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 .
DETAILED ACTION
The amended claims filed on 11/12/2024 are acknowledged. Claims 1-10 are pending.
Information Disclosure Statement
References 6 and 7 in the non-patent literature section of the IDS filed 4/17/2026 have not been considered as they are unreadable.
The Information Disclosure Statements filed on 4/17/2026 and 11/21/2025 have been considered. An initialed copy is attached hereto.
Specification
The use of the terms Thermo Fisher, Falcon, TaqMan, ITGAX, Qiagen, Corning, Lonza, Biolegend, Keyence, Vector Laboratories, Invitrogen, Olympus, and others which are trade names or marks used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
It should be noted that the cited occurrences of improper use are only exemplary and Applicant should review the entire specification to correct any other improper use of trademarks.
Claim Objections
Claim 2 is objected to because it recites “hidradentitis” which is an apparent typographical error, it should be spelled “hidradenitis”.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 recites the limitation "The method of claim 1, wherein the agent that blocks the interaction of CD2 and CD58”. There is insufficient antecedent basis for this limitation in the claim because claim 1 does not recite “the interaction of CD2 and CD58”. The rejection can be overcome by making claim 7 dependent on claim 3. In the interest of compact prosecution, the examiner will interpret claim 7 as being dependent on claim 3.
Claim Rejections - 35 USC § 102
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 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Pincelli et al.(Mechanisms Underlying the Clinical Effects of Apremilast for Psoriasis August 2018 | Volume 17 | Issue 8).
Regarding claim 1, Pincelli discloses “In a phase II open-label, single-arm trial in patients with recalcitrant psoriasis, 12 weeks of treatment with apremilast 20 mg twice daily reduced infiltration of myeloid dendritic cells, T cells, and NK cells into the dermis and epidermis” [p.837 par.3]. This is a reduction in NK cell activity in the skin. Psoriasis is an inflammatory disorder of the skin [Pincelli, p.835 Introduction]. Thus, Pincelli anticipates a method for treating an inflammatory skin disorder in a subject comprising administering to a subject having an inflammatory skin disorder an agent that inhibits NK cell activity.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over US20200368363A1 (Published 11/26/2020) hereinafter US363 in view of US20030185824A1 (Published 2/10/2003) hereinafter US824 as evidenced by US20210205632A1 (Published 7/8/2021).
Regarding claims 1, US363 teaches a method to treat an autoimmune disease, such as by administration of an anti-CD2 antibody so as to deplete a population of CD2+ autoimmune cells e.g. natural killer (NK) cells, the disease may be a skin disease such as psoriasis or hidradenitis suppurativa [par.173]. US363 fig.4 discloses an anti-CD2 antibody (RPA-2.10) causes killing of NK cells [par.315] Depletion of NK cells by killing reduces their activity.
It is noted that psoriasis and hidradenitis suppurativa are inflammatory skin disorders [instant specification p.8 last paragraph].
US363 does not specifically teach that the anti-CD2 antibody was effective in treating a skin disorder even though they suggest its use for skin disorders.
US824 teaches a method of treating, or preventing, in a subject, an epidermal or dermal disorder characterized by aberrant T cell activity or proliferation, comprising administering to the subject an inhibitor of the CD2/LFA-3(CD58) interaction [par.2 and claim 1]. The skin disorder can be an inflammatory disorder e.g. psoriasis [par.12]. US824 teaches that a CD2 binding agent, e.g., an LFA-3 soluble protein, in combination therapy, light therapy, is effective to clear psoriasis [par.222]. Taken together a person having ordinary skill in the art would understand that disruption of the CD2/CD58 interaction can treat inflammatory skin disorders and reduce NK cell activity.
It is noted that LFA-3 is an alternative name for CD58 [US363 par.435].
It would have been obvious to a person having ordinary skill in the art to combine the teachings of US363 with US824 in order to arrive at treating an inflammatory skin disorder in a subject comprising administering to a subject an agent that disrupts the CD2/CD58 interaction and inhibits NK cell activity. A person having ordinary skill in the art would have been motivated to treat skin disorders so that patients will not have unattractive skin.
There would have been reasonable expectation of success because US824 demonstrated that disrupting the CD2/CD58 binding could clear psoriasis and US363 demonstrated an anti-CD2 antibody depleted NK cells which cause inflammation.
Regarding claim 2, US363 teaches the disease can be hidradenitis suppurativa [par.173] and it would have been obvious to try other inflammatory skin diseases if the treatment worked in psoriasis.
Regarding claim 3, US824 teaches CD2/LFA-3(CD58) interaction [par.2 and claim 1],
Regarding claim 4-5, US824 teaches an anti-CD2 antibody [par.18] and US363 teaches and anti-CD2 antibody [par.173] these are anti-CD2 agents.
Regarding claim 6, US363 teaches in one embodiment, the anti-CD2 antibody is Siplizumab [par.456].
Regarding claim 7-8, US824 teaches in a preferred embodiment, the LFA-3- binding agent is an anti-LFA-3 antibody [par.21]. It is noted that LFA-3 is an alternative name for CD58 [US363 par.435].
Regarding claim 9, US824 teaches an anti-fibrotic agent in the form of UVA light as an additional auxiliary agent used in therapy, US824 teaches the use of an auxiliary agents which include light therapy (e.g., UVA) [par.23]. It is noted that UVA is an anti-fibrotic agent [US20210205632A1 par.335].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US363 in view of US824 as applied to claim 1 above in further view of Napolitano et al. (Treatment of Pediatric Psoriasis: A Review. Dermatol Ther (Heidelb). 2016 Jun;6(2):125-42. doi: 10.1007/s13555-016-0117-6. Epub 2016 Apr 16. PMID: 27085539; PMCID: PMC4906111).
Regarding claims 10, US363 and US824 teach claim 1 as indicated in the above rejection. They do not specifically teach wherein the subject's inflammatory skin disorder is refractory to one or more previous treatments of the inflammatory skin disorder, wherein the previous treatment was not an agent that blocks the interaction of CD2 and CD58.
Napolitano teaches a variety of treatments for pediatric psoriasis which is an inflammatory skin disorder. Napolitano teaches due to the risk of adverse reactions and other potential adverse effects, use of systemic medications for the treatment of psoriasis in children is generally reserved for recalcitrant disease [p.128 par.2] This is interpreted to mean that the initial treatment was not systemic, and the psoriasis was recalcitrant to the initial treatment and subsequently a systemic treatment was administered. As an example, Napolitano teaches sporadic case reports have demonstrated infliximab efficacy for the treatment of recalcitrant, generalized pustular or erythrodermic psoriasis in children after an initial treatment failure with methotrexate [p.135 par.3]. Methotrexate is an antimetabolite that modulates the immune system and the inflammatory processes [p.130 par.2], and Infliximab is a chimeric monoclonal antibody that acts by TNF alpha. These 2 treatments have different targets. Thus, methotrexate was administered and psoriasis was recalcitrant to its effect and treatment was switched to infliximab. Napolitano’s publication as a whole indicates this was a well-known strategy of a person of ordinary skill in the art prior to the effective filing date of the instant application.
Therefore, it would have been obvious to a person of ordinary skill in the art to combine the teachings of US363 and US824 with Napolitano to arrive at treating a person for an inflammatory skin disorder with an anti-CD2 antibody if that person was recalcitrant to a previous treatment that was not one that blocks the interaction of CD2 and CD58. A person of ordinary skill in the art would have been motivated to improve the skin disorder of a person who was unable to find improvement in a previous treatment by trying a treatment which targets a different mechanism of action.
There would be a high probability of success because Napolitano discloses a variety of treatments of recalcitrant symptoms improved when an alternative treatment was used.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 10am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647
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