NON-FINAL REJECTION
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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-23) in the reply filed on 4/2/2026 is acknowledged.
Information Disclosure Statement
The various information disclosure statements (IDS) submitted in this application have been considered. It is noted that there are a lot of references cited therein; however, consideration by the examiner of the information submitted in an IDS means that the examiner will consider the documents in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search (MPEP 609.05(b)).
Furthermore, Applicant is reminded that: each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability as defined in 37 CFR 1.56(b), and that there is no duty to submit information which is not material to the patentability of any existing claim (see 37 CFR 1.56(a)); and that 37 CFR 1.56(b) defines material to patentability as follows:
(b) Under this section, information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and
(1) It establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or
(2) It refutes, or is inconsistent with, a position the applicant takes in:
(i) Opposing an argument of unpatentability relied on by the Office, or
(ii) Asserting an argument of patentability.
A prima facie case of unpatentability is established when the information compels a conclusion that a claim is unpatentable under the preponderance of evidence, burden-of-proof standard, giving each term in the claim its broadest reasonable construction consistent with the specification, and before any consideration is given to evidence which may be submitted in an attempt to establish a contrary conclusion of patentability.
Many of the references appear to be cumulative in nature and/or not relevant to the invention as claimed. In this sense, many of the references are arguably not material to patentability. With regard to 37 CFR 1.56(b)(1), the examiner was not able to find any reference or combination of references cited in the IDS that establishes a prima facie case of unpatentability. With regard to 37 CFR 1.56(b)(2), the Office had not made any argument of unpatentability of any claim at the time the IDS were filed (i.e., IDSs were filed before the first action on the merits), therefore there is no argument for the unpatentability relied on by the Office for the Applicant to take a position in opposition thereof; further, the Applicant has not made any particular argument of patentability beyond an implied position of patentability by virtue of filing the patent application disclosing their invention along with a set of claims (i.e., it is presumed that Applicant believes the claimed invention is patentable).
While (1) the filing of an IDS shall not be construed to be an admission that the information cited therein is, or is considered to be, material to patentability as defined in § 1.56(b) (see 37 CFR 1.97(h)) and (2) there does not appear to be any statute or regulation explicitly establishing a duty to not submit information which is not material to the patentability, it is noted that submitting a reference that is material to patentability along with many references that are not material to patentability can potentially add unnecessary burden for the examiner (e.g., a “needle-in-the-haystack” situation) which can potentially lead to reduced patent quality. If there is/are reference(s) in the IDS of particular importance (i.e., establishes a prima facie case of unpatentability) that the Applicant believes the examiner may have overlooked, the Applicant may consider submitting (albeit, not required to) another IDS particularly pointing out said reference(s) including why it/they establish a prima facie case of unpatentability.
Claim Rejections - 35 USC § 102
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 1-18 and 21-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sahagen, US 5,526,112 (hereinafter “Sahagen”).
Regarding claim 1: Sahagen discloses an apparatus comprising:
a needle (hypodermic needle, col. 15, lines 14-20; Figs. 28 and 28A) comprising a substantially cylindrical shaft and a lumen, wherein the lumen comprises a hollow space located within the shaft, and the shaft comprises a tip located at an end of the shaft, the tip comprising an opening; and
an optical fiber (16 and 17, Fig. 28A) comprising an end face, wherein the end face and at least a portion of the optical fiber are located within the lumen, and the optical fiber is configured to transmit a pump-Stokes beam of light along the optical fiber toward the tip of the needle and to the end face, wherein the pump-Stokes beam is emitted from the end face and directed through the opening of the needle along a propagation direction that is at an angle with respect to a central axis of the needle (e.g., see Fig. 8, which illustrates angled end faces of the optical fibers 4 and 5).
It is further noted that the recitation that the beam of light is a pump-Stokes beam of light is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why the optical fiber of Sahagen couldn’t be used to transmit a pump-Stokes beam of light.
Regarding claim 2: Sahagen discloses the end face of the optical fiber is angled, wherein the angle along which the pump-Stokes beam is directed corresponds to an angle of the end face of the optical fiber (e.g., see Fig. 8).
Regarding claim 3: Sahagen discloses a faceted optic (diaphragm 1) comprising an angled face (e.g., see Figs. 16-20), wherein the faceted optic is configured to direct the pump-Stokes beam along the propagation direction that is at the angle with respect to the central axis.
Regarding claim 4: Sahagen discloses that the angled face comprises a lens configured to collimate or focus the pump-Stokes beam of light (diaphragm acts as a lens, col. 4, lines 6-10; the ordinarily skilled artisan understands that this is due to the angled face of the diagphragm; thus, the angled face, in a sense, comprises a lens).
Regarding claim 5: The recitation of the needle being “configured to be rotated about the central axis to change the propagation direction of the pump-Stokes beam” is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why the needle couldn’t be rotated about the central axis to change the propagation direction of the pump-Stokes beam.
Regarding claim 6: Sahagen needle further comprises a reference feature corresponding to the propagation direction of the pump-Stokes beam (the asymmetry of the needle itself can be considered to read on the claimed reference feature in the sense that it provides a rotational/angular reference that may be used to determine the propagation direction of the pump-Stokes beam if the structural relationship between the propagation direction and the needle is known).
Regarding claim 7: The recitation that “the pump-Stokes beam is used to perform a measurement along the propagation direction that is at the angle with respect to the central axis” is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why the pump-Stokes beam couldn’t be used to perform a measurement along the propagation direction that is at the angle with respect to the central axis.
Regarding claim 8: Sahagen teaches another optical fiber (e.g., see Fig. 10 which shows fibers 16 and 17). The recitation that said another optical fiber is “configured to emit another pump-Stokes beam that propagates along a direction that is substantially parallel to the central axis of the needle” is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why both fibers 16 and 17 couldn’t be used to emit pump-Stokes beam as discussed above. In the case of Fig. 10, the flat end face of fiber 16 would allow for the pump-Stokes beam that propagates along a direction that is substantially parallel to the central axis of the needle.
Regarding claim 9: the optical fiber is one of a plurality of optical fibers, each optical fiber comprising an end face (e.g., see Fig. 28A), wherein: the end face and at least a portion of each optical fiber are located within the lumen (see Fig. 28A). The recitation that “each optical fiber is configured to transmit a pump-Stokes beam of light along the optical fiber toward the tip of the needle and to the end face, wherein the pump-Stokes beam is emitted from the end face and directed through the opening of the needle along a propagation direction that is at an angle with respect to the central axis of the needle, wherein each pump-Stokes beam is directed in a different propagation direction from the other pump-Stokes beams” is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why both fibers 17 couldn’t be used to emit pump-Stokes beam of light along the optical fiber toward the tip of the needle and to the end face such that the pump-Stokes beam is emitted from the end face and directed through the opening of the needle along a propagation direction. Additionally, considering the arrangement of fibers as shown in for example Figs. 9-13, the propagation directions would be at angles with respect to the central axis of the needle and each pump-Stokes beam is directed in a different propagation direction from the other pump-Stokes beams.
Regarding claim 10: Sahagen further discloses the end face of each of the optical fibers is angled, wherein the angle along which a pump-Stokes beam is directed corresponds to an angle of the end face of the optical fiber from which the pump-Stokes beam is emitted (e.g., see Fig. 9 which illustrate fibers 17 have angled end faces).
Regarding claim 11: Sahagen further discloses a lens (1) configured to receive the pump-Stokes beams from each of the optical fibers and direct each of the pump-Stokes beams along one of the different propagation directions (e.g., see Figs. 16-20).
Regarding claim 12: a faceted optic (1) comprising a plurality of angled faces, wherein each angled face is configured to direct one of the pump-Stokes beams along one of the different propagation directions (e.g., see Figs. 16-20).
Regarding claim 13: each angled face comprises a lens configured to collimate or focus the pump-Stokes beam of light (diaphragm acts as a lens, col. 4, lines 6-10; the ordinarily skilled artisan understands that this is due to the angled faces of the diagphragm; thus, each of the angled faces, in a sense, comprises a lens).
Regarding claim 14: The recitation that “each of the pump-Stokes beams is used to perform a measurement along one of the different propagation directions” is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why each of the pump-Stokes beams couldn’t be used to perform a measurement along one of the different propagation directions.
Regarding claim 15: The discussion above regarding claim 6 similarly applies. The asymmetry of the needle itself can be considered to read on the claimed reference feature in the sense that it provides a rotational/angular reference that may be used to determine the propagation direction of one of the pump-Stokes beams if the structural relationship between the propagation direction and the needle is known.
Regarding claim 16: The recitation that “each optical fiber is further configured to (i) receive a Raman signal produced by coherent Raman scattering of the pump-Stokes beam transmitted by the optical fiber and (ii) transmit the Raman signal along the optical fiber in a direction opposite the pump-Stokes beam” is a recitation of intended use and therefore not give patentable weight beyond the capability of the invention to function or be used in recited manner. In this case, there does not seem to be any reason why each optical fiber couldn’t be used in the aforementioned manner.
Regarding claim 17: Other than the fact that there are a plurality of optical fibers, the recitation that “each of the plurality of optical fibers is an output optical fiber; each pump-Stokes beam is configured to produce a Raman signal by coherent Raman scattering of the pump-Stokes beam; and the apparatus further comprises an input optical fiber comprising an input-fiber end face, wherein the input-fiber end face and at least a portion of the input optical fiber are located within the lumen, and the input optical fiber is configured to receive at least a portion of the Raman signal produced by each of the pump-Stokes beams via the input-fiber end face and transmit the received Raman signal along the input optical fiber in a direction away from the tip of the needle” is a recitation of intended use and therefore not give patentable weight beyond the capability of the optical fibers to function or be used in recited manner. In this case, there is no reason why the each of the fibers 17 couldn’t be used as output optical fibers; further there is not reason why each pump-Stokes beam couldn’t produce a Raman signal by coherent Raman scattering of the pump-Stokes beam; there is no reason why optical fiber 16 couldn’t be used as an input fiber to receive at least a portion of the Raman signal produced by each of the pump-Stokes beams via the input-fiber end face and transmit the received Raman signal along the input optical fiber in a direction away from the tip of the needle.
Regarding claim 18: Sahagen further discloses a lens configured to focus the received Raman signal into the input optical fiber via the input-fiber end face (diaphragm acts as a lens, col. 4, lines 6-10).
Regarding claim 21: Sahagen further discloses that the tip further comprises a point, wherein at least the tip of the needle is configured to be inserted into a body of a subject by using the point to (i) pierce through skin of the subject or (ii) pierce into an organ or another part of the body (see Figs. 28 and 28A; the needle is characterized as a hypodermic-needle, col. 15, line 16).
Regarding claim 22: The recitation that “the pump-Stokes beam of light comprises a pump beam of light at a pump frequency and a Stokes beam of light at a Stokes frequency, wherein the pump and Stokes frequencies are offset by a frequency offset Ω; and the pump-Stokes beam is directed to a sample which produces a Raman signal by coherent Raman scattering of the pump and Stokes beams of light at the sample” is a recitation of intended use and therefore not give patentable weight beyond the capability of the optical fibers to function or be used in recited manner (i.e., able to emit/transmit the particularly recited pump-Stokes beam. In this case, there is no reason why the optical fiber couldn’t emit/transmit the particularly recited pump-Stokes beam.
Regarding claim 23: the optical fiber is configured to be coupled to a Raman spectroscopy system (via connectors 38, Figs. 28 and 28B). Recitation that the “Raman spectroscopy system is configured to: produce the pump-Stokes beam of light that is directed through the opening of the needle via the optical fiber; receive a Raman signal produced by coherent Raman scattering of the pump-Stokes beam of light at a sample; and measure the Raman signal” reads like a recitation of intended use in the sense that it does not limit the claimed apparatus (the Raman spectroscopy system is not recited as part of the claimed apparatus). There is not reason why the connectors 38 wouldn’t be able to couple the optical fiber to the Raman spectroscopy system recited in the claim or any other Raman spectroscopy system for that matter.
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.
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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sahagen in view of Wanner et al., US 2024/0131267 A1 (hereinafter “Wanner”).
Regarding claims 19 and 20: Sahagen does not disclose a catheter comprising a catheter connector and a catheter tube having a substantially cylindrical shape, wherein the catheter tube surrounds at least a portion of the needle shaft, let alone that the apparatus, comprising the needle, the optical fiber, and the catheter, is configured to be at least partially inserted into a body of a subject; and after insertion of the apparatus, the needle and the optical fiber are configured to be removed, leaving at least a portion of the catheter tube inserted into the body of the subject.
Wanner teaches a catheter (cannula 1000, Fig. 10) comprising a catheter connector (cannula hub as shown in Fig. 10) and a catheter tube having a substantially cylindrical shape (the cannula itself appears to have a cylindrical body as shown in Fig. 10), wherein the catheter tube surrounds at least a portion of the needle shaft (implied: “In this configuration, the cannula [1000] slides over a custom needle hub [1001] before the needle is inserted into the body”, ¶ [0073]). Wanner further teaches that the apparatus, comprising the needle, the optical fiber, and the catheter, is configured to be at least partially inserted into a body of a subject (“In this configuration, the cannula [1000] slides over a custom needle hub [1001] before the needle is inserted into the body. Vascular detection from the needle allows for placement of cannula in bloodstream [1003].” ¶ [0073]); and after insertion of the apparatus, the needle and the optical fiber are configured to be removed, leaving at least a portion of the catheter tube inserted into the body of the subject (“After placement, the cannula can be fixed to the body and the custom needle hub removed using a removal tab for easy grip [1004].” ¶ [0073]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sahagen such that the apparatus further comprises a catheter comprising a catheter connector and a catheter tube having a substantially cylindrical shape, wherein the catheter tube surrounds at least a portion of the needle shaft, and further such that the apparatus, comprising the needle, the optical fiber, and the catheter, is configured to be at least partially inserted into a body of a subject; and after insertion of the apparatus, the needle and the optical fiber are configured to be removed, leaving at least a portion of the catheter tube inserted into the body of the subject, as taught by Wanner; and the ordinarily skilled artisan would have been motivated to make this modification in order to guide placement of a catheter into the a target location in the body such as blood vessel.
Additional Cited Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see PTO-892 form attached herewith).
Conclusion
Claims 1-23 are rejected; this application is not in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLIN T. SAKAMOTO whose telephone number is (571)272-4958. The examiner can normally be reached Monday - Friday, ~9AM-5PM Pacific.
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, KEITH M. RAYMOND can be reached at (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
13 June 2026
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