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 1-18) 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 1-4, 8-10, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sipple et al., US 2022/0015635 A1 (hereinafter “Sipple”).
Regarding claim 1: Sipple discloses an apparatus comprising:
a needle (needle 302, Fig. 3A) comprising a substantially cylindrical shaft comprising a tip (tip 324) located at a distal end of the shaft, the tip comprising an opening; and
an optical waveguide (lumen 320, interior walls 322 thereof, and “higher-index fluid in the lumen”, Fig. 3A and 3B; ¶ [0053]) located within the shaft of the needle.
The recitation of the optical waveguide being “configured to (i) receive a pump-Stokes beam of light emitted from an end face of an optical fiber, wherein the optical-fiber end face is located at a proximal end of the shaft opposite the distal end and (ii) convey the pump-Stokes beam along the optical waveguide to the tip of the needle, wherein the pump-Stokes beam is emitted from the optical waveguide and directed through the opening of the needle to a sample” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the optical waveguide couldn’t receive a pump-Stokes beam of light emitted from an end face of an optical fiber located at a proximal end of the shaft opposite the distal end as recited in the claim. Furthermore, here does not seem to be any reason why the optical waveguide couldn’t convey the pump-Stokes beam along the optical waveguide to the tip of the needle and ultimately emitted from the optical waveguide and directed through the opening of the needle to a sample as recited in the claim. Therefore, Sipple is considered to disclose the feature in question.
Regarding claim 2: Sipple further discloses a fiber-optic connector (308, 312, 316, 318, Figs. 3A and 3B) coupled to the needle at the proximal end of the shaft, wherein the fiber-optic connector is configured to be connected (via 318) to a fiber-optic connector (314, Fig. 3B) of the optical fiber (310).
Regarding claim 3: Sipple further discloses the optical fiber (310, Fig. 3A and 3B), wherein the optical fiber is attached to the needle at the proximal end of the shaft (via 308, 312, 314, 316, 318, Fig. 3B). The recitation that “the optical fiber is configured to transmit the pump-Stokes beam of light along the optical fiber and emit the pump-Stokes beam from the end face to direct the pump-Stokes beam into the optical waveguide” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the optical fiber couldn’t transmit the pump-Stokes beam of light along the optical fiber and emit the pump-Stokes beam from the end face to direct the pump-Stokes beam into the optical waveguide as recited in the claim. Therefore, Sipple is considered to disclose the feature in question.
Regarding claim 4: Sipple further discloses that the optical waveguide comprises a transparent material (“higher-index fluid in the lumen”, ¶ [0053]). The recitation that the transparent material is “configured to transmit the pump-Stokes beam of light” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the transparent material of Sipple couldn’t transmit the pump-Stokes beam of light. Therefore, Sipple is considered to disclose the feature in question.
Regarding claim 8: Sipple further discloses that the optical waveguide comprises a hollow space within the shaft (lumen 320, Fig. 3A).
Regarding claim 9: Sipple further discloses an interior surface of the shaft comprises a reflective optical coating (¶ [0053]). The recitation that the reflective optical coating is “configured to reflect the pump-Stokes beam of light as it propagates along the optical waveguide” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the reflective optical coating in Sipple couldn’t reflect the pump-Stokes beam of light as recited in the claim. Therefore, Sipple is considered to disclose the feature in question.
Regarding claim 10: Sipple further discloses a lens (312, Figs. 3A and 3B). The recitation that the lens is “configured to receive the pump-Stokes beam of light from the optical-fiber end face and produce a collimated or focused pump-Stokes beam that is directed into the optical waveguide” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the lens couldn’t receive the pump-Stokes beam of light from the optical-fiber end face and produce a collimated or focused pump-Stokes beam that is directed into the optical waveguide as recited in the claim. Therefore, Sipple is considered to disclose the feature in question.
Regarding claim 14: Sipple further discloses a point (tip 324). The recitation that “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” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the tip of needle in Sipple couldn’t be inserted into a body of the subject as recited in the claim. Futhermore, there does not seem to be any reason why the tip of the needle in Sipple could be used to (i) pierce through skin of the subject or (ii) pierce into an organ or another part of the body as recited in the claim.
Regarding claim 15: 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 a Raman signal is produced by coherent Raman scattering of the pump and Stokes beams of light at the sample” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the invention of Sipple couldn’t be used with a pump-Stokes beam of light and Raman signal as particularly recited in the claim. Therefore, Sipple is considered to disclose the feature in question.
Regarding claims 16-18: Recitation that the “the optical waveguide is further configured to receive a portion of the Raman signal that is directed through the opening and convey the received Raman signal along the optical waveguide to the proximal end of the shaft; and the Raman signal is coupled into the optical fiber via the optical-fiber end face, wherein the optical fiber is configured to convey the Raman signal to a Raman spectroscopy system configured to: produce the pump-Stokes beam of light that is directed to the sample via the optical waveguide; receive a Raman signal produced by coherent Raman scattering of the pump-Stokes beam of light at the sample; and measure the Raman signal” (claim 16) is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the invention of Sipple couldn’t be used with a Raman spectroscopy system as particularly recited in the claim. It is noted that the Raman spectroscopy system is not within the scope of the claimed invention because the claim does not ever recite that the apparatus comprises the Raman spectroscopy system. Therefore, Sipple is considered to disclose the feature in question.
Claims 17 and 18 also include intended use recitations which are therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. As discussed above, there does not seem to be any reason why the needle couldn’t be inserted into a body of the subject. Furthermore, there does not seem to be any reason why the invention of Sipple couldn’t be used with a Raman spectroscopy system as particularly recited in the claim. Again, it is noted that the Raman spectroscopy system is not within the scope of the claimed invention because the claim does not ever recite that the apparatus comprises the Raman spectroscopy system. Therefore, Sipple is considered to disclose the feature in question.
Claims 1, 4-7, 10, and 14-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tearney et al., US 2007/0239033 A1 (hereinafter “Tearney”).
Regarding claim 1: Tearney discloses an apparatus comprising:
a needle (52, Figs. 2 and 4) comprising a substantially cylindrical shaft comprising a tip located at a distal end of the shaft, the tip comprising an opening (see Fig. 4); and
an optical waveguide (optical fiber 25, Figs. 2 and 4) located within the shaft of the needle (see Fig. 4).
The recitation of the optical waveguide being “configured to (i) receive a pump-Stokes beam of light emitted from an end face of an optical fiber, wherein the optical-fiber end face is located at a proximal end of the shaft opposite the distal end and (ii) convey the pump-Stokes beam along the optical waveguide to the tip of the needle, wherein the pump-Stokes beam is emitted from the optical waveguide and directed through the opening of the needle to a sample” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the optical waveguide couldn’t receive a pump-Stokes beam of light emitted from an end face of an optical fiber located at a proximal end of the shaft opposite the distal end as recited in the claim. Furthermore, here does not seem to be any reason why the optical waveguide couldn’t convey the pump-Stokes beam along the optical waveguide to the tip of the needle and ultimately emitted from the optical waveguide and directed through the opening of the needle to a sample as recited in the claim. Therefore, Tearney is considered to disclose the feature in question.
Regarding claim 4: Tearney further discloses that the optical waveguide comprises a transparent material (core 62, Fig. 3A). The recitation that the transparent material is “configured to transmit the pump-Stokes beam of light” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the transparent material of Tearney couldn’t transmit the pump-Stokes beam of light. Therefore, Tearney is considered to disclose the feature in question.
Regarding claim 5: Tearney further discloses that an end face of the optical waveguide located in the tip of the needle is angled (“Alternatively, the fiber 25 may be angle cleaved or otherwise configured to produce an arbitrary pattern of electromagnetic radiation.” ¶ [0054]).
The recitation that “the pump-Stokes beam is emitted from the optical-waveguide end face along a direction that is at an angle with respect to a central axis of the needle” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the pump-Stokes beam couldn’t be emitted from the optical-waveguide end face along a direction that is at an angle with respect to a central axis of the needle as recited in the claim. Therefore, Tearney is considered to disclose the feature in question.
Regarding claim 6: The recitation that “the needle is configured to be rotated about the central axis to change the propagation direction of the pump-Stokes beam” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. 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 as recited in the claim. Therefore, Tearney is considered to disclose the feature in question.
Regarding claim 7: Tearney further discloses that the optical waveguide comprises one or more gradient-index (GRIN) lenses (“Other lenses or optical elements may be attached to the fiber 25 to allow for focusing deeper into tissue, including a gradient index lens 66 (see portion B of FIG. 3), sometimes referred to as a GRIN lens” ¶ [0054]).
Regarding claim 10: Tearney further discloses a lens (¶ [0054]). The recitation that the lens is “configured to receive the pump-Stokes beam of light from the optical-fiber end face and produce a collimated or focused pump-Stokes beam that is directed into the optical waveguide” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the lens couldn’t receive the pump-Stokes beam of light from the optical-fiber end face and produce a collimated or focused pump-Stokes beam that is directed into the optical waveguide as recited in the claim. Therefore, Tearney is considered to disclose the feature in question.
Regarding claim 14: Tearney further discloses that the tip comprises a point (see Fig. 4) 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 (¶ [0022], [0053]).
Regarding claim 15: 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 a Raman signal is produced by coherent Raman scattering of the pump and Stokes beams of light at the sample” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the invention of Tearney couldn’t be used with a pump-Stokes beam of light and Raman signal as particularly recited in the claim. Therefore, Tearney is considered to disclose the feature in question.
Regarding claims 16-18: Recitation that the “the optical waveguide is further configured to receive a portion of the Raman signal that is directed through the opening and convey the received Raman signal along the optical waveguide to the proximal end of the shaft; and the Raman signal is coupled into the optical fiber via the optical-fiber end face, wherein the optical fiber is configured to convey the Raman signal to a Raman spectroscopy system configured to: produce the pump-Stokes beam of light that is directed to the sample via the optical waveguide; receive a Raman signal produced by coherent Raman scattering of the pump-Stokes beam of light at the sample; and measure the Raman signal” (claim 16) is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the invention of Tearney couldn’t be used with a Raman spectroscopy system as particularly recited in the claim. It is noted that the Raman spectroscopy system is not within the scope of the claimed invention because the claim does not ever recite that the apparatus comprises the Raman spectroscopy system. Therefore, Tearney is considered to disclose the feature in question.
Claims 17 and 18 also include intended use recitations which are therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. As discussed above, needle is can be inserted into a body of the subject. Furthermore, there does not seem to be any reason why the invention of Tearney couldn’t be used with a Raman spectroscopy system as particularly recited in the claim. Again, it is noted that the Raman spectroscopy system is not within the scope of the claimed invention because the claim does not ever recite that the apparatus comprises the Raman spectroscopy system. Therefore, Tearney is considered to disclose the feature in question.
Claims 1, 3-6, 9, 11, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wijbrans et al., US 2018/0088044 A1 (hereinafter “Wijbrans”).
Regarding claim 1: Wijbrans discloses an apparatus comprising:
a needle (“optical biopsy needle”, ¶ [0064]) comprising a substantially cylindrical shaft (10, Fig. 3) comprising a tip located at a distal end of the shaft (see Fig. 3), the tip comprising an opening (implied from ¶ [0007]); and
an optical waveguide (illumination fiber 40, Figs. 2 and 3) located within the shaft of the needle (see Fig. 3.
The recitation of the optical waveguide being “configured to (i) receive a pump-Stokes beam of light emitted from an end face of an optical fiber, wherein the optical-fiber end face is located at a proximal end of the shaft opposite the distal end and (ii) convey the pump-Stokes beam along the optical waveguide to the tip of the needle, wherein the pump-Stokes beam is emitted from the optical waveguide and directed through the opening of the needle to a sample” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the optical waveguide couldn’t receive a pump-Stokes beam of light emitted from an end face of an optical fiber located at a proximal end of the shaft opposite the distal end as recited in the claim. Furthermore, here does not seem to be any reason why the optical waveguide couldn’t convey the pump-Stokes beam along the optical waveguide to the tip of the needle and ultimately emitted from the optical waveguide and directed through the opening of the needle to a sample as recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 3: Wijbrans further discloses the optical fiber (42, Fig. 1), wherein the optical fiber is attached to the needle at the proximal end of the shaft (see Fig. 1). The recitation that “the optical fiber is configured to transmit the pump-Stokes beam of light along the optical fiber and emit the pump-Stokes beam from the end face to direct the pump-Stokes beam into the optical waveguide” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the optical fiber couldn’t transmit the pump-Stokes beam of light along the optical fiber and emit the pump-Stokes beam from the end face to direct the pump-Stokes beam into the optical waveguide as recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 4: Wijbrans further discloses that the optical waveguide comprises a transparent material (core 20, Fig. 2). The recitation that the transparent material is “configured to transmit the pump-Stokes beam of light” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the transparent material of Wijbrans couldn’t transmit the pump-Stokes beam of light. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 5: Wijbrans further discloses that an end face of the optical waveguide located in the tip of the needle is angled (see Fig. 3).
The recitation that “the pump-Stokes beam is emitted from the optical-waveguide end face along a direction that is at an angle with respect to a central axis of the needle” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the pump-Stokes beam couldn’t be emitted from the optical-waveguide end face along a direction that is at an angle with respect to a central axis of the needle as recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 6: The recitation that “the needle is configured to be rotated about the central axis to change the propagation direction of the pump-Stokes beam” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. 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 as recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 9: Wijbrans further discloses an interior surface of the shaft comprises a reflective optical coating (¶ [0071]). The recitation that the reflective optical coating is “configured to reflect the pump-Stokes beam of light as it propagates along the optical waveguide” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the reflective optical coating in Wijbrans couldn’t reflect the pump-Stokes beam of light as recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 11: Wijbrans further discloses a lens or optical window (plug 50) attached to the needle at or near the opening of the needle (see Fig. 3). The lens or optical window is configured to prevent a fluid from flowing through the opening and into a space within the shaft (implied from “The second surface of the plug may have the size and shape of the opening formed in the bevel surface, so that a smooth distal surface without any gaps is formed at the distal end by the bevel surface and the second surface when the optical fiber together with the plug are accommodated within the channel.” ¶ [0045] in the sense that fluid cannot flow through the opening if there is no gap in the distal end bevel surface of the needle).The recitation that “the lens or optical window is configured to (i) transmit the pump-Stokes beam of light” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the lens or optical window couldn’t transmit the pump-Stokes beam of light as recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claim 14: Wijbrans further discloses 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 (¶ [0038]).
Regarding claim 15: 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 a Raman signal is produced by coherent Raman scattering of the pump and Stokes beams of light at the sample” is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the invention of Wijbrans couldn’t be used with a pump-Stokes beam of light and Raman signal as particularly recited in the claim. Therefore, Wijbrans is considered to disclose the feature in question.
Regarding claims 16-18: Recitation that the “the optical waveguide is further configured to receive a portion of the Raman signal that is directed through the opening and convey the received Raman signal along the optical waveguide to the proximal end of the shaft; and the Raman signal is coupled into the optical fiber via the optical-fiber end face, wherein the optical fiber is configured to convey the Raman signal to a Raman spectroscopy system configured to: produce the pump-Stokes beam of light that is directed to the sample via the optical waveguide; receive a Raman signal produced by coherent Raman scattering of the pump-Stokes beam of light at the sample; and measure the Raman signal” (claim 16) is considered a recitation of intended use of the claimed invention and therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. In this case, there does not seem to be any reason why the invention of Wijbrans couldn’t be used with a Raman spectroscopy system as particularly recited in the claim. It is noted that the Raman spectroscopy system is not within the scope of the claimed invention because the claim does not ever recite that the apparatus comprises the Raman spectroscopy system. Therefore, Wijbrans is considered to disclose the feature in question.
Claims 17 and 18 also include intended use recitations which are therefore not given patentable weight beyond the capability of the invention to perform or be used in the manner recited in the claim. As discussed above, needle can be inserted into a body of the subject. Furthermore, there does not seem to be any reason why the invention of Wijbrans couldn’t be used with a Raman spectroscopy system as particularly recited in the claim. Again, it is noted that the Raman spectroscopy system is not within the scope of the claimed invention because the claim does not ever recite that the apparatus comprises the Raman spectroscopy system. Therefore, Wijbrans is considered to disclose the feature in question.
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 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Sipple view of Wanner et al., US 2024/0131267 A1 (hereinafter “Wanner”); or alternativey over Tearney in view of Wanner; or alternatively over Wijbrans in view of Wanner.
Sipple, Tearney, and Wijbrans individually teach the invention of claim 1 as discussed above; however, none of them teaches 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 apparatus, comprising the needle, the optical waveguide, and the catheter, is configured to be at least partially inserted into a body of a subject, and that after insertion of the apparatus, the needle and the optical waveguide are configured to be removed, leaving at least a portion of the catheter tube inserted into the body.
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 either Sipple, Tearney, or Wijbrans 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 Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Scepanovic et al., US 2007/0167836 A1
Wang et al., US 2008/0267562 A1
Zuluaga, US 2012/0220880 A1
Sipple et al., US 2022/0409100 A1
Sahagen et al., US 5,510,895
Janes et al., US 5,280,788
Alfano et al., US 5,983,125
Motz et al., US 2004/0073120 A1
Kittrell et al., US 5,106,387
Aharoni et al., US 2016/0256101 A1
Aharoni et al., US 2016/0278694 A1
Conclusion
Claims 1-18 are rejected; this application is not in condition for allowance.
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COLIN T. SAKAMOTO
Primary Examiner
Art Unit 3798
/COLIN T. SAKAMOTO/Primary Examiner, Art Unit 3798
14 June 2026
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