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 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.
Claim(s) 1 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coleman et al. (US 4,551,129, Nov. 5, 1985) (hereinafter “Coleman”).
Regarding claim 1: Coleman discloses a fiber optic needle probe comprising a hollow needle having a lumen, the hollow needle supporting a single optical fiber inserted inside the lumen along a length of the single optical fiber so that the single optical fiber is centrally disposed inside the hollow needle (figs. 4-5, hypodermic tube 6 and light guide 9), wherein a flexural rigidity of the hollow needle is higher than that of the single optical fiber by at least a factor ten (column 5, lines 12-13 - fiber 9 comprising polypropylene; column 4, line 46 - hypodermic tube 6 is stainless steel; as evidenced by Engineering Toolbox (https://www.engineeringtoolbox.com/young-modulus-d_417.html; retrieved 03/20/2026)), wherein a distal end of the single optical fiber is formed by a convex tip protruding beyond a distal end of the hollow needle (figs. 4-5), wherein the distal end of the single optical fiber is polished together with the distal end of the hollow needle to form combined distal ends of the single optical fiber and hollow needle into a continuous convex tip of the fiber optic needle probe (figs. 4-5; column 5, lines 31-37; it is noted that “polished together” is a product-by-process limitation and there does not appear to be any structural difference between the claimed convex tip and the convex tip of Coleman), and wherein the continuous convex tip forms a flush surface between respective interfaces of the distal end of the optical fiber and the distal end of the hollow needle (figs. 4-5; column 5, lines 31-37).
Regarding claim 10: Coleman discloses the fiber optic needle probe according to claim 1, wherein the hollow needle is formed by a metal tube having an outer diameter less than one millimeter and an inner diameter larger than an outer diameter of an outer protective coating of the single optical fiber (column 4, lines 46-47 - a 20 gauge needle is less than 1mm in diameter; "an outer protective coating" is not a positively recited structural element, the inner diameter of the needle is larger than the optical fiber such that there is a space between the fiber and the needle - column 5, lines 40-43).
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) 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Puppels et al. (US 2018/0317818 A1, Nov. 8, 2018) (hereinafter “Puppels”) in view of Pisanello et al. (US 2020/0138296 A1, May 7, 2020) (hereinafter “Pisanello”) and Zhao (US 6,916,329 B1, Jul. 12, 2005) (hereinafter “Zhao”).
Regarding claim 11: Puppels discloses an apparatus for measuring a tissue, the apparatus comprising: a fiber optic needle probe comprising a hollow needle supporting a single optical fiber along a length of the single optical fiber that is centrally disposed inside the hollow needle ([0014], [0065] - obvious to provide support for puncturing the tissue), the distal end of the single optical fiber is configured for injection into the tissue ([0014], [0065]); and a housing comprising a tissue engaging surface and a needle guiding structure configured to guide the fiber optic needle probe transverse to the tissue engaging surface for repeated insertion of the tip of the fiber optic needle probe into the tissue at different locations to reach a respective depth position below the tissue surface (fig. 8, probe 10 with housing 16), wherein the housing comprises at least one device taken from the group consisting of: an actuator, and a sensor ([0073], [0079]) wherein the at least one device is configured to receive or generate a depth signal to determine a depth position of the tip relative to the tissue engaging surface ([0073], [0079]). Puppels does not disclose wherein a distal end of the single optical fiber is formed by a convex tip protruding beyond a distal end of the hollow needle, wherein the distal end of the single optical fiber is polished together with the distal end of the hollow needle to form combined distal ends of the single optical fiber and hollow needle into a continuous convex tip of the fiber optic needle probe, wherein the distal end of the single optical fiber is polished together with the distal end of the hollow needle to form combined distal ends of the single optical fiber and hollow needle into a continuous convex tip of the fiber optic needle probe,
Pisanello, in the same field of endeavor, discloses a fiber optic probe comprising a pointed, convex tip ([0041]-[0044]) which is inserted into tissue ([0046]) for providing depth-resolved optical spectroscopy ([0012]). Pisanello further teaches that depth-resolved measurements may improve the quality of acquired data with advantages for both research and diagnostics ([0002], [0007], [0024]-[0029]).
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 probe of Puppels with the convex, depth-resolving tip of Pisanello in order to achieve the benefits of improved data acquisition and diagnostics in view of the further teachings of Pisanello. It is noted that the fiber tip of Pisanello would need to extend beyond the tip of any surrounding needle in order to function as disclosed, since the light is transmitted/received through the tapered surface 12/window 11c as shown in figs. 1-7.
Further regarding claim 11: Zhao, in the same problem-solving area of fiber optic probes, discloses a fiber optic probe comprising a metal needle (fig. 2, conductive outer layer 20) surrounding an optical fiber (fig. 2, optical fiber core 16) having a protruding convex tip (fig. 2, needle point 22) which is “polished together” with the needle to create combined distal ends of the single optical fiber and hollow needle into a continuous convex tip of the fiber optic needle probe, and wherein the continuous convex tip forms a flush surface between respective interfaces of the distal end of the optical fiber and the distal end of the hollow needle (fig. 2; column 3, lines 50-57). Zhao further teaches that the purpose of this continuous convex tip is to improve light transmission and to provide sufficient tapered sharpness of the point for comfortable insertion thereof into body tissue and through the skin of the patient (column 3, lines 50-57).
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 probe of Puppels and Pisanello by “polishing together” the needle and fiber as taught by Zhao in order to provide a smooth, continuous tip surface as taught by Zhao to facilitate insertion into the patient’s tissue.
Regarding claim 12: Puppels, Pisanello and Zhao disclose the apparatus according to claim 11. In another embodiment, Puppels discloses wherein the fiber optic needle probe is exchangeable from the housing of the apparatus ([0069] – disposable needle).
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 implement the needle/probe of Puppels, Pisanello and Zhao as being exchangeable from the housing of the apparatus in order to maintain sanitary conditions for the patient by providing disposable needles.
Regarding claim 13: Puppels, Pisanello and Zhao disclose the apparatus according to claim 11. Puppels further discloses wherein the hollow needle comprises a connection structure configured to fixate the fiber optic needle probe to a moveable part of the housing which moveable part is configured to move the fiber optic needle probe with respect to the tissue engaging surface into the tissue ([0076] - needle mount 11a).
Regarding claim 14: Puppels, Pisanello and Zhao disclose the fiber optic needle probe according to claim 1. Puppels and/or Pisanello further disclose an optical device configured to perform: transmitting source light into a proximal end of the single optical fiber, and receiving measurement light from the proximal end resulting from the source light having interacted with the tissue at the tip (Puppels - interrogator 20, [0085]; Pisanello – [0042]).
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coleman et al. (US 4,551,129, Nov. 5, 1985) (hereinafter “Coleman”) in view of Zhao (US 6,916,329 B1, Jul. 12, 2005) (hereinafter “Zhao”).
Regarding claim 15: Coleman discloses a method of manufacturing a fiber optic needle probe, the method comprising: providing a hollow needle having a lumen (hypodermic tube 6), inserting a single optical fiber into the lumen of the hollow needle such that a length of the of single optical fiber is centrally disposed inside the hollow needle for supporting the single optical fiber along the length, and forming a distal end of the single optical fiber to form a convex tip protruding beyond a distal end of the hollow needle (column 5, lines 31-40), wherein the distal end of the single optical fiber together with the distal end of the hollow needle forms combined distal ends of the single optical fiber and hollow needle into a continuous convex tip of the fiber optic needle probe (figs. 4-5; column 5, lines 31-37), wherein the continuous convex tip forms a flush surface between respective interfaces of the distal end of the optical fiber and the distal end of the hollow needle (figs. 4-5; column 5, lines 31-37).
Coleman is silent on polishing the convex tip/polishing the convex tip together with the distal end of the hollow needle.
Zhao, in the same problem solving area of fiber optic needles, discloses a method manufacturing a fiber optic needle probe including polishing a convex tip of the fiber together with a distal end of a hollow needle (fig. 2; column 3, lines 50-57). Zhao further discloses that polishing allows all light energy passing through the core 16 to emanate from the distal tip (column 3, lines 50-53).
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 method of Coleman by polishing the convex tip and distal end of the needle together to provide a highly polished surface to improve efficiency of light transfer from the fiber into the tissue in view of the teachings of Zhao.
Regarding claim 16: Coleman and Zhao disclose the method of claim 15. While Coleman and Zhao do not explicitly describe surface roughness, both Coleman (figs. 4-5 – end 9c and tube 6; column 5, lines 35-37) and Zhao (fig. 2, point 22 and transition taper 24) disclose a smooth transition between the convex tip and the needle. Additionally, both Coleman and Zhao are made for insertion into tissue (Coleman – column 3, lines 33-35; Zhao – column 2, lines 46-47).
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 both the convex tip and the distal end of the needle with the same surface roughness in order to create a smooth surface without a distinct roughness transition point to avoid catching or tugging tissue during insertion.
Allowable Subject Matter
Claims 8-9 are allowed.
Claims 2-7 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 3U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: There is insufficient reason to modify Coleman to have the features of claims 2, 3, and 7 (and dependents thereof) in the absence of impermissible hindsight reasoning.
Response to Arguments
Applicant’s arguments with respect to prior art rejection of claims 1 and 15, filed 01/12/2026, have been fully considered but are moot in view of the updated grounds of rejection necessitated by amendment.
Applicant’s arguments with respect to claim 11, see Remarks pg. 16 (first paragraph), have been fully considered but are not persuasive.
Applicant argues that claim 11 is not obvious over the cited prior art teaching
combination since there is no disclosure or suggestion of an apparatus configured for repeated, guided insertion with depth determination in combination with the specific probe architecture defined in the present claims, which mitigates fouling during said repeated insertion. The cited art does not recognize fouling at distal material interfaces as a problem in repeated diagnostic use, nor does it disclose or suggest configuring an apparatus in reliance on a probe having a protruding convex fiber tip and a continuous flush convex distal surface.
Examiner notes that the apparatus being configured for repeated, guided insertion and probe architecture to mitigate fouling do not appear to correspond to any limitations in the instant claims. Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rios et al. (US 2016/0155363 A1, Jun. 2, 2016) – discloses a fiber optic needle probe having a convex, conical tip extending beyond the distal tip of the needle
Gellman (US 8,277,411 B2, Oct. 2, 2012) – discloses a fiber optic needle probe having a convex lens tip extending beyond the distal tip of the needle.
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 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.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799