DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Following the Reply filed 11/17/2025, claims 30-50 are pending in the application. Claims 30-47 are withdrawn. Claims 48-50 are presently considered.
Election/Restrictions
Applicant’s election of Group III, claims 48-50, and the species, (A) hydrolase domain of SEQ ID NO: 3 (as recited in claim 30), in the reply filed on 11/17/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 30-47 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2020/082604 filed on 11/18/2020. The present application and all claims are being examined with the earliest effective filing date of 11/18/2020.
Information Disclosure Statement
The information disclosure statement (IDS) filed 05/18/2023 is in compliance with the provisions of 37 CFR 1.97 and is being considered by the examiner.
Claim Objections
Claim 48 is objected to because of the following informalities: For clarity, please amend “a composition of claim 45” recited in lines 2-3 to read “the composition of claim 45”. Appropriate correction is required.
Claim 49 is objected to because of the following informalities:
(1) For clarity, please amend “A method according to claim 48” recited in line 1 to read “The method according to claim 48”.
(2) The subjects of the first “wherein” clause recited in lines 1-3 (“the polypeptide, nucleic acid, vector, cell or composition…”) are singular and recited in the alternative, while the recited functions (“prevent, disperse, treat… decolonize… kill… prevent”) are in their plural form. For clarity, please amend the claim to read “prevents, disperses, treats and/or decolonizes…kills or prevents” in lines 2-3.
(3) The claim is incomplete because it does not end in a period (“.”).
Appropriate correction is required.
Claim 50 is objected to because of the following informalities: For clarity, please amend “A method according to claim 48” recited in line 1 to read “The method according to claim 48”. Appropriate correction is required.
Claim Interpretation
Claim 48 recites “A method of treating or preventing a bacterial infection in a subject”, wherein the term, “subject”, is not defined by the specification. The broadest reasonable interpretation of the claim is that the “subject” can be any subject, because the limitation of “preventing” does not require the subject to have a bacterial infection. As dependent claim 49 recites the bacteria to “optionally” include Gardnerella spp. as a further limitation, it is broadly interpreted that the limitation of “a bacterial infection” in claim 48 is directed to any infection caused by any bacteria. As any subject would be susceptible to a bacterial infection, the BRI of the claim is a method to treat or prevent any bacterial infection in any subject.
Claim Rejections - 35 USC § 112(b)
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 49 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.
Regarding claim 49, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 49 also recites “A method according to claim 48, wherein the polypeptide, nucleic acid, vector, cell or composition prevent…” which renders the claim indefinite, because it is unclear how one can select, for example, “the polypeptide” from “the composition” when the composition is recited as comprising the polypeptide. Here, the method of parent claim 48 clearly requires the composition of claim 45, which is recited as comprising either the polypeptide, isolated nucleic acid, vector or cell. Hence, it is unclear how the composition can have the recited effects, while the element it comprises does not, or vice versa.
Examiner notes that claim 49 can be amended to recite, for example, “The method according to claim 48, wherein the composition prevents…” which would obviate this issue.
Claim Rejections - 35 USC § 112(a) – Written Description
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 48-50 are 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.
Brief Statement of the Issue(s)
The claims are drawn to polypeptides comprising hydrolases, wherein the hydrolases as claimed comprise a vast and varied genus of undisclosed structures (i.e., fragments and variants of the recited sequences), defined using functional limitations that do not correspond to any particular set of prior art structures. Accordingly, the specification as filed fails to permit an ordinary artisan to envisage the full scope of the claimed invention.
Claim Scope
Claim 48 is drawn to 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, wherein the composition comprises a polypeptide, an isolated nucleic acid encoding the polypeptide, a vector comprising the nucleic acid, or a cell comprising the isolated nucleic acid (claim 45), wherein the polypeptide has anti-Gardnerella spp. activity and comprises a hydrolase domain, wherein the hydrolase domain comprises or consists of an amino acid sequence selected from any one of SEQ ID NOs 1-6, or a sequence having at least 80, 85, 90, 95, 96 97, 98, 99, 99.5 or 100% identity thereto or a fragment thereof (claim 30).
Claim 49 recites wherein the polypeptide, nucleic acid, vector, cell or composition prevents, disperses, treats and/or decolonizes a bacterial biofilm and/or kills or prevents growth of a bacteria.
Because of the phrase “an amino acid sequence” recited in instant claim 30, it is interpreted that an amino acid sharing at least 3 contiguous amino acids with any of the recited sequences is all that is required by the limitation. The broadest reasonable interpretation of “a fragment thereof” requires that the fragment retains the activity of the original or reference amino acid sequence.
Examiner notes that even a sequence sharing 80% sequence identity to one of the recited SEQ ID NOs, may still possess as many as 37 modifications compared to the reference sequence. The claims also include fragments of these modified sequences which may differ even further, yet are still required to possess the functions recited by the claims.
Thus, it is unclear if the claim scope encompass trillions of species or perhaps only a few in view of the functional limitations set forth in the claim(s). Accordingly, the claim scope reasonably appears to be vast and highly varied.
Actual Reduction to Practice
The specification discloses that the invention relates to the treatment of bacterial infections, in particular bacterial vaginosis, using novel polypeptides (see pg. 1, lines 1-5). However, the specification has only reduced to practice the bacteriolytic activity of polypeptides CCB2.1 (SEQ ID NO: 21), CCB2.2 (SEQ ID NO: 73), CCB2.3 (SEQ ID NO: 74), CCB2.4 (SEQ ID NO: 75), CCB3.2 (SEQ ID NO: 76), CCB4.1 (SEQ ID NO: 23), CCB4.2 (SEQ ID NO: 77), CCB7.1 (SEQ ID NO: 25), and CCB8.1 (SEQ ID NO: 26) (see FIG. 6; Table 4 on pgs. 15-22), all of which have different levels of activity. Moreover, the SEQ ID NOs representing these polypeptides are not recited by the claims at issue.
Examiner notes that the polypeptides of Applicant’s Examples are longer sequences comprising SEQ ID NO: 1-6. For example, CCB2.1 (SEQ ID NO: 21) is 306 residues in length and comprises the hydrolase domain of SEQ ID NO: 1, which is 186 residues in length. Hence, the polypeptides reduced to practice required additional structure compared to those recited in the claims. Furthermore, all of the polypeptides used in Applicant’s Examples comprised the full-length of the hydrolase (i.e., SEQ ID NOs 1-6), and none of these polypeptides comprised a “fragment” of said SEQ ID NOs. Hence, every reduction to practice involved an endolysin comprising a hydrolase domain having no less than 100% sequence identity to one of the polypeptide sequences represented by SEQ ID NOs 1-6.
Identifying characteristics of the genus
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied by disclosure of relevant, identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
The specification teaches that endolysins normally consist of two domains: a catalytic domain, such as a hydrolase domain (typically located at the N-terminal of the polypeptide), which cleaves specific motifs in the peptidoglycan layer, and a cell wall binding domain (classically located at the C-terminal of the polypeptide), which is involved in specific binding and processing of the bacterial peptidoglycan. However, the specification teaches this typical architecture is not a defined characteristic of all endolysins. The specification teaches that some endolysins can comprise catalytic domains and cell wall binding domains in different orientations, and endolysins that target certain gram negative bacteria may not comprise a dedicated cell wall binding domain. The specification also teaches that specificity of an endolysin is often attributed to the cell wall binding domain, which recognizes a cell wall feature specific to the bacteria that it targets. See specification at pg. 2, lines 16-24. The specification also teaches that the cell wall binding domain may comprise or consist of one of SEQ ID NOs 7-13, or a sequence having at least 80% identity thereto, or a fragment thereof (see pg. 10 lines 24-30; Table 2).
However, the specification does not disclose any fragments of SEQ ID NOs 1-13, or any sequence having less than 100% sequence thereto, that retains the functional limitations of the claims. Moreover, there is zero disclosure of any structure-function relationship between the amino acid sequences of these polypeptides, or their fragments, and their recited functions.
In view of the prior art of record, no clear correlation can be found between the reported activities of these polypeptides and the recited SEQ ID NOs. Hence, neither the prior art of record nor the specification disclose a structure-function relationship between the bacteriolytic activity of the polypeptides and their amino acid structure.
Accordingly, the functional limitations of “having anti-Gardnerella spp. activity”, “prevent, disperse, treat and/or decolonize a bacterial biofilm” and “kill or prevent growth of a bacteria” are only utilized as a vague attempt to capture unknown and undisclosed structures, sufficient to achieve some functional result desired for the disclosed invention to achieve. However, the disclosure does not meaningfully disclose an unambiguous structure/function relationship permitting an artisan to identify, a priori, which exact structures do or do not satisfy the functional limitations at issue. Accordingly, one of ordinary skill in the art would not have recognized that the inventors had possession of the invention as claimed.
Conclusion
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). The courts have stated that “merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus” (see, e.g., AbbVie v. Janssen, 111 USPQ2d 1780 (Fed. Cir. 2014) at 1789). In addition, the Courts have stated:
“[r]egardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to the subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.” University of Rochester v. G.D. Searle Co., 69 USPQ2d 1886 1984 (CAFC 2004) (emphasis added).
This is pertinent because, in the instant case, Applicants have claimed a broad and highly varied genus comprising an unknown number of species defined by reference to one or more functional limitations; however, the originally filed disclosure has failed to identify any common structure/function relationship sufficient to permit an artisan to identify what structures are included or excluded by the claim scope. This also means that the skilled artisan cannot envisage what structures infringe or do not infringe upon the pending claim scope.
In conclusion, for the reasons discussed above, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claim Rejections - 35 USC § 112 – Scope of Enablement
Claims 48-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating a Gardnerella infection, does not reasonably provide enablement for a method of preventing any bacterial infection. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Enablement requires that the specification teach those in the art to make and use the
invention without undue experimentation. Factors to be considered in determining whether a
disclosure would require undue experimentation include (1) the nature of the invention, (2) the state of the prior art, (3) the predictability or lack thereof in the art, (4) the amount of direction or guidance present, (5) the presence or absence of working examples, (6) the quantity of experimentation necessary, (7) the relative skill of those in the art, and (8) the breadth of the claims.
Summary of the Problem
While the specification teaches methods of administering polypeptides (i.e., endolysins) having activity against species of Gardnerella to treat subjects having a Gardnerella infection, the claims are directed to methods of administering the same endolysins to not only treat infections caused by Gardnerella, but also to prevent infections caused by any bacteria. For the reasons discussed below, the amount of guidance, direction, and exemplification disclosed in the specification, as filed, would not have been sufficient to have enabled the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation.
The nature of the invention/ breadth of the claims
As discussed under Claim Interpretation, the claims recite a method to treat or prevent any bacterial infection in any subject. It is interpreted that this includes preventing a bacterial infection caused by any bacteria in an individual who is not yet infected with said bacteria. As discussed under Written Description, the step of administering includes the administration of any polypeptide comprising essentially any portion/fragment of SEQ ID NOs 1-6, wherein the polypeptide retains anti-Gardnerella spp. activity.
The state of the prior art/ the predictability or lack thereof in the art
Broendum et al. (cited on Form 892; hereafter, “Broendum”) teach that bacteriophage-encoded endolysins can recognize and bind specific bacteria (see Abstract), but the current understanding of how the structure of endolysins facilitate their function is still modest (see pg. 892, col. 1, para. 2). Broendum teaches that the specificity of endolysins for their bacterial host can vary from an entire bacterial genus down to the strain level (see pg. 879, col. 2, para. 1). Broendum teaches that the cell-wall binding domain (CBD) confers specificity to endolysins by recognizing and binding to ligand molecules, and such specificity can be broad, encompassing an entire bacterial genus or even multiple genera, or narrow, restricted down to the serovar or even strain level (see pg. 886, col. 2, para. 2). However, Broendum teaches that not all endolysins require a CBD for lytic activity (see pg. 890, col. 1, para. 2). Broendum teaches that modular design can facilitate simple domain swapping experiments to alter endolysin specificity and improve their activity; however, whether the effects are additive, synergistic or detrimental cannot yet be predicted (see pg. 890, col. 2, para. 2).
Hence, while there may be some predictability in the art when designing endolysins to be specific to particular groups of bacteria, the prior art of record indicates that in each and every case (e.g., for each genus, strain, group of genera), further experimentation would be required in order to arrive at an effective endolysin (i.e., one that inhibits/kills the targeted bacteria). Furthermore, the prior art indicates that the results of such experimentation would have been unpredictable at the time of filing. Moreover, the prior art of record is silent regarding any method to prevent a bacterial infection by administering such endolysins, and it remains unknown how one can accomplish this by administering endolysins to an uninfected subject.
The amount of direction or guidance present
The specification discloses that a subject may have G. vaginalis within the vaginal flora but lack presentation of acute BV related symptoms, and the polypeptide of the invention can therefore be administered prophylactically to prevent or reduce the risk of prenatal health concerns (see pg. 34, lines 6-14). However, this guidance is limited to preventing certain health outcomes (e.g., preterm birth) in a specific patient population (e.g., pregnant women) caused by an active infection, and there is no guidance as to how to prevent any bacterial infection in any subject by administering endolysins.
The presence or absence of working examples
Similarly, Applicant’s working examples disclose the effects of the endolysins against Gardnerella spp., specifically G. vaginalis ATCC 14018 (see pg. 40, Example 4). However, these effects involve the lysing of the bacterial strains themselves, which would only be present during an active infection, and there is no disclosure of any effects that would be expected to prevent the infection before its onset.
Although a working example is not required to enable an invention, the skilled artisan must be able to practice the claimed invention without undue experimentation. See also, MPEP §2164.02, which states in part: The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.
The quantity of experimentation necessary/ The relative skill of those in the art
It should be made clear that the enabling specification must teach those skilled in the art to make and use the full scope of the claimed invention without undue experimentation. “Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without "undue experimentation." Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444; Wands, 858 F.2d at 736-37, 8 USPQ2d at 1404; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (the first paragraph of section 112 requires that the scope of protection sought in a claim bear a reasonable correlation to the scope of enablement provided by the specification).” In re Wright (CAFC) 27 USPQ2d 1510 at 1513.
In this case, the claims explicitly encompass preventing a bacterial infection in a subject. Looking to the prior art for guidance, a search of the prior art did not identify any methods which utilized polypeptides comprising a hydrolase domain which could effectively prevent a bacterial infection in a subject. In fact, no prior art was identified which taught effective prevention of a bacterial infection using any agent similar to the agents utilized in the instant claims. The specification also does not provide any working example demonstrating prevention of a bacterial infection in a subject. Therefore, given the lack of knowledge present in the prior art and the lack of guidance provided in the specification with respect to preventing a bacterial infection in a subject, further experimentation would be required. Considering that the additional experimentation would require de novo experimentation without a guarantee of success, and further considering that any positive results (i.e., successful prevention of a bacterial infection in a subject) would amount to a significant advancement in the state of the art, the additional experimentation required is considered undue.
Furthermore, in In re Vaeck, 947 F.2d 488,495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991), the Court ruled that a rejection under 35 U.S.C. 112, first paragraph for lack of enablement was appropriate given the relatively incomplete understanding in the biotechnological field involved, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims. Such is the case here where there is a relatively incomplete understanding in the biotechnological field involved, as described above, and the lack of a reasonable correlation between the narrow disclosure in the specification and the broad scope of protection sought in the claims.
Conclusion
The amount of guidance, direction, and exemplification disclosed in the specification, as filed, would not have been sufficient to have enabled the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue and/or unreasonable experimentation.
What Applicant has shown is a starting point from which, when given the bid to do so by the instant claims, someone else skilled in the art may pick up a path of studies that may lead to the completion of the claimed invention. However, it is not sufficient for the specification to provide merely “a starting point, a direction for further research”; it must provide “reasonable detail” sufficient to enable a person of ordinary skill in the art to make or use the invention. Automotive Technologies Intern., Inc. v. BMW of North America, Inc., 501 F.3d 1274, 1284 (Fed. Cir. 2007).
“Enabling the full scope of each claim is part of the quid pro quo of the patent bargain. A patentee who chooses broad claim language must make sure the broad claims are fully enabled. The scope of the claims must be less than or equal to the scope of the enablement to ensure that the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.” Sitrick v. Dreamworks, LLC, 516 F.3d 993, 999 (Fed. Cir. 2008).
In deciding In re Fisher, 166 USPQ 18, 24 (CCPA 1970), the Court indicated the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. “Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC 1997).
In conclusion, upon careful consideration of the factors used to determine whether undue experimentation is required, in accordance with the Federal Circuit decision of In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988), the amount of guidance, direction, and exemplification disclosed in the specification, as filed, is not deemed sufficient to have enabled the skilled artisan to make and/or use the full scope of the claimed invention at the time the application was filed without undue and/or unreasonable experimentation.
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.
Claim(s) 48-50 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Corsini et al., US 20220315908 A1 (cited on Form 892), with the effective filing date of 05/08/2019, hereafter, “Corsini”.
Regarding claim 48, Corsini teaches a method of treating a bacterial infection, comprising administering to a subject in need thereof a therapeutically effective amount of a recombinant endolysin (see claim 12; pg. 6, para. [0075]), wherein the endolysin has a genus-selective killing activity against Gardnerella, and comprises an N-terminal catalytic domain (see claim 1), which is a polypeptide comprising or consisting of the amino acid sequence of SEQ ID NO: 2 (see claim 2). As shown in the following alignment, instant SEQ ID NO: 1 (top) shares more than 96% sequence identity with Corsini’s SEQ ID NO: 2 (bottom) over the full-length of the claimed sequence:
PNG
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352
642
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Greyscale
Regarding claim 49, Corsini teaches the endolysin has killing activity against species of the genus Gardnerella (see claim 8) which meets the limitation of “wherein the polypeptide…kill[s]…a bacteria”.
Regarding claim 50, Corsini teaches the method, wherein said bacterial infection is bacterial vaginosis (see claim 14).
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 48-50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 24-25 and 27 of copending Application No. 17/610,249 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are anticipated by the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 48, reference claim 24 of ‘249 recites “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 at least one 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 full-length SEQ ID NO:2, an amino acid sequence having at least 95% identity to full-length SEO ID NO:3, an amino acid sequence having at least 95% identity to full-length SEQ ID NO:4, an amino acid sequence having at least 95% identity to full-length SEQ ID NO:5, and an amino acid sequence having at least 95% identity to full-length SEQ ID NO:6; 2) an isolated nucleic acid encoding the polypeptide; and 3) a vector comprising the isolated nucleic acid.” Note that SEQ ID NOs 1-6 of reference application ‘249 are identical to instant SEQ ID NOs 1-6.
Regarding the limitation of “anti-Gardnerella spp. activity”, reference claim 1 recites “A polypeptide having anti-Gardnerella spp. activity comprising a hydrolase domain” and reference claim 3 recites “The polypeptide of claim 1, wherein the hydrolase domain comprises or consists of an amino acid sequence selected from any one of SEQ ID NOs: 1 to 6 or a sequence having at least 80, 85, 90, 95, 96, 97, 98, 99, 99.5 or 100% identity thereto or a fragment thereof.” Hence, it is understood that the amino acid sequences according to SEQ ID NOs 1 to 6 of the reference application have “anti-Gardnerella spp. activity”.
Regarding instant claim 49, reference claim 25 of ‘249 recites “The method according to claim 24, wherein the composition disperses, treats, and/or decolonizes a bacterial biofilm, and/or kills, or inhibits growth of, a bacteria.”
Regarding instant claim 50, reference claim 27 of ‘249 recites “The method according to claim 24, wherein the bacterial infection is bacterial vaginosis.”
Conclusion
No claims are allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DENNIS IGNATIUS ARMATO JR/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651