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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/14/2026 is in compliance with the provisions of 37 C.F.R. 1.97. All references cited in this IDS have been fully considered.
Amendments
Claims 1, 13-27, and 29-33 now longer recite the “prevention” aspect.
Claim 1 now requires the malt extract to comprise amylases and fructanases.
Claims 11-12, 28, and 34-35 are canceled.
Claim 16 now has the list of dosages joined by the conjunction “or”.
Claim 25 now depends from claim 24 and has had a minor typographic change.
Claims 26-27 now require the treatment to be treating the avian granivore for one or more pathogenic bacteria.
Claim 29 now requires the treatment to be treatment of the avian granivore for improving energy utilization originating from feed for the avian granivore.
Claim 30 now requires the treatment to be treatment of the avian granivore for low voluntary food intake.
Claim 31 now requires the treatment to be treatment of the avian granivore for low egg weight.
Claim 32 now requires the treatment to be treatment of the avian granivore for low egg shell thickness.
Claim 33 now requires the treatment to be treatment of the avian granivore for low feed conversion.
Claims 36-37 are newly added and limit the pathogenic bacteria.
Specification
Previous objection to the specification
The specification was objected to for improper use of trade names or marks and for minor informalities. Applicant has made the appropriate correction. Therefore, the objections to the specification have been withdrawn.
New objection to the specification
Applicant has added a hyperlink into the specification (spec. at p. 2, lines 25-26). The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
Claim Objections
Previous objections to the claims
Claim 12 was objected to for minor informalities. This claim has been canceled, rendering the objection moot.
Claims 16 and 25-26 were objected to for minor informalities. Applicant has made the appropriate correction and the objections have been withdrawn.
New objection to the claims
Claims 32-33 are objected to because they contain an erroneous misspelling of “avian” in line 4.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112:
(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.
(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 specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Previous rejection under 35 U.S.C. § 112(a)
RE: Rejection of claims 1, 11-27, and 29-35 under 35 U.S.C. 112(a) because the specification, while being enabling for a generic method of “treatment”, does not reasonably provide enablement for a generic method of “prevention”.
The claims were previously considered to be enabled for a generic method of “treatment” but not “prevention”. In response, applicant has removed the “prevention” aspect of the methods and the rejection is therefore withdrawn.
RE: Rejection of claim 28 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement.
Claim 28 was considered to fully lack enablement. In response, applicant has canceled the claim, rendering the rejection moot.
RE: Rejection of claims 11-12 under 35 U.S.C. 112(d), as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11-12 were rejected for depending from subsequently numbered claims. In response, applicant has canceled these claims and reintroduced them as claims 36-37. Accordingly, the rejection is moot.
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.
Previous rejections under 35 U.S.C. § 103
RE: Rejection of claims 1, 13-20, and 24-25 under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914).
Claims 1, 13-20, and 24-25 were rejected as obvious over Hunter et al. in view of Aderibigbe et al. Applicant traverses by arguing that the instant claims are nonobvious because claim 1 has been amended to specify that the malt extract comprises amylases and fructanases and it is allegedly non-obvious to combine the teachings of Aderibigbe with Hunter because Aderibigbe only addresses starch digestibility with alpha-amylase and not fructanase. Moreover, applicant asserts that Aderibigbe’s alpha-amylase is a recombinant amylase and therefore is structurally different from a natural amylase.
Applicant’s argument has been fully considered but is not sufficient to overcome the rejection of record.
As discussed in the rejection of record, Hunter teaches treating enterometabolic gut disorders using a malt extract including fructanase and amylase ([0031]) and additionally teaches that such compositions can be used in animal feed in order to increase the energy utilization from the feed ([0019]-[0020]). Hunter differs only from the instant claims because it does not specify that the animal is an avian granivore. Aderibigbe et al. teaches that exogenous carbohydrases can improve energy utilization and performance of no-ruminant animals such as broiler chicks. Accordingly, for the reasons discussed in the rejection of record, it would have been obvious to have used Hunter’s malt extract (which comprises both components recited in the instant claim) for a generic method of avian granivore treatment. And although it is acknowledged that Aderibigbe uses a recombinant alpha-amylase, alpha-amylase is nonetheless an “amylase” and there is no evidence of record that the recombinant alpha-amylase is structurally or functionally different than natural amylase. Rather, the pertinent conclusion from Aderibigbe’s disclosure is that avian granivores (in this case, broiler chickens) can benefit from carbohydrase supplementation. This alone is sufficient motivation to use Hunter’s carbohydrases on avian granivores.
For at least this reason, the rejection must be maintained but has been modified in response to applicant’s amendments to the claims.
RE: Rejection of claims 1, 11-20, 24-26, 29-30, and 33 under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Reinikainen et al. (EP 3542639 A1; cited in IDS filed on 07/26/2023).
Claims 1, 11-20, 24-26, 29-30, and 33 were rejected as obvious over a combination of Hunter, Aderibigbe, and Reinikainen. Applicant has not argued the merits of Reinikainen other than by arguing that the results “are very inconsistent” (Remarks, p. 11, par. 3). Applicant further argues that the claims are non-obvious by virtue of the alleged non-obviousness of claim 1.
For the reasons discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Accordingly, the rejection of Hunter in view of Aderibigbe and Reinikainen is proper and must be maintained but has been modified in response to applicant’s amendments to the claims.
RE: Rejection of claims 1, 13-25, and 27 under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Mehdi et al. (Animal Nutrition, 2018, Vol. 4, pages 170-178).
Claims 1, 13-25, and 27 were rejected as obvious over a combination of Hunter, Aderibigbe, and Mehdi.
With respect to claims 21-23, applicant argues that he claims are non-obvious by virtue of the alleged non-obviousness of claim 1. For the reasons discussed above, claim 1 is obvious over Hunter in view of Aderibigbe.
With respect to claim 27, applicant argues that it would not be obvious to administer an antibiotic with/after using the feet additive of claim 1 because antibiotics remove or deplete many gut bacterial strains indiscriminately and their mode of action is therefore contrary to that of the action of the feed additive of claim 1.
Applicant’s argument has been fully considered but is not sufficient to overcome the rejection of record for the following reasons. Although the examiner acknowledges that antibiotics are well-known to indiscriminately deplete gut bacteria, the combination of the malt extract and antibiotics is not contrary to the feed additive because the claim does not require any timing component and therefore could be include administration of the one or more antibiotics prior to administration of the malt extract. For example, applicant’s working examples discuss treating an E. coli outbreak with a single dose of antibiotics before treatment with EquiNectar® (p. 10, lines 6-10).
For the reasons discussed above, the rejection of Hunter in view of Aderibigbe and Mehdi is proper and must be maintained but has been modified in response to applicant’s amendments to the claims.
RE: Rejection of claims 1, 13-20, 24-25, and 31-32 under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Kebede et al. (Global Journal of Science Frontier Research: D Agriculture and Veterinary, 2015, Vol. 15, Issue 7, pages 19-25).
Claims 1, 13-20, 24-25, and 31-32 were rejected as obvious over a combination of Hunter, Aderibigbe, and Kebede. Applicant argues that claims 31-32 are nonobvious because Kebede does not demonstrate an improvement on egg weight and shell thickness.
Applicant argues that the table on p. 22 demonstrates that there was no significant effect on sample egg weight or shell thickness. Applicant’s arguments have been fully considered but are not sufficient to overcome the rejection of record.
As discussed in the rejection of record, the claims previously did not require any particular effect to occur. The claims have been amended to require treatment of low egg weight and low shell thickness. The examiner disagrees with applicant’s assertion that “[a]ccording to page 22…there was no significant effect on sample egg weight or shell thickness” (citing p. 22, left col., section c)). To the contrary, Kebede states “there was a significant effect on sample egg weight, Yolk color, Albumen weight and Shell thickness” (Id.). This is also shown in Table 4 on p. 23.
For the reasons discussed above, the rejection of Hunter in view of Aderibigbe and Kebede is proper and must be maintained but has been modified in response to applicant’s amendments to the claims.
RE: Rejection of claims 1, 13-20, 24-25, and 34 under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Collett (Animal Feed Science and Technology, 2012, Vol. 173, pages 65-75).
Claims 1, 13-20, 24-25, and 34 were rejected as obvious over a combination of Hunter, Aderibigbe, and Collett. Claim 34 has been canceled, rendering the rejection moot.
RE: Rejection of claims 1, 13-20, 24-25, and 35 under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and The Pigeon Insider (“The Racing Pigeon Diet –Optimizing Nutrition with Supplementation Part 1”, The Pigeon Insider, https://www.pigeonracingpigeon.com/whats-new/the-racing-pigeon-diet-optimizing-nutrition-with-supplementation-part-1, accessed September 2025).
Claims 1, 13-20, 24-25, and 35 were rejected as obvious over a combination of Hunter, Aderibigbe, and The Pigeon Insider. Claim 35 has been canceled, rendering the rejection moot.
Maintained but modified rejections under 35 U.S.C. § 103
Claims 1, 13-20, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914).
Hunter teaches formulations including enzyme-rich malt extracts and kits comprising the same as well as feeds including the formulations for veterinary or human medicaments (abstract; [0001]).
Hunter teaches that that digestion in mammals might be improved by providing several different enzymes at once, to improve breakdown of plant-based products ([0002]). Specifically, Hunter teaches formulations comprising malt extract including a plurality of enzymatically active enzymes (ERME) including at least fructanase and amylase, one or more medium-chain triglycerides (MCTs) and at least one biologically acceptable marker ([0008]).
Regarding claim 1, Hunter teaches methods for treatment of conditions or diseases selected from insulin resistance, diabetes, laminitis, and acidosis ([0032]) and can be equally useful for treating enterometabolic gut disorders such as IBS or IBD ([0033]).
Hunter’s composition is a malt extract comprising a plurality of enzymatically active enzymes including at least fructanase and amylase ([0031]). As discussed above, Hunter teaches that the administered composition can be in an animal feed (i.e., as a feed additive) in order to increase the energy utilization from the feed ([0019]-[0020]).
Hunter differs from the instantly claimed methods because it does not teach that the treatment is used in avian granivores.
Nonetheless, Aderibigbe et al. (hereinafter Aderibigbe) teaches that among the nutrients in poultry feed ingredients and diets, starch is quantitatively the most important source of energy and starch digestibility is affected by the proportion of amylose and its variability in corn and other cereal grains can significantly influence the apparent metabolizable energy (AMEn) content of feedstuffs to livestock (p. 5907, left col., par. 1). Therefore, the use of exogenous carbohydrases such as xylanases, amylases, and glucanases as feed additives have been reported to improve energy utilization and the performance of non-ruminant animals (p. 5907, left col., par. 1 through right col., par. 1). Specifically, Aderibigbe tested the supplementation of 240 male 0-day-old broiler chicks with varying levels of α-amylase (0, 80, or 160 KNU/kg)(p. 5908, left col., par. 3). Aderibigbe reports that increasing α-amylase supplementation leads to a linear increase in bodyweight gain (Table 2) and a linear increase in starch digestibility at the posterior jejunum, anterior ileum, posterior ileum, and total tract as well as a quadratic increase in the posterior jejunum and anterior jejunum (Table 3)(p. 5909, right col., par. 3).
Thus, because Hunter teaches a malt extract-derived feed additive comprising fructanase and amylase and because Aderibigbe teaches that exogenous carbohydrases such as amylases can significantly improve energy utilization and performance of non-ruminant animals (specifically broiler chickens), it would have been obvious to have modified the methods of Hunter such that the composition is administered to an avian granivore such as a broiler chicken rather than a mammal. There would have been a reasonable expectation of success because Aderibigbe demonstrates that avian granivores (in this case, broiler chickens) can benefit from carbohydrase supplementation. Therefore, although Hunter’s teachings are directed to treatment of a generic human or animal (in some embodiments, a mammal; p. 2, lines 19-22), it would have been obvious to have adapted this animal feed additive for use in avian granivore feed. There would have been a reasonable expectation of success because the claim is to a generic “method of avian granivore treatment” with no particular effect required to occur and a positive effect (e.g., improved performance or feed conversion) would have been expected based upon Aderibigbe’s teachings. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claim 1 is obvious over Hunter in view of Aderibigbe.
Regarding claim 13, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
Hunter teaches that the malt extracts comprise a plurality of enzymes including proteases (i.e., proteinases)([0037]). As such, it would have been obvious for the modified method of administering a feed additive comprising a malt extract to further comprise proteinases because these are taught to be included in malt extracts and there is a reasonable expectation that Hunter’s malt extract contained this component.
Regarding claim 14, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have arrived at a method of avian granivore treatment comprising administering a feed additive to an avian granivore.
The composition administered in Hunter’s method is a malt extract. And although Hunter does not directly teach that the malt extract additionally comprises one or more water soluble sugars selected from the group consisting of maltose, maltotriose, and maltose polymers, Hunter demonstrates that malt extracts administered in its methods inherently possess maltose. Specifically, Hunter teaches that α-amylase breaks starch down into maltotriose and maltose ([0038]) and beta-amylase breaks starch down into maltose ([0039]). Thus, because Hunter’s methods involve the use of malt extracts comprising amylases with standard feed components such as grains ([0003] and [0028]), it is reasonable to conclude that Hunter’s composition also comprises the breakdown product of these two components.
Regarding claim 15, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
Hunter teaches that a variety of seeds may be used to produce the malt including wheat, triticale, sorghum, maize, buck wheat, or rice and barley is typically used and most preferred ([0044]; emphasis added). As such, it would have been obvious to have based the malt extract on the seeds recited in this claim.
Regarding claim 16, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
Although Hunter does not teach a particular dosage of the malt extract as being 0.3-30, 0.4-20, 0.5-10, 0.7-5, or 1-3 g per 1000 g granivore body weight, a person having ordinary skill in the art could have arrived at these recited ranges through routine experimentation. Particularly, a person having ordinary skill in the art would have been motivated to routinely experiment with various amounts of malt extract when modifying Hunter’s generic method of treating animals to instead be directed to treating an avian granivore (such as a broiler chicken). There would have been a reasonable expectation of success because the generic claim does not require any particular effect to occur in the avian granivore and therefore any amount of malt extract would have been reasonably expected to “treat” an avian granivore. Additionally, there is no evidence that the recited ranges of concentrations elicit some unexpected or remarkable result. Generally, differences in concentration or will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical (MPEP § 2144.05(II)(A)).
Thus, claim 16 is obvious over Hunter in view of Aderibigbe as a result of routine experimentation.
Regarding claim 17, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
Hunter teaches that degrees Lintner (°L) is a measurement of the diastatic power of the malt and a malt with enough power to self-convert into starch has a diastatic power near 35 °L ([0043]). A high diastatic malt typically has a value of above 35°L or typically above 45° L, 50 °L, 60 °L, 70 °L, or 80 °L (Id.). Hunter also teaches that the production of malt extracts is known in the art and the malt used is a “green” malt having high diastatic power, including in some embodiments, a diastatic power of 50 °L or more ([0041]). Thus, Hunter renders obvious the method wherein the diastatic power is above 35 °L as claimed.
Regarding claim 18, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
As discussed above, Hunter teaches formulations comprising malt extract including a plurality of enzymatically active enzymes (ERME) including at least fructanase and amylase, one or more medium-chain triglycerides (MCTs) and at least one biologically acceptable marker ([0008]).
Regarding claim 19, as discussed above, claim 18 is obvious over Hunter in view of Aderibigbe.
Particularly, it would have been obvious to have used Hunter’s method on an avian granivore including the administration of one or more MCT.
Hunter teaches that, in some embodiments, the formulation comprises up to 10% MCT w/w or more preferably up to 5% MCT w/w ([0023]). As such, Hunter explicitly teaches the ranges of 1-5% and 1-10% and teaches a range falling within the claimed range of 1-15%.
Regarding claim 20, as discussed above, claim 18 is obvious over Hunter in view of Aderibigbe.
Particularly, it would have been obvious to have used Hunter’s method on an avian granivore including the administration of one or more MCT.
Hunter teaches that, in some embodiments, the MCT is coconut oil ([0024]).
Regarding claim 24, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
As discussed above, Hunter teaches that the composition is administered in an animal feed. Accordingly, it would have been similarly obvious for the modified method to further comprise administering granivore feed when adapting the method for treatment in an avian granivore.
Regarding claim 25, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore such as a broiler chicken.
Broiler chickens are Gallus gallus domesticus (see Specification p. 2, line 25 which defines “chicken” as being Gallus gallus domesticus).
Claims 1, 13-20, 24-26, 29-30, 33, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Reinikainen et al. (EP 3542639 A1; cited in IDS filed on 07/26/2023).
The teachings of Hunter and Aderibigbe are set forth above and applied herein. Hunter and Aderibigbe are found to render obvious claims 1, 13-20, and 24-25.
Regarding claim 26, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
The instant claim differs because neither Hunter nor Aderibigbe teach or suggest the use of said method in an avian granivore suffering from one or more pathogenic bacteria.
Nonetheless, Reinikainen et al. (hereinafter Reinikainen) teaches animal feeds comprising germinated grains and dried grains ([0001]). Reinikainen teaches that the feed industry has been applying carbohydrate digesting enzymes in industrial feed for nearly 30 years and enzymes for the hydrolysis of non-starch polysaccharides are widely used in feed industry for improvement of feed utilization and alleviation of digestive disorders in the production of animals ([0003]). Malted grains express many enzymes which have activities specifically targeted to hydrolyze plant macromolecules including amylases, proteases, glucanases, xylanases, phytases and many others ([0006]). Reinikainen teaches, inter alia, that broiler chicks fed with malts having α-amylase activity ([0108]) had significantly improved gain, feed conversion ratio (p. 16, Table 3; p. 17, Table 5), and both fresh and dry malt appeared to increase lactic acid bacteria (Figure 11). Reinikainen further teaches that anaerobic bacterial fermentation in carbohydrate-rich habitats typically produce short-chain fatty acids (SCFAs) as a metabolic end product ([0145]) and the dry malt diet significantly increased acetic acid levels (Figure 15). Finally, butyric acid has gained particular interest because it is known to inhibit the invasion of Salmonella enterica serovar Enteritidis and in this study, caecal butyric acid concentration tended to be higher with the dry malt α-amylase-rich diet as compared to negative control (Figure 20).
Accordingly, because Hunter in view of Aderibigbe renders obvious the method of administering a feed additive comprising malt-derived carbohydrase enzymes to a broiler chicken and because Reinikainen teaches that it was well-known that supplemental feed enzymes can be beneficial to broiler chicken health, it would have been obvious to have further modified the method such that the subject is an avian granivore suffering from one or more pathogenic bacteria (in this case, Salmonella Enteritidis). Reinikainen teaches that such a population would benefit from exogenous enzyme therapy by teaching that malt-derived enzymes improve butyric acid levels (which are known to decrease Salmonella enterica serovar Enteritidis levels). There would have been a reasonable expectation of success because Reinikainen teaches that the use of such enzymes is widely accepted and has been employed for over 30 years and because the methods do not require any particular effect to occur. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claim 26 is obvious over Hunter in view of Aderibigbe and Reinikainen.
Regarding claim 29, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
As discussed above, Reinikainen teaches that broiler chicks fed malts having α-amylase activity ([0108]) had significantly improved weight gain and feed conversion ratio (p. 16, Table 3; p. 17, Table 5). Despite these increases, Reinikainen teaches that the malt test group had less feed intake (p. 17, Table 4; Figure 5). Accordingly, because Hunter in view of Aderibigbe renders obvious the method of administering a feed additive comprising malt-derived carbohydrase enzymes to a broiler chicken and because Reinikainen teaches that α-amylase supplementation can significantly improve weight gain and feed conversion while decreasing overall feed consumption, it would have been obvious to have further modified the method such that the method further comprises decreasing the amount of feed provided to the avian granivore and treatment for improving energy utilization originating from feed. There would have been a reasonable expectation of success because the proposed modification would have been expected to significantly improve weight and feed conversion in the subject while overall amount of feed is decreased. There would have been particular motivation to make such modification in order to, for example, lower the overall cost of animal husbandry because the subject would have been expected to be able to more effectively utilize a smaller amount of feed, as demonstrated by Reinikainen. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Regarding claim 30, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
As discussed above, Reinikainen teaches that broiler chicks fed malts having α-amylase activity ([0108]) had significantly improved weight gain and feed conversion ratio (p. 16, Table 3; p. 17, Table 5). Accordingly, because Hunter in view of Aderibigbe renders obvious the method of administering a feed additive comprising malt-derived carbohydrase enzymes to a broiler chicken and because Reinikainen teaches that α-amylase supplementation can significantly weight gain and feed conversion, it would have been obvious to have further modified the method such that the avian granivore to which the therapy is administered is an avian granivore suffering from low voluntary food intake for the purpose of treatment of the avian granivore for low voluntary food intake. There would have been a reasonable expectation of success because the proposed modification would have been expected to significantly improve feed conversion in said subject and therefore alleviate the effects of low feed intake. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Regarding claim 33, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe. Particularly, it would have been obvious to have used Hunter’s method on an avian granivore.
As discussed above, Reinikainen teaches that broiler chicks fed malts having α-amylase activity ([0108]) had significantly improved feed conversion ratio (p. 17, Table 5).
Accordingly, because Hunter in view of Aderibigbe renders obvious the method of administering a feed additive comprising malt-derived carbohydrase enzymes to a broiler chicken and because Reinikainen teaches that α-amylase supplementation can significantly improve feed conversion, it would have been obvious to have further modified the method such that the avian granivore to which the therapy is administered is an avian granivore suffering from low feed conversion ratio and would have similarly been obvious to have modified the method such that it is for treatment of the avian granivore for low feed conversion ratio. There would have been a reasonable expectation of success because Reinikainen teaches that such enzymes would be useful for this purpose. This obviousness is based upon the “Some Teachings, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Regarding claims 36-37, as discussed above, Hunter in view of Aderibigbe and Reinikainen render obvious the method wherein the avian granivore is suffering from one or more pathogenic bacteria (specifically, Salmonella Enteritidis).
Claims 1, 13-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Mehdi et al. (Animal Nutrition, 2018, Vol. 4, pages 170-178).
The teachings of Hunter and Aderibigbe are set forth above and applied herein. Hunter and Aderibigbe are found to render obvious claims 1, 13-20, and 24-25.
Regarding claims 21-22, as discussed above, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe.
However, neither Hunter nor Aderibigbe teach or suggest that the feed additive further comprises an effective amount of one or more water soluble organic acid or salt thereof.
Nonetheless, Mehdi et al. (hereinafter Mehdi) reviews the use of alternatives to antibiotics in poultry farming and teaches that organic acids are conservation agents used to protect feed from microbial and fungal proliferation (p. 174, right col., par. 6). The organic acids can be simple monocarboxylic acids such as acetic acid, formic acid, butyric acid, and propionic acid (p. 175, left col., par. 1). Studies have also shown that organic acid addition to broiler feed promotes growth, feed conversion rate, and feed utilization (Id.). For example, 2% citric acid has been shown to improve cell proliferation and villi height of the gastrointestinal tract and formic and propionic acid (0.0525%) has been shown to increase Lactobacillus populations in the gastrointestinal tract (Id.).
Thus, because Hunter in view of Aderibigbe renders obvious a method of administering a feed additive which comprises a malt extract and which increases the energy utilization from the feed ([0019]-[0020]) and because Mehdi teaches that organic acids have been used routinely in the art for reducing bacterial growth in animal feeds and for improving feed efficiency and weight gain in broiler chickens, it would have been obvious to have further modified Hunter’s method such that the administered composition further comprises one or more water soluble organic acids such as acetic acid, formic acid, butyric acid, or propionic acid. It would have been obvious to have made a modification which comprises an effective amount of the organic acid in order to achieve the above effects. There would have been a reasonable expectation of success because Mehdi demonstrates the previous widespread use of organic acids for precisely this purpose. The modification would have been expected to improve the method further improving animal health, as discussed by Mehdi. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claims 21 and 22 are obvious over Hunter in view of Aderibigbe and Mehdi.
Regarding claim 23, as discussed above, Hunter in view of Aderibigbe and Mehdi renders obvious the method further comprising a feed which comprises an effective amount of one or more water soluble organic acid or a salt thereof.
Mehdi teaches the use of various percentages of acid. For example, for citric acid, Mehdi teaches the use of 2% in order to improve cell proliferation and villi height in the gastrointestinal epithelium (p. 175, left col., par. 1). Moreover, Mehdi teaches the use of 0.0525% formic and propionic acid to improve the gastrointestinal microbiota. The values taught by Mehdi fall within the claimed range of 0.001-5% w/w.
Alternatively, even if Mehdi does not teach acceptable concentrations for combinations of organic acids with Hunter’s malt extract, it would have been obvious to have arrived at the recited ranges as a result of routine experimentation. A person having ordinary skill in the art would have been prompted to experiment with various concentrations of organic acid based upon Mehdi teachings of the known benefits of including organic acids into animal feeds. Thus, a person having ordinary skill in the art would have been prompted to vary the concentration of the organic acid in order to optimize the previously known beneficial effects of organic acid supplementation. There would have been a reasonable expectation of success because Mehdi teaches the conventional use of various amounts of organic acids to achieve beneficial host effects. Finally, there is no evidence that the recited ranges elicit an unexpected or remarkable result.
Thus, claim 23 is obvious over Hunter in view of Aderibigbe and Mehdi.
Regarding claim 27, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe.
The instant claim differs from Hunter and Aderibigbe because neither reference requires that the method further comprises administration of one or more antibiotics to the avian granivore, and wherein the avian granivore is suffering from one or more pathogenic bacteria.
Nonetheless, Mehdi reviews the use of antibiotics in poultry production and teaches that antibiotics are known to be successful in controlling infectious pathologies and increasing feed efficiencies (p. 170, left col., par. 1). Mehdi teaches that antibiotics have been used for the past fifty years in order to prevent the negative impacts of many avian diseases (p. 170, right col., par. 2). In poultry farming, antibiotics such as tetracycline, bacitracin, tylosin, salinomycin, virginiamycin and bambermycin are often used (p. 171, left col., par. 3). In general, antibiotics are used in animal feeds for preventative or curative treatment of bacterial diseases, reducing animal mortality (p. 171, left col., par. 3 and Figure 1).
Thus, because Hunter in view of Aderibigbe renders obvious a method of administering a feed additive which comprises a malt extract and which increases the energy utilization from the feed ([0019]-[0020]) and because Mehdi teaches that antibiotics can be administered to avian granivores which are suffering from one or more pathogenic bacteria in order to reduce animal mortality and increase feed efficiency, it would have been obvious to have further modified the method such that the method further comprises administration of one or more antibiotics to the avian granivore, and wherein the avian granivore is suffering from one or more pathogenic bacteria, and the treatment is treatment of the avian granivore for one or more pathogenic bacteria. There would have been a reasonable expectation that such a modification would result in a method which decreases mortality of the avian granivore and which further improves the efficiency of the animal feed. This obviousness is based upon the “Some Teachings, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claim 27 is obvious over Hunter in view of Aderibigbe and Mehdi.
Claims 1, 13-20, 24-25, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Hunter et al. (US 2019/0307859 A1) in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914) and Kebede et al. (Global Journal of Science Frontier Research: D Agriculture and Veterinary, 2015, Vol. 15, Issue 7, pages 19-25).
The teachings of Hunter and Aderibigbe are set forth above and applied herein. Hunter and Aderibigbe are found to render obvious claims 1, 13-20, and 24-25.
Regarding claims 31-32, as discussed above, as discussed above, claim 1 is obvious over Hunter in view of Aderibigbe.
Although Hunter in view of Aderibigbe renders obvious the use of Hunter’s method on an avian granivore such as a chicken, neither reference teaches or suggests that the method is carried out on an avian granivore suffering from low egg weight (claim 31) or low shell thickness (claim 32).
Nonetheless, Kebede et al. (hereinafter Kebede) investigates the supplementation of maize with malted barley grain on egg quality in laying hens (abstract). Kebede finds that when substituting maize with malted barley grain, egg weight and shell thickness were significantly improved (P<0.05 and P<0.01, respectively)(p. 23, Table 4).
As such, because Hunter teaches a method of administering a malted grain animal feed in which barley is “typically used and most preferred” ([0028] and [0044]) and because Kebede teaches that malted barley grains significantly improve egg weight and shell thickness, it would have been obvious to have further modified Hunter’s method such that the avian granivore is one which is suffering from low egg weight or low shell thickness for the purpose of treating low egg weight and low egg shell thickness. There would have been a reasonable expectation of success because Kebede demonstrates that malted grains can improve these characteristics. This obviousness is based upon the “Some Teaching, Suggestion, or Motivation in the Prior Art That Would Have Led One of Ordinary Skill To Modify the Prior Art Reference or To Combine Prior Art Reference Teachings To Arrive at the Claimed Invention” rationale set forth in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007). See MPEP 2143(I)(G).
Thus, claims 31-32 are obvious over Hunter in view of Aderibigbe and Kebede.
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.
Previous double patenting rejections
RE: Provisional rejection of claims 1 and 11-35 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/135,671 in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914).
Applicant asserts that the claims are not obvious over the copending application in view of Aderibigbe because the claim requires a malt extract comprising amylases and fructanases. For the reasons discussed above, Aderibigbe provides sufficient motivation to use a malt extract comprising amylases and fructanases in an avian granivore. Accordingly, the nonstatutory double patenting rejection is maintained.
Maintained double patenting rejections
Claims 1 and 13-27, 29-33, and 36-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/135,671 in view of Aderibigbe et al. (Poultry Science, 2020, Vol. 99, pages 5907-5914).
Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claim 1 of the ‘671 application is directed to “a feed additive for a dog”. The phrase “for a dog” is the intended use of the feed additive composition and does not impart patentable weight on the “feed additive”. The feed additive comprises a malt extract, the malt extract comprising one or more enzymes selected from the group consisting of amylases, maltases, cellulases, fructanases, glucanases, xylanases, and deacetylases. The amended claims require a composition comprising amylase and fructanase. By virtue of the comprising language, the composition is open to unrecited components. Thus, the instant claims encompass the use of compositions recited in the copending claims.
And although the copending claims do not provide any teaching or suggestion that the composition would be useful in a generic method of avian granivore treatment, Aderibigbe teaches that among the nutrients in poultry feed ingredients and diets, starch is quantitatively the most important source of energy and starch digestibility is affected by the proportion of amylose and its variability in corn and other cereal grains can significantly influence the apparent metabolizable energy (AMEn) content of feedstuffs to livestock (p. 5907, left col., par. 1). Therefore, the use of exogenous carbohydrases such as xylanases, amylases, and glucanases as feed additives have been reported to improve energy utilization and the performance of non-ruminant animals (p. 5907, left col., par. 1 through right col., par. 1). Aderibigbe reports that increasing α-amylase supplementation leads to a linear increase in bodyweight gain (Table 2) and a linear increase in starch digestibility at the posterior jejunum, anterior ileum, posterior ileum, and total tract as well as a quadratic increase in the posterior jejunum and anterior jejunum (Table 3)(p. 5909, right col., par. 3).
Thus, because the copending claims recite a malt extract-derived feed additive comprising exogenous enzymes such as amylase and fructanase and because Aderibigbe teaches that exogenous carbohydrases such as amylases can significantly improve energy utilization and performance of non-ruminant animals (specifically broiler chickens), it would have been obvious to have used the composition recited in the copending claims in a generic method of avian granivore treatment involving the administration of a feed additive comprising a malt extract.
Although some of the instant claims further limit the structure of the administered feed additive, these limitations are also recited in the copending claims.
For example, claim 13 further requires the malt extract to comprise one or more proteinases and/or lipases. Claim 9 of the copending application recites this limitation.
Claims 14-23 are akin to copending claims 10-19, respectively.
Therefore, because the copending application is directed to the feed additive required by the instant methods, the claims are unpatentable over each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/GRANT C CURRENS/Examiner, Art Unit 1651
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