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 .
Claims 14-26 are under consideration in this office action.
Claim Objections
Claims 17-18 are objected to because of the following informalities: Both claims recite “the dirofilarial larvae” in reference to “dirofilarial L3 larvae” in base claim 14. As such, “the dirofilarial larvae” lack antecedent basis”. Amending the recitation to recite, “the dirofilarial L3 larvae” in claims 17 and 18 would be remedial Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 14-20 are 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 14 recites administering glucocorticoid in a dietary feed admixture in steps a, b, and d. Step c recites inoculating the rat with larvae. However, there is nothing that links step c to steps a, b, and c. As such, it is not apparent how administering glucocorticoids to feed admixture relates to inoculating a rat with larvae. For purposes of interpretation any method of adds glucocorticoids to feed and also discloses, teaches or suggests inoculating rats with said larvae will be deemed applicable prior art.
Claims 15-20 depend upon claim 14 and therefore also comprise the above indefinite subject matter.
Claim 19, recites “Claim 14, step a, wherein the rat is administered…step c, wherein the is administered”. However, neither step a or c comprises a rat and only administers glucocorticoids to dietary feed admixture. A rat is recited in step b. But steps a, c, and d have no connection to said rat. As such, claim 19 lacks sufficient antecedent basis and is also indefinite because it is not apparent how “the rat” of claim 19 relates to step a and c a recited.
Claim 20 depends upon claim 19. As such, it also comprises the indefinite issues of claim 19.
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.
Claim(s) 1-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abraham (WO 2018/148392 A1 pub date:8/16/2018; effectively filed 2/8/2017; IDS 10/15/2024) in further view of Gration (Gration et al. Veterinary Parasitology 42 (1992) 273-279; of record in IDS 10/15/2024).
Regarding claims 1, 21, and 24, Abraham teaches that immune compromised rodents can be used to model filarial parasite infections and infections by other parasitic worms (p. 5, lines 24-27). Applicant found that immunocompromised rodents harbor “complete infection” meaning that a given early state larval form (e.g. L3) persists and develops into mature worms that may be capable of releasing microfilariae into the bloodstream of an infected host (p. 6). Abraham teaches that their invention provides for an immunocompromised rodent model for support of complete infection and development of parasitic worms. In some embodiments the rodent is a rat (p. 7. Lines 8-19). Abraham discloses that the parasitic worm can be Dirofilaria immitis or Dirofilaria repens (p. 10, paragraph starting line 5). Abraham discloses that the model can be made by infecting an immunocompromised rodent can be made by infecting an immunocompromised rodent with a specific number of parasitic worm larvae (p. 11, lines 21-22). Thus Abraham teaches inoculating a rat with dirofilarial L3 larvae as claimed in step b, wherein the rat is immunocompromised.
Abraham does not teach that administering a glucocorticoid in a dietary feed mixture as recited in steps a, c, and d. However, long before effective filing of the instant claims, glucocorticoids were being admixed into feed for delivery by diet and to immunosuppress rats for used of developing models for round worm non-host infection models. For example, Gration teaches immunosuppression of rats with 60 ppm hydrocortisone acetate in rat diet and infecting the immunosuppressed rats with nematode larvae (abstract). Gration teaches rats were fed on a diet containing 60 ppm hydrocortisone acetate (immunosuppression ration ) or norm diet (non-immunosuppression ration). Immunosuppression commenced one week prior to infection with nematodes and was maintained until necropsy (p. 274, paragraph under animal husbandry). These teaching encompass administering about 200ppm of a glucocorticoid in dietary feed admixture for at least 3 day as recited in step a, administering about 200ppm of a glucocorticoid in dietary feed admixture for at least 3 day post-inoculation in as recited in step c, and administering about 50 ppm of a glucocorticoid in a dietary feed admixture for at least 70 days through necropsy as recited in step d. Gration teaches that attempts to establish adult, patent infections in non-immunosuppressed rats were unsuccessful. In contrast, high levels of infection were obtained in rats maintained on an immunosuppression ration (p. 276, first paragraph under results).
It is also acknowledged that step a and c requires a higher concentration of 200 ppm and Gration uses 60 ppm throughout.
However, MPEP § 2144.05 (II) states the following:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929) (“It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.”). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying “the need for caution in granting a patent based on the combination of elements found in the prior art.”).
A review of the specification fails to provide evidence that the claimed concentrations are critical. Absent such evidence it would have been obvious to an artisan of ordinary skill at the time of effectively filing Gration to try a finite number of possible concentrations of the precursor component to predictably arrive at the claimed concentration through routine optimization. An artisan would have a reasonable expectation of success in optimizing the concentrations because methods of determining hydrocortisone concentration were long established in the art. Thus, Gration renders the instantly claimed concentration above.
As such, it would have been obvious to an artisan of ordinary skill before the time of effective filing to administer hydrocortisone acetate in dietary feed for about 3 days, as taught by Gration, then inoculate the rat with the dirofilarial L3 larvae, as taught by Abraham and then administer hydrocortisone acetate in dietary feed for about 3 and then about 70 days to necropsy post-inoculation, as taught by Gration, to arrive at the limitations of claims 1, 21, and 24 using routine timing and concentration optimization procedures. The artisan would have a reasonable expectation of success because both Gration and Abraham are inoculating rats with round worm species and Gration demonstrates that immunosuppression permits infection of rat with round worms that they would not normally host. Further the artisan would be motivated to administer the pre- and post-infection doses of hydrocortisone acetate to the rats in Abraham because Gration teaches that it allows for persistent and complete infection that is not present without such hydrocortisone acetate treatment. Thus, Abraham in view of Gration renders claims 1, 21, and 24 obvious.
Regarding claims 15 and 16, Gration teaches hydrocortisone acetate as discussed above.
Regarding claims 17, 18, 22, 23, 25, and 26, Abraham teaches Dirofilaria immitis or Dirofilaria repens as discussed above.
Regarding claims 19 and 20, these claims further specify timing of administration of hydrocortisone acetate in diet. As discussed above, determining timing and concentration are generally not given patentable weight due to the ability to determine them by routine optimization.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/Primary Examiner, Art Unit 1632
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