DETAILED ACTION
Final Rejection
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 .
Claims Status
Claims 1-9 are withdrawn. Claims 10-24 are amended. Claims 10-24 are currently under consideration.
Response to Arguments
The 35 U.S.C. § 112(b) or 35 U.S.C. § 112, 2nd paragraph rejection of claims 10-24 are withdrawn in view of the amendments to claims 10 and 13.
Applicant’s arguments with respect to claim(s) 10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pg. 10, filed 12/10/2025, with respect to the rejection(s) of claim(s) 10-24 under 35 USC 101 have been fully considered and are not persuasive. Step 2A: Prong Two of the test for patent eligibility evaluates whether a claim recites additional element(s) or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Limitations that are indicative of integration into a practical application include those that effect a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c). Applicant argues that the amendments to claim 10 amounts to a practical application whereby fluorescence data is transformed in a gastric emptying profile that is outputted to clinicians for clinical interpretation. However, the particular article to be transformed here is fluorescence intensity data. An “article” includes a physical object or substance. The physical object or substance must be particular, meaning it can be specifically identified (MPEP 2106.05(c)). In this case, fluorescence data is arguably not considered an article under this section of the MPEP, but rather intangible data (see CyberSource, 620 F. Supp. 2d at 1073). The rejections are maintained.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 10-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a normalising step and an analysing step in the body of the claim. Both steps were interpreted as mental and/or mathematical processes involving mathematical computations/evaluations of the fluorescent data. This judicial exception is not integrated into a practical application because there are no steps that apply, rely on, or use the judicial exceptions in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. The steps listed before the abstract ideas were interpreted as related to extra-solution data gathering. The recitation of a computer for implementing the method in the preamble was considered mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)). The final step of outputting the gastric emptying profile to a graphical display for clinical interpretation was interpreted as adding insignificant post solution activity. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the other steps were interpreted as extra solution data gathering and insignificant post solution activity. Claims 11-19 were also interpreted as extra-solution data gathering. Claims 20-24 were interpreted as additional abstract mathematical subject matter. A possible amendment to overcome the rejections would be a positive step of clinical interpretation of the outputted gastric emptying profile.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10, 12, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gastrosense Application Note (2012).
Regarding claim 10, Gastrosense discloses a computer-implemented method for measuring gastric emptying rate of a subject (see Abstract on first page, the method requires the use of a FMT system to quantitate gastric emptying which requires a computer for operation) the method comprising:
orally administering a test meal comprising a fluorescent contrast agent that is absorbable by a healthy gut to the subject (second page – “mice were gavaged with agent (0.25 nmole) in PBS, final volume of 200 µL. The effect of solid food on gastric emptying rates was assessed by feeding some mice cooked egg yolk into which 25 µL of GastroSense 750 (0.25 nmole) was pipetted”, thus two options were tried and either would meet the limitation);
irradiating, using a light source, a location on the skin on a body part of the subject using light radiation, such that the light radiation causes at least a portion of the fluorescent contrast agent in the test meal which has been emptied from the stomach of the subject and has entered the bloodstream of the subject to fluoresce;
detecting, using a transcutaneous sensing device (transcutaneous interpreted in view of the specification as meaning the sensing is capable of making non-invasive measurements through the skin rather than a device that physically penetrates through the skin to sense), fluorescence emitted by the fluorescent contrast agent in the test meal at said location to generate fluorescence intensity data as a function of time (in this case, the FMT device can acquire fluorescent images of the excited molecule in the body, see second page);
normalising the fluorescence intensity data to a peak value to produce normalized fluorescence data as a function of time (third page – “normalization to starting stomach signal allows”; “a peak value” is not defined in the claimed, in this case the starting stomach signal was interpreted as a peak value; normalization is applied to all images and thus shows a time course); and
analysing the normalised fluorescence data using a computational model to calculate a gastric emptying profile representing the percentage of the test meal remaining in the stomach of the subject over time (see Fig. 4 plot which shows percentages remaining throughout the time course); and
outputting the gastric emptying profile to a graphical display for clinical interpretation (Fig. 4 is a computer output).
Note: Applicant may amend to indicate the measurement of the fluorescent markers in the blood stream as appears to be noted in the specification to overcome this reference.
Regarding claim 12, Gastrosense discloses wherein the test meal comprises a liquid test or a solid test meal (See claim 1 rejection).
Regarding claim 19, Gastrosense discloses wherein said body part is a finger, wrist, arm or earlobe (the cassette encloses the entire body and would therefore be adjacent to the parts listed).
Claims 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gastrosense Application Note (2012) as evidenced by Perkin Elmer FMT spec sheet (2012).
Regarding claim 16, Gastrosense does not expressly disclose wherein the light source comprises a light emitting diode or a laser. However, the Perkin Elmer FMT Fluorescence Molecular Tomography system disclosed in the note uses laser diodes for excitation as noted in the Perkin Elmer FMT spec sheet (see highlighted note on page 10).
Regarding claim 17, Gastrosense discloses wherein the transcutaneous sensing device comprises one or more photodiodes, phototransistors and/or fibre-optic probes (page 6 indicates the system includes a CCD camera) and is configured to be worn on and/or around said body part of the subject (the system includes a cassette in which the animal is placed as shown on page 6, the cassette is inserted into the system, the arrangement in this situation interpreted as the device worn around the animal’s body).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11, 18, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gastrosense Application Note (2012).
Regarding claim 11, Gastrosense does not disclose wherein the peak value of the intensity is the value of the intensity at a first peak or at a second peak in the fluorescence data, or is a maximum value of the intensity in the fluorescence data. However, such a modification would have been obvious modification in view of Gastrosense’s teachings. As noted above, Gastrosense normalizes the data to a starting stomach fluorescent signal value. Whether this value amounts to a first, second, or maximum peak value would be routine optimization. MPEP 2144.05 states, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Whether the starting stomach signal can be characterized as a particular peak or a maximum peak would have been an obvious choice to program the system to detect.
Regarding claim 18, Gastrosense discloses wherein in the step of detecting, using the transcutaneous sensing device, fluorescence emitted by the fluorescent contrast agent measurements are recorded by said transcutaneous sensing device (Figs. 3-6 show time course measurements of fluorescence). Gsatrosense does not disclose the measurements are taken at least once per minute (the graphs indicate larger periods between measurements). However, depending on what dynamics of gastric emptying needs to be quantified and observed, the choice of modifying sampling rates amounts to routine optimization and obvious modification of Gastrosense in view of MPEP 2144.05 cited above. Additionally, changing sampling rates allows one to detect end points more accurately.
Regarding claim 24, Gastrosense discloses wherein the step of analysing said the normalised fluorescence data comprises calculating the percentage of the test meal which is remaining in the stomach of the subject as a function of time (see for example graph 4 which tracks the percentage of food remaining in the stomach over time). Gastrosense does not disclose a variable (e.g. Rₚc) represented by the equation in claim 24:
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and wherein I(t) represents the normalised data of said intensity as a function of time; and tpeak1 represents the time at which the first peak is observed in said intensity as a function of time. However, the Office takes official notice that this is just a well-known formula for representing percentage remaining over time and would have been an obvious modification to Gastrosense for representing the amount remaining.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Gastrosense Application Note (2012) in view of Annapragada et al. (US 2010/0202974).
Regarding claim 13, Gastrosense does not disclose wherein the fluorescent contrast agent comprises a dye selected from fluorescein, methylene blue or fluorescein isothiocyanate conjugated dextran, or salts thereof, or combinations thereof (Gastrosense does not disclose what comprises the Gastrosense 750 contrast agent molecule). However, contrast agents such as those listed were known in the arts at the time of the filing of the invention. Annapragada et al. teach contrast agents and their method of use (Abstract) notes some examples including fluorescein iso-thiocynate ([0026]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to modify Gastrosense to use a contrast agent such as . There would have been a reasonable expectation of success fluorescein iso-thiocynate as taught by Annapragada et al. for imaging within the body because it amounts to combining prior art elements according to known methods to yield predictable results. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gastrosense Application Note (2012) in view of Daures e al. (US 20220313092, cited previously).
Regarding claim 14, Gastrosense discloses wherein the transcutaneous sensing device has an acquisition time (time course data sets are shown in Fig. 3) and the light source has an excitation power (this is inherent in the FMT system disclosed), but do not disclose wherein the fluorescence data is normalised based on said acquisition time and said excitation power. However, normalization of such data is known in the arts. Daures et al. teach a method and device for monitoring fluorescence emitted at the surface of a biological tissue. Daures teaches that in order to obtain greater reproducibility in measurements, factors such as power fluctuations of the excitation source and exposure time (amongst others) can be used for normalization (see [0060]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to There would have been a reasonable expectation of success to modify Gsatrosense et al. to include the normalization factors claimed and taught by Daures et al. for measuring fluorescence because Daures teaches that this can improve reproducibility of measurement results.
Regarding claim 15, Gastrosense does not disclose wherein the transcutaneous sensing device begins taking periodic measurements before the test meal is administered to the subject, such that the periodic detection of the intensity of the fluorescence of the test meal begins before the test meal is administered to the subject, to obtain a background signal to be used in the step of normalising the fluorescence data ( Gastrosense tackles normalization of a different aspect of the acquired data as explained previously). However, obtaining a background signal against which to normalize fluorescence data was known in the arts. Daures et al. also teach, "The average image I.sub.Ref serves as an original image, i.e. a reference fluorescence image that includes potential autofluorescence, fluorescence or background residues induced by wanted or unwanted excitation, such as lighting of the operating theater for example. This average image I.sub.Ref serves as a reference image I.sub.Ref that is subtracted from each new fluorescence image I.sub.i(Y.sub.j). [0046]). It would have been obvious to a person having ordinary skill in the art at the time of the filing of the invention to further modify Gastrosense to obtain a background signal for subtraction from the acquired fluorescence signal as taught by Daures et al. to enhance the quality of the data signal. There would have been a reasonable expectation of success given that this merely requires obtaining extra data and performing a mathematical operation.
Conclusion
Claims 1-9 are withdrawn. Claims 10-24 are rejected. However, no prior art rejections are included for claims 20-23. Resolution of the 101 issues would likely result in allowable subject matter.
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 Tho Q. Tran whose telephone number is (571)270-1892. The examiner can normally be reached 7-5.
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/THO Q TRAN/ Examiner, Art Unit 3791
/JACQUELINE CHENG/ Supervisory Patent Examiner, Art Unit 3791