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 .
The amendment filed 04/13/2026 has been entered. Claims 1-5, 7-8, 16, 18, 20-23 and 26 have been cancelled. Claims 6, 9-15, 17, 19, 24-25 and 28-33 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claim(s) 6, 10, 11, 13-15, 17, 19 and 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petit et al. WO 2012062782 5-18-2012 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 6, 11, 21 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petit et al. WO 2012062782 5-18-2012 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 6, 11, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petit et al. WO 2012062782 5-18-2012 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 6, 11, 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petit et al. WO 2012062782 5-18-2012 in view of Capizzano et al. The Hours That Children Under Five Spend in Child Care: Variation Across States. New Federalism. Series B, No. B-8, March 2000, 11 pages. Retrieved from https://www.urban.org/sites/default/files/publication/62106/309439-The-Hours-That-Children-Under-Five-Spend-in-Child-Care.PDF on 1/13/2026 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 6, 9-15, 17, 19, 21, 23 24-25 and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Petit et al. WO 2012062782 5-18-2012 in view of Albrecht et al. US 2017/0354696 12/14/2017 cited in previously is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 28-29 under 35 U.S.C. 103 as being unpatentable over Petit et al. WO 2012062782 5-18-2012 and Albrecht et al. US 2017/0354696 12/14/2017 cited in previously as applied to claims 6, 9-15, 17, 19, 24-25 and 30-31 above further in view of Capizzano et al. The Hours That Children Under Five Spend in Child Care: Variation Across States. New Federalism. Series B, No. B-8, March 2000, 11 pages. Retrieved from https://www.urban.org/sites/default/files/publication/62106/309439-The-Hours-That-Children-Under-Five-Spend-in-Child-Care.PDF on 1/13/2026 is withdrawn in view of the amendment to the claims.
New Claim Rejections Based on Amendment
Claim Rejections - 35 USC § 103
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.
Claim(s) 6, 10, 11, 13, 14, 15, 17, 19, 24, 25 and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cazzola et al. Ther Adv Respir Dis (2010) 4(5) 271-278.
Claims 6, 10, 11, 13, 14, 15, 24, 25: Cazzola et al disclose a step of administering a composition comprising viable (Live) Bifidobacterium longum sub sp. infantis R0033 (B. infantis R0033) to a human infant children aged 3 to 7 years old who have experienced maternal separation by attending nursery or primary school. See under methods page 272, p. 273 under study population and study design.
Cazzola et al disclose the administering occurs prior to the time period of later childhood of between 6 and 12 ages since some of the children are less than 6 years old.
The children were administered daily a sachet comprising lyophilized powder comprising viable R0033 at a concentration of 5 x 109 CFU in combination with fructooligosaccharides and other viable probiotics such as Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071,wherein the composition is a pharmaceutical or food or drink comprising the probiotics because they are diluted in water or milk; wherein the duration of the administration is for 3 months. See under methods at page 272 and p. 273 under study design and treatments.
Regarding the concentration of R0033 100g body weight, it would not have been inventive for a person of ordinary skill in the art as of the effective filing date to have administered the B. infantis at a dose of 1x104 to 1x1012 cfu per day per 100g body weight in view of the teaching by Cazzola et al administering 5 x 109 CFU to children 3-7 years of age daily. Taking the average body weight of a three year old being 13-17 kg, the concentration disclosed by Cazzola et al would be in the range of 2.94 x 107 – 3.84 x 107 CFU per day per 100g body weight.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. "In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Since the B. infantis R0033 is administered prior to later childhood at 3-7 years of age, it follows that the B. infantis R0033 will improve memory ability wherein the memory ability is working memory ability; prevent or improve a disease, disorder, condition, symptom which can be prevented or improved by improvement of memory ability in later child hood between 6-12 years of age of the school age children, wherein the memory ability is working memory ability or a learning disorder or dyslexia, dysgraphia, dyscalculia, geometric disorder, disorder of arithmetic skills or anomia.
Regarding claim 17 and claim 19: Cazzola et al is set forth above but does not disclose the composition consists of the live Bifidobacterium longum subsp infantis and does not disclose the method further comprising he step of measuring improved memory ability.
Claim 17 and claim 19 claim interpretation: These claims recite “ a composition comprising”… “wherein said composition consists..”. The transition language “composition comprising” in claim 6 and claim 11 allows the claims to cover additional components of the composition even if claims 17 and claim 19 recite “wherein said composition consists of a live Bifidobacterium longum subsp infantis”.
Claim 30-31: the study population comprises male children. See table 1 on page 274.
Regarding claims 28 and 29, Cazzola et al is set forth above but does not disclose the period of maternal separation is 3 hours or longer per day i.e. day spent in nursery or at primary school.
However, it would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention that children between the ages of 3-7 years old will necessarily spend three hours or longer away from maternal care when they attend nursery school or primary school which would have been a reasonable amount of time to achieve some learning.
Claim(s) 9 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cazzola et al. Ther Adv Respir Dis (2010) 4(5) 271-278 as applied to claims 6, 10, 11, 13, 14, 15, 17, 19, 24, 25 and 28-31 above, in view of Albrecht et al. US 2017/0354696 12/14/2017 cited in previously.
Regarding claims 9 and 12: Cazzola et al is set forth above but does not disclose the Bifidobacterium longum subsp. infantis is Bifidobacterium longum subsp. infantis NITE BP-02623.
Albrecht et al disclose a method for improving memory ability in later childhood of a subject including a step of administering an infant formula comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant up to 36 months of age. See abstract and paragraphs 6, 9 and 37.
The method step of Albrecht et administers the composition comprising the B. infantis to the infant up to 36 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Albrecht et al disclose the B. infantis is B. infantis M-63 aka Bifidobacterium longum subsp. infantis NITE BP-0263 according to paragraph 33 of the specification.
Albrecht et al disclose the same method step which administers the same B. infantis M-63 thus, the method also improves working memory ability.
Albrecht et al disclose a method for preventing or improving a condition, or symptom which can be prevented or improved by improvement of memory ability in later childhood, including administering an infant formula containing Bifidobacterium longum subsp. infantis (B. infantis) in an effective amount for the prevention or the improvement to human infants up to 36 months of age in need of the prevention or the improvement of e.g. cognition, learning or memory. See abstract and paragraphs 6, 9 and 37.
The method step of Albrecht et administers the composition comprising the B. infantis M-63 to the infant up to 36 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Albrecht et al disclose that the infant formula can improve cognition, learning and memory. See paragraph 7.
Albrecht et al disclose that the term “cognition” as used herein, unless otherwise specified, refers to the learning, thinking, and memory (i.e., memory acquisition, memory retention and memory recall) of the brain. The term “improving cognition” as used herein, unless otherwise specified, refers to improving at least one of the learning, thinking, and memory functions of an infant. See paragraph 12.
Albrecht et al disclose that infant formula including probiotics, such as those of the Lactobacillus and the Bifidobacterium genera, can improve neurological functions, such as cognition, learning, and memory, associated with the CNS. Albrecht et al disclose the amount of B. infantis administered is 103-1012 cfu/g or 106 to 107 cfu/g. See paragraph 38.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of Cazzola et al by adding the composition of Albrecht et al comprising B. infantis M-63 aka Bifidobacterium longum subsp. infantis NITE BP-0263 to the composition administered in the method of Cazzola et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Albrecht et al disclose that B. infantis M-63 strain is a well characterized strain that is readily available and also has the added benefit of being able to improve neurological functions, such as cognition, learning, and memory. Thus, the resulting method will result in the improvement of memory ability and working memory ability and also result in prevention of or improving a disease, disorder, condition or symptom which can be prevented or improved by improvement of memory ability in later childhood of the school age children such as working memory ability or learning disorder or dyslexia or dysgraphia or geometric disorder or disorder of arithmetic skills or anomia in later childhood of the subject.
Status of Claims
Claims 6, 9-15, 17, 19, 24-25 and 28-31 are rejected. Claims 32-33 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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