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 § 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 22 is rejected under 35 U.S.C. 101 because “A computer program product” requires “non-transitory” such as “A non-transitory computer program product” in order to be eligible under 35. U.S.C. 101 in view of Bilski v. Kappos, 561 U.S. 593, 658, 95, USPQ2d1001, 1007 (2010).
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(s) 1 – 5, 18 – 20 and 22 – 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lundstedt (US 2011/0054864 A1, cited in the IDS).
With respect to independent claim 1, Lundstedt teaches a method of quantifying an amount oleic content of a substance in a sample of material canola seeds for a delivery system see paragraph [0265], the method comprising:
obtaining first near infra-red spectroscopy data for the sample of material in a first wavelength range 4226.5 cm-1 to 4601.4 cm-1 in paragraph [0275];
obtaining second near infra-red spectroscopy data for the sample of material in a second wavelength range 5449.9 cm-1 to 7501 cm-1 in paragraph [0275],
wherein the second wavelength range is separated from the first wavelength range as discussed above; and using the first and second near infra-red spectroscopy data to estimate predict the oleic oil content using a refined filter…. Of two spectral subregions in paragraph [0275] an amount of the substance in the sample of material.
With respect to dependent claim 2, the limitation of “wherein the material comprises a liquid for a delivery system” cannot carry any patentability unless it is invented. This is interpreted as an intended use. Since Lundstedt teaches NIR spectroscopy, Lundstedt’s spectroscopy can be employed for any sample.
With respect to dependent claim 3, Lundstedt teaches wherein the material comprises a solid canola seeds as discussed above for a delivery system. This is interpreted as an intended use. Any sample cannot carry any patentability unless it is invented.
With respect to dependent claims 4 – 5, the limitations of “wherein the material comprises a gel for a delivery system” and wherein the material comprises a material for an aerosol delivery system” cannot carry any patentability unless it is invented. These limitations are interpreted as an intended use.
With respect to independent claim 18, Lundstedt teaches A method of obtaining calibration data in paragraph [0008] to use for quantifying an amount of a substance in a sample of material for a delivery system, the method comprising: obtaining first near infra-red spectroscopy data for a calibration sample of material containing a first known amount of the substance in a first wavelength range; obtaining second near infra-red spectroscopy data for the calibration sample of material in a second wavelength range; and combining the first near infra-red spectroscopy data and the second near infra-red spectroscopy data to provide the calibration data as discussed above in the rejection justification to claim 1.
With respect to dependent claim 19, Lundstedt teaches in paragraph [0022] obtaining further first near infra-red spectroscopy data for a further calibration sample of material containing a further known amount of the substance in a first wavelength range; obtaining further second near infra-red spectroscopy data for the further calibration sample of material in a second wavelength range; and combining the further first near infra-red spectroscopy data and the further second near infra-red spectroscopy data with the calibration data.
With respect to dependent claim 20, Lundstedt teaches wherein the first wavelength range covers the range from 5700 to 6100 cm-1 5449.9 cm-1 to 7501 cm-1 in paragraph [0275].
With respect to independent claim 22, Lundstedt teaches a computer program product in paragraph [0124] for quantifying an amount of substance in a sample of material for a delivery system, the computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of: obtaining first near infra-red spectroscopy data for the sample of material in a first wavelength range; obtaining second near infra-red spectroscopy data for the sample of material in a second wavelength range, wherein the second wavelength range is separated from the first wavelength range; and using the first and second near infra-red spectroscopy data to estimate an amount of the substance in the sample of material as discussed in the rejection justification to claim 1 above.
With respect to independent claim 23, Lundstedt teaches a computer program product in paragraph [0124] for obtaining calibration data to use for quantifying an amount of a substance in a sample of material for a delivery system, the computer program product comprising instructions which, when the program is executed by a computer, cause the computer to carry out the steps of: obtaining first near infra-red spectroscopy data for the sample of material in a first wavelength range; obtaining second near infra-red spectroscopy data for the sample of material in a second wavelength range, wherein the second wavelength range is separated from the first wavelength range; and using the first and second near infra-red spectroscopy data to estimate an amount of the substance in the sample of material as discussed above in the rejection justification to claim 1 above.
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.
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) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of Ridder (US 2012/0078473 A1).
The teaching of Lundstedt has been discussed above.
With respect to dependent claim 6, Lundstedt is silent with wherein the material comprises a material for use in an oral delivery system selected from a list comprising snus, snuff, gums, gels, spray, and patches.
As discussed above, any sample cannot carry patentability unless it is invented.
Ridder, a pertinent art, teaches in paragraph [0192] a gel. In view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to quantify concentration of desired material. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
Claim(s) 7 – 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of Maggard (US 5,243,546).
The teaching of Lundstedt has been discussed above.
With respect to dependent claims 7 – 8, Lundstedt is silent with wherein the substance comprises an active substance and wherein the substance comprises nicotine.
As discussed above, any sample cannot carry patentability unless it is invented.
Maggard, a pertinent art, teaches in column 6, line 28 nicotine. In view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to quantify concentration of desired material. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of Yarden (US 2019/0033210 A1).
The teaching of Lundstedt has been discussed above.
With respect to dependent claim 9, Lundstedt is silent with wherein the substance comprises a cannabinoid
As discussed above, any sample cannot carry patentability unless it is invented.
Yarden, a pertinent art, teaches in paragraph [0023] cannabinoid and in view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to quantify concentration of desired material. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of Burns (US 2010/0249664 A1).
The teaching of Lundstedt has been discussed above.
With respect to dependent claim 10, Lundstedt is silent with wherein the substance comprises vegetable glycerin.
As discussed above, any sample cannot carry patentability unless it is invented.
Burns, a pertinent art, teaches in paragraph [0023] a glycerin sample and in view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to quantify concentration of desired material. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
Claim(s) 11 – 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of Lober (US 2016/0047741 A1).
The teaching of Lundstedt has been discussed above.
With respect to dependent claim 11, Lundstedt is silent with wherein the substance comprises propylene glycol.
As discussed above, any sample cannot carry patentability unless it is invented.
Lober, a pertinent art, teaches in paragraph [0024] propylene glycol and in view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to quantify concentration of desired material. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
With respect to dependent claim 12, Lober teaches in paragraph [0021] wherein the substance comprises water.
Claim(s) 13 – 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of Eaton (US 2002/0197725 A1).
The teaching of Lundstedt has been discussed above.
With respect to dependent claim 13, Lundstedt is silent with wherein the amount of the substance in the sample of liquid is estimated using a chemometric model.
In paragraph [0046], Eaton, a pertinent art, teaches chemometric model in order to quantify desired material and in view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to quantify desired sample. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
With respect to dependent claim 14, Eaton teaches in paragraph [0046] wherein the chemometric model is derived using a partial least squares approach.
With respect to dependent claim 15, Eaton teaches in paragraph [0046] wherein the chemometric model is derived using a neural network approach Heirarchical Cluster Analysis.
With respect to dependent claim 16, Lundstedt should have this limitation of” wherein the chemometric model is derived based on spectroscopy data for a plurality of calibration samples of liquid, wherein the plurality of samples of liquid have different known amounts of the substance” in order to quantify desired sample.
With respect to dependent claim 17, when modified by Eaton, Lundstedt modified by Eaton teaches wherein the amount of the substance in the sample of liquid is quantified by providing, as an input to the chemometric model, the first near infra-red spectroscopy data for the sample of liquid in the first wavelength range, and the second near infra-red spectroscopy data for the sample of liquid in the second wavelength range, and wherein the output of the chemometric model comprises an estimate of an amount of the substance in the sample of liquid.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundstedt, and further in view of CA 2936184 (Hereunder D1).
The teaching of Lundstedt has been discussed above.
With respect to dependent claim 21, Lundstedt is silent with wherein the second wavelength range covers the range from 8200 to 9200 cm-1.
D1, a pertinent art, teaches 8200 cm-1 and in view of this, it would be obvious at the time of the claimed invention was filed to modify the teaching of Lundstedt in order to determine concentration of water. This is in consistency with the Supreme Court Decision of the KSR. V. International Co.: applying a known technique to a known device (method or product) ready for improvement to yield predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIHO KIM, Ph.D. whose telephone number is (571)270-1628. The examiner can normally be reached M-F: 8-5 EST.
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KIHO KIM, Ph.D.
Primary Examiner
Art Unit 2884
/Kiho Kim/Primary Examiner, Art Unit 2884