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 .
Status Of Claims
This Office Action is in response to an amendment received 5/11/2026 in which Applicant lists claims 7-10, 12-13, 16-17 as being withdrawn, and claims 1-6, 11, 14-15 as being original. It is interpreted by the examiner that claims 1-17 are pending.
If applicant is aware of any relevant prior art, or other co-pending application not already of record, they are reminded of their duty under 37 CFR 1.56 to disclose the same.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/11/2026 is acknowledged.
Claims 7-10, 12-13 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to at least one nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/2026.
Applicant's remarks filed 5/11/2026 stating that all grounds of rejection are properly traversed and requesting that the Examiner reconsider and withdraw all outstanding rejections, have been fully considered but they are not persuasive since there were no outstanding rejections at the time of the filing of the remarks.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on 8/5/2024 and 6/12/2025 were considered.
The information disclosure statement filed 8/1/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the IDS was not signed. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). It is noted that the 8/5/2024 IDS was considered instead of the 8/1/2024 IDS, as requested by applicant on 8/5/2024.
Drawings
The drawings are objected to because figure 4 appears to be partially cutoff where element 340 is, and is missing the indicator line for element 340. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 6 is objected to because of the following informalities: the language “tested loaded” is not grammatically correct and should be corrected. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 11, 14-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an optical instrument wherein a relative distance between the second lens group and a miniature objective is less than a first preset distance threshold (see claim 1), wherein the relative distance between the second lens group and the miniature objective is a ratio of an absolute distance between the second lens group and the miniature objective to a diameter of the miniature objective (see claim 14), wherein the first preset distance threshold is one-third (see claim 15), does not reasonably provide enablement for an optical instrument wherein a relative distance between the second lens group and a miniature objective is less than a first preset distance threshold which does not include the relative distance between the second lens group and the miniature objective being a ratio of an absolute distance between the second lens group and the miniature objective to a diameter of the miniature objective (see claim 14), wherein the first preset distance threshold is one-third (see claim 15). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims (see e.g. claim 1).
The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to: 1) nature of the invention, 2) state of the prior art, 3) relative skill of those in the art, 4) level of predictability, 5) existence of working samples, 6) breadth of claims, 7) amount of direction or guidance by the inventor, and 8) quantity of experimentation needed to make or use the invention. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention is drawn to an optical instrument applied to a miniature multi-photon microscope wherein a relative distance between the second lens group and a miniature objective is less than a first preset distance threshold (see claim 1), such that the technical problem of scattered fluorescent photons entering a collection optical path and a limited signal-to-noise ratio of fluorescence imaging are overcome (paras. [0003]-[0004], [0052]).
The state of the art discloses optical instruments/microscopes for performing fluorescence imaging.
The level of skill in the art is related to the areas of fluorescence multi-photon microscopes. The skill level is high (e.g. Master’s or PhD level).
There is one working model of wherein the relative distance between the second lens group and the miniature objective is a ratio of an absolute distance between the second lens group and the miniature objective to a diameter of the miniature objective, and wherein the first preset distance threshold is one-third (see paras. [0018]-[0019], [0056])
Applicants’ claims are excessively broad due, in part, to the complex and diverse nature of fluorescence multi-photon microscopy.
Due to the large quantity of experimentation necessary to determine when the technical problems of the prior art/invention may be overcome by having a relative distance between the second lens group and a miniature objective be less than a first preset distance threshold, without the relative distance between the second lens group and the miniature objective being a ratio of an absolute distance between the second lens group and the miniature objective to a diameter of the miniature objective (see claim 14), and without the first preset distance threshold being one-third (see claim 15), the lack of direction/guidance presented in the specification regarding same, the absence of sufficient working examples directed to same, the complex nature of the invention, the state of the prior art, and the breadth of the claims which fail to recite that the relative distance between the second lens group and the miniature objective is a ratio of an absolute distance between the second lens group and the miniature objective to a diameter of the miniature objective, and that the first preset distance threshold is one-third, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Therefore, the specification fails to teach the skilled artisan how to make and/or use the claimed apparatus without resorting to undue experimentation.
Claims 2-6, 11, 14-15 are rejected for inheriting the scope of enablement issues of claim 1. It is noted that claims 14-15 define the relative distance and the first preset distance threshold and are suggested to be moved up into claim 1.
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 1-6, 11, 14-15 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 “miniature” in at least claim 1 is a relative term which renders the claim indefinite. The term “miniature” 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. Therefore, it is not clear from the claim(s) what size or other physical characteristics would make a multi-photon microscope, or an objective, be considered to be “miniature” and therefore the metes-and-bounds of the claims are not clear.
Claims 2-6, 11, 14-15 are rejected for inheriting the indefiniteness of claim 1 from which they depend.
In claim 1, it is not clear what is meant by “a relative distance between the second lens group and a miniature objective is less than a first preset distance threshold” since no preset distance is claimed, and claim 1 does not set forth what is meant by “relative distance” or how it is determined. At least paragraph [0018] of the disclosure states that “the relative distance between the second lens group and the miniature objective is a ratio of a absolute distance between the second lens group and the miniature objective to a diameter of the miniature objective”, and paragraph [0019] of the disclosure gives an example wherein “the preset distance threshold is 1/3”. However, a value for preset distance is not recited in claim 1, and claim 1 does not recite that the “relative distance” is the described ratio. Therefore, the metes-and-bounds of claim is not clear.
Claims 2-6, 11, 14-15 are rejected for inheriting the indefiniteness of claim 1 from which they depend. It is noted that claims 14-15 define the relative distance and the first preset distance threshold and would not be indefinite for the above reasons if claims 14 and 15 were moved up into claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hillman et al., WO 2015/109323 A2, of record (hereafter Hillman).
Regarding claim 1, as best understood, Hillman discloses an optical instrument, applied to a miniature multi-photon microscope, wherein the optical instrument is configured to have a fluorescence excitation optical path and a fluorescence collection optical path (see at least figure 37, as well as pages 9, 14-16, 24-26 of the specification regarding multiple fluorophore excitation in SCAPE microscopy and two-photon implementation), and the optical instrument comprises:
a condenser (see at least figure 37), wherein the condenser comprises a first lens group (see at least annotated figure 37, 1st lens group) and a second lens group (see at least figure 37, “Electric lens”) separately disposed (see at least figure 37), the first lens group is located in the fluorescence collection optical path (see at least annotated figure 37, 1st lens group between the Sample and the Camera/Image Splitter), the second lens group is located in the fluorescence excitation optical path and the fluorescence collection optical path (see at least figure 37, “Electric lens”), and a relative distance between the second lens group and a miniature objective is less than a first preset distance threshold (see at least figure 37 and page 16 of the specification, “Electric lens” which may be moved with respect to the objective lens and therefore is considered “less than a first preset distance threshold” in at least one position).
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The recitation “applied to a miniature multi-photon microscope” has not been given significant patentable weight under MPEP Chapter 2111.02 [R-3] – Effect of Preamble because the recitation occurs in the preamble where it merely recites the intended use of a structure and fails to structurally limit the body of the claim.
MPEP 2112.02 (II) states that “statements in the preamble reciting the purpose of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, then the recitation serves to limit the claims.” Additionally, In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962), is a case where the “statement of intended use in an apparatus claim did not distinguish over the prior art apparatus”.
Claims 1-5 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Okugawa et al., U.S. Patent Application Publication Number 2010/0182683 A1 (hereafter Okugawa).
Regarding claim 1, as best understood, Okugawa discloses an optical instrument, wherein the optical instrument is configured to have a fluorescence excitation optical path and a fluorescence collection optical path (see at least the title and figure 1), and the optical instrument comprises:
a condenser (see at least figure 1), wherein the condenser comprises a first lens group (see at least figure 1, element 27) and a second lens group (see at least figure 1, element 24 and/or 25) separately disposed (see at least figure 1), the first lens group is located in the fluorescence collection optical path (see at least figure 1, elements 27 and 50), the second lens group is located in the fluorescence excitation optical path and the fluorescence collection optical path (see at least figure 1, element 24 and/or 25), and a relative distance between the second lens group and a miniature objective is less than a first preset distance threshold (see at least figure 1 wherein element 24 and/or 25 must be positioned such that light is collected by the element and focused/transmitted on to element 23, 24, 25 and/or 26, and being placed at a distance greater than “a first preset distance threshold” could result in not all of the light being collected or light not being properly focused/transmitted on to element 23, 24, 25 and/or 26).
The recitation “applied to a miniature multi-photon microscope” has not been given significant patentable weight under MPEP Chapter 2111.02 [R-3] – Effect of Preamble because the recitation occurs in the preamble where it merely recites the intended use of a structure and fails to structurally limit the body of the claim.
MPEP 2112.02 (II) states that “statements in the preamble reciting the purpose of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, then the recitation serves to limit the claims.” Additionally, In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962), is a case where the “statement of intended use in an apparatus claim did not distinguish over the prior art apparatus”.
Regarding claim 2, as best understood, Okugawa discloses the limitations of claim 1, and further comprising a third lens group located in the fluorescence excitation optical path (see at least figure 1, element 21), wherein in the fluorescence excitation optical path, configurations of the third lens group and the second lens group are tube lenses (see at least figure 1, element 21, and 24 and/or 25).
Regarding claim 3, as best understood, Okugawa discloses the limitations of claim 2, and further comprising a beam splitting optical element located in the fluorescence excitation optical path and the fluorescence collection optical path, wherein the beam splitting optical element is configured to transmit or reflect a light beam based on a wavelength of the light beam (see at least figure 1, element 22, para. [0054]).
Regarding claim 4, as best understood, Okugawa discloses the limitations of claim 3, and wherein the beam splitting optical element comprises a dichroic mirror (see at least figure 1, element 22, para. [0054])
Regarding claim 5, as best understood, Okugawa discloses the limitations of claim 4, and wherein the first lens group and the second lens group are separated by the dichroic mirror, and the second lens group and the third lens group are separated by the dichroic mirror (see at least figure 1, elements 27, 22, 21, 24 and/or 25).
Regarding claim 11, as best understood, Okugawa discloses the limitations of claim 1, and wherein in the fluorescence excitation optical path, a configuration of the second lens group is a tube lens (see at least figure 1, element 24 and/or 25).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Okugawa et al., U.S. Patent Application Publication Number 2010/0182683 A1 (hereafter Okugawa) in view of Ammar et al., U.S. Patent Application Publication Number 2013/0149734 A1, of record (hereafter Ammar).
Regarding claim 6, as best understood, Okugawa further discloses a laser device configured to enable a sample to be tested on the optical instrument to absorb photons (see at least the abstract and figure 1, element “S”).
Okugawa does not specifically disclose a femtosecond laser device located in the fluorescence excitation optical path, wherein the femtosecond laser device is configured to enable a sample to be tested loaded on the optical instrument to simultaneously absorb at least two photons.
However, Ammar is related to Okugawa for also disclosing fluorescent imaging of a sample (see at least figures 3A-3B, para. [0057] of Ammar), including a femtosecond laser device located in the fluorescence excitation optical path (see at least figures 3A-3B, element 34, para. [0057] of Ammar), wherein the femtosecond laser device is configured to enable a sample to be tested loaded on the optical instrument to simultaneously absorb at least two photons (see at least figures 3A-3B, element 48, paras. [0057]-[0059] of Ammar).
Therefore, it would have been obvious to an ordinarily skilled artisan before the effective filing date of the claimed invention to modify the optical instrument of Ammar to include the teachings of Okugawa so that the optical instrument includes a femtosecond laser device located in the fluorescence excitation optical path, wherein a sample may simultaneously absorb at least two photons, for the purpose of using a known type of laser for performing a known type of microscopy.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEREK S. CHAPEL whose telephone number is (571)272-8042. The examiner can normally be reached M-F 9:30am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephone B. Allen can be reached at 571-272-2434. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Derek S. Chapel/Primary Examiner, Art Unit 2872 7/13/2026
Derek S. CHAPEL
Primary Examiner
Art Unit 2872
Prosecution Insights