DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/24/2025 has been entered.
Claims 1-2, 7-14 and 16-21 are pending in this application.
Applicant’s amendment to the claims filed 11/24/2025 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed on 11/24/2025 in response to the final rejection mailed on 05/22/2025 are acknowledged and have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Election
The elected subject matter is
Invention I, corresponding to claims 1-2, 7-14, 16-18 and 21, drawn to a method of increasing vitamin B-12 by administering a microbial composition,
elected in the reply filed on 08/03/2024.
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. The election was made with traverse in the reply filed 08/03/2024.
Claim Objections
The objection to claim 7 is withdrawn in view of the amendment to recite “Active Fluorescent Units (AFU)”.
The objection to claim 21 is withdrawn in view of the amendment to capitalize the first letter of each genus and insert a comma between “Propionibacterium jensenii” and “Propionibacterium thoenii”.
Claim 21 is objected to for the typos in “Lactobacilli fermentum”, “Lactobacilli plantarum”, “Lactobacilli rhamnosus”, “Lactobacilli casei”, Lactobacilli reuteri”, “Lactobacilli gasseri”, “Streptococcus Salivarius”, and “Streptococci thermophilus”. In the interest of improving claim form, Applicant should consider an amendment to recite species names in lower case, and use the genus names of “Lactobacillus” and “Streptococcus” where appropriate.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-2, 7-14, and 16-18 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention is withdrawn in view of
the amendments to claims 1 and 7-8 to remove the term “about”.
Claim 21 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
The instant rejection is maintained from the previous Office Action.
Claim 21 is indefinite for the phrase “A method … comprising administering … a composition comprising: at least one strain of bacteria … wherein the at least one strain of bacteria comprises at least a second strain of bacteria”, as it is unclear whether the method requires administering at least one strain of bacteria or at least two strains of bacteria.
Response to Remarks: beginning p 5 of Applicant’s response to rejections under 35 USC 112(b); Applicant in summary contends the amendments to the claims obviate the 112(b) rejections of record.
Applicant’s remarks are considered and found not convincing. As stated above, while the amendments to claims overcome the rejection of claims 1-2, 7-14, and 16-18 in the previous Office action(s), the rejection of claim 21 is maintained.
Claim Rejections - 35 USC § 103
Claims 1-2, 11, 13 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (PNAS, 2020, vol 117(1): 602-609; cited on the IDS submitted 08/03/2023; herein referred to as Li) in view of Ge et al. (Mucosal Immunity, 2019, vol 12:434-444; cited on the IDS submitted 08/03/2023; herein referred to as Ge).
The instant rejection is maintained from the previous office action.
Claim 1 is drawn to a method for increasing vitamin B12 levels in a subject comprising administering to the subject a composition comprising: at least one strain of bacteria, wherein the at least one strain of bacteria comprises Propionibacterium freudenreichii UF (UF1), and wherein the composition administered delivers a dose of UF1 to the subject from 5 x 109 to 1 x 1010 colony forming units (CFU).
Li discusses regulating Vitamin B12 (VB12) biosynthesis in Propionibacterium strain UF1 [title].
Regarding claim 1 and the limitation of increasing VB12 levels and a strain of bacteria comprising Propionibacterium freudenreichii UF1, Li teaches that VB12 is provided by some gut microbes through fermentation of complex carbohydrates, as VB12 is a crucial cofactor for critical enzymes [p 602, col 1, para 1-2]. Li further teaches UF1 is a probiotic [p 602, col 2, para 1] that produces VB12 [abstract], and that probiotics are known to benefit the host when administered in adequate amounts [p 608, col 1, para 2].
Li does not teach the administration of UF1 or the dosage of 5 x 109 to 1 x 1010 CFU.
Ge discusses the neonatal intestinal immune regulation by Propionibacterium UF1 [title], and describes the administration of UF1 to newborn mice and its acceleration of neonatal protection against intestinal infection [p 434, col 2, para 2].
Regarding claim 1, Ge teaches the administration of UF1 at doses of 109 CFU to neonatal mice [p 440, col 2, para 2]. As stated in MPEP 2144.05(I), a prima facie case of obviousness exists where the claimed ranged or amounts do not overlap with the prior art but are merely close. Considering the method of determining CFU known in the art regards plating serial dilutions of bacterial cultures and counting colonies upon growth, the difference in the claimed range of 5 x 109 CFU and the amount disclosed by Ge of 109 equates to at least 1 colony growing from a 10-9 dilution compared to 5 colonies. As such, these two amounts of CFU are considered to be close.
Additionally, MPEP 2144.05(II)(B) sets forth that the differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence suggesting that such concentration is critical, as MPEP 2144.05(B) 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). As Ge provides a motivation for increasing the dosage of UF1 for enhanced effect as well as the disclosure that the dosage of bacteria is a result-effective variable in the teaching “it may be of significance if mothers and newborn mice would be continuously gavaged with P. UF1 to increase the enhancement of T cell immunity in newborn mice” [p 435, col 1, para 1], it would have been considered mere routine experimentation to identify the optimum or workable concentration range of the result-effective variable to achieve the desired results.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine Li and Ge by using the UF1 of Li with the administration method and dosages of Ge to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to combine the elements of Li and Ge, because Li teaches that UF1 produces VB12, and Ge teaches the administration dosage of UF1 conveys the acceleration of neonatal protection against intestinal infection in neonatal mice. One of ordinary skill in the art would have had a reasonable expectation of success because Li and Ge discuss the health benefits of the probiotic UF1 bacterial strain.
Regarding claims 2 and 11, Li teaches that UF1 is a probiotic [p 602, col 2, para 1].
Regarding claim 13, Ge teaches the significant increase in Th17 cells over time with UF1 treatment [Figure 1C].
Regarding claim 16-17, Ge teaches “it may be of significance if mothers and newborn mice would be continuously gavaged with P. UF1 to increase the enhancement of T cell immunity in newborn mice” [p 435, col 1, para 1], which is interpreted to be comparative to newborn mice without administration of UF1.
Therefore, the invention of claims 1-2, 11, 13 and 16-17 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ge as applied to claims 1-2, 11, 13 and 16-17 above, and further in view of Bernardeau et al. (J Appl Microbiol, 2001, vol 91:1103-1109; cited on the Form PTO-892 mailed 12/13/2023; herein referred to as Bernardeau).
The instant rejection is maintained from the previous office action.
Claim 7 is drawn to the method of claim 1, wherein the dose of UF1 is from 1 x 109 to about 2 x 1010 AFU.
The combined teachings of Li and Ge as applied to claims 1-2, 11, 13 and 16-17 are discussed above. These references do not teach dosages in Active Fluorescent Units (AFU).
Bernardeau discusses the usefulness of epifluorescence for quantitative analysis of lactobacilli in probiotic feed [title], wherein methods are described for the distinction between living and dying cells [p 1103, col 2, para 2] as well as the quantification of alive but not culturable (ABNC) microorganisms [p 1103, col 2, para 3] that include the determination of active fluorescence units (AFU) within a product [p 1104, col 1, para 1].
Regarding claims 7-8 and the limitation of AFU, Bernardeau teaches that methods of epifluorescence are important for the quantification of ABNC because some probiotic features are linked with the viability properties of cells, and therefore the ability to culture bacteria from probiotic product cannot be used as the sole indicator of the probiotic capabilities of functional food products [p 1104, col 1, para 1]. As Ge teaches that UF1 can be cultured in MRS medium [p 440, col 1, para 2], and Bernardeau teaches that epifluorescence is an alternative viable cell quantitation to culturing bacteria, one of skill in the art would recognize that the AFU ranges of the claimed composition comprising UF1 would be the same as the CFU ranges disclosed by Ge and discussed in the above rejection of claim 1.
In view of Bernardeau, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention modify the combined method of Li and Ge by using the dosages of bacteria as determined by the method of Bernardeau to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Li and Ge, because Bernardeau teaches that probiotic features are linked with the viability properties of cells, and therefore the ability to culture bacteria from probiotic product cannot be used as the sole indicator of the probiotic capabilities of functional food products. One of ordinary skill in the art would have had a reasonable expectation of success because Li, Ge and Bernardeau discuss the health benefits of probiotic bacteria.
Therefore, the invention of claims 7-8 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ge as applied to claims 1-2, 11, 13 and 16-17 above, and further in view of Nataraj et al. (Microb Cell Fact, 2020, v 19:168-189; cited on the Form PTO-892 mailed 12/13/2023; herein referred to as Nataraj).
The instant rejection is maintained from the previous office action.
Claim 9 is drawn to the method of claim 1, wherein the UF1 is a mixture of probiotic and parabiotic.
Parabiotic is defined in the instant specification as a product comprising killed or inactivated microbes that may positively affect subject health.
The combined teachings of Li and Ge as applied to claims 1-2, 11, 13 and 16-17 are discussed above. These references do not teach that the UF1 is a mixture of probiotic and parabiotic.
Nataraj reviews postbiotics and parabiotics for their uses in microbial biotherapy and functional foods [title], and describes the use of postbiotics and parabiotics to provide the health benefits of probiotics without the limitations of viability controls [abstract].
Regarding claim 9, Nataraj teaches examples of parabiotics wherein inactivated/dead/nonviable microbial cells of probiotics are either intact or ruptured containing cell components such as teichoic acids, peptidoglycan-derived muropeptides, surface protruding molecules (pili, fimbriae, flagella), polysaccharides such as exopolysaccharides, cell surface-associated proteins, and cell wall-bound biosurfactants [p 170, col 1, para 4 to col 2, para 1]. Nataraj further teaches the use of said non-viable parabiotic bacteria for anti-adhesion potential, immunomodulatory and gut barrier function; and the use of metabolites such as biosurfactants and organic acids for antagonistic knack against enteropathogens and nutrition and anti-oxidant properties [Figure 1].
In view of Nataraj, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Li and Ge by adding parabiotic bacteria, as taught by Nataraj, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Li and Ge by using parabiotic UF1, because Nataraj teaches that non-viable parabiotic bacteria have utility for anti-adhesion potential, immunomodulatory and gut barrier function. One of ordinary skill in the art would have had a reasonable expectation of success because Li, Ge and Nataraj discuss the health benefits of probiotic bacteria.
Regarding claim 10, Nataraj further teaches the use of said non-viable parabiotic bacteria for anti-adhesion potential, immunomodulatory and gut barrier function; and the use of metabolites such as biosurfactants and organic acids for antagonistic knack against enteropathogens and nutrition and anti-oxidant properties [Figure 1].
Therefore, the invention of claims 9-10 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ge as applied to claims 1-2, 11, 13 and 16-17 above, and further in view of Woodard et al. (J Gastrointest Surg, 2009, v 13:1198-1204; cited on the Form PTO-892 mailed 12/13/2023; herein referred to as Woodard).
The instant rejection is maintained from the previous office action.
Claim 12 is drawn to the method of claim 1, wherein the administration of the composition increases the subject’s serum B12 levels by at least 10% relative to the subject’s serum B12 level prior to administration of the composition. It is to be noted here that the method of claim 1 does not exclude the presence of additional strains of bacteria because of the transitional phrase “comprising at least one strain”.
The combined teachings of Li and Ge as applied to claims 1-2, 11, 13 and 16-17 are discussed above. These references do not teach that their bacterial composition increases a subject’s serum B12 levels by 10% upon administration.
Woodard discusses the results of probiotics given to surgery patients [title], wherein it is described that potential mediators to the gut microbiota, which perform symbiotic digestive and metabolic functions within the human GI tract, are considered to be safe therapy, and have been effective treatment for infective gastroenteritis, irritable bowel syndrome, general inflammation, preventing and treating acute respiratory infections and urogenital infection [p 1199, col 1, paras 2-3].
Regarding claim 12, Woodard teaches that the administration of probiotics comprised of Lactobacillus species [p 1201, col 1, para 2] to post-surgical patients resulted in an increase of B12 from preoperative levels of 668 pg/ml to 1215 pg/ml after three months [Table 3] as a result of serology analysis [p 1201, col 1, para 1].
In view of Woodard, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Li and Ge by including the probiotic comprised of Lactobacillus species, as taught by Woodard, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Li and Ge by including the probiotic of Woodard in the composition, because Woodard teaches that three months of administering a Lactobacillus-containing probiotic resulted in an 81.88% increase in serum B12 levels compared to before administration. One of ordinary skill in the art would have had a reasonable expectation of success because Woodard teaches the increase in serum B12 levels upon administration of Lactobacillus probiotics, and Le and Ge discuss administration of UF1 probiotics known to synthesize B12 and their associated health benefits.
Therefore, the invention of claim 12 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ge as applied to claims 1-2, 11, 13 and 16-17 above, and further in view of Brasili et al. (J Nutrition, 2013, v 143(10):1549-1557; cited on the Form PTO-892 mailed 12/23/2023; herein referred to as Brasili).
The instant rejection is maintained from the previous office action.
Claim 14 is drawn to the method of claim 1, wherein the administration of the composition increases the levels of NAD+ and/or NMN in the subject.
NAD+ and NMN are known in the art as the cofactor-related molecules nicotinamide adenine dinucleotide and nicotinamide mononucleotide, respectively.
The combined teachings of Li and Ge as applied to 1-2, 11, 13 and 16-17 are discussed above. These references do not teach increases of NAD+ and/or NMN levels upon administration.
Brasili discusses the metabolic profiles induced in mice by Lactobacillus acidophilus and Bifidobacterium lactis as determined by H-NMR [title], wherein it is described that the dietary manipulation of the gut microbiota through probiotic supplementation can improve or restore a healthy microbial community and induce several benefits [p 1550, col 1, para 2].
Regarding claim 14, Brasili teaches that treatment of mice with L. acidophilus and B. lactis resulted in decreased N-methylnicotinamide (Mnam) concentration, which based on the concurrent reduction in nicotinamide (Nam) suggested enhanced utilization of Nam towards NAD synthesis [p 1555, col 1, para 2]. Here again, it is to be noted that the method of claim 1 does not exclude the presence of additional strains of bacteria because of the transitional phrase “comprising at least one strain”.
In view of Brasili, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Li and Ge by including in the mixture the probiotics L. acidophilus and B. lactis, as taught by Brasili, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Li and Ge by including the probiotics of Brasili, because Brasili teaches that the dietary manipulation of the gut microbiota through probiotic supplementation can improve or restore a healthy microbial community and induce several benefits. One of ordinary skill in the art would have had a reasonable expectation of success because Brasili, Le, and Ge all discuss the health effects of probiotics.
Therefore, the invention of claim 14 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ge as applied to claims 1-2, 11, 13 and 16-17 above, and further in view of Torow et al. (J Immunol, 2017, vol 198(2):557-563; cited on the Form PTO-892 mailed 12/13/2023; herein referred to as Torow).
The instant rejection is maintained from the previous office action.
Claim 18 is drawn to the method of claim 17, wherein the infant was born preterm.
The combined teachings of Li and Ge as applied to claims 1-2, 11, 13 and 16-17 are discussed above. These references do not teach administration to preterm infants.
Torow reviews the effects of the enteric microbiota on the innate and adaptive immune system following periods after birth [abstract].
Regarding claim 18, Torow teaches that there is a downside to preventing infectious disease burden on newborns, in that there is a need to compensate for the lack of microbial exposure during early development without the risk for potential life-threatening infections, and that facilitating exposure of children to benign nonpathogenic microbes can be a solution, such as the administration of probiotic bacteria to preterm neonates [p 562, col 1, para 1].
In view of Torow, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined method of Li and Ge by including administration to preterm infants, as taught by Torow, to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to modify the combined method of Li and Ge by administering to preterm infants, because Torow teaches that facilitating exposure of children to benign nonpathogenic microbes can increase microbial exposure during early development without the risk of like-threatening infection. One of ordinary skill in the art would have had a reasonable expectation of success because Torow, Li and Ge all discuss the health effects of probiotic administration.
Therefore, the invention of claim 18 would have been obvious to one of ordinary skill in the art before the effective filing date.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Li in view of Ge, Bernardeau and Nataraj.
The instant rejection is maintained from the previous office action.
Claim 21 is drawn to a method for increasing vitamin B12 levels in a subject comprising administering to the subject a composition comprising:
at least one strain of bacteria wherein the at least one strain of bacteria comprises UF1 and wherein the composition administered delivers a dose of UF1 to the subject from 5 x 109 to 1 x 1010 Active Fluorescent Units (AFU), wherein the at least one strain of bacteria comprises at least a second strain of bacteria consisting essentially of: Propionibacterium acnes, Propionibacterium avidum, Propionibacterium granulosum, Propionibacterium lymphophilum, Propionibacterium acidiproprionic, Propionibacterium jensenii, Propionibacterium thoenii, lactic acid bacteria including Lactobacillus acidophilus, Lactobacilli fermentum, Lactobacilli plantarum, Lactobacilli rhamnosus, Lactobacilli casei, Lactobacilli reuteri, Lactobacilli gasseri and Streptococcus salivarius, Streptococci thermophilus, spore forming bacteria including Bacillus coagulans, Bacillus subtilis, bifidobacteria, yeast-derived bacteria including Saccharomyces boulardii, and/or mixtures of the foregoing.
The teachings of Li, Ge and Bernardeau are discussed above, and include the administration of UF1 to increase Vitamin B12 levels in subject at dosages of 5 x109 to 1 x 1010 AFU as discussed in the rejection of claims 7-8. These references do not teach a second strain of bacteria comprising those listed in the claim.
Nataraj reviews postbiotics and parabiotics for their uses in microbial biotherapy and functional foods [title], and describes the use of postbiotics and parabiotics to provide the health benefits of probiotics without the limitations of viability controls [abstract].
Regarding claim 21, Nataraj teaches lactic acid bacteria cultures such as Lactobacillus fermentum that synthesize EPS provide the health benefits of anti-biofilm effects against the pathogens L. monocytogenes, E. faecalis, S. aureus, P. aeruginosa, and Salmonella spp., and that using mixtures of Lactobacillus paracasei and Lactobacillus plantarum provide the benefit of immunomodulation [Table 1]. One of skill in the art would therefore be motivated to add an additional strain to the composition of Li and Ge, because Nataraj teaches the above strains provide the health benefits of immunomodulation.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine Li, Ge, Bernardeau and Nataraj by using the UF1 of Li with the administration method and dosages of Ge as determined by the method of Bernardeau, and by adding a second strain as taught by Nataraj to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to combine the elements of Li, Ge, Bernardeau and Nataraj, because Li teaches that UF1 produces VB12, Ge teaches the administration dosage of UF1 conveys the acceleration of neonatal protection against intestinal infection in neonatal mice, Bernardeau teaches that probiotic features are linked with the viability properties of cells, and therefore the ability to culture bacteria from probiotic product cannot be used as the sole indicator of the probiotic capabilities of functional food products, and Nataraj teaches lactic acid bacteria cultures when administered in mixtures with other strains can provide a benefit of immunomodulation. One of ordinary skill in the art would have had a reasonable expectation of success because Li, Ge, Bernardeau and Nataraj discuss the health benefits of probiotic bacteria.
Therefore, the invention of claim 21 would have been obvious to one of ordinary skill in the art before the effective filing date.
Response to Remarks: Beginning on page 6 of Applicant’s response to the 35 U.S.C. 103 rejections; Applicant in summary contends the claims would not be obvious according to MPEP 2144.05 as the prior art concentration of 109 CFU is not functionally equivalent to the claimed 5 x 109 CFU of the claims, as it represents 1/5th of the minimum claimed dosage; Applicant further contends that a person of ordinary skill in the art would note the difference in properties between the two amounts of CFU, as the differences in number are being underestimated as they are in the billions or tens of billions.
Applicant’s remarks are considered and found not convincing. As Ge discloses a dosage of 109 CFU, it is considered broad such that it could be interpreted as overlapping with the dosage range recited in the claims. However, as Ge does not explicitly disclose 5 x 109 CFU as recited by the claim, MPEP 2144.05 was used to support an obviousness rationale for rejection under 35 USC 103, as 5 x 109 and 109 both represent values within the same order of magnitude, and such variation is considered common for quantitative enumeration of CFU in the field with various methods as evidenced by Corry et al. (Food Microbiol, 2007, 24:230; cited on the attached Form PTO-892) [p 232, col 1, para 3; p 243, col 1, para 3; p 243, col 2, para 3]. Applicant states a person of ordinary skill in the art would note the difference in properties between the two amounts of CFU from the art and the claims, however it is unclear from Applicant’s argument as to what properties would be imparted by this difference in CFU. While MPEP 2144.05 provides examples of cases where the obviousness of close or overlapping ranges does not apply, the example given by Applicant corresponds to a different field of study, with different standards for measurement, different acceptable variation, and different conventional methods for reporting numbers commonly measured in the field as evidenced by Corry, and therefore the difference in the contested numbers of the instant application is not comparable to the difference in percentage of nickel in metal alloys described by the example reference in Applicant’s argument.
Additionally, MPEP 2144.05(II)(B) sets forth that the differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence suggesting that such concentration is critical, as MPEP 2144.05(B) 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). As Ge provides a motivation for increasing the dosage of UF1 for enhanced effect as well as the disclosure that the dosage of bacteria is a result-effective variable in the teaching “it may be of significance if mothers and newborn mice would be continuously gavaged with P. UF1 to increase the enhancement of T cell immunity in newborn mice”, it would have been considered mere routine experimentation to identify the optimum or workable concentration range of the result-effective variable to achieve the desired results.
Conclusion
Status of the Claims:
Claims 1-2, 7-14 and 16-21 are pending.
Claims 19-20 are withdrawn from consideration.
Claims 1-2, 7-14, 16-18 and 21 are rejected.
No claim is in condition for allowance.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656