DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 submissions filed on February 3, 2026 and May 12, 2025 have been entered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
3. Claims 1-14 and 21-26 are currently pending.
Election/Restrictions
4. Applicant’s election without traverse of the combination of Bifidobacterium longum subsp. longum, B. animalis subsp. lactis, B. longum subsp. infantis, Lactobacillus rhamnosus, and L. acidophilus for the species in the reply filed on February 3, 2026 is acknowledged.
5. In the reply filed on February 3, 2021, applicant elected of Group I, now claims 1-14 and 21-26, a combination of bovine colostrum, bovine colostrum extract, and egg yolk for species A and a combination of xylooligosaccharide, galactooligosaccharide, and fructooligosaccharide for species B without traverse. The claims to non-elected group II have been cancelled.
6. Claims 1-14 and 21-26 are examined on the merits.
Claim Rejections - 35 USC § 112
7. Claims 12-14 and 21-26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 12 and 21 are indefinite because they state that they are drawn to a “probiotic component selected from the group consisting of B. longum subsp. longum, B. animalis subsp. lactis, B. longum subsp. infantis, L. rhamnosus, and L. acidophilus” but do not state an alternative where more than one of the probiotics can be listed. Thus, claims 12 and 21 are inconsistent with applicant’s elected species which requires a combination of all of the listed probiotics. Please note that MPEP section 2111.03(II) states ‘If the claim element is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. In the absence of such qualifying language there is a presumption that the Markush group is closed to combinations or mixtures.’
Claim Rejections - 35 USC § 103
8. Claim(s) 1-5, 7-9, 11-14, 21-22, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritter (US 2011/0189148) in view of in view of Lisonbee (US 2008/0081076).
Ritter teaches a combination of a prebiotic ingredient and probiotic bacteria from the Lactobacillus and Bifidobacteria genera. The reference teaches that the prebiotic ingredient is fructooligosaccharde, galactooligosaccharide, and xylooligosaccharide (see claims 1, 8, 9, and 13). The reference teaches that the composition improves the immune system (see paragraph 36).
The reference teaches that the probiotic bacteria are selected from L. acidophilis, L. rhamnosus, B. lactis, B. animalis subsp. lactis, B. infantis, and B. longum (see paragraphs 38 and 39). Applicant’s specification defines B. longum as synonyms with B. longum subsp. longum, B. lactis as synonymous with B. animalis subsp lactis, and B. longum subsp infantis as synonymous with B. infantis (see paragraph 24). The reference does not specifically teach an embodiment which consists of or consists essentially of these bacteria; however, since the reference teaches that each can be selected as alternatives, an embodiment with just these members is encompassed by the reference. As discussed in MPEP section 2144.07:
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)…"Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.
Thus, is not considered to be inventive to select well known probiotics from the list taught in the prior art. An artisan of ordinary skill would be motivated to select these specific members from the grouping taught by reference based on the teaching that each of these bacteria is an appropriate probiotic organism to use in the composition.
The reference does not teach an immune modulating component comprising transfer factor, a bovine colostrum, egg yolk, and a bovine colostrum extract.
However, Lisonbee teaches a composition for improving immune function which comprises transfer factor, bovine colostrum extract, a fraction from bovine colostrum, and egg yolk. The reference teaches a fraction with a molecular weight of less than 3,000 Da which lacks transfer factor and moderates T-cell activity. The reference teaches combining the immune modulating components with additives. The reference teaches that the transfer factor can be from bovine colostrum (see claims 7, 10, and 11; paragraphs [0010], [0012], [0016], [0033], [0034], [0043]-[0048], [0065]; and Tables 4, 5, and 8).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that improve the immune health of a subject. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to improve the immune health of a subject, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions improve the immune health of a subject. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach adding the ingredients together in the amounts claimed by the applicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of the applicant’s claimed invention.
The references do not specifically teach that the transfer factor increases the rate at which is probiotic organisms grow or multiples. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In addition, the fact that the applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Ritter teaches a composition with 10^6 to 10^9 of probiotic bacteria (see paragraph 41). Lisonbee teaches that an effective amount of the transfer factor is 150 mg (see Table 5). Thus, a combination of the amounts specifically taught by the references would yield a composition with 150 mg of transfer factor and 100 million CFU of probiotic bacteria. The applicant’s specification teaches that 100 mg of an immune modulating component is capable of stimulating the growth of 2 billion CFU of probiotic bacteria (see Tables 2 and 4). The ratio of immune modulating component to probiotic bacteria in the composition taught by the references is higher than this ratio of immune modulating component to probiotic bacteria exemplified in the specification. Thus, the concentration of immune modulating component in the reference composition should be sufficient to achieve the intended use claimed by the applicant. Therefore, the references together are considered to properly teach the stated claims.
9. Claim(s) 6 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritter (US 2011/0189148) in view of Lisonbee (US 2008/0081076) as applied to claims 1-5, 7-9, 11-14, 21-22, 24-25 above, and further in view of Chichlowski (US 2018/0064739).
The teachings of Ritter and Lisonbee are set forth above. Ritter teaches that the composition can contain an oligosaccharide. However, the references do no teach that the composition contains 3-sialyllactose or 6’-sialyllactose. However, Chichlowski teaches using a 3’-sialyllactose and/or 6’-sialyllactose oligosaccharide in combination with probiotic bacteria to improve the immune system (see abstract and claims 1, 2, 16, and 17).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that improve the immune health of a subject. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to improve the immune health of a subject, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions improve the immune health of a subject. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
10. Claims 10 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritter (US 2011/0189148) in view of Lisonbee (US 2008/0081076) as applied to claims 1-5, 7-9, 11-14, 21-22, 24-25 above, and further in view of Sozzi (US 4,332,790).
The teachings of Ritter and Lisonbee are discussed above. The references do not teach that the probiotics are microencapsulated. However, Sozzi teaches microencapsulated probiotics. Sozzi teaches that the microencapsulation improves the probiotic composition because it allows for better storage stability and for the probiotic to be delivered to the desired site in the digestive tract without degradation in the stomach (see column 1, lines 36-56). Thus, given these benefits, an artisan of ordinary skill would have reasonably expected that the composition taught by the combination of Ritter and Lisonbee would be improved if the probiotic ingredients were microencapsulated. This reasonable expectation of success would have motivated the artisan to modify Ritter and Lisonbee to include microencapsulation of the probiotic ingredient.
11. Claim(s) 21-22 and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masri (US 2010/0166721) in view of Lisonbee (US 2008/0081076) (maintained from the Office action of March 10, 2025).
Masri teaches a probiotic composition comprising Lactobacillus rhamnosus, L. acidophilus, Bifidobacterium lactis, B. infantis, and B. longum (see Table 7). Applicant’s specification defines B. longum as synonyms with B. longum subsp. longum, B. lactis as synonymous with B. animalis subsp lactis, and B. longum subsp infantis as synonymous with B. infantis (see paragraph 24). Masri also teaches that the composition can include a prebiotic component such as fructooligosaccharide, xylooligosaccharide, and galactooligosaccharide (see paragraph 25). The reference teaches that the composition improves the immune system (see paragraph 9). The reference does not teach an immune modulating component comprising transfer factor, a bovine colostrum, egg yolk, and a bovine colostrum extract.
However, Lisonbee teaches a composition for improving immune function which comprises transfer factor, bovine colostrum extract, a fraction from bovine colostrum, and egg yolk. The reference teaches a fraction with a molecular weight of less than 3,000 Da which lacks transfer factor and moderates T-cell activity. The reference teaches combining the immune modulating components with additives. The reference teaches that the transfer factor can be from bovine colostrum (see claims 7, 10, and 11; paragraphs [0010], [0012], [0016], [0033], [0034], [0043]-[0048], [0065]; and Tables 4, 5, and 8).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that improve the immune health of a subject. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to improve the immune health of a subject, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions improve the immune health of a subject. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach adding the ingredients together in the amounts claimed by the applicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of the applicant’s claimed invention.
The references do not specifically teach that the transfer factor increases the rate at which is probiotic organisms grow or multiples. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In addition, the fact that the applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Masri teaches a composition with 10^8 to 10^12 of probiotic bacteria (see paragraph 18). Lisonbee teaches that an effective amount of the transfer factor is 150 mg (see Table 5). Thus, a combination of the amounts specifically taught by the references would yield a composition with 150 mg of transfer factor and 100 million CFU of probiotic bacteria. The applicant’s specification teaches that 100 mg of an immune modulating component is capable of stimulating the growth of 2 billion CFU of probiotic bacteria (see Tables 2 and 4). The ratio of immune modulating component to probiotic bacteria in the composition taught by the references is higher than this ratio of immune modulating component to probiotic bacteria exemplified in the specification. Thus, the concentration of immune modulating component in the reference composition should be sufficient to achieve the intended use claimed by the applicant. Therefore, the references together are considered to properly teach the stated claims.
12. Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masri (US 2010/0166721) in view of Lisonbee (US 2008/0081076) as applied to claims 21-22, 24-25 above, and further in view of Chichlowski (US 2018/0064739) (maintained from the Office action of March 10, 2025).
The teachings of Masri and Lisonbee are set forth above in paragraph 11. Masri teaches that the composition can contain an oligosaccharide. However, the references do no teach that the composition contains 3-sialyllactose or 6’-sialyllactose. However, Chichlowski teaches using a 3’-sialyllactose and/or 6’-sialyllactose oligosaccharide in combination with probiotic bacteria to improve the immune system (see abstract and claims 1, 2, 16, and 17).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that improve the immune health of a subject. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to improve the immune health of a subject, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions improve the immune health of a subject. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
13. Claim 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masri (US 2010/0166721) in view of Lisonbee (US 2008/0081076) as applied to claims 21-22, 24-25 above, and further in view of Sozzi (US 4,332,790) (maintained from the Office action of March 10, 2025).
The teachings of Masri and Lisonbee are discussed above. The references do not teach that the probiotics are microencapsulated. However, Sozzi teaches microencapsulated probiotics. Sozzi teaches that the microencapsulation improves the probiotic composition because it allows for better storage stability and for the probiotic to be delivered to the desired site in the digestive tract without degradation in the stomach (see column 1, lines 36-56). Thus, given these benefits, an artisan of ordinary skill would have reasonably expected that the composition taught by the combination of Masri and Lisonbee would be improved if the probiotic ingredients were microencapsulated. This reasonable expectation of success would have motivated the artisan to modify Masri and Lisonbee to include microencapsulation of the probiotic ingredient.
Response to Arguments
14. Applicant's arguments filed May 12, 2025 have been fully considered but they are not persuasive. In regards to the 103 rejections based on Masri and Lisonbee, applicant argues that Masri does not teach claim 21 because Masri’s probiotic ingredient requires a Propionibacterium rather than a probiotic component “selected from the group consisting of B. longum subsp. longum, B. animalis subsp. lactis, B. longum subsp. infantis, L. rhamnosus, and L. acidophilus” as required by claim 21. However, claim 21 at line 1 uses the broad transitional phrase “comprising” which “is inclusive or open-ended and does not exclude additional, unrecited elements or method steps…” (see MPEP section 2111.02 (I)).” In addition, section II of MPEP 2111.02 states that in a claim with a Markush grouping, “the claim’s ‘comprising’ transition phrase does not foreclose additional binders and disintegrants when an accused infringing product contains and meets the limitation’s requirements for one of the binders or disintegrants recited in the Markush groupings – there is no inconsistency with another binder or disintegrant outside of the Markush group also being part of the claimed formulation…”. Thus, the use of Markush grouping does not exclude additional, unrecited probiotics from the claim. Therefore, Masri is still considered to properly reject claim 21 because the additional probiotic bacteria in Masri are not excluded from the claim.
Applicant also argues that “one of ordinary skill in the art would have had no reason to expect that the immune modulators of Lisonbee would have caused each probiotic organism of the probiotic composition of Chichlowski to grow and/or multiply at an increased rate, as required by claims 1, 12, and 21. Instead, from the teachings of Lisonbee, one of ordinary skill in the art would have merely expected the immune modulators to affect the cell-mediated immunity of a multicellular organism.” However, as discussed above, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In addition, the fact that the applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Masri teaches a composition with 10^8 to 10^12 of probiotic bacteria (see paragraph 18). Lisonbee teaches that an effective amount of the transfer factor is 150 mg (see Table 5). Thus, a combination of the amounts specifically taught by the references would yield a composition with 150 mg of transfer factor and 100 million CFU of probiotic bacteria. The applicant’s specification teaches that 100 mg of an immune modulating component is capable of stimulating the growth of 2 billion CFU of probiotic bacteria (see Tables 2 and 4). The ratio of immune modulating component to probiotic bacteria in the composition taught by the references is higher than this ratio of immune modulating component to probiotic bacteria exemplified in the specification. Thus, the concentration of immune modulating component in the reference composition should be sufficient to achieve the intended use claimed by the applicant. Therefore, the references together are considered to properly teach the stated claims.
In addition, applicant argues “while probiotics and immune modulators may both have positive effects on the immune system of a subject, one of ordinary skill in the art would have considered their effects to have been totally unrelated. As Masri teaches, probiotics "form beneficial temporary colonies which may assist the body in the same functions as the natural flora, while allowing the natural flora time to recover from depletion." Masri, paragraph [0006]. In contrast, immune modulators may cause a subject's immune system to elicit an active, cell-mediated immune response against pathogens. Lisonbee, paragraph [0006].” However, it is unclear why applicant believes that an artisan would find these effects to be unrelated as both are effects related to improving the immune system. Thus, this argument is not persuasive.
Double Patenting
15. Claims 1-5, 7-9, 11-14, 21-22, 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of Lisonbee (U.S. Patent No. 10,471,100) in view of Ritter (US 2011/0189148).
Lisonbee claims a composition for modulating immune function which comprises transfer factor, bovine colostrum extract, a fraction from bovine colostrum and egg yolk. The reference teaches a fraction with a molecular weight of less than 3,000 Da which lacks transfer factor and moderates T-cell activity. The patent does not claim including a probiotic or a prebiotic ingredient in the composition.
However, Ritter teaches a combination of a prebiotic ingredient and probiotic bacteria from the Lactobacillus and Bifidobacteria genera. The reference teaches that the prebiotic ingredient is fructooligosaccharde, galactooligosaccharide, and xylooligosaccharide (see claims 1, 8, 9, and 13). The reference teaches that the composition improves the immune system (see paragraph 36).
The reference teaches that the probiotic bacteria are selected from L. acidophilis, L. rhamnosus, B. lactis, B. animalis subsp. lactis, B. infantis, and B. longum (see paragraphs 38 and 39). Applicant’s specification defines B. longum as synonyms with B. longum subsp. longum, B. lactis as synonymous with B. animalis subsp lactis, and B. longum subsp infantis as synonymous with B. infantis (see paragraph 24). The reference does not specifically teach an embodiment which consists of or consists essentially of these bacteria; however, since the reference teaches that each can be selected as alternatives, an embodiment with just these members is encompassed by the reference. As discussed in MPEP section 2144.07:
The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)…"Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.
Thus, is not considered to be inventive to select well known probiotics from the list taught in the prior art. An artisan of ordinary skill would be motivated to select these specific members from the grouping taught by reference based on the teaching that each of these bacteria is an appropriate probiotic organism to use in the composition.
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that improve the immune health of a subject. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to improve the immune health of a subject, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions improve the immune health of a subject. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach adding the ingredients together in the amounts claimed by the applicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of the applicant’s claimed invention.
16. Claim(s) 6 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over Lisonbee (U.S. Patent No. 10,471,100) in view of Ritter (US 2011/0189148) as applied to claims 1-5, 7-9, 11-14, 21-22, 24-25 above, and further in view of Chichlowski (US 2018/0064739).
The teachings of Ritter and Lisonbee are set forth above. Ritter teaches that the composition can contain an oligosaccharide. However, the references do no teach that the composition contains 3-sialyllactose or 6’-sialyllactose. However, Chichlowski teaches using a 3’-sialyllactose and/or 6’-sialyllactose oligosaccharide in combination with probiotic bacteria to improve the immune system (see abstract and claims 1, 2, 16, and 17).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that improve the immune health of a subject. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to improve the immune health of a subject, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions improve the immune health of a subject. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
17. Claims 10 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over Lisonbee (U.S. Patent No. 10,471,100) in view of Ritter (US 2011/0189148) as applied to claims 1-5, 7-9, 11-14, 21-22, 24-25 above, and further in view of Sozzi (US 4,332,790).
The teachings of Ritter and Lisonbee are discussed above. The references do not teach that the probiotics are microencapsulated. However, Sozzi teaches microencapsulated probiotics. Sozzi teaches that the microencapsulation improves the probiotic composition because it allows for better storage stability and for the probiotic to be delivered to the desired site in the digestive tract without degradation in the stomach (see column 1, lines 36-56). Thus, given these benefits, an artisan of ordinary skill would have reasonably expected that the composition taught by the combination of Masri and Lisonbee would be improved if the probiotic ingredients were microencapsulated. This reasonable expectation of success would have motivated the artisan to modify Masri and Lisonbee to include microencapsulation of the probiotic ingredient.
18. No claims are allowed.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655
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