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 .
Claim(s) 1-19 are currently pending and under examination.
Information Disclosure Statement (IDS)
The information disclosure statements (IDS) submitted on May 17, 2023 and November 14, 2023 have been considered by the Examiner.
Please note, the listing of references in the specification is not a proper information disclosure statement. (see E.g. Specification, page 12 [0066]- page 13 [0067]). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification & Claim Objections
The claims and/or disclosure is objected to because of the following informalities:
The use of the term(s) “Arla” (Specification, page 6, [0032]), “DHASCO” and “ARASCO” (Specification, page 24, [0131]), which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; Furthermore, the terms 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 above are considered necessary corrections; however, is not exhaustive of all possible informalities, as examination is not made for the purpose of securing grammatical perfection.
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.
Claim(s) 1-19 is/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.
Regarding claim 1, the phrase "improving neurological development in a pediatric subject" renders the claim indefinite because the metes and bounds of the claim(s) are vague and unclear. See MPEP § 2173.05(d). Claims 2-19 depend directly or indirectly from the rejected claim 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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim(s) 1-19 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite a nutritional composition materially comprising nothing more than milk fat globule membrane (MFGM) which is a naturally occurring component of mammalian milk (see claim 1). Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, the claimed invention is a nutritional composition comprising materially nothing more than amounts of MFGM. There is no evidence or reason to expect that any new compounds/properties/functions are formed.
Likewise, additional components such as phospholipids, sphingomyelin, gangliosides, lactoferrin, galactooligosaccharaides are well known to routinely and conventionally occurring naturally in breast milk (see Boquien, CY. “Human Milk: An Ideal Food for Nutrition of Preterm Newborn.” Front Pediatr. 2018 Oct 16;6:295). The composition itself is a mixture of the naturally occurring compounds that are simply soluble in a nutritional composition form (i.e. a mixture of ingredients which are naturally-found in nature); i.e., the compound is not inventive or “man-made.” Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, Applicant’s claim is directed to a nutritional composition comprising MFGM for use in improving neurological development in a pediatric subject. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Similarly, the nutritional composition wherein MFGM is provided by a whey protein concentrate, enriched milk product, and/or buttermilk provides only a source for delivering the MFGM and does not change the constitution of MFGM itself and therefore there is no additional element to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the claims do not integrate the composition into a distinguishing practical application (for example, do not broadly or specifically recite dosage form(s) and/or the therapeutically-effective amounts of the material), but merely recites the natural materials themselves or a multiplicity of natural materials.
In addition, applicant’s intended use of improving neurological development in a pediatric subject is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
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 1-19 is/are rejected under 35 U.S.C. 103 as obvious over Ao, et al. (US 2017/0006897 A1) in view of Li, et al., “Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial” J Pediatr. 2019 Dec;215:24-31.e8 and Nieto-Ruiz, et al. “The Effects of an Infant Formula Enriched with Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids and Synbiotics on Child Behavior up to 2.5 Years Old: The COGNIS Study.” Nutrients 2020, 12, 3825.
The instant claim(s) is/are of record, drawn to the following: a nutritional composition comprising milk fat globule membrane (MFGM) for use in improving neurological development in a pediatric subject.
Ao, et al. generally teaches nutritional compositions and methods for promoting cognitive development in a pediatric subject. Ao, et al. teaches in some embodiments, the nutritional composition may comprise an enriched milk product; fat or lipid; protein or protein equivalent source; a source of long chain polyunsaturated fatty acid; and a prebiotic (see Abstract) (as required in the instant claims. Ao, et al. teaches “pediatric subject” means a human no greater than 13 years old (Specification, para [0026])
Regarding instant claim(s) 1-19, Ao, et al. teaches the 0.06g/100 Kcal to about 1.5g/100 kcal of “enriched milk product” (as required in the instant claim 13) in the nutritional composition comprises a milk product enriched with MFGM components (Specification, para [0011], ) (as required in the instant claims 1-19). Ao, et al. teaches the enriched milk product can be formed by e.g., fractionation of non-human (e.g. bovine) milk (Specification, para [0011]). Ao, et al. further teaches the nutritional composition may be delivered to an infant from birth until at least on year corrected age (Specification, para [0185) (teaching administration to a pediatric subject for at least 3 months during the first year of life, as required in the instant claim 1-19).
Ao, et al. teaches the nutritional composition when administered to a pediatric subject, can provide broad benefits including brain development, optimally providing a synergistic combination to improve cognition and cognitive development in an infant or child (see Specification, para [0196]) (broadly teaching improvement in neurological development, as required in the instant claim(s) 1-6).
Ao, et al. teaches the enriched milk product may comprise from 0.5% to 5% (and, at times, 1.2% to 2.8%) sialic acid, from 2% to 25% (and, in some embodiments, 4% to 10%) phospholipids, from 0.4% to 3% sphingomyelin, from 0.05% to 1.8%, and, in certain embodiments 0.10% to 0.3%, gangliosides and from 0.02% to about 1.2%, more preferably from 0.2% to 0.9%, cholesterol (Specification [0011]) (as required in the instant claims 8-10).
Ao, et al. teaches the milk source of the nutritional composition may comprise in some embodiments bovine milk protein sources, (e.g. whey protein) (Specification, para [0104]) (as required in claims 11-12; broadly teaching a milk source (e.g. buttermilk) as required in the instant claims 15-16).
Ao, et al. teaches the nutritional composition may further comprise 5 mg/100 kcal to about 300 mg/100 kcal of lactoferrin (see Abstract; Specification, para [0010]) (as required in the instant claims 17 and 18).
Ao, et al. teaches the nutritional composition in some embodiments may comprise sialic acid (1 mg/100 Kcals to about 120 mg/100 Kcal) (Specification, para [0093]) (broadly teaching human milk oligosaccharide (HMO), 3’-sialyllacrose (3SL), as required in the instant claim 19).
Ao, et al. teaches the nutritional composition may in some embodiments comprise prebiotics such as polydextrose (PDX) (0.015 g/100 Kcal to about 1.5 g/100 Kcal) and/or galactooligosaccharides (GOS) (0.015g/100 Kcal to about 1.0 g/100 Kcal) (Specification, para [0085], [0087]) (as required in the instant claim 19).
Ao, et al. teaches the nutritional composition may comprise in some embodiments a source of long chain poly unsaturated fatty acids (LCPUFA) (5 mg/100 Kcal to 90 mg/100 Kcal) (see Specification, para [0009]) (as required in the instant claim 19).
Ao, et al. is silent to a nutritional composition comprising (whole) MFGM (see instant claims 1-19); the improvement in neurological development of the pediatric subject from at least two years of age persists until at least five years of age (instant claim 6); and the range(s) of MFGM and/or percentages dry weight of MFGM (see instant claims 11-16).
However, Li et al. teaches infants receiving formula with added bovine MFGM and bovine lactoferrin (page 24, “Conclusions”) (broadly teaching a nutritional composition comprising (whole) MFGM, as required in the instant claims 1-19). Li, et al. teaches administration from birth to 545 days (18 months old) (page 25) (broadly teaching administration taking place for at least 6 months during the first year (instant claim 4) and three months to six months of age (instant claim 5)). Li, et al teaches rapid acceleration in expressive language and increased attentional engagement from 12 to 18 months of age (pages 28) (broadly teaching the improvement in cognitive development language acquisition, as required in claim 3 & 6).
Nieto-Ruiz, et al. teaches that early life nutrition can influence brain development and mental health (see Abstract). Nieto-Ruiz, et al. teaches the effects (reduced behavioral problems) of a bioactive nutrient enriched infant formula on children’s behavior up to 2.5 years compared to standard infant formula and/or breastfeeding (see Abstract). Nietz-Ruiz, teaches MFGM, when fed to infants showed greater cognitive development at 2 months of age and when fed to preschool children 2.5-6 years old over four months, showed reduced internal/external and total behavioral problems (see Introduction).
It would have been obvious to one of person of ordinary skill in the art at
the time of the instant invention effective filing to have modified the nutritional composition comprising MFGM for improving cognitive development in pediatric subjects as taught by Ao, et al. with (whole) MFGM as taught by Li, et al. particularly where it was known in the art that (whole) MFGM was associated with improved cognitive outcomes (i.e. language acquisition) and long-term health effects at 2.5 years old as taught by Nieto-Ruiz, et al., as required in the instant claims.
A person of ordinary skill in the art would have had a reasonable expectation of success for using MFGM in a nutritional composition because the references teach administration of MFGM compositions to infants within the first year of life and the resultant health benefits (i.e. cognitive benefits) thereof in pediatric patient(s). Accordingly, it would have been obvious to a person of ordinary skill in the art to combine the teachings of the references to arrive at the instantly claimed invention(s) with a reasonable expectation of success.
The references is/are relied upon for the reasons discussed above. If not expressly taught by the references, based on the overall beneficial teaching provided by the references with respect to the ingredients of the composition(s) and/or method(s) of making and/or using disclosed therein, the adjustments of particular conventional working conditions (E.g. the range(s) of MFGM and/or percentages dry weight of MFGM) in which to perform such method is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Thus, absent some demonstration of unexpected results or criticality from the claimed parameters, this optimization would have been obvious before the effective filing date of applicant’s claimed invention.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was filed, 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' composition with the composition of the prior art (including
compositions within the processes thereof), the burden is on applicant to show a novel or
unobvious difference between the claimed product and the product of the prior art. 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).
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
Claim(s) 1-19 is/are rejected on the ground of non-statutory double patenting as being unpatentable over claim(s) 1-12 of U.S. Patent No. 10,582,714 B2 (‘714 reference patent) and claim(s) 1-14 of U.S. Patent No. 10,945,446 B2 (‘446 reference patent) in view of Li, et al., “Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial” J Pediatr. 2019 Dec;215:24-31.e8 and Nieto-Ruiz, et al. “The Effects of an Infant Formula Enriched with Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids and Synbiotics on Child Behavior up to 2.5 Years Old: The COGNIS Study.” Nutrients 2020, 12, 3825.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant 18,198,753 (instant ‘753) application is broadly drawn to a nutritional composition comprising milk fat globule membrane (MFGM) for use in improving neurological development in a pediatric subject.
However, the ’714 reference patent is not patentably distinguishable from the instant ‘753 application, wherein the ‘714 reference patent recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) for use in improving neurological development in a pediatric patient (broadly teaching a composition comprising components of MFGM including fat or lipid, protein, phospholipids, sphingomyelin, gangliosides, long chain polyunsaturated fatty acids, et al; ‘714 at claims 1-12).
Similarly, the ‘446 reference patent is not patentably distinguishable from the instant ‘753 application, wherein the’446 reference patent recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) for use in improving neurological development in a pediatric patient (broadly teaching a composition comprising components of MFGM including fat or lipid, protein, phospholipids, sphingomyelin, gangliosides, long chain polyunsaturated fatty acids, et al; see ‘446 at claims 1-14).
The ‘714 and ‘416 reference patents is/are silent as to (i) “the synthetic nutritional composition is administered to the pediatric subject for at least three months during the first year of life,” (see instant ‘753, claim 1) and (ii) “wherein said administration of synthetic nutritional composition improves neurological development of the pediatric subject from at least two years of age.” (see instant ‘753, claim 1). However, Li, et al. teaches administration from birth to 545 days (18 months old) (page 25) (broadly teaching administration taking place for at least 6 months during the first year (instant ‘753 claim 4) and three months to six months of age (instant ‘753, claim 5)). Li, et al teaches rapid acceleration in expressive language and increased attentional engagement from 12 to 18 months of age (page 28) (broadly teaching the improvement in cognitive development language acquisition, as required in the instant ‘753, claim 3 & 6). Nieto-Ruiz, et al. further teaches that early life nutrition can influence brain development and mental health (see Abstract). Nieto-Ruiz, et al. teaches the effects (reduced behavioral problems) of a bioactive nutrient enriched infant formula on children’s behavior up to 2.5 years compared to standard infant formula and/or breastfeeding (see Abstract). Nietz-Ruiz, teaches MFGM, when fed to infants showed greater cognitive development at 2 months of age and when fed to preschool children 2.5-6 years old over four months, showed reduced internal/external and total behavioral problems (see Introduction).
Accordingly, it would have been obvious to one skilled in the art to combine the teachings of the reference patent(s) and Li, et al. and to produce the synthetic nutritional composition comprising milk fat globule membrane (MFGM) of the instant ‘753 application.
A person of ordinary skill in the art would have been motivated to combine the references because although the claims at issue are not identical, both sets of claims are drawn to synthetic nutritional composition(s) for enhancing cognitive development in a pediatric subject. Accordingly, practicing one invention would at least render obvious the other as claimed.
Claim(s) 1-19 is/are rejected on the ground of non-statutory double patenting as being unpatentable over claim(s) 1-10 of U.S. Patent No. 9,980,506 B2 (‘506 reference patent), 1-20 of U.S. Patent No. 9,661,874 B2 (‘874 reference patent), and 1-20 of U.S. Patent No. 10,445,854 (‘854 reference patent) in view of Li, et al., “Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial” J Pediatr. 2019 Dec;215:24-31.e8 and Nieto-Ruiz, et al. “The Effects of an Infant Formula Enriched with Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids and Synbiotics on Child Behavior up to 2.5 Years Old: The COGNIS Study.” Nutrients 2020, 12, 3825.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant 18,198,753 (‘753) application is broadly drawn to a nutritional composition comprising milk fat globule membrane (MFGM) for use in improving neurological development in a pediatric subject.
The ‘506 reference patent is not patentably distinguishable from the instant ‘753 application, wherein the ‘506 reference patent broadly recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) (broadly teaching a composition comprising milk fat globules; see ‘506 at claims 1-10).
Similarly, the ‘874 reference patent is not patentably distinguishable from the instant ‘753 application, wherein the ‘874 reference patent broadly recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) (broadly teaching a composition comprising milk fat globules; see ‘874 at claims 1-20).
Moreover, the ‘854 reference patent is not patentably distinguishable from the instant ‘753 application, wherein the ‘854 reference patent broadly recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) (broadly teaching a composition comprising milk fat globules; see ‘854 at claims 1-20).
The ‘506 reference patent, ‘874 reference patent and ‘854 reference patent is/are silent as to (i) “the synthetic nutritional composition is administered to the pediatric subject for at least three months during the first year of life,” (see instant ‘753, claim 1) and (ii) “wherein said administration of synthetic nutritional composition improves neurological development of the pediatric subject from at least two years of age.” (see instant ‘753, claim 1). However, Li, et al. teaches administration from birth to 545 days (18 months old) (page 25) (broadly teaching administration taking place for at least 6 months during the first year (instant ‘753 claim 4) and three months to six months of age (instant ‘753, claim 5)). Li, et al teaches rapid acceleration in expressive language and increased attentional engagement from 12 to 18 months of age (page 28) (broadly teaching the improvement in cognitive development language acquisition, as required in the instant ‘753, claim 3 & 6). Nieto-Ruiz, et al. further teaches that early life nutrition can influence brain development and mental health (see Abstract). Nieto-Ruiz, et al. teaches the effects (reduced behavioral problems) of a bioactive nutrient enriched infant formula on children’s behavior up to 2.5 years compared to standard infant formula and/or breastfeeding (see Abstract). Nietz-Ruiz, teaches MFGM, when fed to infants showed greater cognitive development at 2 months of age and when fed to preschool children 2.5-6 years old over four months, showed reduced internal/external and total behavioral problems (see Introduction).
Accordingly, it would have been obvious to one skilled in the art to combine the teachings of the reference patent(s) and Li, et al. and to produce the synthetic nutritional composition comprising milk fat globule membrane (MFGM) of the instant ‘753 application.
A person of ordinary skill in the art would have been motivated to combine the references because although the claims at issue are not identical, both sets of claims are drawn to synthetic nutritional composition(s). Accordingly, practicing one invention would at least render obvious the other as claimed.
Claim 1-19 is/are provisionally rejected on the ground of non-statutory double patenting as being unpatentable over claim(s) 31-40, 45, 49, 52-54, 56 and 58 of co-pending Application No. 2024/0008520 Al (co-pending ‘520 application) and 1-4, 6-19, 22, 24, 31-32, 36, 40, 43-44 of co-pending Application No. 2024/0216434 A1 (co-pending ‘434 application) in view of Li, et al., “Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial” J Pediatr. 2019 Dec;215:24-31.e8 and Nieto-Ruiz, et al. “The Effects of an Infant Formula Enriched with Milk Fat Globule Membrane, Long-Chain Polyunsaturated Fatty Acids and Synbiotics on Child Behavior up to 2.5 Years Old: The COGNIS Study.” Nutrients 2020, 12, 3825.
Although the claims at issue are not identical, they are not patentably distinct from each other. The instant 18,198,753 (‘753) application is broadly drawn to a nutritional composition comprising milk fat globule membrane (MFGM) for use in improving neurological development in a pediatric subject.
The co-pending ‘520 application is not patentably distinguishable from the instant ‘753 application, wherein the co-pending ‘520 application broadly recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) (broadly teaching a composition comprising milk fat globules; see ‘520 at claims 31-40, 45, 49, 52-54, 56 and 58).
Similarly, the co-pending ‘434 application is not patentably distinguishable from the instant ‘753 application, wherein the co-pending ‘434 application broadly recites a synthetic nutritional composition comprising milk fat globule membrane (MFGM) (broadly teaching a composition comprising milk fat globules; see ‘434 at claims 1-4, 6-19, 22, 24, 31-32, 36, 40, 43-44).
The co-pending ‘520 application and co-pending ‘434 application is/are silent as to (i) “the synthetic nutritional composition is administered to the pediatric subject for at least three months during the first year of life,” (see instant ‘753, claim 1) and (ii) “wherein said administration of synthetic nutritional composition improves neurological development of the pediatric subject from at least two years of age.” (see instant ‘753, claim 1). However, Li, et al. teaches administration from birth to 545 days (18 months old) (page 25) (broadly teaching administration taking place for at least 6 months during the first year (instant ‘753 claim 4) and three months to six months of age (instant ‘753, claim 5)). Li, et al teaches rapid acceleration in expressive language and increased attentional engagement from 12 to 18 months of age (page 28) (broadly teaching the improvement in cognitive development language acquisition, as required in the instant ‘753, claim 3 & 6). Nieto-Ruiz, et al. further teaches that early life nutrition can influence brain development and mental health (see Abstract). Nieto-Ruiz, et al. teaches the effects (reduced behavioral problems) of a bioactive nutrient enriched infant formula on children’s behavior up to 2.5 years compared to standard infant formula and/or breastfeeding (see Abstract). Nietz-Ruiz, teaches MFGM, when fed to infants showed greater cognitive development at 2 months of age and when fed to preschool children 2.5-6 years old over four months, showed reduced internal/external and total behavioral problems (see Introduction).
Accordingly, it would have been obvious to one skilled in the art to combine the teachings of the reference patent(s) and Li, et al. and to produce the synthetic nutritional composition comprising milk fat globule membrane (MFGM) of the instant ‘753 application.
A person of ordinary skill in the art would have been motivated to combine the references because although the claims at issue are not identical, both sets of claims are drawn to synthetic nutritional composition(s). Accordingly, practicing one invention would at least render obvious the other as claimed.
This is a provisional non-statutory double patenting rejection.
Conclusion
No claims are currently allowed.
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/V.G.V./Examiner, Art Unit 1655
/TERRY A MCKELVEY/Supervisory Patent Examiner, Art Unit 1655