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 .
Election/Restrictions
Applicant's election with traverse of Group 1, claims 1-16 in the reply filed on 11/07/2025 is acknowledged. The traversal is on the ground(s) that no serious search or examination burden has been shown, the process-apparatus and kit relationship is not patentably distinct on this record, and common “special technical feature unifies the groups”. This is not found persuasive because where a group of inventions is claimed in an application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression "special technical features" shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. In the instant case, the requirement of restriction mailed 9/12/2025 sets forth that among the groups the special technical feature is considered not a special technical feature in view of Sutter et al (US 2010/0136500), the methods of performing a periradicular surgery and the method of keeping a surgical site dry are considered to lack unity of invention due to no shared corresponding technical feature, and the methods do not share the same or corresponding technical feature with the surgical kit with instructions. Applicant argues that the shared corresponding feature of a “claimed geometry, sealing interface configuration and functional cooperation with the operative site” distinguishes from the art. The examiner disagrees, as there is no shared geometry or specific sealing interface which is common among the claimed inventions. With regard to the functional cooperation with the operative site, the prior art is capable of operating as disclosed in view of the disclosed figures 1 and 4, which position the opening adjacent to a treatment site.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.84(h)(5) because Figure 4, 5a, 5b, and 9 show(s) modified forms of construction in the same view. 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.
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 1-5, 8, and 10-12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Otsuka et al (US 2022/0079711).
Regarding claim 1, Otsuka discloses a borehole shield (figures 1-10) useful for performing an endodontic surgery wherein said endodontic surgery comprises removing a portion of the alveolar bone of a subject to create a borehole for accessing a treatment site (par 51-52 discloses the removal or opening of the root canal to position the guide member, seen in figures 2-4, 6-7, and 9-10), said borehole shield comprising:
a body (guide member 21, 21A/guiding tool 2B, 2B1), configured to fit the borehole (see figures 2-4, 6-7, and 9-10); and
a sealable opening (outlet port 2c/2Ac/2Bc/2B1c) disposed on the body (see figures 1-10),
wherein said sealable opening is capable of forming a seal around the treatment site to prevent surrounding biological fluid from entering the treatment site (this limitation is interpreted as intended use of the claimed invention, Otsuka ability to perform the intended use limitation is supported by the disclosure of par 23 which discloses positioning the guiding tool to enable access to the desired lateral branch, par 37 which discloses the guide being flexible or elastically deformable and therefore able to adapt to the root canal and par 63=45 which discloses positioning the outlet adjacent to the lateral branch; the disclosed flexibility and positionality of the opening would enable the opening to be positioned adjacent to the treatment site in a tight fit which would seal around the treatment site and prevent fluid from entering the treatment site. With regard to the statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over Otsuka which is capable of being used as claimed if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963)).
Regarding claim 2, Otsuka discloses the endodontic surgery is a periradicular surgery and the treatment site is the root of a tooth (see figures 2-4, 6-7, and 9-10).
Regarding claim 3, Otsuka discloses the body is hollow (see figures 1-10).
Regarding claim 4, Otsuka discloses the body has a shape selected from the group consisting of tubular, cylindrical, conic, bullet-like shape, truncated cone, and customized shape (see figures 1-10).
Regarding claim 5, Otsuka discloses portion of the body is made of an elastic material (par 37).
Regarding claim 8, Otsuka discloses the sealable opening has a polygonal or circular shape (see figures 1,5 and 9).
Regarding claim 10, Otsuka discloses comprises a guiding mechanism for guiding a surgical instrument to access the treatment site (holder 20C, see par 104 which discloses the holder as holding and guiding the tool into the guide device 2C), wherein said guiding mechanism is operatively connected to the body via an anchoring element (chuck part 20Ca).
Regarding claim 11, Otsuka discloses the guiding mechanism further comprises an annular portion (pivot part 21Cb) configured to allow a surgical instrument passing therethrough so as to guide the surgical instrument's access to the treatment site (see par 107 and figure 9).
Regarding claim 12, Otsuka discloses the body further comprises a slit (thread of the male screw part 2Ah, see figure 5) disposed thereon.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Otsuka et al as applied to claim 1 above, and further in view of Suter et al (US 2010/0136500).
Regarding claim 6, Otsuka discloses the claimed invention as set forth above in claim 1, and further discloses the body has a length from greater than 0.2 cm (see figure 5, where at least 15 mm are marked on the body 21, wherein par 44 discloses the numerals indicate length in mm), but fails to explicitly disclose the body has: a length from about 0.2 cm to about 10 cm, an inner size from about 0.2 cm to about 10 cm, and a thickness from about 0.1 mm to about 3 mm.
However, Suter discloses drill sleeve that teaches dimensions of the body (20) has a length from about 0.2 cm to about 10 cm (par 17 discloses a height of the drill sleeves is preferably about 3-8 mm), an inner size from about 0.2 cm to about 10 cm (an inner diameter of 2.8 mm, and a thickness from about 0.1 mm to about 3 mm (outer diameter 3.8mm subtracted from inner diameter 2.8 mm, would have a thickness of 1.00 mm) for the purpose of providing guidance for a dental drill when there is limited lateral space (par 7).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Otsuka to have the body have a length from about 0.2 cm to about 10 cm, an inner size from about 0.2 cm to about 10 cm, and a thickness from about 0.1 mm to about 3 mm as taught by Suter for the purpose of providing a desired guidance in a limited lateral space.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Otsuka et al.
Regarding claim 7, Otsuka discloses the claimed invention as set forth above in claim 1, and further discloses the opening (outlet port) being sized to enable passage of a surgical instrument (par 24 and figure 1), but fails to disclose the sealable opening has a size from about 3 mm to about 15 mm.
However, Otsuka disclosing an opening that allows for the passage of known surgical tools to operate on lateral wall at a specific position (figure 2 and par 41). The size of the opening would limit or allow the passage of a desired tool and is therefore considered a result effective variable which when changed affects the operability of the boreshield. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying Otsuka to have the opening be a size within the claimed range as it involves only adjusting the dimension of the opening or having it sized to allow the passage of the surgical tool.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention to modify the device of Otsuka to have the sealable opening has a size from about 3 mm to about 15 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Otsuka et al as applied to claim 12 above, and further in view of Takahashi (WO 2009/116650).
Regarding claim 13-14, Otsuka discloses the claimed invention as set forth above in claim 12, but fails to disclose the anchoring element connects the guiding mechanism to the body via the slit and the guiding mechanism is capable of being slidably displaced along the slit.
Takahashi teaches an anchoring element (elevation dial 4 of oral retainer 3) connecting to the body via the slit (lifting screw 2, see figure 1) and the anchoring element is capable of being slidably displaced along the slit (the elevation dial being slidably displaced by rotation to raise or lower relative to the lifting screw 2, see par 17).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Otsuka to have the anchoring element connects the guiding mechanism to the body via the slit and the guiding mechanism is capable of being slidably displaced along the slit as taught by Takahashi for the purpose of adjusting the guiding mechanism adjustable relative to the body.
Regarding claim 15, Otsuka further discloses the surgical instrument is selected from the group consisting of endoscopes, photo-taking devices, light sources, lasers, curettes, ultrasonically-powered tips, irrigation devices, and suction devices (par 24).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Otsuka et al as applied to claim 1 above, and further in view of Keles (WO 2022/146382).
Regarding claim 16, Otsuka discloses the claimed invention as set forth above in claim 1, but fails to disclose the body further comprises a mirror adapted to reflect an image of the treatment site.
Keles teaches a body (endoscope tube 2) comprising a mirror (3) adapted to reflect an image of the treatment site (page 3, lines 12-17) for the purpose of visualizing the inner and side walls of the canal during an operation or procedure (page 3, lines 15-18).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Otsuka to have the body further comprises a mirror adapted to reflect an image of the treatment site as taught by Keles for the purpose of enabling visualization of the inner and side walls of a root canal during a procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANNEL N BELK whose telephone number is (571)272-9671. The examiner can normally be reached Mon. -Fri. 11:30 am - 3:30 pm.
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/S.N.B./Examiner, Art Unit 3772
/THOMAS C BARRETT/SPE, Art Unit 3799