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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 8, 9, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eder et al (US 20080262527 A1).
Regarding claim 8, Eder discloses a method (see claims 1-2; figures 1-10c), comprising:
placing a rigid dome 70 at a surgical site with a patient interface of the rigid dome surrounding the surgical site (fig 1);
coupling a vacuum source to a vacuum port of the rigid dome (claims 1-2, abstract; port seen in fig 8);
reducing a pressure on an interior of the rigid dome with the vacuum source to raise tissue at the surgical site at least partially into the interior of the rigid dome (applying suction, fig 3);
inserting a medical apparatus 14 into the interior of the rigid dome from an exterior of the rigid dome through a septum disposed in an aperture of the rigid dome [0019,0041, 0043];
inserting the medical apparatus 14 into the raised tissue at the surgical site to deliver a gas below a surface of the surgical site to form a temporary pneumoperitoneum [0019,0041, 0043];
normalizing the pressure within the rigid dome (by regulating pressure through valve regulator 16b [0021-0022];
separating a first dome portion 96 from a second dome portion 97 (fig 8; split shell housing 70 in figures 6a-10b) to remove the rigid dome from the surgical site with the medical apparatus remaining indwelling at the surgical site [0045-0052], wherein:
the rigid dome is further separated from the septum; and the septum remains attached to the medical apparatus after the rigid dome is removed from the surgical site (fig 11a); and
removing the septum from the medical apparatus after the rigid dome is removed from the surgical site with the medical apparatus remaining indwelling at the surgical site (once the shell housing is separated, [0045]).
Regarding claim 9, Eder discloses the septum is separated from the rigid dome 70 by a retention ring 93 separable to remove the septum 73 and the retention ring from the rigid dome to facilitate removal of the rigid dome from the surgical site with the medical apparatus left indwelling at the surgical site ([0045]; figs 6a-6b,8 and 9b).
Regarding claim 11, Eder further discloses comprising plugging the vacuum port to prevent pressure equalization through the vacuum port [0020-0022].
Regarding claim 12, Eder further discloses comprising manipulating the rigid dome relative to the surgical site through an application of force at a raised structure 91 [0048], (fig 8) extending from an exterior surface of the rigid dome.
Claims 8, 10-11, 13-14, 16, 18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Edelstein et al (US 20080058603 A1).
Regarding claim 8, Edelstein discloses a method (see claims 1-2; figures 1-7a), comprising:
placing a rigid dome 60,70 at a surgical site with a patient interface of the rigid dome surrounding the surgical site;
coupling a vacuum source to a vacuum port of the rigid dome (claims 1-2, abstract);
reducing a pressure on an interior of the rigid dome with the vacuum source to raise tissue at the surgical site at least partially into the interior of the rigid dome (applying suction, fig 3);
inserting a medical apparatus into the interior of the rigid dome from an exterior of the rigid dome through a septum disposed in an aperture of the rigid dome [0019,0042,0044];
inserting the medical apparatus into the raised tissue at the surgical site to deliver a gas below a surface of the surgical site to form a temporary pneumoperitoneum [0019,0042,0044];
normalizing the pressure within the rigid dome (by regulating pressure through valve regulator 16b [0021-0022];
separating a first dome portion from a second dome portion to remove the rigid dome from the surgical site with the medical apparatus remaining indwelling at the surgical site, wherein (figs 6a-6b, [0044-0050]:
the rigid dome is further separated from the septum; and the septum remains attached to the medical apparatus after the rigid dome is removed from the surgical site; and
removing the septum from the medical apparatus after the rigid dome is removed from the surgical site with the medical apparatus remaining indwelling at the surgical site.
Regarding claim 10, Edelstein discloses wherein removing the septum from the medical apparatus comprises: dividing the septum into a first septum portion and a second septum portion; and removing the divided septum from the medical apparatus with the medical apparatus remaining indwelling at the surgical site [0044-0050].
Regarding claim 11, Edelstein further discloses comprising plugging the vacuum port to prevent pressure equalization through the vacuum port [0020-0022].
Regarding claim 13, Edelstein discloses a system (figs 1-8), comprising:
a medical apparatus 14 [0019,0042, 0044] configured to be inserted at a surgical site;
a rigid dome 12,60,70 configured to admit the medical apparatus through a septum into an interior of the rigid dome to allow the medical apparatus to be inserted at the surgical site, wherein:
the rigid dome is at least partially separable into a first dome section and a second dome section to remove the rigid dome from a surgical site without removing the medical apparatus from the surgical site [0042,0044-0046];
the septum is separable from the rigid dome and remains attached to the medical apparatus as the first dome section and the second dome section are separated from each other [0042,0044-0046]; and
the septum is at least partially divisible into a first septum portion and a second septum portion to remove the septum from the medical apparatus without removing the medical apparatus from the surgical site [0042,0044-0046]; and
a vacuum source (16) configured to connect to a vacuum port of the rigid dome to reduce a pressure within the rigid dome and deflect the surgical into the interior of the rigid dome for the insertion of the medical apparatus at the surgical site.
Regarding claim 14, wherein the medical apparatus comprises a trocar for a laparoscopic surgical operation [0019,0021,0037].
Regarding claim 16, wherein a material of the septum is different from a material of the rigid dome to allow for penetration of a medical apparatus into an interior of the rigid dome [0047].
Regarding claim 18, wherein the first dome section of the rigid dome fully separates from the second dome section of the rigid dome (figs 6- 7a; [0044]).
Regarding claim 20, wherein the first dome section and the second dome section are connected by a hinge, or a joint [0044].
Allowable Subject Matter
Claims 1-7 are allowed.
Claims 15, 17, and 19 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.
The following is a statement of reasons for the indication of allowable subject matter: with respect to claim 1, the art of record does not teach or render obvious a medical device including a rigid dome comprising a first dome section and a second dome section, and a retaining band configured to apply a retaining force to secure the first dome section relative to the second dome section, wherein the retaining band is positioned on a band region extending around both the first dome section and the second dome section; a sealing element configured to removably seal the first joining interface of the first dome section to the second joining interface of the second dome section, in combination with the elements set forth in the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Mon-Thur 8am- 2pm..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783