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
The restriction requirement dated December 9, 2025 is hereby withdrawn since it referred to another application and not the present application.
Claim Objections
Claims 1, 3, and 4 are objected to because of the following informalities:
Claim 1 recites the limitation “a sheath flexible portion” in line 5-6 of the claim. The claim later recites the limitations “the sheath flexible portion” in line 9 of the claim and “the flexible portion” in line 10 of the claim. claim 3 also refers to the limitation as “the sheath flexible portion” in lines 3-4 of the claim. Therefore, it is suggested the limitation in line 10 of claim 1 be changed to “the sheath flexible portion” to consistently refer to the limitation in lines 5-6 of claim 1.
Claim 3 recites the limitation “the internal lumen” in line 2 of the claim. Claim 1 previously introduces “an internal lumen” in line 4-5 of the claim and later recites “the lumen” in line 13 of the claim. It is suggested the limitation “the lumen” in line 13 of claim 1 be changed to “the internal lumen” to consistently refer to the limitation in lines 4-5 of claim 1 throughout all of the claims.
Claim 4 recites the limitation “the gradually bent flexible portion of the sheath” in line 3 of the claim. Although it is clear this refers to when claim 1 recites the limitation “gradually bending the flexible portion” in line 10 of the claim, it is suggested this limitation be changed to “the bent flexible portion of the sheath when it is gradually bent” to maintain antecedent basis for refer to the limitation “a sheath flexible portion” in claim 1.
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.
Claims 1-20 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 recites the limitation “a sheath flexible portion” in line 5-6 of the claim, “the sheath flexible portion” in line 9 of the claim, and “the flexible portion” in line 10 of the claim. It is unclear whether the limitation “the flexible portion” in line 10 refers to the same “the sheath flexible portion” in lines 5-6 and 9 of the claim or an additional flexible portion. The examiner interprets the limitation to be “the sheath flexible portion” for examination purposes.
Claim 3 recites the limitation “the working channel” in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 only previously provides antecedent basis for the limitation “a working channel device” in line 2 of the claim.
Claim 4 recites the limitation “said inserting the arthroscopic tool through the internal lumen of the sheath” in lines 1-2 of the claim. There is insufficient antecedent basis for this step in the claim since the step of “inserting the arthroscopic tool through the internal lumen of the sheath” has only been previously recited in claim 3 and not claim 2 from which the claim depends. The examiner interprets the limitation to be “wherein said accessing includes inserting the arthroscopic tool through the lumen of the sheath and…” for examination purposes.
Claim 10 recites the limitation “the shaft flexible portion” in lines 1-2 of the claim. There is insufficient antecedent basis for this limitation since claim 1 only previously recites “a sheath flexible portion” in line 5-6 and not a ‘shaft flexible portion’ as recited in the claim. The examiner interprets the limitation to b e “the sheath flexible portion” for examination purposes.
Claims 11-14 recite the limitation “The arthroscopic surgical device of claim 1” in line 1 of the claims, respectively, which renders the claims indefinite since claim 1 is directed to a method of arthroscopic treatment rather than a device. Claim 1 only recites “an arthroscopic tool” in a step of the method in line 12-13 of the claim, but does not disclose an ‘arthroscopic surgical device’ as referenced in claims 11-14. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. See MPEP 2173.05(p).
Claim 15 recites the limitation “the spine distal portion” in lines 4, 5-6, 7-8, and 10 of the claim. There is insufficient antecedent basis for this limitation in the claim since the claim only previously introduces “a distal portion of the spine” in line 4 of the claim and not a spine distal portion. It is suggested these limitations be changed to “the distal portion of the spine” to consistently refer to the first limitation in line 4. The examiner interprets the limitation to be “the distal portion of the spine” for examination purposes.
Claims 16, 18, and 19 recite the limitation “The arthroscopic surgical device of claim 15” in line 1 of the claims, respectively, which renders the claims indefinite since claim 15 is directed to the method of arthroscopic treatment of claim 1 and not a device. Claim 1 only recites “a working channel device” and “an arthroscopic tool” in a step of the method in line 12-13 of the claim, but does not disclose an ‘arthroscopic surgical device’ as referenced in claims 16, 18, and 19. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. See MPEP 2173.05(p).
Claims 17 recite the limitation “The arthroscopic surgical device of claim 16” in line 1 of the claims, respectively, which renders the claims indefinite since claim 15 from which claim 16 depends is directed to the method of arthroscopic treatment of claim 1 and not a device. Claim 1 only recites “a working channel device” and “an arthroscopic tool” in a step of the method in line 12-13 of the claim, but does not disclose an ‘arthroscopic surgical device’ as referenced in claims 16, 18, and 19. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. See MPEP 2173.05(p).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-14 and 16-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 11-14 recite the limitation “The arthroscopic surgical device of claim 1” in line 1 of the claims, respectively, which fails to include all the limitations of the claim upon which it depends, since it omitting the method of claim 1. Furthermore, it fails to further limit a limitation of the independent claim since claim 1 also only recites “an arthroscopic tool” in a step of the method in line 12-13 of the claim, but does not disclose an ‘arthroscopic surgical device’ as referenced in claims 11-14. Therefore, claims 11-14 are improper dependents.
Claims 16, 18, and 19 recite the limitation “The arthroscopic surgical device of claim 15” in line 1 of the claims, respectively, which fails to include all the limitations of the claim upon which it depends, since it omitting the method of claim 1. Furthermore, it fails to further limit a limitation of the independent claim since claim 1 also only recites “an arthroscopic tool” in a step of the method in line 12-13 of the claim, but does not disclose an ‘arthroscopic surgical device’ as referenced in claims 16, 18, and 19. Therefore, claims 16, 18, and 19 are improper dependents. Claim 20 is also an improper dependent since it depends on claim 19.
Claims 17 recites the limitation “The arthroscopic surgical device of claim 16” in line 1 of the claims, respectively, which fails to include all the limitations of the claim upon which it depends, since it omitting the method of claim 1. Furthermore, it fails to further limit a limitation of the independent claim since claim 1 also only recites “an arthroscopic tool” in a step of the method in line 12-13 of the claim, but does not disclose an ‘arthroscopic surgical device’ as referenced in claim 16 and 17. Therefore, claim 17 is an improper dependents.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Smith (US 20170065290).
Regarding claim 1, Smith teaches a method of arthroscopic treatment comprising: positioning an outlet (194) of a working channel device (figure 6A-6D) within tissue of a subject, wherein the working channel device comprises: an elongated sheath (180) arranged along a sheath longitudinal axis, the sheath having an internal lumen (196) running along the sheath longitudinal axis and the sheath comprising a sheath flexible portion (184); and an elongated spine (190, 182) arranged along a spine longitudinal axis, the spine connected to the sheath (figure 6A, 6B), the spine comprising a spine joint (182); wherein the sheath flexible portion axially overlaps with the spine joint (see image below), and; bending the spine only at the spine joint (angulation of spine joint 182, paragraph 0071) thereby gradually (the limitation ‘gradually’ is sufficiently broad to encompass the practitioner performing movement along guide notches or while watching a video feed, paragraphs 0071-0072) bending the flexible portion to reposition the outlet (paragraph 0071, 0072 and repeated change from straight to angled form, paragraph 0073); initially inserted in its straight configuration and then angulation of the joint assumes its angled configuration); and treating tissue at a treatment site within tissue of the subject with an arthroscopic tool (cutting tool) accessing the treatment site from the lumen and through the outlet (paragraph 0073).
Regarding claim 2, Smith teaches method of claim 1, wherein the spine joint (182) is radially offset from the sheath longitudinal axis (figure 6D).
Regarding claim 3, Smith teaches method of claim 1, wherein said accessing includes inserting the arthroscopic tool through the internal lumen of the sheath and through the outlet of the working channel, to position a flexible portion of the arthroscopic tool in an axially overlapping position with the sheath flexible portion (paragraph 0073, cutting tool passed through pivot point and then redirected with linkage to enter disc laterally).
Regarding claim 4, Smith teaches method of claim 2, wherein said accessing includes inserting the arthroscopic tool through the internal lumen of the sheath and gradually bending the arthroscopic tool at a flexible portion of the arthroscopic tool (redirect cutting device with linkage, paragraph 0073, paragraph 0071 describes aiding practitioner to bend gradually along notches or indicia to get a particular angle), as the arthroscopic tool passes through the gradually bent flexible portion of the sheath (paragraph 0073).
Regarding claim 5, Smith teaches method of claim 1, wherein the spine is rigid in a direction of elongation of the spine (defined as a rod, and thus rigid).
Regarding claim 6, Smith teaches method of claim 1, wherein the sheath longitudinal axis and the spine longitudinal axis are aligned, for at least a portion of a sheath longitudinal length (figures 6A, 6B).
Regarding claim 7, Smith teaches method of claim 1, wherein the treatment site is within a joint of the subject (spinal disc, paragraph 0003, 0008, 0009, 0073).
Regarding claim 8, Smith teaches method of claim 1, wherein the sheath is rigidized by the spine (rod is within the sheath and therefore rigidizes it).
Regarding claim 9, Smith teaches method of claim 1, where the outlet is an outlet of the sheath (distal most end of portion 194 of the sheath); and wherein said bending comprises bending the spine at the spine joint to bend the sheath (figure 6D).
Regarding claim 10, Smith teaches method of claim 1, wherein said bending includes conforming the shaft flexible portion to an angle of the spine joint (figure 6D).
Regarding claim 11, Smith teaches method of claim 1, wherein the spine joint is positioned in a distal portion of the spine (figure 6C, 6D).
Regarding claim 12, Smith teaches method of claim 1, wherein the spine joint is a pivot joint (6A-6D, 184, paragraph 0073).
Regarding claim 14, Smith teaches method of claim 1, wherein the sheath flexible portion is radially expandable (expands in a radial direction since the overall width of the device increases by the angled distal portion).
Claim Rejections - 35 USC § 103
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.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 20170065290).
Regarding claim 13, Smith teaches method of claim 1, wherein said bending the spine joint includes bending the spine joint from a straight orientation in a single bending plane between 0-90° (figures 6A-6D), but does not specifically disclose in this specific embodiment that the angle is by 0-130°. However, Smith teaches that it was known in the art at the time of the invention to make the arthroscopic tool configured to bend at any angle between 1-90° or even more than 90° (paragraph 0079). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the spine joint bend by 0-130° in order to allow the arthroscopic tool to be advanced into and cut the desired portion of the disc material since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and to resolve the 112(b) issues identified above.
Claims 16-19 would also be subsequently allowable if re-written to overcome the 112(b) and 112(d) rejections set forth above and in independent form including all of the limitations of the base claim and any intervening claims since they depend off of claim 15. .
The following is a statement of reasons for the indication of allowable subject matter: The claims have not been rejected over the body of prior art because although Smith further teaches the spine comprises: a first elongated spine rod (190); a second elongated spine rod (182, figure 6D, shows 182 as a second smaller rod); a distal portion of the spine (190a), wherein said bending of the spine joint includes axial movement of the first spine rod in a distal direction to change an angle of the spine distal portion with respect to long axes of the first and the second spine rods (figure 6D), the prior art fails to teach the combination of limitations in claims 1 and 15, wherein the method includes the spine distal portion attached to a distal end of the a spine rod at a first point on the spine distal portion and is attached to a second spine rod at a second point on the spine distal portion, spaced from the first point, in order to bend the spine joint in a distal direction to change an angle of the spine distal portion with respect to the long axes of the first and second spine rods, since there is no teaching, suggestion, or motivation to produce the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771