DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 45-64 are pending.
Election/Restrictions
Applicants’ election with traverse of Group I, claims 45-51, in the reply filed on 3/12/26 is acknowledged. The traversal is on the ground that Boileau fails to teach the method of Group I, and further that “although Boileau generically describes certain fiber sources, the reference fails to teach or suggest that any composition comprising a fiber-bound polyphenol component may be used for increasing the level of urinary cytokines, including Flt3-L, SCF and/or IL-12p40” and thus “does not establish a lack of unity” (pages 2-3).
These arguments have been fully considered but are not found persuasive. First, Boileau was only cited with respect to the lack of unity of Groups I and III, and not with regard to Group I with respect to Group II or IV. Second, in Group III, claims 57-60, the recitation of “for use in increasing the level of a urinary cytokine” is an intended use for the claimed product, and does not result in any structural difference between the claimed product and a prior art product having the same structure. Thus, it is maintained that Boileau teaches a composition encompassed by claim 57 of Group III, and therefore the technical feature linking Groups I and III does not constitute a special technical feature as defined by PCT rule 13.2, as it does not define a contribution over the prior art.
Claims 52-64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Three elections of species were also required; see pages 4-7 of the 1/12/26 Office action. The election of Flt3-L as the species of first urinary cytokine at page 2 of 3/12/26 reply is acknowledged. The reply does not appear to contain an elected species with respect to the other two requirements for election of species. However, on further consideration of the invention, these two requirements for elections of species are withdrawn.
Claims 45-51 are under consideration, as they read upon the elected species.
Specification
The disclosure is objected to because of the following informalities:
---The title of the invention is not descriptive because (1) in part it is directed to kits and compositions, but the claimed invention is directed to a method, and (2) it is directed to any means of assessing and treating interstitial cystitis, but the claims are limited to assessing feline interstitial cystitis by measuring a urinary cytokine. A new title is required that is clearly indicative of the invention to which the claims are directed.
Appropriate correction is required.
Claim Objections
Claims 45-51 are objected to because of the following informalities:
Claim 45 includes two steps: “identifying” (lines 3-12) and “administering” (lines 13, and said “identifying” step includes three sub-steps: “analyzing” (lines 5-6), “analyzing” (lines 7-8) and “comparing” (lines 9-12). The sub-steps of the “identifying” step should be more clearly delineated as such by linking them with commas (instead of semi-colons) and by joining them with an “and” clause:
“analyzing … of a urinary cytokine,”
“analyzing … of the urinary cytokine, and”
“comparing … of developing interstitial cystitis; and”
In claim 46, line 2, the semi-colon should be a comma.
In claim 48 and 49, line 2 of each, “brewers rice” should be “brewers’ rice”.
The remaining claim(s) are objected to for depending from an objected claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112, enablement
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 45-46 and 48-51 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 method of claim 1, wherein the biological sample is urine, and the urinary cytokine that is Flt3-L or SCF;
does not reasonably provide enablement for:
A method of claim 1 (i.e., wherein the biological sample is any type of biological sample, and the urinary cytokine is any type of urinary cytokine).
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is “undue” include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability in the art, 5) existence of working examples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The prior art teaches that feline idiopathic cystitis (FIC) is “the most common lower urinary tract disorder in domestic cats” and is “strikingly similar to those of an idiopathic “cystopathy of people called interstitial cystitis/painful bladder syndrome (IC/PBS)”; see page 274 of Parys et al, 2018. J Vet Med. 32:274-279 (cited on the 6/21/23 IDS). With regard to diagnosis, Parys teaches that “As of yet, no consistently reliable diagnostic markers establish a diagnosis of FIC or IC/PBS and differentiate among various clinical and pathologic disease phenotypes” (page 274). The instant specification teaches that currently diagnosis of FIC is based on “urinalysis, urine culture and abdominal ultrasound examination” to exclude “other possible causes including stone formation, infection, tumor formation or renal disease”, with “no consistent or specific diagnostic molecular marker(s) which may serve as reliable marker for assessing FIC” (¶ 3).
Thus, the claimed invention is directed to markers that can distinguish between a feline subject having or at risk of developing FIC and a healthy feline. The goal of the claimed method, as stated in the preamble, is to “reduce the risk of developing or delaying the onset and/or severity of interstitial cystitis”. The method includes steps of identifying a subject by determining the concentration of a urinary cytokine in a biological sample from a test subject as compared to that of a healthy subject, where a decrease in concentration of the urinary cytokine indicates an increased risk, followed by treatment by means of administering “a composition comprising an effective amount of a fiber-bound polyphenol component”.
The term “urinary cytokine” is not defined in the instant specification, but the working example (starting at ¶ 69) provides a list of 19 cytokines that were measured in both urine and serum. The presence of the same cytokines in both types of biological samples indicates that the term “urinary cytokine” as used in the claims is not limited to cytokines found exclusively in the urine, but encompasses any cytokine found in the urine, even if also expressed elsewhere. As such, the analyzing steps of the claimed method broadly include measuring any “urinary cytokine” (i.e., a cytokine that can be found in urine) in any type of “biological sample” (i.e., urine or another sample showing expression of a cytokine also expressed in the urine).
While 19 cytokines were analyzed in the working example, only two, Flt3-L and SCF, were found to have expression that was “clinically significant different (p<0.5) between the groups” (¶ 71, Example 1), with “urinary Flt3-L and cytokine SCF [having] a 76% and 72% predictability of diagnosis, respectively” (¶ 71). The fact that the other 17 cytokines, did not have significantly decreased expression in urine or serum in FIC felines provides evidence that the claimed method is not enabled with respect to each of these other individual cytokines, and further with respect to the genus as a whole.
Two representative examples does not provide support for a genus comprising at least 19 members, particularly when the other species have been tested and found to not be exemplary of the required characteristic. As such, the skilled artisan at the time of filing would have considered this working example to only provide support for predictability in practicing the method of the claims with respect to urine samples, and the urinary cytokines Flt3-L and SCF, and further to provide evidence against the use of each of the other tested urinary cytokines.
Furthermore, with respect to measuring “urinary cytokines” in other biological samples, such as serum, Parys teaches that 4 cytokines, including Flt3L and IL-12p40, had “significantly higher” expression, and that 15 other cytokines, including SCF, had no significant difference in the serum of FIC felines as compared to healthy controls, rather than exhibiting a decrease as required by the instant claims.
Due to the large quantity of experimentation necessary to determine how to use each of the other 17 urinary cytokines in diagnosis of feline interstitial cystitis when evidence suggests there is no clinically significance decrease in expression in FIC felines, the lack of guidance presented in the specification as to how to use such other cytokines beyond Flt3-L and SCF in diagnosis, the working examples which provide limited evidence with respect to the use of the full genus of urinary cytokines for diagnosis of FIC, the complex nature of the invention, the lack of prior art providing predictability between decreased urinary cytokine expression and FIC, and the breadth of the claims with respect to the scope of biological samples to be used, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674
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