FINAL 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/21/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/21/2025 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Status of the Claims
This action is in response to papers filed 09/17/2025 and 10/21/2025 in which claims 2-7, 9-10, 12-17, and 19-20 were previously canceled; and no claim was amended.
Claims 1, 8, 11, 18, and 21-24 are under examination.
Maintained Rejections
Claim Rejections - 35 USC § 112
WRITTEN DESCRIPTION
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 1, 8, 11, 18, and 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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. Further, Written Description Requirement is an inquiry/analysis of whether the applicant was in possession of the invention he/she seeks to patent (MPEP §2163) and ensures that the inventor had possession, as of the filing date of the application, of the specific subject matter claimed. With respect to the description requirement in full, clear, concise and exact terms, a review of the instant specification does not find support for any type of cancer that is encompassed broadly by the instant claims.
While the subject matter of the claim need not be described literally (i.e., using the same terms or in haec verba) in order for the disclosure to satisfy the description requirement. However, the description must clearly allow persons of ordinary skilled in the art to recognize that the applicant(s) invented what is being claimed. The appearance of merely indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. MPEP §2163 (II).
Instant claims 1 and 11 (to which claims 8, 18, and 21-24 depend from, respectively) are directed to a method of treating dilated cardiomyopathy (DCM) in a dog, comprising administering to the dog having DCM, a low legume diet comprising between about 4 g/kg/day and 6 g/kg/day of legume (claim 1) and a method of reducing the risk of developing dilated cardiomyopathy (DCM) in a dog comprising administering to the dog at risk of developing DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume (claim 11).
Instant specification describes “[s]ince 2018, certain diets have been associated with an increase in the prevalence of the condition in dogs across breed and age. These diets are typically so-called grain-free, legume-rich diets, especially those containing high inclusion levels of peas and/or lentils.” (page 1, lines 22-24). The specification further describes treatment regimen for treating DCM in dogs include a dietary therapy such as a low legume diet (pages 21-22). The specification provide one example (Example 1—pages 36-48) of a pilot study of a longitudinal feeding trial to establish whether legume-containing diets lead to the development of DCM in dogs. The specification describe that the data from the pilot study “indicate that feeding adults dogs feeding adult dogs, e.g., Labrador retriever dogs, a diet containing a combination of peas and red and green lentils (20% inclusion of each) for 30 days caused reduced nutrient digestibility, a rapid reduction in red blood cell counts, hyperphosphatemia, and increased fecal losses of primary bile acids, with possible implications on sterol metabolism and taurine status, as indicated by reduced urinary losses of taurine” (pages 36-43). The specification indicated that while “[r]eports from humans and rodents indicate that these data have the potential to explain pathophysiological processes in the heart muscle,” [i]nterrogation of medical records from dogs diagnosed with DCM, as well as more refined and longer-term feeding trials, is needed to investigate whether the findings from this 30-day study are transient or self-limiting, or whether they are indeed newly discovered causes of the diet-induced, canine DCM cases recently highlighted by the FDA” (page 43, last paragraph to page 44). The specification further disclosed that the data from the example “indicate that the legume-rich test diet containing peas, lentils and a relatively high level of flaxseed can cause reduced nutrient digestibility, normocytic anemia and hyperphosphatemia, as well as possible disturbances in taurine and sterol metabolism due to increased primary bile acid losses in feces” (page 46, last paragraph to page 47). The specification further discloses that the example “investigates and identifies biomarkers for predicting development of DCM by using a machine learning approach” and that “these biomarkers (hematocrit, phosphorus, alkaline phosphatase and creatinine) can be used for prognostic and diagnostic methods to predict and treat DCM” (pages 47-48). Thus, the example in the specification only provided data to be used “for prognostic and diagnostic methods to predict and treat DCM.”
Applicant does not have possession of the claimed method of “treating dilated cardiomyopathy (DCM) in a dog comprising administering to the dog having DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” (claim 1), as well as, the claimed method of “reducing the risk of developing dilated cardiomyopathy (DCM) in a dog comprising administering to the dog at risk of developing DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” (claim 11). The specification only provide one example drawn to a pilot study to establish whether legume-containing diets lead to the development of DCM in dogs. The dogs were administered legume-rich diet and biomarkers such as hematocrit, phosphorus, alkaline phosphatase and creatinine were measured to provide “data to be used “for prognostic and diagnostic methods to predict and treat DCM.” The example provide no experimental data and there is lack of any working example showing that the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” to a dog having DCM or at risk of developing DCM was an effective treatment of DCM in the dogs or an effective treatment in reducing the risk of developing DCM in the dogs. Applicant merely describe in generality that “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” can be used for treating DCM in dogs or reducing the risk of developing DCM in dogs, but does not provide any guidance or showing that the method of administration provides an effective treatment of DCM or was effective in reducing the risk of developing DCM in dogs. Applicant from the disclosure of the specification even indicated that “[i]nterrogation of medical records from dogs diagnosed with DCM, as well as more refined and longer-term feeding trials, is needed to investigate whether the findings from this 30-day study are transient or self-limiting, or whether they are indeed newly discovered causes of the diet-induced, canine DCM cases recently highlighted by the FDA,” raising doubts that “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” when administered to said dogs may not work pending further investigations. The unpredictability in dietary arts is generally high, and requires undue experimentation in order to determine the efficacy of the instant claimed methods. Even the state of the art in view of McCauley (Journal of Animal Science, 2020, 98(6): 1-20; previously cited) describes “no definitive correlation for grain-free diets [having legumes] or their ingredients to DCM," adding that "there is insufficient evidence-based research on whether diet is the cause for the subjective claims." See McCauley at page 10, right column. McCauley further states that the hypothesis of an association between grain-free diets and DCM "lack[s] the support from the literature." See McCauley at page 13. McCauley also illustrates an additional study where the potential association between grain-free diet and DCM was biased because dogs of the test group "were eating less than the maintenance energy requirement," resulting "in a suboptimal intake of sulfur-containing amino acids." See McCauley at page 13. Also see pages 10-14 of McCauley highlighting current limitations in DCM studies in dogs including sampling bias, inconsistencies in sampling parameters, confounding variables, and lack of complete data for case studies on DCM.
McCauley further expressed at page 14, left column:
“[t]he use of the acronym “BEG” [grain-free diet] and its association with DCM are without merit because there is no definitive evidence in the literature. At this time, information distributed to the veterinary community and the general public has been abbreviated synopses of case studies, with multiple variables and treatments, incomplete medical information, and conflicting medical data and opinions from veterinary nutrition influencers. Also, in past literature, sampling bias, overrepresentation of subgroups, and confounding variables in the data weaken this hypothesis. Additionally, based on current literature, the incidence of DCM in the overall dog population is estimated to be between 0.5% and 1.3% in the United States. However, the FDA case numbers (560 dogs) are well below the estimated prevalence. Therefore, it is impossible to draw any definitive conclusions, in these cases, linking specific diets or specific ingredients to DCM.
In hopes of better understanding a potential correlation with diets to DCM, more objective data need to be collected and analyzed, without sampling bias and confounding factors.”
While Applicant from the Example of the specification may provide some association between a legume-rich diet and DCM, just as the FDA as discussed above by McCauley also hypothesize the association of a legume-rich diet and DCM, Applicant has not provided any working example or experimental data showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” to a dog having DCM or at risk of DCM was effective in treating DCM or reducing the risk of DCM in said dogs. Applicant has a general idea that the a low legume diet may function as instantly claimed but is leaving it to others to figure out. That is not sufficient. In In re ‘318 Patent Infringement Litigation, 92 USPQ2d 1385 (Fed. Cir. 2009) at 1391, 1392 the court stated, “Thus, at the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. See Rasmusson V. SmithKline Beecham Corp., 413 F.3d 1318, 1325 (Fed. Cir. 2005).
Conclusion: The specification fails to satisfy the written description requirement of 35 U.S.C.112, first paragraph, with respect to the full scope of claims 1, 8, 11, 18, and 21-24.
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Applicant argues by alleging that the Examiner has failed to establish a prima facie case of lack of written description. Applicant alleged that the cited cases (In re '318 Patent Infringement Litig. and Rasmusson v. SmithKline Beecham Corp.) never discuss the written description requirement and focused only on the enablement requirement. Applicant cited Ariad Pharms. Inc. v. Eli Lilly & Co. to support Applicant's position that the rejection's rationale was based on the enablement requirement and that the Examiner has not provide evidence or reasons why one skilled in the art would not recognized the written description of the claimed subject matter. Applicant further alleged that the instant specification provide adequate written description of the claimed methods on pages 21-22, as well as, provided working example (Example 1 of the specification). Applicant alleged that Table 1 of Example 1 illustrated that while having comparable nutrient values, the control diet (i.e., low legume diet) showed a protective effect in the development of hallmarks of DCM. Thus, Applicant alleged that in light of the experimental data in the examples, one skilled in the art would have therefore concluded that low legume diets can be administered for reducing the risk and/or treating DCM. (Remarks, pages 5-7).
In response, the Examiner disagrees. To the extent the cited case laws of In re '318 Patent Infringement Litig. and Rasmusson v. SmithKline Beecham Corp., may have been focused on enablement, the context or gist of the 112(a) rejection with respect to lack of possession of the claimed methods is directed to written description. Even when these two case laws are not cited, the content of the written description can stand alone to establish that Applicant does not have possession of the claimed methods. In fact, Applicant citation of Ariad Pharms. Inc. v. Eli Lilly & Co., supports the Examiner's 112(a) written description rejection, in that the specification of Applicant's claimed invention did not contain a written description that is "full, clear, concise, and exact terms as to enable any person skill in the art ... to make and use the same."
As discussed above in the standing written description rejection (pages 6-8 of this office action), the specification merely describe in generality that “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” can be used for treating DCM in dogs or reducing the risk of developing DCM in dogs, but does not provide any guidance or showing that the method of administration provides an effective treatment of DCM or was effective in reducing the risk of developing DCM in dogs. The only example (Example 1) in the specification provided data to be used “for prognostic and diagnostic methods to predict and treat DCM.”
Contrary to Applicant allegation, Example 1 does not describe or show the control diet (i.e., low legume diet) provided a protective effect in the development of hallmarks of DCM. There is no indication in the Example that the control diet is even a low legume diet, much less "a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume". Thus, as discussed in the written description rejection, while Applicant from the Example of the specification may provide some association between a legume-rich diet and DCM, just as the FDA as described by McCauley also hypothesize the association of a legume-rich diet and DCM, Applicant has not provided any working example or experimental data showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” to a dog having DCM or at risk of DCM was effective in treating DCM or reducing the risk of DCM in said dogs.
Example 1 of Applicant's specification and the McCauley reference are evidence to show that Applicant does not have possession of the claimed methods.
Accordingly, it is maintained that the specification fails to satisfy the written description requirement of 35 U.S.C.112, first paragraph, with respect to the full scope of claims 1, 8, 11, 18, and 21-24.
Claim Rejections - 35 USC § 112
TOTAL LACK OF 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 11, 18, 23 and 24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification does not reasonably provide enablement for a method of reducing the risk of developing dilated cardiomyopathy (DCM) in a dog comprising administering to the dog at risk of developing DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims without an undue amount of experimentation.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation.
The nature of the invention and (2) the breadth of the claims:
Claim 11 (to which claims 18, 23 and 24 depend from) is drawn to a method of reducing the risk of developing dilated cardiomyopathy (DCM) in a dog comprising administering to the dog at risk of developing DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume.
Instant specification describes “[s]ince 2018, certain diets have been associated with an increase in the prevalence of the condition in dogs across breed and age. These diets are typically so-called grain-free, legume-rich diets, especially those containing high inclusion levels of peas and/or lentils.” (page 1, lines 22-24). The specification further describes treatment regimen for treating DCM in dogs include a dietary therapy such as a low legume diet (pages 21-22).).
Thus, the claims taken together with the specification imply that administering a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume would to a dog at risk of having DCM would reduce the risk of developing dilated cardiomyopathy (DCM) in said dog.
The state of the prior art and (4) the predictability or unpredictability of the art:
It is highly unlikely that the adminstration of a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume to a dog at risk of developing DCM would be effective in reducing the risk of developing dilated cardiomyopathy (DCM) in said dog.
The state of the art in view of McCauley (Journal of Animal Science, 2020, 98(6): 1-20; previously cited) describes “no definitive correlation for grain-free diets [having legumes] or their ingredients to DCM," adding that "there is insufficient evidence-based research on whether diet is the cause for the subjective claims." See McCauley at page 10, right column. McCauley further states that the hypothesis of an association between grain-free diets and DCM "lack[s] the support from the literature." See McCauley at page 13. McCauley also illustrates an additional study where the potential association between grain-free diet and DCM was biased because dogs of the test group "were eating less than the maintenance energy requirement," resulting "in a suboptimal intake of sulfur-containing amino acids." See McCauley at page 13. Also see pages 10-14 of McCauley highlighting current limitations in DCM studies in dogs including sampling bias, inconsistencies in sampling parameters, confounding variables, and lack of complete data for case studies on DCM.
McCauley further expressed at page 14, left column:
“[t]he use of the acronym “BEG” [grain-free diet] and its association with DCM are without merit because there is no definitive evidence in the literature. At this time, information distributed to the veterinary community and the general public has been abbreviated synopses of case studies, with multiple variables and treatments, incomplete medical information, and conflicting medical data and opinions from veterinary nutrition influencers. Also, in past literature, sampling bias, overrepresentation of subgroups, and confounding variables in the data weaken this hypothesis. Additionally, based on current literature, the incidence of DCM in the overall dog population is estimated to be between 0.5% and 1.3% in the United States. However, the FDA case numbers (560 dogs) are well below the estimated prevalence. Therefore, it is impossible to draw any definitive conclusions, in these cases, linking specific diets or specific ingredients to DCM.
In hopes of better understanding a potential correlation with diets to DCM, more objective data need to be collected and analyzed, without sampling bias and confounding factors.”
In light of the state of the art in view of McCauley indicating that there is no definitive evidence showing the potential correlation with diets to DCM and the need of “more objective data need to be collected and analyzed, without sampling bias and confounding factors,” as well as, the lack of evidence or predictability in the state of the art as a whole, showing the effectiveness of a low legume diet in reducing the risk of developing dilated cardiomyopathy (DCM) in said dog, it is highly unlikely that the use of a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume would be effective in reducing the risk of developing dilated cardiomyopathy (DCM) in dogs at risk of developing DCM.
(5) The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience veterinary and dietary fields).
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification provide one example (Example 1—pages 36-48) of a pilot study of a longitudinal feeding trial to establish whether legume-containing diets lead to the development of DCM in dogs. The specification describe that the data from the pilot study “indicate that feeding adults dogs feeding adult dogs, e.g., Labrador retriever dogs, a diet containing a combination of peas and red and green lentils (20% inclusion of each) for 30 days caused reduced nutrient digestibility, a rapid reduction in red blood cell counts, hyperphosphatemia, and increased fecal losses of primary bile acids, with possible implications on sterol metabolism and taurine status, as indicated by reduced urinary losses of taurine” (pages 36-43).
The specification indicated that while “[r]eports from humans and rodents indicate that these data have the potential to explain pathophysiological processes in the heart muscle,” [i]nterrogation of medical records from dogs diagnosed with DCM, as well as more refined and longer-term feeding trials, is needed to investigate whether the findings from this 30-day study are transient or self-limiting, or whether they are indeed newly discovered causes of the diet-induced, canine DCM cases recently highlighted by the FDA” (page 43, last paragraph to page 44).
The specification further disclosed that the data from the example “indicate that the legume-rich test diet containing peas, lentils and a relatively high level of flaxseed can cause reduced nutrient digestibility, normocytic anemia and hyperphosphatemia, as well as possible disturbances in taurine and sterol metabolism due to increased primary bile acid losses in feces” (page 46, last paragraph to page 47). The specification further discloses that the example “investigates and identifies biomarkers for predicting development of DCM by using a machine learning approach” and that “these biomarkers (hematocrit, phosphorus, alkaline phosphatase and creatinine) can be used for prognostic and diagnostic methods to predict and treat DCM” (pages 47-48). Thus, the example in the specification only provided data to be used “for prognostic and diagnostic methods to predict and treat DCM.”
While Applicant from the Example of the specification may provide some association between a legume-rich diet and DCM, just as the FDA as discussed above by McCauley also hypothesize the association of a legume-rich diet and DCM, Applicant has not provided any working example or experimental data showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” to a dog at risk of DCM was effective in reducing the risk of DCM in said dogs.
Thus, Applicant is not enabled for the full breadth of a method of reducing the risk of developing dilated cardiomyopathy (DCM) in a dog comprising administering to the dog at risk of developing DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume, in light of the unpredictability of the state of the art, as well as, lack of working examples and experimental data from the specification showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” effectively reduces the risk of DCM in dogs at risk of development DCM. No dogs were administered a low legume diet in the Example provided in the specification.
Applicant’s one example in the specification (as discussed supra) does not provide any predictability or evidence that the use of a low legume diet effectively reduces the risk of DCM in dogs at risk of development DCM. There is no predictability or evidence in the state of the art as a whole, that the use of a low legume diet would have any effective results of reducing the risk of DCM in dogs at risk of development DCM.
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by the reference above, particularly with regards to claims 11, 18, 23 and 24 and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Genetech, 108 F.3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.” (Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997)).
Response to Arguments
Applicant's arguments filed 09/17/2025 have been fully considered but they are not persuasive.
Applicant argues the instant specification provides a specific example [example 1] comparing the effects of a low legume diet and a legume-enriched diet, and showing a protective effect of the former in the development of hallmarks of DCM. Applicant alleged that in light of the working examples, one skilled in the art would have been able to make use the claimed subject matter. Applicant goes on to alleged that "the Examiner heavily relies upon the Applicant's previous statements about obviousness for allegedly weighing in favor of undue experimentation. See Office Action at 11. However, whether one skilled in the art would have found the claimed subject matter obvious before the filing of the instant application is irrelevant to whether they would have been able to make and use the claimed subject matter after being provided with the instant specification. Applicant then cited Allergan, Inc. v. Sandoz Inc. to support Applicant's position that "previous statements related to the reasonable expectation of success in light of the cited art are not and cannot be dispositive of whether one skilled in the art, having read the instant specification, could make and use the claimed subject matter without undue experimentation." Applicant goes on to cite In re Brana and MPEP 2107.03 to support Applicant's position that "the MPEP also notes that it is "while an applicant may on occasion need to provide evidence to show that an invention will work as claimed, it is improper for Office personnel to request evidence ... regarding the degree of effectiveness." MPEP 2107.03. As outlined above, Applicant has more than carried their burden in establishing that the claimed subject matter will work as claimed." (Remarks, pages 8-9).
In response, the Examiner disagrees. Applicant's citation of Allergan, Inc. v. Sandoz Inc., In re Brana, and MPEP 2107.03, do not support Applicant's position of enablement because Applicant has not provided any working example or experimental data in the specification showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” to a dog at risk of DCM was effective in reducing the risk of DCM in said dogs. In fact, contrary to Applicant's allegation, the one example provided in the specification (Example 1) did not show the control diet (i.e., low legume diet) provided a protective effect in the development of hallmarks of DCM. There is no indication in the Example that the control diet is even a low legume diet, much less "a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume."
The McCauley reference cited by the Examiner in the enablement rejection was proper evidence of unpredictability of the state of art. As discussed in the enablement rejection, in light of the state of the art in view of McCauley indicating that there is no definitive evidence showing the potential correlation with diets to DCM and the need of “more objective data need to be collected and analyzed, without sampling bias and confounding factors,” as well as, the lack of evidence or predictability in the state of the art as a whole, showing the effectiveness of a low legume diet in reducing the risk of developing dilated cardiomyopathy (DCM) in said dog, it is highly unlikely that the use of a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume would be effective in reducing the risk of developing dilated cardiomyopathy (DCM) in dogs at risk of developing DCM.
Thus, as discussed in the enablement rejection, [w]hile Applicant from the Example of the specification may provide some association between a legume-rich diet and DCM, just as the FDA as discussed above by McCauley also hypothesize the association of a legume-rich diet and DCM, Applicant has not provided any working example or experimental data showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” to a dog at risk of DCM was effective in reducing the risk of DCM in said dogs.
Accordingly, it is maintained that Applicant is not enabled for the full breadth of a method of reducing the risk of developing dilated cardiomyopathy (DCM) in a dog comprising administering to the dog at risk of developing DCM a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume, in light of the unpredictability of the state of the art, as well as, lack of working examples and experimental data from the specification showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” effectively reduces the risk of DCM in dogs at risk of development DCM, especially when no dogs were administered a low legume diet in the Example provided in the specification. Absence working example showing the administration of “a low legume diet comprising between about 4 g/kg/day and about 6 g/kg/day of legume” reduces the risk of DCM in dogs at risk of development DCM, there is no predictability in light of the state of art, as a whole, that the use of a low legume diet would have any results of reducing the risk of DCM in dogs at risk of development DCM.
Conclusion
No claim is allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613