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 .
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.
Also please note that claims 28 and 30 are rejoined after further consideration.
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. The amendment received on March 31, 2026, amended claims 21, 29, 38, 41, and 42.
Claims 21-33 and 36-42 are currently pending and claims 21-25, 28-31, 38, and 41-42 are under consideration as claims 26-27, 32-33, 36-37, and 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 claims 21, 28-31, and 41-42, 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 claims 21, 28-30, and 41-42, 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 3/31/26, with respect to the 112(a), scope of enablement, rejection have been fully considered and are persuasive. The rejection of claims 21-25, 29, 31, and 38 as failing the enablement requirement, regards as the invention has been withdrawn.
Applicant’s arguments, see Response, filed 3/31/26, with respect to the 112(b) rejections have been fully considered and are persuasive. The rejections of claims 21-25, 29, 31, and 38 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 have been withdrawn.
New Objections
Claim 42 is objected to because of the following informalities: the claim recites “…and where the improving intestinal maturation includes one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity and increased colonic enteroendocrine cell count with respect to a subject fed the same protein fraction comprising whey proteins which are made non-native." The phrase, “includes one or more of” is analogous to “comprising one or more of”. Pursuant to MPEP 2173.05(h), a Markush group can be recited with the transitional phrase “comprising” but with “or” instead of “and” as the article at the end of the claim. Thus, it is respectfully requested that claim 42 recite, “…and where the improving intestinal maturation includes 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 protein fraction comprising whey proteins which are made non-native.” See MPEP § 2173.05(h). Appropriate correction is required.
New Rejections in light of Applicants’ Amendments
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, 28-29, 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 nutritional composition comprising a pasteurized protein fraction comprising native whey protein where the whey proteins have nativity of at least 95% where the reducing and/or preventing intestinal permeability includes a reduced occurrence with respect to the occurrence thereof in a subject fed a protein fraction comprising whey proteins which are made non-native and have a nativity 38% or less, and wherein the improving intestinal maturation includes an improved intestinal maturation with respect to the maturation in a subject fed the a protein fraction comprising whey proteins which are made non-native resulting in a nativity 38% or less;
for improving intestinal maturation in a subject in need thereof, where the intestine includes at least the colon, by administering to the subject a nutritional composition comprising a pasteurized protein fraction comprising native whey proteins where the whey proteins have a nativity of at least 95%, and where the improving intestinal maturation includes an improved intestinal maturation with respect to a subject fed a protein fraction comprising whey proteins which are made non-native resulting in a nativity 38% or less;
for improving intestinal maturation in a subject in need thereof, where the intestine includes at least the colon, by administering to the subject a nutritional composition comprising a pasteurized protein fraction comprising native whey proteins where the whey proteins have a nativity of at least 95%, and where the improving intestinal maturation includes one or more of a decreased colonic crypt depth, a more differentiated phenotype of colonic cells, an increased colonic alkaline phosphatase activity and increased colonic enteroendocrine cell count with respect to a subject fed a protein fraction comprising whey proteins which are made non-native resulting in a nativity 38% or less,
and does not reasonably provide enablement for any of the above methods where the whey proteins have a nativity less than 95% and compared to whey proteins made non-native resulting in a nativity greater than 38%. (NOTE: each bullet point represents each independent claim of 21 and 41-42. For succinctness purposes, the rejection will refer to the method of claim 21 (i.e., 1st bullet point), but each of the independent claims is encompassed by such reference.)
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, 28-29, 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 nutritional composition comprising a pasteurized protein fraction comprising native whey protein where the whey proteins have nativity of at least 80% to the subject where the reducing and/or preventing intestinal permeability includes a reduced occurrence with respect to the occurrence thereof in a subject fed the same protein fraction comprising native whey proteins which are made non-native, and wherein the improving intestinal maturation includes an improved intestinal maturation with respect to the maturation in a subject fed the same protein fraction comprising whey proteins which are made non-native, Applicants only demonstrate such desired results when the whey protein is made via a specific method thereby resulting in a whey protein nativity of 95.73 and 97.03% (i.e., pasteurized whey protein) when compared to a whey protein that is made non-native thereby resulting in a nativity ranging from 21-38% (i.e., denatured whey protein subjected to a high treatment at 100°C) (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). 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 (i.e., heat treatment required for pasteurization); 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]). Notably, there is no indication what is considered “non-native”, or what amount of nativity is considered “non-native”, especially given that the denatured whey protein sample had a nativity amount, albeit, a lower amount.
However, the scope of claims 21 and 41-42 with respect to the administered native whey protein is made by a pasteurization method thereby correlating to native whey protein having a nativity to at least 80%. But as discussed supra, the whey protein made by the pasteurization method resulted in a nativity of least 95%, not 80%. Moreover, the whey protein which is made “non-native” would correspond to whey protein made by any process and an unspecified amount of nativity (presumably less than 80%). Accordingly, claims 21-25, 28-29, 31, 38, and 41-42 are unduly broad with respect to 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). However, Li et al. did not determine the nativity of each of the whey protein samples. Given that the overview of the steps utilized to prepare each whey protein sample does not indicate high temperature, it is presumed that each whey protein sample has a nativity of at least 80%. 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. Therefore, the level of predictability in the art is dependent on many factors including the method by which the whey protein is processed, the amount of nativity of the whey protein, and the nativity of the non-native whey protein being compared to the native whey protein fraction.
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 nutritional composition comprising a pasteurized whey protein fraction comprising whey protein with a nativity of at least 95% to a subject in order to improve intestinal maturation and/or reduce/prevent intestinal permeability in a subject when compared to when the subject is fed a whey protein subjected to a heat treatment of 100°C thereby resulting in whey protein with a nativity ranging from 21-38%), 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%, which was made via a pasteurization process, 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%, which was subjected to a heat treatment at 100°C (See instant, Example 6 at [0086], [0091]-[0093]; Figures 1, 2a-c, 3a and 4). Applicants appear to rely on the assumption that by providing evidence that a whey protein sample with a nativity of at least 95% made by a pasteurization process improved intestinal maturation and/or reduced and/or prevented intestinal permeability relative to a whey protein with a nativity of 37% or less that is denatured at high temperature, i.e., heat treatment at 100°C, would exhibit similar intended results for a pasteurized whey protein with a nativity less than 95%. However, such an assumption cannot be made because there is no indication that a pasteurized whey protein with a nativity less than 95% would exhibit such results. In other words, given that the nativity percentage gap amount between the pasteurized whey protein sample (i.e., at least 95%) compared to the denatured whey protein sample (i.e., 21-38%) is vast, it is unpredictable without more experimentation to determine the nativity percentage at which the beneficial intended results would occur, e.g., at least 50%, at least 60%, at least 70%, at least 80% nativity. As such, without more experimentation demonstrating the efficacy of a representative number of pasteurized whey protein samples with a nativity of at least 80% to 95% the level of unpredictability remains high, especially when compared to a denatured whey protein sample with a nativity of 21-38%, the level of unpredictability remains high. Therefore, it is unpredictable that the claimed administered pasteurized native whey protein sample with a nativity of at least 80% will improve intestinal maturation and/or reduce and/or prevent intestinal permeability when compared to a whey protein sample that is made via a non-native process without any indication of the comparable whey protein’s nativity amount.
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 nutritional composition comprising a pasteurized whey protein fraction comprising whey protein with a nativity of at least 95% to a subject in order to improve intestinal maturation and/or reduce/prevent intestinal permeability in a subject when compared to when the subject is fed a whey protein subjected to a heat treatment of 100°C thereby resulting in whey protein with a nativity ranging from 21-38%) 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 and/or the reduction/prevention of intestinal permeability by administering a pasteurized native whey protein sample having a nativity of at least 80% when compared to a subject fed a whey protein with an undefined amount of nativity but made via any non-native process. Applicants fail to provide the guidance and information required to ascertain where the full scope of the claimed pasteurized 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 pasteurized native whey protein has a nativity of at least 80% and is made via a pasteurization method compared to a whey protein that is made via any non-native method having an undefined nativity amount.
Absent a reasonable a priori expectation of success for administering a pasteurized whey protein sample with a nativity of at least 80% to improve intestinal maturation and/or reduce/prevent intestinal permeability when compared to a subject fed a whey protein sample made via a non-native process and having an undefined nativity amount, one skilled in the art would have to extensively perform in vitro and/or in vivo experiments for a representative number of pasteurized whey protein samples with a nativity of 80-95% when compared to a representative number of whey protein samples made via a non-native process resulting in a range of nativity percentages less than 80%. 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 deactivated native whey protein sample made via a specific pasteurization method (See “Breadth of the Claims and The Nature of the Invention” section supra for further details) and having a nativity amount of at least 95% when compared to a whey protein subjected to a heat treatment of 100°C thereby resulting in a nativity ranging from 21-38%. 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 sample has 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 deactivated whey protein sample 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 whey protein sample is made via pasteurization as described in instant Example 1 and having a nativity of at least 95% when compared to a whey protein that is subjected to a heat treatment of 100°C as described in instant Example 1 and having a nativity of ranging from 21-38%. However, as noted in “Breadth of the Claims and Nature of the Invention" Section, the scope of claims 21 and 41-42 encompass a pasteurized whey protein sample having a nativity of at least 80% when compared to a whey protein that is made non-native via any method and having any amount of nativity. In the absence of a representative number of pasteurized whey protein samples with a representative number of nativity percentages demonstrating improved intestinal maturation and/or reduced intestinal permeability when compared to a representative number of whey protein samples with a representative number of nativity percentages, 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, 28-29, 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, 28-29, 31, 38, and 41-42 would not be enabled by the written disclosure excluding that of improving intestinal maturation and/or reducing/preventing intestinal permeability in a subject by administering a nutritional composition comprising a pasteurized whey protein fraction comprising native whey protein with a nativity of at least 95% when compared to a nutritional composition comprising a whey protein fraction comprising whey protein that is made via a non-native method by subjecting the whey protein to a heat treatment of 100°C thereby resulting in a nativity ranging from 21-38%.
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, 28-29, 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 directed to where the administered nutritional composition comprising a pasteurized whey protein fraction comprising native whey proteins having a nativity of at least 80% improve intestinal maturation and/or reduce/prevent intestinal permeability in a subject when compared to the subject fed the same protein fraction comprising native whey proteins that are made non-native (claim 21), or when compared to the subject fed the same protein fraction that are made non-native. However, it is unclear how the whey protein in the comparable protein fraction can be the same when the nativity is distinct. Even if the comparable protein fraction contains a smaller amount of native whey protein, it still cannot be the same. Thus, an ordinary skilled artisan would be unable to ascertain the metes and bounds of the presently claimed invention with respect to the comparable protein fraction.
Please note that the Examiner is interpreting the scope of claims 21 and 41-42 such that they recite – a subject fed a protein fraction comprising whey protein that is made by a non-native method – in order to advance prosecution.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 38 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Claim 38 is directed to where the nutritional composition is obtained by a process comprising steps (a) to (d) where step (c) is directed to optional pasteurization of the recombined stream from step (b). However, claim 38 is dependent upon claim 21, which has been amended to recite that the whey protein fraction is a pasteurized whey protein fraction. As such, the pasteurization step of (c) in claim 38 cannot be optional, but rather required. Thus, the scope of claim 38 broadens the scope of claim 21 by encompassing pasteurization as optional. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant’s arguments with respect to claims 21-25, 28-29, 31, 38, and 41-42 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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