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 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 1-12 and 15-16 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.
Claims 1 and 15 recite “ the sample comprising one or more fluorophores and representing a disease of health condition…” and it is unclear whether the fluorophores or another part of the sample represent a disease or health condition. It has been interpreted that it’s the signal emitted from the sample that is used to represent a disease or health condition.
In addition, both claims 5 and 6 recite “one or more light sources”, “one or more light receivers” and “one or more fluorophores”, and that each of these phrases encompass a single (one) light source, a single (one) light receiver and a single (one) fluorophore, and wherein if only one light source, light receiver and/or fluorophore was utilized than light could not and would not be able emitted independently.
In addition, claim 15 has been interpreted as a use claim and MPEP 2173.05 recites “ "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process”
Furthermore, MPEP 2173.05 recites that it is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b).
Therefore, since claim 15 appears to only recite a “use”, and fails to recite any additional method steps, claim 15 is rejected by at least 35 USC 112(b).
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.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 15 recites “Use of an apparatus for detecting fluorescence of a sample obtained from a human or animal by surgery during fluorescence guided surgery” and “ in a method selected from the group consisting of an invasive medical treatment method, a detection method of a diseased tissue or a diseased body fluid comprising one or more fluorophores and representing a disease or health condition, a detection method of a tumor and in the diagnosis of cancer” and therefore does not recite any actual process or method steps that would need to performed.
Furthermore, claim 15 has been interpreted as a use claim and MPEP 2173.05 recites “ "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process”.
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.
Claim 13 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujimoto et al (US PGPub 2018/0259762 A1).
Regarding Claim 13, Fujimoto et al teaches a method for detecting fluorescence of a sample obtained from a human or animal by surgery during fluorescence guided surgery, the sample comprising one or more fluorophores and representing a disease or health condition (see abstract, [0010]-[0011] and [0065]) and the sample being transported away from the human or animal in a transparent conduit (which is interpreted as specimen holder 104 with spectrally separated channels of a tissue specimen, the holder having a transparent window 105)(see [0058]), the method comprising:
transporting a sample, comprising one or more fluorophores (i.e. a fluorescent contrast agent) and representing a disease or condition, in a transparent conduit ((which is interpreted as specimen holder 104 with spectrally separated channels of a tissue specimen, the holder having a transparent window 105)(see [0058])), away from the human or animal (see [0058]-[0059] and [0126]);
ii) emitting light towards the sample being transported in the conduit (through a light source, such as illumination source 211 or light source 113)(see [0058] and [0062]);
iii) detecting fluorescence generated by one or more fluorophores comprised in the sample being transported in the conduit (see [0055]-[0060] and [0062]).
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.
Claim(s) 1-2, 5-9 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimoto et al (US PGPub 2018/0259762 A1) in view of Sandstrom et al (US PGPub 2009/0112482).
Regarding Claims 1-2, Fujimoto et al teaches an apparatus for near-real time detection of fluorescence of a sample obtained from a human or animal by surgery during fluorescence guided surgery, the sample comprising one or more fluorophores and representing a disease or health condition (see [0058] and Figure 1), and the sample being transported away from the human or animal in a transparent conduit (which is interpreted as specimen holder 104 with spectrally separated channels of a tissue specimen, the holder having a transparent window 105)(see [0058]), the apparatus comprising:
a housing (such as protective housing 1909, which protects both the first and second imaging systems) being adapted to surround at least a part of the transparent conduit (see [0125]).
In addition, Fujimoto et al teaches that the apparatus (illustrated in Figures 1-3 66and described in [0058]) comprises:
one or more light sources (referred to as illumination source 113 or 211, which is a part of the primary imaging system 103, 203) operable to emit light towards the sample being transported in the transparent conduit (see [0058]-[0062] and Figures 1-2);
one or more light receivers operable to detect fluorescence generated by one or more fluorophores comprised in the sample being transparent in the transparent conduit (referred to as one or more detector 223) (see [0062]);
a computing device (referred to as a processing unit, such as processing unit 110) comprising computing means (see abstract, [0102]-[0103] and claim 22), which receives a first signal from at least one of the one or more light receivers, the first signal being proportional to the detected fluorescence by the at least one of the one or more light receivers (see [0060], [0070] and [0103]).
Fujimoto et al does not explicitly disclose that the computing means compare the first signal to a predefined threshold for the first signal; and outputting a first information indicating comparison result.
However, in the analogous art of microarray detectors, Sandstrom et al teaches an optical relay system 34 which includes a light source assembly 20, a microarray substrate 38 (onto which light beams hit), a photodetector 48 (which is analogous to a light receiver) and a data acquisition means 56 and CPU 60 (which together encompass a computing means) (see Figure 1 and [0137]-[0147]). Furthermore, Sandstrom et al teaches that its computing means compares signals to a predefined threshold (i.e. a reference value) and outputs this comparison value (to the CPU, and potentially a display) (see [0092], [0124] and [0160]-[0164]). It would have been obvious to one of ordinary skill in the art to modify the computing means by replacing the processing unit of Fujimoto et al with the computing means (i.e. data acquisition means 56 and CPU 60 of Sandstrom et al ) for the benefit of enabling repetitive comparison to increase the SNR (signal to noise ratio) measurements, such that the background fluctuations are essentially averaged out, while the desired difference signal is retained (see [0167] of Sandstrom et al).
In addition, the combination of Fujimoto et al and Sandstrom et al does not explicitly disclose that the housing is adapted to surround at least a part (specifically the whole perimeter) of the transparent conduit.
However, Fujimoto et al does disclose that the edges of the transparent window can be protected from damage by the user, or from contact with a microtome during specimen cutting (see [0079]) and that the primary and secondary imaging systems are enclosed in a protective housing 1909 (see [0125]) and it would have been obvious to one of ordinary skill in the art to place the one or more light sources, one or more light receivers and a computing device within a protective housing (such as protective housing 1909) for the benefit of preventing contamination to the all elements of the apparatus, thereby minimizing risk of damage to all the above elements (the light source, light receiver and computing means).
Regarding Claim 5, the combination of Fujimoto et al and Sandstrom et al teaches that the one or more light sources (ref# 113 or 211 of Fujimoto et al) are operable to emit light of one of more fluorescence excitation curve wavelengths of the one or more fluorophores comprised in the sample (see [0060]-[0063] and [0116]-[0117]) of Fujimoto et al. Furthermore, it is noted that since the claim recites “one or more light sources” and “one or more fluorophores”, this would encompass a single (one) light source and single (one) fluorophore, and wherein if only one light source and/or fluorophore was utilized than light could not be emitted independently.
Regarding Claim 6, the combination of Fujimoto et al and Sandstrom et al teaches that the one or more light receivers are operable to detect fluorescence at one or more wavelengths of one or more fluorescence emission curves of the one or more fluorophores comprised in the sample see [0060]-[0063] and [0116]-[0117] of Fujimoto et al). Furthermore, it is noted that since the claim recites “one or more light receivers” and “one or more fluorophores”, this would encompass a single (one) light source and single (one) fluorophore, and wherein if only one light source and/or fluorophore was utilized than light could not be emitted independently.
Regarding Claim 7, the combination of Fujimoto et al and Sandstrom et al teaches that each light source further comprises either an emission light filter or an incoming light filter (see [0070] of Fujimoto et al and [0094], [0125] and [0137] of Sandstrom et al).
Regarding Claim 8, the combination of Fujimoto et al and Sandstrom et al teaches that the one or more fluorophores (i.e. fluorescent contrast agents) may be methylene blue (see [0067] of Fujimoto et al) or a fluorescently labeled antibody (see [0116] of Fujimoto et al).
Regarding Claim 9, the combination of Fujimoto et al and Sandstrom et al teaches that the light source (ref # 113 or 211 of Fujimoto et al) is located before the one or more light receivers (such as detector 223) in respect of the transport direction of the sample being transported in the transparent conduit (see [0062] and Figure 2 of Fujimoto et al).
Regarding Claim 14, Fujimoto et al teaches generating a first signal being proportional to the detected fluorescence (see [0060] and [0117]).
Fujimoto et al does not explicitly disclose comparing the first signal to a predefined threshold for the first signal; and outputting a first information indicating comparison result.
However, in the analogous art of microarray detectors, Sandstrom et al teaches an optical relay system 34 which includes a light source assembly 20, a microarray substrate 38 (onto which light beams hit), a photodetector 48 (which is analogous to a light receiver) and a data acquisition means 56 and CPU 60 (which together encompass a computing means) (see Figure 1 and [0137]-[0147]). Furthermore, Sandstrom et al teaches that its computing means compares signals to a predefined threshold (i.e. a reference value) and outputs this comparison value (to the CPU, and potentially a display) (see [0092], [0124] and [0160]-[0164]). It would have been obvious to one of ordinary skill in the art to modify the computing means by replacing the processing unit of Fujimoto et al with the computing means (i.e. data acquisition means 56 and CPU 60 of Sandstrom et al ) for the benefit of enabling repetitive comparison to increase the SNR (signal to noise ratio) measurements, such that the background fluctuations are essentially averaged out, while the desired difference signal is retained (see [0167] of Sandstrom et al).
Regarding Claim 15, the combination of Fujimoto et al and Sandstrom et al teaches using the apparatus of claim 1 (as described above) in a detection method of a diseased tissue or a diseased body fluid comprising one or more fluorophores and representing a disease or health condition, a detection method of a tumor and in the diagnosis of cancer (see [0003] and [0123] of Fujimoto et al).
Regarding Claim 16, the combination of Fujimoto et al and Sandstrom et al teaches a kit-of-parts of an apparatus for detecting fluorescence of a sample obtained from a human or animal by surgery during fluorescence guided surgery and comprising one or more fluorophores and representing a disease or health condition according to claim 1 (as described above) combined with a transparent conduit (see [0013], [0116]-[0117] and [0134] of Fujimoto et al).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fujimoto et al and Sandstrom et al as applied to claim 1 above, and further in view of Wittwer et al (US PGPub 2005/0064582).
Regarding Claim 3, the combination of Fujimoto et al and Sandstrom et al does not disclose that the housing is formed of two parts being attached to each other with attaching means.
However, in the analogous art of chambers/containers for carrying out and monitoring biological processes, Wittwer et al teaches a thermal cycling device 10 includes a closed loop fluid (most preferably air) chamber, generally designated at 11, which is adapted to accept samples to be cycled through vent door 14. The closed loop fluid chamber 11 includes a plurality of compartments (i.e. having at least 2 parts) (see [0089]) and Wittwer et al further discloses that baffles 32 and 33 (as shown in FIG. 3) may be used if desired to achieve better temperature homogeneity within the sample compartment 27. As shown in this embodiment, baffles 32 and 33 decrease the temperature variation in the reaction compartment 30 from about 10.degree. C., to about 2.degree. C. If desired, further (or more complicated) baffles may be used to further decrease the temperature variation in reaction compartment 30 (see [0117]). It would have been obvious to one of ordinary skill in the art to modify the housing of the previous combination by making the housing have a plurality of compartments and incorporating baffles (attachment means) attaching the plurality of compartments for the benefit achieving better temperature homogeneity within each compartment of the housing and further enabling a decrease in the temperature variation of one compartment. Furthermore, by providing attachment means attaching the plurality of compartments the risk of leakage and contamination would be diminished.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Fujimoto et al and Sandstrom et al as applied to claim 1 above, and further in view of Hargis et al (US PGPub 2020/0026090).
Regarding Claim 4, the previous combination of Fujimoto et al and Sandstrom et al does not teach that the housing comprises seals at opposite longitudinal ends of the housing for sealing the housing against the transparent conduit.
However, in the analogous art of laser systems and optical devices, Hargis et al teaches an optical system 5100, which can include an output window 5121 that allows the beams of light 5120A-5120D to exit the internal chamber 5104. In some embodiments, the housing 5102 includes an aperture 5122 in a wall thereof and the output window 5121 comprises a transparent window pane 5124, positioned over the aperture 5122. The window 5121 can be attached to the housing 5102 by a plurality of fasteners such as bolts 5126. In FIG. 12, only two bolts 5126 are shown in the cross-sectional view, but in some embodiments, additional bolts can be positioned along the edges of the window 5121. In some embodiments, the window 5121 can include a flange 5123 for mounting the window. The flange 5123 may have a plurality of through holes through which fasteners (e.g., bolts 5126) can pass to secure the window 5121 to the housing 5102. A seal 5128 (e.g., an O-ring) can be positioned between the housing 5102 and the window 5121 (e.g., the flange 5123). The bolts 5126 can be tightened, causing the O-ring 5128 to be compressed between the housing 5102 and the window 5121. In some embodiments, the O-ring 5128 produces a hermetic seal (see [0148]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the housing of the invention of the previous combination (of Fujimoto et al and Sandstrom et al) by incorporating seals at opposite longitudinal ends of the housing (as taught by Hargis et al) for the benefit of providing a hermetic seal to the housing, such that contamination is diminished.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fujimoto et al and Sandstrom et al as applied to claim 1 above, and further in view of Fine et al (US PGPub 2011/0249109).
Regarding Claim 12, the previous combination of Fujimoto et al and Sandstrom et al teaches does not explicitly disclose that the computing device is provided in the housing.
However, in the analogous art of microscopy imaging, Fine et al teaches that a microscopy imaging device in which an imaging system, the imaging integrated circuit, associated electronics, and analysis device are integrated so as to be combined in a portable housing; the light source may be integrated, standalone, or supplied from ambient light, allowing for desktop-, laptop-, cellphone-, or smaller-sized microscopes as the desired application requires (see [0142]). It would have been obvious to one of ordinary skill in the art to place the computing device within the housing (as taught by Fine et al) for the benefit of producing a portable, integrated, standalone device, allowing for desktop-, laptop-, cellphone-, or smaller-sized microscopes as the desired application requires.
Allowable Subject Matter
Claims 10-11 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: Srienc et al (US PGPub 20080268469) teaches first and second light sources and light receiver (see [0124] and [0158]). However, neither Srienc et al, nor Fujimoto et al, nor Sandstrom et al teaches or fairly suggests that the computing means is further configured to verify a fluorescence detection of the first light receiver from two or more light receivers, by receiving the first signal from the first light receiver, the first signal being proportional to the detected fluorescence by the first light receiver; - determining, in response to the receiving the first signal, a verifying value for the second signal; - receiving a second signal from the second light receiver, the second signal being proportional to the detected fluorescence by the second light receiver; - comparing the second signal to the verifying value; - outputting, in response to the second signal exceeding or being equal to the verifying value, a first information on the second signal; and - outputting, in response to the second signal failing to exceed or be equal to the verifying value, a second information on the second signal (as required by claim 10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tichauer et al (US PGPub 2015/0374308, cited on the IDS) discloses a method of generating corrected fluorescence data of concentrations of a targeted fluorophore in tissue of a subject includes administering first and second fluorescent contrast agents to the subject, the first contrast agent targeted to tissue of interest, the second agent untargeted. The tissue is illuminated with light of a first stimulus wavelength and first data is acquired at an appropriate emissions wavelength; the tissue is illuminated at a second stimulus wavelength and second data is acquired at a second emissions wavelength associated with the second agent, the first and second emissions wavelength differ. Difference data is generated by subtracting the second data from the first data. A system provides for stimulus and capture at multiple wavelengths, with image storage memory and subtraction code, to perform the method. Corrected data may form an fluorescence image, or is used to generate fluorescence tomographic images (see abstract). Furthermore, Tichauer et al teaches a fluorescent imaging system 100 (FIG. 1), which has an optical subsystem 102, 108, 110, 109 (FIG. 1, 2, 3, or 4) an interface subsystem 104, and an image processing system 106. In various embodiments, the optical subsystem 102 may be integrated with a surgical microscope 112 as illustrated in FIG. 1, may have a fluorescence camera 114 integrated with a surgical microscope 112 having a lens subsystem 161, may have multiple fluorescence cameras 116 and scanned-laser stimulus light sources 118, 118A as illustrated in FIG. 2 or 2A, may have a single fluorescence camera 120 mounted on a motorized track 122 as illustrated in FIG. 3, may have multiple laser stimulus light sources 124, 125 coupled through optical fibers 126 and optodes to tissue 128, with additional optodes coupled through fibers 130 to a multichannel spectrally-selective or spectrographic detector 132 or may have another configuration not shown (see [0025]). Tichauer et al also discloses that its system includes a photodetector array 147 and a processor 140 of image processing system 106 (see [0027]-[0028]).
Werner et al (US PGPub 2008/0085550 A1) discloses an apparatus and method were used to track the movement of fluorescent particles in three dimensions. Control software was used with the apparatus to implement a tracking algorithm for tracking the motion of the individual particles in glycerol/water mixtures. Monte Carlo simulations suggest that the tracking algorithms in combination with the apparatus may be used for tracking the motion of single fluorescent or fluorescently labeled biomolecules in three dimensions (see abstract). Furthermore, Werner et al teaches that the apparatus includes at least one light source and at least one light receiver (i.e. first and second photon detectors) and a computing device (see Figure 1 and [0034]).
Katzlinger et al (US PGPub 2018/0128676 A1) discloses systems, apparatuses, and methods for optical-based monitoring of various operating conditions internal to a sample analyzing apparatus. The sample analyzing apparatus may be one that carries out one or more types of optical-based measurements or analyses of samples, such as fluorescence-based, absorbance-based, and/or luminescence-based measurements, and/or microscopic imaging (see [0001]). Furthermore, Katzlinger et al teaches that their apparatus 100 comprises light sources, light detectors and a computing device (a system controller 190) (see [0018], [0026] and Figure 1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797