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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 6, 2025, has been entered.
Election/Restrictions
Applicant’s election without traverse of Species A (i.e., improving intestinal maturation as a single and specific use); Species B (i.e., at least 90% as a single and specific whey protein nativity range); Species C (i.e., at least 70% of α-lac / at least 70% of β-lg as a single and specific whey protein component range); and Species D (i.e., as a single and specific production process) in the reply filed on April 22, 2024, is acknowledged.
Please note that after further consideration, Species A is expanded to include claim 22.
Status of Claims
Claims 1-20 were originally filed on April 30, 2021.
The amendment received on April 30, 2021, canceled claims 1-20; and new claims 21-40. The amendment received on October 21, 2024, canceled claim 35; and amended claim 21. The amendment received on June 6, 2025, canceled claim 34; amended claim 21; and added new claims 41-42.
Claims 21-33 and 36-42 are currently pending and claims 21-25, 29, 31, 38, and 41-42 are under consideration as claims 26-28, 30, 32-33, 36-37, and 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 22, 2024.
Priority
The present application claims status as a 371 (National Stage) of PCT/NL2020/050059 filed February 3, 2020, and claims priority under 119(a)-(d) to International Application No. PCT/NL2020/050067 filed on February 1, 2019.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for PCT Application No. PCT/NL2020/050067, which papers have been placed of record in the file. Please note that the PCT application is in English and therefore no further action is necessary.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claim 21, regarding what constitutes native whey protein, it is noted that the instant specification does not define what constitutes native whey protein. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. The plain and ordinary meaning of “native whey protein” is made from pasteurized, skimmed milk instead of the liquid by-product resulting from cheese production (See Schinetsky, R., “Native Whey vs Whey Protein: Is Native Whey Worth It?,” Supplement Engineer, available online at https://supplementengineer.com/blogs/supplements/native-whey-vs-whey, 16 pages (2023) at pg. 12, 3rd paragraph) (cited in the Action mailed on 6/21/24). Similarly, native whey protein refers to a process in which whey protein and the milk become separated emphasizing that the whey as related to being “native” is NOT a byproduct of a cheese manufacturing process (coagulation/curdling) but instead is isolated from the milk by pressuring pasteurized milk via microfiltration in order to filter the whey protein particles from other macronutrients such as casein proteins, fats and sugars (See “Native Whey Explained,” AGN Roots, available online at https://agnroots.com/blogs/faq-the-best-unflavored-grassfed-whey/native-whey-facts-fiction, 11 pages (accessed on 6/13/24) at pg. 2, last paragraph) (cited in the Action mailed on 6/21/24). Thus, whey protein is “native” based on the process by which is it processed and excludes whey protein that is processed from cheese production.
For claims 29 and 31, regarding what constitutes a percent nativity, it is noted that the instant specification defines “nativity” as referring to the percentage of native protein of a particular type based on the total amount of protein of the same type (See instant specification, paragraph [0013]). In claim 29, the nativity of the whey protein refers to the amount of native whey protein based on the total amount of whey protein (See instant specification, paragraph [0013]). In claim 31, the nativity of the alpha-lactalbumin (la) and the beta-lactoglobulin (lg) refers to the amount of native la and lg based on the total amount of la and lg, respectively.
Response to Arguments
Applicant’s arguments, see Response, filed 6/6/25, with respect to the 103(a) rejection have been fully considered and are persuasive. The rejection of claims 21-25, 29, 31, and 34 \ as being unpatentable over Li et al., J. Nutr. 143:1934-1942 (2013) (cited in the IDS received on 4/30/21) in view of Brandt Bering, et al., Final Report for collaborative projects funded via the Danish Dairy Research Foundation, available online at https://mejeri.dk/media/xgmpxsxw/2017-145-stine-bering-valleproteinkoncentrat-som-supplement-til-moderm%C3%A6lkserstatning-og-human-donorm%C3%A6lk-slutrapport.pdf, 60 pages (2017) (note copy provided 2/27/24 by third party) has been withdrawn.
Applicant’s arguments, see Response, filed 10/21/24, with respect to the 102(a)(1) rejection have been fully considered and are persuasive. The rejection of claims 21 and 38 as being unpatentable over Li et al., J. Nutr. 143:1934-1942 (2013) (cited in the IDS received on 4/30/21) and Brandt Bering et al., Final Report for collaborative projects funded via the Danish Dairy Research Foundation, available online at https://mejeri.dk/media/xgmpxsxw/2017-145-stine-bering-valleproteinkoncentrat-som-supplement-til-moderm%C3%A6lkserstatning-og-human-donorm%C3%A6lk-slutrapport.pdf, 60 pages (2017) (note copy provided 2/27/24 by third party), and further in view of David et al. WO 2018/029216 A1 published on February 15, 2018 (note copy provided 2/27/24 by third party) has been withdrawn.
New Rejections
Claim Rejections - 35 USC § 112
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 21-25, 29, 31, 38, and 41-42 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 improving intestinal maturation and/or reducing and/or preventing intestinal permeability in a subject in need thereof, where the intestine includes at least the colon, by administering to the subject a native whey protein made by a method comprising skimming whole raw milk at 55°C and then cooled to 4°C, microfiltration at 10°C, ultrafiltration and diafiltration at 10°C, stored at 4°C, heated to 30°C, and sprayed dried with a nativity amount of 100% and with or without one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count when compared a whey protein that is subjected to a temperature of at least 73°C and has a nativity amount of less than 100%; and,
does not reasonably provide enablement for any embodiments encompassed outside the aforementioned parameters.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As stated in MPEP §2164.01(a), “there are many factors to consider when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any experimentation is ‘undue’.” These factors include, but are not limited to:
1. The breadth of the claims;
2. The nature of the invention;
3. The state of the prior art;
4. The level of skill in the art;
5. The level of predictability in the art;
6. The amount of direction provided by the inventor;
7. The presence or absence of working examples;
8. The quantity of experimentation necessary needed to make or use the invention based on the disclosure.
See In re Wands USPQ 2d 1400 (CAFC 1988).
The eight In re Wands factors are applied to Claims 21-25, 29, 31, 38, and 41-42 as follows:
The Breadth of the Claims and The Nature of the Invention
Although addressing that the subject is in need of improved intestinal maturation and/or reduced and/or prevented intestinal permeability in claims 21 and 41-42 by administering a native whey protein to the subject where the improved intestinal maturation is improved when compared to a whey protein that is made non-native with or without one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count with respect to a subject fed the same whey protein having an undefined amount of nativity, or the reduced/prevented intestinal permeability includes a reduced occurrence with respect to the occurrence thereof in a subject fed the same whey protein having an undefined amount of nativity, Applicants only demonstrate such desired results when the whey protein is made via a specific method thereby resulting in a whey protein nativity of 100% when compared to a whey protein that is made non-native by being subjected to a temperature of at least 73°C and having a nativity of less than 100% (See instant, Examples 1-2 and 6). More specifically, the instant specification distinguishes three whey protein samples; namely, native, deactivated and denatured (See instant, Examples 1-2). None of the samples are derived from cheese including the deactivated and the denatured (See instant, Examples 1-2). As such, all three samples would constitute the produced whey protein as native in light of the plain and ordinary meaning defined by Schinetsky, R. and AGN Roots supra. It is noted that all three samples utilized the same initial steps, i.e., skimming whole raw milk at 55°C and then cooled to 4°C, microfiltration at 10°C, ultrafiltration and diafiltration at 10°C, stored at 4°C, and heated to 30°C and sprayed dried at 11% DM with a dryer operated with an inlet temperature of 185°C and outlet temperature of 90°C (See instant Example 1). However the deactivated whey protein sample was further subjected to re-hydration at 40°C and heat-treatment at 73°C, and then freeze-dried thereby inactivating bioactive components such as alkaline phosphatase; and the denatured whey protein sample was further subjected to re-hydration at 40°C and heat treatment at 100°C, and then freeze-dried (See instant Example 1). Notably, each sample contains native whey protein, albeit, in different amounts, i.e., the “native” whey protein samples have 100% nativity, the deactivated whey protein samples have 95.73 and 97.03%, and the denatured whey protein samples have 21.43% and 37.16% (See instant, tables in [0073] and [0078]).
However, the scope of claims 21 and 41-42 with respect to the administered native whey protein is made by any process as long as it is not derived from cheese (See “Claim Interpretation” section supra), and has any amount of nativity. Moreover, the whey protein which is made “non-native” would correspond to whey protein derived from cheese, and has any amount of nativity. Accordingly, claims 21-25, 29, 31, 38, and 41-42 are unduly broad with respect to the methods by which the native and non-native whey protein is made and the amounts of nativity for the native and non-native whey protein.
The State of the Prior Art
It is noted that the state of the art teaches mixed results regarding the effects of native whey protein on intestinal maturation and/or intestinal permeability, and in particular, colonic maturation and/or permeability. Li et al., J. Nutr. 143:1934-1942 (2013) (cited in the IDS received on 4/30/21) investigated whey protein concentrates (WPCs) produced differently with regards to casein precipitation method (acid or sweet whey), filtration (with or without a special filtration step), pasteurization (multi, single, or none), and drying method (standard, gentle, spray-drying, or freeze-drying) (See Li, pg. 1940, col. 2, 2nd paragraph). Li et al. concluded that their results do not allow for conclusions regarding the effects of specific production processes, could not exclude that milder production methods can lead to decreased hygiene quality (See Li, pg. 1940, col. 2, 2nd paragraph). Moreover, the stability of bioactive components during storage and following formula production still remains to be investigated (See Li, pg. 1940, col. 2, 2nd paragraph). Nonetheless, Li et al. found that WPCs produced by different processing methods contain different amounts of bioactive proteins and possess different maturational effects on the immature gut (See Li, pg. 1940, col. 2, 2nd paragraph). Thus, although the teachings of Li et al. demonstrate positive results of improved small intestinal maturation, Li et al. also demonstrates the unpredictability of the whey protein’s maturational effects depending on the method by which the whey protein is processed.
Furthermore, Brandt Bering, et al., Final Report for collaborative projects funded via the Danish Dairy Research Foundation, available online at https://mejeri.dk/media/xgmpxsxw/2017-145-stine-bering-valleproteinkoncentrat-som-supplement-til-moderm%C3%A6lkserstatning-og-human-donorm%C3%A6lk-slutrapport.pdf, 60 pages (2017) (note copy provided 2/27/24 by third party), hypothesizes that raw human donor milk (DM) is superior to pasteurized human donor milk to improve intestinal maturation in preterm newborns (See Brandt Bering article, pg. 4, 3rd paragraph). To evaluate this hypothesis, Brandt Bering et al. analyzed various parameters including intestinal morphology, fecal lipid content, fecal short chain fatty acid (SCFA) content and composition, and fecal microbiota (See Brandt Bering article, pg. 5, 3rd paragraph). These parameters reflect the intestinal structure and barrier function, digestive and absorptive functions (See Brandt Bering article, pg. 5, 3rd paragraph). Raw milk exhibited similar results compared to other whey protein compositions with respect to birth weights, weights at death, life-time, overall growth rates and organ weights or lengths (See Brandt Bering article, pg. 7, 3rd paragraph). The total bacterial load in the cecum (i.e., part of the colon) content did not differ among the whey protein groups (See Brandt Bering article, pg. 8, 1st paragraph). Moreover, Brandt Bering et al. found that formate, acetate, lactate and succinate were the main SCFAs present in colon contents (See Brandt Bering article, pg. 8, 3rd paragraph). As such, Brandt Bering et al. demonstrates that colon bacterial and SCFA contents remain relatively stable among native whey protein and non-native whey protein with respect to colonic maturation and/or permeability. Thus, Brandt Bering et al. demonstrates that colonic maturation and/or permeability is similarly affected by native and non-native whey protein. Therefore, the level of predictability in the art is dependent on many factors including the method by which the whey protein is processed, and the amount of nativity of the whey protein.
The Level of Skill in the Art
Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art for improving intestinal maturation and/or reducing and/or preventing intestinal permeability in a subject.
The Level of Predictability in the Art
The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., administering a native whey protein with any amount of nativity and made via any process that does not include cheese derivatization to a subject in order to improve intestinal maturation and/or reduce/prevent intestinal permeability when compared to a non-native whey protein with any amount of nativity and made via a process that includes cheese derivatization), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species, what other species will work.
In the instant case, Applicants demonstrate that the deactivated whey protein sample of Example 1 with a nativity of 95.73% exhibited a significantly decreased lactulose/mannitol ratio in urine thereby indicative of a lower gut permeability and improved gut maturation, significantly decreased crypt depth indicative of a more natural gut development, a significantly decreased number of Ki67 positive proliferating cells per crypt thereby indicative of a more differentiated phenotype and improved gut maturation, a significantly higher amount of animals had histological positive alkaline phosphatase activity, and an increased enteroendocrine cell count when compared to the denatured whey protein sample with a nativity of 21.43% (See instant, Example 6 at [0086], [0091]-[0093]; Figures 1, 2a-c, 3a and 4). However, Applicants refer in the Results section of Example 6 that the native whey protein sample exhibited the above-identified results when compared to the denatured whey protein sample (See instant, Example 6 at [0091]-[0093]), but the description of the study in the beginning of Example 6 states that the comparison is between the deactivated whey protein sample and the denatured whey protein sample (See instant, Example 6 at [0086]). Given that Example 1 delineates the native whey protein sample from the deactivated whey protein sample (See instant, [0073]), and given that Example 6 refers to both the native and deactivated whey protein sample, it is not readily apparent which whey protein sample, i.e., the native or the deactivated, exhibits the above-identified results. To exacerbate matters, Example 4 examined the alkaline phosphatase activity of each of the three whey protein samples in Examples 1 and 2, i.e., native, deactivated and denatured, and demonstrates that the deactivated whey protein sample exhibited low ALP activity or was not determined (See instant, Example 4 at [0084]). As such, the significantly higher amount of animals having histological positive alkaline phosphatase activity in Example 6 would not be expected from the deactivated whey protein sample. Assuming arguendo that the whey protein sample that exhibits the above-identified results is the native whey protein sample and not the deactivated whey protein sample, it would then follow that the process by which the whey protein is made and the amount of nativity is critical in achieving the above-identified results, especially given that all three whey protein samples were not produced from cheese, which renders a whey protein as non-native. Clarification with respect to Example 6 is respectfully requested.
Furthermore, although Example 6 indicates statistical significance of the above-identified results, the Figures do not appear to indicate statistical significance. More specifically, the error bars overlap in Figures 1, 2a-b, 3a and 4. Thus, clarification with respect to the errors bars compared to the indicated statistical significance depicted in the Figures is respectfully requested. Thus, assuming arguendo that the whey protein sample that exhibits the above-identified results is the native whey protein sample and assuming arguendo that the above-identified results are statistically significant, the improved intestinal maturation and/or reducing intestinal permeability in a subject is dependent upon the whey protein being processed via a specific method as described in Example 1 and having a nativity of 100%. Without more experimentation demonstrating the efficacy of the claimed administered native whey protein that is made via a representative number of processes and containing a representative number of nativity amounts thereby constituting a representative number of whey protein samples, the level of unpredictability remains high. Therefore, it is unpredictable that the claimed administered native whey protein will improve intestinal maturation with or without one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count when compared to a subject fed the same whey protein having a nativity has an undefined amount of nativity, or the reduced/prevented intestinal permeability includes a reduced occurrence with respect to the occurrence thereof in a subject unless the whey protein is produced via the method described in Example 1 of the specification and having a nativity of 100%.
The Amount of Direction Provided by the Inventor,
The Presence or Absence of Working Examples, and
The Quantity of Experimentation Necessary
The specification does not enable any person skilled in the art to which it pertains (i.e. administering a native whey protein with any amount of nativity and made via any process that does not include cheese derivatization to a subject in order to improve intestinal maturation and/or reduce/prevent intestinal permeability when compared to a non-native whey protein with any amount of nativity and made via a process that includes cheese derivatization) to make and/or use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification or prior art with regard to the improvement of intestinal maturation with or without one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count by administering a native whey protein having any nativity amount and made via any process as long as it is not derived from cheese when compared to a subject fed the same whey protein with an undefined amount of nativity and made via any process as long as it is derived from cheese, or the reduction of intestinal permeability including a reduced occurrence with respect to the occurrence thereof by administering to a subject a native whey protein having any nativity amount and made via any process as long as it is not derived from cheese when compared to a subject fed the same whey protein with an undefined amount of nativity and made via any process as long as it is derived from cheese. Applicants fail to provide the guidance and information required to ascertain where the full scope of the claimed native whey protein will be effective in improving intestinal maturation and/or reduce intestinal permeability when compared to a whey protein that is made non-native without resorting to undue experimentation. Applicant's limited disclosure is noted but is not sufficient to justify claiming where the native whey protein is processed via any method and has any amount of nativity compared to a whey protein that is processed via any method as long as it is derived from cheese and has any nativity amount.
Absent a reasonable a priori expectation of success for administering a native whey protein to improve intestinal maturation with or without one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count when compared to a subject fed the same whey protein that is made non-native, or to reduce intestinal permeability including a reduced occurrence with respect to the occurrence thereof when compared to a whey protein made non-native, one skilled in the art would have to extensively test colonic crypt depth, phenotype of colonic cells, colonic alkaline phosphatase activity, colonic enteroendocrine cell count for a representative number of whey proteins having differing nativity amounts and/or produced via different methods. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope, because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is limited to a native whey protein made via a specific method (See “Breadth of the Claims and The Nature of the Invention” section supra for further details) and having a nativity amount of 100% when compared to a whey protein that is made non-native via specific methods and having a nativity amount of less than 100%. More specifically, as discussed in the “Breadth of the Claims and The Nature of the Invention” section supra, the instant specification distinguishes three whey protein samples; namely, native, deactivated and denatured (See instant, Examples 1-2). It is noted that all three samples utilized the same initial steps, i.e., skimming whole raw milk at 55°C and then cooled to 4°C, microfiltration at 10°C, ultrafiltration and diafiltration at 10°C, stored at 4°C, and heated to 30°C and sprayed dried at 11% DM with a dryer operated with an inlet temperature of 185°C and outlet temperature of 90°C (See instant Example 1). However the deactivated whey protein sample was further subjected to re-hydration at 40°C and heat-treatment at 73°C, and then freeze-dried thereby inactivating bioactive components such as alkaline phosphatase; and the denatured whey protein sample was further subjected to re-hydration at 40°C and heat treatment at 100°C, and then freeze-dried (See instant Example 1). Notably, each sample contains native whey protein, albeit, in different amounts, i.e., the “native” whey protein samples have 100% nativity, the deactivated whey protein samples have 95.73 and 97.03%, and the denatured whey protein samples have 21.43% and 37.16% (See instant, tables in [0073] and [0078]). Examples 4-5 demonstrate that the native whey protein samples exhibited alkaline phosphatase activity whereas the deactivated and denatured whey protein samples exhibited low alkaline phosphatase activity (See instant, Examples 4-5). Example 6 demonstrates that the native whey protein sample of Example 1 (note: presuming Example 6 is referring to the native and not deactivated whey protein sample and presuming statistical significance is depicted in the Figures) exhibits a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count when compared to the denatured whey protein sample (See instant, Example 6). As such, the instant specification demonstrates the desired intended result of improved intestinal maturation and/or reducing intestinal permeability when a native whey protein is made via the method described in instant Example 1 and having a nativity of 100% when compared to a whey protein that is made non-native via the methods described in instant Example 1 and having a nativity of less than 100%. However, as noted in “Breadth of the Claims and Nature of the Invention" Section, the scope of claims 21 and 41-42 encompass a native whey protein made via any method and having any amount of nativity when compared to a whey protein that is made non-native via any method including cheese derivatization and having any amount of nativity. In the absence of a representative number of native whey proteins made via a representative number of methods and having a representative number of nativity amounts demonstrating improved intestinal maturation and/or reduced intestinal permeability, a person of ordinary skill in the art would reasonably require an undue quantity of experimentation.
Conclusion of 35 U.S.C. 112(a) (Enablement) Analysis
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC), states that, “[p]atent 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,” citing Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005.
After applying the Wands factors and analysis to claims 21-25, 29, 31, 38, and 41-42, in view of the applicant’s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 21-25, 29, 31, 38, and 41-42 would not be enabled by the written disclosure excluding that of improving intestinal maturation and/or reducing intestinal permeability in a subject by administering a native whey protein made by a method comprising skimming whole raw milk at 55°C and then cooled to 4°C, microfiltration at 10°C, ultrafiltration and diafiltration at 10°C, stored at 4°C, heated to 30°C, and sprayed dried with a nativity amount of 100% and with or without one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity, or increased colonic enteroendocrine cell count when compared a whey protein that is subjected to a temperature of at least 73°C and has a nativity amount of less than 100%.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-25, 29, 31, and 38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 21 has been amended to include where the improving intestinal maturation and/or reducing and/or preventing intestinal permeability includes a reduced occurrence with respect to the occurrence thereof in a subject fed the same whey protein which is made non-native. Given the first recitation of “and/or” it would correlate to where improving intestinal maturation includes a reduced occurrence with respect to the occurrence thereof. Such a limitation is internally inconsistent because improving intestinal maturation is desired by administering a native whey protein in the preamble. As such, reducing the occurrence of intestinal maturation conflicts with the preamble of improving intestinal maturation. Therefore, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to a reduced occurrence of intestinal maturation.
Please note that the Examiner is interpreting the scope of claim 21 such that the reduced occurrence only applies to intestinal permeability in order to advance prosecution. Also please note that claims 22-25, 29, 31, and 38 are rejected by virtue of their dependency.
Claims 21-25, 29, 31, 38, and 41-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 21 and 41-42 are generally directed to administering a “native” whey protein to a subject in order to improve intestinal maturation when compared to a whey protein that is made “non-native”, and to reduce/prevent intestinal permeability when compared to a whey protein that is made “non-native”. As discussed in the “Claim Interpretation” supra, the instant specification does not define what constitutes a “native” whey protein. As such, the plain and ordinary meaning of the term applies. Schinetsky, R. and AGN Roots both define “native” whey protein as being derived from pasteurized, skimmed milk and NOT being derived from cheese.
However, the instant specification distinguishes three whey protein samples; namely, native, deactivated and denatured (See instant, Examples 1-2). None of the samples are derived from cheese including the deactivated and the denatured (See instant, Examples 1-2). As such, all three samples would constitute the produced whey protein as native in light of the plain and ordinary meaning defined by Schinetsky, R. and AGN Roots supra. It is noted that all three samples utilized the same initial steps, i.e., skimming whole raw milk at 55°C and then cooled to 4°C, microfiltration at 10°C, ultrafiltration and diafiltration at 10°C, stored at 4°C, and heated to 30°C and sprayed dried at 11% DM with a dryer operated with an inlet temperature of 185°C and outlet temperature of 90°C (See instant Example 1). However the deactivated whey protein sample was further subjected to re-hydration at 40°C and heat-treatment at 73°C, and then freeze-dried thereby inactivating bioactive components such as alkaline phosphatase; and the denatured whey protein sample was further subjected to re-hydration at 40°C and heat treatment at 100°C, and then freeze-dried (See instant Example 1). Notably, each sample contains native whey protein, albeit, in different amounts, i.e., the “native” whey protein samples have 100% nativity, the deactivated whey protein samples have 95.73 and 97.03%, and the denatured whey protein samples have 21.43% and 37.16% (See instant, tables in [0073] and [0078]). Therefore, it is unclear what constitutes the instant “native” whey protein and the instant whey protein that is made “non-native” given that all the whey protein samples contain an amount of native whey protein, and given that the deactivated and denatured whey protein samples were not processed from cheese. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to what constitutes a native whey protein versus a whey protein that is made non-native.
Please note that the Examiner is interpreting the scope of claims 21 and 41-42 such that the native whey protein is made via the process identified as enabled supra and has a nativity amount of 100% and whey protein that is made non-native via a process other than the one identified as enabled supra and has a nativity of less than 100% in order to advance prosecution. Also please note that claims 22-25, 29, 31, and 38 are rejected by virtue of their dependency.
Conclusion
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654