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 .
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:
“An optical imaging system configured to image the un-labelled tissue . . .” in claims 1-2, 4, 6-9, 13, 21, 30, and 36-40.
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.
Claim 30 is 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.
As for claim 30, the claim states that the cartridge includes fiducials that, among other functions, identify one or more of a pressure and a vacuum to apply to the cartridge to compress the un-labelled tissue against the optical substrate. However, it is unclear how the fiducials can perform this function, as the fiducials only have the function to ensure proper orientation for imaging of the tissue (see paragraphs 0077-0080 of the instant specification), not for identifying how much pressure or vacuum to apply to the cartridge. How can the fiducials be used to perform the claimed function? For purposes of examination below, the examiner will interpret the identification of pressure or vacuum to be performed via information in a unique identifier as disclosed in paragraph 0067 of the instant specification.
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.
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 1, 2, 4-9, 12, 21, 30, 32, and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Mak et al (WO 2018/068121) in view of Boktor et al (“Virtual histological staining of label-free total absorption photoacoustic remote sensing (TA-PARS)”).
Regarding claims 1 and 12, Mak (Figs. 1 and 2A) discloses a system for optical imaging of an un-labelled tissue, the system comprising an optical imaging system configured to image the un-labelled tissue (see page 13, line 31 – page 14, line 13, for instance); and a cartridge 100 for storing the un-labelled tissue 36 to be imaged by the optical imaging system (see page 6, line 31 – page 7, line 2), the cartridge comprising a container 22, 24 to store the un-labelled tissue (see page 7, lines 3-12 and Fig. 2A), and to interface with the optical imaging system (see page 7, line 32 – page 8, line 6, for instance); an optical substrate 28, provided on a bottom surface of the container (see claim 1 of Mak, for instance), through which the optical imaging system is configured to image the un-labelled tissue (see page 7, line 32 – page 8, line 6); and a lid 10, provided on a top surface of the container (see Fig. 1 and 2A), including a membrane 18 to compress the un-labelled tissue against the optical substrate such that an entire margin of the un-labelled tissue is flat against the optical substrate (see page 8, lines 7-14).
While Mak discloses an optical imaging system as discussed above, Mak fails to disclose that the optical imaging system is configured to image the un-labelled tissue to generate a virtually-stained histological image of the un-labelled tissue or perform molecular detection or diagnosis, with the optical imaging system being a label-free absorption microscopy system configured to generate radiative, non-radiative, and scattering effects in the un-labelled tissue (see claim 12).
Boktor discloses an optical imaging system that is configured to image un-labelled tissue to generate a virtually-stained histological image of the un-labelled tissue or perform molecular detection or diagnosis (see the TA-PARS system in Fig. 2 for imaging a sample; the “Materials and methods” portion of page 3 states that the tissue sections being measured are unstained; the imaging generates a virtually-stained histological image (see Fig. 3) of the un-labelled tissue). Boktor further discloses that TA-PARS provides an array of directly measured label-free contrasts such as scattering and total absorption (radiative and non-radiative), which meets the limitations of instant claim 12 (see Boktor abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to replace the optical imaging system of Mak with the TA-PARS system disclosed by Boktor, the motivation being that typically the preparation of stained specimens for brightfield assessment such as in typical microscopy requires lengthy sample processing, and the virtually-stained histological image generated by the TA-PARS system will dramatically reduce sample preparation time (see Boktor abstract).
As for claim 2, Mak discloses that the cartridge includes orientation marks 20, 32 on one or more of the cartridge, container, or optical substrate, the orientation marks permitting maintenance of an orientation of the un-labelled tissue relative to a patient from which the un-labelled tissue is resected (see page 9, line 3 – page 10, line 11; this is also implied by page 13, lines 3-6).
As for claim 4, Mak discloses that one or more of the cartridge, container, or optical substrate includes a unique identifier 34 (see page 12, line 31 – page 13, lin3 2).
As for claim 6, Mak discloses that the unique identifier is a QR code, a barcode, or an RFID code (see page 13, lines 1-2).
As for claim 7, the combination of Mak and Boktor discloses the claimed invention as set forth above regarding claim 4, but fails to disclose that the unique identifier is an interlock for the optical imaging system. However, page 12, line 31 – 32 of Mak discloses that the unique identifier in Mak is used for tracking and tissue correlation. Additionally, the examiner takes Official notice as to the well known definition of an interlock as a feature that keeps devices from operating until required circumstances are met. As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the unique identifier in the combination of Mak and Boktor be an interlock for the optical imaging system, the motivation being to ensure that, as suggested by page 12, lines 31-32 of Mak discussed above, the proper tissue is in place prior to any optical imaging that may wind up staining or otherwise adversely impacting the tissue after imaging and to make sure proper diagnoses are made for the patient whose tissue is being imaged.
As for claim 8, the combination of Mak and Boktor discloses the claimed invention as set forth above regarding claim 4, but fails to disclose that the unique identifier prevents the cartridge from being used with another un-labelled tissue. However, page 12, line 31 – 32 of Mak discloses that the unique identifier in Mak is used for tracking and tissue correlation. Additionally, as this limitation is similar to the interlock discussed above in claim 7, the examiner takes Official notice as to the well known definition of an interlock as a feature that keeps devices from operating until required circumstances are met. This is the equivalent to the limitation that the unique identifier prevents the cartridge from being used with another un-labelled tissue. As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the unique identifier in the combination of Mak and Boktor prevent the cartridge from being used with another un-labelled tissue, the motivation being to ensure that, as suggested by page 12, lines 31-32 of Mak discussed above, the proper tissue is in place prior to any optical imaging that may wind up staining or otherwise adversely impacting the tissue after imaging and to make sure proper diagnoses are made for the patient whose tissue is being imaged.
As for claim 9, Mak discloses that the cartridge includes fiducials 32 for measurement by the optical imaging system (see page 9, lines 18-24). However, Mak fails to disclose that the unique identifier includes information identifying a pressure and/or vacuum to apply to the cartridge to compress the un-labelled tissue against the optical substrate.
However, the examiner notes that on page 8, lines 7-14, Mak discusses the benefits of using different types of flexible membranes as tissue engaging members based on the type of tissue being measured. This is considered to be the equivalent of identifying a pressure to apply to the cartridge to compress the un-labelled tissue against the optical substrate. The examiner also takes Official notice as to the well known practice of storing information of all kinds onto a unique identifier that is tied to the tissue being imaged.
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the unique identifier contain information to identify a pressure and/or vacuum to apply to the cartridge to compress the un-labelled tissue against the optical substrate, the motivation being that Mak already anticipates different pressures being applied to the sample based on the type of the sample as discussed above; the unique identifier would be able to store the tissue information to allow the user to know how much pressure is needed to compress certain types of tissue against the optical substrate as needed for imaging.
Regarding claims 21 and 32, Mak (Figs. 1 and 2A) discloses a cartridge 100 for storing an un-labelled tissue 36 to be imaged by an optical imaging system (see page 6, line 31 – page 7, line 2), the cartridge comprising: a container 22, 24 to store the un-labelled tissue (see page 7, lines 3-12 and Fig. 2A), and to interface with the optical imaging system (see page 7, line 32 – page 8, line 6, for instance); an optical substrate 28, provided on a bottom surface of the container (see claim 1 of Mak, for instance), through which the optical imaging system is configured to image the un-labelled tissue (see page 7, line 32 – page 8, line 6); and a lid 10, provided on a top surface of the container (see Fig. 1 and 2A), including a membrane 18 to compress the un-labelled tissue against the optical substrate such that an entire margin of the un-labelled tissue is flat against the optical substrate (see page 8, lines 7-14).
While Mak discloses an optical imaging system as discussed above, Mak fails to disclose that the optical imaging system is configured to image the un-labelled tissue to generate a virtually-stained histological image of the un-labelled tissue, with the optical imaging system being a label-free absorption microscopy system configured to generate radiative, non-radiative, and scattering effects in the un-labelled tissue (see claim 32).
Boktor discloses an optical imaging system that is configured to image un-labelled tissue to generate a virtually-stained histological image of the un-labelled tissue or perform molecular detection or diagnosis (see the TA-PARS system in Fig. 2 for imaging a sample; the “Materials and methods” portion of page 3 states that the tissue sections being measured are unstained; the imaging generates a virtually-stained histological image (see Fig. 3) of the un-labelled tissue). Boktor further discloses that TA-PARS provides an array of directly measured label-free contrasts such as scattering and total absorption (radiative and non-radiative), which meets the limitations of instant claim 32 (see Boktor abstract).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to replace the optical imaging system of Mak with the TA-PARS system disclosed by Boktor, the motivation being that typically the preparation of stained specimens for brightfield assessment such as in typical microscopy requires lengthy sample processing, and the virtually-stained histological image generated by the TA-PARS system will dramatically reduce sample preparation time (see Boktor abstract).
As for claim 30, in the best understanding of the examiner, Mak discloses that the cartridge includes fiducials 32 for measurement by the optical imaging system (see page 9, lines 18-24). However, Mak fails to disclose that the unique identifier includes information identifying a pressure and/or vacuum to apply to the cartridge to compress the un-labelled tissue against the optical substrate.
However, the examiner notes that on page 8, lines 7-14, Mak discusses the benefits of using different types of flexible membranes as tissue engaging members based on the type of tissue being measured. This is considered to be the equivalent of identifying a pressure to apply to the cartridge to compress the un-labelled tissue against the optical substrate. The examiner also takes Official notice as to the well known practice of storing information of all kinds onto a unique identifier that is tied to the tissue being imaged.
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the unique identifier contain information to identify a pressure and/or vacuum to apply to the cartridge to compress the un-labelled tissue against the optical substrate, the motivation being that Mak already anticipates different pressures being applied to the sample based on the type of the sample as discussed above; the unique identifier would be able to store the tissue information to allow the user to know how much pressure is needed to compress certain types of tissue against the optical substrate as needed for imaging.
As for claim 37, Mak inherently discloses that the membrane is configured to compress the tissue by positive pressure applied over the membrane such that the tissue adheres to the imaging substrate (see page 8, lines 7-14; using the membrane itself to flatten the tissue in one compressed position implies the use of positive pressure).
Claims 13, 36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Mak et al (WO 2018/068121) in view of Boktor et al (“Virtual histological staining of label-free total absorption photoacoustic remote sensing (TA-PARS)”) and in further view of Oei et al (2021/0318341).
As for claim 13, the combination of Mak and Boktor discloses the claimed invention as set forth above regarding claim 1. However, the combination fails to disclose a pressure assembly configured to apply pressure or vacuum to compress the tissue against the optical substrate.
Oei, in a device for extracting tissue samples into cartridges, looks to solve a similar problem to the instant application of having the tissue adhering to a substrate inside the cartridge. As seen in Fig. 1B and paragraph 0054, Oei teaches this by having a tissue on a slide that is placed into a cartridge and using a vacuum to press a film onto the tissue; the “imposition of a vacuum” in Oei requires some kind of pressure assembly to create that vacuum (such as “vacuum suction is applied through a port in the base to press the film against the tissue on the slide” as found in paragraph 0009).
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to compress the tissue in the combination of Mak and Boktor using negative pressure or a vacuum applied under the membrane to adhere the tissue to the imaging substrate as taught by Oei, the motivation being to press the tissue onto the side without relying on mechanical force that may damage the tissue such as by compressing the tissue directly with the membrane itself as disclosed by Mak.
As for claim 36, the combination of Mak and Boktor discloses the claimed invention as set forth above regarding claim 1. However, the combination fails to disclose that the membrane is configured to compress the tissue by negative pressure or a vacuum applied under the membrane, such that the tissue adheres to the imaging substrate.
Oei, in a device for extracting tissue samples into cartridges, looks to solve a similar problem to the instant application of having the tissue adhering to a substrate inside the cartridge. As seen in Fig. 1B and paragraph 0054, Oei teaches this by having a tissue on a slide that is placed into a cartridge and using a vacuum to press a film onto the tissue.
As a result, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to compress the tissue in the combination of Mak and Boktor using negative pressure or a vacuum applied under the membrane to adhere the tissue to the imaging substrate as taught by Oei, the motivation being to press the tissue onto the side without relying on mechanical force that may damage the tissue such as by compressing the tissue directly with the membrane itself as disclosed by Mak.
As for claim 38, in an extension of claim 13, Oei discloses a flexible membrane (a film on the cartridge in paragraph 0054) that is configured to conform to the tissue and hermetically seal the tissue within the container.
Allowable Subject Matter
Claims 39 and 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
As to claim 39, the prior art of record, taken either alone or in combination, fails to disclose or render obvious the further limitation of claim 13, wherein the pressure assembly includes a series of spatially distributed springs with articulating ends configured to provide even mechanical pressure across the tissue, in combination with the rest of the limitations of the above claim.
With further regard to the above claim, while the combination of Mak, Boktor, and Oei discloses the claimed invention as set forth above regarding claim 13, the pressure assembly of Oei relies on vacuum or negative pressure to operate, so it would not be obvious to have that pressure assembly be switched with a series of spatially distributed springs with articulating ends to provide even mechanical (positive) pressure across the tissue. Additionally, there does not appear to be any prior art of record that would disclose such a pressure assembly in combination with the claimed system.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0359903 to Haji Reza et al. discloses a coherence gated photoacoustic remote sensing (CG-PARS) system that could be used with the claimed cartridge;
US 2016/0113507 to Haji Reza et al. discloses photoacoustic remote sensing (PARS) system that could be used with the claimed cartridge; and
US 2013/0182318 to Eastman et al. discloses a cassette 10 for facilitating optical sectioning of a retained specimen featuring a base member 12, an upper member or lid 14, and a transparent window 16 situated in an aperture 18, where when the lid is closed, a hermetic seal is formed to define an enclosed cavity or compartment 27 between a membrane 26 and a window 16 containing tissue specimen 13 (see paragraphs 0048-0055).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael A. Lyons whose telephone number is (571)272-2420. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michelle Iacoletti can be reached at 571-270-5789. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael A Lyons/Primary Examiner, Art Unit 2877 August 21, 2026
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