Prosecution Insights
Last updated: April 19, 2026
Application No. 18/117,559

SYSTEMS AND METHODS FOR ADMINISTERING DERMAL AND TRANSDERMAL IMMUNOTHERAPY TOPICAL APPLICATION COMPOUNDS TO ANIMALS

Non-Final OA §102§103
Filed
Mar 06, 2023
Examiner
ROONEY, NORA MAUREEN
Art Unit
1641
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Allibre Animal LLC
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
3y 7m
To Grant
84%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
444 granted / 736 resolved
At TC average
Strong +23% interview lift
Without
With
+23.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
29 currently pending
Career history
765
Total Applications
across all art units

Statute-Specific Performance

§101
5.8%
-34.2% vs TC avg
§103
22.0%
-18.0% vs TC avg
§102
22.5%
-17.5% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 736 resolved cases

Office Action

§102 §103
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. 2. Applicant’s response filed on 01/09/2026 is acknowledged. 3. Claims 1-18 and 21-22 are pending. Claims 1 and 11 are independent claims 4. Applicant’s election without traverse of Group I, claims in the reply filed on 01/09/2026 is acknowledged. 5. Claims 15-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/09/2026. 6. Claims 1-14 and 21-22 are currently under consideration for their full scope. 7 . Applicant’s IDS document filed on 06/21/2023 is acknowledged. 8 . Independent claims are claims 1 and 11 : Claim 1. A method for treating an allergy condition of an animal, comprising: detecting that the animal has the allergy condition; determining a first quantity of a topical application medium and a first quantity of an allergen based at least in part on one or more attributes of the animal; providing a first topical application compound, the first topical application compound comprising: the first quantity of the allergen; and the first quantity of the topical application medium; and applying the first topical application compound to one or more ears of the animal one or more times to treat the allergy condition. Claim 11. A method for treating an allergy condition of an animal, comprising: detecting that the animal has the allergy condition; determining a first quantity of a topical application medium and a first quantity of an allergen based at least in part on one or more attributes of the animal; providing a first topical application compound, comprising: the first quantity of the topical application medium; and the first quantity of the allergen; affixing an Elizabethan collar to a neck or a head of the animal; and applying the first topical application compound to one or more locations on the animal's skin one or more times. Claim Rejections - 35 USC § 102 9 . 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. 10 . Claim s 1-2, 4-6 and 8 -10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Gao et al (PTO-892; Reference U) . Gao et al. teaches Induction of Dermatitis in the Mouse Ear. Both surfaces of mouse ear lobes were stripped three times using surgical tape. One hour after the tape stripping, 25 μl of 10 mg/ml mite antigen solution (mite antigen dissolved in PBS and .5% Tween 20) was painted onto each surface of both ear lobes. Tape stripping and mite antigen painting was repeated five times at 7-day intervals and ear thickness was measured using a dial thickness gauge immediately before each tape stripping, and 1, 4 and 24 h after each mite antigen application. In control mice, carrier solution only was painted instead of mite antigen solution. Blood samples were obtained 24 h after each antigen application and used for measuring serum IgE . Cervical lymph nodes and ears were removed for evaluating cytokine mRNA expression 4 h after the fifth antigen application. Ears for the histological observation were separated 24 h after the fifth antigen application. (In particular, page 193, left column). Atopic dermatitis was diagnosed by the swelling in the ear induced and the increase in IgE levels (In particular, page 194). Claims 8-9 are included in this rejection because the additional applications of the mite allergen to the ear are encompassed by the recitation of providing a second topical application compound. The second quantity and the first quantity are the same as taught in the art. The reference teachings anticipate the claimed invention. Claim Rejections - 35 USC § 103 1 1 . 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. 1 2 . Claims 1- 6, 8-11, 13- 14 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2002/093998 (PTO-892; Reference N) in view of Gao et al (PTO-892; Reference U) . WO 2002/093998 teaches a method for suppressing an IgE -mediated hypersensitivity allergic reaction in a mammal comprising the steps of: transdermally administering to a mammal in need of such treatment a composition comprising: a) at least one allergen; and b) a non-ADP ribosylating toxin or subunit thereof, wherein the amounts of a) and b) together are effective to suppress said allergic reaction; further comprising administering an adjuvant with said composition ; wherein said allergen is selected from the group consisting of food allergens, plant allergens, pollen allergens, tree allergens, animal allergens, parasitic allergens, mite allergens, bacterial allergens, viral allergens, mycoplasma allergens, fungal allergens, drug allergens and occupational allergens. (In particular, page 13, claims). The reference teaches that the i nvention is useful for the treatment of allergic diseases in humans, other primates, and mammalian subjects, such as dogs, cats, and horses. ( In particular, first paragraph on page 13, whole document). The reference teaches that processes for preparing a pharmaceutical formulation for transdermal delivery are well known in the art, whereby the antigen and adjuvant are combined with a pharmaceutically acceptable carrier vehicle. Suitable vehicles and their preparation are described, for example, in Remington's Pharmaceutical Sciences by E. W. Martin. Such formulations will contain an effective amount of the antigen and adjuvant together with a suitable amount of vehicle in order to prepare pharmaceutically acceptable compositions suitable for administration to a human or animal . The formulation may be applied in the form of a cream , emulsion, gel, lotion, ointment, paste, solution, suspension, spray or other forms known in the art. In particular, formulations that enhance skin hydration, penetration, or both are preferred. There may also be incorporated other pharmaceutically acceptable additives or excipients including, for example, diluents, binders, stabilizers, preservatives, penetration enhancers and colorings. Furthermore the transdermal delivery system could be given by untrained personnel, and is also amenable to self-application. (In particular, page 26-27, whole document). The reference teaches that the transdermal delivery system may be applied directly to the skin and allowed to air dry; rubbed into the skin or scalp; held in place with a dressing, patch, or absorbent material or sprayed onto the skin to maximize contact with the skin. The formulation may be applied in an absorbent dressing or gauze. The formulation may be covered with an occlusive dressing such as, for example, AQUAPHOR (an emulsion of petrolatum, mineral oil, mineral wax, wool wax, panthenol, bisabol, and glycerin from Beiersdorf, Inc.), plastic film, COMFEEL (Coloplast) or vaseline ; or a non-occlusive dressing such as, for example, DUODERM (3M) or OPSITE (Smith & Napheu ). An occlusive dressing completely excludes the passage of water. (In particular, page 27, whole document). The formulation may be applied to single or multiple sites, to single or multiple limbs, or to large surface areas of the skin by complete immersion. The formulation may be applied directly to the skin. (In particular, page 27, whole document). An advantage to using transdermal administration, in addition to eliminating the need for injection, is that lower doses of allergens can be used to achieve improved treatment of allergic responses compared to oral routes for therapy. Transdermal administration also makes it simpler to administer allergens to the patient, avoids gastrointestinal tract difficulties during absorption that may be caused by oral administration, and avoids first pass i.e. the initial passage of a drug substance through the systemic and portal circulation. Transdermal administration also has the capacity for multi-day therapy with a single application thereby improving patient compliance. (In particular, page 27, whole document). Compared to subcutaneous immunotherapy, transdermal administration is a non- invasive method and does not require special facilities and trained personnel. (In particular, page 28, whole document). The reference teaches that an effective amount of purified allergen for use with CTB would range between about 1 μg to 1 mg, preferably about 100 μg /cm 2 . Administration is variable according to the nature of the allergen(s) present in the composition. It would not be difficult to one skilled in the art to determine such concentrations using e.g., provocation tests, skin prick tests or determining specific IgE levels against the allergen. One would determine the dose tolerated by giving 1 dose weekly for 3-6 months or daily doses for 4 weeks. (In particular, page 32, whole document). The reference teaches treating mice by application of the compounds to their ears. (In particular, Example 6, Figure 5). The claimed invention differs from the prior art in the elements of the metho d combined as it is recited in the claims 1-14 and 21-22 ; the recitation of atopic dermatitis in claims 5 and 21-22; and the recitation of using an Elizabethan collar of claim 11 . Gao et al. teaches that atopic dermatitis is a chronic eczematous skin disease accompanied by severe itch, episodes which are frequently repeated. Elevated serum IgE levels are also a characteristic feature in many patients. Itchiness is the most important problem for atopic patients and scratching worsens the dermatitis itself. (In particular, page 191). The reference teaches an allergic dermatitis model in NC/Nga mice by repeated local exposure of mite antigen. The dermatitis possesses some characteristic features observed in atopic dermatitis patients,such as eczematous skin lesion with inflammatory cell accumulation,a Th1/Th2 balance skewed to Th2 and elevated serum IgE levels. The Th1/Th2 imbalance has been considered to be an important feature of atopic disease (In particular, page 192). It would have been obvious to one of ordinary skill in the art at the time of invention to have topically administered a composition to the skin of an animal including a cat or a dog because WO 2002/093998 teaches doing so. It would have been obvious to have determined the initial and the subsequent doses of the allergen based on the animal and the allergen as taught in WO 2002/ 093998 based in part on the animal, provocation tests, skin prick tests and determining specific IgE levels against the allergen. It would have been obvious to have increased subsequent doses based upon this information. It would have been obvious to have administered the allergen to the ears of the animal because the reference teaches that administration can be on any skin, but also because the reference teaches administering the compositions to mouse ears which are shown to comprise increased amounts of dendritic and Langerhans cells in response to the allergen treatments (In particular, Example 6). It would have been obvious to treat patients, including animal patients, diagnosed with atopic dermatitis as taught by Gao et al. using the method of WO 2002/093998 particularly since the disease involves the skin. It would have been obvious to have used an Elizabethan collar in the animal being treated both because atopic dermatitis itself is accompanied by severe itch and because when treating an animal it is desired to keep the animal from the treatment site. Since the treatment site is the ear the animal would be inhibited from accessing the ears through use of an Elizabethan collar. From the reference teachings, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary. 1 3 . Claims 7 and 12 are objected to for dependence upon rejected base claims 1 and 11 but appear to be allowable if rewritten in independent form. 1 4 . Any inquiry concerning this communication or earlier communications from the examiner should be directed to NORA MAUREEN ROONEY whose telephone number is (571)272-9937. The examiner can normally be reached on M-F from 8:00am to 4:30pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Misook Yu, can be reached at telephone number (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. March 21, 2026 /Nora M Rooney/ Primary Examiner, Art Unit 1641
Read full office action

Prosecution Timeline

Mar 06, 2023
Application Filed
Mar 21, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
60%
Grant Probability
84%
With Interview (+23.4%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 736 resolved cases by this examiner. Grant probability derived from career allow rate.

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