DETAILED ACTION
Claims 9, 11-13, 15-17 and 24-26 are currently pending in the instant application.
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 .
Response to Amendment/Arguments
Applicant's amendments and arguments filed 01/24/2026 have been fully considered but they are not persuasive.
Applicant argues that Snyder teaches away from applying the disclosed formulation to a premises surface. However, according to MPEP 2123, Section II teaches that “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”. Snyder teaches that “topical formulation” means a formulation that is suitable to be applied to the external surface of the animal so the ectoparasites will be exposed to lethal levels of the spinosyn component of the formulation. Thus, Snyder does not criticize, discredit or discourage application of the formulation to other surfaces but rather teaches the formulation applied to the external surface of an animal as a preferred embodiment. As a result, Applicant’s argument that the prior art of Snyder teaches away from application of the formulation to a premises is incorrect.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant attacks the PCT reference as not teaching the same formulation would be safe and/or effective for direct application to both animal and premise surfaces. However, the Pest Control Technology (PCT) reference is used to illustrate that it is known that flea control efforts must be directed at all points of flea activity and development which includes the animals, inside premises and the outside. Effective flea control occurs when appropriate amount of insecticide reaches the site where flea adults and larvae life. Most flea larvae will be found within a foot or two of the area where the pets rest or sleep (see p. 3). Although PCT suggests that emulsifiable concentrate formulation is ideal for treating carpets and rugs, microencapsulated insecticide is best for concrete surfaces, PCT does not criticize, discredit or discourage application of the formulation to surfaces but rather effective flea control involves killing of flea larvae, which are usually found within a foot or two of the area where the pets rest or sleep. Thus, the formulation taught Snyder which teaches controlling an ectoparasite infestation referring to preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas (see p. 8, lines 13-17) would be appropriate for application to inside premises since an insecticide that would kill adult flea and larvae is desired.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Snyder teaches use of a spinosyn for providing control of an ectoparasite infestation, specifically fleas, on a companion animal (see p. 2-3). Further, Snyder teaches controlling an ectoparasite infestation referring to preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas (see p. 8, lines 13-17). In fact, Snyder teaches the formulation may be applied to as ready-to-use towel, collar or tag, which are textile materials. Thus, Snyder teaches application of the spinosyn formulation onto textiles. Snyder teaches formulations having Spinosad in an aqueous suspension (i.e. water) – see Examples 3 and 4, p. 12-13. Snyder does not exemplify application of the formulation directly to the premises surface where the flea infestation is present. Pest Control Technology (PCT) teaches that an effective flea control program includes efforts directed at all points of flea activity and development: the animal, the inside premises and the outside. The flea larvae develop in the substrates (e.g. carpeting, furniture, soil) where pets spend time (see p. 2). It would be obvious to one of ordinary skill in the art to apply a formulation which taught to controlling an ectoparasite infestation referring to preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas to an inside premises where an animal rests and the outside as said formulation is taught to prevent, minimize or eliminate infestations, which includes the egg, larval and adult stages of fleas.
Applicant refers to the declaration, filed 05/08/2025, stating that a product producing a lethal effect in all life cycle stages of fleas on an animal as being surprising. However, Applicant has not provided evidence that the formulation of Snyder does not perform as taught. Snyder teaches formulations having Spinosad in providing control of an ectoparasite infestation wherein controlling an ectoparasite infestation referring to preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas. According to MPEP 716.01(c), Section III, in assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). (declarations of seven persons skilled in the art offering opinion evidence praising the merits of the claimed invention were found to have little value because of a lack of factual support); Ex parte George, 21 USPQ2d 1058 (Bd. Pat. App. & Inter. 1991) (conclusory statements that results were “unexpected,” unsupported by objective factual evidence, were considered but were not found to be of substantial evidentiary value).
Applicant has not shown actual evidence that the formulation of Snyder would not function as taught. Rather that it could be considered a “surprising” result. However, Applicant still has not shown how the claimed formulation of Spinosad being administered is different from that in prior art of Snyder. Given the teachings of Snyder are directed towards controlling an ectoparasite infestation referring to preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas by applying formulations having Spinosad, one of ordinary skill in the art would still expect to obtain the same results and effect using the formulation of Snyder as found in the instant claims.
Finally, Applicant argues that Synder does not teach a formulation having at least one carrier consisting of at least one non-organic carrier. To the contrary, Examples 3-4 of Snyder teaches spinosad applied as a spot-on as in Example 2. In two groups, it was administered in an aqueous suspension (45%). In two other groups, it was administered in an IPM concentrate differentiate the instant claims from those of the prior art. Thus, Spinosad is taught in an aqueous suspension, which means that water is the non-organic carrier. Examples 3 and 4 teach formulations of Spinosad that meet the limitation of “consisting of at least one non-organic carrier”, specifically that water is the non-organic carrier.
Thus the 103 rejections have been maintained.
Maintained 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.
Claims 9, 11-13, 15-17 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Snyder (see WIPO Pub No. 2001/011962, pub. 02/22/2001) in view of Pest Control Technology (see https://www.pctonline.com/article/attacking-fleas-on-all-fronts/, published 07/01/1997).
Snyder teaches use of a spinosyn for providing control of an ectoparasite infestation, specifically fleas, on a companion animal (see p. 2-3). Snyder teaches a product comprised of two spinosyns is known as Spinosad (see p. 4, line 12). The spinosyn components may be formulated into number of topically applied end-use products or formulations, including but not limited to spot-ons, pour-ons, sprays, dips, dusts, lotions, dressings, sprays, collars, towels, etc (see p. 8, lines 3-9). Further, Snyder teaches controlling an ectoparasite infestation referring to preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas (see p. 8, lines 13-17). Snyder teaches that the formulation may be a ready-to-use towel, collar or tag that contains a sustained-release formulation with diffusion holes or openings that affords contact with the external surface of the animal (See p. 8, lines 1-9). Further formulations having Spinosad in an aqueous suspension (i.e. water), which is a non-organic carrier, are taught – see Examples 3 and 4, p. 12-13. Snyder does not teach application of the formulation directly to the premises surface where the flea infestation is present.
Pest Control Technology (PCT) teaches that an effective flea control program includes efforts directed at all points of flea activity and development: the animal, the inside premises and the outside. The flea larvae develop in the substrates (e.g. carpeting, furniture, soil) where pets spend time (see p. 2). An emulsifiable concentrate formulation of adulticide is ideal for treating carpets and rugs because they penetrate well into carpet fibers where larvae and pupae may be located. In addition, an EC will bind with carpet fibers, making it difficult to dislodge when sitting or crawling on the surface or when vacuuming (see p. 3). Research has repeatedly shown that most flea larvae will be found within a foot or two of the area where the pets rest or sleep. Therefore, time must be taken to identify the high-risk areas for fleas and to concentrate efforts at those sites (see p. 3).
It would be obvious to one of ordinary skill in the art to apply the formulation of Snyder to premises such as carpet, furniture, etc or other areas where pets spend time for effective flea control. PCT teaches most flea larvae will be found within a foot or two of the area where the pets rest or sleep and in order to provide effective flea control, it would be obvious to kill flea larvae developing in substrates (e.g. carpeting, furniture, etc) so as to avoid increase in flea populations in peoples’ homes. As Snyder teaches formulation comprising spinosyns in providing control of an ectoparasite infestation, which includes preventing, minimizing or eliminating an infestation, which includes the egg, larval, pupal, nymphal and adult stages of fleas, it would be obvious to apply the formulation of Snyder to premises having flea infestation, which includes the flea larvae, in order to control fleas. Snyder teaches spray application having a solution of Spinosad diluted in water (a non-organic carrier) diluted to the desired concentration (see Example 2, p. 11) with 100% reduction in adult fleas.
Although the prior art is silent regarding “the lethal effect in all life cycle stages of fleas on the premises surface is 100% mortality in flea ova, flea larvae and adult fleas on the premises surface” by practicing the method made obvious by the prior art: "A method of controlling a flea infestation, the method comprising applying a formulation directly to the premises surface where the flea infestation is present”, one will also be meeting the limitations of "producing a lethal effect in all life cycle stages of fleas on the premises surface”, even though the prior art was silent as to these parameters as the formulation of the prior art meets the limitations of the same formulation being applied in the instant claims.
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Snyder also teaches spinosyn components may be formulated into number of topically applied end-use products or formulations, including but not limited to dips, dusts, etc. Thus, it would be obvious to take such products, dilute in an aqueous suspension to the desired concentration into a spray and utilize it on premises such as carpet, furniture, etc. in order to control the flea population. Snyder teaches preparation of a spray application through a solution of Spinosad diluted with water. Snyder teaches spinosyn may be formulated into a spray as a dip or dust, which is a solid form/powder, and diluted with an aqueous suspension before application. Regarding the concentration of Spinosad in water, Example 5 of Snyder teaches aqueous suspensions of Spinosad diluted in water just prior to use and applied as a spray with treatment ranges of 500 ppm-10,000 ppm. It is well known that "in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. See In re Swain et al., 33 C.C.P.A. (Patents) 1250, 156 F.2d 239, 70 USPQ413. In re Aller, Lacey, and Hall (105 USPQ 233) teaches that
“Normally, it is to be expected that a change in temperature, or in concentration, or in both, would be an unpatentable modification. Under some circumstances, however, changes such as these may impart patentability to a process if the particular ranges claimed produce a new and unexpected result which is different in kind and not merely in degree from the results of the prior art. In re Dreyfus, 22 C.C.P.A. (Patents) 830, 73 F.2d 931, 24 USPQ 52 ; In re Waite et al., 35 C.C.P.A. (Patents) 1117, 168 F.2d 104, 77 USPQ 586 . Such ranges are termed “critical” ranges, and the applicant has the burden of proving such criticality. In re Swenson et al., 30 C.C.P.A. (Patents) 809, 132 F.2d 1020, 56 USPQ 372 ; In re Scherl, 33 C.C.P.A. (Patents) 1193, 156 F.2d 72, 70 USPQ 204.”
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623