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 .
Response to Arguments
Applicant’s arguments have been considered but are moot in view of the new ground of rejection set forth below addressing the amendments to the claims.
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.
Claims 16-19, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Akahoshi et al (US 20210161710).
Regarding claim 16, Akahoshi et al (hereafter Akahoshi) discloses a surgical instrument (figure 18), comprising: a handle (250) comprising a distal end; a probe (needle 100) comprising: a proximal end coupled to the distal end of the handle (figure 18, paragraph 0050); a micro structure pattern and a coating formed on a surface of the probe (paragraph 0051, texturizing process forms a microstructure pattern and the limitation “coating” is sufficiently broad to encompass sleeve 300 or molding secondary material to exterior surface 303 as a covering over the probe, figure 17); a driver (paragraph 0050, 251) in communication with the probe, wherein the driver is configured to cause vibration of the probe; and wherein the micro-structure pattern or coating and the vibration are configured to reduce adhesion of the probe to a vitreous of an eye (paragraph 0049), wherein the coating is formed on an exterior surface of the probe (paragraph 0051). Akahoshi teaches in a different embodiment that it was known to apply the micro-structure pattern on the inner surface of the probe in order to enhance the safety and efficiency of the probe (paragraph 0048). Therefore, it would have been within the skill of one with ordinary level in the art at the time of the invention to apply the micro-structure pattern on the inner surface of the probe in the embodiment of figure 17, as taught as known in the other embodiment of Akahoshi, in order to enhance the safety and efficiency of the probe.
Regarding claim 17, Akahoshi teaches all of the limitations set forth in claim 16, wherein the micro-structure pattern on the interior surface of the probe is formed by chemical etching, physical etching, wet etching, dry etching, stamping, or molding (paragraph 0048 and 0051, surface treatment for texturizing, sandblasting as physical etching).
Regarding claim 18, Akahoshi teaches all of the limitations set forth in claim 16, wherein a depth of the micro-structure pattern is between 0.1 microns and 100 microns (paragraph 0051, 12-36VDI equivalent to .4-6.3 microns).
Regarding claim 19, Akahoshi teaches all of the limitations set forth in claim 16, wherein the driver is configured to cause at least one of a rotational vibration, a gyrational vibration, or an axial vibration of the probe (paragraph0011-0012).
Regarding claim 22, Akahoshi teaches all of the limitations set forth in claim 16, wherein the coating forms a micro-structure on the distal end of the probe (exterior surface 303 of coating, paragraph 0051).
Claims 1, 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over Akahoshi et al (US 20210161710) in view of Carter et al (US 2020/0289319).
Regarding claim 1 , Akahoshi discloses a surgical instrument (figure 18), comprising: a handle (250) comprising a distal end; a probe (needle 100) comprising: a proximal end coupled to the distal end of the handle (figure 18, paragraph 0050); a coating formed on a surface of the probe (paragraph 0051, texturizing process forms a microstructure pattern and the limitation “coating” is sufficiently broad to encompass sleeve 300 or molding secondary material to exterior surface 303 as a covering over the probe, figure 17); a driver (paragraph 0050, 251) in communication with the probe, wherein the driver is configured to cause vibration of the probe; and wherein the micro-structure pattern or coating and the vibration are configured to reduce adhesion of the probe to a vitreous of an eye (paragraph 0049), wherein the coating is formed on an exterior surface of the probe (paragraph 0051). Akahoshi teaches in a different embodiment that it was known to apply the micro-structure pattern on the inner surface of the probe in order to enhance the safety and efficiency of the probe (paragraph 0048), but does not specifically teach a coating formed on an inner surface of the probe.
Carter et al (hereafter Carter) discloses a known ophthalmic cutting instrument (figure 1), comprising: a handle (114) comprising a distal end; a probe (112) comprising: a proximal end coupled to the distal end of the handle (figure 2A); a coating formed on a surface of the probe (paragraph 0098); a driver (116, paragraph 0094) in communication with the probe, wherein the driver is configured to cause vibration of the probe; and wherein the micro-structure pattern or coating and the vibration are configured to reduce adhesion of the probe to a vitreous of an eye (paragraph 0098), wherein Carter teaches a hydrophobic coating (paragraph 0098) as an art-recognized equivalent surface treatment at the time of the invention to further reduce the roughness of the cutting tube. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to also apply the coating on the inner surface of the probe in the embodiment of figure 17, since Carter teaches coatings are known art-recognized equivalent surface treatments to microstructure patterns and Akahoshi teaches it was known to apply surface treatments to the inner surfaces of probes in order to enhance the safety and efficiency of the probe.
Regarding claim 6, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, further comprising a micro-structure pattern on an exterior surface of the probe (paragraph 0051, texturizing process) formed by chemical etching, physical etching, wet etching, dry etching, stamping, or molding (paragraph 0051, surface treatment for texturizing, sandblasting as physical etching).
Regarding claim 7, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, further comprising a micro-structure pattern on an exterior surface of the probe (paragraph 0051, texturizing process), wherein a depth of the micro-structure pattern is between 0.1 microns and 100 microns (paragraph 0051, 12-36VDI equivalent to .4-6.3 microns; It is noted that although the prior art meets the limitations, the micro-structure pattern is only alternatively recited in claim 1, since the prior art meets the coating limitation. These limitations directed to the micro-structure pattern are not further limiting).
Regarding claim 8, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, wherein the driver is configured to cause at least one of a rotational vibration, a gyrational vibration, or an axial vibration of the probe (paragraph 0007, 0011).
Regarding claims 9, Akahoshi in view of Carter teaches all of the limitations set forth in claims 8, wherein Carter further teaches it was known for the vibration is at a frequency between 1-100 MHz (paragraph 0187, 0191) and an amplitude between 1-500 micrometers (paragraph 0187). Therefore, it would have been within the skill of one with ordinary skill in the art at the time of the invention to make the device of Akahoshi in view of Carter to have the vibration is at a frequency between 1-100 MHz and an amplitude between 1-500 micrometers, since it has been held discovering the optimal or workable ranges involves routine skill in the art.
Regarding claim 10, Akahoshi in view of Carter teaches all of the limitations set forth in claim 8, wherein the vibration comprises a rotational vibration comprising a continuous circular movement of the probe about a longitudinal axis of the surgical instrument (torsional vibration, paragraph 0011-0012).
Regarding claim 11, Akahoshi in view of Carter teaches all of the limitations set forth in claim 8, wherein the vibration comprises a gyrational vibration comprising a rotational movement of the probe in a conical path about a longitudinal axis of the surgical instrument (torsional vibration, paragraph 0011-0012).
Regarding claim 12, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, wherein the depth of the micro-structure pattern is 0.01 microns to 100 microns (paragraph 0051, 12-36 VDI equivalent to .4-6.3microns), but not specifically that a coating on the probe comprises a hydrophobic material having a thickness of 0.01 microns to 100 microns (It is noted that although the prior art meets the limitations, the coating is only alternatively recited in claim 1.Since the prior art meets the micro-structure pattern limitation and the coating is not required, limitations directed to the coating are not further limiting). However, Carter teaches a known ophthalmic cutting instrument comprising a hydrophobic coating (paragraph 0098) as an art-recognized equivalent surface treatment at the time of the invention to further reduce the roughness of the cutting tube. Therefore, it would have been obvious to one with ordinary skill in the art to alternatively utilize a hydrophobic coating for the surface treatment of the needle in Akahoshi in view of Carter, as an art recognized equivalent by Carter, in order to further reduce the roughness of the cutting tube, since it has been held that substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Regarding claim 13, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, wherein the coating forms a micro-structure on the distal end of the probe (exterior surface 303 of coating, paragraph 0051; It is noted that although the prior art meets the limitations, the coating is only alternatively recited in claim 1, since the prior art meets the micro-structure pattern limitation. These limitations directed to the coating are not further limiting).
Regarding claims 14, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, wherein Carter teaches it was known in the art at the time of the invention for the coating to form a hydrophobic interface on a distal end of the probe (ptfe, paragraph 0098). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the coating material of Akahoshi with the coating material of Carter as an art-recognized equivalent coating at the time of the invention and it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Regarding claim 15, Akahoshi in view of Carter teaches all of the limitations set forth in claim 1, Carter teaches it was known in the art at the time of the invention for the coating to comprise a ceramic or polytetrafluoroethylene (ptfe, paragraph 0098). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the coating material of Akahoshi with the coating material of Carter as an art-recognized equivalent coating at the time of the invention and it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Claim 20-21, 23-24 is rejected under 35 U.S.C. 103 as being unpatentable over Akahoshi, as applied to claim 16 above, and further in view of Carter et al (US 2020/0289319).
Regarding claim 20, Akahoshi teaches all of the limitations set forth in claims 19, wherein Carter further teaches it was known for the vibration is at a frequency between 1-100 MHz (paragraph 0187, 0191) and an amplitude between 1-500 micrometers (paragraph 0187). Therefore, it would have been within the skill of one with ordinary skill in the art at the time of the invention to make the device of Akahoshi to have the vibration is at a frequency between 1-100 MHz and an amplitude between 1-500 micrometers, as taught as a known vibration at the time of the invention by Carter, since it has been held discovering the optimal or workable ranges involves routine skill in the art.
Regarding claim 21, Akahoshi discloses all of the limitations set forth in claim 16, wherein the depth of the micro-structure pattern is 0.01 microns to 100 microns (paragraph 0051, 12-36 VDI equivalent to .4-6.3microns), but not specifically that a coating on the probe comprises a hydrophobic material having a thickness of 0.01 microns to 100 microns (It is noted that although the prior art meets the limitations, the coating is only alternatively recited in claim 1.Since the prior art meets the micro-structure pattern limitation and the coating is not required, limitations directed to the coating are not further limiting). However, Carter teaches a known ophthalmic cutting instrument comprising a hydrophobic coating (paragraph 0098) as an art-recognized equivalent surface treatment at the time of the invention to further reduce the roughness of the cutting tube. Therefore, it would have been obvious to one with ordinary skill in the art to alternatively utilize a hydrophobic coating for the surface treatment of the needle in Akahoshi, as an art recognized equivalent by Carter, in order to further reduce the roughness of the cutting tube, since it has been held that substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Regarding claims 23, Akahoshi teaches all of the limitations set forth in claim 16, wherein Carter teaches it was known in the art at the time of the invention for the coating to form a hydrophobic interface on a distal end of the probe (ptfe, paragraph 0098). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the coating material of Akahoshi with the coating material of Carter as an art-recognized equivalent coating at the time of the invention and it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Regarding claim 24, Akahoshi in view of Carter teaches all of the limitations set forth in claim 16, Carter teaches it was known in the art at the time of the invention for the coating to comprise a ceramic or polytetrafluoroethylene (ptfe, paragraph 0098). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the coating material of Akahoshi with the coating material of Carter as an art-recognized equivalent coating at the time of the invention and it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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, Darwin Erezo can be reached at (571) 272-4695. 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.
/ANH T DANG/Primary Examiner, Art Unit 3771
Prosecution Insights