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 06/04/2026 is duly acknowledged.
Claims 1-208 have been canceled by applicants.
Claims 209-234 as currently presented are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Species C (represented by SEQ ID NO: 3; directed to “A bacteriophage composition comprising one or more bacteriophages…”) in the reply filed on 06/04/2026 (see REM, p. 7) is acknowledged.
However, upon further search and considerations, the species election requirement as previously made by the examiner, has been withdrawn, and all species from A to E (i.e. SEQ ID NOs: 1-5) have been rejoined for the examination purposes hereinafter.
Claims 209-234, as currently presented (directed to “A bacteriophage composition comprising one or more bacteriophages…”), have been examined on their merits in this action hereinafter.
Priority
This application is a CON of 17/917,543 (filed on 10/06/2022), which is a 371 of PCT/US21/29412 (filed on 04/27/2021) which claims domestic benefit from a US PRO 63/016,132 filed on 04/27/2020.
Claim Objections
Claim 233 (as presented) is objected to because of the following informalities: Claim 233 (line 3) appears to recite a Markush group in the form of “selected from: a polynucleotide sequence of…and a polynucleotide sequence of SEQ ID NO: 22”, which should be amended for clarity to recite a 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.
1. Claims 211-213 (as presented) 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. Claims 211-213 recite the following:
“211. (Previously Presented) The bacteriophage composition of claim 209 comprising two or more bacteriophages.”
“212. (Previously Presented) The bacteriophage composition of claim 209 comprising three or more bacteriophages.”
“213. (Previously Presented) The bacteriophage composition of claim 209 comprising four or more bacteriophages.”
The limitations as recited in instant claims 211-213, wherein the “bacteriophage composition of claim 209” comprises “two or more”, “three or more”, or “four or more” bacteriophages is ambiguous because it is not clear which bacteriophages are being referred to. Does the composition comprise the same bacteriophages that are already recited in instant claim 209, or they are some other and/or different unrecited bacteriophages? It is not clear as to what exactly is being encompassed by the product invention as currently being claimed. As such, the metes and bounds of the claims are not properly defined. Appropriate correction is required.
2. Claims 220 (as presented) 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 220 (depends directly from claim 219) recites the following:
“220. (Previously Presented) The composition of claim 219, wherein the composition is a liquid, semi-liquid, solid, frozen, freeze-dried, cryodesiccated, or lyophilized formulation.”
The recitation of limitations “solid, frozen, freeze-dried, cryodesiccated, or lyophilized formulation” is ambiguous and confusing because the composition as recited in independent claim 209 (from which claim 219 directly depends from) does not provide a reasonable basis for a “solid” or “lyophilized” formulation, for instance. Claim 219 (from which claim 220 directly depends from) requires the limitations of “a pharmaceutically acceptable carrier, diluent, excipient or combinations thereof”, but does not specifically provide for the limitations of “solid, frozen, freeze-dried, cryodesiccated, or lyophilized formulation”, as currently required by claim 220. In addition, the composition of claim 209 appears to encompass liquid composition as it recites the limitations “wherein the composition comprises between 1 x 108 and 1 x 1011 plaque-forming units (PFU) per milliliter of each bacteriophage”. Thus, the metes and bounds of the claimed product does not appear to be properly defined. Appropriate correction is required.
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.
1. Claims 209-234 (as presented) are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite judicial exceptions in the form of natural product (i.e. product of nature, a composition comprising “one or more bacteriophages”, that are naturally existing or natural isolates from certain bacteria; see discussion below) as depicted below:
“209. (Previously Presented) A bacteriophage composition comprising one or more bacteriophages; wherein the one or more bacteriophages comprises a polynucleotide sequence with at least 95% identity to SEQ ID NO: 1, a polynucleotide sequence with at least 95% identity to SEQ ID NO:2, a polynucleotide sequence with at least 95% identity to SEQ ID NO:3, a polynucleotide sequence with at least 95% identity to SEQ ID NO:4, and/or a polynucleotide sequence with at least 95% identity to SEQ ID NO:5; wherein the composition comprises between 1 x 108 and 1 x 1011 plaque-forming units (PFU) per milliliter of each bacteriophage.”
“225. (Previously Presented) The composition of claim 209, wherein the sequence of at least one bacteriophage is genetically modified.” (generically recited, no specific modification required in claim and/or disclosed on record)
The claimed product is interpreted as a composition comprising “one or more bacteriophages” as recited with SEQ ID NOs 1-5 in instant claim 209, wherein the composition comprises certain “plaque-forming units (PFU) per milliliter of each bacteriophage” (i.e. encompasses a composition comprising one bacteriophage within the parameters of recited polynucleotide sequence identity). The aforementioned nature-based judicial exception has not been integrated into any meaningful practical application(s), and the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception itself (see also dependent claims 210-234 that have been generically recited, at best). The analysis under 35 UCS 101 guide lines (USPTO October, 2019) is as follows:
Step 1. Does the claim fall within any of the statutory categories ?
Under BRI in light of the parent disclosure of record (see parent specification 17/917543; Example 1 in its entirety, starting on p. 138), instant claims are directed to a composition of matter- in the form of a bacteriophage composition, presumably obtained and/or isolated from bacteria Pseudomonas aeruginosa (see parent SPEC, p.139, [0351] reproduced below):
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Step 2A. (Prong one)- Does the claim recite a judicial exception ?
As noted above, instant claim 209 recites the composition that comprises one or more bacteriophages having more than 95% polynucleotide sequence identity to SEQ ID NOs: 1 to 5, which are isolated/purified/concentrated to a specific concentration range (expressed in PFU; see instant claim 209; SPEC, [0053], for instance) from naturally occurring infected bacteria Pseudomonas aeruginosa as per applicant’s awn disclosure of record. Thus, independent claim 209 under examination does recite a nature-based judicial exception. The dependent claims are generically recited either for intrinsic features and/or capabilities of the bacteriophages, such as to target Pseudomonas, reduce biofilm mass (see instant claim 214, 217, 218, 223-224, 226-231), or to generic formulation such as diluents, excipients, etc., that could encompass aqueous solution comprising infected host Pseudomonas bacteria per se (see instant claims 215, 219-221, 232), none of which would structurally change the nature-based product. The limitations of dependent claims 225 (“wherein the sequence of at least one bacteriophage is genetically modified”) has been recited generically, without reasonable specificity as to what exact genetic modification(s), if any has been done to the claimed bacteriophage(s). The limitations of dependent claim 222 (“wherein the one or more bacteriophages are not naturally occurring”) does not correspond to the disclosure of record as it clearly mentions the fact that composition can comprise “at least one naturally occurring phage”( see parent 17/917,543 SPEC, [0263] reproduced below):
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Thus, as presented, claims of record are deemed to encompass nature-based bacteriophage composition that are isolates from naturally occurring Pseudomonas aeruginosa bacteria as per applicant’s own disclosure of record (see discussion above).
Step 2A. (Prong two)- Does the claim as a whole integrates the recited judicial exception into a practical application of the exception ?
As currently presented, none of the claims (see claims 209 and claims dependent therefrom) recite any specific structural and/or functional feature(s) or any additional limitations (other than intrinsic capability/activity of bacteriophages) that would provide and/or integrate the recited nature-based judicial exception into a meaningful practical application, for example- for treating a Pseudomonas aeruginosa infection in a subject in need thereof. No practical application of the nature-based product has been recited with required specificity in the claims, and therefore, the claims as a whole do not integrate the judicial exception to a practical application of the exception, and therefore are directed to the nature-based judicial exception.
Step 2B. Does the claim as a whole amounts to significantly more than the recited exception ?
As discussed above, instant claims as presented do not recite any other structural and/or functional features, and/or provide any other limitation(s) that amount to “significantly more” than the recited judicial exceptions itself. The intrinsic features and/or capabilities of the bacteriophage, generic formulations in liquid such as an aqueous solution, and/or storage at room temperature, isolation/concentration to certain range of plaque-forming units (PFU) per milliliter, etc., would be deemed routine, and moreover would not be understood to structurally and/or functionally change the nature-based product per se, unless evidence/data provided on record to contrary, which is currently lacking on record.
It is clear that the composition as claimed encompasses nature-based judicial exception in the form of “one or more” bacteriophages. Thus, taken as a whole, instant claims are not deemed to be patent eligible for reciting nature-based product as a judicial exception, for the reasons discussed above. 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 209-234 (as presented) are rejected under 35 U.S.C. 103 as being unpatentable over Morales et al (WO 2019/136108 A1; FOR cited in applicant’s IDS dated 09/18/2024).
Claim 209 is directed to “A bacteriophage composition comprising one or more bacteriophages; wherein the one or more bacteriophages comprises a polynucleotide sequence with at least 95% identity to SEQ ID NO: 1, a polynucleotide sequence with at least 95% identity to SEQ ID NO:2, a polynucleotide sequence with at least 95% identity to SEQ ID NO:3, a polynucleotide sequence with at least 95% identity to SEQ ID NO:4, and/or a polynucleotide sequence with at least 95% identity to SEQ ID NO:5; wherein the composition comprises between 1 x 108 and 1 x 1011 plaque-forming units (PFU) per milliliter of each bacteriophage.”
See also limitations of dependent claims 207-234, as currently presented.
NOTE: For the prior art purposes herein, claims have been interpreted as having component bacteriophages that are not naturally occurring and have genetic modifications that are different in polynucleotide sequence from their natural counterparts.
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 209) bacteriophage composition comprising one or more pharmaceutically acceptable carriers, excipients or diluents, and wherein at least one of bacteriophages comprises a polynucleotide sequence having 100% sequence identity to SEQ ID NO: 2 (designated by Morales et al as SEQ ID NO: 1; see homology below):
SEQ ID NO: 2 (instant claim 209)
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
Application/Control Number: 17/917,543 Page 11
Art Unit: 1657
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 nucleotide sequences showing 100% homology has been omitted because of excessive length)
In addition, Morales et al disclose the bacteriophage having at least 94.6% sequence identity to SEQ ID NO: 18 (designated as SEQ ID NO: 8, Pa226; see polynucleotide sequence homology reproduced below):
SEQ ID NO: 18 (instant claims 233-234)
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.
Application/Control Number: 17/917,543 Page 8
Art Unit: 1657
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 209, 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 (regarding instant claims 210-213) may comprise between 1 x 105 and 1x 1011 PFU of each bacteriophage per ml of composition (see p. 29, [0074], in particular); wherein 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: 11 and 20 (see instant claims 233-234) that are identical to Morales et al SEQ ID NOs: 3 and 5, respectively. Morales et al disclose Pseudomonas infecting lytic bacteriophages having polynucleotide sequences of SEQ ID NO: 1, 3 and 5 that are identical in sequence to the bacteriophages of the instant application with SEQ ID NO: 2 (discuss above) 11 and 20, respectively (as recited in the instant claims 209 and 233-234, in particular).
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 (being 100% identical to SEQ ID NO: 2 as recited in instant claim 209).
Regarding instant claim 221, 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
210-213) the composition comprises three or more or four or more bacteriophages (see Morales et al, claims 2-3, 9-10, for instance); wherein (regarding instant claims 217-218) 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 226) 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 215-216) 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 224) 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 227-231, 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 220) 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 214) 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 claims 222 and 225) 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 223) the bacteriophages reduce biofilm mass (see Morales et al,
p. 41, [0118], for instance).
Regarding instant claims 229 and 231, although, Morales et al do not explicitly disclose the specific genera of the bacteriophages infecting Pseudomonas, as recited in instant claims 229 and 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. 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 209-234 (as presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 206-209 of copending Application No. 17/917,543 (parent application, filed by common inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘543 is also directed to a product in the form of “A human therapeutic composition comprising a formulation” of one or more bacteriophages as reproduced below:
“206. (Previously Presented) 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.”
As noted above, the claimed composition in the parent application (from which the instant application is filed as a CON, and therefore has the same disclosure on record) also comprises the same bacteriophage components, wherein the claimed product is clearly co-extensive in scope with the instant claims (see claim 209 in the instant application, for instance, which appears to be generic to the species recited in the parent application ‘543), and therefore and ODP rejection is deemed proper. The recitation of limitations “a single dosage between 1 x 108 and 1 x 1011 PFU of each bacteriophage” in the parent application is deemed to encompass the required limitations of instant claim 209 for the same amount of each bacteriophage “per milliliter”, that has been fully disclosed in the parent application (see parent SPEC. [0053], Example 4, for instance).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 209-234 (as presented) are rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 210-212 of U.S. Patent No. 12594312 (issued from application 17/241,957 filed by common inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because though the claims in the issued patent ‘312 are drawn to a method of treating a bacterial infection (see issued independent claim 208 below), they employ essentially similar bacteriophage composition comprising combination(s) of two or more bacteriophages (see issued claim 210), three or more bacteriophages (see issued claim 211), wherein the sequences recited (i.e. at least for SEQ ID NOs: 1, 3 and 4) have the same and/or overlapping percent identities (see claims 208, 210-211 as reproduced hereinbelow):
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Since, the issued claims in ‘312 are clearly co-extensive in scope with the instant claims in this application (see independent claim 209), an ODP rejection is deemed proper.
Conclusion
NO claims are currently allowed.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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