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 .
Status of Claims
Claims 1-21 are pending, of which Claims 1 & 16 are independent. All claims are examined on the merits.
Claim Objections
Claim 11 is objected to because of the following informalities:
Re Claim 11, “to perform an operation at a sight of a blockage therein” should be “to perform an operation at a site of a blockage therein.“
Appropriate correction 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.
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.
Claims 1-14, 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Asfora (US 2012/0004629) in view of Edelman et al. (US 2010/00063452).
Re Claim 1, Asfora discloses a surgical evacuation port device (10, see Figs. 17-18), comprising:
a port body (body member 152) having proximal and distal ends and defining:
a distal evacuation opening (at first end 166) at the distal end,
a proximal evacuation opening (at negative pressure portion 160) at the proximal end, and
an evacuation lumen (clearly seen in Fig. 18) extending from the distal evacuation opening to the proximal evacuation opening; and
a bone engagement portion (first end 166, Figs. 17-18 show the threads for tapping the port device into a patient’s skull, as explained in [0050] and shown in Fig. 1) associated with the port body and configured to attach to a bone to enable evacuation of fluid through the evacuation lumen (e.g., shown in Fig. 7).
Asfora does not teach wherein at least a viewing portion of the port body that defines the evacuation lumen is made from an optically transparent material that allows a user to optically see into the evacuation lumen to view obstructions therein. Edelman discloses a surgical port formed between a body cavity and an external environment (see Fig. 18), the port comprising a transparent top plate (480, see Figs. 11 & 16, [0049] “If a clear material, such as polycarbonate is used to form the plate 480, then removing the material enables a clear window to be formed through the top of the port to enable direct visualization of the abdominal cavity.”) that allows a surgeon to have direct visualization of the wound through the port. Even though Edelman does not explicitly disclose that the transparent material is used on an evacuation lumen to allow the surgeon to see obstruction within the lumen, having a transparent top for the surgical port, as disclosed by Edelman, would allow one to see the entire interior space/lumen of the port as well as seeing the wound tissue directly beneath the port, such that any obstruction within the port can also be optically observed. It would have been obvious to one skilled in the art at the time of filing to glean from Edelman’s teaching of having a transparent material to form at least a portion of a surgical port, doing so allows a surgeon an additional way to assess the medical condition of the patient and thus be able to adapt the treatment as needed.
Re Claim 2, the combination discloses claim 1, and Edelman also discloses wherein the viewing portion is a window, and a remainder of the port body around the window is less transparent or opaque (implied by [0049] disclosing 480, but without disclosing other portions of the port, as being clear and allowing direct visualization).
Re Claims 3-5, the combination discloses claim 1, but neither Asfora nor Edelman explicitly discloses wherein the viewing portion surrounds the evacuation lumen, wherein the entire port body is formed from the optically transparent material, or wherein the entire surgical evacuation port device is formed from the optically transparent material. While Edelman only discloses a top plate (480, Figs. 15-17) of a surgical port is made of transparent material, one skilled in the art would find it obvious to manufacture the entire port (therefore including the evacuation lumen) from transparent material because it would all the surgeon an improved view of the wound/tissue that needs treatment and it can additionally simplify the manufacturing process (e.g., a port made from one material instead of multiple materials).
Re Claim 6, after the combination in claim 1, Asfora also discloses wherein the proximal end (negative pressure portion 160) includes a fitting (clearly seen in Figs. 17-18) configured to operably connect to a suction device.
Re Claim 7, after the combination in claim 1, Asfora also discloses wherein the bone engagement portion is configured to mount the port body through a hole in the bone to evacuate fluid through the evacuation lumen across the bone (see Fig. 7 & [0073]).
Re Claim 8, after the combination in claim 1, Asfora also discloses wherein the bone engagement portion includes threads disposed about the exterior of the distal end of the port body and configured to screw into bone (see e.g., [0014] “An exterior surface of the proximal end of the tubular portion has self-tapping threads formed thereon for cutting threads into a skull.”).
Re Claim 9, after the combination in claim 8, Asfora also discloses wherein the threads are configured and dimensioned to screw into a skull to position the port body in communication with a subdural region of a cranium (e.g., [0014], also see Fig. 7).
Re Claim 10, after the combination in claim 1, while neither Asfora nor Edelman explicitly discloses wherein at least a portion of the bone engagement portion is optically transparent to allow the user to optically see into the evacuation lumen, one skilled in the art would find it obvious to manufacture the entire port (therefore including bone engagement portion) from transparent material because it would all the surgeon an improved view of the wound/tissue that needs treatment and it can additionally simplify the manufacturing process (e.g., a port made from one material instead of multiple materials).
Re Claim 11, after the combination in claim 1, Asfora further discloses:
a needle access port (aspiration portion 158) defining an access port lumen in communication with the evacuation lumen; and
a seal (cap 162 having closing structure 164) that seals the needle access port to preserve a suction within the evacuation lumen.
While Asfora does not disclose the needle access port is used “to perform an operation at a site of a blockage therein,” this language is directed at the intended use of the needle access port. Since a needle is capable of being inserted all the way into the subdural space (as shown in Fig. 15), the needle access portion can allow operation in the lumen of the port body, including a site of a possible blockage.
Re Claim 12, the combination discloses claim 11, while neither Asfora nor Edelman explicitly discloses wherein the needle access port includes an access port viewing portion formed from an optically transparent material to allow the user to see therein, one skilled in the art would find it obvious to manufacture the entire port (therefore including the needle access port) from transparent material because it would all the surgeon an improved view of the wound/tissue that needs treatment and it can additionally simplify the manufacturing process (e.g., a port made from one material instead of multiple materials).
Re Claims 13-14, after the combination in claim 1, Edelman also discloses wherein the viewing portion is made from an optically transparent polymer and wherein the optically transparent polymer is polycarbonate ([0049]).
Re Claim 16, Asfora discloses a surgical evacuation port device (10) comprising:
a port body (152) having proximal and distal ends and defines:
a distal evacuation opening (at 166) at the distal end,
a proximal evacuation opening (at 160) at the proximal end, and
an evacuation lumen (see Fig .18) extending from the distal to the proximal evacuation opening;
a bone engagement portion associated with the port body and including threads that are configured and dimensioned to screw into a skull to position the port body in communication with a subdural region of a cranium; and a fitting associated with the port body configured to attach to a suction device to provide suction to the subdural region of the cranium.
Asfora does not teach wherein at least a viewing portion of the port body that defines the evacuation lumen is made from an optically transparent material that allows a user to optically see into the evacuation lumen to view obstructions therein.
Re Claims 17-21, the limitations are taught by the combination as explained under Claims 2-4 and 11-12, respectively.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Asfora and Edelman as applied to claim 1 above, and further in view of Cai et al. (US 2012/0064274).
Re Claim 15, Asfora and Edelman combine to disclose claim 13 but they do not teach wherein the optically transparent polymer is crystalized acrylonitrile butadiene styrene (ABS). Cai discloses that it is known in the medical field that medical connectors can be made of acrylonitrile butadiene styrene and/or polycarbonates, thus establishing that these materials are known equivalents of each other in the field of medical tubing/connectors. It would have been obvious to one skilled in the art at the time of filing to modify with ABS since substituting equivalents known for the same purpose (i.e., substituting polycarbonate with ABS for a medical connector) establishes a prima facie case of obviousness (MPEP 2144.06).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN S SU whose telephone number is (408)918-7575. The examiner can normally be reached M-F 9:00 - 5:00 Pacific.
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, Rebecca Eisenberg can be reached at 571-270-5879. 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.
/SUSAN S SU/ CPrimary Examiner, Art Unit 3781 2 March 2026