DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Response to Arguments
Applicant’s amendment has overcome the previous rejections made in view of Pingleton.
In view of applicant’s amendments, new rejections were made in view of Fig 17 of Taylor.
In response to applicant's argument (rejections made in view of Fig 9 of Taylor) that retention member #155 is external to the body and thus does not disclose “configured for insertion into a body cavity”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Applicant is not claiming a method and there is nothing precluding the retention member/ring #155 of being placed in a body cavity.
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.
Claim 13 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.
Claim 13 recites that only the arcuate members are adjustable but Paragraph 39 in the current specification recites “Each arcuate member 342 is rotatable relative to an adjacent straight member 344 around a local longitudinal axis, resulting in a reshapeable inner ring 330.” Since the arcuate member can rotate about the straight member, it stands to reason that when holding onto the arcuate member, the straight member could also be rotatable adjusted. As such, it is not clear how only the arcuate members are adjustable. It seems that this is intended use, that the one is capable of only adjusting the arcuate members. Clarification is requested and the examiner will treat with art as best understood.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 3-5, 7-11, 13, 15, 22 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Taylor US 2004/0054353.
Regarding Claim 1, Taylor discloses a tissue retractor (Fig 17, it is noted that Fig 17 shares similar features to that of Fig 4, paragraph 75) comprising:
an instrument access channel (#80, see Fig below, paragraph 69) extending from a proximal end to a distal end and defining a longitudinal axis (see Fig below);
an outer ring (see Fig below);
a reshapeable inner ring (see Fig below) configured for insertion into a body cavity (this limitation is intended use and the inner ring is capable of being placed in a body cavity), wherein the reshapeable inner ring comprises a plurality of arcuate members (see Fig below, where there are at least two arcuate members, one has teeth #295, one has pawl #296) connected together to define a closed loop (see Fig below), wherein an angle of one or more of the plurality of arcuate members is adjustable (see Fig below where the angle between two end surfaces of two of the arcuate members relative to the center of the inner ring is adjustable, paragraph 80-81) thereby reshaping a shape of the inner ring such that the inner ring is configured to maintain more than one reshaped configuration (paragraph 80-81) such that the reshapeable inner ring is selectively reshapeable upon insertion (paragraph 80-81, capable of being reshaped after insertion); and
a flexible sheath (#75, see Fig below, paragraph 71, see also Fig 9) extending between the outer ring and the inner ring, wherein the longitudinal axis defined by the instrument access channel extends through the outer ring, the inner ring, and the sheath (see Fig below).
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Regarding Claim 3, Taylor discloses an orientation of one or more of the plurality of arcuate members is adjustable (paragraph 80-81, see Fig in claim 1 where the orientation of one of the end surfaces from one of the members relative to the other is adjustable, thereby also adjusting the angle as discussed in claim 1 above).
Regarding Claim 4, Taylor discloses an adjustment of one or more of the plurality of arcuate members comprises rotating the orientation of one of the plurality of arcuate members with respect to an adjacent arcuate member (Fig 17, paragraph 80, 81 ,where one of the members, for example, the one that has the pawl #296 is rotated clockwise or counter clockwise about the longitudinal axis to adjust the angle and diameter of the inner ring).
Regarding Claim 5, Taylor discloses the rotating of the one arcuate members is around a local longitudinal axis of the inner ring (as discussed above in claim 4).
Regarding Claim 7, Taylor discloses each of the plurality of arcuate members are adjustable (paragraph 80-81, arcuate members are adjusted to adjust the diameter of the ring).
Regarding Claim 8, Taylor discloses each of the plurality of arcuate members have varying lengths with respect to other arcuate members (as seen in Fig 17, Fig in claim 1 above, the member with teeth #295 is longer than the one with pawl #296).
Regarding Claim 9, Taylor discloses a number of arcuate members making up the inner ring correspond to lengths of each of the plurality of arcuate members making up the inner ring (as seen in Fig 17, where the arcuate members make up the inner ring)
Regarding Claim 10, Taylor discloses one or more of the plurality of arcuate members are lockable thereby preventing subsequent adjustments to each of the plurality of arcuate members that are in a locked state (paragraph 81 locked via pawl #296 engaged in one of the teeth #295).
Regarding Claim 11, Taylor discloses the closed loop of the inner ring is further defined with a plurality of straight members (#291, #292, Fig 17) that are connected with the plurality of arcuate members (Fig 17, see Fig above in claim 1).
Regarding Claim 13, Taylor discloses wherein only the plurality of arcuate members are adjustable (paragraph 81, Fig 17 where the curvature of the arcuate members are adjusted to adjust the diameter of the closed ring while the straight members #291, #292 remain straight and their dimensions do no vary when when adjusting the diameter of the closed ring).
Regarding Claim 15, Taylor discloses the shape of the inner ring is lockable under one of tension and compression thereby preventing further adjustments (paragraph 81 locked via pawl #296 engaged in one of the teeth #295 in tension).
Regarding Claim 22, Taylor discloses the reshapable inner ring is selectively reshapable to conform to the body cavity (paragraph 81, selectively reshapable via pawl #296 in one of the teeth #295 and thus capable of conforming to a diameter of the body cavity).
Claims 1, 2, 11, 12, 14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Taylor US 2004/0054353.
Regarding Claim 1, Taylor discloses a tissue retractor (Fig 9, which is similar to that of Fig 4, paragraph 75) comprising:
an instrument access channel (#80, paragraph 69) extending from a proximal end (where ring #65 is located, Fig9) to a distal end (where ring #155 is located, Fig 9) defining a longitudinal axis (axis extending vertically through channel #80, Fig 9) defining;
an outer ring (#65);
a reshapeable inner ring (#155) configured for insertion into a body cavity, (this limitation is intended use and the ring #155 is capable of being inserted into a body cavity), wherein the reshapable inner ring comprises a plurality of arcuate members (#156, #157, Fig 9, paragraph 73) connected together to define a closed loop (Figs 9),
wherein an angle of one or more of the plurality of arcuate members is adjustable thereby reshaping a shape of the inner ring such that the inner ring is configured to maintain more than one reshaped configuration such that the reshapeable inner ring is electively reshapeable upon insertion (paragraph 75 where actuating a single sleeve #200 or #220 can alter the shape of the inner ring and change an angle between the arcuate members, see also Fig 12, where the shape can be maintained unless one of the sleeves is actuated where reshaping of the ring is capable of being selectively reshaped upon insertion)(as discussed in the Response to Arguments section above, the inner ring #155 is capable of being placed in a body cavity) ); and
a flexible sheath (#75, paragraph 71, Fig 9) extending between the outer ring and the inner ring (Fig 9),
wherein the longitudinal axis defined by the instrument access channel extends through the outer ring, the inner ring, and the sheath (Fig 9, extends completely through the retractor to allow objects to pass completely through the channel, likewise, the longitudinal axis extends through the two rings and sheath).
Regarding Claim 2, Taylor discloses the plurality of arcuate members are connected using link elements (connecting each arcuate member would be “adjusting screws” paragraph 75, #210, #230)
Regarding Claim 11, Taylor discloses wherein the closed loop of the inner ring is further defined with a plurality of straight members that are connected with the plurality of arcuate members (Fig 9, where straight members #210 #230 are connected with the arcuate members).
Regarding Claim 12, Taylor discloses wherein the closed loop is defined with the plurality of arcuate members and the plurality of straight members (as discussed in claims 1, 11 above), and the closed loop has convex and concave sections (Fig 9, the exterior of the closed loop is convex and the interior is concave).
Regarding Claim 14, Taylor discloses the plurality of arcuate members and the plurality of straight members are connected end-to-end in an alternating configuration (as seen in Fig 9, the straight members are between the arcuate members).
Claims 16-18, 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Taylor US 2004/0054353.
Regarding Claim 16, Taylor discloses a tissue retractor (Fig 9, which is similar to that of Fig 4, paragraph 75) comprising:
an instrument access channel (#80, paragraph 69) extending from a proximal end (where ring #65 is located, Fig 9) to a distal end (where ring #155 is located, Fig 9) defining a longitudinal axis (axis extending vertically through channel #80, Fig 9) defining;
an outer ring (#65);
a reshapable inner ring (#155) configured for insertion into a body cavity (this limitation is intended use and the inner ring #155 is capable of being placed in a body cavity) that comprises a plurality of members comprising more than three members (Fig 9, while only two members #156, #158 are shown, see paragraph 75 where there can be at least a third and fourth sleeves such that there would be at least a third member and fourth member, not shown), the plurality of members comprising arcuate members (see 9 where at its smallest diameter, the members form a ring/circle and as such each would be arcuate), wherein the arcuate members are connected together to define a closed loop (Fig 9) having convex (Fig 9, outer section of each member that faces away from the other members) and concave sections (Fig 9, inner section of each member that faces other members), and wherein an angle of one or more of the plurality of members are adjustable thereby reshaping a shape of the convex or concave sections of the closed loop of the inner ring such that the inner ring is configured to maintain more than one reshaped configuration such that the reshapeable inner ring is selectively reshapeable upon insertion (paragraph 75 where actuating a single sleeve #200, or #220, the third or fourth sleeve can alter the shape of the inner ring and change an angle between the arcuate members, see also Fig 12, likewise , see paragraph 75 where each sleeve can be actuated non-uniformly from each other, which would also adjust the angle between the members and reshape the ring, where the shape of the ring is maintained unless actuation of one of the sleeves, where reshaping of the ring is capable of being selectively reshaped upon insertion)(as discussed in the Response to Arguments section above, the inner ring #155 is capable of being placed in a body cavity); and
a flexible sheath (#75, paragraph 64) extending between the outer ring and the inner ring (Fig 9),
wherein the longitudinal axis defined by the instrument access channel extends through the outer ring, the inner ring, and the sheath (Fig 9, extends completely through the retractor to allow objects to pass completely through the channel, likewise, the longitudinal axis extends through the two rings and sheath).
Regarding Claim 17, Taylor discloses the plurality of members further comprises straight members (#210, #230, Fig 9, paragraph 75 where more straight members may be included such as four or more), wherein the arcuate and straight members are connected together end-to-end to define the closed loop (as seen in Fig 9, paragraph 75, there would be straight members in between arcuate members) having convex and concave sections (Fig 9, exterior of the closed loops is convex and the interior is concave).
Regarding Claim 18, Taylor discloses the arcuate and straight members are connected together in an alternating configuration (as seen in Fig 9, paragraph 75, there would be straight members in between arcuate members).
Regarding Claim 20, Taylor discloses each of the plurality of member is adjustable (paragraph 75, as discussed above in claim 16, where each member is adjustable via actuation of a respective sleeve).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Taylor US 2004/0054353.
Taylor discloses the claimed invention as discussed above in claim 16, where there can be more than one two arcuate members (paragraph 75 where there can be four or more sleeves such that there are four or more arcuate members) and allows for non-uniform stretching of the sheath (paragraph 75) but does not disclose wherein lengths for each of the plurality of members can differ.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to place the third and fourth sleeves of Taylor to be placed unevenly with respect to the other two sleeves (#220, #200) such that each of the members have different lengths, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. See MPEP 2144.04 (VO)(C). Furthermore, the examiner notes that it would have been obvious to one having ordinary skill in the art at the time the invention was made to place the third and fourth sleeves of Taylor to be placed unevenly with respect to the other two sleeves (#220, #200) since this provides one of two finite possibilities for placing the third and fourth sleeves (evenly or unevenly)(see also MPEP 2143 (I)(E) for adjustment of the ring and would also provide non-uniform stretching of the sheath (paragraph 75). Examiner notes that applicant has not provided any criticality for having different lengths.
Allowable Subject Matter
Claim 21 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 any intervening claims.
See PTO-892 for art of cited interest, in particular Rodriguez (Fig 3a-3b) but the publication and filing dates do not qualify as prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773