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 04/13/2026 is duly acknowledged.
Claims 1-20 as currently amended are pending in this application.
Election/Restrictions
Applicant's election with traverse of Species of claim 1 (including the step of “bringing a medium containing 2-hydroxy-1,4-naphthoquinone and water into contact with a conductor having a bacterium-derived biofilm” reading on claims 1-10 and 16-20) in the reply filed on 04/13/2026 (see REM, p. 1 and 6-8) is acknowledged. The traversal is on the ground(s) that inventions of species of claims 1 and 11 do not lack unity a priori because, as currently amended, the “process claim (Claim 1) and a sub-process or preparation claim (amended Claim 11) are related and the sub-process is a precursor step in the realization of the broader method” (see REM, p. 7).
Upon further considerations of the amended claims as currently presented by applicants, the requirement for election of species as previously made by the examiner, has been withdrawn, and both species (of claims 1 and 11) have been rejoined hereinafter.
Claims 1-20, as currently amended/presented (directed to “A biofilm activity adjusting method…”), have been examined on their merits in this office action hereinafter.
Priority
This application is a 371 of PCT/JP2022/023139 (filed on 06/08/2022), which claims foreign priority from a Japanese application JP 2021-099812 (filed on 06/16/2021).
Claims
Instant claims as presented have been interpreted as encompassing an in vitro method, wherein instant claims 10 and 17-18 are being taken as relating to an intended use.
Claim Objections
1. Claim 4 (as presented) is objected to because of the following informalities: claim 4 recites various limitations for genera of bacteria such as “Klebsiella”, “Enterobacter”, etc. (in lines 3-4), which have not been italicized or underlined in order to conform to the biological names of the bacterial genera (for instance “Klebsiella”). 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 1-20 (as amended/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.
Claim 1 as currently presented recites the following limitations:
“adjusting the biofilm activity by applying, to the conductor, a first electric potential of higher than a lower limit value of an electric potential window and -0.4 V or lower with respect to a silver/silver chloride electrode reference”
In addition, claim 11 recites the following limitations:
“applying, to the conductor, a second electric potential of higher than -0.4 V with respect to the silver/silver chloride electrode reference and lower than an upper limit value of the electric potential window to form the biofilm on the conductor”
It is noted that instant claims 1 and 11 as presented do not specifically define the “electric potential window” per se, and said term has not been defined by the applicants on record (see SPEC, p. 2, [0008], sections [1] and [11], for instance). Since, it is unclear as to what exact window of “electrical potential” is being employed (i.e. as a range), the recitations encompassing “lower limit” or “upper limit” values as required in claims 1 and 11, are ambiguous in scope and would be confusing to a person of ordinary skill in the art. Since, the electric potential applied (a variable employed in the process) would have to inherently depend from another variable (i.e. “electric power window”) that has not been explicitly defined in the claims, the scope of the process as claimed is deemed indefinite, because an artisan of ordinary skill in the art would not be appraised of the exact metes and bounds of the claimed invention.
Since, none of the dependent claims as presented clearly specify or define the claimed “electric potential window”, they are also deemed indefinite for the same reasons as discussed above.
For the purposes of this office action, the term has been taken as electric potential window pertinent to a silver/silver chloride reference electrode. Appropriate correction and/or explanation is required.
Claim Rejections - 35 USC § 103
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.
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.
1. Claims 1-10 and 16-18 (as amended/presented) are rejected under 35 U.S.C. 103 as being unpatentable over Ehrensberger et al (US 2015/0076000 A1; cited in IDS dated 08/14/2025) when taken with Aminin et al (2020; NPL cited as ref. [U] on PTO 892 form).
Claim 1 is directed to “A biofilm activity adjusting method, comprising:
bringing a medium containing 2-hydroxy-1,4-naphthoquinone and water into contact with a conductor having a bacterium-derived biofilm; and
adjusting the biofilm activity by applying, to the conductor, a first electric potential of higher than a lower limit value of an electric potential window and -0.4 V or lower with respect to a silver/silver chloride electrode reference.” (see also 112b rejection above; it is also noted that instant process as claimed does not require any specific type of “conductor”, the amount of “2-hydroxy-1,4-naphthoquinone” in the medium, or the amount of time the electric potential is being applied, per se).
Ehrensberger et al (2015), while teaching electrochemical eradication of microbes on surfaces of objects including implants that are affected by formation of bacterial biofilms (see Title, Abstract and [0004]-[0006]), regarding instant claims 1 and 10, disclose the method of reducing the biofilm forming activity comprising applying (for an appropriate treatment duration; see [0054]), to the conductor having biofilms, an electric potential of higher than a lower limit value of an electric potential window and -0.4 V or lower with respect to a silver/silver chloride electrode reference, wherein the number of biofilm forming microbes on the object/implant is reduced (see [0008], [0031], [0035], [0052]-[0053], for instance); wherein (regarding instant claims 2-3) the microbes may comprise gram negative or positive bacteria (see [0005], [0028], [0039]), including biofilms formed by bacteria from family of Enterobacteriaceae such as Acinetobacter sp. (see Example 1, [0016], [0062]); wherein (regarding instant claim 5) the conductor is an electrode made of a carbon or graphite material (see [0040], [0058], claim 10, for instance); wherein the method further comprises the step of providing an antimicrobial agent (including suitable antibiotics) to the region surrounding the implanted object being treated with said electric potential (see [0011], [0033], [0055], [0071], claim 5); wherein the method comprises providing information regarding the change in biofilm activity in terms of reduction in CFUs using suitable current density during treatments (see Figures 3-7; [0016]-[0020]; and [0053], [0065], [0068]), wherein effective reduction in CFUs was obtained using a current density of around -1 mA/cm2 (see Example 3, [0068], Figure 5, for instance), when compared to control samples under similar treatment conditions, the information of which can be used in order to determine changes in the biofilm activity upon a given treatment, i.e. determinations based on pre- and post-treatment evaluations of the current values observed (see Figures 3a-d, and Figures 4-6, for instance).
However, the method for adjusting biofilm activity comprising the step of - 1) bringing a medium containing 2-hydroxy-1,4-naphthoquinone and water into contact with a conductor having a bacterium-derived biofilm” (see instant claim 1); and 2) wherein bacterium belonging to Enterobacteriaceae is “at least one selected from a group consisting of genus Klebsiella, genus Enterobacter, genus Escherichia, genus Salmonella, genus Serratia, genus Shigella, and genus Yersinia” (see instant claim 4), has not been explicitly disclosed by the cited reference of Ehrensberger et al as discussed above (although, they do disclose the fact that the method that further comprises the step of including an antimicrobial agent such as an antibiotic before, during or after the treatment with electric potential in order to synergistically reduce bacteria-derived biofilm forming activity; see [0011], [0033], [0055], [0063], [0071], claim 5, and teachings discussed above).
Aminin et al (2020), while reviewing various biological properties and applications of 1, 4-naphthoquinones (see Title, Abstract, and Introduction, p. 46-48), disclose the fact that lawsone, 2-hydroxy-1,4-naphthoquinone (and derivatives thereof), historically known for its use in dying hair (a quinone compound naturally produced by tropical herb “henna”), has also been shown to possess anti-inflammatory as well as antimicrobial activities (see p. 49-50, sections 2.4-2.5, for instance), including their effects on reducing growth of various gram negative bacteria, such as Escherichia coli and biofilms formation thereof (see p. 50, section 2.5). Thus, Aminin et al clearly disclose the antibacterial and/or inhibitory effects of quinone compounds, including 1, 4-naphthoquinone derivatives on growth and proliferation of bacteria-derived biofilms.
Thus, to an artisan of ordinary skill in the art, given the beneficial disclosure from Aminin et al for use of antimicrobial agent such as natural derivatives of 1, 4-naphthoquinones (i.e. lawsone, 2-hydroxy-1, 4-naphthoquinones; see teachings above), it would have been obvious to combine and/or substitute another art-known, functional equivalent of an antimicrobial agent such as an effective quinone derivative found naturally, as taught by Aminin et al (i.e. in place of the antibiotic taught by Ehrensberger et al; see teachings discussed above) that is known to be used for the same purposes of inhibiting growth of bacteria-derived biofilms. Since, the two antimicrobial agents have been known to be employed for the same purposes, an artisan in the would have been motivated and would have had a reasonable expectation of success in replacing and/or substituting with said natural quinone in the method disclosed by Ehrensberger et al in order to obtain an effective alternative using safer, nature-based compound for the same purposes of inhibiting or controlling biofilm activity on a given surface as already taught by the cited prior art of Ehrensberger et al. Since, instant claim 1 does not require any specific amount and/or concentration of the quinone compound employed in the method as claimed, unless evidence/data provided on record to the contrary, such modification in the method of Ehrensberger et al (when taken with the disclosure from Aminin et al) would have been deemed obvious and/or fully contemplated by an artisan of ordinary skill in the art.
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 claimed.
Claims Free of Prior Art
Claims 11-15, 19 and 20 are deemed free of prior art issues, as the cited prior art does not teach and/or reasonably suggest the specific step of applying electric potential higher than -0.4 V (as recited in instant claims 11, 19 and 20) “to form the biofilm on the conductor” for preparing “the conductor having the bacterium-derived biofilm”.
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 1-10 and 16-18 (as amended/presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 4 of co-pending Application No. 18/569,539 (reference application; filed on the SAME day by the same inventors and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 4 of the co-pending application ‘539 is also directed to a “biofilm activity adjusting method” as reproduced below:
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As noted above, since the claims in two same day filed applications are clearly obvious and co-extensive in scope (see also the 103a rejection discussed above over the cited prior art references of Ehrensberger et al, 2015 taken with Aminin et al, 2020), an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 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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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
Prosecution Insights