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 .
Election/Restrictions
Applicant’s election without traverse of invention I corresponding to claims 1-12 in the reply filled on 12/19/2025 is acknowledged.
Claims 13-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/19/2025.
Specification
The disclosure is objected to because of the following informalities:
Paragraph 0151 states “micromanipulator is used to insert a fluorescently coated micropipette through the opening at a 200 angle into the bone marrow with micrometer spatial precision (see FIGS. SA-SC).” The examiner believes the figures mentioned are referring to figures 5A-5C.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1-12 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-7, and 9-12 recites at least one step or instruction for analyzing cell aspirated from a region of interest (e.g. estimating an individual’s blood glucose), which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-7, and 9-12 recites an abstract idea.
Specifically, Claim 1 recite:
Claim 1 | “A method for image-guided cell isolation from a region of interest of a subject, the method comprising the steps of: imaging the subject using optical microscopy to identify the region of interest in a target anatomy (Observation); inserting a micropipette into the region of interest under guidance of the optical microscopy; aspirating at least one cell of a target population of cells in the region of interest under guidance of the optical microscopy; and analyzing the at least one cell aspirated from the region of interest (Judgement).”
Regarding the dependent claims, the following dependent claims are directed to steps that are also abstract or organizing human activity:
These are a few examples, all applications will contain different bullets
Claim 12 include steps that are also abstract as a mental process through additional data gathering or analysis.
Claims 2-7, 9-11, include narrow definitions for the claims it depends on.
Claims 7 and 8 include additional elements [Examiner’s note, claim 7 recites a physical manor of opening in the bone, which can be done by a laser. Claim 8 recites an ablation laser.].
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrowing idea is still an abstract idea and an abstract idea with additional well-known equipment/functions are not significantly more than the abstract idea.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
Regarding Claims 1-7, and 9-12 (and their respective dependent claims) meets Step 2A, Prong 2 because the above-identified abstract idea in each of independent claims are not integrated into a practical application. The above-identified abstract ideas do not improve the following: function of a particular machine, manufacture or other technology; treatment or prophylaxis for a disease or medical condition; or transforming or reducing of a particular article to a different state or thing (MPEP 2106.04(d)).
Step 2B
Lastly, the claims as a whole are analyzed to determine whether any elements, or in combination, to ensure that they amount to significantly more than the judicial exception itself. However, these claims do not appear to recite additional elements that amount to significantly more than the judicial exception.
The recited additional elements, more specifically micropipette, laser, ablation laser, and aspiration steps, are not significantly more because the following references Reich et al (US 20020118005 A1) provides evidence within Paragraph 0119, Tan (US 20160236296 A1) provides evidence within Paragraphs 0005 and 0006, and Dean (US 20060182662 A1) provides evidence within Paragraph 0005 that the micropipette, laser, ablation laser, and aspiration steps are well-known, routine, and conventional and therefore not significantly more.
Therefore, none of the Claims 1-7, and 9-12 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-7, and 9-12 are not patent eligible and rejected under 35 U.S.C. 101.
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.
Claims 1-4, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bosio et al. (WO 2021170710 A1) in view of Hirtz et al. (US 20180024134 A1).
Regarding Claim 1, Bosio discloses a method for image-guided cell isolation from a region of interest of a subject (Paragraph 0052), the method comprising the steps of:
imaging the subject using optical microscopy to identify the region of interest in a target anatomy (Paragraphs 0015, 0054);
inserting a dissection tool (dissection tool – element 306) into the region of interest under guidance of the optical microscopy (Figure 1; Paragraphs 0015-0016);
aspirating at least one cell of a target population of cells in the region of interest under guidance of the optical microscopy (Figure 1; Paragraphs 0015-0016); and
analyzing the at least one cell aspirated from the region of interest (Paragraph 0016).
Bosio is silent in teaching the dissection tool is a micropipette. Hirtz teaches a micropipette (Hirtz | Paragraph 0051). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio to incorporate the teachings of the micropipette from Hirtz because the micropipette allows for aspiration of individual cells (Hirtz | Paragraph 0051).
Regarding Claim 2, Bosio in view of Hirtz teaches the method of claim 1, wherein imaging the subject using optical microscopy further comprises a one-photon imaging mode or a multi-photon imaging mode (Bosio | Paragraph 0015, 0019; [Examiner’s note, the imaging unit uses multi-photon microscopy, thus using a multi-photon imaging mode.]).
Regarding Claim 3, Bosio in view of Hirtz teaches the method of claim 1, wherein the target population of cells further comprises a label configured to be identified using the optical microscopy (Bosio | Paragraph 0022 – more specifically step ii).
Regarding Claim 4, Bosio in view of Hirtz teaches the method of claim 3, wherein the label further comprises a fluorescently tagged molecule that is expressed by or selectively binds to the target population of cells (Bosio | Paragraph 0022 – more specifically step ii; [Examiner’s note, photoactivated crosslinked tags on cells are a form of fluorescence]).
Regarding Claim 10, Bosio in view of Hirtz teaches the method of claim 1, wherein analyzing the target population of cells comprises single-cell RNA sequencing (Bosio | Paragraph 0020 – more specifically step vi).
Regarding Claim 11, Bosio in view of Hirtz teaches the method of claim 1, wherein analyzing the target population of cells comprises cell transplantation (Bosio | Paragraph 0036), multi-omic analysis, or colony formation assays [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Regarding Claim 12, Bosio in view of Hirtz teaches the method of claim 1, further comprising dissecting the target anatomy from the subject (Bosio | Figure 1; Paragraph 0036) before inserting the dissection tool into the region of interest (Bosio | Figure 6; Paragraph 0040; [Examiner’s note, the dissection tool collects a sample of interest after the area of interest is sliced].
Bosio is silent in teaching the dissection tool is a micropipette. Hirtz teaches a micropipette (Hirtz | Paragraph 0051). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio to incorporate the teachings of the micropipette from Hirtz because the micropipette allows for aspiration of individual cells (Hirtz | Paragraph 0051).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bosio in view of Hirtz and Turcotte et al. (“Characterization of multiphoton microscopy in the bone marrow following intravital laser osteotomy,” 12 September 2014, reference U on PTO-892).
Regarding Claim 5, Bosio in view of Hirtz teaches the method of claim 1. Bosio in view of Hirtz is silent in teaching the target anatomy comprises a bone. Turcotte teaches the target anatomy comprises a bone (Turcotte | Abstract; Page 6 Section 3.2 Characterization of TPEF imaging after osteotomy; [Examiner’s note, the local laser osteotomy is used on the cortical bone to get optical access to the user’s bone marrow.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio in view of Hirtz to incorporate the teachings of the target anatomy being the bone from Turcotte because the bone marrow inside the bone is a frequent site for solid tumor metastasis, and local laser osteotomy provides a better way to observe targeted cells that may contain a tumor. (Turcotte | Abstract).
Regarding Claim 6, Bosio in view of Hirtz and Turcotte teaches the method of claim 5. Bosio in view of Hirtz is silent in teaching the region of interest comprises a marrow cavity of the bone. Turcotte teaches the region of interest comprises a marrow cavity of the bone (Turcotte | Abstract). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio in view of Hirtz to incorporate the teachings of the region of interest comprising bone marrow from Turcotte because the bone marrow inside the bone is a frequent site for solid tumor metastasis, and local laser osteotomy provides a better way to observe targeted cells that may contain a tumor. (Turcotte | Abstract).
Regarding Claim 7, Bosio in view of Hirtz and Turcotte teaches the method of claim 6, further comprising: creating an opening configured to receive the dissection tool (Figure 6; Paragraph 0040; [Examiner’s note, the dissection tool collects a sample of interest after the area of interest is sliced]).
Bosio is silent in teaching the dissection tool is a micropipette. Hirtz teaches a micropipette (Hirtz | Paragraph 0051). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio to incorporate the teachings of the micropipette from Hirtz because the micropipette allows for aspiration of individual cells (Hirtz | Paragraph 0051).
Bosio in view of Hirtz is silent in teaching the opening is the bone. Turcotte teaches the opening is the bone (Turcotte | Abstract; Page 6 Section 3.2 Characterization of TPEF imaging after osteotomy; [Examiner’s note, the local laser osteotomy is used on the cortical bone to get optical access to the user’s bone marrow.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio in view of Hirtz to incorporate the teachings of the opening is the bone from Turcotte because the bone marrow inside the bone is a frequent site for solid tumor metastasis, and local laser osteotomy provides a better way to observe targeted cells that may contain a tumor. (Turcotte | Abstract).
Regarding Claim 8, Bosio in view of Hirtz and Turcotte teaches the method of claim 7. Bosio in view of Hirtz is silent in teaching wherein creating the opening further comprises: creating the opening by directing an ablation laser beam operating in an ablation modality.
Turcotte teaches wherein creating the opening further comprises: creating the opening by directing an ablation laser beam operating in an ablation modality (Turcotte | Page 6 Section 3.2 Characterization of TPEF imaging after osteotomy; [Examiner’s note, the local laser osteotomy is a specific application of laser ablation.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio in view of Hirtz to incorporate the teachings of local laser osteotomy from Turcotte because the bone marrow inside the bone is a frequent site for solid tumor metastasis, and local laser osteotomy provides a better way to observe targeted cells that may contain a tumor. (Turcotte | Abstract).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bosio in view of Hirtz, Turcotte, and Balaban et al. (Robust fluorescent labelling of micropipettes for use in fluorescence microscopy: application to the observation of a mosquito borne parasite infection, 2018, reference V on PTO-892).
Regarding Claim 9, Bosio in view of Hirtz and Turcotte teaches the method of claim 1. Bosio in view of Turcotte is silent in teaching the micropipette includes a coating comprising a fluorescent molecule.
Bosio in view of Turcotte is silent in teaching the dissection tool is a micropipette. Hirtz teaches a micropipette (Hirtz | Paragraph 0051). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio in view of Turcotte to incorporate the teachings of the micropipette from Hirtz because the micropipette allows for aspiration of individual cells (Hirtz | Paragraph 0051).
Bosio in view of Hirtz and Turcotte is silent in teaching the micropipette coating comprises a fluorescent molecule. Balaban teaches the micropipette coating comprises a fluorescent molecule (Balaban | Fluorescent Enamel – Pages 3-4 and Pipette Coating with Enamels – Page 4 under the third through fourth paragraph of this section). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Bosio in view of Hirtz and Turcotte to incorporate the teachings of the fluorescent molecule coating on the micropipette from Balaban because the fluorescent coating a glass micropipette allows for the transparent tip more visible under a fluorescence microscope. Thus, enabling researchers to precisely guide and target the pipette to specific microscopic structures. For example, the fluorescent micropipette system proved optimal for mimicking a mosquito bite into the dermis and significantly improved procedures for intravital imaging of these parasites in the skin (Balaban | Discussion – Page 6 under the first paragraph).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Friday: 9AM to 5PM EST.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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