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 claims 1-6, 18, 20 and 22-25 in the reply filed on September 22, 2026 is acknowledged. Claims 8-15 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 17, 2025 and July 16, 2026 are being considered by the examiner.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains the legal term “means”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 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. he 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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) 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) except as otherwise indicated in an Office action.
Claim limitations subject to interpretation under 35 U.S.C. 112(f) are:
-“impedance measurement means” in claim 3; and
-“means for adding a chemical substance to the dissociated cells prior to the cells being evaluated by the evaluation device” in claim 6.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) they 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 these limitations interpreted under 35 U.S.C. 112(f), Applicant may:
(1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or
(2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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.
Claims 3 and 6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
As discussed above, the limitations “means arranged for measuring the impedance of the cells” in claim 3 and “means for adding a chemical substance to the dissociated cells prior to the cells being evaluated by the evaluation device” in claim 6 are being interpreted pursuant to 35 U.S.C. 112(f). However, the specification does not disclose structures corresponding to the respective limitations so as to enable one of ordinary skill in the art to ascertain the metes and bounds of the limitations. Consequently, the limitations are indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 5, 18 and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zohar et al. (“Zohar”) (US 2017/0355950 A1).
With respect to claim 1, Zohar discloses a system for analyzing tissue, the device comprising (see Figs. 2B and 3):
a dissociation unit comprising a compartment arranged to receive a tissue sample (the left half of Fig. 2B), the dissociation unit being arranged to at least partially dissociate the tissue sample so as to obtain individual cells (see [0008]);
a microfluidic flow device through which a fluid comprising the dissociated cells can be made to flow (the right half of Fig. 2B); and
an evaluation device arranged to evaluate the cells as they are being transported through the microfluidic flow device, the evaluation device comprising an imaging device (e.g. a CCD camera) arranged to obtain images of the cells as they are being transported through the microfluidic flow device (see [0007]).
With respect to claim 4, the system further comprises a filter for filtering out debris created during the dissociation of the tissue sample (see [0024]).
With respect to claim 5, the system is arranged so that the individual cells are made to flow through the microfluidic flow device as they are output by the dissociation unit (see mapping in rejection of claim 1).
With respect to claim 18, the evaluation device images unlabeled cells (see [0007]). Consequently, the system is arranged for a label free analysis of tissue.
With respect to claim 22, the dissociation unit comprises grinding vanes (constrictions that mechanically dissociate tissue, see [0009]) arranged within the compartment. Alternatively, the compartment comprises an enzymatic dissociation medium (see [0025]).
With respect to claim 23, the dissociation unit is a tissue grinder (the constrictions mechanically grind tissue into smaller fragments, see [0009]) and the compartment is a grinding compartment, the grinding vanes being arranged at different distances relative to each other (see Fig. 3).
With respect to claim 24, the dissociation unit and the microfluidic flow device are contained within a single housing (see mapping in rejection of claim 1).
With respect to claim 25, as discussed above (see rejection of claim 1), the imaging device comprises a CCD camera.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Zohar.
With respect to claim 2, the evaluation device further comprises an image analysis device (computer, see Fig. 1) arranged for analyzing the images obtained of the cells, wherein the image analysis device is arranged to analyze the images in real time (see Fig. 1 and [0007] disclosing “direct” observation).
The system differs from the claimed invention in that Zohar does not disclose that the image analysis device is arranged for analyzing light scattering. However, Zohar discloses that the system can integrate other conventional features of microfluidic systems (see [0011]), for example detectors and sensors (see [0060]), which include a Raman scattering detector (see [0068]). Naturally, such a detector would be connected to the image analysis device, which controls the system (see [0036]). In light of the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the image analysis device to analyze light scattering (i.e. configure the computer taught by Zohar to analyze data from the Raman scattering detector).
With respect to claim 6, Zohar does not explicitly disclose a means for adding a chemical substance to the dissociated cells prior to the cells being evaluated by the evaluation device. However, Zohar discloses that the system can integrate other conventional features, for example means for performing an assay (see [0061]). In light of the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the system with a platform for adding a reagent to the dissociated cells prior to the cells being evaluated by the evaluation device*, which can further comprise a detector that detects assay signals (see [0068]).
*As evidenced by claim 3, the scope of the limitation “evaluation device” is not intended to be limited to a device comprising a singular means of evaluating cells. Consequently, the assay detector can be considered to be a part of the “evaluation device” of Zohar.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zohar in view of Kashanin et al. (“Kashanin”) (US 2020/0316603 A1).
With respect to claim 3, Zohar does not disclose that the evaluation device further comprises an impedance measurement means for measuring the impedance of the cells as they are being transported through the microfluidic flow device. However, Zohar discloses that the system can integrate other conventional features of microfluidic systems (see [0011]), for example detectors (see [0060]), including ones that measure electrical properties (see [0068]). In light of the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the evaluation device with an impedance detector for measuring the impedance of the dissociated cells (see [0018] of Kashanin disclosing use of impedance measurements to sort cells). The modification would enable sorting of individual cells, the practicality of which is well-known in the art (e.g. identify diseased cells).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Zohar in view of Veltri et al. (“Veltri”) (US 6,463,438 B1).
With respect to claim 20, Zohar does not disclose that the image analysis device uses a neuronal network. However, the use of neural networks to analyze images of cells is well-known in the art. For example, Veltri discloses a neural network that can detect abnormal cells by analyzing images of cells (see abstract). In light of the disclosure of Veltri, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the image analysis device taught by Zohar to use a neural network. The modification would enable the system to continuously improve without intervention (e.g. software updates).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
