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 Arguments
Applicant’s arguments, see pages 8-10, filed 05/05/2026, with respect to the rejection of claims 8, 9, and 11 under Eder et al (US 20080262527 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Edelstein et al (US 20080058603 A1) in view of Eder et al (US 20080262527 A1) to claim 12.
Applicant's arguments with respect to claims 8, 10, and 13 over Edelstein et al have been fully considered but they are not persuasive.
In regards to arguments to claims 8, 10, and 13 (pages 10-12) stating that Edelstein fails to disclose “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”, or at least separable into a first dome section and a second dome section”, the examiner disagrees.
In [0044-0046] Edelstein discloses that the housing (dome 70) splits in two through seal 71 and hinges open through hinges 72 leaving the medical apparatus in place (see [0044],
“Once the vacuum has been implemented, the skin and underlying tissue and fat layers are physically raised above the underlying organs, and the trocar can be safely advanced through this tissue into the body to allow implementation of the laparoscopic procedure. Once the trocar has penetrated the tissue, a pneumoperitoneum can be applied as well by the introduction of insufflating medium into the patient's body cavity. At this point, the housing can be removed, for example by breaking a seal between the insert plug and housing, and raising the housing upwards around the removable plug and trocar and out of the sterile field. The removable plug can then be removed. The plug can be a tear-away, split-wing type device 63 that breaks in two or that opens when pulled apart, or it can be a clamshell hinge-type device. In an alternative embodiment (see FIGS. 7A/7B), the entire bell itself may be a tear-away or a clamshell device which facilitates removal thereof so that the trocar may be fully advanced into the fully deployed position for surgical use.”.
In [0046], Edelstein further discloses in figures 7a-7b the split dome 70 having a seal 71 and hinge 72 that splits apart.
“Once the trocar has penetrated the tissue of the patient and a pneumoperitoneum (if desired) is established, the housing is opened along the sides, and the halves of the housing are spread apart along the hinge. The housing is then readily removed and the procedure may go forward without the housing being in the way of the surgeon performing the procedure. While a hinge and clasp seal are shown in FIGS. 7A/7B, those skilled in the art will appreciate that other arrangements may be used to provide a housing that may separate into two or more sections. For example, the housing may include a bead and mating groove that allows the sections of the housing to seal together, or the housing may be secured by engaging a groove of a resilient silicon member with respective edges of two or more housing hemispheres. This allows the housing to be quickly separated into multiple sections.”.
Therefore, Edelstein meets all the claimed the limitations.
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, 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 1-7b), 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].
Claim Rejections - 35 USC § 103
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 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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Edelstein et al (US 20080058603 A1) in view of Eder et al (US 20080262527 A1).
Regarding claim 12, Edelstein discloses the invention substantially as claimed. However, Edelstein fails to disclose further comprising manipulating the rigid dome relative to the surgical site through an application of force at a raised structure extending from an exterior surface of the rigid dome.
Eder teaches in figures 6a-6b a split shell vacuum dome 70 with a hinge 72 and a breakable seal 71 (clasp like seal which can be other types; [0045]), that is removable and in an alternative embodiment where the split shell dome 70 includes hinges 72 and seal 90 in figure 8 includes a raised structure 91 extending from an exterior surface of the rigid dome [0048], (fig 8). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Edelstein’ seal with the teachings of Eder’s seal having a raises structure since such modification would have expedited the removal of the dome during the medical procedure.
Allowable Subject Matter
Claims 1-7 are allowed.
Claims 9, 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,
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; and
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..
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, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights