. 103.
In addition, Falk teaches and claims pharmaceutical compositions from which effective non-toxic (to the patient) dosage amounts may be taken and applied to the skin and/or exposed tissue of a human, comprising pharmaceutical excipients suitable for topical application, an effective non-toxic dosage amount of a drug to treat and to assist to resolve a disease and/or condition of the skin and/or exposed tissue of a human and an effective non-toxic dosage amount of hyaluronic acid or analogue thereof (p. 77, claim 1).
Falk further claims the hyaluronic acid or analogue thereof is hyaluronic acid (p. 77, claim 2), and wherein the drug is an NSAID (p. 78, claim 6). Falk claims the disease and/or condition is selected from a group that includes psoriasis (p. 77, claim 3).
Falk teaches excipients that may be used in their composition include glycerin and benzyl alcohol (p. 20, line 35). Glycerin is one excipient recited in claims 7 and 21.
Moreover, Falk teaches benefits of their composition, including that they are quick to penetrate into the skin to the site of the trauma and/or pathology because the effective dosage amount of the form of hyaluronic acid transports or facilitates transport of the drug (for example NSAID) particularly to the epidermis where the composition, combination or formulation accumulates and remains for prolonged periods (p. 13, lines 4-10).
Falk does not teach a composition comprising topiramate, as required by independent claim 1, or a method of treating a dermatological condition by administering a composition comprising topiramate, as required by independent claim 10.
Ryback teaches as described in the above rejection under 35 U.S.C. 103.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to formulate a composition comprising topiramate, hyaluronic acid, and an NSAID for topical drug delivery for the purposes of treating psoriasis. One of ordinary skill in the art would have been motivated formulate a composition comprising topiramate, hyaluronic acid, and an NSAID for topical drug delivery because Falk teaches a method of treating skin conditions, including psoriasis, by topically administering a composition comprising hyaluronic acid and an NSAID, and because Ryback teaches topical topiramate for treating psoriasis.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because Falk recognizes a composition comprising hyaluronic acid and an NSAID for treating psoriasis and Ryback teaches topical topiramate for treating psoriasis, a composition comprising these components and administration of this composition for treating psoriasis may be a more effective psoriasis treatment than either of hyaluronic acid and NSAID or topiramate alone.
Moreover, because Falk teaches the benefits of their delivery system include accumulation of the drug to the epidermis where it remains for prolonged periods of time, one of ordinary skill in the art would have recognized that the effective dosage of the NSAID and/or topiramate may be reduced because of enhanced accumulation of the drug at the site of administration, such as at the site of psoriasis.
Regarding the limitations of claims 5 and 19, which depend from claims 4 and 10, respectively, and require topiramate and/or at least one excipient is encapsulated in said hyaluronic acid, because Falk teaches formulations comprising, for example, topiramate, hyaluronic acid, and excipient as a semi-solid cream or gel formulation, these formulations would be expected to have excipient encapsulated in the hyaluronic acid that is present in the gel or cream, absent evidence to the contrary.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed.
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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693