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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12 and 18-26, drawn to a method of preparing a preparation of enriched or selected viruses and/or phages capable of targeting or killing a microbe, classified in C12N7/00; and
II. Claim 13, drawn to a method of using the product of Group I for facilitating establishment of or generating a desired microbial niche or microenvironment, classified in A61K35/76 and A01N63/40.
The inventions are distinct, each from the other because of the following reasons:
Inventions I and II are directed to related methods. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the method of Group I and the method of Group II have a materially different design, mode of operation, function and effect. Furthermore, the inventions as claimed do not overlap in scope; and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all these inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because at least the following reason(s) apply:
the inventions have acquired a separate status in the art in view of their different classification.
the inventions have acquired a separate status in the art due to their recognized
divergent subject matter.
the inventions require a different field of search (e.g., searching different classes /subclasses
or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention. Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Election over the phone:
During a telephone conversation with Attorney Gregory P. Einhorn on 09/15/2026, the examiner states the restriction requirement over the inventions of Group I and Group II. A provisional election was made by Attorney Gregory P. Einhorn to prosecute Group II (the method of claim 13) without traverse. Affirmation of this election must be made by applicant in replying to this Office action.
Status of the Application
Applicant’s amendment submitted on 10/01/2024 is acknowledged.
Claims 1-13 and 18-26 are pending.
Claims 1 and 3-13 are amended.
Claims 14-17 are canceled.
Claims 18-26 are new.
Claims 1-12 and 18-26 are withdrawn as being drawn to a non-elected invention.
Claim 13 has been examined on the merits.
Priority
This application, U.S. Application number 18/789850, is a CON of U.S. Application number 16/761,037 filed on 05/01/2020, now issued as US Patent number 12241092, which is a national stage entry of International Application Number PCT/US2018/058879, filed on 11/02/2018 and claims domestic priority under 35 U.S.C. 119(e) to provisional application No. 62/581,309 filed on 11/03/2017.
Specification
The abstract of the disclosure is objected to because it does not disclose the claimed invention (the claim 13) elected by Applicant for the restriction requirement. Appropriate correction is required. See MPEP § 608.01(b).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/31/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97., and has been considered by the examiner.
Claim Objections
Claim 13 is objected to due to the recitation of “phase”. The recited term should be corrected to “phage”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b), or 112, Second Paragraph
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.
Claim 13 is 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 pre-AIA the applicant regards as the invention.
Claim 13 is indefinite due to the recitation of “the microbe” at lines 5 and 8 of the claim. There is no sufficient antecedent basis for this limitation in the claim. It is unclear what specific microbe this term refers to. For the purpose of examination, the recited term “the microbe” at line 5 of the claim is interpreted as “a microbial niche or environment or a microbe in the microbial niche or environment” to be consistent with limitations recited in the preamble and at line 8 of the claim.
Claim Rejections - 35 USC § 102
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.
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 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.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huff et al. (Poultry Science, 2002, 81:437–441).
Huff et al. teach a method for enriching a bacteriophage capable of targeting or killing a pathogenic E. coli bacterium and inhibiting/preventing respiratory infection in broiler chickens (i.e. generating a desired microbial niche or microenvironment in broiler chickens or manipulating a switch between one condition/pathogenic condition and another condition/nonpathogenic condition of the niche or microenvironment for inhibiting the infection in the chickens), comprising steps: (a) obtaining samples of bacteriophages from sewer treatment and poultry processing plants, and providing a culture of E. coli (i.e. a microbial niche or microenvironment having a plurality of E. coli microbes) by culturing E. coli in a trypticase phosphate broth medium; (b) inoculating the culture of E. coli (microbial niche or microenvironment) with bacteriophages by adding them to the culture; (c) culturing the inoculated E. coli by incubation at 37oC for enrichment of the bacteriophages, followed by collecting and isolating enriched bacteriophages capable of inhibiting or killing the E. coli; and (d) contacting a culture of E. coli (i.e. E. coli microbe or a microbial niche or microenvironment having a plurality of E. coli microbes) with enriched bacteriophages, and injecting the resulted mixture of the E. coli and bacteriophages into the thoracic air sac of broiler chickens (title; page 438: from left col./last para to right col./para 3; see the “Study 1” in abstract and page 438/last full para); wherein the presence of the bacteriophages reduces mortality of the chickens to 25%, 5%, 35% or zero, compared to 80% or 85% in controls without added bacteriophages (abstract/right panel/lines 5 -11; and table 2). As such, the enriched bacteriophages in the method of Huff et al. have the ability to generate a desired microbial niche or microenvironment for reducing mortality of the broiler chickens and to manipulate a switch between a pathogenic condition and a nonpathogenic condition of microbial niche or microenvironment.
Therefore, in view of the teachings of Huff et al., the method of Claim 13 is anticipated by the method of Huff et al.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 13 is rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11975035. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of the '035 patent are directed in part to a method for treating, ameliorating and/or preventing a bacterial infection in an individual in need thereof, comprising steps: administering, feeding or applying to the individual a food, a feed, a drink, or a pharmaceutical preparation comprising a plurality of isolated and purified Caudovirales bacteriophages (reading on the “phage” in the claim 13); wherein the Caudovirales bacteriophage are formulated per dose, serving, or unit dosage between about 10.sup.1 and 10.sup.20 plaque-forming units (PFUs), or between about 10.sup.3 and 10.sup.17 PFUs, or between about 10.sup.5 and 10.sup.12 PFUs, or between about 10.sup.7 and 10.sup.9 PFUs; wherein the composition is formulated for administration in vivo; or for enteral or parenteral administration, or for ophthalmic, topical, oral, intranasal, intrarectal, intravaginal, intravenous, intra-peritoneal, intraocular, intra-placental, intra-bladder, cutaneous, intravenous, intramuscular, intrathecal, subcutaneous, intracerebral, epidural, intracranial or rectal administration, or by inhalation; wherein the individual is a mammal, a human or a human infant; wherein the bacterial infection is caused by a gram negative bacteria or a gram positive bacteria, specifically a Staphylococcus, a Staphylococcus aureus, a Clostridium, or a Clostridium difficile, Escherichia coli, a Shigella, a Salmonella, a Campylobacter, a Cholerae, a Bacillus, or a Yersinia. It is noted that given the claimed method of the '035 patent comprises using the bacteriophages to inhibit, control, or treat bacterial infection caused by various pathogenic bacteria, contacting between the bacteriophages and the pathogenic bacteria (i.e. microbes or a microbial niche/environment) is involved in the claimed method of the '035 patent. Thus, the claimed method of the '035 patent meets the requirement of comprising the contacting step in the instant claim 13.
It is noted that the purified Caudovirales bacteriophages used in the method of the claims of the '035 patent are enriched since they are isolated and purified, and maintained at a level between about 10.sup.7 and 10.sup.9 PFUs. The claims of the '035 patent do not expressively teach using the method of the instant claim 1 for enriching, selecting, or isolating the bacteriophages, as required by the claim 13. However, this is a product-by-process limitation. The phage in the claim 13 is not limited to the manipulations of the steps recited in the claim 1, only to the structure implied by the steps. Thus, determination of patentability is based on the product/phage itself, not on a method/steps for its production. The bacteriophage/phage in the claims of the '035 patent appears to be structurally the same, thus anticipating the phage in the claim 13 of the instant application. In the case that the process limitations in the claim impart a slightly different product, the claims of the '035 patent are considered to render the phage obvious since the patented claims teach a substantially similar phage. Now, the burden is shifted to applicant to show a novel or unobvious difference. See MPEP 2113.
Therefore, the method of Claim 13 of the instant application is anticipated by or deemed obvious over the method of Claims 1-28 of U.S. Patent No. 11975035.
Conclusion
No claim is in condition for allowance.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Qing Xu, Ph.D., whose telephone number is (571) 272-3076. The examiner can normally be reached on Monday-Friday from 9:30 AM to 5:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached at (571) 272-0939. Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the receptionist whose telephone number is (571) 272-1600.
/Qing Xu/
Patent Examiner
Art Unit 1656
Prosecution Insights