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 .
Priority
The examiner notes that support for claims was found in US Provisional Application 63,390,842 and as such the claims have an effective filing date of July 20, 2022.
Response to Arguments
Applicant's arguments filed 8/16/2025 have been fully considered but they are not persuasive. Applicant argues that Edoga does not disclose a hollow interior central lumen. The examiner disagrees as even though members #14a and #14b, are placed in the hollow interior, the interior itself is still hollow such that it can be filled by members #14a-14b. Likewise, removal of #14a and #14b and the central lumen is still hollow. Alternatively, even if #14a and #14b are considered to be part of the body member, see paragraph 33 where at #16, an instrument, such as a tube, can pass there through and thus define a hollow interior lumen. Likewise, with the amendments, new rejections were made in view of Worrel.
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.
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.
Claims 1-3, 5 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Edoga US 2006/0129165.
Regarding Claim 1, Edoga discloses a cannula (Figs 2-4) for surgical procedures (paragraph 33), the cannula comprising:
a body member having an inner wall forming a hollow interior central lumen along at least a proximal portion of a length of said body member to form a port for a surgical tool (see Fig below, paragraph 33 where an inner wall defines a hollow interior central lumen, where gel membranes #14a-b are able to be placed inside hollow the interior central lumen and where instruments are able to pass though the lumen, alternatively a tube or similar instrument can be placed through gel members at #16 and define the hollow interior);
a hollow exterior central lumen formed above said hollow interior central lumen (see Fig below, paragraph 33, 45 where the central lumen is hollow to allow instruments to pass therethrough), said hollow exterior central lumen having an opening at a top end (see Fig below), and said exterior central lumen also having a bottom wall separating said interior central lumen from said hollow exterior central lumen (see Fig below), said bottom wall having one (#32, paragraph 40, where the slit is in the form of a perforation) or more slits formed thereon; and
a plurality of flexible fins (#26) formed on said body member, wherein a cavity is disposed within each of said plurality of flexible fins (see Fig below, Fig 3-4), wherein an elongate shaft is embedded within each of said cavities (paragraph 33, 38 where each fin as at least one shaft or “strip” of shape memory material embedded in respective cavities).
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In the alternative, Edoga discloses a perforation (#32) that ruptures/tears upon entry of an instrument (paragraph 40) but does not explicitly disclose the perforation is in the form of a slit.
However, 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 have the perforation of Edoga be in the form of a slit since this is a typical shape/type opening for perforations and provides a known shape for instruments to pass there-through. Examiner notes that a change of shape is usually within the skillset of one of ordinary skill in the art [See MPEP 2144.04 (IV)(B)].
Regarding Claim 2, Edoga discloses each elongate shaft is naturally biased in an outward direction (paragraph 39-40, Fig 4 where pull ties #28 hold the shafts in generally straight configuration).
Regarding Claim 3, Edoga discloses a distal tip of each elongate shaft protrudes from a distal end of the respective cavities in which each of said elongate shaft is embedded within (see Fig above in claim 1 where each distal tip protrudes past their respective fins and thus protrudes from a distal end of their respective cavity).
Regarding Claim 5, Edoga discloses each elongate shaft comprises a shape memory alloy (paragraph 39).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Edoga US 2006/0129165 in view of Fogarty US 2002/0059938.
Edoga discloses the claimed invention as discussed above where each of the elongate shafts are made from a shape memory material such as nitinol (paragraph 39) that are naturally biased outward (paragraph 39-40, see also rejection for claim 2 above) but does not disclose each elongate shaft comprises a polymer.
Fogarty, pertinent in the field of shape memory materials that are biased outwardly, teaches an elongate shaft (#200, Fig 3a) made from a shape memory material (paragraph 159), that when unconstrained, is biased outwardly in a curved shape (paragraph 159), where the shape memory material can be an alloy such as nitinol or a shape memory polymer (paragraph 159).
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 elongate shafts of Edoga to be made from a shape memory polymer in view of Fogarty because this is a known alternative shape memory material that can be made to be naturally biased outwardly.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Worrel US 2012/0065589 in view of Edoga US 2006/0129165.
Regarding Claim 1, Worrel discloses a cannula (Fig 1, 3, 10) for surgical procedures, the cannula comprising:
a body member (#108) having an inner wall forming a hollow interior central lumen along at least a proximal portion of a length of said body member to form a port for a surgical tool (Fig 1, paragraph 31, see also paragraph 30, Fig 4 where the interior central lumen is hollow such that it is able to receive instrument shaft #118);
and a plurality of flexible fins formed on said body member (see Fig below, paragraph 33),
wherein a cavity (cavity that houses shaft #1002, Fig 10, paragraph 44, see Fig below) is disposed within each of said plurality of flexible fins (paragraph 44-45),
wherein an elongate shaft (#1004) is embedded within each of said cavities (paragraph 44 where the shaft is elongated as it a strip of material that has a length along the fins #106 to bias the fins outwardly).
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Worrel discloses the use of seals (#112, paragraph 32) and that the cannula can be used other areas of the body (end of paragraph 41) does not disclose a hollow exterior central lumen formed above said hollow interior central lumen, said hollow exterior central lumen having an opening at a top end, and said hollow exterior central lumen also having a bottom wall separating said interior central lumen from said hollow exterior central lumen, said bottom wall having one or more slits formed thereon
Edoga discloses a cannula (Figs 2-4) for surgical procedures (paragraph 33), the cannula comprising:
a body member having an inner wall forming an interior central lumen along at least a proximal portion of a length of said body member to form a port for a surgical tool (see Fig below, paragraph 33 where an inner wall defines an interior central lumen, where gel membranes #14a-b are located in the interior central lumen and where instruments are able to pass though the lumen);
a hollow exterior central lumen formed above said interior central lumen (see Fig below, paragraph 33, 45, Fig 4 where the lumen is hollow to allow passage of instruments therethrough), said hollow exterior central lumen having an opening at a top end (see Fig below), and said hollow exterior central lumen also having a bottom wall separating said 12interior central lumen from said exterior central lumen (see Fig below), said bottom wall having one (#32, paragraph 40, where the slit is in the form of a perforation)(Examiner notes that it is obvious that the perforation of Edoga be in the form of a slit since this is a typical shape/type opening for perforations and provides a known shape for instruments to pass there-through. Examiner notes that a change of shape is usually within the skillset of one of ordinary skill in the art [See MPEP 2144.04 (IV)(B)]) or more slits formed thereon; and
a plurality of flexible fins (#26) formed on said body member, wherein a cavity is disposed within each of said plurality of flexible fins (see Fig below, Fig 3-4), wherein an elongate shaft is embedded within each of said cavities (paragraph 33, 38 where each fin as at least one shaft or “strip” of shape memory material embedded in respective cavities)
where the bottom wall with the slit allows serves as an additional seal around an inserted instrument (paragraph 40),
the hollow exterior central lumen allows instruments to pass therethrough without feat of contact with or contamination of the surrounding anatomy as the instruments are completely contained within the hollow exterior central lumen (paragraph 45).
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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 cannula of Worrel to include 1. a bottom wall with the slit, 2. the hollow exterior central lumen in view of Edoga above because 1. the bottom wall with the slit allows serves as an additional seal around an inserted instrument and 2. the hollow exterior central lumen allows instruments to pass therethrough without feat of contact with or contamination of the surrounding anatomy as the instruments are completely contained within the hollow exterior central lumen.
Regarding Claim 2, Worrel as modified discloses each elongate shaft is naturally biased in an outward direction (paragraph 44 in Worrel).
Regarding Claim 4, Worrel as modified discloses the elongate shaft comprises a polymer (paragraph 44 “or polymers that exert..” in Worrel)
Regarding Claim 5, Worrel as modified discloses each elongate shaft comprises a shape memory alloy (paragraph 44 in Worrel).
Regarding Claim 3, Worrel as modified discloses the claimed invention as discussed above but does not disclose discloses a distal tip of each elongate shaft protrudes from a distal end of the respective cavities in which each of said elongate shaft is embedded within
However, Edoga further teaches a distal tip of each elongate shaft protrudes from a distal end of the respective cavities in which each of said elongate shaft is embedded within (see Fig 3 of Edoga above in where each distal tip protrudes past their respective fins and thus protrudes from a distal end of their respective cavity) so that the distal tip of each shaft is able to be anchored to the body member below their respective fins (Fig 3 of Edoga).
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 have a distal tip of each elongate shaft of Worrel as modified protrude from a distal end of the respective cavities in which each of said elongate shaft is embedded within in view of additional teachings of Edoga so that the distal tip of each shaft is anchored to the body member below their respective fines.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Worrel US 2012/0065589 and Edoga US 2006/0129165, as applied to claim 1 and in further view of Maxson US 5,215,531
Worrel as modified does not disclose a ring configured to mount around an outer surface of said body member, said ring being further configured to slide along at least a portion of said outer surface of said body member between a distal end of said body member and a proximal end of said body member.
Maxson disclose a ring (#1) configured to mount around an outer surface of said body member (Fig 1-2, ring has an opening #5 that is able to receive the outer surface of a body member, Col 5 lines 5-15), said ring being further configured to slide along at least a portion of said outer surface of said body member between a distal end of said body member and a proximal end of said body member (Col 5 lines 45-55) where the ring is used to immobilize the body member and maintain the position of the body member during use (abstract, Col 10 lines 11-20).
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 device of Worrel as modified to include a ring in view of Maxson above because the ring is used to immobilize the body member and maintain the position of the body member during use.
Conclusion
See PTO-892 for art of cited interest, in particular other cannulas that uses rings.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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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