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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 31, 2025 has been entered.
Applicants' arguments, filed December 31, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Response to Amendment
The declaration under 37 CFR 1.132 filed December 31, 2025 is insufficient to overcome the rejection of claims 1 – 3, 5, 6, 8 and 10 – 15 based upon Reme et al. in view of Paufique and Allart et al. as set forth in the last Office action because: there is no comparison with the closest prior art, the expected results are not set forth and the results are not reasonably commensurate in scope with the claims.
The declaration indicates that a shampoo, applied during the first week, and a mousse applied twice in the first week and three times per week with at least two days between applications whose “key component” was ophytrium, a natural extract from the roots of Ophiopogon japonicus, resulted in a decrease in the CADSEI-04, with more than 60% of dogs having a decrease of equal to or greater than 50% after 21 days of product application. The unexpected substantial decrease in CADSEI-04 score could never have been expected by one skilled in the art knowing the cited prior art.
These data are insufficient to outweigh the prima facie case of obviousness reiterated below. Attention is directed to MPEP 716.02 et seq. for a complete discussion of secondary considerations such as unexpected results. A comparison with the closest prior art is required and there is no comparison – the data merely show that a methodology works, not that the results are in fact unexpected. Such a conclusion requires a comparison and an indication as to what the expected results would be. That the results are unexpected is a conclusion and insufficient evidence has been provided to determine if the obtained results are in fact unexpected. As discussed in both the specification and the applied prior art (see below), there is an expectation that such ingredients could relieve symptoms such as itching. It would also seem possible that some symptoms could improve over time even without any treatment being applied. White et al. (Br J Derm, 1987) discloses that the stratum corneum of atopic patients was thinner and had fewer layers of dead cells and intercellular lipid than normal and given that little surface lipid remained, washing with soap and water may be detrimental to the barrier function of the stratum corneum in such patients (abstract). Thus, less improvement in subjects with atopic dermatitis subject to more shampooing (washing) events could be expected by one of ordinary skill in the art. Any such evidence must also be reasonably commensurate in scope with the claims. Only animals suffering from atopic dermatitis were tested and there is no explanation as to how evidence from such animals extends to the full scope of animals exhibiting itching or having exhibited itching that can arise from causes other than atopic dermatitis that are encompassed by the claims. The results on bottom of p 3 state “[a]fter 21 days of product application”, which is not the same as 21 days duration since the onset of treatment as Table 1 of the declaration indicates a minimum interval of 2 days between applications, so for every day that product was applied, multiple calendar days toward the total time frame are required. Therefore even a comparison was set forth, the expected results expressed and the actual results obtained were different from the expected results, any such evidence would not be reasonably commensurate in scope based on the scope of the possible ingredients and number of applications required by the claims being less than carried out in the results set forth in the declaration. Therefore the evidence of record in support of the alleged unexpected results is insufficient to outweigh the prima facie case of obviousness.
Claim Objections
Claim 1 is objected to because of the following informalities: Latin names for plants and animals must be italicized and the Latin name in claim 1 is not. Claim 1 is also objected to because the word “for” should be present after the phrase “helping to care”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, from which claim 13 depends, requires the presence of either phytosphingosine or a compound obtained from Ophiopogon japonicus, which are prefaced by the phrase “a compound intended for treating or helping to care [for] the skin or coat of animals”. Claim 13 states that “a compound intended for treating or helping to care the skin or coat of animals is at least one compound intended to reduce the itching of animals”. In view of the narrowing amendment to claim 1, this limitation no longer makes sense as both Ophiopogon japonicus and phytosphingosine are compounds intended to reduce the itching of an animal to which the composition is applied. Is this requiring the presence of an additional ingredient beyond the compound obtained from Ophiopogon japonicus and/or phytosphingosine already required to be present in order for claim 13 to be a proper dependent claim? Please clarify.
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, 5, 6, 8 and 10 – 15 were rejected under 35 U.S.C. 103 as being unpatentable over Reme et al. (Vet Dermat, 2004) in view of Paufique (WO 2017/121965; all citations from US 2019/0060390, the PGPub of the national stage entry as WO’965 was published in French) and Allart et al. (US 2005/0037035). This rejection is MAINTAINED for the reasons of record set forth herein.
Reme et al. discloses a treatment regimen for atopic dermatitis comprising the use of ALLERNYL® shampoo and lotion alternately every 3 days for alleviating the signs of atopic dermatitis in dogs (col 1). Such an animal is an atopic animal. The median lesional and pruritus (itching) index reduction was 55% and 58% respectively with 3 weeks of antiallergic topical treatment (col 2). While shampoos will be rinsed off, lotions read on a non-rinse-off composition.
Administration using both a rinse-off shampoo and non-rinse off composition in the form of a foam applied multiple times to the animal as claimed is not disclosed.
Paufique discloses methods of treatment for atopic dermatitis, a chronic and pruritic (itching) dermatitis (¶ [0004]) in humans or animals, an atopic animal, comprising administering topically to the subject an active ingredient obtained from Ophiopogon japonicus (whole document, e.g., abstract). As atopic dermatitis is a pruritic dermatitis, the humans or animals are either exhibiting itching or have exhibited itching as required by the instant claims. The composition is topically applied to the skin to act on all parameters of atopic dermatitis and is used to reduce the relapse rate, reduce the severity score of atopic dermatitis, reduce the intensity and frequency of flareups, reduce the extent of eczema and improve the quality of life of animals and owners (¶ [0040] onward). The efficacy arises from effects of the active ingredient including reducing the inflammation of the skin cells and/or restoring the integrity and resistance of the barrier function of the skin (¶ [0051] onward). The active ingredient is preferably used in a dermatological composition including different dosage forms suitable for administration by dermal topical treatment (¶ [0097]). The compositions can be more or less fluid and exemplified forms include foam (¶ [0098]) and shampoo (claim 15).
Allart et al. discloses the use of a sphingoid base, sphingoid base derivative or mixture thereof as the active component in a cosmetic composition suitable for topical application to animals having at least partly fur covered skin for maintaining and/or repairing the keratoseborrheaic condition of the skin and/or fur (whole document, e.g., abstract). The cosmetic composition can be applied in the form of a shampoo, foaming bath, spot on, lotion, gel, emulsion or other forms of application known to the man skilled in the art with a spray mostly being used in curative applications, a shampoo will mostly have a cleaning and preventive function and a lotion being especially suitable for cleaning of exsudative lesions and ensures a major antiseptic action without distorting the microflora of the fur (¶ [0040]). The posology will usually be adapted to the phenomenon being treated and the characteristics of the animal with preventative treatment purposes having one or a few administrations per week most often being sufficient with two administrations per day sufficing for the treatment of a disorder in animals about 5 - 50 kg (¶ [0031]). The comparative study looked at dogs having DAPP (atopic dermatitis) due to flea bites who were treated with the inventive composition in the form of a foam once a day for 3 days and then two applications per week for 3 weeks (¶ [0046]). The examples showed an overall improvement in the quality of the fur, the smell, pruritus (itching) and desquamation (¶ [0045]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use both a shampoo that is rinsed off and a second composition in the form of a foam that is not rinsed off and to optimize the administration schedule of the multiple compositions for treatment of skin conditions such as atopic dermatitis in an animal. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the use of separate compositions such as a shampoo and lotion are taught by the applied prior art along with explicit teachings of the different effects and administration schedules of different compositions. The compositions are taught for application to animals having atopic dermatitis which is a pruritic dermatitis so application of the shampoo and mousse to subjects as required by claim 1 is rendered obvious. A shampoo will have a cleaning effect and when rinsed off, remove material from the animal but can be used in conjunction with compositions in other forms and the application of foams for the treatment of skin conditions including atopic dermatitis is known in the art. Depending on the condition being treated, stage of treatment and observed effects, one of ordinary skill in the art would routinely optimize the administration schedule of the different forms of compositions such as shampoos and foams that can applied from multiple times a day to multiple times a week depending on the condition and stage of treatment (e.g., treating or preventing). Application of a product that is not rinsed off can, compared to shampooing, reduce the burden and stress on the animal and person applying the composition. Too frequent washing could have a negative impact on the skin of the animal such as by altering the barrier function that treatments for atopic dermatitis seek to restore as taught by Paufique. As taught by Allart et al., a few administrations a week can be a suitable administration regimen and one of ordinary skill in the art would optimize the length of the treatment regimen overall and shampooing frequency based on factors such as how treatment of the condition is progressing.
As to claim 8, the active steps required are the same so the effects from the methods must necessarily be the same even if identical language to that claimed is not recited in the applied prior art.
Claim 9 is drawn to a kit which comprises the compositions to be applied and instructions, which read on a printed material but the written indicia are not linked to the functionally related to the substrate. See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ("Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability …. [T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." (see MPEP 2111.05). The required presence for instructions for use does functionally link the printed material to the substrate and even if such a link was present, it would be prima facie obvious to provide instructions for the use of the compositions being provided in the claimed kit.
Applicants traverse this rejection on the grounds that the applied prior art references, alone or in combination do not disclose or suggest the claimed method. The claimed methods also yields unexpected and therapeutic results compared to known protocols such as one in which shampooing and foam application were alternated with the same products. The declaration confirms unexpected results with Ophiopogon japonicus. The method is also not the result of routine optimization and provides remarked improved anti-itching effect while simultaneously simplifying the treatment regimen to improve compliance, representing a genuine technical advance rather than routine optimization.
These arguments are unpersuasive. While the applied prior art does not explicitly disclose the claimed method, based on the explicit, implicit and inherent teachings of the applied prior art and the knowledge of one of ordinary skill, the claimed method is rendered obvious as discussed in greater detail above. Evidence of unexpected results that includes a comparison with the closest prior art that establishes the expected results and shows results for the claimed regimen that are different than the expected results that are reasonably commensurate in scope with the claims is not of record as herein. The specification uses a phytosphingosine containing shampoo and mousse product but the testing is limited to animals previously diagnosed with atopic [sic], were receiving treatment with an additional therapeutic (oclacitinib or cyclosporin) and exhibiting a clinical relapse of atopic dermatitis (¶ [0054] of the PGPub of the instant application). A comparison of two different conditions as detailed in Figures 1A and 1B was carried out but no explanation as to the expected results were seen. White et al. (Br J Derm, 1987) discloses that the stratum corneum of atopic patients was thinner and had fewer layers of dead cells and intercellular lipid than normal and given that little surface lipid remained, washing with soap and water may be detrimental to the barrier function of the stratum corneum in such patients (abstract). Thus, less improvement in subjects with atopic dermatitis subject to more shampooing events could be expected by one of ordinary skill in the art. The evidence of record in support of the alleged unexpected results is insufficient to outweigh the prima facie case of obviousness.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Regarding the provisional nonstatutory double patenting rejections reiterated below, Applicants request that the rejections be withdrawn or held in abeyance until patentable subject matter is determined in this application.
These provisional nonstatutory double patenting are maintained for the reasons set forth below.
Claims 1 – 3, 5, 6, 8 and 10 – 15 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 15 of copending Application No. 17/780,749 in view of Reme et al. (Vet Dermat, 2004) in view of Paufique (WO 2017/121965; all citations from US 2019/0060390, the PGPub of the national stage entry as WO’965 was published in French) and Allart et al. (US 2005/0037035). This rejection is MAINTAINED for the reasons of record set forth herein.
The claims of US’749 recite a shampoo veterinary composition (e.g., claim 1) that can be used in a method for cleaning and/or washing the skin and/or the coat of a non-human mammal by application of the composition to the skin and/or coat (claim 12).
Application of both a shampoo and non-rinse-off foam as recited by the instant claims is not claimed in US’749.
Reme et al., Paufique and Allart et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use both a shampoo as in US’749 that is rinsed off and a second composition in the form of a foam that is not rinsed off and to optimize the administration schedule of the multiple compositions for treatment of skin conditions such as atopic dermatitis in an animal. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the use of separate compositions such as a shampoo and lotion are taught by the applied prior art along with explicit teachings of the different effects and administration schedules of different compositions. The compositions are taught for application to animals having atopic dermatitis which is a pruritic dermatitis so application of the shampoo and mousse to subjects as required by claim 1 is rendered obvious. A shampoo will have a cleaning effect and when rinsed off, remove material from the animal but can be used in conjunction with compositions in other forms and the application of foams for the treatment of skin conditions including atopic dermatitis is known in the art. Depending on the condition being treated, stage of treatment and observed effects, one of ordinary skill in the art would routinely optimize the administration schedule of the different forms of compositions such as shampoos and foams that can applied from multiple times a day to multiple times a week depending on the condition and stage of treatment (e.g., treating or preventing). Application of a product that is not rinsed off can, compared to shampooing, reduce the burden and stress on the animal and person applying the composition. Too frequent washing could have a negative impact on the skin of the animal such as by altering the barrier function that treatments for atopic dermatitis seek to restore as taught by Paufique. As taught by Allart et al., a few administrations a week can be a suitable administration regimen.
As to claim 8, the active steps required are the same so the effects from the methods must necessarily be the same even if identical language to that claimed is not recited in the applied prior art.
Claim 9 is drawn to a kit which comprises the compositions to be applied and instructions, which read on a printed material but the written indicia are not linked to the functionally related to the substrate. See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ("Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability …. [T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." (see MPEP 2111.05). The required presence for instructions for use does functionally link the printed material to the substrate and even if such a link was present, it would be prima facie obvious to provide instructions for the use of the compositions being provided in the claimed kit.
This is a provisional nonstatutory double patenting rejection.
Claims 1 – 3, 5, 6, 8 and 10 – 15 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 14 of copending Application No. 17/780,764 in view of Reme et al. (Vet Dermat, 2004) in view of Paufique (WO 2017/121965; all citations from US 2019/0060390, the PGPub of the national stage entry as WO’965 was published in French) and Allart et al. (US 2005/0037035). This rejection is MAINTAINED for the reasons of record set forth herein.
The claims of US’764 recite a non-rinsed veterinary composition (claim 1) that can be used in a method for cleaning and/or washing the skin and/or the coat of a non-human mammal by application of the composition to the skin and/or coat (claim 11). The composition can be a mousse (claim 5), which reads on a foam.
Application of both a shampoo and non-rinse-off foam as recited by the instant claims is not claimed in US’764.
Reme et al., Paufique and Allart et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use both a shampoo that is rinsed off and a second composition in the form of a foam such as the mousse of US’764 that is not rinsed off and to optimize the administration schedule of the multiple compositions for treatment of skin conditions such as atopic dermatitis in an animal. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the use of separate compositions such as a shampoo and lotion are taught by the applied prior art along with explicit teachings of the different effects and administration schedules of different compositions. The compositions are taught for application to animals having atopic dermatitis which is a pruritic dermatitis so application of the shampoo and mousse to subjects as required by claim 1 is rendered obvious. A shampoo will have a cleaning effect and when rinsed off, remove material from the animal but can be used in conjunction with compositions in other forms and the application of foams for the treatment of skin conditions including atopic dermatitis is known in the art. Depending on the condition being treated, stage of treatment and observed effects, one of ordinary skill in the art would routinely optimize the administration schedule of the different forms of compositions such as shampoos and foams that can applied from multiple times a day to multiple times a week depending on the condition and stage of treatment (e.g., treating or preventing). Application of a product that is not rinsed off can, compared to shampooing, reduce the burden and stress on the animal and person applying the composition. Too frequent washing could have a negative impact on the skin of the animal such as by altering the barrier function that treatments for atopic dermatitis seek to restore as taught by Paufique. As taught by Allart et al., a few administrations a week can be a suitable administration regimen.
As to claim 8, the active steps required are the same so the effects from the methods must necessarily be the same even if identical language to that claimed is not recited in the applied prior art.
Claim 9 is drawn to a kit which comprises the compositions to be applied and instructions, which read on a printed material but the written indicia are not linked to the functionally related to the substrate. See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ("Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability …. [T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." (see MPEP 2111.05). The required presence for instructions for use does functionally link the printed material to the substrate and even if such a link was present, it would be prima facie obvious to provide instructions for the use of the compositions being provided in the claimed kit.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618
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