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 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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith US 2013/0172684.
Regarding Claim 1, Smith discloses a surgical access port (Fig 1), comprising:
an outer sheath (#150) having a tapered distal end (see Fig below);
an inner sleeve fitting (#1000) inside the outer sheath (see Fig below, Fig 7-8); and
a cannulated core (#100) fitting inside the inner sleeve (see Fig below),
wherein a distal opening of the outer sheath is configured to expand when the inner sleeve is inserted into the outer sheath (as seen in Fig 6-7 below, paragraph 46-47, when the inner sleeve is inserted, the distal opening is able to expand), and
wherein the cannulated core forms a first working channel and a second working channel between a first end of the cannulated core and an opposing second end of the cannulated core (see Fig below, paragraph 34).
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Regarding Claim 2, Smith discloses the outer sheath forms a flange surrounding the distal opening of the outer sheath (see Fig below).
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Regarding Claim 3, Smith discloses a proximal end of the inner sleeve is removably coupled to a proximal end of the outer sheath (see Fig below, paragraph 46 where the inner sleeve and outer sheath are separate components and where the proximal ends are capable of be removably coupled to each other, for example placing the proximal end of the inner sleeve as at least partially within the proximal end of the outer sheath).
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Regarding Claim 4, Smith discloses n the proximal end of the inner sleeve includes a deformable projection (see Fig above in claim 3 where the proximal end includes a groove with a rim or projection projecting from the groove) configured to fit into a cavity in the proximal end of the outer sheath (see Fig above in claim 3, paragraph 38 where the proximal end of the inner sleeve is flexible and is able to be compressed such that one can at least partially place the projection in a cavity of the outer sheath).
Regarding Claim 5, Smith discloses the cannulated core is an elastic material (paragraph 35 “resilient”).
Regarding Claim 6, Smith discloses the second working channel is narrower than the first working channel (see Fig 2 where the middle portion of the working channel is narrower than the first working channel)(examiner notes that applicant is not claiming how the second working channel is narrower).
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The examiner notes an alternate interpretation for claim 1 and 6 where the working channels are in communication with each other such that the second working channel is narrower than the first working channel, see below.
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Claims 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith US 2013/0172684.
Regarding Claim 9, Smith discloses surgical access port (Fig 1), comprising:
an outer sheath (#150) having a tapered distal end (see fig below);
an inner sleeve (#1000) fitting inside the outer sheath (see Fig below, Fig 7-8); and
a cannulated core (#100) fitting inside the inner sleeve (see Fig below),
wherein a distal opening of the outer sheath is configured to expand when the inner sleeve is inserted into the outer sheath (as seen in Fig 6-7 below, paragraph 46-47 when the inner sleeve is inserted, the distal opening is able to expand),
wherein the cannulated core forms a first working channel and a second working channel between a first end of the cannulated core and an opposing second end of the cannulated core (see Fig below, paragraph 34), and
wherein the first working channel and the second working channel form an angle of separation (see Fig below where the channels are separate and parallel to each other, forming an angle separation of 0 degrees) (it is noted that applicant is not claiming any specific values for the angle).
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Regarding Claim 10, Smith discloses the outer sheath forms a flange surrounding the distal opening of the outer sheath (see Fig below).
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Regarding Claim 11, Smith discloses a proximal end of the inner sleeve is removably coupled to a proximal end of the outer sheath (see Fig below, paragraph 46 where the inner sleeve and outer sheath are separate components and where the proximal ends are capable of be removably coupled to each other, for example placing the proximal end of the inner sleeve as at least partially within the proximal end of the outer sheath).
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Regarding Claim 12, Smith discloses n the proximal end of the inner sleeve includes a deformable projection (see Fig above in claim 3 where the proximal end includes a groove with a rim or projection projecting from the groove) configured to fit into a cavity in the proximal end of the outer sheath (see Fig above in claim 3, paragraph 38 where the proximal end of the inner sleeve is flexible and is able to be compressed such that one can at least partially place the projection in a cavity of the outer sheath).
Regarding Claim 13, Smith discloses the second working channel is narrower than the first working channel (see Fig 2 where the middle portion of the working channel is narrower than the first working channel)(examiner notes that applicant is not claiming how the second working channel is narrower).
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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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 7-8, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Smith US 2013/0172684in view of Opfermann US 2020/0121360.
Regarding Claim 7-8, 15 Smith discloses the claimed invention as discussed above but does not disclose a cannulated plug connected to the cannulated core via a tether, the cannulated plug forming a third working channel, wherein the cannulated plug is configured to be inserted into the second working channel and wherein the third working channel is narrower than the second working channel, wherein the tether includes a demarcation along a length of the tether.
Opfermann discloses a core (Fig 1a) with first and second working channels (see Fig below), a cannulated plug (see Fig below, paragraph 62-63) connected to the cannulated core via a tether (see Fig below), the cannulated plug forming a third working channel (see Fig below, paragraph 62-63 where the instruments can be inserted through the plug), wherein the cannulated plug is configured to be inserted into the second working channel (see Fig below, paragraph 62) and wherein the third working channel is narrower than the second working channel (see Fig below, paragraph 62, since the plug is inserted into the second working channel, the third working channel would be smaller/narrower to accommodate surgical instruments of reduced diameters), wherein the tether includes a demarcation along a length of the tether (see Fig below where along a middle portion of its length, the tether has a reduced diameter section defining a demarcation for the tether)(examiner notes the structure for the demarcation is not specifically claimed), where the plug acts as an adapter to accommodate a wide variety of differently sized tools of reduced diameters (paragraph 62-63),
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the core of Smith to include a cannulated plug and a tether in view of Opfermann above because the tether holds onto the plug, where the plug acts as an adapter to accommodate a wide variety of differently sized tools of reduced diameters.
Claim 14 are rejected under 35 U.S.C. 103 as being unpatentable over Smith US 2013/0172684in view of Okoniewski US 2011/0082343.
Smith discloses the claimed invention as discussed above but does not disclose the angle of separation between the first working channel and the second working channel is an acute angle.
Okoniewski discloses a core (#100, Fig 2b), with first and second working channels (see Fig below), wherein the first working channel and the second working channel form an acute angle of separation (paragraph 35 and see Fig 2b where the core #200 is similar to core #100 having first and second working channels #108a, #108b forming an angle of separation “theta”, see also paragraph 27) which allows for less probability of interreference from instruments inserted in the working channels and allows greater/reach access to anatomy within the surgical field (paragraph 27).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the first and second working channels to have an acute angle of separation in view of Okoniewski above because the angle of separation allows for less probability of interreference from instruments inserted in the working channels and allows greater/reach access to anatomy within the surgical field.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Smith US 2013/0172684in view of Okoniewski US 2011/0082343.
Regarding Claim 9, Smith discloses surgical access port (Fig 1), comprising:
an outer sheath (#150) having a tapered distal end (see fig below);
an inner sleeve (#1000) fitting inside the outer sheath (see Fig below, Fig 7-8); and
a cannulated core (#100) fitting inside the inner sleeve (see Fig below),
wherein a distal opening of the outer sheath is configured to expand when the inner sleeve is inserted into the outer sheath (as seen in Fig 6-7 below, paragraph 46-47 when the inner sleeve is inserted, the distal opening is able to expand),
wherein the inner sleeve is removably coupled to the outer sheath (see Figs below, paragraph 46 where the inner sleeve and outer sheath are separate components and where the proximal ends are capable of be removably coupled to each other, where one is able to remove the inner sleeve from the outer sheath);
wherein the cannulated core forms a first working channel and a second working channel between a first end of the cannulated core and an opposing second end of the cannulated core (see Fig below, paragraph 34), and
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Smith discloses the first and second working channels are for receiving instruments (paragraph 10, 36) but does not disclose wherein the first working channel and the second working channel form an angle of separation and wherein an outer wall of the cannulated core forms a notch at a proximal end of the cannulated core oriented towards a proximal opening of the second working channel.
Okoniewski discloses a core (#200, Fig 3), with first (#208) and second working channels (#208), wherein the first working channel and the second working channel form an angle of separation (paragraph 35 and see Fig 2b where the core #200 is similar to core #100 having first and second working channels forming an angle of separation “theta”, see also paragraph 27) which allows for less probability of interreference from instruments inserted in the working channels and allows greater/reach access to anatomy within the surgical field (paragraph 27) and
wherein an outer wall (see Fig below, an outer upper wall of the core) of the cannulated core forms a notch (#2101) at a proximal end of the cannulated core oriented towards a proximal opening of the second working channel (see Fig below) where the notch facilitates stabilization of an instrument inserted in the second working channel (paragraph 35).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to 1. modify the first and second working channels to have an angle of separation and 2. to include a notch in view of Okoniewski above because 1. the angle of separation allows for less probability of interreference from instruments inserted in the working channels and allows greater/reach access to anatomy within the surgical field and 2. the notch facilitates stabilization of an instrument inserted in the second working channel.
Regarding Claim 17, Smith as modified discloses the outer sheath forms a flange surrounding the distal opening of the outer sheath (see Fig 7 of Smith below).
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Regarding Claim 18, Smith as modified discloses the angle of separation between the first working channel and the second working channel is an acute angle (with the modification in view of Okoniewski the angle is an acute angle, as seen in Fig 2b in Okoniewski and paragraph 27, it is noted that angles greater than an acute angle would cause the openings to extend through lateral sides of the core and not through the top and bottom of the core).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Smith US 2013/0172684in view of Okoniewski US 2011/0082343, as applied to claim 16 above, and in further view of Opfermann US 2020/0121360.
Regarding Claim 19, Smith as modified discloses the claimed invention as discussed above but does not disclose the second working channel is narrower than the first working channel.
Opfermann discloses a core (#700, Fig 7a-7b) having first and second working channels (#710, #715) where the second working channel is narrower than the first working channel (Fig 7a-7b) to accommodate instruments (#722, #721) with different diameters (paragraph 77, Fig 7a-7b).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Smith as modified to have the second working channel be narrower than the first working channel in view of Opfermann above such that working channels can accommodate instruments of different diameters, where the second working channel can be used to accommodate instruments with a smaller diameter.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Smith US 2013/0172684in view of Okoniewski US 2011/0082343, as applied to claim 16 above, and in further view of Opfermann US 2020/0121360.
Regarding Claim 20, Smith as modified discloses the claimed invention as discussed above but does not disclose a cannulated plug connected to the cannulated core via a tether, the cannulated plug forming a third working channel, wherein the cannulated plug is configured to be inserted into the second working channel and wherein the third working channel is narrower than the second working channel.
Opfermann discloses a core (Fig 1a) with first and second working channels (see Fig below), a cannulated plug (see Fig below, paragraph 62-63) connected to the cannulated core via a tether (see Fig below), the cannulated plug forming a third working channel (see Fig below, paragraph 62-63 where the instruments can be inserted through the plug), wherein the cannulated plug is configured to be inserted into the second working channel (see Fig below, paragraph 62) and wherein the third working channel is narrower than the second working channel (see Fig below, paragraph 62, since the plug is inserted into the second working channel, the third working channel would be smaller/narrower to accommodate surgical instruments of reduced diameters), where the plug acts as an adapter to accommodate a wide variety of differently sized tools of reduced diameters (paragraph 62-63).
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the core of Smith as modified to include a cannulated plug and a tether in view of Opfermann above because the tether holds onto the plug, where the plug acts as an adapter to accommodate a wide variety of differently sized tools of reduced diameters.
Conclusion
See PTO-892 for art of cited interest, in particular other surgical access ports with cores.
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.
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, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773