DETAILED NOTICE
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 .
Priority
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional application 63/376,469 (filed 09/21/2022).
Response to Amendment
The amendment filed 07/202/2026 in which claims 1, 2, 4, 7, 11, 12, 16, and 18 were amended, claims 6, 13-14, and 19-20 were cancelled, and claims 21-25 were added has been entered.
Election/Restrictions
Applicant’s election with traverse of Group I, corresponding to claims 1, 7-10, and 21-25 and the bacteriophage ECCR-664-1, corresponding to claims 1, 7-10, and 21-22, in the reply filed 20 July 2026 is acknowledged. The traversal is in the ground(s) that no serious search burden is evident as a search for one group would overlap with the other groups and that for the species election, the bacteriophage can be included in combination products. However, this is not found persuasive at least because Groups I-IX are written independently from each other and the Groups have acquired a separate status in the art in view of their different classifications and the separate species also require additional search parameters. Claims 23-25 are withdrawn for not encompassing the elected species as Applicant elected a single bacteriophage species not a combination.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2-5, 11-12, 15-18, and 23-25 are withdrawn from further consideration pursuant 37 CFR 1.142(b), as being drawn to nonelected inventions/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed 20 July 2026.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. The incorporation by reference paragraph must contain the size of the XML file in bytes.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The specification is objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)).
Drawings
The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP §
608.02 (V)).The different views must be numbered in consecutive Arabic numerals,
starting with 1,independent of the numbering of the sheets and, if possible, in the order
in which they appear on the drawing sheet(s). Partial views intended to form one
complete view, on one or several sheets, must be identified by the same number
followed by a capital letter. View numbers must be preceded by the abbreviation “FIG.”
Where only a single view is used in an application to illustrate the claimed invention, it
must not be numbered and the abbreviation “FIG.” must not appear.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in
reply to the Office action to avoid abandonment of the application. Any amended
replacement drawing sheet should include all of the figures appearing on the immediate
prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure
is to be canceled, the appropriate figure must be removed from the replacement sheet,
and where necessary, the remaining figures must be renumbered and appropriate
changes made to the brief description of the several views of the drawings for
consistency. Additional replacement sheets may be necessary to show the renumbering
of the remaining figures. Each drawing sheet submitted after the filing date of an
application must be labeled in the top margin as either “Replacement Sheet” or “New
Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner,
the applicant will be notified and informed of any required corrective action in the next
Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 7-10 are objected to because of the following informalities: “dietary supplement / feed additive / nutraceutical / pharmaceutical (drug) composition” should read “dietary supplement, feed additive, nutraceutical, or pharmaceutical (drug) composition”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 7-10 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.
Regarding claims 7-10, the phrase “(drug)” renders the claims indefinite because it is unclear whether the limitation(s) in the parentheses are part of the claimed invention or an example. See MPEP § 2173.05(d).
Regarding claims 9-10, the term “preferably” renders the claims indefinite because it is unclear whether the limitation(s) following the term are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections – Improper Markush
Claims 1, 7-10, and 21-22 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the bacteriophages do not share a common core structure of a consensus sequence. The common use of all the bacteriophages is to lyse pathogenic E. coli, the bacteriophage all share <80% average nucleotide identity between the bacteriophages which is recognized as the bacteriophages having divergent genomes (Instant Specification ¶103 and Table 4), expect ECML-123-2 and ECCML-363 which share 95% average nucleotide identity which still classifies the two strains in different taxa (Instant Specification ¶103 and Table 4). However, as each bacteriophage lyses different strains and has a different sequence they do not share a common structure that yields a common use. Claims 7-10 and 21-22, which depend or require the bacteriophage of claim 1, are similarly rejected.
Claim Rejections - 35 USC § 112(a)
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.
Deposit
Claims 1, 7-10, and 21-22 are 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 invention appears to employ a specific strain of a bacteriophage (ECCR-664-1, Accession number PTA-127249). It is not clear if the written description is sufficiently repeatable to avoid the need for a deposit. Further it is unclear if the starting materials were readily available to the public at the time of invention.
It appears that a deposit was made in this application as filed as noted on page 11 of the specification. However, it is not clear if the deposit meets all of the criteria set forth in 37 CFR 1.801-1.809. Applicant or applicant's representative may provide assurance of compliance with the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, in the following manner.
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and averring the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material.
Identifies declarant.
States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
States that the deposited material has been accorded a specific (recited) accession number.
States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g. see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
Written Description
Claims 7-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claims 7-10 broadly encompasses the bacteriophage recited in claim 1. Claim 7 further recites variants of the bacteriophage which have an average nucleotide identity over genome of greater than or equal to 80% relative to the bacteriophage recited in claim 1 and has lytic activity against pathogenic E. coli.
The Specification has failed to sufficiently describe the structural features that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the bacteriophage to lyse pathogenic E. coli. The claims define the bacteriophage phage of what it does – not what it is.
“[S]aid variants have an average nucleotide identity over genome of ≥80% relative to the bacteriophage” encompasses a large pool of sequences, as allowing for changed to 20% of the nucleotide residues allows for many nucleotide sequences/bacteriophages. ECCR-664-1 has 134,587 nucleotides. A variant sharing only 80% identity can have anywhere from 1 to 26,917 substitutions, deletions, or additions in any combination, along any length of the sequence. Thus, just for substitutions with canonical nucleotides alone, the instant claims encompass an enormous genus (426,917 = 4.45437 x 1016205) comprising trillions upon trillions of sequences.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully reduced to practice specific bacteriophages (ECML-1, ECML-10, ECML-123-2, ECML-183-2, ECML-363, ECML-606-1, and ECCR-664-1). As such, the Specification reasonably demonstrates that the Applicant was in possession of the bacteriophages. However, this is not representative of the extremely large genus of sequences claimed since these sequences only encompass the claimed bacteriophage and not the innumerable sequenced contained within variants having an average nucleotide identity over genome of 80% or greater relative to the bacteriophage.
The data generated for the claimed bacteriophage described in the Specification cannot reasonably be extrapolated and applied to support possession of the entire claimed genus of variants because no one species, combination, or variant accounts for the variability amongst the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Koskella, et al. (Viruses. 2013 Mar 11;5(3):806-23., hereinafter “Koskella”) provides a review of phage specificity, many phages are only specific to a single bacterial species and often to only a few strains within that species (pg. 808 ¶1), so variants of the bacteriophage are unlikely to keep the same specificity. While Applicant may have possession of variants of the bacteriophages, these variants have not been shown to have lytic activity against pathogenic E. coli.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 7-10, and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
The instant claims are broadly drawn to a bacteriophage and compositions comprising the same. As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (STEP 1: YES).
The instant Specification evidences the bacteriophages were isolated from various environmental sources and were not altered (¶0087 and 0217). As such, the bacteriophages are naturally occurring bacteriophages. Moreover, the broadest reasonable interpretation of a capsule, syrup, etc. recited by instant claim 8 encompasses e.g. placing the bacteriophage in a cellulose (also naturally occurring) capsule or mixing with glucose (also naturally occurring) to create a syrup. Additionally, the probiotic bacteria and yeast recited by claims 9-10 are also naturally occurring and lyophilizing or spray-drying the bacteriophage as recited in claim 1 does not alter the naturally occurring bacteriophages., increasing the concentration of the bacteriophages also does not alter the naturally occurring bacteriophage, the only consequence being a larger amount of naturally occurring bacteriophage.
Isolating bacteriophages and, in some embodiments, formulating with glucose or in a cellulose capsule, or lyophilizing or spray-drying the bacteriophage, would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed bacteriophage from their naturally occurring counterparts.
Accordingly, the instant claims recite a natural phenomenon, i.e. naturally occurring bacteriophage, which is a judicial exception (STEP 2A, Prong One: YES).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g., a specific treatment or prophylaxis. As such, the instant claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Murthy, et al. (US 20090130196, hereinafter “Murthy”) evidenced that it was well-understood, routine, and conventional (WURC) at the time of filing to formulate the bacteriophage for administration to subjects (¶0015). As such, beyond the JE, the instant claims only recite WURC formulations for administration to a subject. The WURC formulations constitute insignificant extra-solution activities, which do not reasonably provide an inventive concept. As such, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
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.
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Dalmasso, et al. (PLoS One. 2016 Jun 9;11(6):e0156773., hereinafter “Dalmasso”) and further in view of Murthy.
Regarding claim 7, Dalmasso teaches the phage APCEc01 (abstract), which shares 97% query coverage and 97.36% percent identity with the claimed ECCR-664-1 phage (see alignment below). Dalmasso further teaches that the phage has lytic activity against the E. coli strain DPC6051 which is used in lab settings to mimic pathogenic E. coli in experiments (Abstract). Dalmasso does not teach that the bacteriophage is used in a pharmaceutical composition or is lyophilized. However, Murthy teaches that phage therapeutics can be stabilized by lyophilizing the phages before use as a therapeutic (¶0051).
It would be prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Dalmasso for a lytic bacteriophage against E. coli with the teachings of Murthy for lyophilizing bacteriophage for therapeutics. Murthy provides motivation by teaching that lyophilizing stabilizes the bacteriophage (¶0003). One of skill in the art would have a reasonable expectation of success in combining the teachings of Dalmasso and Murthy because they both teach bacteriophages.
PNG
media_image1.png
607
1350
media_image1.png
Greyscale
Regarding claim 8, Murthy teaches formulating bacteriophage compositions as a gel (abstract).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 9-10 is rejected under 35 U.S.C. 103 as being unpatentable over Dalmasso and Murthy, as applied to claim 7-8 above, and further in view of Rohwer, et al. (US 20170312322 A1, hereinafter “Rohwer”) and Kiani, et al. (Acta Biomed. 2020 Nov 9;91(13-S):e2020025., hereinafter “Kiani”).
As discussed above, claims 7-8 were rendered prima facie obvious over Dalmasso and Murthy.
Regarding claims 9-10, Dalmasso and Murthy do not teach formulating the bacteriophage with probiotic bacteria or yeast. However, Rohwer teaches bacteriophage compositions for treating, ameliorating and preventing various infections, disorders and conditions in mammals, including genetically-predisposed and chronic disorders, where a microbial or bacterial flora is at least one causative or symptom-producing factor and adding probiotic yeast and probiotic bacteria to bacteriophage compositions (¶0035).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Dalmasso and Murthy for a bacteriophage composition with the teachings of Rohwer for adding probiotic bacteria and yeast to bacteriophage compositions. Kiani provides motivation by teaching that probiotics help maintain microbiome balance and strengthen the immune system (pg. 2 column 1). One of skill in the art would have had a reasonable expectation of success in combining the teachings Dalmasso, Murthy, Rohwer, and Kiani because they all teach bacteriophages.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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, Thomas J. Visone can be reached at 571-270-0684. 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.
/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
Prosecution Insights