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 .
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.
Claim Objections
Claim 26 is objected to because of the following informalities:
-In claim 26: ‘to be operably emit’ in Line 3 should read ‘to operably emit’
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-‘guidance mechanism for performing range sensing and providing feedback’ in claim 17 interpreted to be the structures such as the LCI detector in claim 18 or the miniature camera module in claim 19 and equivalents thereof.
-‘guidance mechanism for performing range sensing and providing feedback’ in claim 42 interpreted to be the structures such as the LCI detector in claim 43 or the miniature camera module in claim 44 and equivalents thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “efficiency” in claim 1 is a relative term which renders the claim indefinite. The term “efficiency” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation at least one second fiber, and the claim also recites a plurality of second fibers which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 5 recites the term ‘itself’ and it is unclear what ‘itself’ is meant to refer to. For examination purposes it will be treated as the lens.
Claim 5 recites ‘Raman signature’ and is dependent back to claim 1 which recites ‘Raman signal’ making it unclear if the recitation in claim 5 is meant to be the same element as the recitation in claim 1 or not. For examination purposes they will be treated as the same element.
The term “small” in claim 5 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 6 recites the limitation "the at least second fiber" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one second fiber’.
Claim 6 recites the limitation "the probe tip" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites ‘a lens’ and is dependent back to claim 1 which recites the same making it unclear if each recitation is meant to refer to the same element or not. For examination purposes they will be treated as the same element.
Claim 7 recites the limitation "the Raman signals" in Line 3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the Raman signal’.
Claim 8 recites the limitation "the at least first fiber" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one first fiber’.
Claim 8 recites the limitation "the at least second fiber" in Line 3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one second fiber’.
Claim 9 recites the limitation "the at least second fiber" in Line 6. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one second fiber’.
Claim 11 recites ‘wherein the first wavelength and the second wavelength are adapted such that when excited by the first wavelength….when excited by the second wavelength’ it is unclear what exactly is meant to be excited. For examination purposes it will be treated as if the target site is being excited.
Claim 11 recites the limitation "the first wavelength light" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the second wavelength light" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
The term “about” in claims 12-14 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “specific” in claim 17 is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 18 recites the limitation "the LCI feedback" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the position" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the excitation light spot" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the probe tip" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the lateral position" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites ‘or the like’ thus Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
The term “efficiency” in claim 22 is a relative term which renders the claim indefinite. The term “efficiency” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 23 recites the limitation "the collected Raman scattering light" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the Raman scattering light’.
Claim 23 recites ‘each Raman spectrum’ and it is unclear if this is part of the earlier recited ‘a plurality of Raman spectra’ or not. For examination purposes this will be read as ‘each Raman spectrum of the plurality of Raman spectra’.
Claim 23 recites ‘wherein the plurality of Raman spectra is processed’ but provides no structures capable of performing this function, making it unclear is this limitation is being positively recited or not.
Claim 23 recites the limitation "the identified spectral features" in Line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites ‘spectral features’ and is dependent back to claim 23 which recites the same making it unclear if each recitation is meant to refer to the same element or not. For examination purposes they will be treated as the same element.
Claim 24 recites the limitation "the identified spectral features" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the identified spectral features" in Lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the assessment" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 27 recites the broad recitation at least one second fiber, and the claim also recites a plurality of second fibers which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 30 recites the term ‘itself’ and it is unclear what ‘itself’ is meant to refer to. For examination purposes it will be treated as the lens.
Claim 30 recites ‘Raman signature’ and is dependent back to claim 30 which recites ‘Raman signal’ making it unclear if the recitation in claim 5 is meant to be the same element as the recitation in claim 22 or not. For examination purposes they will be treated as the same element.
The term “small” in claim 30 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 31 recites the limitation "the at least second fiber" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one second fiber’.
Claim 31 recites the limitation "the probe tip" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites ‘a lens’ and is dependent back to claim 22 which recites the same making it unclear if each recitation is meant to refer to the same element or not. For examination purposes they will be treated as the same element.
Claim 32 recites the limitation "the Raman signals" in Line 3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the Raman signal’.
Claim 33 recites the limitation "the at least first fiber" in Line 2. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one first fiber’.
Claim 33 recites the limitation "the at least second fiber" in Line 3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one second fiber’.
Claim 34 recites the limitation "the at least second fiber" in Line 6. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the at least one second fiber’.
Claim 36 recites ‘wherein the first wavelength and the second wavelength are adapted such that when excited by the first wavelength….when excited by the second wavelength’ it is unclear what exactly is meant to be excited. For examination purposes it will be treated as if the target site is being excited.
Claim 36 recites the limitation "the first wavelength light" in Line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 36 recites the limitation "the second wavelength light" in Line 5. There is insufficient antecedent basis for this limitation in the claim.
The term “about” in claims 37-39 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “specific” in claim 42 is a relative term which renders the claim indefinite. The term “specific” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 43 recites the limitation "the LCI feedback" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation "the position" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation "the excitation light spot" in Line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the probe tip" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 44 recites the limitation "the lateral position" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 46 recites ‘or the like’ thus Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim.
Claim 47 recites ‘Raman scattering light’ and incorporates the system of claim 22 which recites the same making it unclear if each recitation is meant to refer to the same element or not. For examination purposes they will be treated as the same element.
Claim 47 recites the limitation "the collected Raman scattering light" in Line 7. There is insufficient antecedent basis for this limitation in the claim. It would appear this should read ‘the Raman scattering light’.
Claim 47 recites the limitation "the identified spectral features" in Line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 48 recites the limitation "the identified spectral features" in Line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 48 recites the limitation "the assessment" in Lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-5, 7-9, 17, 19-20, 22-25, 27-30, 32-34, 42, 44, and 46-48 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (US 2015/0335248).
Regarding claim 1, Huang teaches a probe for collecting Raman signal of a target site of interest (Abstract), comprising:
at least one first fiber (excitation fiber 25) operably coupled with a first light source (laser source 21) and having a working end for delivering excitation light emitted from the first light source to the target site (Paragraph 0095; “the transmitted light from the excitation fiber 25 at least in part undergoes Raman scattering within the tissue 27”; Figures 1, 1a-1b);
at least one second fiber (collection fibers 28) operably coupled with a detector (at least CCD 34 and spectrograph 30) and having a working end for collecting Raman scattering light scattered from the target site in response to excitation by the excitation light to the detector (Paragraphs 0096-0097; Figures 1, 1a-1b); and
a lens (lens 26) positioned between the working ends of the at least one first fiber and the at least one second fiber and the target site for focusing the excitation light onto the target site and retrieving collection efficiency of the Raman scattering light (Paragraphs 0095-0096; Figure 1b).
Regarding claim 2, Huang teaches wherein the at least one second fiber includes a plurality of second fibers spatially arranged surrounding the at least one first fiber (Paragraph 0095; “The collection fibres 28 may be arranged in any suitable configuration, for example in a circular arrangement surrounding the excitation fiber 25.”).
Regarding claim 3, Huang teaches wherein the at least one first fiber and the plurality of second fibers are spatially arranged in a row, a matrix, a wing, or a ring form (Paragraph 0095; “The collection fibres 28 may be arranged in any suitable configuration, for example in a circular arrangement surrounding the excitation fiber 25.”).
Regarding claim 4, Huang teaches wherein the plurality of second fibers spatially is arranged in a radial ring form originated from the at least one first fiber (Paragraph 0095; The collection fibres 28 may be arranged in any suitable configuration, for example in a circular arrangement surrounding the excitation fiber 25.”).
Regarding claim 5, Huang teaches wherein the lens is adapted to minimize optical signal contribution from the lens itself that does not to interfere with Raman signature from the target site while maintaining a small outer diameter (Paragraph 0173; “ A miniature 1.0 mm sapphire ball lens (NA=1.78) is coupled to the fiber tip of the confocal probe to tightly focus the excitation light onto tissue, enabling the effective Raman spectrum collection from the epithelial lining (<200 μm).”).
Regarding claim 7, Huang teaches wherein the lens includes a quartz lens, a sapphire lens, a calcium fluoride (CaF2) lens, or a lens formed of any material whose inherent signal does not interfere with the Raman signals of the target site (Paragraph 0095; “a sapphire ball lens”).
Regarding claim 8, Huang teaches further comprising a first optical filter placed at the working end of the at least first fiber and a second optical filter placed at the working end of the at least second fiber, respectively (Paragraph 0095; band pass filter 22 and long pass filter 29)
Regarding claim 9, Huang teaches wherein the first optical filter is a short-pass or band-pass optical filter that blocks all wavelengths longer than that of the excitation light (Paragraph 0095; band pass filter 22); and the second optical filter is a long-pass or band-notch optical filter that blocks all wavelengths equal to or shorter than that of the excitation light, thereby preventing backscattered excitation light from being collected by the at least second fiber (Paragraph 0096; long-pass filter 29).
Regarding claim 17, Huang teaches further comprising a guidance mechanism for performing range sensing and providing feedback on orientation and position of the probe in lateral and axial directions to repeatably measure specific locations on the target site (Paragraph 0094).
Regarding claim 19, Huang teaches wherein the guidance mechanism comprises a miniature camera module located at the probe tip for providing wide-field visualization of the lateral position of the probe relative to the target site, wherein the miniature camera module includes a camera and an illumination fiber that delivers broadband light to visualize an imaging field of the camera (Paragraph 0094; Figure 1a).
Regarding claim 20, Huang teaches wherein the target site includes oral cavity and lymphoid tissues, middle ear tissues, cervical, gastrointestinal, esophageal and nasal tissues, or the like (Paragraph 0091).
Regarding claim 22, Huang teaches a system for assessment of a target site of interest (Abstract), comprising:
a first light source configured to operably emit excitation light (laser source 21); and
a probe (Figure 1b; Paragraph 0038) comprising:
at least one first fiber (excitation fiber 25) operably coupled with the first light source and having a working end for delivering the excitation light emitted from the first light source to the target site (Paragraph 0095; “the transmitted light from the excitation fiber 25 at least in part undergoes Raman scattering within the tissue 27”; Figures 1, 1a-1b);
at least one second fiber (collection fibers 28) having a working end for collecting Raman scattering light scattered from the target site in response to excitation by the excitation light (Paragraphs 0096-0097; Figures 1, 1a-1b); and
a lens (lens 26) positioned between the working ends of the at least one first fiber and the at least one second fiber and the target site for focusing the excitation light onto the target site and retrieving collection efficiency of the Raman scattering light (Paragraphs 0095-0096; Figure 1b).
Regarding claim 23, Huang teaches further comprising a detector (at least CCD 34 and spectrograph 30) coupled with the probe for obtaining a plurality of Raman spectra from the collected Raman scattering light, wherein each Raman spectrum is associated with biomolecular content of a spot of the target site at which the Raman scattering light is scattered, and wherein the plurality of Raman spectra is processed to identify spectral features and assess the target site from the identified spectral features (Paragraphs 0096-0097; Figures 1, 1a-1b).
Regarding claim 24, Huang teaches further comprising a controller (Paragraph 0097) operably coupled with the detector and configured to process the plurality of Raman spectra so as to identify spectral features and assess the target site from the identified spectral features (Paragraph 0103; Figures 1, 1a, 1b).
Regarding claim 25, Huang teaches further comprising a display operably coupled with the controller for displaying the plurality of Raman spectra, the identified spectral features, and/or the assessment of the target site (Paragraphs 0099 and 0103).
Regarding claim 27, Huang teaches wherein the at least one second fiber includes a plurality of second fibers spatially arranged surrounding the at least one first fiber (Paragraph 0095; “The collection fibres 28 may be arranged in any suitable configuration, for example in a circular arrangement surrounding the excitation fiber 25.”).
Regarding claim 28, Huang teaches wherein the at least one first fiber and the plurality of second fibers are spatially arranged in a row, a matrix, a wing, or a ring form (Paragraph 0095; “The collection fibres 28 may be arranged in any suitable configuration, for example in a circular arrangement surrounding the excitation fiber 25.”).
Regarding claim 29, Huang teaches wherein the plurality of second fibers spatially is arranged in a radial ring form originated from the at least one first fiber (Paragraph 0095; The collection fibres 28 may be arranged in any suitable configuration, for example in a circular arrangement surrounding the excitation fiber 25.”).
Regarding claim 30, Huang teaches wherein the lens is adapted to minimize optical signal contribution from the lens itself that does not to interfere with Raman signature from the target site while maintaining a small outer diameter (Paragraph 0173; “ A miniature 1.0 mm sapphire ball lens (NA=1.78) is coupled to the fiber tip of the confocal probe to tightly focus the excitation light onto tissue, enabling the effective Raman spectrum collection from the epithelial lining (<200 μm).”).
Regarding claim 32, Huang teaches wherein the lens includes a quartz lens, a sapphire lens, a calcium fluoride (CaF2) lens, or a lens formed of any material whose inherent signal does not interfere with the Raman signals of the target site (Paragraph 0095; “a sapphire ball lens”).
Regarding claim 33, Huang teaches wherein the probe further comprises a first optical filter placed at the working end of the at least first fiber and a second optical filter placed at the working end of the at least second fiber, respectively (Paragraph 0095; band pass filter 22 and long pass filter 29).
Regarding claim 34, Huang teaches wherein the first optical filter is a short-pass or band-pass optical filter that blocks all wavelengths longer than that of the excitation light (Paragraph 0095; band pass filter 22); and the second optical filter is a long-pass or band-notch optical filter that blocks all wavelengths equal to or shorter than that of the excitation light, thereby preventing backscattered excitation light from being collected by the at least second fiber (Paragraph 0096; long-pass filter 29).
Regarding claim 42, Huang teaches wherein the probe further comprises a guidance mechanism for performing range sensing and providing feedback on orientation and position of the probe in lateral and axial directions to repeatably measure specific locations on the target site (Paragraph 0094).
Regarding claim 44, Huang teaches wherein the guidance mechanism comprises a miniature camera module located at the probe tip for providing wide-field visualization of the lateral position of the probe relative to the target site, wherein the miniature camera module includes a camera and an illumination fiber that delivers broadband light to visualize an imaging field of the camera (Paragraph 0094; Figure 1a).
Regarding claim 46, Huang teaches wherein the target site includes oral cavity and lymphoid tissues, middle ear tissues, cervical, gastrointestinal, esophageal and nasal tissues, or the like (Paragraph 0091).
Regarding claim 47, Huang teaches a non-transitory tangible computer-readable medium storing instructions which, when executed by one or more processors (Paragraph 0034), cause the system of claim 22 (see rejection of claim 22 above) to
to deliver excitation light emitted from the first light source to the target site (Paragraphs 0154-0156; see rejection of claim 22 above);
collect Raman scattering light scattered from the target site in response to excitation by the excitation light (Paragraphs 0154-0156; see rejection of claim 22 above);
obtain a plurality of Raman spectra from the collected Raman scattering light (Paragraphs 0154-0156; see rejection of claim 22 above); and
process the plurality of Raman spectra so as to identify spectral features and assess the target site from the identified spectral features (Paragraphs 0154-0156; see rejection of claim 22 above).
Regarding claim 48, Huang teaches wherein the instructions, when executed by the one or more processors, further cause the system to display the plurality of Raman spectra, the identified spectral features, and/or the assessment of the target site (Figures 22A and 22B and Paragraph 0155).
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) 6 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248).
Regarding claim 6, Huang is silent on wherein the lens is positioned at a distance of 2F from the working end of the at least second fiber, thereby providing an imaging relay with a working distance of 2F from the probe tip, wherein F is a focal length of the lens.
The applicant's specification provides no specifical reasoning or critical functionality for the use of the lens is positioned at a distance of 2F, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the lens is positioned at a distance of 2F as desired by the user as a matter of routine engineering design choice and since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C)
Regarding claim 31, Huang is silent on wherein the lens is positioned at a distance of 2F from the working end of the at least second fiber, thereby providing an imaging relay with a working distance of 2F from the probe tip, wherein F is a focal length of the lens.
The applicant's specification provides no specifical reasoning or critical functionality for the use of the lens is positioned at a distance of 2F, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the lens is positioned at a distance of 2F as desired by the user as a matter of routine engineering design choice and since it has been held that rearranging parts of an invention involves only routine skill in the art MPEP 2144.04 VI. (C).
Claim(s) 10-12 and 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Brennan (US 2011/0313299).
Regarding claim 10, Huang is silent on the dual regions being measured. Brennan teaches wherein the first optical filter and the second optical filter are configured such that the probe is capable of measuring dual regions of the Raman scattering light from the target site, wherein the dual regions include a fingerprint (FP) region and a high-wavenumber (HW) region. (Paragraph 0072). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan because it allows for sampling of wavelength or bandwidth spectra in the same location thus providing a plethora of information that is useful in differentiating the different aspects of the target site (Paragraph 0019 of Brennan).
Regarding claim 11, Huang is silent on the dual regions being measured. Brennan teaches wherein the dual regions of the Raman scattering light are sequentially acquired by switching the excitation light between a first wavelength and a second wavelength, wherein the first wavelength and the second wavelength are adapted such that when excited by the first wavelength light, the Raman scattering light corresponds to the FP region; and when excited by the second wavelength light, the Raman scattering light corresponds to the HW region (Paragraphs 0070-0072; Figures 7-8). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan because it allows for sampling of wavelength or bandwidth spectra in the same location thus providing a plethora of information that is useful in differentiating the different aspects of the target site (Paragraph 0019 of Brennan).
Regarding claim 12, Huang is silent on the dual regions being measured. Brennan teaches wherein the first wavelength is in a range of about 630- 1064 nm, and the second wavelength is in a range of about 570-900 nm (Paragraph 0072). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan because it allows for sampling of wavelength or bandwidth spectra in the same location thus providing a plethora of information that is useful in differentiating the different aspects of the target site (Paragraph 0019 of Brennan). The applicant's specification provides no specifical reasoning or critical functionality for the use of the first wavelength is in a range of about 630- 1064 nm, and the second wavelength is in a range of about 570-900 nm, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the first wavelength is in a range of about 630- 1064 nm, and the second wavelength is in a range of about 570-900 nm as desired by the user as a matter of routine engineering design choice.
Regarding claim 35, Huang is silent on the dual regions being measured. Brennan teaches wherein the first optical filter and the second optical filter are configured such that the probe is capable of measuring dual regions of the Raman scattering light from the target site, wherein the dual regions include a fingerprint (FP) region and a high-wavenumber (HW) region (Paragraph 0072). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan because it allows for sampling of wavelength or bandwidth spectra in the same location thus providing a plethora of information that is useful in differentiating the different aspects of the target site (Paragraph 0019 of Brennan).
Regarding claim 36, Huang is silent on the dual regions being measured. Brennan teaches wherein the dual regions of the Raman scattering light are sequentially acquired by switching the excitation light between the first wavelength and the second wavelength, wherein the first wavelength and the second wavelength are adapted such that when excited by the first wavelength light, the Raman scattering light corresponds to the FP region; and when excited by the second wavelength light, the Raman scattering light corresponds to the HW region (Paragraphs 0070-0072; Figures 7-8). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan because it allows for sampling of wavelength or bandwidth spectra in the same location thus providing a plethora of information that is useful in differentiating the different aspects of the target site (Paragraph 0019 of Brennan).
Regarding claim 37, Huang is silent on the dual regions being measured. Brennan teaches wherein the first wavelength is in a range of about 750-1064 nm, and the second wavelength is in a range of about 630-750 nm (Paragraph 0072). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan because it allows for sampling of wavelength or bandwidth spectra in the same location thus providing a plethora of information that is useful in differentiating the different aspects of the target site (Paragraph 0019 of Brennan). The applicant's specification provides no specifical reasoning or critical functionality for the use of the first wavelength is in a range of about 750-1064 nm, and the second wavelength is in a range of about 630-750 nm, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the first wavelength is in a range of about 750-1064 nm, and the second wavelength is in a range of about 630-750 nm as desired by the user as a matter of routine engineering design choice.
Claim(s) 13-14 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Brennan (US 2011/0313299) and in further view of Tamada et al. (US 2015/0369742).
Regarding claim 13, Huang is silent on the dual regions being measured. Brennan teaches wherein the first wavelength is about 785 nm, and the second wavelength about 680 nm (paragraph 0072), and Tamada teaches wherein the short pass optical filter has a cut-off wavelength at about 785 nm, and the long pass filter has cut-on wavelength at about 800 nm (Paragraph 0112; Examiner notes that about is not defined by the specification and thus the values taught by Tamada can be considered about the claimed values). The applicant' s specification provides no specifical reasoning or critical functionality for the use of wherein the first wavelength is about 785 nm, and the second wavelength about 680 nm and wherein the short pass optical filter has a cut-off wavelength at about 785 nm, and the long pass filter has cut-on wavelength at about 800 nm, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use wherein the first wavelength is about 785 nm, and the second wavelength about 680 nm and wherein the short pass optical filter has a cut-off wavelength at about 785 nm, and the long pass filter has cut-on wavelength at about 800 nm as desired by the user as a matter of routine engineering design choice
Regarding claim 14, Huang is silent on the dual regions being measured. Brennan teaches wherein the first wavelength is about 830 nm, and the second wavelength about 710 nm (Paragraph 0072), and Tamada teaches wherein the short pass optical filter has a cut-off wavelength at about 830 nm, and the long pass filter has cut-on wavelength at about 850 nm (Paragraph 0112; Examiner notes that about is not defined by the specification and thus the values taught by Tamada can be considered about the claimed values). The applicant' s specification provides no specifical reasoning or critical functionality for the use of wherein the first wavelength is about 830 nm, and the second wavelength about 710 nm and wherein the short pass optical filter has a cut-off wavelength at about 830 nm, and the long pass filter has cut-on wavelength at about 850 nm, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use wherein the first wavelength is about 830 nm, and the second wavelength about 710 nm and wherein the short pass optical filter has a cut-off wavelength at about 830 nm, and the long pass filter has cut-on wavelength at about 850 nm as desired by the user as a matter of routine engineering design choice
Regarding claim 38, Huang is silent on the dual regions being measured. Brennan teaches wherein the first wavelength is about 785 nm, and the second wavelength about 680 nm (Paragraph 0072), and Tamada teaches wherein the short pass optical filter has a cut-off wavelength at about 785 nm, and the long pass filter has cut-on wavelength at about 800 nm (Paragraph 0112; Examiner notes that about is not defined by the specification and thus the values taught by Tamada can be considered about the claimed values). The applicant' s specification provides no specifical reasoning or critical functionality for the use of wherein the first wavelength is about 785 nm, and the second wavelength about 680 nm and wherein the short pass optical filter has a cut-off wavelength at about 785 nm, and the long pass filter has cut-on wavelength at about 800 nm, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use wherein the first wavelength is about 785 nm, and the second wavelength about 680 nm and wherein the short pass optical filter has a cut-off wavelength at about 785 nm, and the long pass filter has cut-on wavelength at about 800 nm as desired by the user as a matter of routine engineering design choice
Regarding claim 39, Huang is silent on the dual regions being measured. Brennan teaches wherein the first wavelength is about 830 nm, and the second wavelength about 710 nm (Paragraph 0072), and Tamada teaches wherein the short pass optical filter has a cut-off wavelength at about 830 nm, and the long pass filter has cut-on wavelength at about 850 nm (Paragraph 0112; Examiner notes that about is not defined by the specification and thus the values taught by Tamada can be considered about the claimed values). The applicant' s specification provides no specifical reasoning or critical functionality for the use of wherein the first wavelength is about 830 nm, and the second wavelength about 710 nm and wherein the short pass optical filter has a cut-off wavelength at about 830 nm, and the long pass filter has cut-on wavelength at about 850 nm, thus claimed limitation is a design choice. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to use wherein the first wavelength is about 830 nm, and the second wavelength about 710 nm and wherein the short pass optical filter has a cut-off wavelength at about 830 nm, and the long pass filter has cut-on wavelength at about 850 nm as desired by the user as a matter of routine engineering design choice.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Freudiger et al. (US 2016/0178439).
Regarding claim 15, Huang is silent on the high-wavenumber region being measured. Freudiger teaches wherein the first optical filter and the second optical filter are configured such that the probe is capable of measuring the Raman scattering light in a high-wavenumber (HW) region from the target site (Paragraph 0131 and 0171). It would have been obvious to one of ordinary skill in the art to have modified Huang with Freudiger because this is a conventional technique known in the art (Paragraph 0169 of Freudiger) and thus one of ordinary skill in the art could chose those numbers through routine experimentation with a reasonable expectation of predictable results.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Freudiger et al. (US 2016/0178439) and in further view of O’rourke et al. (US Patent No. 6205272).
Regarding claim 16, Huang is silent on the lens being glass. O’Rourke teaches wherein the lens includes a glass lens (Claim 2). It would have been obvious to one of ordinary skill in the art to have modified Huang with O’Rourke since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the sapphire lens of Huang with the glass lens of O’Rourke.
Claim(s) 18 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Brennan (US 2008/0304074).
Regarding claim 18, Huang is silent on the guidance mechanism comprising LCI. Brennan teaches wherein the guidance mechanism comprises a low- coherence interferometry (LCI) detector having at least one third fiber operably coupled with a second light source and having a working end for delivering low coherence light emitted from the second light source to the target site, wherein the at least one third fiber is located next to the at least one first fiber such that both beams of the excitation light and the low coherence light share the lens and are co-localized on the target site, ensuring that the LCI feedback is co-registered to the position of the excitation light spot (Paragraph 0056). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the camera guidance mechanism of Huang with the LCI guidance mechanism of Brennan.
Regarding claim 43, Huang is silent on the guidance mechanism comprising LCI. Brennan wherein the guidance mechanism comprises a low- coherence interferometry (LCI) detector having at least one third fiber operably coupled with a second light source and having a working end for delivering low coherence light emitted from the second light source to the target site, wherein the at least one third fiber is located next to the at least one first fiber such that both beams of the excitation light and the low coherence light share the lens and are co-localized on the target site, ensuring that the LCI feedback is co-registered to the position of the excitation light spot (Paragraph 0056). It would have been obvious to one of ordinary skill in the art to have modified Huang with Brennan since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the camera guidance mechanism of Huang with the LCI guidance mechanism of Brennan.
Claim(s) 21 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Azimi et al. (US 2009/0033928).
Regarding claim 21, Huang is silent on the system not having contact with the target site. Azimi teaches being configured to measure the Raman scattering light without contact to the target site (Paragraphs 0003 and 0018-0019). It would have been obvious to one of ordinary skill in the art to have modified Huang with Azimi because it allows for a non-invasive technique for investigation and analysis of a target (Paragraph 0003 of Azimi).
Regarding claim 45, Huang is silent on the system not having contact with the target site. Azimi teaches wherein the probe is configured to measure the Raman scattering light without contact to the target site (Paragraphs 0003 and 0018-0019). It would have been obvious to one of ordinary skill in the art to have modified Huang with Azimi because it allows for a non-invasive technique for investigation and analysis of a target (Paragraph 0003 of Azimi).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Gellermann et al. (US 2006/0244913).
Regarding claim 26, Huang is silent on the type of light source. Gellermann teaches wherein the first light source comprises a single wavelength laser module configured to operably emit the excitation light of a single wavelength, or a dual wavelength laser module configured to be operably emit the excitation light of a wavelength switchable between a first wavelength and a second wavelength (Paragraph 0084). It would have been obvious to one of ordinary skill in the art to have modified Huang with Gellermann since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the light source of Huang with that of Gellermann.
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Brennan (US 2011/0313299) in further view of Freudiger et al. (US 2016/0178439).
Regarding claim 40, Huang is silent on the high-wavenumber region being measured. Freudiger teaches wherein the first optical filter and the second optical filter are configured such that the probe is capable of measuring the Raman scattering light in a high-wavenumber (HW) region from the target site (Paragraph 0131 and 0171). It would have been obvious to one of ordinary skill in the art to have modified Huang with Freudiger because this is a conventional technique known in the art (Paragraph 0169 of Freudiger) and thus one of ordinary skill in the art could chose those numbers through routine experimentation with a reasonable expectation of predictable results.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (US 2015/0335248) in view of Brennan (US 2011/0313299) and Freudiger et al. (US 2016/0178439) in further view of O’rourke et al. (US Patent No. 6205272).
Regarding claim 41, Huang is silent on the lens being glass. O’Rourke teaches wherein the lens includes a glass lens (Claim 2). It would have been obvious to one of ordinary skill in the art to have modified Huang with O’Rourke since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case the sapphire lens of Huang with the glass lens of O’Rourke.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791