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 .
Claim Status
Claims 1, 5-13, and 15-22 are pending (claim set as filed on 11/20/2025). Claims 6-7 are withdrawn from further consideration as they do not read on the species Blautia producta and SEQ ID NO: 5, as elected in the reply filed on 11/27/2024.
Claims 1, 5, 8-13, and 15-22, are currently under examination and were examined on their merits.
Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed on 11/20/2025 has been received and considered.
Claim Rejections - 35 USC § 103
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 8-10, 12-13, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. (US 2012/0039956 A1, published on 02/16/2012), hereinafter ‘Harel’, in view of Couto et al. (WO 2018/081550 A1, published on 05/03/2018), hereinafter ‘Couto’, as evidenced by Cassir et al. (“Clostridium butyricum: from beneficial to a new emerging pathogen”, published on 10/20/2015, Clin Microbiol Infect 2016, Vol. 22, pages 37–45), hereinafter ‘Cassir’, Graco (“Atomization Concept and Theory”, published 1995, downloaded from https://wwwd.graco.com/training/concept_and_theory/Atomization%20v2.pdf, pages 1-18), hereinafter ‘Graco’, Beteta et al. (“Cool Down with Liquid Nitrogen”; published Sep 2015, CEP, downloaded from https://www.aiche.org/sites/default/files/cep/20150930r.pdf, pages 30-35), hereinafter ‘Beteta’, and Caballero et al. (“Cooperating Commensals Restore Colonization Resistance to Vancomycin-Resistant Enterococcus faecium”, published on 05/10/2017, Cell Host & Microbe, Vol. 21, pages 592–602), hereinafter ‘Caballero’.
Harel’s general disclosure relates to “compositions and drying methods for preserving sensitive bioactive materials, such as peptides, proteins, hormones, nucleic acids, antibodies, drugs, vaccines, yeast, bacteria (probiotic or otherwise), viruses and/
or cell suspensions, in storage” (see entire document, including abstract).
Regarding claim 1, pertaining to a method of preparing a preserved bacterial composition, Harel teaches a method of preparing a preserved bacterial composition (“compositions and drying methods for preserving sensitive bioactive materials, such as … bacteria (probiotic or otherwise), …, in storage”; paragraph [0012], see abstract), comprising flash freezing liquid droplets of a bacterial composition comprising an anaerobic bacterial strain such that flash frozen bacterial composition droplets are formed (“The freezing and drying process comprises: mixing the biological material and the composition in a liquid slurry, snap-freezing said composition slurry in liquid nitrogen to form droplets, strings or beads,”, “the slurry can be snap-frozen by atomizing through a nozzle, dripping or injecting in dry ice or liquid nitrogen bath to form small particles or solid droplets”, “the biological material comprises live bacteria (e.g., probiotic bacteria)”, “Specific examples of suitable probiotic microorganisms would be represented by the following species and include all culture biotypes within those species: …, Clostridium butyricum,… Lactobacillus acidophilus”; paragraphs [0014], [0046], [0066]; it is noted that Clostridium butyricum is an anaerobic bacterial strain, as evidenced by Cassir (“Clostridium butyricum, a strictly anaerobic spore-forming bacillus”, see entire document, including abstract)). The Examiner notes that according to the instant specification, the term snap-freezing taught by Harel corresponds to flash freezing (“"flash freezing," also known to as "snap freezing," refers to a process by which the temperature of a bacterial composition is rapidly lowered to temperatures below -70°C, for example using liquid nitrogen or dry ice”; instant specification, page 14, paragraph 3). The Examiner notes that ‘atomizing through a nozzle’ as taught by Harel (see above) leads to the formation of droplets, as evidenced by Graco (“Atomization refers to the process of breaking up bulk liquids into droplets”; see entire document, including pages 2-3).
Harel further teaches lyophilizing the flash frozen bacterial composition droplets to produce a preserved bacterial composition (“Collecting the particles, beads, strings or droplets from the liquid nitrogen bath and drying in a freeze drier or vacuum drier”, “Drying includes for example, spray drying, fluidized bed drying, lyophilization, and vacuum drying … "Lyophilize" or freeze drying refers to the preparation of a composition in dry form by rapid freezing and dehydration in the frozen state (sometimes referred to as sublimation)“, “The compositions and methods described herein stabilize the biological material and preserve its activity for an extended storage period”; paragraphs [0021], [0042]-[0043], [0073]).
Regarding claims 12 and 13, pertaining to flash freezing, Harel teaches wherein the flash freezing is performed by contacting the liquid droplets of the bacterial composition with liquid nitrogen (instant claim 12) (“the slurry can be snap-frozen by atomizing through a nozzle, dripping or injecting in dry ice or liquid nitrogen bath to form small particles or solid droplets”; paragraphs [0066]). As discussed above, the Examiner notes that ‘atomizing through a nozzle’ as taught by Harel (see above) leads to the formation of droplets, as evidenced by Graco (“Atomization refers to the process of breaking up bulk liquids into droplets”; see entire document, including page 2). The Examiner further notes that immersing droplets into liquid nitrogen, as taught by Harel (see above), intrinsically leads to frozen droplets having a spherical, and therefore symmetrical shape (instant claim 13), as evidenced by Beteta (“Liquid nitrogen (LIN)”, “Cryopelletization is a low-temperature technique for manufacturing pellets that are most often spherical or semispherical …It is often used to pelletize heat-sensitive materials, such as bacterial cultures and probiotics”; “LIN immersion freezing…Droplets freeze as they are immersed in LIN. As droplets are immersed, the LIN boils turbulently, which makes it more difficult to control the size distribution and the shape of pellets. Nevertheless, this method produces a high percentage of spherical pellets”; page 30, left column, paragraph 1; page 32, right column, paragraphs 1 and 3).
Regarding claim 19, pertaining to culturing the bacterial composition, Harel further teaches culturing the bacterial composition (“Fresh concentrate of Lactobacillus rhamnosus. (100 ml at 10% solids, direct from fermentation harvest) was added…”; paragraph [0081]). The Examiner notes that the phrase “direct from fermentation harvest” indicates that the bacterial strain had been cultured.
Additionally, Harel teaches storage of a flash frozen bacterial composition at -80 °C (“Collecting the particles, beads, strings or droplets from the liquid nitrogen bath and drying in a freeze drier or vacuum drier, or alternatively storing them in a deep freezer (between -30° C. and -80° C.) for later use in a frozen form or until drying.”; paragraph [0021]). Harel further discloses determining a level of viability in the preserved bacterial composition after drying (“The present invention includes compositions and drying methods for preserving sensitive bioactive materials, such as …bacteria”, “Drying includes for example, spray drying, fluidized bed drying, lyophilization”, “A "stable" formulation or composition is one in which the biologically active material therein essentially retains its physical stability, chemical stability, and/or biological activity upon storage ”, “"Viability" with regard to bacteria, refers to the ability to form a colony (CFU or Colony Forming Unit) on a nutrient media appropriate for the growth of the bacteria.”, “Storage Stability of the Dry Probiotic Bacteria …The commercial probiotic bacteria completely lost its viability within the first few weeks under the accelerated storage conditions, while the dry composition of the probiotic bacteria of the present invention lost only 1.18 logs after 60 days at 30° C”; paragraphs [0037]-[0038], [0042], [0084]-[0085]; see abstract).
Harel does not teach
wherein the one or more anaerobic bacterial strains belong to Clostridium cluster XIVa or XVII (instant claim 1), wherein one or more of the bacterial strains belong to the class Clostridia (instant claim 5), wherein one or more of the bacterial strains is the elected species Blautia producta (instant claim 8), and wherein one or more bacterial strains comprise a 16S rDNA sequence having at least 97 % sequence identity with nucleic acid sequence SEQ ID NO: 5 (instant claim 9),
wherein the method further comprises washing the bacterial composition and resuspending the bacterial composition in a formulation buffer (instant claim 10).
subjecting the preserved bacterial composition to a temperature of -80 °C (instant claim 15),
wherein the lyophilizing comprises a primary drying step and a secondary drying step (instant claim 16), wherein the primary drying step comprises subjecting the flash frozen bacterial composition to a temperature of -10°C and a pressure of 70 mTorr (instant claim 17), and wherein the secondary drying step comprises subjecting the flash frozen bacterial composition to a temperature of +20°C and a pressure of 70 mTorr (instant claim 18),
wherein the method further comprises determining a level of viability in the preserved bacterial composition after lyophilizing (instant claim 20), wherein the level of viability in the preserved bacterial composition is at least 10% of colony forming units of the bacteria over a period of time compared to the number of colony forming units prior to flash freezing (instant claim 21), wherein the period of time is at least 1 week (instant claim 22).
Couto’s general disclosure relates to methods and compositions for the preservation of bacteria (see entire document and abstract).
Regarding claims 1, 5, and 8-9, pertaining to the bacterial strain and 16S rDNA sequence, Couto teaches the anaerobic bacterial strain Blautia producta (instant claim 8) (“preservation of anaerobic bacterial strains …, Blautia producta,”; page 14 lines 11-12), wherein the bacterial strain Blautia producta belongs to Clostridium cluster XIVa (instant claim 1) (strain number 5 in Table 1 on page 15). Couto teaches wherein the bacterial strain Blautia producta comprises a 16S rDNA sequence (“the composition includes one or more bacterial strains, wherein the one or more bacterial strains include one or more 16s rDNA sequences having at least 97% homology with nucleic acid sequences of SEQ ID NO: 1, SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5”, “SEQ ID NO:5 … Blautia producta”; page 18, lines 8-11; pages 39, line 45 - page 40, line 15; see Table 1 on page 15), that is identical with instant SEQ ID NO: 5 (instant claim 9), as shown in the alignment attached to the previous Office Action (see sequence alignment on pages 1-4 and duplicate information on BFF89651 on pages 4-5). The Examiner notes that Blautia producta belongs to the class Clostridia (instant claim 5), as evidenced by Caballero (“Clostridia class consisted mainly of cluster XIVa members Clostridium bolteae and Blautia producta”; page 594, left column, paragraph 2).
Regarding claim 10, pertaining to washing and resuspending the bacterial composition, Couto teaches washing a bacterial composition and resuspending the bacterial composition in a formulation buffer (“Each sample was washed twice using the formulation buffers shown in Table 5. A volume of 25mL was used for the final resuspension, to concentrate the starting sample. Each formulation shown in Table 5 had aliquots of 5mL added to separate 20mL vials and were then lyophilized.”; page 47, lines 3-6; see Tables 5 and 6). Couto further teaches wherein formulation buffers comprising sucrose or trehalose as a lyoprotectant led to recovery of lyophilized bacteria (“After lyophilization, the final viable cell counts were determined by resuspending each vial in 5mL of media and plating on EGHB (Table 6). The data indicates that bacteria that were lyophilized in formulations containing sucrose or trehalose as a lyoprotectant were able to be recovered.”; page 47, lines 10-13; see Tables 5 and 6).
Regarding claim 15, pertaining to subjecting the preserved bacterial composition to a temperature of -80°C, Couto teaches subjecting the preserved bacterial composition to a temperature of -80°C (“lyophilized product, stored at -80°C”; see Figure 1).
Regarding claims 16, 17 and 18, pertaining to lyophilizing, Couto teaches wherein lyophilizing comprises a primary drying step and a secondary drying step (instant claim 16) (“the lyophilization cycle involves the steps of freezing, primary drying, and secondary drying”, page 26, lines 10-11), wherein a primary drying step comprises subjecting the bacterial composition to a temperature of -10°C and a pressure of 70 mTorr (instant claim 17), and a secondary drying step comprises subjecting a bacterial composition to a temperature of +20°C and a pressure of 70 mTorr (instant claim 18) (“The primary drying step using 70 mTorr and -10°C along with a secondary drying step using 70 mTorr and 20°C successfully lyophilized strain 3 in the freeze-draying trays”; page 55, lines 11-13). Additionally, Couto et al. teaches wherein “the lyophilization cycle, such as the temperature ramp rate, may also contribute to the beneficial preservation properties of the compositions and methods described herein (page 2, lines 1-3).
Regarding claims 20, 21 and 22, pertaining to the level of viability in the preserved bacterial composition after lyophilization, Couto teaches determining a level of viability of a preserved bacterial composition after lyophilizing (instant claim 20) (“measuring the number of colony forming units after subjecting the composition comprising the bacteria to the lyophilization cycle.”; page 37, lines 6-8), wherein the level of viability in the preserved bacterial composition is at least 10% of colony forming units of the bacteria over a period of time compared to the number of colony forming units prior to lyophilizing (instant claim 21) (“The stabilization functionality of the composition can also be assessed by comparing the number of viable bacteria (e.g., colony forming units) before and after a specific event (e.g., lyophilization or a freeze-thaw event).”, “a stabilizing composition is a composition that allows for the recovery of at least I%, at least 10%, … of the colony forming units over a period of time.”; page 33, lines 1-3; page 35, lines 26-29), wherein the period of time is at least 1 week (instant claim 22) (“the period of time is at least 1 week”; page 35, lines 29-30).
Additionally, Couto discloses that “anaerobic bacteria are challenging to preserve because of their sensitivity to oxygen”, and “[i]mproved compositions and methods for the preservation of anaerobic bacteria are needed therefore.” (page 1, lines 17-19). Couto further teaches that “the disclosure provides compositions that allow for the lyophilization of anaerobic bacterial strains”, and that “prior to the current disclosure, compositions comprising such bacterial strains would lose all, or most, of their viability upon lyophilization, severely impeding the options for preserving such bacterial strains in amounts sufficient for therapeutic applications.” (page 1, lines 26-29). Couto further discloses that “the compositions and methods provided … allow for the stabilization and preservation of anaerobic bacterial strains …, Blautia producta,” (page 14, lines 10-12).
While Harel does not teach a method for preparing a preserved bacterial composition wherein one or more anaerobic bacterial strains belongs to Clostridium cluster XIVa or XVII (instant claim 1), wherein one or more bacterial strains belongs to the class of Clostridia (instant claim 5), wherein one or more bacterial strains belong to the elected species Blautia producta (instant claim 8), and wherein one or more of the bacterial strains comprises a 16S rDNA sequence having at least 97 % sequence identity with nucleic acid sequence SEQ ID NO: 5 (instant claim 9), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method for preparing a preserved bacterial composition taught by Harel with Couto’s bacterial strain Blautia producta comprising the 16S rDNA SEQ ID NO: 5, in order to develop a method of preparing a preserved bacterial composition wherein a anaerobic bacterial strain is Blautia producta belonging to Clostridium cluster XIVa and to the class of Clostridia, and has a 16S rDNA sequence identical to instant SEQ ID NO: 5. One would have been motivated to do so, in order to create a superior preservation method for anaerobic bacteria including Blautia producta since anaerobic bacteria are challenging to preserve due to their anaerobic nature
(see Couto above).
While modified Harel does not expressly teach wherein the method further comprises washing the bacterial composition and resuspending the bacterial composition in a formulation buffer (instant claim 10), and subjecting the preserved bacterial composition to a temperature of -80°C (instant claim 15), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Harel’s teachings with Couto’s teachings on washing and resuspending a bacterial composition in formulation buffer, and to further combine with Harel’s and Couto’s teachings on storing a bacterial composition at -80°C, in order to have created a preservation method for bacteria comprising washing the bacterial composition and resuspending the bacterial composition in a formulation buffer, further comprising subjecting the preserved bacterial composition to a temperature of -80°C. One would have been motivated to do so, in order to create an improved preservation method for anaerobic bacteria with optimal bacterial recovery.
While modified Harel does not teach wherein the lyophilizing comprises a primary drying step and a secondary drying step (instant claim 16), wherein a primary drying step comprises subjecting the flash frozen bacterial composition to a temperature of -10°C and a pressure of 70 mTorr (instant claim 17), and a secondary drying step comprises subjecting the flash frozen bacterial composition to a temperature of +20°C and a pressure of 70 mTorr (instant claim 18), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further combine modified Harel’s method with Couto’s teachings on the primary and secondary steps of lyophilization, in order to develop a method of preparing a preserved bacterial composition wherein the lyophilizing comprises a primary drying step and a secondary drying step, wherein a primary drying step of lyophilization comprises subjecting the flash frozen bacterial composition to a temperature of -10°C and a pressure of 70 mTorr, and a secondary drying of lyophilization step comprises subjecting the flash frozen bacterial composition to a temperature of +20°C and a pressure of 70 mTorr. One would have been motivated to do so, to further increase viability of preserved anaerobic bacteria, since the lyophilization cycle can impact preservation of a bacterial composition (see Couto above).
While modified Harel does not teach wherein the method further comprises determining a level of viability in the preserved bacterial composition after lyophilizing (instant claim 20), wherein the level of viability in the preserved bacterial composition is at least 10% of colony forming units of the bacteria over a period of time compared to the number of colony forming units prior to flash freezing (instant claim 21), wherein the period of time is at least 1 week (instant claim 22), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Harel’s method with Couto’s teachings on viability of preserved bacterial compositions after lyophilizing in order to create a method for preparing a preserved bacterial composition wherein the method further comprises determining a level of viability in the preserved bacterial composition after lyophilizing, wherein the level of viability in the preserved bacterial composition is at least 10% of colony forming units of the bacteria over a period of time compared to the number of colony forming units prior to flash freezing, further wherein the period of time is at least 1 week. One would have been motivated to do so in order to create a superior method for preserving a bacterial composition which leads to improved and extended bacterial viability after the preservation process.
A skilled artisan would have reasonably expected success in combining Harel’s and Couto’s teachings, since both references are directed to methods for preparing a preserved bacterial composition (see above).
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Harel et al. (US 2012/0039956 A1, published on 02/16/2012), hereinafter ‘Harel’, in view of Couto et al. (WO 2018/081550 A1, published on 05/03/2018), hereinafter ‘Couto’, as evidenced by Cassir et al. (“Clostridium butyricum: from beneficial to a new emerging pathogen”, published on 10/20/2015, Clin Microbiol Infect 2016, Vol. 22, pages 37–45), hereinafter ‘Cassir’, Graco (“Atomization Concept and Theory”, published 1995, downloaded from https://wwwd.graco.com/training/concept_and_theory/Atomization%20v2.pdf, pages 1-18), hereinafter ‘Graco’, Beteta et al. (“Cool Down with Liquid Nitrogen”; published Sep 2015, CEP, downloaded from https://www.aiche.org/sites/default/files/cep/20150930r.pdf, pages 30-35), hereinafter ‘Beteta’, and Caballero et al. (“Cooperating Commensals Restore Colonization Resistance to Vancomycin-Resistant Enterococcus faecium”, published on 05/10/2017, Cell Host & Microbe, Vol. 21, pages 592–602), hereinafter ‘Caballero’, in view of Wong et al. (“Phasing-in of vitrification into routine practice: why, how, what”, published April 2011, Hong Kong Med J, Vol. 17, No. 2, pages 119-126), hereinafter ‘Wong’.
The teachings of Harel, Couto, Cassir, Graco, Beteta, and Caballero have been set forth above.
Additionally, Harel teaches “atomization onto a cold surface, followed by sublimation” (paragraph [0022]).
Modified Harel does not expressly teach wherein the flash freezing is performed by contacting the liquid droplets of the bacterial composition with a super-cooled surface (instant claim 11).
Wong et al.’s general disclosure relates to cryopreservation of embryos and blastocysts in an in-vitro fertilization program (see entire document, including abstract).
Regarding claim 11, Wong et al. teaches wherein cryopreservation of embryos comprises the use of a super-cooled surface (“Cryopreservation of embryos generally consists of three steps. The first is the preparation of embryos with varying concentrations of different kinds of cryoprotectant solutions. The second is the loading of embryos into the chosen holding-and storage devices. …. Third, such devices are prepared for the final step of freezing either by a controlled-rate freezer, direct plunge into liquid nitrogen, or contact with a super-cooled surface”; see entire document, including page 124, right column, paragraph 5).
While modified Harel does not teach wherein the flash freezing is performed by contacting the liquid droplets of the bacterial composition with a super-cooled surface (instant claim 11), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Harel’s method of preparing a preserved bacterial composition with Wong’s teachings on cryopreservation using a super-cooled surface, in order to create a method of preparing a preserved bacterial composition wherein the flash freezing is performed by contacting the liquid droplets of the bacterial composition with a super-cooled surface. One would have been motivated to do so, in order to develop a superior method for the preservation of droplets of a bacterial composition that results in an increased level of viability of the preserved bacterial cells. A skilled artisan would have reasonably expected success in combining the above references, since modified Harel and Wong are directed to preservation of biological material (see above).
Response to Arguments
Applicant has traversed the previous rejections of claims 1, 5, 8-13, and 15-22, under 35 U.S.C. 103 in the reply filed on 11/20/2025 (remarks, pages 5-14). Applicant's arguments and Declaration under 37 CFR 1.132 have been fully considered but they are not persuasive.
Applicant states that the “viscous slurries of Harel are not interchangeable with liquid droplets” (remarks, pages 8 and page 12).
The Examiner responds that Harel teaches “mixing the biological material and the composition in a liquid slurry” (paragraph [0046]), and that “the slurry can be snap-frozen by atomizing through a nozzle, dripping or injecting in dry ice or liquid nitrogen bath to form small particles or solid droplets” (paragraphs [0066]). It is noted that ‘atomizing through a nozzle’ as taught by Harel leads to the formation of droplets, as discussed above. As such, Harel teaches ‘liquid droplets’.
In response to Applicant's argument that Harel’s liquid droplets fail to show certain features of the invention, it is noted that the feature upon which Applicant relies, i.e. a specific level of viscosity, is not recited in the rejected claims, and that the viscosity of the instant liquid droplets is not defined or described in the instant specification. The Examiner further notes that instant claim 1 recites comprising language, indicating that the liquid droplets can contain not only the recited bacteria but also additional components.
Applicant states that “[v]acuum drying as preferred by Harel is not interchangeable with lyophilization” (remarks, page 9).
The Examiner responds that Harel teaches “[c]ollecting the particles, beads, strings or droplets from the liquid nitrogen bath and drying in a freeze drier or vacuum drier” (paragraph [0021]), and that “[d]rying includes for example, spray drying, fluidized bed drying, lyophilization, and vacuum drying” (paragraphs [0042]-[0043]), as discussed above. As such, Harel teaches lyophilizing as a method step for drying flash-frozen bacterial cultures.
Applicant concludes that “the skilled artisan would thus not have had a reasonable expectation of success in preserving bacteria by modifying Harel as the Office proposes.” (remarks, page 13).
The Examiner responds that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, regarding base claim 1, Harel teaches a method of preparing a preserved bacterial composition comprising the claimed method steps of flash freezing liquid droplets comprising bacteria and lyophilizing the obtained frozen droplets, and Couto teaches on Clostridium cluster XIVa member Blautia producta, as discussed above. It would have been obvious to combine Harel’s method and Couto’s Blautia producta to improve preservation of Blautia producta since anaerobic bacteria are challenging to preserve (Couto, page 1, lines 17-19).
Applicant describes that “[t]he claimed methods unexpectedly improved viability of preserved bacteria in Clostridium clusters XIVa and XVII” (remarks, page 14).
The Examiner responds that Harel teaches that “[t]he compositions and methods described herein stabilize the biological material and preserve its activity for an extended storage period at above ambient temperature and relative humidity” (paragraph [0073]), and that “[t]he present invention includes compositions and drying methods for preserving sensitive bioactive materials, such as […], bacteria (probiotic or otherwise), […], in storage” (paragraph [0012]). Couto teaches lyophilizing for stabilizing and preserving bacteria including Clostridium cluster XIVa member Blautia producta (page 1, lines 22-27; page 14, lines 5-15). A skilled artisan would have reasonably expected that modified Harel’s method that includes lyophilizing increases the viability of Blautia producta during storage. Applicant has not claimed any process parameter that provides improved lyophilizing of the claimed bacteria.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence Information
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/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653