DETAILED ACTION
Response to Amendment
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) 1-3, 6-7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Poddar et al. (WO 2014/061030; hereafter Poddar) in view of Nakagami et al. (US 2002/0099341; hereafter Nakagami).
In regard to claim 1, Poddar discloses a medical puncture needle comprising: a needle body (1) formed in a tubular shape and comprising: a blade surface (2) formed at a distal end portion of the needle body, a first transmission window (6) configured to transmit light, and a second transmission window (other of 6) configured to transmit light transmitted through the first transmission window, wherein: the second transmission window is located on a proximal end side relative to the blade surface (see Fig. 3), and the first transmission window and the second transmission window are shifted from each other in a circumferential direction of the needle body (see Fig. 3).
Poddar fails to disclose the specific material set forth in claim 1 that the needle is metal. Nakagami teaches at paragraph [0002] that it is known in the art of injection needles to use the claimed material (metal) to manufacture the needle. In view of the teaching of Nakagami, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select metal as the specific type of material from which to manufacture the needle of Poddar, because it amounts to selection of a known material based on its known suitability for the purpose.
In further regard to claim 1, Poddar discloses wherein: the blade surface (2) is inclined with respect to an axis of the needle body (see Fig. 3); and the needle body comprises: a first wall portion (bottom portion of 1) located below an axis of the needle body in a horizontal state of the needle body in which the axis of the needle body is located in a horizontal direction such that the blade surface faces upward (see Fig. 3), and a second wall portion located above the axis of the needle body in the horizontal state, wherein: the first transmission window is provided in the first wall portion, and the second transmission window is provided in the second wall portion (see Fig. 3).
In further regard to claim 1, the instant disclosure describes the parameters of window distance from the blade surface as being merely preferable, and does not describe this distance as contributing any unexpected results to the system. As such, parameters such as the distance from the blade surface are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the recited distance would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
In regard to claim 3, Poddar discloses wherein: a plurality of the second transmission windows are provided (see Fig. 3).
In regard to claim 7, Poddar discloses: each of the first transmission window and the second transmission window is configured to transmit near-infrared light (all of the openings 6 are empty space and can therefore transmit near-infrared light).
In regard to claim 10, please see the rejection of claim 1. Poddar further discloses a catheter (5).
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 11-19 are allowed.
Response to Arguments
Applicant's arguments filed 1/21/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Poddar fails to expressly disclose a 2 mm or less distance from the proximal end of the blade surface to a proximal end of the second transmission window and therefore the claims are allowable, the examiner respectfully disagrees. The examiner agrees that Poddar does not expressly disclose the recited distance but maintains that the limitation is a design consideration that fails to patentably distinguish over the art. The applicant argues that the recited distance provides specific benefits when the claimed puncture needle is used as part of a vascular puncture system that allows for determination of a positional relationship between the needle body and a blood vessel. However, this is not persuasive because the specification does not specifically link the recited distance to the alleged benefit. There is no disclosure that the recited distance works better than or to the exclusion of other similar distances. For this reason, the recited distance is still considered to be a design consideration.
The applicant further argues that Poddar does not recognize that the distance from a proximal end of the blade to the proximal end of the holes is a result effective variable. Applicant further argues that Poddar is directed to fluid injection so that the distance is not particularly relevant. These arguments are not persuasive. The applicant is ignoring the skill of the ordinary artisan in this field which is quite high. The ordinary skilled artisan would readily appreciate that the distance of the opening from the blade would control where in the body the fluid was injected. The distance would be easily adjustable to provide the necessary injection profile that the artisan desired. While Poddar is not concerned with early detection of entrance into a blood vessel, the distance could clearly be chosen to allow for a distal injection into the tissue.
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 THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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