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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/12/2026, has been entered.
Claims 1-3, 10, 11, 13-16, 18-20, 22 and 25 are pending.
Withdrawal of Claim Objections/Rejections
Any previous objection or rejection not reiterated herein has been withdrawn.
Response to Amendment
The Declaration of Joseu Moran, Ph.D, under 37 CFR 1.132 filed 2/12/2026, is insufficient to overcome the rejection of claims 1-3, 10, 11 and 22 based upon 35 U.S.C. 103 as being unpatentable over Hacket et al. and the rejection of claims 13-15 based upon 35 U.S.C. 103 as being unpatentable over Hacket et al in view of McAnnally et al. as set forth in the last Office action.
Applicant submits that the evidence provided controverts “[t]he Office Action’s assertion that it would be obvious to one of ordinary skill in the art to exclude agents having miticidal activity and irritating agents in a formulation intended for the eyes purely for cost/marketability reasons” and demonstrates “unpredictability in the art.” Declaration at page 2. Although the evidence presented is well-taken, the evidence is not persuasive because it does not establish any correlation between a concern for a democidal formulation and a concern for reducing costs and improving marketability, much less that the concerns are mutually exclusive. Furthermore, the evidence is immaterial insofar as the claims do not even require any amount democidal performance nor are they directed to a democidal formulation. With that said, a topical composition with no indicated amount of democidal performance comprising spinosyn compounds and without eye-irritating agents or another other miticidal agent would have been reasonably predictable to one of ordinary skill in the art in view of the cited prior art.
Having considered the evidence provided by the declaration to be unpersuasive, Applicant’s remaining remarks regarding Hackett and McAnnally et al. are considered merely attorney argument.
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 1-3, 10, 11, 13-16, 18-20, 22 and 25 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 a topical composition comprising 0.1% to 10% (w/v) of one or more spinosyn compounds having the formulas of Tables 1-5, does not reasonably provide enablement for a topical composition comprising 0.1% to 10% (w/v) of one or more spinosyn compounds wherein the composition comprises only non-eye irritating agents and no additional agent that have miticidal activity against a Demodex mite. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Regarding the quantity of experimentation necessary, Applicant admits that “the selection of a vehicle system that is both suitable for peri-ocular use and provides the intended Demodex-killing performance requires extensive empirical testing.” Declaration at page 5.
Regarding the amount of direction or guidance presented, while the specification provides generally that a composition may comprise an “ophthalmically acceptable base” which “refers to one or more non-detergent excipients that do not irritate or otherwise harm the surface of the eye when topically administered to ocular surface at effective concentrations,” Specification at page 8, it does not provide any direction or guidance with respect to the selection of any particular non-eye-irritating agents much less any non-irritating agents that would preserve democidal performance in conjunction with spinosyn and without an additional agent that has miticidal activity against a Demodex mite as contemplated by Applicant’s reply and the Declaration of Joseu Moran, Ph.D. Further, it does not provide any direction or guidance as to the “effective concentrations” of such excipient.
Regarding the presence or absence of working examples and the nature of the invention, the specification provides five examples of topical formulations wherein two examples are creams, one is a lotion and the remaining two are ointments. Otherwise the specification provides the disclosure of topical compositions with ingredients and in forms typically found in the prior art. That said, the specification provides a disclosure much in line with the state of the prior art which provides composition comprising spinosyns that are known for pesticidal use.
As for the relative skill of those in the art and the predictability or unpredictability of the art, the skill and predictability in preparing a composition broadly claimed as being a topical with a one or more spinosyns would be easily matched or found, particularly in light of the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 11 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 requires that the topical composition not contain an additional agent that has miticidal activity against a Demodex mite. Claim 11, which depends on claim 1, requires dimethicone, cyclomethicone and a combination thereof. These are known to be used as miticidal agents. Accordingly, claim 11 does not include all the limitations of the claim upon which it depends and is improper. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102/103
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)(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.
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.
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.
Claim(s) 1-3, 10 and 11 is/are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Calabrese et al. (U.S. Patent No. 10,711,026).
Regarding claim 1, Calabrese et al. teaches composition including derivative of spinosyns. See Abstract. “Optionally, the formulation can include a contact-acting insecticide and/or miticide.” Col. 66, lines 46-48. Calabrese et al. further states that “claims may be drafted to exclude any optional element.” Col. 139, lines 56-57. Thus, it may be inferred that Calabrese et al. would teach or suggest the formulation would have “no additional agent that has miticidal activity against a Demodex mite.” “The total active spinosyn derivative in the treatment formulations preferably amounts to 0.01 % to 80% by weight.” Col. 69, lines 36-38. “In general, a present formulation comprising at least one spinosyn compound is applied to the exterior surface of an animal, whereby it contacts pests already present on the host as well as those which arrive on the host's body within the efficacy period.” Col. 73, lines 38-42. Further, Calabrese et al. teaches that “[m]ore typically, the spinosyn compounds are applied as a dispersion in a liquid carrier, where the liquid carrier is water.” Col. 68, lines 64-66. This would read on “only non-eye-irritating agents.” To the extent, this disclosure would not be considered to read on “only non-eye-irritating agents,” it is noted that “[w]here applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103, expressed as a 102 /103 rejection. Once a product appearing to be substantially identical is found a 35 U.S.C. 102/103 rejection is made, the burden shifts to the application to show an unobvious difference. Here, not only would a liquid carrier of water not be considered as non-eye-irritating agent but any disclosure of a potential eye-irritating agent is not necessarily considered to be eye-irritating absent a disclosure of an concentration.
Regarding claims 2-3, Calabrese et al. teaches Spinosad which comprises spinosyn A as a major component and spinosyn D as a minor component. Col. 1, lines 42-43.
Regarding claims 11, “The compositions may be concentrated and dispersed in water or may be used in the form of a dust, bait or granular formulation. The dispersions are typically aqueous suspensions or emulsions prepared from concentrated formulations of the compounds.” Col. 67, lines 62-66.
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.
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.
Claim(s) 1-3, 10, 11 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacket et al. (U.S. Patent No. 7,709,447).
Regarding claim 1, Hacket et al. teaches topical formulations such as ointments, creams and gels that comprises spinosyns. See col. 6, lines 66-67. In addition to these formulations, other formulations including liquid, drops or thickened liquid may “be administered to the eye to treat lacrimal gland injuries, disorders and pathologies in humans.” Col. 9, lines 1-3. To this end the dosage amount of spinosyns are taught generally in the terms of mg/kg body weight. See col. 6, lines 22-24. According to Hacket et al. “[t]he specific therapeutically effective dose level for any particular patient will depend on a variety of factors” and the determination of such dosage is within the purview of one of ordinary skill in the art. See generally, col. 5, line 6 - col. 6 line 9. That being said, “[t]he amount of spinosyns incorporated into the formulation is not critical.” Col. 8, lines 55-54. Nonetheless, Hacket et al. discloses a two exemplary formulation with concentration of spinosyn of 0.445 %w/w and 2.7 % w/w.
Hacket et al. does not teach “wherein the composition comprises only non-eye-irritating agents and no additional agent that has miticidal activity against Demodex mite, wherein the additional agent having miticidal activity comprise permethrin, fipronil, Neem oil, tea-tree oil, or ivermectin.” However, these limitations would have been prima facie obvious to one of ordinary skill in the art. At the outset, Hacket et al. does not teach or require an additional agent that have miticidal activity against a Demodex mite. Thus, as a corollary to the absence of such requirement, excluding such additional agent would have been obvious to one of ordinary skill in the art, if not motivated to do so purely for economic reasons of making the formulation less costly. Furthermore, excluding non-irritating agents in a formulation intended for application to the eye would have been obvious to one of ordinary skill in the art, if not motivated to do so purely to make the formulation less costly and/or more marketable to or useable by subjects.
Regarding claims 2 and 3, Spinosad is “comprised primarily of spinosyn A, 85%, and spinosyn D, 15%.” Col. 2, lines 5 and 6.
Regarding claim 10, Hacket et al. teaches the composition may be in the form of a suspension or emulsion. See col. 6, liens 47-50.
Regarding claim 11, Hacket et al. teaches that ointments and emulsion may include petrolatum. See col. 7, lines 4-6 and lines 13-15.
Regarding claim 22, Hacket et al. teaches the use of distilled water and discloses examples of 80.2 %w/w and 64.43 %w/w. See Tables 1 and 3.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hacket et al. (U.S. Patent No. 7,709,447) as applied to claims 1-3, 10, 11 and 22 above, and further in view of McAnnally et al. (US 2017/0196928).
Teachings of Hacket et al. are discussed above.
McAnnally et al. teaches “[a] composition for the treatment of Demodex blepharitis containing tea tree oil and/or Neem oil and coconut oil in glycerol or in water or in a mixture of glycerol and water”. Abstract. “The composition is used to treat Demodex blepharitis by applying the composition to the eyelid margin and eyelashes and scrubbing the eyelid margin, eyelashes, and eyelash roots with the composition using any suitable cloth, wipe, sponge, brush, or cotton tipped applicator” (current claims 13-15 and 20). Id.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the invention in view of the combined teachings of Hacket et al., and McAnnally et al. to arrive at the claimed invention. Here, it would have been prima facie obvious to modify the teachings of Hacket et al. by using the application teachings of McAnnally et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S CABRAL whose telephone number is (571)270-3769. The examiner can normally be reached M-F 8 am - 5 pm.
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/ROBERT S CABRAL/Primary Examiner, Art Unit 1614