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 .
DETAILED ACTION
Applicant’s response filed on 11/26/2026 is duly acknowledged.
Claims 4, 7, 12, 56, 65, 68-70, 72, 73, 75, 78-81, 83, 89, 92-97, 100, 102-105, 107-113, 127, 142, 158, 159, 169, 173, 187 and 191, that were previously presented, have now been canceled by applicant's current claim amendments. Thus, claims 1-205 (all previous claims in this application) have been canceled by applicants.
Claims 206-240 have been newly recited (as being representative for the elected invention of group I; see discussion below) and are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (represented by new claims 206-240; directed to “A human therapeutic composition comprising a formulation…”) in the reply filed on 11/26/2026 (see REM, p. 7) is acknowledged.
Claims 206-240, as newly presented (taken as elected invention of Group I, without traverse), have been examined on their merits in this action hereinafter.
Priority
This application is a 371 of PCT/US2021/029412 (filed on 04/27/2021), which claims domestic benefit from a US provisional application 63/016,132 filed on 04/27/2020.
Claim Objections
Claim 219 is objected to because of the following informalities: Claim 219 (see line 3) appears to recite a Markush group in the form of “selected from a polynucleotide sequence…and a polynucleotide sequence of SEQ ID NO: 22”, which should be amended to recite in proper Markush group language of “selected from the group consisting of A, B, C, and D”, for instance. Appropriate correction is required.
Claim 226 is objected to because of the following informalities: Claim 219 (see lines 4-5) appears to recite a Markush group in the form of “selected from salbutamol…and inhaled beta-agonist”, which should be amended to recite in proper Markush group language of “selected from the group consisting of A, B, C, and D”, for instance. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 235 (new) 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 235 recites the limitations “wherein the composition is to be administered at a dosage of at least 3 x 108 PFU of total bacteriophages per milliliter”, which is ambiguous and confusing because the “human therapeutic composition” as recited in independent claim 206 (from which claim 235 directly depends from) does not provide a reasonable basis for said composition to be in a liquid or solution form per se. Thus, it is unclear if there are other components and/or steps required for the “composition is to be administered at a dosage of at least 3 x 108 PFU of total bacteriophages per milliliter”, as currently required by claim 235. The metes and bounds of the claimed product as recited does not appear to be properly defined. Appropriate correction and/or explanation is required.
NOTE: 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.
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 206-240 (as newly recited) are rejected under 35 U.S.C. 103 as being unpatentable over Morales et al (WO 2019/136108 A1; FOR cited in IDS dated 12/19/2022).
Independent Claim 206 as presented is reproduced as follows:
“206. (New) A human therapeutic composition comprising a formulation of one or more pharmaceutically acceptable carriers, excipients or diluents, and two or more bacteriophages wherein at least one of the two or more bacteriophages comprises a polynucleotide sequence having at least 97% sequence identity to the polynucleotide sequence of SEQ ID NO: 1, at least 95% sequence identity to SEQ ID NO: 3, at least 94% sequence identity to the polynucleotide sequence of SEQ ID NO:4, at least 94% sequence identity to SEQ ID NO: 6,at least 93% sequence identity to SEQ ID NO: 12, or at least 93% sequence identity to SEQ ID NO:18, wherein the composition comprises a single dosage between 1 x 108 and 1 x 1011 PFU of each bacteriophage.”
See also limitations of dependent claims 207-240, as currently presented.
Morales et al (2019), while teaching bacteriophage compositions for treating Pseudomonas infections (see Title, Abstract, “Summary” starting on p. 2; section “Bacteriophage Compositions” starting on page 13; section “Formulations” starting on p. 31; and Claims starting on p. 64, for instance), disclose (regarding instant claim 206) bacteriophage composition comprising a formulation of one or more pharmaceutically acceptable carriers, excipients or diluents, and two or more bacteriophages wherein at least one of the two or more bacteriophages comprises a polynucleotide sequence having 100% sequence identity to SEQ ID NO: 6 (designated by Morales et al as SEQ ID NO: 4, bacteriophage Pa223; see sequence homology summary reproduced below), and at least 94.6% sequence identity to SEQ ID NO:18 (designated by Morales et al as SEQ ID NO: 8, Pa226; see polynucleotide sequence homology summary reproduced below):
SEQ ID NO: 6 (Instant claim 206)
RESULT 1 (GenSeq database results)
BGM87253
(NOTE: this sequence has 3 duplicates in the database searched.
See complete list at the end of this report)
ID BGM87253 standard; DNA; 45703 BP.
XX
AC BGM87253;
XX
DT 22-AUG-2019 (first entry)
XX
DE Pseudomonas infecting bacteriophage polynucleotide (Pa223), SEQ ID 4.
XX
KW antibacterial; antiinflammatory; antimicrobial-gen.; cardiant;
KW dermatological; ds; endocarditis; lung infection; pseudomonas infection;
KW respiratory-gen.; skin infection; therapeutic; urinary tract infection;
KW uropathic; vulnerary agent.
XX
OS unidentified phage; ECACC reference no. 17062002.
XX
CC PN WO2019136108-A1.
XX
CC PD 11-JUL-2019.
XX
CC PF 02-JAN-2019; 2019WO-US012113.
XX
PR 02-JAN-2018; 2018US-0613049P.
PR 31-MAY-2018; 2018US-0678600P.
PR 14-SEP-2018; 2018US-0731774P.
XX
CC PA (AMPL-) AMPLIPHI BIOSCIENCES CORP.
XX
CC PI Morales SP, Mearns G, Rankin DA, Smrekar F;
XX
DR WPI; 2019-607645/57.
XX
CC PT Bacteriophage composition useful e.g. for treating bacterial infection,
CC PT and for killing bacteria on surface, comprises obligately lytic
CC PT bacteriophage that infects and lyses Pseudomonas.
XX
CC PS Claim 12; SEQ ID NO 4; 79pp; English.
XX
CC The present invention relates to a bacteriophage composition comprising
CC one or more obligately lytic bacteriophage that infect and lyse
CC Pseudomonas, useful for treating Pseudomonas infection. The bacteriophage
CC selected can be Pa223 of SEQ ID NO: 4 (seeBGM87253) (deposited under
CC ECACC reference no. 17062002), Pa222 of SEQ ID NO: 3 (seeBGM87252)
CC (deposited under ECACC reference no. 17062003), Pa193 of SEQ ID NO: 1
CC (seeBGM87250) (deposited under ECACC reference no. 17062004) and Pa204 of
CC SEQ ID NO: 2 (seeBGM87251) (deposited under ECACC reference no.
CC 17062006). The invention further refers to: (1) a composition comprising
CC a bacteriophage composition which is frozen, lyophilized, liquid, or
CC solid; (2) the use of a bacteriophage or a composition for manufacturing
CC a medicament to treat a bacterial infection; (3) a method for treating a
CC bacterial infection by administering the bacteriophage or the composition
CC to a subject; (4) a kit comprising: (i) a bacteriophage or the
CC composition; and (ii) instructions for use of same; (5) a method for
CC killing bacteria on a surface by applying a bacteriophage or the
CC composition to the surface; (6) a bandage or wound dressing comprising a
CC bacteriophage or the composition according to any one of claims 1-34; (7)
CC a method for manufacturing the bacteriophage composition by admixing at
CC least two bacteriophages selected from Pa222, Pa223, Pa193, and Pa204.
CC The bacteriophage composition can be used for treating lung infection,
CC urinary tract infection, intra-abdominal infection, skin infection, skin
CC structure infection, bacteremia, endocarditis or implant infection.
XX
SQ Sequence 45703 BP; 11075 A; 11862 C; 12128 G; 10638 T; 0 U; 0 Other;
Query Match 100.0%; Score 45703; Length 45703;
Best Local Similarity 100.0%;
Matches 45703; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
SEQ ID NO: 18 (Instant claim 206)
RESULT 5 (GenSeq database)
BGM87257
ID BGM87257 standard; DNA; 65838 BP.
XX
AC BGM87257;
XX
DT 22-AUG-2019 (first entry)
XX
DE Pseudomonas infecting bacteriophage polynucleotide (Pa226), SEQ ID 8.
XX
KW antibacterial; antiinflammatory; antimicrobial-gen.; cardiant;
KW dermatological; ds; endocarditis; lung infection; pseudomonas infection;
KW respiratory-gen.; skin infection; therapeutic; urinary tract infection;
KW uropathic; vulnerary agent.
XX
OS unidentified phage.
XX
CC PN WO2019136108-A1.
XX
CC PD 11-JUL-2019.
XX
CC PF 02-JAN-2019; 2019WO-US012113.
XX
PR 02-JAN-2018; 2018US-0613049P.
PR 31-MAY-2018; 2018US-0678600P.
PR 14-SEP-2018; 2018US-0731774P.
XX
CC PA (AMPL-) AMPLIPHI BIOSCIENCES CORP.
XX
CC PI Morales SP, Mearns G, Rankin DA, Smrekar F;
XX
DR WPI; 2019-607645/57.
XX
CC PT Bacteriophage composition useful e.g. for treating bacterial infection,
CC PT and for killing bacteria on surface, comprises obligately lytic
CC PT bacteriophage that infects and lyses Pseudomonas.
XX
CC PS Example 2; SEQ ID NO 8; 79pp; English.
XX
CC The present invention relates to a bacteriophage composition comprising
CC one or more obligately lytic bacteriophage that infect and lyse
CC Pseudomonas, useful for treating Pseudomonas infection. The bacteriophage
CC selected can be Pa223 of SEQ ID NO: 4 (seeBGM87253) (deposited under
CC ECACC reference no. 17062002), Pa222 of SEQ ID NO: 3 (seeBGM87252)
CC (deposited under ECACC reference no. 17062003), Pa193 of SEQ ID NO: 1
CC (seeBGM87250) (deposited under ECACC reference no. 17062004) and Pa204 of
CC SEQ ID NO: 2 (seeBGM87251) (deposited under ECACC reference no.
CC 17062006). The invention further refers to: (1) a composition comprising
CC a bacteriophage composition which is frozen, lyophilized, liquid, or
CC solid; (2) the use of a bacteriophage or a composition for manufacturing
CC a medicament to treat a bacterial infection; (3) a method for treating a
CC bacterial infection by administering the bacteriophage or the composition
CC to a subject; (4) a kit comprising: (i) a bacteriophage or the
CC composition; and (ii) instructions for use of same; (5) a method for
CC killing bacteria on a surface by applying a bacteriophage or the
CC composition to the surface; (6) a bandage or wound dressing comprising a
CC bacteriophage or the composition according to any one of claims 1-34; (7)
CC a method for manufacturing the bacteriophage composition by admixing at
CC least two bacteriophages selected from Pa222, Pa223, Pa193, and Pa204.
CC The bacteriophage composition can be used for treating lung infection,
CC urinary tract infection, intra-abdominal infection, skin infection, skin
CC structure infection, bacteremia, endocarditis or implant infection.
XX
SQ Sequence 65838 BP; 14561 A; 18311 C; 18279 G; 14687 T; 0 U; 0 Other;
Query Match 94.6%; Score 62146.4; Length 65838;
Best Local Similarity 96.8%;
Matches 63829; Conservative 0; Mismatches 1701; Indels 432; Gaps 23;
(NOTE: The recitation of individual sequences showing homology have been omitted herein because of excessive lengths)
Regarding instant claim 206, Morales et al disclose the therapeutic composition comprising bacteriophages in formulations that comprise of one or more pharmaceutically acceptable carriers, excipients or diluents, conventional antibiotic or antibacterial agents, etc. (see p. 21, [0055]-[0057], section “Formulations”, for instance); and wherein the composition comprising combination of one or more bacteriophages comprise dosage between 1 x 108 and 1 x 1011 PFU of each bacteriophage per ml of the composition (see p. 29, [0074], for instance).
Regarding instant claim 210, Morales et al disclose two or more bacteriophage combinations in the composition with a bacteriophage comprising a polynucleotide sequence having at least 94% identity to SEQ ID NO: 6 (see discussion above; disclosed by Morales et al as SEQ ID NO: 4, Pa223, which is 100% identical to SEQ ID NO: 6 of instant claims 206 and 210; see also Morales et al, p. 7, [0006]; claim 1-3, 12, for instance); wherein (regarding instant claim 212) the composition comprises a bacteriophage comprising a polynucleotide sequence having at least 93% identity to SEQ ID NO:18 (Morales et al disclose SEQ ID NO: 8 designated as Pa226, which is 94.6% identical to SEQ ID NO: 18 of the instant claims 206 and 212; see also discussion above); wherein (regarding instant claim 219) the composition can further comprise at least one bacteriophage comprising a polynucleotide sequence having at least 90% - 100% identity to a sequence with SEQ ID NOs: 2, 11 and 20 that are identical to Morales et al SEQ ID NOs: 1, 3 and 5, respectively (see also discussion above).
Although, Morales et al do not explicitly exemplify the formulation with the same combination of the bacteriophages as specifically recited in instant depending claims 207-209, 211, 213-218, it is to be noted that they do disclose Pseudomonas infecting lytic bacteriophages having polynucleotide sequences of SEQ ID NO: 1, 4, 3 and 5 that are identical in sequence to the bacteriophages of the instant application with SEQ ID NO: 2, 6, 11 and 20, respectively (as recited in the instant claims 206 and 219, in particular). Also, the bacteriophage disclosed by Morales et al as SEQ ID NO: 6 is 95.9% identical to the polynucleotide sequence of SEQ ID NO: 1 of the instant application. In addition, it is to be noted that Morales et al disclose inclusion of mutant bacteriophages “having 76% - 100% identity (and all sub values and sub ranges therein, inclusive of endpoints) to any one of SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, or SEQ ID NO: 8” (see p. 2-3, [0008], for instances), wherein SEQ ID NO: 4 represents Pa223 and SEQ ID NO: 8 represents Pa226 phage as already discussed above, and that would also encompass bacteriophages recited in instant claim 206 and 219 (see for example, sequence homology summery for SEQ ID NO: 2 recited in instant claim 219 reproduced hereinbelow).
SEQ ID NO: 2 (instant claim 219)
RESULT 1 (GenSeq database)
BGM87250
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
ID BGM87250 standard; DNA; 66657 BP.
XX
AC BGM87250;
XX
DT 22-AUG-2019 (first entry)
XX
DE Pseudomonas infecting bacteriophage polynucleotide (Pa193), SEQ ID 1.
XX
KW antibacterial; antiinflammatory; antimicrobial-gen.; cardiant;
KW dermatological; ds; endocarditis; lung infection; pseudomonas infection;
KW respiratory-gen.; skin infection; therapeutic; urinary tract infection;
KW uropathic; vulnerary agent.
XX
OS unidentified phage; ECACC reference no. 17062004.
XX
CC PN WO2019136108-A1.
XX
CC PD 11-JUL-2019.
XX
CC PF 02-JAN-2019; 2019WO-US012113.
XX
PR 02-JAN-2018; 2018US-0613049P.
PR 31-MAY-2018; 2018US-0678600P.
PR 14-SEP-2018; 2018US-0731774P.
XX
CC PA (AMPL-) AMPLIPHI BIOSCIENCES CORP.
XX
CC PI Morales SP, Mearns G, Rankin DA, Smrekar F;
XX
DR WPI; 2019-607645/57.
XX
CC PT Bacteriophage composition useful e.g. for treating bacterial infection,
CC PT and for killing bacteria on surface, comprises obligately lytic
CC PT bacteriophage that infects and lyses Pseudomonas.
XX
CC PS Claim 12; SEQ ID NO 1; 79pp; English.
XX
CC The present invention relates to a bacteriophage composition comprising
CC one or more obligately lytic bacteriophage that infect and lyse
CC Pseudomonas, useful for treating Pseudomonas infection. The bacteriophage
CC selected can be Pa223 of SEQ ID NO: 4 (seeBGM87253) (deposited under
CC ECACC reference no. 17062002), Pa222 of SEQ ID NO: 3 (seeBGM87252)
CC (deposited under ECACC reference no. 17062003), Pa193 of SEQ ID NO: 1
CC (seeBGM87250) (deposited under ECACC reference no. 17062004) and Pa204 of
CC SEQ ID NO: 2 (seeBGM87251) (deposited under ECACC reference no.
CC 17062006). The invention further refers to: (1) a composition comprising
CC a bacteriophage composition which is frozen, lyophilized, liquid, or
CC solid; (2) the use of a bacteriophage or a composition for manufacturing
CC a medicament to treat a bacterial infection; (3) a method for treating a
CC bacterial infection by administering the bacteriophage or the composition
CC to a subject; (4) a kit comprising: (i) a bacteriophage or the
CC composition; and (ii) instructions for use of same; (5) a method for
CC killing bacteria on a surface by applying a bacteriophage or the
CC composition to the surface; (6) a bandage or wound dressing comprising a
CC bacteriophage or the composition according to any one of claims 1-34; (7)
CC a method for manufacturing the bacteriophage composition by admixing at
CC least two bacteriophages selected from Pa222, Pa223, Pa193, and Pa204.
CC The bacteriophage composition can be used for treating lung infection,
CC urinary tract infection, intra-abdominal infection, skin infection, skin
CC structure infection, bacteremia, endocarditis or implant infection.
XX
SQ Sequence 66657 BP; 14690 A; 18601 C; 18508 G; 14858 T; 0 U; 0 Other;
Query Match 100.0%; Score 66657; Length 66657;
Best Local Similarity 100.0%;
Matches 66657; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
(NOTE: The recitation of full sequences showing homology has been omitted because of excessive length)
Regarding instant claim 220, Morales et al disclose wherein the composition is formulated as an injectable, nasal, oral, transdermal, or an inhalable composition (see section “Formulations” starting on p. 31, [0084]-[0086], for instance); wherein (regarding instant claims 221-222) the composition comprises three or more or four or more bacteriophages (see claims 2-3, 9-10, for instance); wherein (regarding instant claim 223) the composition’s target bacteria range is broader than the cumulative range of the individual bacteriophages in the composition (see Morales et al, p. 3, [0008]-[0009], for instance); wherein (regarding instant claim 224) the at least one of the bacteriophages infect and kill Pseudomonas aeruginosa (see Morales et al, p. 23, paragraph “[0060] In an aspect, the bacteriophage composition includes at least one, at least two, at least three, or at least four bacteriophages such that the composition is effective against at least about 60% of target bacterial strains in a panel. For example, the bacteriophage composition is effective against (e. g. , kills or lyses) at least 60% of Pseudomonas aeruginosa strains”); and wherein (regarding instant claims 225, 236, 237) the composition further comprises a storage medium for storage at room temperature or a temperature at or below 8°C, wherein the storage medium comprises a cryoprotectant (see Morales et al, p. 31, [0082]; p. 33, [0085]; and claims 26-27, wherein the composition comprises “at least one cryoprotectant” such as glycerol, for instance); wherein (regarding instant claim 226) the “bacteriophage remains in the lung” after administration (taken as an intrinsic property of the bacteriophages disclosed upon use for treatment in a subject in need; see Morales et al, Summary, [0007]; p. 7, [0016]; Example 6-7, for instance).
Regarding instant claims 227 and 228, Morales et al disclose, wherein the one or more bacteriophages belong to the Family Podoviridae or Myoviridae (see Morales et al, p. 30, [0077], for instance); wherein (regarding instant claim 232) the composition can be substantially free of bacterial components such as bacterial endotoxin, bacterial host protein, and the like (see Morales et al, p. 5-6, [0005]; p. 13, [0037], p. 17, [0049], claims 1 and 12, for instances); wherein (regarding instant claim 233) the bacteriophage composition is a liquid, semi-liquid, solid, frozen, freeze-dried, cryodesiccated, or lyophilized formulation (see Morales et al, p. 33, [0085], and claim 29, for instance); wherein (regarding instant claim 234) the bacteriophage composition “targets one or more of Pseudomonas aeruginosa, antibiotic-resistant Pseudomonas aeruginosa, and multiple antibiotic-resistant Pseudomonas aeruginosa” (see Morales et al, p. 28, [0068], for instance); wherein (regarding instant claim 235) the “composition is to be administered at a dosage of at least 3 x 108 PFU of total bacteriophages per milliliter” (see Morales et al, p. 29, [0074]; p. 38, [0108], for instance); wherein (regarding instant claim 238) at least one bacteriophage is “obligately lytic” (see Morales et al, p. 2, [0007]; p. 44, [0133]; claims 1, 12, for instance); wherein (regarding instant claim 239) the sequence of at least one bacteriophage is “genetically modified” (see mutants that are “not naturally occurring”, as disclosed by Morales et al, p. 4, first paragraph; p. 8, full [0022] paragraph, for instance); wherein (regarding instant claim 240) the bacteriophages reduce biofilm mass (see Morales et al, p. 41, [0118], for instance).
Regarding instant claims 229-231, though, Morales et al do not explicitly disclose the specific genera of the bacteriophages infecting Pseudomonas, as recited in instant claims 229-231, they do disclose that such obligately lytic bacteriophages are encompassed in the composition that have 70% - 100% identity to sequences disclosed (as having SEQ ID NO: 1, 4, 3, 5 and 6, that are homologous within the 70%-100% range and correspond to SEQ ID NO: 2, 6, 11, 20 and 1, respectively of the instant application), and therefore, irrespective of the classification in a particular genus within the two disclosed families of Podoviridae or Myoviridae, the bacteriophages with encompassing polynucleotide sequences are deemed to be covered in the composition disclosed by Morales et al.
Although, Morales et al do not explicitly disclose the specific limitations of instant claims 207-209, 211 (with reference to SEQ ID NOs: 1, 3, 4, and 12) and specific combinations of bacteriophages as recited in instant claims 213-218, since they disclose the mutant/variant bacteriophages encompassing a sequence homologies between 70%-100% identity to sequences disclosed (that include compositions comprising the exemplified bacteriophages Pa223, or Pa226; see discussion above) such variants from the same family would be deemed encompassed within the claimed composition, and would have been obvious to an artisan in the art to be included in the therapeutic bacteriophage compositions, as currently being claimed, unless evidence presented on record to the contrary. The limitations of instant claim 206 for the composition comprising “a single dosage between 1 x 108 and 1 x 1011 PFU of each bacteriophage” would have been obvious to an artisan in the art because Morales et al already teaches such therapeutic amount ranges for the bacteriophages (see discussion above, and Morales et al, p. 29, [0074], for instance) that can be combined to form compositions suitable for treating Pseudomonas infections in subjects in need thereof. Therefore, the invention as claimed fails to distinguish itself over the detailed teachings and/or suggestions from the cited prior art reference as discussed above.
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as currently being claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 206-240 (as presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 210-212, 217 and 225-227 of copending Application No. 17/241,957 (reference application, NOA sent by the office on 01/16/2026; filed by common inventors and assignee, from the same US provisional application 63/016132 that was filed on 04/27/2020). Although the claims at issue are not identical, they are not patentably distinct from each other because though the allowed claims in the copending application are drawn to a method of treating a bacterial infection (see independent claim 208 of the ‘957 application), they employ essentially the same composition comprising combination(s) of two or more bacteriophages (see claim 210 of the ‘957 application), three of more bacteriophages (see claim 211 of the ‘957 application), wherein the sequences recited (i.e. SEQ ID NOs: 6, and 1, 3, 4) have the same percent identities (see claims 208, 210-211 as reproduced below):
PNG
media_image1.png
79
679
media_image1.png
Greyscale
PNG
media_image2.png
291
667
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Claim 217 of the copending application ‘957 also recites additional limitations of “a polynucleotide sequence with at least 90% identity to SEQ ID NO: 18” (i.e. in addition to SEQ ID NOs: 1, 3, 4, as alternatives), which is encompassed by the scope recited in claim 206 in the instant application under examination. The generic limitations of “one or more pharmaceutically acceptable carriers, excipients or diluents” and amount of PFU of each bacteriophage recited in claim 206 of the instant application would have been obvious as the two applications (see for instance, p.12, [0053] of instant as well as co-pending specification) have the same disclosure for such formulations employing mixture of bacteriophages for treating bacterial infections. Moreover, such formulations comprising bacteriophages with pharmaceutically acceptable carriers, excipients or diluents, and amounts of PFU for each phages are well known and/or would have been obvious from the prior art disclosure (see Pouillot et al, WO 2015/059298 A1; cited as FOR ref. [N] on PTO 892 form; see p. 28, 3rd and 4th paragraphs, for instance; also published as EP 2865383 A1, FOR cited in applicant’s IDS dated 12/19/2022). Therefore, an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 206-240 (as presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 209 of U.S. Patent No. 18/592,379 (filed as CON of the instant application; by same inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claim of the copending ‘379 application is also directed to a product composition in the form of a bacteriophage composition comprising “one or more” bacteriophages having the same SEQ ID NOs: 1, 3 and 4 with at least 95% identity (or “two or more bacteriophages”; see also claims 210-211 in the copending ‘379 application) as reproduced below:
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As noted above, the scope of the claims in the CON application is clearly co-extensive with claim 206 as presented in the instant application, and therefore an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO claims are currently allowed.
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/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657