DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
EXAMINER’S COMMENT
The amendment submitted on 5/30/2025 is entered and the claims interpreted in this paper.
Regarding priority, please note that provisional application 61/227206 does not provide support for the subject matter corresponding to figures 7-15 in the invention.
There does not appear to be any overlapping subject matter requiring a Double Patenting over US Patents 8469883, 9867604, 10456125 and 12161317 at this time.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 21-25 and 33 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 9-17 of U.S. Patent No. 11278271. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 18968489
US Patent 11278271
21. a surgical access device comprising: a wound retractor comprising an outer ring, an inner ring, and a tubular sheath connected to the outer ring; and an internal retractor comprising a longitudinal axis extending between a proximal end and a distal end, an access channel, and a plurality of shapeable members coupled to the outer ring of the wound retractor.
Claims 9-17
9. A surgical access device comprising: a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end, and an access channel extending therethrough; a wound retractor comprising an outer ring, an inner ring, a hub, and a tubular sheath extending between the outer ring and the inner ring; and an internal retractor that retracts nearby objects, wherein the internal retractor comprises one or more shapeable members, wherein each shapeable member has connective features that connects the shapeable member to the wound retractor, and wherein each of the shapeable members connected to the wound retractor are removeable, wherein the one or more shapeable members are connected to the wound retractor via the hub, and wherein the hub includes tracks that allow adjustment of a degree of retention/retraction for each of the one or more shapeable members; wherein a retention ring is attached to ends of the one or more shapeable members of the internal retractor, wherein the retention ring is disposed proximally of the outer ring of the wound retractor in an undeployed state, wherein converting the internal retractor from the undeployed state to a deployed state requires the retention ring to pass through the wound retractor, and wherein the retention ring is disposed distally of the outer ring of the wound retractor in a deployed state to retract object in a desired area.
10. A surgical access device comprising: a proximal end, a distal end, a longitudinal axis extending from the proximal end to the distal end, and an access channel extending therethrough; a wound retractor comprising an outer ring, an inner ring, a hub, and a tubular sheath extending between the outer ring and the inner ring; and an internal retractor that retracts nearby objects, wherein the internal retractor comprises one or more shapeable members, wherein each shapeable member has connective features that connects the shapeable member to the wound retractor, and wherein each of the shapeable members connected to the wound retractor are removeable, wherein a retention ring is attached to ends of the one or more shapeable members of the internal retractor, wherein the retention ring is disposed proximally of the outer ring of the wound retractor in an undeployed state, wherein converting the internal retractor from the undeployed state to a deployed state requires the retention ring to pass through the wound retractor, and wherein the retention ring is disposed distally of the outer ring of the wound retractor in a deployed state to retract object in a desired area.
22. the surgical access device of claim 21, wherein a proximal end of one of the plurality of shapeable members comprises a connection feature that couples the one of the plurality of shapeable members to the outer ring.
Claims 9-17, see bolded sections in claims 9 and 10 above
23. the surgical access device of claim 22, wherein the plurality of shapeable members are spaced from one another.
Claims 9-17, see bolded sections in claims 9 and 10 above (e.g., via connective features)
24. the surgical access device of claim 23, wherein spacing between the plurality of shapeable members is adjustable.
Claims 9-17, see bolded sections in claims 9 and 10 above (note that this limitation is functional)
25. the surgical access device of claim 24, wherein a distal end of each of the plurality of shapeable members is insertable through the access channel.
Claims 9-17, see bolded sections in claims 9 and 10 above (note that this limitation is functional)
33. the surgical access device of claim 21, wherein the outer ring of the wound retractor is rotatable around an annular axis thereof, thereby permitting adjustment of an effective length of the tubular sheath between the inner ring and the outer ring.
Claims 9-17, see bolded sections in claims 9 and 10 above (note that this limitation is functional)
Thus, the invention of US Patent 11278271, claims 9-17, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
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.
Claim(s) 21-24, 27, 28, 33-36 and 39 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Kahle (US 20070151566).
With respect to claim 21, Kahle discloses a surgical access device (e.g., see fig. 4 and 6 below) comprising: a wound retractor (110) comprising an outer ring (160), an inner ring (115), and a tubular sheath (165) connected to the outer ring, and inner ring (see fig. 4 below, para. 47, also see fig. 11); and an internal retractor (55a, 65a, 100), see fig. 4, 6 and 10 below) comprising a longitudinal axis extending between a proximal end and a distal end (see fig. 10 below), an access channel (through 65c and 100, see fig. 10 below and also para. 42), and a plurality of shapeable members (125, see fig. 6 and 10 below, also see para. 8, 39-40, 42 and 44 and note the elastomer material makes this element shapeable) coupled to the outer ring of the wound retractor (see fig. 6 and 10 below).
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As for claim 22, Kahle further discloses the surgical access device of claim 21, wherein a proximal end of one of the plurality of shapeable members comprises a connection feature (e.g., via mold or bond to 100, see para. 42) that couples the one of the plurality of shapeable members to the outer ring.
As for claim 23, Kahle further discloses the surgical access device of claim 22, wherein the plurality of shapeable members are spaced from one another (see fig. 6 and 10 above, and para. 42).
As for claim 24, Kahle further discloses the surgical access device of claim 23, wherein spacing between the plurality of shapeable members is adjustable (note that due to the material properties of elastomeric material, this element is capable of performing this function, e.g., one of elements 125 being moved without moving another of 125, thus impacting the spacing).
With respect to claim 27, Kahle discloses a surgical access device (e.g., see fig. 4 and 6) comprising: a wound retractor (110) comprising an outer ring (160), an inner ring (115), and a tubular sheath (165) connected to the outer ring, and inner ring (see fig. 4 below, para. 47, also see fig. 11); and an internal retractor (55a, 65a), see fig. 4, 6 and 10) comprising a longitudinal axis extending between a proximal end and a distal end (see fig. 10), an access channel (through 65c, see fig. 10 and also para. 42), and a plurality of shapeable members (125, see fig. 6 and 10, also see para. 8, 39-40, 42 and 44 and note the elastomer material makes this element shapeable) coupled to the outer ring of the wound retractor (see fig. 6 and 10); 27; further comprising an arcuate base (e.g., 100/105) releaseably mating with the outer ring, the plurality of shapeable members coupled to the arcuate base (see fig. 6, para. 42).
As for claim 28, Kahle further discloses the surgical access device of claim 27, further comprising a connector (e.g., mold/bond, see para. 42) coupling the plurality of shapable members to the arcuate base.
As for claim 33, Kahle further discloses the surgical access device of claim 21, wherein the outer ring of the wound retractor is rotatable around an annular axis thereof (see para. 47), thereby permitting adjustment of an effective length of the tubular sheath between the inner ring and the outer ring (note that this device is capable of performing this function, see fig. 4, 11).
As for claim 34, Kahle further discloses the surgical access device of claim 33, wherein the internal retractor is user coupled to the wound retractor in the operative state (see para. 48-49)
As for claim 35, Kahle further discloses the surgical access device of claim 21, wherein the internal retractor comprises a body (e.g., 105) comprising a groove (e.g., to receive 110) extending along at least a proximal edge of the body (see fig. 6), the groove configured to receive the inner ring of the wound retractor (note that this device is capable of performing this function, e.g., if the wound retractor were to be installed upside down).
As for claim 36, Kahle further discloses the surgical access device of claim 35, further comprising an extender (e.g., another of 125) coupled to the body.
As for claim 39, Kahle further discloses a method of defining a surgical field in a body cavity comprising: inserting the inner ring of the wound retractor of the surgical access device of claim 21 through an opening in a body wall and into a body cavity (see para. 47-49); retracting the opening in the body wall (see para. 47-49); and deploying the internal retractor within the body cavity and defining the surgical field (see para. 42, 47-49).
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.
Claims 25 and 26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kahle (US 20070151566), as applied to claim 24 above, in view of Norelli (US 5342385).
As for claims 25 and 26, Kahle teaches shapeable members that are reshapeable (due to material) after coupling to the outer ring and are integral with the internal retractor but does not teach wherein a distal end of each of the plurality of shapeable members is insertable through the access channel; and wherein the plurality of shapeable members extends longitudinally when inserted through the access channel.
Norelli, also drawn to surgical access devices, teaches members (shields 58) that is separate from an internal retractor/access channel (see fig. 7) such that the members are insertable through the access channel (see fig. 7); and wherein the plurality of members extends longitudinally when inserted through the access channel (see fig. 7, col. 4lines 41-51) in order to provide separate member that providse the same function of providing a shield to the access channel that prevents punctures when attached to the access device (see col. 4 lines 41-51).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Kahle wherein a distal end of each of the plurality of shapeable members is insertable through the access channel; and wherein the plurality of shapeable members extends longitudinally when inserted through the access channel, in view of Norelli, as a matter of engineering design choice, in order to provide an alternate equivalent construction between the members and internal retractor that provides the same function of providing a shield to the access channel that prevents punctures when attached to the access device but allows the surgeon some flexibility in placement of the members, if needed.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 21 and its dependent claim 27. In particular, none of the cited references teach or suggest wherein each of the plurality of shapeable members are slideable along an inner surface of the arcuate base, as required by claims 29-32.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 21 and its dependent claim 36. In particular, none of the cited references teach or suggest wherein the body further comprises a connection feature disposed along at least a portion of a distal edge of the body, wherein the connection feature is coupleable with the extender comprising a complementary connector disposed along at least a portion of a proximal edge of the extender, as required by claims 37-38.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 29-32, 37 and 38 are 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 20060129165;
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773