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 .
Claim Status
Claims 2-12 and 14-24 are pending.
Claims 2-12 and 14-24 are rejected.
No claims are allowed.
Drawings
The drawings filed on 07/02/2024 are objected to for the following reason:
Figures 1, 2, and 6: The data plots do not adequately covey their meaning on the face of the drawings. Drawings should be capable of communicating the information presented with minimal reliance on the specification, including clear identification of the plotted data, relevant units, and explanatory legends where appropriate. In the present figures, the plotted data are identified solely through numerical reference designations, requiring the reader to repeatedly consult the specification to determine what each plot represents. This practice detracts from clarity and usefulness of the drawings. Accordingly, Applicant is encouraged to replace or supplement the current numbering convention with descriptive legends or other labeling that clearly identifies the corresponding data sets directly within the figures. Additionally, due to the visual similarities between Figures 1 and 2, and although the y-axis of each figure is clear and distinct, Applicant is encouraged to add descriptive titles to further enhance clarity and avoid any potential ambiguity. For consistency and improved readability, a descriptive title should likewise be added to Figure 6.
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.
Priority
Acknowledgment is made of applicant's claim of priority to U.S. Provisional Patent Application No. 63/266,433 filed 01/05/2022, and U.S. Provisional Patent Application No. 63/382,008 filed 11/02/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/02/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
[1] Claims 2, 6, 7, 9, 12, 14, 16, and 23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being unpatentable by Rodemer (US 2009/0306097A1, published 12/10/2009).
In regard to claims 2, 6, 7, Rodemer teaches a pharmaceutical composition for topical administration to the skin comprising from 1-10% by weight of the total composition of allopurinol or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is formulated for topical administration to the skin (claim 27). The pharmaceutical composition further comprises pyridoxine (i.e., co-agent) (claim 31). The pharmaceutical composition is in the form of a hydrophylic cream (i.e., carrier) (claim 32).
In regard to claims 9, Rodemer teaches that creams are oil-in-water emulsions (paragraph [0066]).
In regard to claims 12, 14, and 16, Rodemer teaches that allopurinol can be used for the treatment or prevention of palmar plantar erythrodysesthesia (PPE) (i.e., hand-foot syndrome) (abstract). Pyridoxine has been used to decrease the pain from PPE (paragraph [0028]).
In regard to claim 23, Rodemer teaches that the topical pharmaceutical composition may be applied once, twice, or three times daily (paragraph [0082]).
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.
[2] Claims 2-12, 14, 16, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Rodemer (US 2009/0306097A1, published 12/10/2009) in view of Hersh (US 6,011,067, patented 01/04/2000).
In regard to claims 2, 6, 7, Rodemer teaches a pharmaceutical composition for topical administration to the skin comprising from 1-10% by weight of the total composition of allopurinol or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition is formulated for topical administration to the skin (claim 27). The pharmaceutical composition is in the form of a hydrophylic cream (i.e., carrier) (claim 32).
In regard to claims 9, Rodemer teaches that creams are oil-in-water emulsions (paragraph [0066]).
In regard to claim 11, Rodemer teaches that the pharmaceutical composition further comprises pyridoxine (claim 31). Pyridoxine has been used to decrease the pain from PPE (paragraph [0028]).
In regard to claims 12, 14, and 16, Rodemer teaches that allopurinol can be used for the treatment or prevention of palmar plantar erythrodysesthesia (PPE) (i.e., hand-foot syndrome) (abstract).
In regard to claim 23, Rodemer teaches that the topical pharmaceutical composition may be applied once, twice, or three times daily (paragraph [0082]).
Rodemer further teaches that the composition may comprise conventional additives and adjuvants for dermatological applications, such as antioxidants (paragraph [0076]).
Rodemer differs from the instant claims insofar as not disclosing wherein the pharmaceutical composition comprises glutathione.
However, Hersh discloses a combination of several synergistic antioxidants as adjuncts to therapy of desquamating inflammatory disorders, such as psoriasis, in a topical composition (col. 1, lines 6-10). Glutathione is of value in prevention of tumor formation, making it the ideal antioxidant included in dermatologic preparations (col. 6, lines 9-12). The composition comprises glutathione in an amount from approximately 0.001% to 15% (claim 5). A composition for treating psoriasis comprises as active ingredients L-glutathione and a source of selenium in a suitable carrier for topical application (claim 1).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Rodemer discloses that the composition comprises antioxidants. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.001% to 15% glutathione into the composition of Rodemer since it is a known and effective antioxidant and it has tumor formation prevention properties making it an ideal antioxidant for dermatologic preparations as taught by Hersh.
In regard to claim 10, the composition of Rodemer does not require any active ingredient other than allopurinol (see claim 27). Therefore, inclusion of glutathione into the composition of Rodemer will make allopurinol and glutathione the only active ingredients.
In regard to claim 24, Rodemer discloses that the composition may be applied once, twice or three times daily, but also more frequent daily applications such as 5 to 10 times a day are possible provided that the symptoms of PPE are avoided. The dosage may be variable, in function of the severity of the PPE symptoms, or the cycles or dosages of the chemotherapeutic treatment (paragraph [0082]). Therefore, it would have been obvious that one of ordinary skill in the art would have arrived at the claimed duration depending on the severity of the PPE symptoms.
[3] Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rodemer (US 2009/0306097A1, published 12/10/2009) in view of Hersh (US 6,011,067, patented 01/04/2000), and further in view of Murrell et al. (“Murrell“) (British Medical Journal, Volume 295, published 11/28/1987).
The teachings of Rodemer and Hersh are discussed above. Rodemer and Hersh do not explicitly teach treatment of Dupuytren’s contracture.
However, Murrell teaches that Dupuytren’s contracture tissue contains elevated concentrations of hypoxanthine and detectable xanthine oxidase activity, thereby establishing a potential for oxygen free radical generation (see, Abstract; Discussion). Murrell further teaches that free radicals may stimulate fibroblast proliferation and that allopurinol, by binding to xanthine oxidase and preventing free radical release, may be useful in Dupuytren’s contracture (see, Discussion). Murrell additionally teaches that the “benefit of allopurinol in the management of Dupuytren's contracture and other fibrotic conditions may thus be explained” by inhibition of free radical production (see, Abstract).
Accordingly, it would have been obvious to one of ordinary skill in the art to have utilized the topical formulation taught by Rodemer for treatment of Dupuytren’s contracture since the topical formulation of Rodemer comprises allopurinol and allopurinol is beneficial in the management of Dupuytren’s contracture as taught by Murrell.
[4] Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rodemer (US 2009/0306097A1, published 12/10/2009) in view of Hersh (US 6,011,067, patented 01/04/2000), and further in in view of Lejding et al. (“Lejding“) (Contact Dermatitis, 82(1):45–53, published 10/04/2019), as evidenced by Helm (Allergic Contact Dermatitius, Jun. 24, 2026).
The teachings of Rodemer and Hersh are discussed above. Rodemer and Hersh do not explicitly teach treatment of an allergic reaction, specifically a cutaneous allergic reaction.
However, Lejding teaches skin application of glutathione and iron sulfate containing formulations for inhibition of elicitation of allergic contact dermatitis (ACD) in Cr(VI)-allergic individuals when exposed to Cr(VI) (abstract).
As discussed above, it would have been obvious to have incorporated glutathione into the composition of Rodemer. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have additionally incorporated iron sulfate into the composition of Rodemer motivated by the desire to treat elicitation of allergic contact dermatitis from hexavalent chromium (Cr(VI)) since skin application of glutathione and iron sulfate can inhibit elicitation of allergic contact dermatitis from hexavalent chromium (Cr(VI)) as taught by Lejding.
In regard to claim 19, as evidenced by Helm, allergic contact dermatitis is a delayed-type induced sensitivity resulting from cutaneous contact with a specific allergen to which the patient has developed a specific sensitivity (first paragraph).
[5] Claims 15 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Rodemer (US 2009/0306097A1, published 12/10/2009) in view of Hersh (US 6,011,067, patented 01/04/2000), and further in view of Perricone et al. (“Perricone“) (US 2006/0063718 A1, published 03/23/2006).
The teachings of Rodemer and Hersh are discussed above. Rodemer and Hersh do not explicitly teach treatment of cutaneous cellular proliferative disorder, slowing proliferation of cells involved in such disorders, or relief of symptom associated therewith.
However, Perricone teaches topical glutathione compositions for treatment of psoriasis (see, abstract). The reference teaches that psoriasis results from keratinocyte skin cells to regenerate too quickly (paragraph [0003]) and further teaches that glutathione regulates the cell growth cycle such that skin cells are produced in a normal manner instead of the accelerated state typical of psoriasis (paragraph [0032]) (i.e., proliferation of cells is slowed). The reference additionally teaches improvement and clearing of lesions and decrease in inflammation, irritation, and erythema (i.e., relieving at least one symptom) (paragraph [0031]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have employed the topical formulation taught by Rodemer in view of Hersh for treatment of psoriasis (i.e., a cutaneous cellular proliferative disorder) since the formulation comprises glutathione and glutathione regulates the abnormal keratinocyte growth cycle associated with psoriasis as taught by Perricone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI M ALAOUIE whose telephone number is 571-272-0844. The examiner can normally be reached Flextime: (M-TH) 7:30 am 6:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALI M. ALAOUIE/Examiner, Art Unit 1614
/TRACY LIU/Primary Examiner, Art Unit 1614
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