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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-11, in the reply filed on July 30th, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 30th, 2026.
Applicant’s election without traverse of arachidonic acid as the additional component (Group A), and one or more human milk oligosaccharides consisting of 2'fusosyllactose and free of any dietary butyrate (Group C) in the reply filed on July 30th, 2026 is acknowledged. The species election of arachidonic acid in contrast to vitamin E and vitamin C is withdrawn for compact prosecution; however, the limitation “sphingomyelin” remains withdrawn, as being drawn to a non-elected species. For group C, alternative embodiments not requiring the oligosaccharide 2’FL and/or not requiring the composition to be free of dietary butyrate, are withdrawn as being drawn to non-elected species. However, the species election of 2’FL in contrast to other oligosaccharides is withdrawn for compact prosecution, i.e. all of the oligosaccharides recited in claim 8 are read into the claim.
Applicant's election with traverse of arachidonic acid as the additional component (Group A), a protein content of least 60% of the milk fat globule membrane component (Group B), and one or more in the reply filed on July 30th, 2026 is acknowledged. The traversal is on the grounds that the MFGM This is not found persuasive because claim 6 incorporates the . Claim 6 is withdrawn as being drawn to a non-elected species.
Claims 1-5 and 7-11 are pending and were examined on the merits.
Information Disclosure Statement
The information disclosure statement filed May 7th, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered for the lined-through documents, except U.S. Patent Cite No. 65 on the IDS, after the typographical error in the listing of the patent document number was identified and corrected to 9089157, i.e. US 9089157 B2.
Drawings
The drawings are objected to because it is unclear what the term "scale intensity" refers to; this term is used to label the vertical axes of graphs shown in Figures 5-14. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, requires the specification to be written in “full, clear, concise, and exact terms.” The specification is replete with terms which are not clear, concise and exact. The specification should be revised carefully in order to comply with 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112. Examples of some unclear, inexact or verbose terms used in the specification are: "level" and "levels".
The use of the terms BASF, LycoRed, Kemin, Abbott Nutrition (registered as "ABBOTT NUTRITION HEALTH INSTITUTE SCIENCE. ILLUMINATED"), CytoSport, and Nestle, each of which is a trade name or a mark used in commerce, has been noted in this application. Each term should be accompanied by the generic terminology; furthermore, each term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The applicant’s assistance is requested in correctly reciting any trademarks or tradenames they become aware of in their disclosure, even if not specifically pointed out by the examiner.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The term “fucosyllactose” recited in claim 8 is interpreted as encompassing any fucosyllactose compound, including but not necessarily limited to, 2'-fucosyllactose, 3-fucosyllactose, and difucosyllactose. The abbreviation “3FL” (claim 8) is understood as signifying the chemical compound 3-fucosyllactose.
Claim Objections
Claim 3 is objected to because of the following informalities: the abbreviation 2'FL is not defined. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: the abbreviation "3FL" is not defined. Appropriate correction is required.
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 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 1 recites the term “level” when referring to a phospholipid form of DHA in the blood of the individual. However, the meaning of the term “level” is ambiguous, without clarification regarding the quantity it refers to, for example: mass, moles, volume, or concentration. Claims 2-11, depending from claim 1, do not recite the necessary clarification.
Claim 2 contains an internal contradiction where a phospholipid form of DHA is recited as a complex of DHA or ARA and another fatty acid selected from a group that does not contain DHA. It is unclear whether a phospholipid comprising only two fatty acid residues, ARA and another non-DHA residue, is included among the phospholipids claimed in claim 2.
The term “about” in claims 4is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The weight percents of protein, lactose, fat, and phospholipids of the milk fat globule membrane component are rendered indefinite by the use of the term "about". The weight percent of the milk fat globule membrane component .
Claim 10 recites the term “enhanced” when referring to amounts of DHA in the phospholipid form. It is not clear what effect is implied by the term enhanced, such as an increase or decrease in concentration.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 and 7-11 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 an increase (with unclear statistical significance) in mean plasma levels (in piglet subjects) of certain DHA-containing phospholipids (1-stearoyl-2-docosahexaenoyl-GPC (18:0/22:6) and 1-palmitoyl-2-docosahexaenoyl-GPC (16:0/22:6)) for subjects (piglets) fed milk fat globule membrane (MFGM) and 2'-fucosyllactose, does not reasonably provide enablement for the milk fat globule membrane component and the at least one human milk oligosaccharide synergistically work together with the DHA to increase the level of a phospholipid form of DHA in the blood of the individual (claim 1), where the phospholipid form of DHA is a complex of DHA or arachidonic acid (ARA} and another fatty acid chosen from the group consisting of palmitic acid, linoleic acid and stearic acid (claim 2), wherein the composition provides synergistically enhanced amounts of the DH Ain the phospholipid form due to the synergistic combination of the at least one human milk oligosaccharide, the milk fat globule membrane, and the DHA.. 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.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The nature of the invention and (2) the breadth of the claims:
The claims are drawn to a method comprising administering a nutritional composition to an individual wherein the nutritional composition comprises a milk fat globule membrane component, at least one human milk oligosaccharide, and docosahexaenoic acid (DHA) and wherein the milk fat globule membrane component and the at least one human milk oligosaccharide synergistically work together with the DHA to increase the level of a phospholipid form of DHA in the blood of the individua (claim 1), here the phospholipid form of DHA is a complex of DHA or arachidonic acid (ARA} and another fatty acid chosen from the group consisting of palmitic acid, linoleic acid and stearic acid (claim 2), wherein the composition provides synergistically enhanced amounts of the DHA in the phospholipid form due to the synergistic combination of the at least one human milk oligosaccharide, the milk fat globule membrane, and the DHA (claim 10). Thus, the claims taken together with the specification imply a synergistic effect from the combination of the at least one human milk oligosaccharide, the milk fat globule membrane, and DHA, resulting in an increase the level of a phospholipid form of DHA in the blood of an individual, where the phospholipid form of DHA is a complex of DHA or arachidonic acid (ARA) and another fatty acid chosen from the group consisting of palmitic acid, linoleic acid and stearic acid.
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Yan (WO 2019092021 A1) recites a nutritional composition (page 1, lines 8-12) that comprises, in at least some embodiments, DHA (page 14, lines 1-12), ARA (page 14, lines 1-12), at least one human milk oligosaccharide (page 23, lines 30-31), milk fats (page 14, lines 1-3), and milk fat globule membrane protein (page 16, lines 26-29). Yan further recites "It has further been found that the nutritional compositions of the invention work in synergy such that optimal health effects are observed when the nutritional compositions are used consequently (and/or sequentially)" (page 34, lines 1-3). However, Yan does not recite a synergistic effect of an increase in DHA in phospholipid form.
Since the a synergistic interaction between the components of a milk fat globule membrane, a human milk oligosaccharide, and DHA remains largely unsolved, means for increasing the level of a phospholipid form of DHA in the blood of an individual through a synergistic interaction between any milk fat globule membrane component, any human milk oligosaccharide, and DHA is highly unpredictable.
(5) The relative skill of those in the art:
The relative skill of those in the art is high. The prior art reference Yan has disclosed a nutritional composition comprising, in at least some embodiments, a milk fat globule membrane protein, milk fats, a human milk oligosaccharide, and DHA. Moreover, one of skill in the art could perform blood tests to monitor concentrations of phospholipids and other biomolecules in subjects administered a composition as disclosed by Yan.
Accordingly, one would have turned to the instant disclosure for additional direction and guidance.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The specification has provided an increase in mean plasma levels (in piglet subjects) of certain DHA-containing phospholipids (1-stearoyl-2-docosahexaenoyl-GPC (18:0/22:6) and 1-palmitoyl-2-docosahexaenoyl-GPC (16:0/22:6)) for subjects fed milk fat globule membrane (MFGM) and 2'-fucosyllactose, whereas this increase was not observed in subjects fed milk fat globule membrane but not 2'-fucosyllactose or the control diet (paragraph [0071], Figures 7A and 7B). However, the specification does not provide the statistical significance of the increase in certain DHA-containing phospholipids in subjects on the MFGM + 2'FL diet, and does not provide that this increase is a synergistic effect dependent on the combination of 2'FL, MFGM, and DHA, in the diet of a subject, or a synergistic effect dependent on any combination of any human milk oligosaccharide, any component of a milk fat globule membrane, and DHA, in the diet of the subject. Furthermore, it is unclear whether the increase in DHA-containing phospholipids depends only on dietary 2'FL or the dietary combination of MGFM and 2'FL, because there is no report of a change in DHA-containing phospholipids in a subject administered 2'FL but not MFGM. Moreover, the applicant's disclosure does not show an increase in the ARA-containing phospholipid 1-linoleoyl-2-arachidonoyl-GPC under any dietary condition tested (paragraphs [0067] - [0089], Figure 5A). The statistical significance of an increase in the ARA-containing phospholipid 1-stearoyl-2-arachidonoyl-GPC under an MFGM + 2'FL diet is unclear from the applicant's disclosure (paragraphs [0067] - [0089], Figure 5B).
(8) The quantity of experimentation necessary:
Considering the state of the art as discussed by Yan and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the claimed method to produce a synergistic effect from the combination of the at least one human milk oligosaccharide, the milk fat globule membrane, and DHA, resulting in an increase the level of a phospholipid form of DHA in the blood of an individual, where the phospholipid form of DHA is a complex of DHA or arachidonic acid (ARA) and another fatty acid chosen from the group consisting of palmitic acid, linoleic acid and stearic acid.
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.
Claims 1-5 and 7-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. US 12005083 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter summarized below.
instant independent claim 1, instant dependent claims 2-5 and 7-11 (by incorporation of limitations of claim 1), and reference claim 1 recite a method comprising administering to an individual a nutritional composition comprising a milk fat globule membrane component, at least one human milk oligosaccharide, and docosahexaenoic acid (DHA).
Instant claim 3 and reference claim 2 recite the at least one human milk oligosaccharide comprises 2'FL and the nutritional composition further comprises at least one additional component chosen from the group consisting of arachidonic acid (ARA), Vitamin E, Vitamin C, and sphingomyelin.
Instant claim 4 (and instant non-elected claim 6) and reference claim 4 recite the milk fat globule membrane component has a protein content within the range of at least 60% (instant claim 4) and at least 75% (instant non-elected claim 6).
Instant claim 5 and reference claim 3 recite the milk fat globule membrane has a lactose content of not more than about 5% by weight of the milk fat globule membrane component.
Instant claim 7 and reference claim 5 recite at least one human milk oligosaccharide consists of 2'-fucosyllactose (2'FL) and is free of any dietary butyrate.
Instant claim 8 and reference claim 6 recite the at least one human milk oligosaccharide comprises at least one human milk oligosaccharide chosen from the group consisting of fucosyllactose, 2′FL, 3FL, Lacto-N-fucopentaose I (LNFP I), LNFP II, LNFP III, LNFP V, and mixtures thereof.
Instant claim 9 and reference claim 7 both recite the at least one human milk oligosaccharide is 2'FL and the milk fat globule membrane component comprises from about 10% to about 25 % fat by weight of the milk fat globule component; water present in an amount such that the milk fat globule component has a moisture content of not more than 7% by weight of the milk fat globule component; ash present in an amount of not more than 5% by weight of the milk fat globule component; and one or more phospholipids where the total amount of phospholipids in the milk fat globule component is from about 4% to about 9% by weight of the milk fat globule component.
Instant claim 11 and reference claim 8 both recite the nutritional composition is free of butyrate.
Claims 1-5 and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 18/504043 (reference application, document ID US 20240251838 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter summarized below.
instant independent claim 1, instant dependent claims 2-5 and 7-11 (by incorporation of limitations of claim 1), and reference claim 21 (incorporating the limitations of reference independent claim 1) recite a method comprising administering to a subject a nutritional composition comprising a milk fat globule membrane component, at least one human milk oligosaccharide, and docosahexaenoic acid (DHA). The components “ARA, Vitamin E, Vitamin C, and sphingomyelin” recited in reference independent claim 1 also read on the components further comprising the nutritional composition recited in instant claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 7-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 19/217244 (reference application, document ID US 20250344737 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because of the overlapping subject matter summarized below.
instant independent claim 1, instant dependent claims 2-5 and 7-11 (by incorporation of limitations of claim 1), and reference claim 21 (incorporating the limitations of reference independent claim 1) recite a method comprising administering to a subject a nutritional composition comprising a milk fat globule membrane component, at least one human milk oligosaccharide, and docosahexaenoic acid (DHA). The components “ARA, Vitamin E, Vitamin C, and sphingomyelin” recited in reference independent claim 1 also read on the components further comprising the nutritional composition recited in instant claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 7-9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al. (WO 2019092021 A1), abbreviated "Yan".
Claim 1 recites “A method for supporting cognitive function and/or neuron cellular health comprising the step of administering a nutritional composition to an individual wherein the nutritional composition comprises a milk fat globule membrane component, at least one human milk oligosaccharide, and docosahexaenoic acid (DHA) and wherein the milk fat globule membrane component and the at least one human milk oligosaccharide synergistically work together with the DHA to increase the level of a phospholipid form of DHA in the blood of the individual”. Claim 3 recites “The method of claim 1, wherein the at least one human milk oligosaccharide comprises 2'FL and the nutritional composition further comprises at least one additional component chosen from the group consisting of arachidonic acid (ARA), Vitamin E, Vitamin C, and sphingomyelin”. Claim 4 recites “The method of claim 1, wherein the milk fat globule membrane component has a protein content of at least about 60% by weight of the milk fat globule membrane component”. Claim 5 recites “The method of claim 4, wherein the milk fat globule membrane has a lactose content of not more than about 5% by weight of the milk fat globule membrane component”. Claim 7 recites “The method of claim 1, wherein the at least one human milk oligosaccharide consists of 2'-fucosyllactose (2'FL} and is free of any dietary butyrate”. Claim 8 recites “The method of claim 1, wherein the at least one human milk oligosaccharide comprises at least one human milk oligosaccharide chosen from the group consisting of fucosyllactose, 2'FL, 3FL, Lacto-N-fucopentaose I (LNFP I), LNFP II, LNFP III, LNFP V, and mixtures thereof”. Claim 9 recites “The method of claim 8, wherein the at least one human milk oligosaccharide is 2'FL and the milk fat globule membrane component comprises from about 10% to about 25 % fat by weight of the milk fat globule component; water present in an amount such that the milk fat globule component has a moisture content of not more than 7% by weight of the milk fat globule component; ash present in an amount of not more than 5% by weight of the milk fat globule component; and one or more phospholipids where the total amount of phospholipids in the milk fat globule component is from about 4% to about 9% by weight of the milk fat globule component”. Claim 11 recites “The method of claim 1, wherein the nutritional composition is free of butyrate”.
Yan recites: “The present invention relates to nutritional formulae which are specifically designed to address the needs of infants and young children. In particular, the invention provides an array of nutritional compositions for the infants and young children, each nutritional composition having an age-specific composition which varies according to the age of the infant /child” (page 1, lines 8-12), implying administration of nutritional formulae to infants and young children, i.e. individual subjects (instant claim 1).
Although Yan does not recite the intended use of “supporting cognitive function and/or neuron cellular health”, as in the preamble of instant claim 1, when reading the preamble in the context of the entire claim, the recitation “for supporting cognitive function and/or neuron cellular health” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Yan summarizes the components of their invention “Typically, the compositions forming part of the array of nutritional compositions comprise any of a source of fat, proteins and/or carbohydrates or any mixtures thereof. The compositions usually further comprise vitamins and minerals. The compositions of the invention follow the usual guidelines (CODEX, European directives on infant formula etc.)” (page 11, lines 9-13; instant claims 1 and 3).
Yan further recites milk fat globule membrane protein: “The proteins may include intact or hydrolysed protein, milk fat globule membrane (MFGM) protein, casein, whey, soy protein, rice proteins or any mixtures thereof” (page 16, lines 26-29; instant claims 1 and 9).
Yan further recites oligosaccharide components:
“The composition of the invention may contain 2'-fucosyllactose (2FL) and/or a N-acetyl-lactosamine such as lacto-N-neotetraose (LNnT) or lacto-N-tetraose (LNT). In one embodiment the nutritional composition according the invention comprises human milk oligosaccharide selected from the list consisting of N- acetyl-lactosamine, sialylated oligosaccharides, fucosylated oligosaccharides, 2FL, LNnT, LNT or a combination thereof. … Fucosylated oligosaccharide: The composition according to the invention may comprise one or more fucosylated oligosaccharides. Preferably the fucosylated oligosaccharides consist or comprises 2'-fucosyllactose (2-FL). The fucosylated oligosaccharide may be selected from the group comprising 2'-fucosyllactose, 3-fucosyllactose, difucosyllactose (DiFL), lacto-N-fucopentaoses (that is to say lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-N-fucopentaose III and lacto-N-fucopentaose V), lacto-N-difucohexaose I, fucosyllacto-N-hexaose, Difucosyllacto-N-hexaose I and Difucosyllacto-N- neohexaose II. A particularly preferred fucosylated oligosaccharide is 2'-fucosyllactose (2-FL) or DiFL” (page 23 lines 27-33, and page 25 lines 1-10, emphasis made by the examiner; instant claims 1, 3, and 7-9).
Yan further recites: “The fat in the set of nutritional compositions may be selected from milk and/or vegetable fat. Typical vegetable fats include palm olein, high oleic sunflower oil, high oleic safflower oil or any mixtures thereof. The fats are a source of long-chain polyunsaturated fatty acids (LC-PUFA). LC-PUFA's have been linked to benefits in infant/young child development. Preferably, the LC-PUFA are selected from docosahexaenoic acid (DHA), arachidonic acid (ARA) or any mixtures thereof” (page 14, Fat / Lipids, Paragraph 1; instant claims 1-3 and 10). Therefore, the fats recited by Yan reasonably encompass DHA, ARA, and any lipids present in milk, including those comprising the milk fat globule membrane (instant claims 1, 2, 9, and 10). Although Yan does not recite the milk fat globule membrane component and the at least one human milk oligosaccharide synergistically work together with the DHA to increase the level of a phospholipid form of DHA in the blood of the individual (instant claim 1), the arguments presented in this ground of rejection apply to the process claimed in claim 1 regardless of the effects. The effects of the process claimed in claim 1 are addressed in a separate ground of rejection under 35 U.S.C. 112(a), above.
Yan further recites: “Optionally, the compositions may comprise vitamins selected from vitamin A, beta-carotene, vitamin D, vitamin E, vitamin K1, vitamin C, vitamin B1, vitamin B2, niacin, vitamin B6, folic acid, pantothenic acid, vitamin B12, biotin, choline, inositol, taurine, carnitine or any mixtures thereof” (page 19 lines 31-33, and page 20 lines 1 and 2; instant claim 3).
Yan does not recite butyrate or butyric acid in their disclosure, so the compositions taught by Yan are understood as free from butyrate in at least some embodiments (instant claims 7 and 11).
Yan does not ash in their disclosure, so the compositions taught by Yan are understood as 0% ash in at least some embodiments (instant claim 9).
The instant claims are distinguished from Yan in that Yan does not explicitly recite the following parameters:
the milk fat globule membrane component has a protein content of at least about 60% by weight of the milk fat globule membrane component (instant claim 4).
The milk fat globule membrane component comprises from about 10% to about 25 % fat by weight of the milk fat globule component (instant claim 9).
water present in an amount such that the milk fat globule component has a moisture content of not more than 7% by weight of the milk fat globule component (instant claim 9).
one or more phospholipids where the total amount of phospholipids in the milk fat globule component is from about 4% to about 9% by weight of the milk fat globule component (instant claim 9).
Without evidence to the contrary, the parameters listed above are obvious over routine optimization. One of skill in the art could have weighed the different materials (protein, fat, water, and phospholipids) before combining them, and thereby control the weight percent of each material comprising the “Milk fat globule component”. One of skill in the art could also remove water through evaporation, satisfying the water weight percent parameter. If necessary, one of skill in the art could separate materials comprising milk through centrifugation and liquid chromatography before recombining them. One of skill in the art could administer different compositions to subject organisms, and investigate the biological effects of administration, for instance, through genomic study of the fecal microbiome and testing the blood of the subject for essential nutrient concentrations (instant claims 4 and 9).
Yan is relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the components of a composition administered to an individual, the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the nutritional composition, is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the
skilled artisan.
From the teachings of Yan, the invention as a whole, drawn to a [nutritional composition as described in Claims 1-5 and 7-11, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ methods with the methods (including compositions thereof) of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed methods and the methods of the prior art (and compositions thereof). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Conclusion
No claims are allowed.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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