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 Objections
Claim(s) 39-43 is/are objected to because of the following informalities:
Claim 39 recites “the center lumen” instead of “the central lumen” in order to be consistent with previously used claim terminology.
Appropriate correction is required.
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.
Claim(s) 41 is/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.
Claim 41 recites the limitation “and, the device body further comprises a fluid port configured to receive a fluid from a fluid source” in lines 5-7, which renders the claim indefinite, since it is unclear whether this limitation refers to an additional fluid port or refers back to the fluid port in lines 6-7 of claim 39 from which it depends. It appears that this limitation should be removed from claim 41, since it has already been introduced in claim 39 and for the purpose of compact prosecution will be examined below under this assumption.
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.
Claim(s) 24, 26-28, 30-33, 35, 38 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ARCAND BENJAMIN YONG (WO 2010/132429 A2, hereinafter “Arcand”).
Arcand discloses, regarding claim 24, a discrete accessory (20, see Fig. 1) for attachment to a surgical access device (10, see lines 7-11 of page 5), the accessory comprising: a housing (30) having a lumen (31) extending therethrough (see lines 14-19 of page 5); an attachment interface (see lines 9-11 of page 5) for attaching the housing to a proximal end (11) of a surgical access device (10, see lines 9-11 of page 5); and, an irradiation circuit (30) positioned to direct sterilization energy into the lumen of the accessory to sterilize fluid passing therethrough (see lines 20-30 of page 5).
Regarding claim 26, wherein the housing is removably attachable to a proximal end of a surgical access device (see Fig. 1, see lines 9-11 of page 5).
Regarding claim 27, wherein the lumen of the accessory is configured to align with a center lumen (21) of the surgical access device (see lines 14-19 of page 5).
Regarding claim 28, wherein the lumen of the accessory is configured for the passage of an instrument into the center lumen of the surgical access device (see lines 14-19 of page 5 and lines 31-33 of page 5, “needle or trocar”).
Regarding claim 30, characterized by the absence of a fluid port configured to receive a fluid from a fluid source (see Fig. 1, note that there is no fluid port as a part of accessory 20).
Regarding claim 31, wherein the lumen of the accessory is gasketless (see Fig. 1, note that there is no gasket as a part of accessory 20).
Regarding claim 32, wherein the irradiation circuit comprises an ultraviolet radiation source (see lines 20-24 of page 5).
Regarding claim 33, wherein the ultraviolet radiation source comprises a light emitting diode (see lines 20-24 of page 5).
Regarding claim 35, wherein the irradiation circuit further comprises a plurality of radiation sources (100) positioned around the central lumen (see Fig. 1, see lines 20-30 of page 5).
Regarding claim 38, wherein the surgical access device is a trocar (see lines 14-17 of page 4 and lines 31-33 of page 5, note that the accessory is capable of being used with different tools e.g. a trocar and is capable of being used with a trocar via the catheter sheath 10).
Claim(s) 39-40, 42-43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by YUAN, Ying-chun (CN 108652717 A, hereinafter “Yuan”).
Yuan discloses, regarding claim 39, a surgical access device (see Fig. 1) comprising: a device body (3 and 4) having an instrument receiving region at a proximal end (3) and a cannula (4) at a distal end (see Fig. 1), wherein a diameter of the body is greater at the instrument receiving region than at the cannula (see Fig. 1); the device body defining a central lumen extending from the proximal end to the distal end (see Fig. 1, see para. [0027] note guidewire received through central lumen), and having a fluid port (6) positioned on an exterior of the device body closer to the proximal end than to the distal end (see Fig. 1), the fluid port configured to receive a fluid from a fluid source (see Fig. 1, see para. [0027]); and, a sterilization accessory (1) attachable to the proximal end of the device body (via 2, see Fig. 1, see paras. [0005] and [0028]), wherein the sterilization accessory comprises: a lumen extending therethrough and in communication with the central lumen of the device body when the sterilization accessory is connected to the device body (see Figs. 1-2, see paras. [0027] and [0029]-[0030]), wherein the lumen of the sterilization accessory is configured for the passage of an instrument into the center lumen of the device body (see Fig. 1, see para. [0027] note guide wire received through lumen and central lumen); and, an irradiation circuit (11) positioned to direct sterilization energy into the lumen of the sterilization accessory to sterilize fluid passing therethrough (see Figs. 1-2, see paras [0029] - [0030]).
Regarding claim 40, wherein the sterilization accessory is removably attachable to the proximal end of the device body (via 2, see Fig. 1, see paras. [0005] and [0028]).
Regarding claim 42, wherein the lumen of the sterilization accessory and the central lumen of the device body are gasketless (see Fig. 2, see paras. [0029]-[0030]).
Regarding claim 43, wherein the device body is a trocar (see Fig. 1, see para. [0027], note needle tube).
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.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcand, as applied to claim 24 above, and in view of Selover et al. (U.S. Pub. No. 2007/0100210 A1, hereinafter “Selover”).
Arcand discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 25, wherein the attachment interface comprises at least one of threads, latches, clips, or adhesive.
Selover discloses a surgical access device (10, see Fig. 1) with a discrete accessory / light emitter (30, see Fig. 1) for attachment to a surgical access device (20, see Fig. 1), with an attachment interface (see para. [0032]) for attaching the housing to a proximal end (21) of a surgical access device (20), wherein the attachment interface comprises at least one of threads (see para. [0032] “threaded connection”) in order to enable the discrete accessory / light emitter to be removably and securely coupled to the proximal end of the surgical access device (see para. [0032]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the attachment interface in Arcand to be threads in view of Selover in order to enable the discrete accessory / light emitter to be removably and securely coupled to the proximal end of the surgical access device.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcand, as applied to claim 24 above, and in view of Baril et al. (U.S. Pub. No. 2022/0168013 A1, hereinafter “Baril”).
Arcand discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 29, further comprising an electrical connector positioned on an exterior of the housing and in electrical communication with the irradiation circuit, the electrical connector configured to receive electrical energy from an external power source.
Baril discloses a sterilizing surgical access device (300, see Figs. 6-7) with an irradiation circuit (370), a plurality of ultraviolet light radiation sources (372), wherein the device further comprises an electrical connector (380) positioned on an exterior of the housing (see Fig. 7) and in electrical communication with the irradiation circuit (see para. [0054]), the electrical connector configured to receive electrical energy from an external power source (384, see Fig. 7, note that 384 is external to the lumen 311) in order to enable the surgeon to turn off and on the plurality of ultraviolet light radiation sources and to allow for proper disposal or recharging and re-use of the power source (see para. [0054]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the irradiation circuit in Arcand to further comprise an electrical connector positioned on an exterior of the housing and in electrical communication with the irradiation circuit, the electrical connector configured to receive electrical energy from an external power source in view of Baril in order to enable the surgeon to turn off and on the plurality of ultraviolet light radiation sources and to allow for proper disposal or recharging and re-use of the power source.
Claim(s) 34, 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcand, as applied to claims 24, 31, 35 above, and in view of Stibich et al. (U.S. Pub. No. 2012/0313532 A1, hereinafter “Stibich”).
Arcand discloses all of the features of the claimed invention, as previously set forth above. Arcand further discloses, regarding claim 37, wherein the plurality of radiation sources comprise ultraviolet light radiation sources (see lines 20-24 of page 5). Arcand fails to disclose, regarding claim 34, wherein the irradiation circuit further comprises a bandpass filter positioned on the ultraviolet radiation source, the bandpass filter constructed to only pass a limited range of an ultraviolet light spectrum emitted by the ultraviolet radiation source; regarding claim 36, further comprising a plurality of radiation source filters, wherein each of the radiation source filters is positioned between a respective radiation source and the central lumen, and wherein each of the radiation source filters is configured to only pass a predetermined radiation frequency range emitted by the radiation sources; and regarding claim 37, wherein the plurality of radiation source filters comprise thin-film bandpass filters constructed to only pass a limited range of an ultraviolet light spectrum emitted by the ultraviolet radiation sources.
Stibich discloses an ultraviolet disinfecting lamp (see Fig. 1), wherein the light includes an ultraviolet band-pass filter (see para. [0037]) configured to pass a portion of the bandwidth of ultraviolet light (see para. [0037] in order to configure the light source to pass light in a specific portion of the ultraviolet spectrum and aid in the light source being configured to provide disinfection, decontamination, or sterilization (see para. [0037]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the plurality of radiation sources in Arcand to include ultraviolet bandpass filters configured to pass a portion of the bandwidth of ultraviolet light in view of Stibich in order to configure the light source to pass light in a specific portion of the ultraviolet spectrum and aid in the light source being configured to provide disinfection, decontamination, or sterilization.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuan, as applied to claim 39 above, and in view of Baril et al. (U.S. Pub. No. 2022/0168013 A1, hereinafter “Baril”).
Yuan discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 41, wherein: the sterilization accessory further comprises an electrical connector positioned on an exterior of the housing and in electrical communication with the irradiation circuit, the electrical connector configured to receive electrical energy from an external power source.
Baril discloses a sterilizing surgical access device (300, see Figs. 6-7) with an irradiation circuit (370), a plurality of ultraviolet light radiation sources (372), wherein the device further comprises an electrical connector (380) positioned on an exterior of the housing (see Fig. 7) and in electrical communication with the irradiation circuit (see para. [0054]), the electrical connector configured to receive electrical energy from an external power source (384, see Fig. 7, note that 384 is external to the lumen 311) in order to enable the surgeon to turn off and on the plurality of ultraviolet light radiation sources and to allow for proper disposal or recharging and re-use of the power source (see para. [0054]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the irradiation circuit in Yuan to further comprise an electrical connector positioned on an exterior of the housing and in electrical communication with the irradiation circuit, the electrical connector configured to receive electrical energy from an external power source in view of Baril in order to enable the surgeon to turn off and on the plurality of ultraviolet light radiation sources and to allow for proper disposal or recharging and re-use of the power source.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
The following references disclose surgical devices with germicidal filters / UV light:
PNG
media_image1.png
84
608
media_image1.png
Greyscale
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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, please contact the examiner’s supervisor, Eduardo C. Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
Prosecution Insights