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 Objections
Claim 10 is objected to because of the following informalities: the claim should end with a period. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 9-10, 12, 15-16, and 20-21 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Orbay et al. (US 2008/0195128).
Regarding Claim 1, Orbay discloses:
A medical device, comprising:
a blade complex comprising a blade (165) and a blade guard (182), the blade secured within the blade guard such that a cutting edge of the blade is exposed (see Fig. 8A showing the deployed blade and Paragraph 0124 describing how the guard shields the blade), the blade guard having a superior portion that covers a top edge of the blade and projects over the cutting edge of the blade (top of guard 182; see for example Figs. 7A and 10B showing the blade in the retracted position with the guard projecting over the top of the blade to prevent contact with tissue), the top edge being perpendicular to the cutting edge (see Figs. 8C and 10A-10C, for example, showing the top edge running perpendicular to the cutting edge);
a dilating head (enlarged distal end of 160) comprising a main body (proximal end of the enlarged head of 160) having a blade seat (172), the main body configured to house a camera (162a and 184) and a light source (186), the blade seat configured to receive and secure the blade complex with the blade defining a center plane of the dilating head (see Fig. 8B, for example, the blade seat 172 and blade are centrally located within the head);
an arm (see Fig. 7A, for example, showing the elongated element extending from 162 back to the handle; also shown in Fig. 4B as 167) attached to a proximal end of the dilating head (see Fig. 8C, for example, showing the camera with the arm extending proximally from the head); and
a handle (300) configured to house a controller (400), a video processor (420), a video transmitter (wireless transmitter described in Paragraphs 0169 and 0171), and a power source (430), the controller operatively connected to the camera and the light source via the arm attached to the handle (see Paragraph 0116 and Fig. 4B describing how the camera connects to the electronics in the handle).
Regarding Claim 2, Orbay further discloses wherein the main body comprises a base and a distal portion extending distally at an angle with respect to the base (see Fig. 10A, for example, showing the base, the vertical surface of the main body; the distal portion is the curved cavity formed distally of the flat vertical surface), at least a portion of the blade seat extending into the base such that, when seated, the blade is substantially perpendicular to the base and the cutting edge of the blade faces the distal portion (see Fig. 10B showing the blade seat 172 extending into the base with the distalmost portion of the blade’s cutting surface facing the distal portion), the camera being positioned in the distal portion configured with a field of view of the cutting edge of the blade (see Fig. 10B showing the camera in the distal portion facing the blade to provide a view thereof).
Regarding Claim 3, Orbay further discloses wherein the distal portion comprises a distal tip having a blunt end (180b), the distal portion being contoured to provide a smooth transition to the base of the main body (see Fig. 10A, for example, showing the curvature of the distal end as it connects to the proximal base).
Regarding Claim 9, Orbay further discloses wherein the light source is at least one LED or at least one fiber optic strand (Paragraph 0115).
Regarding Claim 10, Orbay further discloses wherein the blade guard of the blade complex is contoured and configured to act as a spacer from the blade (182 act as a spacer from the blade and have a curved shape; see Fig. 8A, for example).
Regarding Claim 12, Orbay further discloses wherein the dilating head is detachably attached to the arm (see Figs. 4A and 4B showing the components in various stages of assembly; the device is intended to be attached using reversible connection means; see Paragraph 0097 for example).
Regarding Claim 15, Orbay further discloses wherein the arm has a predefined length (when the arm is made it has a length, that length was determined at some point that is considered “predefined”).
Regarding Claim 16, Orbay further discloses wherein the arm is configured with a bend (see Figs. 9B and 9C showing the bend in the shaft such that the arm extending therethrough would also have a bend (Fig. 7A shows a straight shaft with a straight arm, when applied to Figs. 9B and 9C, the arm would be bent with the shaft).
Regarding Claim 20, Orbay further discloses wherein the controller is configured to operate the light source and the camera (see Paragraphs 0162-0163).
Regarding Claim 21, Orbay further discloses wherein the camera captures video and the video is transmitted wirelessly to a client device (Paragraph 0165).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128) in view of Dubois et al. (US 2013/0046199).
Orbay discloses the invention substantially as claimed as stated above but does not explicitly disclose wherein the distal portion further comprises a scraper on a superior surface of the distal portion. Dubois teaches including a scraper on an upper surface (see Fig. 6 and scraping edge 4.1) to scrape tissue. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device to include Dubois’s scraper. Such a modification provides a means to cut tissue and prepare the surgical space.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128) in view of Braam et al. (US 2008/0255600).
Orbay discloses the invention substantially as claimed as stated above but does not explicitly disclose wherein the main body further comprises a pair of fairings extending laterally from the base, the pair of contoured fairings on opposite sides of the base symmetrical about the center plane; and wherein at least a portion of the contoured fairings extend away from the blade seat forming a concave surface on the main body opposite the blade seat. Braam teaches including a pair of lateral fairings (32, see Fig. 3) that extend away from the blade seat to for a concave surface on the main body opposite the blade seat (see Figs. 3-6) showing the contoured edges creating a concave surface). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device to include Braam’s fairings. Such a modification helps direct separated tissue away from the main body.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128) in view of Sauer (US 2007/0255296).
Orbay discloses the invention substantially as claimed as stated above but does not explicitly disclose wherein the main body further comprises a pair of contoured flanges protruding from the base, the pair of contoured flanges positioned on opposite sides of the distal portion symmetrical about the center plane. Sauer teaches using opposed flanges (32E in Fig. 6B). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device to include Sauer’s flanges. Such a modification allows the tissue to be pleated for further suturing.
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128).
Orbay discloses the invention substantially as claimed as stated above.
Regarding Claim 8, Orbay further discloses using a plurality of light sources (Paragraph 0115), but does not explicitly disclose wherein the light source is a pair of light sources positioned symmetrically about the center plane. The Examiner asserts that placing the lights symmetrically around the center plane provides uniform light to the viewing area as is known in the art. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay to place the lights symmetrically. Such a modification provides uniform light to the target area for proper imaging.
Regarding Claim 14, Orbay further discloses making the system modular (see Fig. 4B, for example). As shown in Fig. 4B, the arm (167 with 167a) connects to the EM 40, which is all connected to handle 30. Fig. 4A shows the dilating head connected to the handle. Orbay may not explicitly disclose wherein the dilating head is attached to the arm and the arm is detachably attached to the handle, in that the exact wording is not used, but the Examiner considers this at least obvious in view of Orbay’s focus on making the device modular. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device so that the head is attached to the arm and the arm is detachably attached to the handle. Such a modification is inline with Orbay’s disclosure and would allow for disassembly of the device for cleaning or replacing components as is known in the art.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128) in view of Miller (US 2006/0155209).
Orbay discloses the invention substantially as claimed as stated above but does not explicitly disclose wherein the blade complex is detachably attached and replaceable (although Orbay’s device is modular as seen in Figs. 4A/4B). Miller teaches a detachable cutting device (11, see Abstract). Making something detachable and replaceable is well-known, in particular in the medical field to prevent cross-contamination. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device to include a detachable blade as taught by Miller. Such a modification allows the blade to be replaced after use to avoid costly sterilization or potential cross-contamination with other patients as is known and common in the art.
Claims 13 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128) in view of Swayze et al. (US 2020/0375585).
Orbay discloses the invention substantially as claimed as stated above but does not explicitly disclose a plurality of dilating heads, the dilating head of the medical device being one of a plurality of dilating heads and replaceable, individual ones of the plurality of dilating heads configured with predetermined dimensions and interchangeably attachable to the arm of the medical device. Swayze teaches a selection of tools that are removably coupled to the device (see Paragraph 0020). Also, having multiple heads of the same or varying sizes is known in the medical arts. Such kits are useful so that the surgeon can replace one with another as needed for the particular patient and/or procedure. Having the same generic handle with different heads gives the user options based on the particular needs of the situation. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device to include Swayze’s multiple heads. Such a modification gives the user a selection of heads to meet the needs of the particular situation.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Orbay et al. (US 2008/0195128) in view of Mentis (US 2016/0210411).
Orbay discloses the invention substantially as claimed as stated above but does not explicitly disclose at least one computing device comprising at least one hardware processor, program instructions stored in memory and executable by the at least one computing device that, when executed, direct the at least one computing device to: access real-time video data from the camera of the medical device; and display the real-time video data on a display. Orbay does disclose an external display and related components (see Figs. 3A-4B showing various embodiments). The claimed components are standard electronic and computer components for providing a functioning display. Mentis teaches as much (see Paragraphs 0022 and 0046). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Orbay’s device to include Mentis’s computer components. Such a modification incorporates old and well-known components such as memory so that the images obtained by the camera can be displayed on an external unit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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, Anhtuan Nguyen can be reached at (571)272-4963. 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.
/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795