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 .
Status of Claims
Claims 1, 13 and 14 are amended. Claim 8 is canceled. Claims 9-12 are withdrawn. Claims 13-14 are newly added. Claims 1-7 and 9-14 remain pending.
Response to Remarks
Claim Interpretation under 112(f)
The Applicant argues that the amended claim 1 recites a specific mapping operation and therefore does not invoke 112(f) (REMARKS, 6). The Examiner respectfully disagrees. The amendment adds details about what the image generator does, not what it is. Without adding any specific structure which would preclude the 112(f) interpretation, “image generator” remains a generic placeholder coupled with functional language.
The Applicant further argues that paragraph [0123] provides corresponding disclosure for the phrase “image generator” necessary under 112(f), describing scanning a finger by moving the infrared pulse generator, photoelectric element, and sensing element as a prescribed rate to map and image (REMARKS, 6). The Examiner respectfully disagrees. The description is the result of the function, not an algorithm for performing it. Furthermore, the means for scanning remains absent.
Claim Rejections – 35 USC § 112(b)
The previous rejection based on “during scanning of the target” is withdrawn because the language has been removed. The rejection based on “sensing circuit” is maintained. The corresponding amendment does not address the grounds of the rejection. A new rejection under 35 USC 112(b) is made below in response to the amendment to the image generator function.
Claim Rejections – 35 USC § 112(a)
The written description rejection directed to the sensing circuit language has been withdrawn in light of [0044-0045, 0051-0053] of the specification. The written description and enablement rejections of the image generator and scanning means are otherwise maintained as applied to the amended claims. Applicant relies on [0122-0125] and Fig 10 for the scanning and mapping limitations and on Fig 3, 7, and 9 for enablement. The citations do not describe how the scanning and one-to-one mapping are carried out. Reporting a result neither shows possession of, nor enables, the means of achieving it. Ariad Pharms., Inc. v. Eli Lilly & Co. 598 F.3d 1336, 1349-52 (Fed. Cir. 2010) (en banc); Genentech Inc. v. Novo Nordisk AfS, 108 F.3d 1361 (fed. Cir. 1997).
Claim Rejections – 35 USC § 103
In light of the amendments to claim 9, a new rejection is made below in view of Fantini in view of Wang.
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.
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: “image generator configured to…” in claim 1.
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.
Claims 1-7 and 13-14 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.
Claim 1 recites the phrase “sensing circuit…configured to measure a magnitude of either a first peak current … or a second peak current.” According to the applicant’s disclosure, the sensing circuit appears to be a conventional ammeter capable of measuring current magnitudes, but the claim includes additional functional limitations, measuring the peak associated with a particular edge of the light pulse, that distinguish the element from an ordinary ammeter without reciting what structure isolates the leading-edge or trailing-edge peak. It is unclear whether any current meter connected to the photoelectric circuit is within the claim, or only a circuit with additional, unrecited structure. The scope of the phrase is therefore unclear. For examination purposes, the limitation is interpreted as any current-measuring circuit connected to the photoelectric circuit whose output includes the magnitude of the lead-edge or trailing-edge peak.
Claim 1 recites the phrase, “an image generator configured to continuously map a change value in the magnitude of the peak current measured by the sensing circuit while the infrared pulse generator, the photoelectric circuit, and the sensing circuit are moved relative to the target to scan the target, thereby providing a one-to-one mapping image of the target”. The phrase invokes 112(f) as set forth above under Claim Interpretation. The specification discloses only its function and its result ([0054, 0055, 0057, 0121-0125], Fig 10). The disclose provides no algorithm by which measured values are associated with positions on the target and arranged into a one-to-one mapping image, and a general purpose computer cannot perform this function without special programming. The claim is therefore indefinite. The applicant may amend the claim to avoid 35 USC § 112(f), or amend the specification to disclose the corresponding structure and link it to the function, without adding new matter. The balance of claims are rejected based on dependence.
Claim 14 recites both an apparatus and method of using the apparatus. MPEP 2173.05(p)(II) explains that a claim that recites both an apparatus and method of using the device is indefinite under 112(b). One of ordinary skill in the art would not be apprised of when the claim is infringed: when one provides a device capable of being used according to claimed invention, or when the device is used according to the claimed method.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description: Claims 1-7 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the phrase, “an image generator configured to continuously map a change value in the magnitude of the peak current measured by the sensing circuit while the infrared pulse generator, the photoelectric circuit, and the sensing circuit are moved relative to the target to scan the target, thereby providing a one-to-one mapping image of the target”. The phrase invokes 112(f) as set forth above under Claim Interpretation. Because the phrase is a computer-implemented functional limitation (CIFL), the disclosure must provide a corresponding algorithm, flow chart, mathematical equations or explicit method steps detailing the CIFL.
The specification discloses only its function and its result ([0054, 0055, 0057, 0121-0125], Fig 10). The disclosure provides no algorithm by which measured values are associated with positions on the target and arranged into a one-to-one mapping image, and a general purpose computer cannot perform this function without special programming.
The disclosure does not describe:
any structure that moves the components relative to the target;
how the source and the photoelectric element, on opposite sides of the target (fig. 1; [0042, 0044]), are moved together and kept in register;
the scan path, although Fig. 10 shows 2D images of several centimeters across and only a single speed is disclosed;
how the position of each measurement on the target is determined and tied to the pulse that produced it; or
how values are assigned to image locations, or what one-to-one correspondence and resolution are obtained with a 6 mm beam pulsed at 1 kHz ([0117-0119]), which at 1 mm/s places successive pulses about 1 µm apart.
A result does not show possession of the claimed means of achieving it. Ariad Pharms., Inc. v. Eli Lilly & Co. 598 F.3d at 1349-52 (Fed. Cir. 2010); MPEP 2161.01(I) and MPEP 2181(II). The applicant may amend the claim to avoid 35 USC § 112(f) or amend the specification to disclose the corresponding structure and link it to the function, without adding new matter. The balance of claims are rejected based on dependence.
Enablement: Claims 1-7 and 13-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The In re Wands factors are presented below:
Breadth of claims and nature of the invention. The claims cover forming a 1-to-1 image of any target from peak photocurrents measured pulse by pulse while a source and detector move, by any means, along any path.
State of the prior art. Scanning transmission imaging based on light intensity was known (Fantini, below). The claimed aspects were not explicitly disclosed in a single invention: capturing the transient at each pulse edge, typing it to a position, and forming a 1-to-1 image from a 6 mm beam.
Level of ordinary skill and predictability. The level of skill is high. The predictability of the art is low. The signal magnitude varies during a scan based on source-detector alignment, path length, surface contact, as well as density of the target. Furthermore, the signal of interest is very small (1 µA between undeformed and deformed tissue, [0125]). The disclosure offers no guidance on parsing effects from these factors.
Direction provided and working examples. The amount of direction provided is one sentence ([0123]). The single example (Fig. 1) reports a result without the scan area, line spacing, sampling interval, alignment method, or image formation steps, and cannot be repeated from the disclosure.
Quantity of experimentation needed. A skilled person would have to design the scanning mechanism, source-detector alignment, image formation algorithm, and claimed attainable resolution by trial and error.
Making and using the full scope of the claims would require undue experimentation. Claims 2-7, 13 and 14 do not fix the deficiency. Claim 14 merely adds the speed used in the example.
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.
Claim(s) 1, 3-5, 7, 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wist et al. (US 4945239 A) in view of Wang et al. (US 20210288194 A1).
Regarding claim 1, Wist discloses a biosensing device with a photoelectric circuit, the bio-sensing device (FIG 4; col. 14, ll. 50-52; col. 10, ll. 41-44) comprising:
an infrared pulse generator configured to irradiate infrared pulsed light to a target (light source 16 illuminates the tissue at NIR wavelengths using switched laser diodes or chopped lasers; col. 9, 11. 18-25, 33-34; col. 14, ll. 42-46);
the photoelectric circuit configured to receive the infrared pulsed light which is transmitted through the target, and to generate photocurrent based on the received light (light passes through the target 26 and impinges on the photodiode 14 which generated an analog signal proportional to the intensity of the light; col. 10, ll. 6-12, 41-44; col. 14, ll. 60-64);
a sensing circuit electrically connected to the photoelectric circuit and configured to measure a magnitude of the photocurrent (photodiode signal generated a proportional signal and sends it to a processor (not shown), filters the detector output at the chopping frequency so that only pulsed light is imaged; col. 10, ll. 41-52; col. 15, ll. 21-25);
an image generator configured to continuously map a change value in the magnitude of the peak current measured by the sensing circuit while the infrared pulse generator, the photoelectric, circuit ,and the sensing circuit are moved relative to the target to scan the target, thereby providing a one-to-one mapping image of the target (scanning apparatus 40 moves the light source over the breast (col. 10, ll. 17-20), and a single photodiode used as the detector is moved with the light source (col. 10, ll. 45-47). The data processor constructs the image from the relative position on the photodiode and the intensity of its signal (col. 10, ll. 47-49) so that each scan position produces a value).
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Fig 4 of Wist shows the NIR transillumination tissue inspection system.
Wist does not disclose the sensing circuit measuring the magnitude of a first peak current corresponding to the leading edge, or a second peak current corresponding to the trailing edge of the IR pulsed light. In the same field of photodetectors, Wang discloses a self-powered p-Si/n-TiO2 junction photodetector illuminated by light that is switched on and off via incident light ([0012, 0164-0165]), including NIR light ([0167]), such that when the light switches on, the current shows a trough, and when it switches off, the current shows a peak (i.e. first and second peak currents corresponding to the leading and trailing edges of the pulse [0165]). Wang measures the leading and trailing edges of the pulse with a preamp connected to the electrodes of the device ([0186, 0214]), which is a sensing circuit electrically connected to the photoelectric circuit, where Wang identifies medical imaging as an application for the photodetectors, with the benefit of little to no bias required, improved signal intensity ([0007, 0207]). The use of a known technique (photodetector of Wang) to improve a similar device (pulse detection of Wist likely requiring amplification) in the same way would have been obvious to one of ordinary skill in the art at the time of filing. KSR Int’l Co. v. Teleflex Inc., 550 US 398, 417 (2007). MPEP 2143(I)(C),(D).
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Fig 2A of Wang shows a detector setup with a source and chopper arrangement
Regarding claim 3, Wang discloses the junction has a p-Si layer and an n-type TiO2 layer of nm deposited on it to form the junction ([0164, 0165]), with a transparent ITO electrode on the TiO2 side and an Al electrode on the p-Si side ([0165]), wherein ITO is the transparent current collector on the n-type layer, and light is incident on the TiO2 layer.
Regarding claim 4, Wang discloses the junction generating current with no applied bias (self-bias of the PN junction, [0007]).
Regarding claim 5, Wang discloses the p-type layer is p-Si and the n-type layer is TiO2 ([0164-0165]).
Regarding claim 7, Wang discloses a measuring instrument connected across the electrodes on the p-Si and TiO2 sides ([0165-0168]) such that the sensing circuit is electrically connected to and between the p- and n-type layers.
Regarding claim 13, Wist discloses the image distinguishes tissue by the amount of light absorbed, with relative density as a parameter of transillumination images (col. 2, ll. 29-31).
Regarding claim 14, Wist scans in 0.1 mm steps with 2000 direction reversals per image (col. 9, ll. 53-56) but does not disclose a scan speed. For a given sampling interval, scan speed trades capture time with spatial sampling resolution, which is a result-effective variable. Selecting about 1 mm/s would have been routine optimization. MPEP 2144.05(II).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wist et al. (US 4945239 A) in view of Wang et al. (US 20210288194 A1), further in view of Al Ali (US 6697658 B2).
Regarding claim 2, Wang’s operating frequency (.002-1 kHz; [0165]) corresponds to a period of 0.5 s to 1 ms, overlapping the claimed 1 ms to 0.1 s. Wist and Wang do not disclose a doty cycle of 1-10%. In the same field of endeavor, Al-Ali teaches reducing a duty cycle of an infrared emitter for a finger-transmission sensor from about 25% to 3.125%, to lower power consumption (col. 1, l. 62 – col. 2, l. 42). In light of the teachings of Al-Ali, it would have been obvious to one of ordinary skill in the art at the time of filing to combine with the teachings of Wist and Wang.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wist et al. (US 4945239 A) in view of Wang et al. (US 20210288194 A1), further in view of Fukuda (JP 6554300 B2).
Regarding claim 6, Wang discloses a current collector of ITO ([0165]), comprises In2O3 and SnO2. Alternatively, Fukuda discloses ZnO as an interchangeable transparent electrode oxide for photoelectric conversion devices (paragraph beginning with “the transparent conductive layer 3…”). In light of the teachings of Fukuda, it would have been obvious to one of ordinary skill in the art at the time of filing to select ZnO as the transparent electrode layer, with an expectation of success (good conductivity of the photocurrent). Furthermore, selecting a known material suited to its intended use would have been obvious. See MPEP 2144.07.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY BRYANT whose telephone number is (571)270-7329. The examiner can normally be reached M-F // 7-3P EST.
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CASEY BRYANT
Primary Examiner
Art Unit 2884
/CASEY BRYANT/Primary Examiner, Art Unit 2884
