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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young et al. (US 2002/0055715 A1, May 9, 2002) (hereinafter “Young”) and Katerkamp et al. (US 2011/0071480 A1, Mar. 24, 2011) (hereinafter “Katerkamp”).
Regarding claim 1: Young discloses a cannula attachment for a spinal cannula, the cannula attachment comprising: a body which extends between a proximal end and a distal end (hub 10); a fluid channel which extends through the body and which has an observation channel section visible from outside the body through a transparent region of the body (chamber 23, [0029]); and at least one optical lens which is arranged in the transparent region and by which the observation channel section is visible with optical magnification ([0029], magnifier 17).
Young does not disclose at least one optical prism is present in the observation channel section and configured for refraction and/or reflection of light incident into the observation channel section through the at least one optical lens.
Katerkamp, in the same field of endeavor, teaches a cannula attachment for a spinal cannula, the cannula attachment comprising: a body which extends between a proximal end and a distal end (needle hub 2); a fluid channel which extends through the body and which has an observation channel section visible from outside the body through a transparent region of the body (hollow cavity/observation chamber 3, [0029]); and at least one optical prism is present in the observation channel section and configured for refraction and/or reflection of light incident into the observation channel section ([0029]-[0030]). Katerkamp further teaches that providing prisms improves the ease of detecting whether backflow is occurring ([0007], [0017]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Young to include prisms as taught by Katerkamp in order to improve the ease of backflow detection.
Regarding claim 2: Young and Katerkamp disclose the cannula attachment according to claim 1. Both Young ([0006], [0035]) and Katerkamp ([0013], [0056]) disclose that the magnifying lens and prism(s) (respectively) may be integral to the needle hub and made from a single piece via molding. Katerkamp further discloses that this method provides reduced manufacturing costs ([0013]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to integrally form the lens and prism into the transparent wall in view of the teachings of all of Young and Katerkamp, in order to reduce manufacturing costs.
Further regarding claim 2: Since Young discloses that the lens is provided on an outer surface of the hub ([0018], [0029]) and Katerkamp discloses that the prisms are provided on the inner surface of the hub ([0011], [0030]), it would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide these elements in the same relative positions (outer and inner surfaces, respectively) in order to maintain the functionality provided by the particular structural arrangements.
Regarding claim 3: Young and Katerkamp disclose the cannula attachment according to claim 1 wherein the fluid channel has a total volume, and wherein the observation channel section occupies a predominant volume fraction of the total volume (Young – fig. 2, chamber 23 where the length of the lens 17 delineates the “observation section”; Katerkamp - figs. 6, 7, 10, where the entire hub of Katerkamp is transparent).
Regarding claim 4: Young and Katerkamp disclose the cannula attachment according to claim 1 wherein the fluid channel has a maximum internal diameter which is not more than 45% greater than a maximum internal diameter of the observation channel section (Young – fig. 2, chamber 23 where the length of the lens 17 delineates the “observation section”).
Regarding claim 5: Young and Katerkamp disclose the cannula attachment according to claim 1 wherein the proximal end of the body has a standardized fluid connector having a standardized internal diameter (Young – [0033] – luer lock connection 20). However, Young and Katerkamp are silent on the specific dimensions of the connector and channel including wherein a maximum internal diameter of the observation channel section is not more than 45% smaller than the standardized internal diameter of the fluid connector.
However, It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement the attachment of Young and Katerkamp having a maximum internal diameter of the observation channel section is not more than 45% smaller than the standardized internal diameter of the fluid connector, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984),
Regarding claims 6 and 7: Young and Katerkamp disclose the cannula attachment according to claim 1. Krebs further discloses at least two viewing surfaces that are arranged angularly offset to each other in a circumferential direction of the observation channel section on first and second faces of the body (Young – at least fig. 3 showing cylindrical magnifier 17 having two opposing sides; Katerkamp – figs. 6a and 7a show a plurality of viewing surfaces comprising prisms “angularly offset to each other in a circumferential direction”).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide at least one lens and at least one prism of claim 1 on the two opposing faces as taught by Young and Katerkamp, in order to provide viewing of the chamber even when the body is held in another orientation.
Regarding claim 8: Young and Katerkamp disclose the cannula attachment according to claim 1, wherein the body has a cuboid shape in a region of the observation channel section with a plurality of opposite outer faces, the at least one optical lens being assigned to one of the plurality of opposite outer faces (Young – figs. 1 and 3 – body has a generally “cuboid” shape in cross-section; Katerkamp – fig. 2A).
Regarding claim 9: Young and Katerkamp disclose the cannula attachment according to claim 1, wherein the body is made of a transparent plastic material in one piece (Young - [0006], [0035]; Katerkamp - [0013], [0056]).
Regarding claim 10: Young and Katerkamp disclose a spinal cannula comprising:
a cannula attachment according to claim 1 (see rejection of claim 1 above); and
a hollow needle fixed to the cannula attachment (Young – fig. 1; Katerkamp – fig. 1).
Response to Arguments
Applicant’s arguments, see remarks, filed 12/12/2025, with respect to the rejection(s) of claim(s) 1-10 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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, Chris Koharski can be reached at (571) 272-7230. 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.
/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799