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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/14/2026 has been entered.
Status of the Claims
Claims 1-2, 11, 16-18, and 20-24 are currently pending.
Claims 1-2, 11, 20, and 24 are amended.
Claims 22 and 23 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 3-10, 12-15, and 19 are cancelled.
Claims 1-2, 11, 16-18, 20-21 and 24 have been considered on the merits.
Withdrawn Rejections
The 112(b) rejection made onto claim 20 is withdrawn in light of the amendments made on 04/14/2026.
New and Maintained Rejections Necessitated by Amendment
Claim Interpretation
It is noted that the preamble of the claims states “a biological cell culture media supplement” . This recites an intended use of the claimed invention, biological cell culture media supplement, and therefore is given little patentable weight. See MPEP 2111.02(II).
Claim 1 recites “isolated from honey-bee gut microbiota or honey-bee pollen microbiota” which is a product by process type limitation. Claim 1 is a product by process claim in which the process of obtaining the postbiotics of beneficial aerobic and facultative aerobic/anerobic microorganisms carries little patentable weight. It is only the product, which is anticipated by the prior art and not the process by which the product was made. This is because the final product (postbiotics of beneficial microorganisms) is not distinguished by any particular features or characteristics resulting from the process by which it was made. As such, the limitations of the claimed process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota are met by any process of isolating the identical microorganisms in the prior art. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it which are encompassed by the claimed process of process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota of claim 1. See MPEP 2113(I).
Claim 17 recites “The biological cell culture medium supplement according to claim 1, for promoting cell growth and proliferation in a primary muscle cell culture”. This recites an intended use of the claimed invention, biological supplement, and therefore is given little patentable weight. See MPEP 2111.04.
Claim 18 recites “The biological cell culture medium supplement according to claim 1, for promoting cell growth and proliferation of transformed cell lines”. This recites an intended use of the claimed invention, biological supplement, and therefore is given little patentable weight. See MPEP 2111.04.
Claim 20 recites “wherein the supplement is added to a cell culture medium in place of fetal bovine serum”. This recites an intended use of the claimed invention, biological supplement, and therefore is given little patentable weight. See MPEP 2111.04.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Interpretation: Claim 1 recites “Pediococcus acidilactici isolated from honey-bee gut microbiota” and “Pediococcus pentosaceus isolated from honey-bee pollen microbiota” which are product by process type limitation. It is only the product, which is anticipated by the prior art and not the process by which the product was made. This is because the final product (postbiotics of beneficial microorganisms) is not distinguished by any particular features or characteristics resulting from the process by which it was made. As such, the limitations of the claimed process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota are met by any process of isolating the identical microorganisms in the prior art. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it which are encompassed by the claimed process of process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota of claim 1.
Claims 1, 11, 16-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sirichokchatchawan et al (Probiotics and Antimicrob. Prot., 2018), as evidenced by Thorakkuttu et al (Foods 2022, 11, 3094; reference of record), and in view of Terada et al (Cytotechnology 40: 3–12, 2002; reference of record) and Colussi et al (US20100240099A1).
Regarding claim 1, Sirichochatchawan teaches a biological cell culture medium supplement comprising lactic acid bacteria cell-free supernatants (CFS) (pg. 384, col. 1, last para spanning col. 2), which is bacterial conditioned culture medium comprising only the postbiotics made and released into the medium and not the live bacteria. Sirichochatchawan teaches that the CFS is derived from both P. acidilactici and P. pentosaceus (pg. 384, col. 1, para 4). Sirichochatchawan teaches that the CFS is sterilized by passing the CFS through a sterile membrane filter with a 0.22 µm pore diameter (pg. 384, col. 1, last para spanning col. 2). Sirichochatchawan teaches that the cell culture supplement is used in the cell culture of mammalian VERO cells, a cell line of African green monkey kidney epithelial cells (pg. 384, col. 1, para 3). Additionally, Sirichochatchawan teaches by omission that the CFS supplement does not contain added FBS. Claim 1 recites “isolated from honey-bee gut microbiota or honey-bee pollen microbiota” which is a product by process type limitation. Claim 1 is a product by process claim in which the process of obtaining the postbiotics of beneficial aerobic and facultative aerobic/anerobic microorganisms carries little patentable weight. It is only the product, which is anticipated by the prior art and not the process by which the product was made. This is because the final product (postbiotics of beneficial microorganisms) is not distinguished by any particular features or characteristics resulting from the process by which it was made. As such, the limitations of the claimed process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota are met by any process of isolating the identical microorganisms in the prior art. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it which are encompassed by the claimed process of process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota of claim 1.
Regarding claim 11, Sirichochatchawan meets the limitations of the postbiotics further comprising exopolysaccharides derived from Pediococcus acidilactici as evidenced by Thorakkuttu et al. Thorakkuttu teaches that postbiotics are classified by the metabolites generated including short-chain fatty acids, functional proteins, and exopolysaccharides as required by claim 1 (pg. 3, lines 15-17 and Fig. 1).
Sirichochatchawan does not teach that the biological supplement of postbiotics of P. acidilactici and P. pentosaceus also contains recombinant BSA as required by claim 1. Sirichokchatchawan does not teach that the biological supplement further comprises sericin as required by claim 16.
However, Terada teaches a comparison of BSA, sericin, and FBS in mammalian cell cultures. More specifically, Terada teaches the use of both BSA and sericin in the culture of HEK-293 cells, a cell line of human embryonic kidney cells. (pg. 9, col. 1, para 1-2).
Regarding claim 16, Terada further teaches that sericin is used in cell culture and compared to the results of culturing with BSA (figure 4). Closed Bars 7 and 8 of Fig. 4 include culture conditions containing both Sericin and BSA, and this culture parameter produces the highest cell density, pointing to higher growth and proliferation rates in media containing both Sericin and BSA as compared to BSA, Sericin, and FBS alone as required by claims 1 and 16 (Fig. 4). Sericin is taught to have an equivalent effect as BSA on the culture of mammalian cell hybridomas (abstract, lines 8-10). Finally, Terada teaches that sericin accelerated the proliferation of all cell lines tested and that the 2E3-O cell lines had higher proliferation rate and maximum cell density in sericin as compared to all lots of FBS tested, showing sericin is an effective alternative supplement to FBS (abstract, lines 3-6).
Terada does not specifically teach the use of recombinant BSA as required by claim 1.
However, Colussi et al teaches that recombinant BSA lacks animal viruses associated with animal-derived cell growth supplements (abstract) and that bovine-derived BSA must be tested for contaminating agents which is not ideal because testing can only detect known viruses and does not uncover infectious agents that have not yet been discovered ([0002]).
One of ordinary skill in the art at the time of the effective filling date would find it obvious to combine the bacterial derived postbiotic supplement taught by Sirichokchatchawan with the cell culture supplements of Sericin and BSA taught by Terada, and further recombinant BSA taught by Colussi to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Terada teaches that sericin accelerated the proliferation of all cell lines tested, showing sericin is an effective alternative supplement to FBS (abstract, lines 3-6). Additionally, both Sirichokchatchawan and Terada teach the application of the cell culture supplements on mammalian epithelial cells. One of ordinary skill in the art would have a reasonable expectation of success when combining Sirichokchatchawan, Terada, and Colussi because Sirichokchatchawan teaches the necessary information to make a bacterially derived postbiotic supplement and Terada with Colussi teaches that mammalian cells require a serum replacement in the culture medium during culture (Terada, introduction, lines 1-2).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Although the references do not teach the claimed use of a biological supplement wherein “the postbiotics stimulate cell growth and proliferation” as recited in claim 17, the biological supplement of the prior art (are) the same as those claimed by applicant. Thus, the intended use of the biological supplement is also inherent in the biological supplement of the prior art.
Although the references do not teach the claimed use of a biological supplement wherein “the postbiotics stimulate cell growth and proliferation” as recited in claim 18, the biological supplement of the prior art (are) the same as those claimed by applicant. Thus, the intended use of the biological supplement is also inherent in the biological supplement of the prior art.
Although the references do not teach the claimed use of a biological supplement wherein “wherein the postbiotics are added to a cell culture medium in place of fetal bovine serum” as recited in claim 20, the biological supplement of the prior art (are) the same as those claimed by applicant. Thus, the intended use of the biological supplement is also inherent in the biological supplement of the prior art.
It is noted that the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the composition of the prior art. In the instant case, the intended use fails to create a structural difference, thus, the intended use is not limiting. Please note that when applicant claims a composition in terms of function, and the composition of the prior art appears to be the same, the Examiner may make rejections under both 35 U.S.C 102 and 103 (MPEP 2112).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Sirichokchatchawan et al (Probiotics and Antimicrob. Prot., 2018), as evidenced by Thorakkuttu et al (Foods 2022, 11, 3094; reference of record), in view of Terada et al (Cytotechnology 40: 3–12, 2002; reference of record) and Colussi et al (US20100240099A1), and in view of Huang et al (Frontiers in Microbiology, 09/03/2020).
Regarding claim 2, the limitations of the independent claim 1 have been addressed above.
Sirichokchatchawan does not teach that the postbiotics further comprise postbiotics derived from Weissella cibaria isolated from honey-bee pollen microbiota as required by claim 2.
Claim 2 recites “isolated from honey-bee pollen microbiota” which is a product by process type limitation. Claim 2 is a product by process claim in which the process of obtaining the postbiotics of beneficial aerobic and facultative aerobic/anerobic microorganisms carries little patentable weight. It is only the product, which is anticipated by the prior art and not the process by which the product was made. This is because the final product (postbiotics of beneficial microorganisms) is not distinguished by any particular features or characteristics resulting from the process by which it was made. As such, the limitations of the claimed process isolating the microorganisms from honey-bee pollen microbiota are met by any process of isolating the identical microorganisms in the prior art. Patentability of a product-by-process claim is determined by the novelty and nonobviousness of the claimed product itself without consideration of the process for making it which are encompassed by the claimed process of process isolating the microorganisms from honey-bee gut microbiota or honey-bee pollen microbiota of claim 2.
With regards to claim 2, Huang teaches that the cell-free supernatant of Weissella cibaria (also recognized as the postbiotics of the bacteria) contains antagonistic activity against common bacterial pathogens (pg. 3, col. 1, para 1). Additionally, Huang teaches that the cell free supernatants were able to inhibit the growth of E. coli, S. enterica, and S.aureus (pg. 3, col. 2, para 1).
One of ordinary skill in the art at the time of the effective filling date would find it obvious to combine the cell culture supplement comprising post biotics taught by Sirichochatchawan with the cell-free supernatant/postbiotics of W.cibaria taught by Huang. One of ordinary skill in the art would be motivated to make this combination because Huang teaches that the cell-free supernatant of Weissella cibaria (also recognized as the postbiotics of the bacteria) contains antagonistic activity against common bacterial pathogens (pg. 3, col. 1, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Sirichochatchawan with Huang because Sirichochatchawan teaches the application of cell-free supernatants in cell culture and Huang teaches the anti-bacterial abilities of the cell-free supernatants/postbiotics of Weissella cibaria.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Claims 1 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Sirichokchatchawan et al (Probiotics and Antimicrob. Prot., 2018), as evidenced by Thorakkuttu et al (Foods 2022, 11, 3094; reference of record), and in view of Terada et al (Cytotechnology 40: 3–12, 2002; reference of record) and Colussi et al (US20100240099A1), and in view of Moradi et al (Veterinary Research Forum, 2019).
Regarding claim 16, Sirichokchatchawan teaches the limitations of the independent claim above.
Sirichokchatchawan does not teach that the supplement is in a lyophilized powder form and is soluble in a sterile culture medium or water as required by claim 24.
However, Moradi teaches about the efficacy of lyophilized cell-free supernatants of a lactic acid bacteria on E.coli (abstract). Moradi teaches that the cell-free supernatant of a Lactic acid bacteria which exhibits antibacterial activity was obtained, freeze-dried, and used as a cell-free supernatant powder (pg. 194, col. 1, para 4). Moradi teaches that the cell-free supernatant of the lactic acid bacteria demonstrated a promising antibacterial activity even after lyophilization (abstract and pg. 194, col. 2, para 1).
One of ordinary skill in the art at the time of the effective filling date would find it obvious to combine the postbiotic supplement taught by Sirichokchatchawan with the step of lyophilizing the cell-free supernatants of the bacteria as taught by Moradi. One of ordinary skill in the art would be motivated to make this combination because Moradi teaches that the cell-free supernatant of the lactic acid bacteria demonstrated a promising antibacterial activity even after lyophilization (abstract and pg. 194, col. 2, para 1). One of ordinary skill in the art would have a reasonable expectation of success when combining Sirichokchatchawan with Moradi because all of the cited references teach the necessary information to make a postbiotic (cell-free supernatant) supplement and Moradi teaches the lyophilization of the supplement.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/14/2026, with respect to the rejection(s) of the claims under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sirichokchatchawan et al, Colussi et al, Huang et al, and Moradi et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632
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