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 .
Claims 21-40 are pending and are under examination. Claims 28-40 are withdrawn. Claims 21-27 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I claims 21-27 in the reply filed on 05/26/2026 is acknowledged.
Claims 28-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
Information Disclosure Statement
The information disclosure statement filed 04/15/2024 has been considered and an initialed copy is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification lacks complete deposit information for the deposit of Saccharomyces cerevisiae deposited on October 17, 2007 under number CNCM 1-3856, the strain Saccharomyces cerevisiae deposited on March 22, 2018 under number CNCM I-5298, and the strain of Saccharomyces boulardii deposited on August 21, 2007 under number CNCM I-3799.
Because it is not clear that the strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the claims requires the strains, a suitable deposit for patent purposes is required. Exact replication of the strains is an unpredictable event.
See 37 CFR §1.801-1.809.
If the deposit has been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Amendment of the specification to recite the date of deposit and the complete name and full street address of the depository is required.
If the deposits have not been made under the provisions of the Budapest Treaty, then in order to certify that the deposits comply with the criteria set forth in 37 CFR §1.801-1.809, assurances regarding availability and permanency of deposits are required. Such assurance may be in the form of an affidavit or declaration by applicants or assignees or in the form of a statement by an attorney of record who has the authority and control over the conditions of deposit over his or her signature and registration number averring:
(a) during the pendency of this application, access to the deposits will be afforded to the Commissioner upon request;
(b) all restrictions upon the availability to the public of the deposited biological material will be irrevocably removed upon the granting of a patent on this application;
(c) the deposits will be maintained in a public depository for a period of at least thirty years from the date of deposit or for the enforceable life of the patent of or for a period of five years after the date of the most recent request for the furnishing of a sample of the deposited biological material, whichever is longest; and
(d) the deposits will be replaced if they should become nonviable or non-replicable.
In addition, a deposit of biological material that is capable of self-replication either directly or indirectly must be viable at the time of deposit and during the term of deposit. Viability may be tested by the depository. The test must conclude only that the deposited material is capable of reproduction. A viability statement for each deposit of a biological material not made under the Budapest Treaty must be filed in the application and must contain:
1) The name and address of the depository;
2) The name and address of the depositor;
3) The date of deposit;
4) The identity of the deposit and the accession number given by the depository;
5) The date of the viability test;
6) The procedures used to obtain a sample if the test is not done by the depository; and
7) A statement that the deposit is capable of reproduction.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit.
Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 21-27 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.
Claim 21 recites and “…possibly at least one drying excipient…”. This is indefinite language because “possibly” indicates hesitancy as to whether the at least one drying excipient is part of the mixture.
Claim 22, 24 and 25 recites “prefarably” which is exemplary language. Description of examples or is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. It is not clear whether the narrower range of “cream form”, maltodextrin and the deposited yeast strains in claims 22, 24 and 25, respectively are claim limitations.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dini et al. J Appl Microbiol. 2016 Jul; 121(1):78-88 cited in IDS.
21: Dini et al disclose a method of manufacturing of a dry mixture of Saccharomyces cerevisiae and a bacteriophage isolated CA933P isolated from E. coli, where said mixture being in the form of solid entities, and each solid entity consists of the yeast and the bacteriophage and drying excipient (skim milk), wherein said method is done by the mixing of the yeast and the bacteriophage in suspension (MM +P + skim milk) and the freeze drying of this mixture. See p. 79 under bacteriophage and bacterial strains and p. 79 under lyophilization of phage, probiotics and phage-probiotic to page 80 col. 1 first two paragraphs.
22: Dini et al disclose the method comprises: providing at least one yeast and bacteriophage CA933P in suspension; mixing said yeast and said bacteriophage so as to form a mixture in the presence of skim milk; performing a step of drying the mixture so as to form a dry mixture; and recovering the mixture. See p. 79 under lyophilization of phage, probiotics and phage-probiotic to page 80 col. 1 first two paragraphs.
23: Dini et al disclose the drying step is done by freeze drying. See p. 79 under lyophilization of phage, probiotics and phage-probiotic to page 80 col. 1 first two paragraphs.
24: Dini et al disclose the drying step is done in the presence of the drying excipient skim milk. See p. 79 under lyophilization of phage, probiotics and phage-probiotic to page 80 col. 1 first two paragraphs.
25: Dini et al disclose the yeast is Saccharomyces cerevisiae. See p. 79 under bacteriophage and bacterial strains and p. 79 under lyophilization of phage, probiotics and phage-probiotic to page 80 col. 1 first two paragraphs.
26: Dini et al disclose the bacteriophages are selected from those having an antibacterial activity against bacterial strains i.e. bacteriophage isolated CA933P isolated from E. coli. See p. 79 under bacteriophage and bacterial strains.
Claim(s) 21-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al. US 9950018 4/24/2018.
21-22. Shin et al disclose a method of manufacturing of a dry mixture (powder, dried powder col. 5 lines 39-40, col. 6 lines 47-51) of Saccharomyces cerevisiae (col. 6 lines 64-67, col. 7 lines 9-10) and a bacteriophage that can kill E. coli (col. 1 lines 5-10, col. 2 lines 1-4), where said mixture being in the form of solid entities, and each solid entity consists of the yeast and the bacteriophage and maltodextrin drying excipient (col. 5 line 16-23), wherein said method is done by the mixing of at least one yeast and/or yeast derivative and at least one bacteriophage in suspension and the drying of this mixture (col. 6 lines 56-63). The step of drying the mixture so as to form a dry mixture necessarily recovers the dried powder.
23. Shin et al the drying step is done by freeze drying (lyophilization col. 6 line 56-63).
24. Shin et al disclose the drying step is done in the presence of the drying excipient, maltodextrin. Col. 5 line 16-23.
25. Shin et al disclose the yeast is Saccharomyces cerevisiae.
26. Shin et al disclose the bacteriophages has antibacterial activity against Escherichia coli.
Claim(s) 21-26 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sulakvelidze, Alexander. US 2022/0264896 08/25/2022 filed 12/21/2020.
21-22: Sulakvelidze disclose a method of manufacturing of a dry mixture of at least one yeast and/or yeast derivative (trehalose) and at least one bacteriophage, where said mixture being in the form of solid entities, and each solid entity consists of at least one yeast and/or at least one yeast derivative and at least one bacteriophage and possibly at least one drying excipient such as sorbitol, polyethylene glycol, sorbitol, wherein said method is done by the mixing of at least one yeast and at least one bacteriophage in suspension and the drying of this mixture.
See paragraph 23 disclosing compositions comprising bacteriophages combined with yeast such as Saccharomyces cerevisiae, Saccharomyces boulardii, Saccharomyces cerevisiae var. boulardii, Issatchenkia occidentalis, Lachancea thermotolerans, Metschnikowia ziziphicola, Torulaspora delbrueckii, or a combination thereof.
See paragraph 49 disclosing
a composition may comprise an isolated bacteriophage CJLB-4 (PTA-126839), CJLB-5 (PTA-126840), CJLB-7 (PTA-126841), CJLB-10 (PTA-126842), CJLB-12 (PTA-126843), CJLB-13 (PTA-126844), CJLB-14 (PTA-126845), or CJLB-15 (PTA-126846) deposited to the ATCC, said bacteriophage having lytic activity against Campylobacter strains, progeny, derivatives, and mixtures thereof. In some embodiments, the composition may be a pharmaceutical composition, nutraceutical product, dietary supplement, probiotic, and/or prebiotic. In some embodiments, the composition may be a concentrated aqueous solution or dried powder preparation. In any of the embodiments, the composition comprises one or more of the following ingredients: deionized water, buffer solution, preferably Tris-HCl pH 7.0-7.5, mineral water, sucrose, glycerol, trehalose, dextran, polyethylene glycol, sorbitol, cellulose, tapioca dextrin, hydroxypropyl methylcellulose, gellan gum, gelatin, casein, NaCl, MgSO.sub.4, or a mixture thereof.
See paragraph 59-60 combinations with yeast.
The bacteriophage composition (paragraph 105) in combination with probiotic yeast (paragraph 125) and dried powder preparation obtained by freeze drying fluidized bed drying, or spray drying and recovering the dry mixture (paragraph 133)
23. Sulakvelidze disclose the drying step is done by freeze drying or spray drying or on a fluidized air bed. See paragraph 133.
24. Sulakvelidze disclose the drying step is done in the presence of the drying excipient e.g. not limited to sucrose, glycerol (paragraph 49) or maltodextrin (paragraph 158).
25. Sulakvelidze disclose the yeast comes from a strain selected from the species Saccharomyces cerevisiae and Saccharomyces boulardii. See paragraph 23.
26: Sulakvelidze disclose the one or more bacteriophages are selected from those having an antibacterial activity against Campylobacter jejuni. See paragraph 63
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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(s) 21-24 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malik, Danish J (“Malik”). Curr. Issues Mol. Biol. (2021) 40:303-316 published 07-17-2020 in view of Andrew et al. GB 2424408 09-27-2006.
Malik is drawn to bacteriophage encapsulation using spray drying for phage therapy. See title. Malik et al disclose that exploiting the potential of bacteriophages for phage therapy is an exciting future prospect and that to be successful, there is a pressing need for the manufacture of safe and efficacious phage drug products to treat patients. Malik et al disclose that phage-containing powders can possess good storage shelf-life. Malik et al dry powders are increasingly being considered for phage drug products because they show relatively long storage stability without requiring a cold supply chain and refrigeration. See page 303 under abstract and page 304 under spray drying of bacteriophages.
Malik et al does not disclose manufacturing the bacteriophage in a dry mixture with yeast and/or yeast derivative, where said mixture being in the form of solid entities, and each solid entity consists of at least one yeast and/or at least one yeast derivative and at least one bacteriophage and possibly at least one drying excipient, where said method is characterized in that it is done by the mixing of at least one yeast and/or yeast derivative and at least one bacteriophage in suspension and the drying of this mixture. Malik et al does not disclose the yeast derivative is in cream form (claim 22); Malik et al does not disclose the drying step is by freeze or fluidized air bed; does not disclose the drying excipient is maltodextrin (claim 24); and does not disclose the yeast derivatives are yeast hulls (claim 27)
Andrew et al disclose that it is possible to encapsulate an active inside yeast cell walls with damaged cell membranes or yeast cell walls such as ghost cells (yeast hull). Andrew et al disclose the use of microorganisms, particularly yeast cells, which have been autolysed for example during the yeast extract production process to encapsulate an active and that the microorganism, particularly yeast, cell wall is intact but the cell membrane is damaged, partially, or completely or not present at all. See figures 1-3 and p. 3 paragraph 1-2.
Andrew et al disclose a method of encapsulating of encapsulatable material, such as an active, the method comprising using a recipe of 1 part active to 2 parts yeast to 4 parts water, yeast concentration in the dispersion from 10% - 45%. Andrew et al disclose the yeast is mixed with water until a homogenous dispersion is formed and then actives are then added and the encapsulation mixture stirred at 40 C of 10-70 C for 10 minutes - 24 hours for 4 hours before addition of "mop up material"
Andrew et al disclose the addition of materials to the "mop up" yeast cell walls (yeast derivative) such as yeast cell walls (processed, further or extremely processed yeast cells), de-odorized yeast (extremely processed bleached yeast), yeast cell fragments (ex. Bio- Springer, Lesaifre), whole yeast (active and inactive dried baker’s yeast, active and inactive yeast cake, active and inactive yeast cream), any autolysed yeast (e.g. autolysed yeast ex.Quest, ex.Chemoforma / Probio). Andrew et al disclose that maltodextrin (potato or corn, starch (capsul), gum (Arabic) etc, solutions of these materials can be made from 1-45% solids and added to the "initial encapsulation".
Andrew et al disclose that samples are mixed in for a period of 10 minutes - 24 hours preferably 1 hour at 40 C (temperature range of 10-70 C) using (high shear mixer, propeller mixer, preferably flat blade stirrer) and the samples spray dried (preferably) at 210 C inlet 90 outlet (range of 165 C inlet - 120 C outlet) can be dried via fluidized bed drier, roller drier, freeze drier, (spray drying via preferably rotary atomizer, can be high pressure nozzle, fluid nozzle), can be dried on a box drier and other forms of drying where the material is dehydrated to form a powder. Thus, manufacturing and recovering the encapsulated active.
See page 34-35.
It will have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have encapsulated the bacteriophage of Malik by mixing with yeast, yeast derivative including but not limited to yeast cream or yest ghost cells (yeast hull) etc. and maltodextrin excipient with the bacteriophage in suspension to form a mixture and drying the mixture to form solid entities such as by spray drying, freeze drying or fluidized air bed so as to form a dry mixture comprising the solid entities and recovering the dry mixture as taught by Andrew et al thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Malik disclose that bacteriophage can be encapsulated and Andrew et al disclose that it is possible to encapsulate an active inside yeast cell walls with damaged cell membranes or yeast cell walls such as ghost cells (yeast hull) or yeast cream or other yeast derivative and disclose a method of doing so to obtain dried mixture.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malik, Danish J (“Malik”). Curr. Issues Mol. Biol. (2021) 40:303-316 published 07-17-2020 and Andrew et al. GB 2424408 09-27-2006 as applied to claims 21-24 and 27, further in view of Vanekerckove et al. FR 2928652 09-18-2009.
The combination of Malik and Andrew is set forth above but does not disclose the yeast is Saccharomyces cerevisiae strain deposited under number CNCM No. I-3856 or Saccharomyces boulardii deposited under CNCM No. I-3799.
Vanekerckove et al disclose the yeast strains Saccharomyces cerevisiae strain deposited under number CNCM No. I-3856 and Saccharomyces boulardii deposited under CNCM No. I-3799 useful for obtaining yeast derivatives. See whole patent publication especially claims 1-20.
It would have been prima obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have modified the method of the combination of Malik and Andrew such that the yeast derivatives are obtained from the yeast strains of Vanekerckove et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Vanekerckove et al disclose the yeast strains Saccharomyces cerevisiae strain deposited under number CNCM No. I-3856 and Saccharomyces boulardii deposited under CNCM No. I-3799 are useful for obtaining yeast derivatives.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malik, Danish J (“Malik”). Curr. Issues Mol. Biol. (2021) 40:303-316 published 07-17-2020 and Andrew et al. GB 2424408 09-27-2006 as applied to claims 21-24 and 27 above further in view of Zbikowska et al. The Use of Bacteriophages in the Poultry Industry. Animals 2020, 10, 872. https://doi.org/10.3390/ani10050872
The combination of Malik and Andrew does the disclose the bacteriophage is one or more bacteriophages selected from those having an antibacterial activity against bacterial strains selected from Escherichia coli, Listeria monocytogenes, Campylobacter jejuni, Staphylococcus aureus, Clostridium perfringens or strains of the Salmonella genus.
Zbikowska et al disclose the use of bacteriophages in the poultry industry (see page 1, page 4-6) and disclose bacteriophages having an antibacterial activity against bacterial strains selected from Escherichia coli, Listeria monocytogenes, Campylobacter jejuni, Staphylococcus aureus, Clostridium perfringens or strains of the Salmonella genus. See table 1 and page 7-11.
It would have been prima obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have used the method of the combination of Malik and Andrew to encapsulate bacteriophage that have an antibacterial activity against bacterial strains selected from Escherichia coli, Listeria monocytogenes, Campylobacter jejuni, Staphylococcus aureus, Clostridium perfringens or strains of the Salmonella, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that the method of the combination of Malik and Andrew disclose methods of encapsulating and drying bacteriophages for therapy and Zbikowska et al disclose the use of bacteriophages in the poultry industry and disclose bacteriophages having an antibacterial activity against bacterial strains selected from Escherichia coli, Listeria monocytogenes, Campylobacter jejuni, Staphylococcus aureus, Clostridium perfringens or strains of the Salmonella genus which could benefit from the encapsulation process of the combination of Malik and Andrew.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malik, Danish J (“Malik”). Curr. Issues Mol. Biol. (2021) 40:303-316 published 07-17-2020 and Andrew et al. GB 2424408 09-27-2006 as applied to claims 21-24 and 27 above further in view of Raza et al. Isolation and Characterization of a Phage to Control Vancomycin Resistant Enterococcus Faecium. Open Life Sci. 2018 Dec 31;13:553-560. doi: 10.1515/biol-2018-0066.
The combination of Malik and Andrew does the disclose the bacteriophage is one or more bacteriophages having an antibacterial activity against lactic acid bacteria such as Enterococcus faecium.
Raza disclose that the lytic bacteriophage STH1 capable of targeting Vancomycin resistant Enterococcus faecium (a lactic acid bacteria) with high specificity and that application to host strain grown in milk and water (treated and untreated) showed that the phage efficiently controlled bacterial growth. Raza disclose that the study suggests that the phage STH1 can serve as potential control agent for E. faecium infections in medical facilities and in other environmental contaminations. See abstract and discussion.
It would have been prima obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have used the method of the combination of Malik and Andrew to encapsulate bacteriophage Raza et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that the method of the combination of Malik and Andrew disclose methods of encapsulating and drying bacteriophages for therapy and Raza disclose that the phage STH1 can serve as potential control agent for E. faecium infections in medical facilities and in other environmental contaminations and said bacteriophage for application in medical facilities and in other environmental contaminations could benefit from the encapsulation process of the combination of Malik and Andrew.
Status of Claims
Claims 21-27 are rejected. Claims 28-40 are withdrawn.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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