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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 3/9/2026 in response to the Non-Final Rejection mailed on 1/28/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 39, 41-43, 45-46, 66-71 are pending.
Claims 1-38, 40, 44, 47-65 are canceled.
Applicant’s remarks filed on 3/9/2026 in response to the Non-Final Rejection mailed on 1/28/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/27/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Withdrawn Rejections
The rejection of claims 39, 41-43, 45-46, 66 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘of a respiratory tract disease’ and ‘wherein the method reduces the severity by reducing symptoms or reduces the duration by reducing the number of days during which that the child administered with the culture is symptomatic as compared to another child on a placebo.’
New Objections
Claim 66 is newly objected to because of the following informalities: need to lowercase the C in claim. Appropriate correction is suggested. The new objection is necessitated by new claim 66.
Claims 69-71 are newly objected to because of the following informalities: recitation of ‘administering the culture in the child.’ The claims should recite ‘administering the culture to the child.’ Appropriate correction is suggested. The new objections are necessitated by new claims 69-71.
Maintained 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 39, 41-43, 45-46, 66-71 under pre-AIA 35 U.S.C. 103 as being unpatentable over Luquet et al (US Patent: US 6,607, 905 B1, Date of Patent: Aug. 19, 2003, cited on PTO-892 dated 10/20/2025) {herein Luquet} in view of Kaup et al. (US 2004/0072794, Publication Date: Apr. 15, 2004, cited on PTO-892 dated 4/4/2025) {herein Kaup} and Kullen et al (Date Published 2005, Current Pharmaceutical Design, cited on PTO-892 dated 4/4/2025) {herein Kullen} is maintained. The rejection has been modified in view of new claims 67-71.
Claims 39, 41-43, 45-46, 66-71 are drawn to a method for reducing the severity or duration of a flu-like symptom in a child at risk of a respiratory tract disease, comprising: administering a culture of Lactobacillus acidophilus and Bifidobacterium lactis at a daily dosage of from 10^8 Colony-Forming Units/day to 10^12 Colony-Forming Units/day to the child and the flu-like symptom is selected from fever, coughing and a runny nose, wherein the Lactobacillus acidophilus is NCFM and the Bifidobacterium lactis is Bi-07, and wherein the method reduces the severity by reducing symptoms or reduces the duration by reducing the number of days during which that the child administered with the culture is symptomatic as compared to another child on a placebo.
With respect to claims 39, 42-43, Luquet teaches a method wherein the administration (consumption) (column 7, line 64) of Lactobacillus acidophilus for treating inflammatory reactions and/or infectious diseases such as colds (column 8, lines 31-32) and the flu (abstract and column 2, lines 56-57). Examiner is interpreting the teaching of ‘consumption’ by Luquet to be the same as recited ‘orally administered’ in claim 42 of the instant application as both processes involve the acquisition of the culture orally. The instant application is cited to demonstrate that flu-like symptoms include: fever, cough, runny nose (Instant Application Specification para 15). As such, Examiner is interpreting the ‘cold’ and the ‘flu’ taught by Luquet to be the flu-like symptoms of fever, coughing and runny nose recited in claim 39. In addition, Examiner is interpreting the recitation ‘treating’ taught by Luquet encompasses ‘reducing the severity or duration’ as recited in claim 39 since ‘treating’ the flu-like symptom would result in a reduction and duration of the illnesses. Regarding the limitations directed to reducing the severity or the duration of a flu-like symptom (claim 39), reducing the need for antimicrobial administration (instant application claim 43), these limitations are considered as results obtainable from the claimed method rather than any active step to be carried out for the claimed invention. Therefore, the limitations do not provide any weight in determining patentability of the claimed subject matter. In addition, with respect to the limitation ‘a child a risk of a respiratory infection,’ said limitation encompasses any child as it is the Examiner’s position that all children are ‘at risk of a respiratory infection.’ Therefore, it is not limited to a child at risk of flu-like symptoms. Furthermore, the limitation does not clearly define what encompasses ‘a child at risk of a respiratory infection.’ As recited, a child at risk of a respiratory infection could be a child at risk of fractures, illness, etc. As such, it is the Examiner’s position that said limitation can read on any child. Additionally, Applicant recites ‘a method for reducing the severity or duration of a flu-like symptom in a child at risk of a respiratory tract disease’ which is a contradiction of ‘wherein the method reduces the severity by reducing symptoms or reduces the duration by reducing the number of days during which that the child administered with the culture is symptomatic as compared to another child on a placebo.’ Said recitation is an indication that the child is infected with a respiratory disease and not simply ‘at risk.’
However, Luquet does not teach the method of claim 39 of a daily dosage of from 10^8 Colony-Forming Units/day to 10^12 Colony-Forming Units/day, Lactobacillus acidophilus NCFM and Bifidobacterium lactis is Bi-07 (claim 39). Luquet does not teach the method of claim 41, wherein the child is from 2 to 5 years old (claim 41). Luquet does not teach the method of claim 45, wherein the culture is administered to the child once per day (claim 45). Luquet does not teach the method of claim 46, wherein the culture is administered to the child twice per day (claim 46). Luquet does not teach the method of claim 66, wherein the daily dosage is 10^10 Colony-Forming Units (claim 66). Luquet does not teach the method of claim 67, wherein administering the culture results in a cumulative flu-like symptom duration of no more than 3.4 days over a six-month period (claim 67). Luquet does not teach the method of claim 68, wherein a need for antimicrobial administration is reduced such that fewer than one in ten treated children administered with the culture receive an antimicrobial during a six-month period (claim 68). Luquet does not teach the method of claim 69, wherein administering the culture in the child reduces the risk of fever by 63% as compared to the placebo over a six-month period (claim 69). Luquet does not teach the method of claim 70, wherein administering the culture in the child reduces the risk of cough by 54% as compared to the placebo over a six-month period (claim 70). Luquet does not teach the method of claim 71, wherein administering the culture in the child reduces the risk of runny nose by 44% as compared to the placebo over a six-month period (claim 71).
With respect to claims 39, 45-46, 66, Kaup teaches the oral administration (para 0018) of a composition comprised of Lactobacillus acidophilus NCFM and Bifidobacterium lactis at 10^10 cfu/L (para 0053) to children (para 0044) for the treatment of viral infections (para 0022 and para 0049). It would have been obvious to a person of ordinary skill in the art to use the composition taught by Kaup daily and to use more than one dosage of the composition taught by Kaup since one or two dosages a day would meet the claimed range of the cell concentration (cfu/day).
However, Kaup does not teach said Bifidobacterium lactis is strain Bi-07 (claim 39). Kaup does not teach the method of claim 41, wherein the child is from 2 to 5 years old (claim 41). Kaup does not teach the method of claim 67, wherein administering the culture results in a cumulative flu-like symptom duration of no more than 3.4 days over a six-month period (claim 67). Kaup does not teach the method of claim 68, wherein a need for antimicrobial administration is reduced such that fewer than one in ten treated children administered with the culture receive an antimicrobial during a six-month period (claim 68). Kaup does not teach the method of claim 69, wherein administering the culture in the child reduces the risk of fever by 63% as compared to the placebo over a six-month period (claim 69). Kaup does not teach the method of claim 70, wherein administering the culture in the child reduces the risk of cough by 54% as compared to the placebo over a six-month period (claim 70). Kaup does not teach the method of claim 71, wherein administering the culture in the child reduces the risk of runny nose by 44% as compared to the placebo over a six-month period (claim 71).
With respect to claims 39, 41, Kullen teaches a method wherein B. lactis Bi-07 (probiotic group) is administered to children aged 12 to 36 months (page 69, column 1, para 2) for the reduction of infections (abstract).
Regarding claim 1, the recitation ‘wherein the method reduces the severity by reducing symptoms or reduces the duration by reducing the number of days during which that the child administered with the culture is symptomatic as compared to another child on a placebo’ within the instant application claim 1 is a structural limitation. As such, since Luquet in view of Kaup and Kullen teaches the structure of a method for reducing the severity or duration of a flu-like symptom in a child at risk of a respiratory tract disease by administering Lactobacillus acidophilus is NCFM and the Bifidobacterium lactis is Bi-07, it is the Examiner’s position that the method would necessarily reduce the severity by reducing symptoms or reduces the duration by reducing the number of days during which that the child administered with the culture is symptomatic as compared to another child on a placebo. Additionally, the intended outcome of reducing symptoms or the duration by reducing the number of days during which that the child administered with the culture is symptomatic as compared to another child on a placebo limitations are merely intended results. MPEP. § 2111.02 reads, "If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction." As such, the limitation "reducing the incidence of symptoms of respiratory disease" does not affect the patentability of the claimed method. Methods are defined by their constituent steps, not by an intended use or application.
Although the references of Luquet in view of Kaup and Kullen do not explicitly teach the limitations of claim 67, MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the daily dosage of probiotics depending on the particular application. It would be routine for one to arrive at the dosage for the application they intend on using the probiotic. Therefore, the above invention would have been prima facie obvious.
Since the art teaches the structure of a method for reducing the severity or duration of a flu-like symptom in a child at risk of a respiratory tract disease using Lactobacillus acidophilus NCFM and Bifidobacterium lactis Bi-07, it is the Examiners position that the method would necessarily result in a reduction of antimicrobial administration in fewer than one in ten children whom were administered with the culture of the invention during a six-month period (instant application claim 68); a reduction in the risk of fever by 63% as compared to the placebo over a six-month period (instant application claim 69); a reduction in the risk of cough by 54% as compared to the placebo over a six-month period (instant application claim 70); a reduction in the risk of runny nose by 44% as compared to the placebo over a six-month period (instant application claim 71).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Luquet et al of a method of administrating (consuming) (column 7, line 64) Lactobacillus acidophilus for treating inflammatory reactions and/or infectious diseases such as colds (column 8, lines 31-32) and the flu (abstract and column 2, lines 56-57) or combine the teachings of Kaup and Kullen because Kullen teaches a method wherein B. lactis BI-07 (probiotic group) is administered to children aged 12 to 36 months (page 69, column 1, para 2) for the reduction of infections (abstract). Whereas, Kaup teaches the oral administration (para 0018) of Lactobacillus acidophilus NCFM and Bifidobacterium lactis at 10^10 cfu/L (para 0053) to children (para 0044) for the treatment of viral infections (para 0022 and para 0049).
One of ordinary skill in the art would be motivated to either use the teachings of Luquet et al. by itself or combine the teachings of Kaup and Kullen because Kullen provides the motivation for Luquet to combine Bifidobacterium lactis Bi-07 with Lactobacillus acidophilus for reducing the severity or duration of a flu-like symptom in a child at risk as Kullen teaches the administration of Lactobacillus sp and Bifidobacterium lactis Bi-07 in infant formula (page 55, column 2, para 2) for the treatment of respiratory infections (page 58, table 1, row 3). Furthermore, Luquet teaches lactic acid bacteria, of which is known by those of ordinary skill in the art to include Bifidobacterium lactis Bi-07, are beneficial and helpful to improve the absorption of food while maintaining the equilibrium in the intestinal flora (column 1, lines 37-39) thereby providing an additional therapeutic effect. Additionally, Kaup provides the motivated for Luquet to try utilizing the NCFM strain of Lactobacillus acidophilus as said strain is commonly utilized in the art as a probiotic and is safe and effective when consumed by children (para 0053). Furthermore, Kaup provides the motivation to utilize 10^10 CFU of Lactobacillus acidophilus and Bifidobacterium at 10^10 CFU/L for oral consumption as Kaup teaches said dosage is effective at treating pathogenic infections in infants and children (para 0048 and 0053). Of note, Kaup does not report any deleterious effects from the administration of said dosage to children. As such, one of ordinary skill in the art knowing the benefit of probiotics for reducing the severity or duration of a flu-like symptom in a child at risk based on the teachings of Luquet in view of Kaup and Kullen would have a reasonable expectation of success to combine Lactobacillus acidophilus NCFM and the Bifidobacterium lactis Bi-07 at 10^10 CFU/L because one of ordinary skill in the art would expect them both to reduce the severity or duration of flu-like symptoms in a child at risk without causing any deleterious effects. Furthermore, MPEP 2144.06.I states “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); and Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious).”
RESPONSE TO REMARKS: Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive. Beginning on p. 11 of Applicants’ remarks, Applicants in summary contends that BB1 disclosed in Kaup has strain-specific effects such as incorporating zinc that differ from the claimed B. lactis Bi-07 and a person of ordinary skill in the art would not be able to modify (or hence switch) from one B. lactis strain BB1 to another B. lactis strain Bi-07 readily. Applicant contends that even if Kaup teaches NCFM and a B. lactis strain as co-administered probiotics in pediatric populations, it is for a GI infectious indication, not respiratory flu-like symptom reduction as claimed. Applicant contends that Kullen does not show that NCFM or Bi-07, singularly or in combination, reduce fever, cough, runny nose, or the duration of respiratory symptoms in a pediatric population.
Applicant’s arguments are not persuasive. Examiner contends that the teachings of Kaup is directed to the use of B. lactis Bi-07 as probiotics. As acknowledged, Kaup does not teach the particular species of B. lactis. However, since Kullen teaches the use of B. lactis Bi-07 as probiotics for children aged 12 to 36 months as growing up milk, one skilled in the art would recognize that B. lactis Bi-07 of Kullen is suitable for the method of Kaup with a reasonable expectation of success. Luquet, Kaup and Kullen do not teach every limitation of the claimed invention. The claim rejection is based on the combination of teachings from Luquet, Kaup and Kullen in the 103 rejection. Even otherwise, based on the teachings of Kullen, it would be obvious for one skilled in the art to replace the B.lactis taught in Kaup et al. with B.lactis Bi-07 taught by Kullen since Kullen excoriates the beneficial properties of Bi-07 strain. Applicants are reminded that for an obviousness argument, the reason to combine the teachings of the primary and secondary references need not be the same reason as that of the applicants (MPEP 2144).
Applicant contends that the reference Luquet cited in the Office Action itself recognized strain-specific effects as it taught that the "L.a. 1-492 strain differs from others [strains of L. acidophilus) only in that it degrades cholesterol more efficiently." (emphasis added.) Luquet at Col. 4, lines 5-7. Thus, any physiological effect of any bacterium is strain-specific. Applicant contends that Luquet never mentions: " L. acidophilus NCFM, "any ATCC identifier that corresponds to NCFM, or "any generic teaching that would lead a person of ordinary skill in the art to select NCFM from among all known acidophilus strains. Luquet did not indicate that any L. acidophilus may be used, to the contrary.
Applicants arguments are not persuasive. Examiner contends that Luquet teaches the probiotic effect of the strain L.a. I-1492 is ‘remarkable’ when combined with some other lactic acid bacteria (column 2, lines 9-11). As such, contrary to Applicants assertion, the method of Luquet does encompasses additional strains of lactic acid bacteria. The method is not limited to the strain L.a. I-1492 taught by Luquet. Examiner contends that the fact that Luquet teaches strains of lactic acid bacteria that are beneficial for reducing cholesterol levels does not conclude that any physiological effect of any bacterium is strain-specific. It is merely a correlation.
Applicant contends that the reference Weitzman et al teaches even though GI- related conditions such as diarrhea episodes were reduced, respiratory symptoms were unaffected in the presence of a combination of two strains, Bifidobacterium lactis (BB-12) from the genus Bifidobacterium, and Lactobacillus reuteri (ATCC 55730) from the genus Lactobacillus.
Examiner appreciates Applicant’s reference. However, Examiner maintains that said teaching does not necessitate the withdrawal of the 103 rejection under Luquet, Kaup and Kullen. Examiner contends that Weitzman does not teach a combination of the strains taught by Luquet, Kaup and Kullen. Although Weitzman teaches a combination of two strains, Bifidobacterium lactis (BB-12) from the genus Bifidobacterium, and Lactobacillus reuteri (ATCC 55730) from the genus Lactobacillus do not reduce respiratory symptoms. Applicant has not provided sufficient data showing that other strains of Lactobacillus and Bifidobacterium would not have the same activity against respiratory tract infections as the recited bacterial strains.
Conclusion
Status of Claims
Claims 39, 41-43, 45-46, 66-71 are pending.
Claims 1-38, 40, 44, 47-65 are canceled.
Claims 39, 41-43, 45-46, 66-71 are rejected.
No claims are in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656
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