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 .
Notice of Amendment
The Amendment filed 3/31/2025 has been entered. Claims 13-22 are pending in the application with claims 1-12 cancelled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 recites the limitations ““an elongated body extending along a longitudinal axis between a proximal end and a beveled tip with a bevel angle” and “wherein the bevel angle is equal to the viewing angle”, however Applicant’s original disclosure fails to distinctly recite the bevel angle is equal to the viewing angle. The closest figures that seem to illustrate the feature attempting to be claimed is Figs. 9A-9D which show reflective plug (1600) having angled surfaces and an elongated body in Figs. 9C and 9D which also illustrates angled surfaces. However, the specification fails to define the angled surfaces of the elongated body in Figs. 9C-9D and further fails to specifically state the bevel angle of the elongated body being equal to the bevel angle of the plug. Instead, the specification recites after the mirrored surface is positioned within the elongated body, the plug and elongated body are cut/milled at the same time to create a sharpened tip (1612, not shown in the drawings) as recited in Par. 163. The examiner acknowledges the sharpened tip (1612) would allow the distal angled surfaces of the elongated body and plug to have the same angle, however the distal angled surface of the plug that defines the sharpened tip is not the viewing axis (1610), since the viewing axis (1610) is defined by the mirrored surface (1602). Appropriate correction is required.
Claims 19-22 recite the “wherein the bevel angle and viewing angle are no more than 45 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are no more than 10 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are about 35 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are between about 25 and about 30 degrees from the longitudinal axis” wherein the original disclosure fails to recite the angle of the bevel angle and further fails to recite the bevel angle and viewing angle are the same angle from the longitudinal axis. Appropriate correction is required.
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 13-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okoniewski (US Patent Application Publication No. 2010/0274081).
In regard to claim 13, Okoniewski discloses a tissue visualization device (Fig. 4), comprising:
an elongated body (12) extending along a longitudinal axis between a proximal end and a beveled tip (28) with a bevel angle (α) configured to pierce tissue (Par. 29); and
a visualization element (14) extending through the elongated body, the visualization element comprising a visualization sensor positioned at a distal end of the visualization element (Par. 10),
wherein the elongated body and the visualization element are configured to slide longitudinally relative to each other to allow the visualization element to extend past the elongate body (Fig. 4), and are integrally connected such that the visualization element and the elongated body comprise a single integrated unit (Figs. 1,4 the stylet (14) is intertably mounted to the needle (12)),
wherein the visualization device is configured to provide a view along a viewing axis angled at a viewing angle (β) from the longitudinal axis (Fig. 4), and
wherein the bevel angle is equal to the viewing angle (the tip of the stylet (14) is articulatable enabling the viewing angle to be adjusted to be the same as the bevel angle at select articulated positions).
In regard to claim 14, Okoniewski teaches wherein the elongated body comprises a lumen configured to deliver a fluid to the distal end of the elongated body (via valve (42) enables fluid to be delivered to the elongated body).
In regard to claim 15, Okoniewski teaches wherein the lumen is further configured to aspirate fluid (via valve (42) enables fluid to be aspirated from the elongated body).
In regard to claim 16, Okoniewski teaches further comprising a handpiece (16), wherein the elongated body, the visualization element, and the handpiece are connectable to form a single unit (Fig. 1).
In regard to claim 19, Okoniewski teaches wherein the bevel angle and viewing angle are no more than 45 degrees from the longitudinal axis (Fig. 4 shows the bevel angle being about 45°).
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.
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Okoniewski (US Patent Application Publication No. 2010/0274081), as applied to claim 1, and further in view of Sanders et al. (US Patent Application Publication No. 2008/0108869, hereinafter Sanders).
In regard to claims 17 and 18, Okoniewski is silent with respect to further comprising a rotational sensor, the rotational sensor configured to determine a rotational orientation of the visualization sensor, wherein the rotational sensor communicates with a monitor to rotate an image such that a patient reference direction will always appear on a top of the image.
Sanders teaches of an optical surgical instrument (10) comprising a camera head (42) disposed in a distal end of the shaft (12) and a handle (22) attached to a proximal end of the shaft. The handle comprises an accelerometer (715) disposed therein for sensing rotation of the shaft to correct an image for display on a display device such that the image always appears right-side up (Par. 274).
It would’ve been obvious to one of ordinary skill in the art at the time of the invention to modify the handpiece of Okoniewski with the accelerometer (715) of Sanders ensuring an image is always displayed right-side up with respect to gravity during rotation of the image sensor (Par. 274).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Okoniewski (US Patent Application Publication No. 2010/0274081) in view of Steube (US Patent Application Publication No. 2009/0041924).
In regard to claim 20-22, Okoniewsky does not expressly teach wherein the bevel angle and viewing angle are no more than about 10 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are about 35 degrees from the longitudinal axis, wherein the bevel angle and viewing angle are between about 25 degrees and about 30 degrees from the longitudinal axis.
Steube teaches an analogous needle for penetrating tissue in which the tip of the needle can have a beveled tip (22) which can have a plurality of bevel surfaces having different bevel angles. A first surface (24) can have a bevel angle of 8-18 degrees, a second surfaces (28a, 28b) can have a bevel angle of 16-26 degrees and the sharpest bevel can have a bevel angle of 25 to 35 degrees (Par. 36-38).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the beveled tip of Okoniewski with the beveled tip of Steube thereby providing a plurality of surface having a plurality of bevel angles for optimizing the needle for use in a plurality of applications (Par. 36-38).
Response to Arguments
Applicant's arguments filed 9/22/2025 have been fully considered but they are not persuasive.
Applicant argues:
Claims 13-22 were rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement because the claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one of ordinary skilled in the art that the inventor or joint inventor had possession of the claimed invention. In particular, Claim 13 recites “an elongated body extending along a longitudinal axis between a proximal end and a beveled tip with a bevel angle” and “wherein the bevel angle is equal to the viewing angle,” and the Office Action alleges the original disclosure “fails to distinctly recite the bevel angle is equal to the viewing angle” (Office Action at pg. 5). Claims 19-22 recite particular bevel angles and viewing angles, and the Office Action alleges “the original disclosure fails to recite the angle of the bevel angle and further fails to recite the bevel angle and viewing angle are the same angle from the longitudinal axis” (Office Action at pg. 6). Applicant respectfully disagrees and traverses the rejections.
In the response filed April 19, 2024, Applicant elected Examiner-identified Species A, identified as FIGS. 3A-B, which discloses a sliding embodiment that does not include a mirrored surface. These elected figures and the associated disclosure identify a beveled tip with a bevel angle (for example but not limited to references 1410, 1416, and 1418) and a range of viewing angles, including all recited viewing angles (for example but not limited to 1414 and alpha as well as para. [0136]-[0137]). Therefore, the Specification, at least at FIG. 3B, sufficiently shows the viewing angle being equal to at least the angle of the primary bevel surface 1416. Furthermore, non-elected Examiner-identified Species B, identified as FIGS. 9A-9D, clearly and explicitly discloses advantages to having a bevel angle match a viewing angle. Finally, para. [0168]-[0170] discuss how features that may be discussed in detail with respect to one embodiment are applicable to other embodiments. Therefore, Applicant respectfully submits the recited subject matter is sufficiently described in the Specification in such a way as to reasonably convey to one of ordinary skilled in the art that the inventors had possession of the claimed invention. Accordingly, Applicant respectfully requests reconsideration and withdrawal of these rejections.
The examiner disagrees since, regarding the embodiment of Fig. 3B, the specification is silent regarding any specifics regarding the angle of the bevel angles (1410, 1416, 1418) other than the tip includes the bevel angles. Additionally, Fig. 3B does not appear to show any of the bevel angles (1410, 1416, 1418) matching the viewing angle, nor does the specification provide any relationship between the bevel angle and viewing angle with respect to the embodiment of Figs. 3A-3B. Applicant appears to rely on Figs. 9A-9D to teach the bevel angle and viewing angle to be the same, however Figs. 9A-9D represent a non-elected embodiment and requires a plug having a mirrored surface. The configuration of the bevel angle and viewing angle are not relevant to the configuration of Figs. 3A and 3B due to the substantial different structure required by each of the embodiments. Additionally, the examiner is unable to find a clear teaching from the embodiment of Figs. 9A-9D that the bevel angle is the same as the viewing angle since although Fig. 9D appears to show the bevel angle and viewing angle being similar, this is not sufficient enough to claim they’re the same. At best, the embodiment of Figs. 9A-9D appears to teach the bevel angle and distal surface of the plug are cut to have the same angle, however the distal surface of the plug is not the viewing angle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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.
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 December 13, 2025