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. The amendment filed August 6, 2026 has been received and 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. Any rejection set forth in a previous Office action that is not specifically set forth below is withdrawn.
3. Claims 1-14 and 21-26 are pending.
Election/Restrictions
4. In the reply filed on February 3, 2026, applicant elected the combination of Bifidobacterium longum subsp. longum, B. animalis subsp. lactis, B. longum subsp. infantis, Lactobacillus rhamnosus, and L. acidophilus without traverse.
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 § 103
7. Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masri (US 2010/0166721) in view of Lisonbee (US 2008/0081076).
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.
In regards to claim 12 and the use of the transitional phrase “consisting essentially of”, Masri teaches additional probiotic bacteria in combination with Lactobacillus rhamnosus, L. acidophilus, Bifidobacterium lactis, B. infantis, and B. longum (see Table 7). However, applicant’s claim 12 states that the probiotic component “comprises” these bacteria. Thus, additional probiotic bacteria are not considered to be excluded by the use of “consisting essentially of”. In addition, please note that MPEP section 2111.03 states:
For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355.
Thus, the composition suggested by the references is considered to teach claim 12.
Double Patenting
8. Claims 12-14 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 Masri (US 2010/0166721).
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, 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).
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.
Allowable Subject Matter
9. Claims 1-11 and 21-26 are allowed.
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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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, Anand Desai can be reached at 571-272-0947. 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.
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
