Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/23/25 has been entered.
Claims 1-5, 7-8, 16, 18, 20, 22 and 26-27 have been cancelled. have been cancelled. Claims 28-33 are new. Claims 6, 9-15, 17, 21, 23-25 and 28-33 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claim(s) 6, 9-16, 18, and 20-27 under 35 U.S.C. 102(a)(1) as being anticipated by Albrecht et al. US 2017/0354696 12/14/2017 cited in IDS is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 6, 10, 11, 13-19 and 24-25 under 35 U.S.C. 102(a)(1) as being anticipated by Kuhara et al. WO 2018180728 10/4/2018 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 11-15 under 35 U.S.C. 103 as being unpatentable over Albrecht et al. US 2017/0354696 12/14/2017 in view of Morris et al. WO 2015034984 3/12/15 is withdrawn in view of the amendment to the claims.
The rejection of claim(s) 6, 11 and 26-27 under 35 U.S.C. 103 as being unpatentable over Kuhara et al. WO 2018180728 10/4/2018 is withdrawn in view of the amendment to the claims.
Claim Rejections 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claim 6: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
See p. 18 line 10, title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22, p. 5 lines 29-30,
Claim 10: Petit et al disclose the same method step which administers the same B. infantis thus, the method also improves working memory ability.
Claim 11: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Since B. infantis is administered prior to later childhood, it flows that the B. infantis will 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 subject, wherein the memory ability is working memory ability or a learning disorder or dyslexia, dysgraphia, dyscalculia, geometric disorder, disorder of arithmetic skills or anomia.
See title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22.
Claim 17 and 18: Petit et al disclose the composition consists of B. infantis. See p. 18 line 10.
Claim 24-25: Petit et al disclose the composition is an infant formula which is a food product, drink, nutraceutical, food supplement See p.5 lines 28-30 and p. 6 lines 1-2.
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, 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.
Claim 6: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
See p. 18 line 10, title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22, and p. 5 lines 29-30.
Claim 11: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Since B. infantis is administered prior to later childhood, it flows that the B. infantis will 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 subject, wherein the memory ability is working memory ability or a learning disorder or dyslexia, dysgraphia, dyscalculia, geometric disorder, disorder of arithmetic skills or anomia.
See title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18 and lines 21-22.
Petit et al does not disclose administering 1x104 to 1x1012 cfu per day per 100g body weight.
Petit disclose the amount of B. infantis administered is 106 to 1012 cfu/g. See p. 9 lines 27-30.
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 Petit et al administering 106 to 1012 cfu/g. 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).
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.
Claim 6: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
See p. 18 line 10, title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22, and p. 5 lines 29-30.
Claim 11: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Since B. infantis is administered prior to later childhood, it flows that the B. infantis will 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 subject, wherein the memory ability is working memory ability or a learning disorder or dyslexia, dysgraphia, dyscalculia, geometric disorder, disorder of arithmetic skills or anomia.
See title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18 and lines 21-22.
Petit et al does not disclose that the human infant is a male.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date to have practiced the method of Petit et al in both female and male infants since infants would necessarily comprise both male and female infant who attend daycare.
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.
Claim 6: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
See p. 18 line 10, title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22, and p. 5 lines 29-30.
Claim 11: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Since B. infantis is administered prior to later childhood, it flows that the B. infantis will 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 subject, wherein the memory ability is working memory ability or a learning disorder or dyslexia, dysgraphia, dyscalculia, geometric disorder, disorder of arithmetic skills or anomia.
See title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18 and lines 21-22.
Petit et al does not disclose the period of maternal separation is 3 hours or longer per day.
Capizzano et al disclose that infants are in child care (including child care centers) for 1-14, 15 to 34 or 35 or more 35 or more hours a week. See whole article especially p. 1 left column paragraph 1 and table 1 on p. 3.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date that the infants of method of Petit et al spend 1-14, 15 to 34 or 35 or more 35 or more hours a week in daycare, thus rendering the period of maternal separation 3 hours or longer prima facie obvious. The reason is because Capizzano et al disclose that infants are in child care (including child care centers) for 1-14, 15 to 34 or 35 or more 35 or more hours a week.
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.
Claim 6: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
See p. 18 line 10, title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22, p. 5 lines 29-30,
Claim 10: Petit et al disclose the same method step which administers the same B. infantis thus, the method also improves working memory ability.
Claim 11: Petit et al disclose a step of administering a composition comprising Bifidobacterium longum sub sp. infantis (B. infantis) to a human infant under the age of 12 months of age in order to reduce absence from school or daycare. Thus, the subject has necessarily experienced maternal separation as an infant since the B. infantis is administered to reduce absence from school or daycare.
The method step of Petit et al administers the composition comprising the B. infantis to the infant under the age of 12 months and thus the administering occurs only prior to the time period of later childhood of between 6 and 12 ages.
Since B. infantis is administered prior to later childhood, it flows that the B. infantis will 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 subject, wherein the memory ability is working memory ability or a learning disorder or dyslexia, dysgraphia, dyscalculia, geometric disorder, disorder of arithmetic skills or anomia.
See title, p. 1 lines 1-12, p.3 lines 1-7, p. 4 lines 8-18, lines 21-22
Claim 17 and 18: Petit et al disclose the composition consists of B. infantis. See p. 18 line 10.
Claim 24-25: Petit et al disclose the composition is an infant formula which is a food product, drink, nutraceutical, food supplement See p.5 lines 28-30 and p. 6 lines 1-2.
Petit et al does not explicitly state that the method is for improving memory ability in later childhood of a subject or that the method is a method for preventing or improving a disease, disorder, condition or symptom which can be prevented or improved by improvement of memory ability in later childhood of a subject.
Petit et al does not disclose that the B. 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 to have modified the method of Petit et al by using B. infantis M-63 aka Bifidobacterium longum subsp. infantis NITE BP-0263 as the B. infantis in the method of Petit et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that the method of Petit et al requires B. infantis and Albrecht et al disclose a B. infantis M-63 strain that is well characterized and 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 a subject 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.
Regarding claim 30- 31, practicing the method of Petit et al and Albrecht et al as combined in both female and male infants would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date since infants would necessarily comprise both male and female infant who attend daycare.
Regarding claim 21 and 23, 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 Petit et al and Albrecht et al as combined administering 106 to 1012 cfu/g or 103-1012 cfu/g or 106 to 107 cfu/g. 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).
Claim(s) 28-29 is/are rejected 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.
The combination of Petit et al and Albrecht et al does not disclose the period of maternal separation is 3 hours or longer per day.
Capizzano et al disclose that infants are in child care (including child care centers) for 1-14, 15 to 34 or 35 or more 35 or more hours a week. See whole article especially p. 1 left column paragraph 1 and table 1 on p. 3.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date that the infants of method of Petit et al and Albrecht et al as combined spend 1-14, 15 to 34 or 35 or more 35 or more hours a week in daycare, thus rendering the period of maternal separation 3 hours or longer prima facie obvious. The reason is because Capizzano et al disclose that infants are in child care (including child care centers) for 1-14, 15 to 34 or 35 or more 35 or more hours a week.
Status of Claims
Claims 6, 9-15, 17, 19, 21, 23-25, 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel Kolker can be reached at 5712723181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645