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
The amendment filed 01/27/2025 has been entered. Claims 21-23 have been cancelled. Claims 28-32 have been newly added. Claims 1-20, and 24-32 are pending. Claims 1-20 remain withdrawn. Claims 24-32 are under examination.
The rejection of claims 24-27 under 35 USC 112(a), as failing to comply with the enablement requirement, has been withdrawn in view of Applicant’s amendment.
The rejection of claims 24-27 under 25 USC 102 has been withdrawn in view of Applicant’s amendment.
Claim Objections
Claim 24 is objected to because of the following informalities: the claim language contains redundancies. It is recommended that the claim recite “A method of treating a bacterial infection in a subject, comprising administering to the subject a therapeutically effective of a composition selected from the group consisting of…”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24-32 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 is drawn to a method of treating a bacterial infection in a subject comprising administering to the subject a therapeutically effective amount of a composition selected from the group consisting of: 1) a polypeptide comprising a hydrolase domain, the hydrolase domain comprising an amino acid sequence selected from the group consisting of SEQ ID NO:2, SEQ ID NO:3, SEQ ID NO:4, SEQ ID NO:5, SEQ ID NO:6, an amino acid sequence having at least 95% identity to any thereof; and a functional fragment of any thereof.
Claim 31 recites “The method according to claim 29, wherein the cell wall binding domain comprises i) an amino acid sequence selected from the group consisting of: SEQ ID NO:9, SEQ ID NO:10, SEQ ID NO:11, SEQ ID NO:12, and SEQ ID NO:13; and/or ii) an amnio acid sequence having at least 95% sequence identity to any thereof; and iii) a functional fragment of any thereof.”
Because of the phrase “an amino acid sequence” recited in instant claims 24 and 31, it is interpreted that an amino acid sharing least 3 contiguous amino acids with any of the recited sequences is all that is required by the claims. Moreover, the term “functional fragment” is not
Claim 32 recites “The method according to claim 24 where the polypeptide comprises any one of SEQ ID NO: 22-26, 51-61, 76, 77; and/or an amino acid sequence having at least 95% identity to any thereof; and/or a fragment of any thereof”.
The broadest reasonable interpretation of “functional fragment of any thereof” and “fragment of any thereof” requires that the fragment retains the activity of the original or reference amino acid sequence.
The specification discloses that the invention relates to the treatment of bacterial infections, in particular bacterial vaginosis, using novel polypeptides. However, the specification has only reduced to practice the bacteriolytic activity of polypeptides CCB2.1 (SEQ ID NO:1), CCB2.2 (SEQ ID NO:73), CCB2.3 (SEQ ID NO:74), and CCB2.4 (SEQ ID NO:75) (Figure 6), all of which have different levels of activity. Moreover, SEQ ID NOs:1, and 73-75 are not recited in any of the instant claims.
Neither the prior art nor the specification has disclosed a structure-function relationship between bacteriolytic activity of the polypeptides of the instant invention and the conserved amino acid residues in the polypeptide structure for this activity. One of ordinary skill in the art would not have recognized that the inventors had possession of the invention as claimed.
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 24-28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-50 of copending Application No. 18/037,632 (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 conflicting claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 48 of ‘632 recites a method of treating or preventing a bacterial infection in a subject, the method comprising administering to the subject a therapeutically effective amount of a composition of claim 45. Claim 45 of ‘632 recites a composition comprising the polypeptide of claim 30. Claim 30 recites a polypeptide having anti-Gardnerella spp. activity comprising a hydrolase domain wherein the hydrolase domain comprises an amino acid sequence selected from any one of SEQ ID NOs: 5, 3, 6, 2, 4, or 1.
Claim 49 of ‘632 recites the method according to claim 48 wherein the polypeptide or composition prevents, disperses, treats and/or decolonizes a bacterial biofilm and/or kills or prevents growth of a bacterial wherein the bacteria include Gardernella spp.
Claim 50 of ‘632 recites a method according to claim 48 wherein the bacterial infection is bacterial vaginosis.
Instant claim 24 is unpatentable over claim 30, 45, and 48 of ‘632 because all claims require a method of treating or preventing bacterial infection in a subject, the method comprising administering a composition to a subject wherein the composition comprises a polypeptide with a hydrolase domain, the hydrolase domain comprising an amino acid sequence selected from the group consisting of SEQ ID NO:2-6.
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SEQ ID NO:2 of ‘632 is 100% identical to instant SEQ ID NO:2 (see alignment below).
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SEQ ID NO:3 of ‘632 is 100% identical to instant SEQ ID NO:3 (see alignment below).
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SEQ ID NO:4 of ‘632 is 100% identical to instant SEQ ID NO:4 (see alignment below)
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SEQ ID NO:5 of ‘632 is 100% identical to instant SEQ ID NO:5 (see alignment below).
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SEQ ID NO:6 of ‘632 is 100% identical to instant SEQ ID NO:6 (see alignment below)
Instant claims 25, 26, and 28 are unpatentable over claim 49 of ‘632 because all claims require a method in which the composition comprising a polypeptide with a hydrolase domain comprising the amino acid sequences recited above prevents, disperses, treats and/or decolonizes a bacterial biofilm and/or kills growth of bacteria, wherein the bacterial include Gardnerella spp., including G. leopoldii, G. piotti, G. swidsinskii and G. vaginalis.
Instant claim 27 is unpatentable over claim 50 of ‘632 because both claims require a method of treating a bacterial infection wherein the infection is bacterial vaginosis.
The claims at issue are broader in scope and are therefore anticipated by claims 30, 45, and 48-50 of ‘632.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached on (571) 272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657