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:
A conversion unit in claim 1, because it uses “unit” (MPEP 2181.I.A) coupled with functional language “for converting a spot shape of an excitation light beam from a point shape to a linear shape” without citing sufficient structure to achieve the function. Furthermore the “unit” is not preceded by a structural modifier.
A scanning unit in claim 1, because it uses “unit” (MPEP 2181.I.A) coupled with functional language “for linearly moving the excitation light beam whose spot shape is a point shape” without citing sufficient structure to achieve the function. Furthermore the “unit” is not preceded by a structural modifier.
A sample conveyance unit in claim 1, because it uses “unit” (MPEP 2181.I.A) coupled with functional language “that conveys the sample in a direction which intersects with a plane formed by the optical axis of the irradiation optical system and the optical axis of the light focusing optical system” without citing sufficient structure to achieve the function. Furthermore the “unit” is not preceded by a structural modifier.
A scanning mechanism in claim 4, because it uses “mechanism” (MPEP 2181.I.A) coupled with functional language “that linearly moves a locus of the spot so as to cut the sample” without citing sufficient structure to achieve the function. Furthermore the “mechanism” is not preceded by a structural modifier.
A focal length control unit in claim 6, because it uses “unit” (MPEP 2181.I.A) coupled with functional language “that controls a focal length of the imaging lens so that the normal line to the image formation plane is brought closer to the optical axis of the imaging lens or coincides with the optical axis of the imaging lens” without citing sufficient structure to achieve the function. Furthermore the “unit” is not preceded by a structural modifier.
A fluid control unit in claim 8, because it uses “unit” (MPEP 2181.I.A) coupled with functional language “that controls a flow of the fluid inside the tube in a state in which the tube is filled with the fluid” without citing sufficient structure to achieve the function. Furthermore the “unit” is not preceded by a structural modifier.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
Regarding the conversion unit, paragraph 0028 discloses "The cylindrical lens 16 which is an example of a conversion unit.” Thus, for the purpose of examination, the conversion unit is interpreted to be a cylindrical lens.
Regarding the scanning unit, paragraph 0065 discloses " The galvanoscanner 35 is an example of the scanning unit.” Thus, for the purpose of examination, the scanning unit is interpreted to be a galvanoscanner.
Regarding the sample conveyance unit, paragraph 0008 discloses a sample conveyance unit typified by a sample conveyance tube.” Thus, for the purpose of examination, the sample conveyance unit is interpreted to be a tube.
Regarding the scanning mechanism, the specification fails to disclose the structure of the scanning mechanism. Further there is uncertainty if the scanning mechanism is a component separate from the scanning unit (see Claim Rejections - 35 USC § 112).
Regarding the focal length control unit, paragraph 0071 discloses “a processor of the computer Com is an example of the focal length control unit.” Thus, for the purpose of examination, the focal length control unit is interpreted to be a processor.
Regarding the fluid control unit, paragraph 0023 discloses “In the present embodiment, a microsyringe containing therein a gel G in which samples S are dispersed and a stepping motor that can precisely control a position of a piston of the microsyringe are used as an example of the fluid control unit. In the present embodiment, the stepping motor is controlled by a computer. The microsyringe and the stepping motor configured in this manner can control a flow of the gel G inside the capillary C. Note, however, that the fluid control unit is not limited to the microsyringe and the stepping motor configured in this manner, and an existing flow cytometry technique can be used as appropriate. Other examples of the fluid control unit include a configuration in which a compression unit or a decompression unit is combined with a valve. Hereinafter, the compression unit and the decompression unit are collectively referred to as a pressure control unit. The pressure control unit is configured to control pressure applied to the gel G so that the gel G flows in a predetermined direction inside the capillary C. The pressure applied to the gel G may be positive pressure or negative pressure. In a case where positive pressure is applied, the pressure control unit may be provided on the upstream side of the capillary C. In a case where negative pressure is applied, the pressure control unit may be provided on the downstream side of the capillary C. Examples of the pressure control unit include a pump, a microsyringe, and the like”. Thus, for the purpose of examination, the fluid control unit is interpreted to be one of the following: a microsyringe and a stepping motor, a pump and a valve, a microsyringe and a valve, or any other appropriate structure used in cytometry.
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.
Claims 4 and 6 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.
Regarding claim 4, the claim limitation “the irradiation optical system further includes a scanning mechanism that linearly moves a locus of the spot so as to cut the sample” is indefinite insofar as the examiner is unclear about the structure of “scanning mechanism” and it is impossible to determine the intending scope of the structure of “scanning mechanism” in claim 1. It is unclear if the scanning mechanism is meant to a separate component from the scanning unit of claim 1 or is meant to provide a further limitations to embodiments which use the scanning unit rather than conversion unit because both the scanning unit and scanning mechanism invoke a 112(f) interpretation and provide the same function. Therefore, it is indefinite.
In the case where the scanning mechanism is distinct from the scanning unit, the scanning mechanism invokes a 112(f) interpretation and lacks sufficient structure disclosed in the specification and would be subject to a rejection under 112(a) and 112(b).
For the purposes of examination, it is interpreted that the scanning mechanism and scanning unit are the same structure.
Claim 6 is dependent on claim 4 and is rejected for the same reason.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 8 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Okada et al. US 2019/0033291.
Regarding claim 1, Okada discloses a fluorescence microscope (fig. 1; para. 0090-0092), comprising: an irradiation optical system (#30) that includes a conversion unit (#31, 33; para. 0093 cylindrical lens) for converting a spot shape of an excitation light beam from a point shape to a linear shape (para. 0098) or a scanning unit for linearly moving the excitation light beam whose spot shape is a point shape, the irradiation optical system irradiating a sample (#40, 12), so as to cut the sample (implicit from linear beam and fig 1), with the excitation light beam whose spot shape is a linear shape (para. 0098) or the excitation light beam which is linearly moved; a light focusing optical system (#50) that includes a first objective lens (#51) for focusing fluorescence which is emitted from an irradiation position irradiated with the excitation light beam (para. 0113), an optical axis of the light focusing optical system being perpendicular to an optical axis of the irradiation optical system (fig. 1); and a sample conveyance unit (figs. 1, 2C #40; tube) that conveys the sample in a direction which intersects with a plane formed by the optical axis of the irradiation optical system and the optical axis of the light focusing optical system (fig. 2C), a conveyance route (#41) for the sample in the sample conveyance unit passing through the irradiation position (figs. 2C), an angle formed by a section of the sample obtained by the excitation light beam and an axis of the conveyance route being greater than 0 degrees and smaller than 180 degrees (fig. 2C; para. 0104).
Regarding claim 2, Okada discloses wherein: at the irradiation position, the conveyance route is perpendicular to the plane which is formed by the optical axis of the irradiation optical system and the optical axis of the light focusing optical system (figs. 1, 2C flow direction is in Z direction).
Regarding claim 3, Okada discloses wherein: the excitation light beam is a light sheet in which a shape of a spot at the irradiation position is a linear shape (para. 0098); and the irradiation optical system further includes a cylindrical lens (#31) for converting the shape of the spot into the linear shape (para. 0098).
Regarding claim 8, Okada discloses wherein: the sample conveyance unit further includes a tube that constitutes the conveyance route and that is to be filled with a fluid in which samples are dispersed (fig. 2C), and a fluid control unit that controls a flow of the fluid inside the tube in a state in which the tube is filled with the fluid (para. 0102; flow cell implies additional structure to control flow to maintain laminar flow).
Claims 1-2, 4, and 7 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Truong et al. US 8441633.
Regarding claim 1, Truong discloses a fluorescence microscope (fig. 6a), comprising: an irradiation optical system that includes a conversion unit for converting a spot shape of an excitation light beam from a point shape to a linear shape or a scanning unit (GV; galvanoscanner or galvanometer scanner) for linearly moving the excitation light beam whose spot shape is a point shape (col. 15 ln. 18-20), the irradiation optical system irradiating a sample (S), so as to cut the sample (fig. 6), with the excitation light beam whose spot shape is a linear shape or the excitation light beam which is linearly moved (GV linearly moves the beam); a light focusing optical system that includes a first objective lens (DO; col. 15 ln. 47) for focusing fluorescence which is emitted from an irradiation position irradiated with the excitation light beam (fig. 6a.), an optical axis of the light focusing optical system being perpendicular to an optical axis of the irradiation optical system (fig. 6a); and a sample conveyance unit that conveys the sample in a direction which intersects with a plane formed by the optical axis of the irradiation optical system and the optical axis of the light focusing optical system, a conveyance route for the sample in the sample conveyance unit passing through the irradiation position (fig. 4; the sample flows from 3 to 4 passing the irradiation position at 4), an angle formed by a section of the sample obtained by the excitation light beam and an axis of the conveyance route being greater than 0 degrees and smaller than 180 degrees (fig. 6a
θ
).
Regarding claim 2, Truong discloses wherein: at the irradiation position, the conveyance route is perpendicular to the plane which is formed by the optical axis of the irradiation optical system and the optical axis of the light focusing optical system (fig. 4).
Regarding claim 4, Truong discloses wherein: a shape of a spot of the excitation light beam at the irradiation position is a point shape (col. 15 ln. 18-20); and the irradiation optical system further includes a scanning mechanism (GV; galvanoscanner or galvanometer scanner) that linearly moves a locus of the spot so as to cut the sample (fig. 6).
Regarding claim 7, Truong wherein: the irradiation optical system further includes a plurality of excitation light sources that respectively generate excitation light beams having different wavelengths (fig. 6 lasers 1, 2; col. 14 ln. 34-39); and the light focusing optical system further includes one or more long-pass filters (fig. 6 F) each having a cutoff wavelength which is longer than any of the wavelengths of the excitation light beams respectively generated by the plurality of excitation light sources (col. 15 ln. 55-57; “Appropriate filter” would be understood by one of ordinary skill in the art to consider a long-pass filter with an appropriate cutoff).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. US 2019/0033291 in view of Hillman US 2019/0302437.
Regarding claim 5, Okada teaches wherein: the light focusing optical system further includes an imaging lens (#56) that is disposed downstream of the first objective lens (#51) and forms, on an image formation plane, an image of fluorescence emitted from the section (#61), and a normal line to the image formation plane is inclined with respect to an optical axis of the imaging lens in accordance with the angle formed by the section and the axis of the conveyance route (para. 0154).
Okada fails to teach a second objective lens that focuses a fluorescence image on the image formation plane and the second objective lens is disposed to have an optical axis which is inclined with respect to the optical axis of the imaging lens so that an angle formed by the optical axis of the second objective lens and the normal line to the image formation plane is smaller as compared with a case where the optical axis of the second objective lens coincides with the optical axis of the imaging lens.
Hillman teaches use of multiple objective lenses in focusing systems of fluorescence microscopes for the purpose of improving image stability (para. 0035).
Hillman does not teach the second objective lens is disposed to have an optical axis which is inclined with respect to the optical axis of the imaging lens so that an angle formed by the optical axis of the second objective lens and the normal line to the image formation plane is smaller as compared with a case where the optical axis of the second objective lens coincides with the optical axis of the imaging lens. However, it has been judiciarily determined that rearrangement of parts has been obvious to one of ordinary skill in the art (MPEP 2144.04.IV.C). Rearrangement of parts is insufficient to establish patentability over the prior art of record unless it changes the operation of the device in some unexpected way. Since this device appears to operate in a similar manner to the prior art device, the rearrangement of parts is not of patentable significance.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a second objective lens that focuses a fluorescence image on the image formation plane and the second objective lens is disposed to have an optical axis which is inclined with respect to the optical axis of the imaging lens so that an angle formed by the optical axis of the second objective lens and the normal line to the image formation plane is smaller as compared with a case where the optical axis of the second objective lens coincides with the optical axis of the imaging lens as taught by Hillman in the system of Okada for the purpose of improving image stability.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Truong et al. US 8441633 in view of Okada et al. US 2019/0033291.
Regarding claim 6, Truong teaches wherein: the light focusing optical system includes an imaging lens (TL-4) that is disposed downstream of the first objective lens (DO) and forms, on an image formation plane, an image of fluorescence emitted from the section (EMCCD).
Truong fails to teach a focal length control unit that controls a focal length of the imaging lens so that the normal line to the image formation plane is brought closer to the optical axis of the imaging lens or coincides with the optical axis of the imaging lens.
Okada teaches a deformable mirror (#55; a deformable mirror implies the components required to control the mirror, including a processor) which controls the focal length of the light focusing optical system (#50; para. 0130-0131) for the purpose of improving image resolution.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a focal length control unit that controls a focal length of the imaging lens so that the normal line to the image formation plane is brought closer to the optical axis of the imaging lens or coincides with the optical axis of the imaging lens as taught by Okada in the system of Truong for the purpose of improving image resolution.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Truong et al. US 8441633 in view of Ota US 2021/0269844.
Regarding claim 9, Truong teaches wherein: the sample conveyance unit further includes a tube that constitutes the conveyance route and that is to be filled with water in which samples are dispersed (fig. 4 #3; col. 15 ln. 30-45), and an optical stage for causing the tube to translationally move in an axial direction of the tube (fig. 4 #4; col. 15 ln. 30-45). Truong teaches the fluid for mediating the sample conveyance being water rather than a gel. However, Ota shows that water and gels are both equivalent structures known in the art for their ability to suspending appropriate biological samples for flow cytometry (para. 0057-0060). Therefore, because these two fluids were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to substitute water for a gel.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard Toohey whose telephone number is (703)756-5818. The examiner can normally be reached Mon-Fri: 7:30am – 5pm.
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/RICHARD O TOOHEY/Examiner, Art Unit 2884
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2884
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