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/Restrictions
Applicant’s election without traversal of the species of protozoan disease, and Compound 6027, in the reply filed on June 26, 2026.
Applicant has identified the specific moieties and residues attached to Formula I,
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where R1, R2, and R3 are as follows -
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The species elected without traverse, therefore, claims 1-20 which read upon the elected species has been considered. Claims 1-20 are hereby examined on the merits.
Election was made without traverse in the reply filed on June 26, 2026.
Priority
The present application is a 371 of PCT/EP2022/052891, filed February 7, 2022. Applicant’s claim for the benefit of a foreign application EP 21155878.8, filed February 8, 2021, is acknowledged.
Status of Claims
Claims 1-20 are pending and are currently examined on the merits herein.
Information Disclosure Statement
Information disclosure statements (IDS) submitted by the applicant on August 4, 2023, are in compliance with the provisions of 37 CFR 1.97. It has been considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The use of the terms Corning, ATCC, Taconic Farms, Harlan laboratories, Sigma-Aldrich, etc., which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms 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.
Appropriate correction is required.
Claim Interpretation
Legal standard: Broadest Reasonable Interpretation (BRI):
BRI of claim 1 and dependent claims is a method of treating a skin disease or skin disorder administering a compound, wherein the skin disease or skin disorder or cutaneous disease is caused by protozoa. The claim is given this construction in view of the election of species of protozoan disease, which read on claims 1-20; and in view of the definition in the instant specification which states “in a further preferred embodiment, said skin disease or skin disorder is a protozoan disease. In a further preferred embodiment, said skin disease or skin disorder is a protozoan skin infection. In a further preferred embodiment, said skin disease or skin disorder is caused by a parasite, preferably by a protozoan. In a further preferred embodiment, said skin disease or skin disorder is caused by a species of the genus Leishmania. In a further very preferred embodiment, said skin disease or skin disorder is cutaneous leishmaniasis.” (see instant specification [0217]).
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 1-12 and 15-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the instantly claimed invention is enabled for treating skin disease or skin disorder caused by protozoa, however, does not reasonably provide enablement for treating all skin diseases or disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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.
The nature of the invention and the breadth of the claims
The claims are drawn to a method of treating a skin disease or skin disorder comprising administering to a subject with an amount effective of a compound; wherein the skin infection comprises a protozoan infection; wherein the skin disease or skin disorder is cutaneous leishmaniasis.
Embodiments of the instant specification of skin diseases or skin disorders constitute a broad spectrum of diseases or disorders including inflammatory and infectious skin diseases or disorders (see [0005]); the present invention provides for compounds and pharmaceutical compositions for use in methods of topical treatment of skin diseases or disorders, in particular skin infections, which skin diseases or disorders, in particular skin infections, are caused by protozoal parasites, and here in particular by species of the genus Leishmania (see [0027]).
However, treating all skin infections as claimed reads on administering effective amount of the compound to any individual with a protozoan infection. The specification does not teach a method of treating all types of skin diseases for a patient in need, using the therapeutic compound/peptide as claimed. Accordingly, claim 1 and dependent claims are unduly broad with respect to a method of treating all skin diseases or skin disorders.
The State of the Prior Art and The Level of Predictability in the Art
The state of the art at the time of filing did not recognize that the claimed compound could prevent a range of skin infections or related diseases. For instance, while Applicants are enabled for treating a subset of skin infections (see instant [0216]) and prior art below, the art does not recognize that all skin infections can be prevented, let alone with designed inhibitory compounds such as the instant compound/peptide. Although the instant specification states the method can be used to treat skin disease or skin disorder is caused by a parasite, wherein said parasite is preferably a protozoan (see [0217]), there is no prior art that teaches the instant compound/peptide of claim 1 can treat all skin diseases or disorders. Prior art has investigated therapeutics for treating some skin infections caused by protozoa, that suggest that therapeutic treatment for all skin infections might be possible someday but is presently not an option.
The Level of Skill in the Art
Practitioners in this art (clinicians, scientists) would presumably be highly skilled in the art for prevention or treatment of disease in a subject.
The Amount of Direction Provided by the Inventor
At the time of filing, no direction or guidance was presented in either the prior art or the instant specification that would enable one to administer the instant compound to treat any skin disease or disorder as claimed. The instant specification does not provide adequate guidance with regard to the actual treatment or the effective amount of the compound that is required to prevent any skin disease or disorder. Applicants’ limited disclosure is noted but is not sufficient to justify claiming treatment of all skin diseases or disorders in a subject broadly. Absent a reasonable a priori expectation of success for using the compound/peptide as a method of treatment, one skilled in the art would have to extensively test the inhibitor compound on a representative number of subjects, determine dosing using different concentrations of the compound and ascertain a prevention standard.
The Presence or Absence of Working Examples
The instant specification provides no examples wherein compound is administered to any kind of skin disorders or related diseases.
The quantity of experimentation necessary
As there are no working examples in either the instant specification nor the prior art, reasonable guidance with respect to treating a skin disease or disorder through administration of the compound was limited. Consequently, one skilled in the art would be burdened with undue experimentation to determine the precise parameters and conditions necessary to effectively treat a skin disease or skin disorder.
Therefore, in view of the Wands factors, as discussed above, Applicants fail to provide sufficient information to practice the claimed invention for the treatment of a skin disease or skin disorder.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over EP 3 345 917 (Date of Publication: July 11, 2018; cited in IDS filed August 4, 2023) in view of Bartels et. al. (“Dermaseptins, Multifunctional Antimicrobial Peptides: A Review of Their Pharmacology, Effectivity, Mechanism of Action, and Possible Future Directions”; Emiel Jacob Henri Bartels, Douwe Dekker and Mohamed Amiche; Front. Pharmacol. 10:1421; published November 26, 2019).
EP’917 teaches pharmaceutical compositions comprising compounds and to the use of compounds in a method of treatment of a protozoan disease, wherein preferably said protozoan disease is …. Leishmaniasis (see Abstract); the inventive compounds are very potent inhibitors of protozoan parasites including Leishmania spp., ….and, thus, represents very active compounds for the treatment of protozoan diseases, ….leishmaniasis (see [0011]).
Regarding claims 1, 11-14, 18 and 20: EP’917 discloses pharmaceutical compositions comprising the same and the use of the compounds of formula (I) in methods of treatment of protozoan diseases, …. leishmaniasis, and preferably in methods of treatment of leishmaniasis (see [0001]). EP’917 discloses a compound of formula (I) (see claim 1), wherein said compound is –
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(see claim 11, and [0248]).
EP’917 further discloses certain compounds of formula (I) of the may contain one or two or more centers of chirality and such compounds may be provided as pure enantiomers or pure diastereoisomers as well as mixtures thereof in any ratio; the compounds of the invention also include all tautomeric forms of the compounds of formula (I) (see [0033]).
EP’917 teaches administering an inventive compound or pharmaceutical composition to a patient in a stage of infection with Leishmania genus can treat against cutaneous, mucocutaneous, and visceral forms of the disease (see [0047]), and over 20 species and subspecies of Leishmania infect mammals, such as humans, causing a different spectrum of symptoms (see [0003]).
EP’917 is silent specifically about the topical administration of the compound.
Bartels et. al. teaches about dermaseptins are antimicrobial peptides .. with antimicrobial effects against bacteria, parasites, protozoa (see Abstract and Introduction). Bartels et. al. further teaches dermaseptins shows antiparasitic activity against Leishmania amazonesis (see page 5, left col, paragraph 2). Bartels et. al. reviewed the historical significance of use of dermaseptins, like application involves burning dots on the skin, usually on arms and/or legs, and sticking a small dose (10 mg) ‘dot’ on the open wound (see page 2, left col, paragraph 4); beneficial effects…range from relieving symptoms of pain syndromes, autoimmune diseases, skin disease (see page 2, left col, paragraph 5). Bartels et. al. discusses dermaseptins are potential clinical therapies include treatment of infections caused by specific micro-organisms, the treatment of infections caused by multiple micro-organisms such as skin infections (see page 7, left col, paragraph 1).
Therefore, it would have been obvious to combine the teachings of EP’917 and Bartel’s et. al. before the effective filing date of the claimed invention by administering the compound topically on the skin for treatment of diseases caused by protozoa (i.e., Leishmania). One of ordinary skill in the art can routinely select the subject to be a mammal for improved activity of topical application with a reasonable expectation of succeed in the treatment of skin diseases caused by protozoa. Thus, one skilled in the art would be motivated to adjust the dosage of topical application of the compound for the treatment of skin diseases in the affected area with limited experimentation requiring verifying the effect of treatment.
Examiner’s Note: It is known in the art that species of Leishmania are found worldwide and are transmitted by sandflies, producing cutaneous, mucocutaneous disease; treatment modalities for cutaneous disease include physical, topical, and systemic therapies (see Abstract, Lupi et. al.).
For claims 2-10, 16, 17, and 19: EP’917 discloses R1-R4 in compound 6027 (see claims 3-10). It is noted that R3 of EP’917 is already depicted in the instant formula, therefore the following Rs corresponds to the instantly claimed invention –
Instant R1 is equivalent to the squared region of EP-917 R1,
Instant R2 is equivalent to R2 of EP-917, and
Instant R3 is equivalent to R4 of EP-917.
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(see [0248]).
Regarding claim 15; EP’917 teaches a pharmaceutical composition comprising
compound of any one of the claims 1 to 11 [i.e., including formula (I)] and a pharmaceutically acceptable carrier or adjuvant, wherein said pharmaceutical composition is preferably formulated for use in inhibiting proliferation of a Leishmania parasite in a patient for prophylaxis or to a patient in need of treatment for leishmaniasis (see claim 15).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lupi et. al. (“Tropical dermatology: Tropical diseases caused by protozoa”; Omar Lupi, Brenda L. Bartlett, Reshma Nair Haugen, Lady C. Dy, Aisha Sethi, Sidney N. Klaus, Jackson Machado Pinto, Francisco Bravo, and Stephen K. Tyring; J AM ACAD DERMATOL
VOLUME 60, NUMBER 6, page 897-925; published June 2009).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOYELI BANERJEE whose telephone number is (571)272-5751. The examiner can normally be reached Monday-Friday 8-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KOYELI BANERJEE/ Examiner, Art Unit 1658
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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