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
Claims 38–56 are pending and under examination.
Priority
This application, filed on 8/9/2024, is a 371 of PCT/EP2023/053316 filed on 2/10/2023, which claims benefit to EUROPEAN PATENT OFFICE (EPO) 22156413.1 filed 2/11/2022. The effective filing date of the instant application is February 11, 2022.
Information Disclosure Statement
The information disclosure statement filed on 10/29/2025 complies with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references were considered.
Drawings
The drawings are objected to because the figures are not properly labeled.
37 CFR 1.84 (u)(1) states “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.”
In the instant case, the view numbers for Figures 1-6 are preceded by the word "Figure" instead of the abbreviation "FIG.". Additionally, partial views for figures 3 and 4 should be labelled as “FIG. 3A”, “FIG. 3B”, “FIG. 4A”, and “FIG. 4B”.
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.
Specification
The abstract of the disclosure is objected to because the abstract submitted 10/29/2025 does not describe the claimed invention directed towards a method of administering to a patient a therapeutically effective amount of a recombinant Gardnerella-specific endolysin or a pharmaceutical composition comprising a recombinant Gardnerella-specific endolysin. The abstract submitted 8/9/2024 describes the claimed invention of a method of treating bacterial vaginosis in a patient. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
Claims 40 and 46 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 40 and 46, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 38, 45-50 and 52 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Applicant is referred to MPEP 2163(II)(A)(3)(a)(i and ii), which states that 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 applicant was in possession of the claimed genus. 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. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure indicates that the patentee has invented species sufficient to constitute the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
Claim 45 is drawn to the method of claim 38, wherein said endolysin comprises or consists of (i) an N-terminal catalytic domain or “a functional variant thereof”; and (ii) a C-terminal cell-wall binding region, or “a functional variant thereof”. The specification does not disclose a representative number of functional variants that meet the required functional limitation of an N-terminal catalytic domain or a C-terminal cell-wall binding region.
Claim 46 is drawn to the method of claim 45, wherein the catalytic domain is a polypeptide comprising or consisting of the amino acid sequence of any one of SEQ ID NOs: 2 to 10 or “any functional variant thereof having at least 80% identity with the amino acid sequence of any one of SEQ ID NOs: 2 to 10”.
Claim 47 is drawn to the method of claim 45, wherein the cell-wall binding domain is a polypeptide comprising or consisting of the amino acid sequence of any one of SEQ ID NOs: 11 to 28, “or any functional variant thereof having at least 80% identity with the amino acid sequence of any one of SEQ ID NOs: 11 to 28”.
Claim 48 is drawn to the method of claim 45, wherein said first cell-wall binding domain is a polypeptide comprising or consisting of the amino acid sequence of SEQ ID NO:23, or “any functional variant thereof having at least 80% identity with the amino acid sequence of SEQ ID NO:23”, and wherein said second cell-wall binding domain is a polypeptide comprising or consisting of the amino acid sequence of SEQ ID NO:24 or SEQ ID NO:26, or “any functional variant thereof having at least 80% identity with the amino acid sequence of SEQ ID NO:24 or SEQ ID NO:26”.
Claim 50 is drawn to the method of claim 38, wherein said endolysin is a polypeptide having “at least 80% sequence identity with the amino acid sequence as provided in SEQ ID NO:1 and having a killing activity against Gardnerella”.
The current specification defines “variant” as a polypeptide including insertions, deletions, and/or substitutions relative to the native amino acid sequence, comprising at least 80% identity to the native amino acid sequence (p.17, 1st paragraph). The current specification identifies that methods for the production of endolysins, or a fragment, variant, fusion, or derivative thereof, for use according to the invention are well known in the art (p.17, last paragraph). The current specification states that any functional variant having at least 80% identity with an amino acid sequence would be functional, whereby the function comprises the ability to lyse the cell wall of Gardnerella (p.13, top paragraph). The current specification provides a single example of an endolysin H2B10B11 which has one amino acid exchange in one of the binding domains (p.24, Preparation of PM-477).
The current specification does not provide any guidance on the structure-function relationship of any of the SEQ ID NOs; does not provide any information on which amino acids can be varied or deleted while preserving the function of lysing the cell wall of Gardnerella; nor provide any guidance on which amino acid residues are critical in any of the SEQ ID NOs to determine regions of the SEQ ID NOs that are required to meet the required limitation. The specification does not provide any structural guidance on which portions of the sequence must be preserved or must be modified. Based on the lack of art-recognized structure-function relationship of any of the SEQ ID NOs to other functional variants, it is highly unpredictable whether variants meeting the 80% sequence identity would also retain the desired function of killing activity against Gardnerella or the ability to lyse the cell wall of Gardnerella.
The disclosure of a single endolysin variant comprising a single amino acid substation identified as SEQ ID NO:37 is not a representative number of species of the genus of functional variants of an N-terminal catalytic domain; the genus of functional variants of a c-terminal cell-wall binding region; the genus of functional variants having at least 80% identity with the amino acid sequence of any one of SEQ ID NOs: 2 to 10; the genus of functional variants having at least 80% identity with the amino acid sequence of any one of SEQ ID NOs: 11 to 28; the genus of functional variants having at least 80% identity with the amino acid sequence of SEQ ID NO:23; the genus of functional variants having at least 80% identity with the amino acid sequence of SEQ ID NO:24 or SEQ ID NO:26; or the genus of endolysins having at least 80% sequence identity with the amino acid sequence as provided in SEQ ID NO:1 and having a killing activity against Gardnerella. Thus, one of ordinary skill in the art could not conclude that Applicant was in possession of any species in the claimed genera listed above. This disclosure does not constitute a representative number of species of the genera in view of the potential breadth and variability of the genera, and so there is a failure to satisfy the written description requirement for the genera.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 38-56 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being clearly anticipated by Corsini (WO 2020/225335 A1, published on November 12, 2020).
Regarding claim 38, Corsini teaches that standard treatment of bacterial vaginosis (BV) are antibiotics Metronidazole and Clindamycin, which often fail to eradicate the biofilm, so recurrence rates are up to 60% within 6 months (p.2, [0006]). Corsini teaches preparation of novel recombinant Gardnerella prophage endolysins for treating, decontaminating or detecting bacterial infections and disorders in particular in relation with Gardnerella (p.2, [0008]). Corsini teaches a method for treating bacterial infections and disorders such as BV comprising administering to a subject in need thereof, a therapeutically effective amount of an endolysin of the invention (p.15, [0044]).
Regarding claim 39, Corsini teaches that standard treatment of bacterial vaginosis (BV) are antibiotics, Metronidazole and Clindamycin, which often fail to eradicate the biofilm, so recurrence rates are up to 60% within 6 months (p.2, [0006]).
Regarding claim 40, Corsini teaches that for bacterial vaginosis, recurrence rates are up to 60% within 6 months (p.2, [0006]).
Regarding claim 41, Corsini teaches that bacterial vaginosis may be caused by Gardnerella vaginalis sensu strict, Gardnerella leopoldii, Gardnerella piotii, and/or Gardnerella swidsinskii (p.13-14, [0039]).
Regarding claims 42-43, Corsini teaches the recombinant endolysin of the present invention has killing activity against Gardnerella; for example the endolysin of the present invention may have killing activity against Gardnerella vaginalis sensu stricto, Gardnerella leopoldii, Gardnerella piotii, and/or Gardnerella swidsinskii (p.12, [0033]).
Regarding claim 44, Corsini teaches that said endolysin has no killing activity against Lactobacilli crispatus, Lactobacilli gasseri, and/or Lactobacilli jensenii (p.12, [0033]). Corsini further teaches the endolysins of the invention are substantially or completely incapable of lysing cells of L. crispatus, L. gasseri and L. jensenii (p.30, [0094]).
Regarding claim 45, Corsini teaches an endolysin comprising or consisting of
a N-terminal catalytic domain, or a functional variant thereof;
a C-terminal cell-wall binding region, or a functional variant thereof, wherein the C-terminal cell-wall binding region comprises or consists of at least one cell-wall binding domain; and
a linker region between the N-terminal catalytic domain and the C-terminal cell-wall binding domain; wherein the endolysin has a killing activity against Gardnerella (p.3, [0009]).
Regarding claim 46, Corsini teaches a N-terminal catalytic domain consisting of a polypeptide comprising the amino acid sequence of SEQ ID NO:2 (p.5, [0016]; p.65, SEQ ID NO:2). Corsini SEQ ID NO:2 (subject) has 100% identity to instant SEQ ID NO:3 (query) as shown below.
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Regarding claim 47, Corsini teaches the cell-wall binding domain can be a polypeptide having the amino acid sequence of SEQ ID NO:28 (p.7, [0021]; p.68, SEQ ID NO:28). Corsini SEQ ID NO:28 (subject) has 100% identity to instant SEQ ID NO:23 (query), as shown below.
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Regarding claim 48, Corsini teaches the endolysin comprises a first cell-wall binding domain and a second cell-wall binding domain, wherein said first cell-wall binding domain is selected from SEQ ID NO:28 and said second cell-wall binding domain is selected from the SEQ ID NO:29 (p.7, last paragraph).
Instant SEQ ID NO:23 (query) has 100% identity to Corsini SEQ ID NO:28 (subject, as shown in the alignment below.
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Instant SEQ ID NO:24 (query) has 100% identity to Corsini SEQ ID NO:29 (subject), as shown in the alignment below.
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Regarding claim 49, Corsini teaches the endolysin an N-terminal catalytic domain and a c-terminal cell-wall binding region, and a linker region between the N-terminal catalytic domain and the C-terminal cell-wall binding region, wherein said endolysin has a killing activity against Gardnerella (p.5, [0016]). Corsini further teaches the endolysin is functional, wherein the function comprises the ability to lyse the cell wall of Gardnerella (p.5-6, [0018]).
Regarding claim 50, Corsini teaches an endolysin comprising or consisting of
a N-terminal catalytic domain, or a functional variant thereof;
a C-terminal cell-wall binding region, or a functional variant thereof, wherein the C-terminal cell-wall binding region comprises or consists of at least one cell-wall binding domain; and
a linker region between the N-terminal catalytic domain and the C-terminal cell-wall binding domain; wherein the endolysin has a killing activity against Gardnerella (p.3, [0009]).
Corsini further teaches the endolysin can have amino acid sequence SEQ ID NO:1 (subject), which 95.9% identical to instant SEQ ID NO:1 (query) as shown in the alignment below.
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Regarding claim 51, Corsini teaches an endolysin comprising or consisting of (i) a N-terminal catalytic domain consisting of a polypeptide comprising or consisting of the amino acid sequence of SEQ ID NO:2; and (ii) a C-terminal cell-wall binding domains consisting of polypeptides comprising or consisting of the amino acid sequence of SEQ ID NO:28 (p.10-11 [0029]).
Corsini SEQ ID NO:2 has 100% identity to instant SEQ ID NO:3, as shown above in the alignment for claim 46.
Corsini SEQ ID NO:28 has 100% identity to instant SEQ ID NO:23, as shown above in the alignment for claim 48.
Corsini SEQ ID NO:29 has 100% identity to instant SEQ ID NO:24, as shown above in the alignment for claim 48.
Regarding claim 52, Corsini teaches said first cell-wall binding domain is N-terminally of said second cell-wall binding domain (p.26-27, [0085]).
Regarding claim 53, Corsini teaches the most active N-terminal catalytic domain, also referred to as “H-domain” is H2 (SEQ ID NO:2) (p.5, [0017]). Instant SEQ ID NO:37 (query) is 100% identical to Corsini SEQ ID NO:2 (subject), as shown in the alignment below.
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Regarding claim 54, Corsini teaches that the endolysins can be administered locally, i.e. locally into the vagina of a female subject and/or in a mal subject into or on the glans penis, prepuce or urethral entry (p.33 top paragraph).
Regarding claim 55, Corsini teaches that the endolysins can be co-administered with a compound or composition which adjusts the pH of the vagina to pH 4.0 to 6.0 (p.33 top paragraph).
Regarding claim 56, Corsini teaches said first cell-wall binding domain is N-terminally of said second cell-wall binding domain (p.26-27, [0085]).
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.
Claims 38, 41-49, 51-52 and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, 8-9, 11, 26-27 and 31-33 of copending Application No. 17/609,358 in view of Corsini (WO 2020/225335 A1, published on November 12, 2020).
Claim 1 of ‘358 is drawn to a polypeptide comprising:
(i) an N-terminal domain comprising the amino acid sequence of SEQ ID NO: 2 or a sequence at least 95% identical to SEQ ID NO: 2 (‘358 SEQ ID NO:2 is 95.92% identical to instant SEQ ID NO:2);
(ii) a C-terminal region consisting of two domains, wherein each of the two domains independently comprises an comprising the amino acid sequence selected from the group consisting of SEQ ID NOs: 28, 29, 30, 31, 32, and 33, 19 and 20; or a sequence at least 96% identical to any one of SEQ ID NOs: 28, 29, 30, 31, 32, and 33, 19 and 20 (‘358 SEQ ID NO:28 is 100% identical to instant SEQ ID NO:23); and
(iii) a linker region between the N-terminal domain and the C-terminal region.
Claim 2 of ‘358 is drawn to the polypeptide of claim 1, wherein the N-terminal domain has the ability to lyse the cell wall of Gardnerella (‘358 SEQ ID NO:2 combined with ‘358 SEQ ID NO:28 are (relevant to instant claims 38, 50).
Claim 5 of ‘358 is drawn to the polypeptide of claim 1, wherein the C-terminal region comprises a first domain and a second domain, wherein said first domain comprises an amino acid sequence selected from the group consisting of SEQ ID NOs:28, 30 and 32 or a sequence at least 96% identical to any one of SEQ ID NO:28. 30 and 32 (‘358 SEQ ID NO:28 is 100% identical to instant SEQ ID NO:23); and said second domain comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 29, 31 and 33 or a sequence at least 96% identical to any of SEQ ID NO:29, 31 and 33 (‘358 SEQ ID NO:29 is 100% identical to instant SEQ ID NO:24) (relevant to instant claims 46, 47, 48 and 51).
Claim 6 of ‘358 is drawn to the polypeptide of claim 5, wherein said first domain is located N-terminally of said second domain (relevant to instant claim 52, 56).
Claim 8 of ‘358 is drawn to the polypeptide of claim 1, wherein said polypeptide has a killing activity against Gardnerella vaginalis sensu stricto, Gardnerella leopoldii, Gardnerella piotii and/or Gardnerella swidsinskii, or any other species in the genus Gardnerella (relevant to instant claim 43).
Claim 9 of ‘358 is drawn to the polypeptide of claim 1, wherein said polypeptide has no killing activity against Lactobacilli crispatus, Lactobacilli gasseri, and/or Lactobacilli jensenii (relevant to instant claim 44).
Claim 11 of ‘358 is drawn to a pharmaceutical composition comprising the polypeptide of claim 1 and further comprising a pharmaceutically acceptable carrier and/or diluent (relevant to instant claim 38).
Claim 26 of ‘358 is drawn to the polypeptide of claim 1, wherein the C-terminal region and the domain(s) therein have the ability to bind to the cell wall of Gardnerella (relevant to instant claim 45, 49 and 51).
Claim 27 of ‘358 is drawn to the polypeptide of claim 1, which has a genus-selective killing activity against Gardnerella (relevant to instant claim 41, 42).
Claim 31 of ‘358 is drawn to the pharmaceutical composition of claim 30, wherein the C-terminal region comprises a first domain and a second domain, wherein said first domain comprises the amino acid sequence of any one of SEQ ID NO:28, 30 and 32 or a sequence at least 90% identical to any one of SEQ ID NO:28, 30 and 32 (‘358 SEQ ID NO:28 is 100% identical to instant SEQ ID NO:23), and said second domain comprises the amino acid sequence of any one of SEQ ID NO: 29, 31 and 33 or a sequence at least 90% identical to any one of SEQ ID NO:29, 31 and 33 (‘358 SEQ ID NO:29 is 100% identical to instant SEQ ID NO:24) (relevant to instant claims 46, 47, 48 and 51).
Claim 32 of ‘358 is drawn to wherein the C- terminal region comprises a first domain and a second domain, wherein said first domain comprises the amino acid sequence of any one of SEQ ID NO: 28, 30, and 32 or a sequence at least 95% identical to any one of SEQ ID NO: 28, 30, and 32 (‘358 SEQ ID NO:28 is 100% identical to instant SEQ ID NO:23), and said second domain comprises the amino acid sequence of any one of SEQ ID NO: 29, 31, and 33, or a sequence at least 95% identical to any one of SEQ ID NO: 29, 31, and 33 (‘358 SEQ ID NO:29 is 100% identical to instant SEQ ID NO:24) (relevant to instant claims 47, 48 and 51).
Claim 33 of ‘358 is drawn to the pharmaceutical composition of claim 30, wherein the C- terminal region comprises a first domain and a second domain, wherein said first domain comprises the amino acid sequence of SEQ ID NO: 28 or a sequence at least 90% identical to SEQ ID NO: 28 (‘358 SEQ ID NO:28 is 100% identical to instant SEQ ID NO:23), and said second domain comprises the amino acid sequence of any one of SEQ ID NO: 31 or a sequence at least 90% identical to SEQ ID NO: 31 (‘358 SEQ ID NO:31 is 97.96% identical to instant SEQ ID NO:24) (relevant to instant claim 47).
Claims of ‘358 do not recite a method of treating bacterial vaginosis in a patient who previously failed a treatment with antibiotics, wherein the infective bacteria are resistant to a treatment with antibiotics, wherein the method comprises administering to said patient a therapeutically effective amount of a recombinant Gardnerella-specific endolysin.
However, Corsini teaches that standard treatment of bacterial vaginosis (BV) are antibiotics Metronidazole and Clindamycin, which often fail to eradicate the biofilm, so recurrence rates are up to 60% within 6 months (p.2, [0006]). Corsini teaches preparation of novel recombinant Gardnerella prophage endolysins for treating, decontaminating or detecting bacterial infections and disorders in particular in relation with Gardnerella (p.2, [0008]). Corsini teaches a method for treating bacterial infections and disorders such as BV comprising administering to a subject in need thereof, a therapeutically effective amount of an endolysin of the invention (p.15, [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the polypeptide of ‘358 as the endolysin in the method taught by Corsini. Each of ‘358 and Corsini teach polypeptides related to treating Gardnerella.
This is a provisional nonstatutory double patenting rejection.
Claims 38-45, 50 and 53-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 14-20 and 22, of copending Application No. 19/482,194 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the co-pending claims.
Claim 1 of ‘194 is drawn to a pharmaceutical composition comprising an effective amount of an active agent and a pharmaceutical acceptable excipient, wherein said active agent is a polypeptide having a killing activity against Gardnerella and wherein said excipient is a polyacrylic acid polymer (relevant to instant claim 38).
Claim 2 of ‘194 is drawn to the pharmaceutical composition according to claim 1, wherein said polypeptide is an endolysin having a killing activity against Gardnerella (relevant to instant claim 38 and 41-43).
Claim 3 of ‘194 is drawn to the pharmaceutical composition according to claim 2, wherein said endolysin comprises or consists of
(i) a N-terminal catalytic domain, or a functional variant thereof;
(ii) a C-terminal cell-wall binding region, or a functional variant thereof, wherein the C-terminal cell-wall binding region comprises or consists of at least one cell-wall binding domain; and
(iii) optionally a linker region between the N-terminal catalytic domain and the C-terminal cell-wall binding region (relevant to instant claims 38, 45).
Claim 4 of ‘194 is drawn to the pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide is a polypeptide having at least 80% sequence identity with the amino acid sequence as provided in SEQ ID NO: 1 or SEQ ID NO:37 and having a killing activity against Gardnerella (‘194 SEQ ID NO:1 is 100% identical to instant SEQ ID NO:1; ‘194 SEQ ID NO:37 is 100% identical to instant SEQ ID NO:37) (relevant to instant claims 50, 53).
Claim 5 of ‘194 is drawn to the pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide is a recombinant endolysin comprising the amino acid sequence provided in SEQ ID NO: 1 or SEQ ID NO:37 (‘194 SEQ ID NO:1 is 100% identical to instant SEQ ID NO:1; ‘194 SEQ ID NO:37 is 100% identical to instant SEQ ID NO:37) (relevant to instant claims 50, 53).
Claim 6 of ‘194 is drawn to the pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide has a killing activity against Gardnerella vaginalis sensu stricto, Gardnerella leopoldii, Gardnerella piotii and/or Gardnerella swidsinskii, or any other species in the genus Gardnerella (relevant to instant claims 41, 42, 43).
Claim 7 of ‘194 is drawn to the pharmaceutical composition according to any one of the preceding claims, wherein said polypeptide has no killing activity against Lactobacilli crispatus, Lactobacilli gasseri, and/or Lactobacilli jensenii (relevant to instant claim 44).
Claim 14 of ‘194 is drawn to the pharmaceutical composition according to any one of the preceding claims, wherein said composition is suitable for intra-vaginal delivery of the active agent (relevant to instant claim 54).
Claim 15 of ‘194 is drawn to the pharmaceutical composition according to any one of the preceding claims, for use in treating a bacterial infection in a subject, preferably wherein the bacterial infection is bacterial vaginosis (relevant to instant claim 38).
Claim 16 of ‘194 is drawn to the pharmaceutical composition for use according to claim 15, wherein the subject previously failed a treatment with antibiotics and/or wherein the infective bacteria are resistant to a treatment with antibiotics (relevant to instant claim 38).
Claim 17 of ‘194 is drawn to the pharmaceutical composition for use according to claim 16, wherein said antibiotics are nitroimidazoles and/or Clindamycin (relevant to instant claim 39).
Claim 18 of ‘194 is drawn to the pharmaceutical composition for use according to claim 16 or 17, wherein the antibiotics are Metronidazole, Tinidazole, Secnidazole, Clindamycin or any combination thereof (relevant to instant claim 39).
Claim 19 of ‘194 is drawn to the pharmaceutical composition for use according to any one of claims 15 to 18, wherein said subject suffers from recurrent bacterial vaginosis, preferably wherein said subject had two or more episodes of BV in 6 months or had three or more episodes of BV in 12 months (relevant to instant claim 38).
Claim 20 of ‘194 is drawn to the pharmaceutical composition for use according to any one of claims 15 to 19, which is to be administered locally into the vagina of a female subject and/or into or on the glans penis, prepuce or urethral entry of a male subject (relevant to instant claim 54).
Claim 22 of ‘194 is drawn to a method of treating or preventing a bacterial infection, preferably bacterial vaginosis, in a subject in need thereof comprising administering to said subject a therapeutically effective amount of the pharmaceutical composition according to any one of claims 1 to 14 (anticipates instant claims 38, 41-45, 50 and 53-54).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 38, 41-43 and 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 43-45, and 53-56 of copending Application No. 19/694,308 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the co-pending claims.
Claim 1 of ‘308 is drawn to a pharmaceutical composition comprising as active ingredient an effective amount of a) an endolysin comprising the amino acid sequence provided in SEQ ID NO: 1; or b) an endolysin comprising an amino acid sequence having 80% sequence identity to SEQ ID NO:1,wherein the endolysin has a killing activity against Gardnerella; and at least one pharmaceutically acceptable excipient.
Claim 43 of ‘308 is drawn to the pharmaceutical composition according to any one of claims 1 to 42, wherein said composition is suitable for vaginal administration.
Claim 44 of ‘308 is drawn to the pharmaceutical composition according to any one of claims 1 to 43, for use in the treatment of bacterial infections in a subject.
Claim 45 of ‘308 is drawn to the pharmaceutical composition for use according to claim 44, wherein the bacterial infection is bacterial vaginosis.
Claim 53 of ‘308 is drawn to a method of treating a bacterial infection in a subject, comprising administering to the subject the pharmaceutical composition according to any one of claims 1 to 43 (anticipates instant claim 38).
Claim 54 of ‘308 is drawn to the method according to claim 53, wherein the bacterial infection is bacterial vaginosis (relevant to instant claim 38).
Claim 55 of ‘308 is drawn to the method according to claim 53 or 54, wherein the bacterial infection or bacterial vaginosis is characterized by the presence of one or more Gardnerella species (anticipates instant claims 41-43).
Claim 56 of ‘308 is drawn to the method according to claim 54 or 55, wherein the pharmaceutical composition is administered locally into the vagina of a female subject (anticipates instant claim 54).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/DEEPA MISHRA/Examiner, Art Unit 1657
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