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 .
Response to amendments
Claims 1, 10, and 21 were amended 2/9/26.
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, 3-21 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.
The amendments to the independent claims, “the top third surface extends…to a radial position before the first surface extends from a point radially in a direction from the aperture and outward toward the perimeter.” The meaning of this limitation is unclear. In particular, the terms “before,” “the first surface extends from a point” and “radially in a direction from the aperture” are unclear. Based on the specification, it is assumed that this was intended to read, for example, “the top third surface extends…to a radial position between the first surface and the aperture, and the first surface extends toward the perimeter.” However, further clarification of these limitations is required.
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.
Claim(s) 1, 3-7, 10-19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lapierre et al. [US 2021/0068796 A1] in view of Holsten [US 2019/0059938 A1] and Carter et al. [US 2010/0191261 A1, hereinafter “Carter”].
Regarding claims 1 and 21, as best understood, Lapierre discloses
A seal shield system [Fig. 6], comprising:
an end cap [“first member” 181] having a top first surface and a bottom second surface opposite to the first surface, a perimeter [Annotated Fig. 6] and with an aperture extending through the first surface and second surface [Fig. 6];
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a seal shield [“guard assembly” 140] positioned in contacting relation to the second surface of the end cap, the seal shield having a first thickness [Fig. 6];
a plurality of seals comprising a first seal [“flange seal member”130] and a second seal [“seal assembly” 150] connected to the seal shield such that the seal shield is connected between the end cap and the plurality of seals [Fig 6]
at least one of the plurality of seals having a second substantially uniform thickness [“the seal assembly 150 includes a substantially planar body having a substantially uniform thickness,” Par. 0053].
The first thickness of shield 140 and second seal 150 are not compared. However, Holsten teaches, in a seal shield system [Figs. 1-4], comprising a seal shield [“protective guard member” 128] connected to the end cap, the seal shield having a first thickness [Fig. 4] and one or more seals [“inner seal portion” 118], that it is desirable for the shield [128] to be thin [“In embodiments, the first and second guard members 126, 128 have sufficient flexibility to not interfere with passage of the surgical object and also possess sufficient strength to adequately protect the underlying seal member 110 from damage during e.g., insertion of a pointed instrument. The first and second guard members 126, 128 are each fabricated from respective first and second sheets of material….fabricated from Tyvek®.…These characteristics enable the first and second guard members 126, 128 to be relatively thin [emphasis added] thereby reducing the overall profile of the seal component 108 [i.e. the seal shield system] while satisfying the aforedescribed objectives of strength, flexibility durability, etc . . .” (Par. 0022)]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lapierre by forming the seal shield to be so thin that its first thickness is smaller than the second thickness of the seal because this reduces the overall profile of the seal shield system while ensuring that the guard member has sufficient strength, flexibility, and durability [Holcomb Par. 0022].
Lapierre fails to disclose a top third surface and a plurality of protrusions extending form the top third surface of the end cap around the aperture. However, Carter teaches, in a seal cap system, an end cap [Annotated Fig. 15]
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having a top first surface [the top surface of at least one of the circumferential shelf portions 230, 282, 284 and 286; see Annotated Fig. 15], a bottom second surface [the bottom surface of the cap, not pictured] and a top third surface [Annotated Fig. 15], with the aperture extending through the top third surface and the second bottom surface [Fig. 15], wherein the top third surface extends radially outward in a direction from the aperture to a position between the top first surface and the bottom second surface [Fig. 15 shows the top first surfaces, which are shelves, being raised above the third surface, so that the third surface is between the first and second surfaces in the vertical direction],
and to a radial position before the first surface extends from a point radially in a direction from the aperture and outward to a perimeter [as best understood, Carter teaches this, because the third surface extends from the aperture to a point/position located radially inward of the first surface. Note that this does not preclude the third surface extending, in parts, to the edge. See Response to Arguments for suggestions on how to clarify the relationships between the first and third surfaces];
wherein a plurality of protrusions [296, 298, 300, and 302] extend from the top third surface of the end cap around an aperture [Fig. 15].
The advantage of the arrangement of first/third surfaces and protrusions is they facilitate suture lengths being retained by a grasping member for temporarily securing lengths of suture [Par. 0086]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lapierre by adding protrusions extending from the third surface and spaced from the perimeter, as well as the other necessary cooperating cap features, as taught by Carter in order to removably and securely hold sutures during an operation.
Regarding claim 3, Lapierre discloses one or more slits [the openings between “petals” 144, Par. 0048] extending through the seal shield.
Regarding claim 4, Lapierre discloses the one or more slits is three converging slits. [Fig. 6 shows the slits between petals numbering 6, and converging at central opening 146]
Regarding claim 5, Lapierre discloses a plurality of radial apertures [“bores” 142a] extending through the seal shield [Fig. 6].
Regarding claim 6, Lapierre discloses the plurality of radial apertures are positioned around the three converging slits [Fig. 6 shows the apertures extending around the outer circumference of the seal shield, while the slits are radially inward of these, to converge at the center].
Regarding claim 7, Lapierre discloses a central aperture [132a in seal 130, and 151 in seal 150] extending through at least one of the seals [there is one through each seal].
Regarding claim 10, Lapierre as modified above discloses a seal shield system substantially as set forth with respect to claim 1 above. Lapierre further teaches a cannula body [“cannula assembly” 100, Fig. 1] extending distally from the end cap [it extends away from the end cap].
Regarding claim 11, Lapierre discloses the cannula body comprises a tube [102] with threads [Fig. 1] extending along at least a portion thereof.
Regarding claims 12-15, 18-19, Lapierre discloses these features substantially as set forth with respect to claims 2-7 above.
Regarding claim 16, Lapierre discloses the three converging slits in the seal shield are substantially aligned with the aperture of the end cap [Fig 4-6].
Regarding claim 17, Lapierre discloses the central aperture extending through at least one of the seals is substantially aligned with the aperture of the end cap [Fig 4-6].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lapierre in view of Holsten and Carter, as applied to claim 1 above in further view of Morris et al. [US 7704263 B2, hereinafter “Morris”].
Regarding claim 8, Lapierre discloses the apparatus above, including the seal 150 being constructed of a plurality of segments/layers, but it is unclear whether or not these segments have slits between them. However, Morris teaches, in a seal shield system for a cannula, a seal [94, Fig. 17] having three converging slits [95] extending through the seal. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Lapierre by configuring the seal to have three converging slits extending through at least one of the one or more seals, as taught by Morris, because this configuration allows the cannula to be used with a suture while preventing leakage [“During use a suture 99 which has been retrieved through cannula 80 is positioned within a slit 97 and secured in a slot 102 to maintain tension in and orientation of suture 99. When the suture has been secured, flaps 93 can return to and maintain their closed positions so as to minimize leakage through the seal. This is in contrast to seal 54 of cannula 50 (FIGS. 4 through 6) in which a suture passing through the seal and maintained under tension will frequently hold flaps 53 open thereby causing leakage through the seal,” Col. 5 lines 47-55].
Claim(s) 9, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lapierre in view of Holsten and Carter, as applied to claim 1 above in further view of Van Wyk et al. [US 2015/065808 A1, hereinafter “Van Wyk”].
Regarding claims 9 and 20, Lapierre discloses the seal shield is composed of a polymeric material [Par. 0049] but fails to specifically disclose the seal shield composed of an elastomeric material. However, Van Wyk teaches, in a seal shield system for a cannula, a seal shield [“spray shield 400”] which is composed of an elastomeric material [Par. 0112]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Lapierre by forming the seal shield of an elastomeric material as taught by Van Wyk, because this amounts to a simple substitution of one seal shield material known in the art [the elastomer of Van Wyk] for another [the polymer of Lapierre], with predictable results [elastomeric material is known to be flexible, see Van Wyk Par. 0016, and able to be formed into a thin sheet].
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-21 have been considered but are not persuasive. Applicant argues that Carter teaches the top third surface extending beyond where the radial extension of a tip first surface begins. The examiner agrees. However, the examiner does not find that the claim language is written in a way to preclude this. It is suggested the claims be amended to recite that the third surface is located entirely radially inward of the first surface, and that the first surface is annular and extends around the entire perimeter, in order to overcome Carter.
Conclusion
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 ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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/ERIN MCGRATH/
Primary Examiner, Art Unit 3771
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