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 .
Specification
The abstract of the disclosure is objected to because:
In line 3, “preparation includes” should be changed to “preparation, wherein the dose sensation evaluation method includes”
In line 5, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”
In line 7, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”
In lines 10-11, “the suprahyoid or subhyoid muscle group” should be changed to “a suprahyoid muscle group or a subhyoid muscle group”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-9 and 11-17 are objected to because of the following informalities:
In regards to claim 1, line 5, “preparation comprising:” should be changed to “preparation, the dose sensation evaluation method comprising:”.
In regards to claim 1, lines 7-8, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 1, line 11, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 2, lines 14-15, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 2, lines 16-17, “the suprahyoid or subhyoid muscle group” should be changed to “a suprahyoid muscle group or a subhyoid muscle group”.
In regards to claim 3, lines 20-21, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 3, line 23, “acquiring” should be changed to “the acquiring”.
In regards to claim 4, lines 6-7, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 4, lines 9-10, “the maximum value” should be changed to “a maximum value”.
In regards to claim 5, lines 12-13, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 6, lines 18-19, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 6, line 21, “good dose sensation” should be changed to “a good dose sensation”.
In regards to claim 7, lines 25-26, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 7, line 28, “the dose sensation” should be changed to “the good dose sensation”.
In regards to claim 8, lines 2-3, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 9, line 9, “a pharmaceutical preparation” should be changed to “the pharmaceutical preparation”.
In regards to claim 11, lines 24-25, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
In regards to claim 11, lines 26-27, “the suprahyoid or subhyoid muscle group” should be changed to “a suprahyoid muscle group or a subhyoid muscle group”.
In regards to claim 12, lines 2-3, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
In regards to claim 12, line 5, “acquiring” should be changed to “the acquiring”.
In regards to claim 12, line 8, “generating” should be changed to “generate”.
In regards to claim 13, lines 15-16, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
In regards to claim 13, lines 18-19, “the maximum value” should be changed to “a maximum value”.
In regards to claim 14, lines 21-22, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
In regards to claim 15, lines 27-28, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
In regards to claim 16, lines 6-7, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
In regards to claim 16, line 9, “the dose sensation” should be changed to “the good dose sensation”.
In regards to claim 17, lines 12-13, “The dose sensation evaluation device of a pharmaceutical preparation” should be changed to “The dose sensation evaluation device”.
Appropriate correction is required.
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 1-2, 6-7, 10-11, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kojima et al (US 2009/0030346).
In regards to claim 1, Kojima et al teaches a dose sensation evaluation method of a pharmaceutical preparation comprising:
attaching a part (12) of an electromyograph (15) to a human body and acquiring measurement data measured when dosing a pharmaceutical preparation using the attached electromyograph (paragraph [0012]: A myogenic potential electrometer electrode (surface electrode) 12 is affixed to an equivalency region of the mylohyoid muscle of the digastric muscle… When a thing is swallowed, the device 12 can measure how much force is applied by muscles. A muscle to measure is the suprahyoid muscle group)(paragraph [0005]: a subject swallows food including contrast media)
generating dose sensation evaluation information when dosing a pharmaceutical preparation based on the measurement data (paragraph [0020]: senses such as feeling at the throat at the time of swallowing a drink, an easiness to swallow and drinkability are important evaluation items in order to evaluate characteristics of commercial products)(paragraph [0055]: applying these measured data to the evaluation and diagnosis of the swallowing movement of the subject contributes to a diagnosis capability for swallowing of a subject, as well as evaluation and development of food and drink)
In regards to claim 2, Kojima et al teaches wherein the electromyograph is attached to either the suprahyoid or subhyoid muscle group of the human body when measuring the measurement data (paragraph [0012]).
In regards to claim 6, Kojima et al teaches determining good dose sensation when the dose sensation evaluation information satisfies a predetermined condition (paragraph [0109]: The small amount of the muscle's active amount means easiness to drink).
In regards to claim 7, Kojima et al teaches notifying a determination result of the dose sensation (paragraph [0055]).
In regards to claim 10, Kojima et al teaches a dose sensation evaluation device (Figure 1) comprising:
a processor (of personal computer 22)
a memory (of personal computer 22) configured to store a program, the program executed by the processor to cause the processor to:
attach a part (12) of an electromyograph (15) to a human body and acquire measurement data measured when dosing a pharmaceutical preparation using the attached electromyograph (paragraph [0012]: A myogenic potential electrometer electrode (surface electrode) 12 is affixed to an equivalency region of the mylohyoid muscle of the digastric muscle… When a thing is swallowed, the device 12 can measure how much force is applied by muscles. A muscle to measure is the suprahyoid muscle group)(paragraph [0005]: a subject swallows food including contrast media)
generate dose sensation evaluation information when dosing the pharmaceutical preparation based on the measurement data (paragraph [0020]: senses such as feeling at the throat at the time of swallowing a drink, an easiness to swallow and drinkability are important evaluation items in order to evaluate characteristics of commercial products)(paragraph [0055]: applying these measured data to the evaluation and diagnosis of the swallowing movement of the subject contributes to a diagnosis capability for swallowing of a subject, as well as evaluation and development of food and drink)
In regards to claim 11, Kojima et al teaches wherein the electromyograph is attached to either the suprahyoid or subhyoid muscle group of the human body when measuring the measurement data (paragraph [0012]).
In regards to claim 15, Kojima et al teaches wherein the program causes the processor to determine a good dose sensation when the dose sensation evaluation information meets a predetermined condition (paragraph [0109]: The small amount of the muscle's active amount means easiness to drink).
In regards to claim 16, Kojima et al teaches wherein the program causes the processor to notify a determination result of the dose sensation (paragraph [0055]).
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.
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kojima et al, as applied to claims 1 and 10 above, and further in view of Ghuge (US 2021/0145629).
In regards to claim 8, Kojima et al does not teach wherein the pharmaceutical preparation is one of capsules, tablets, granules, and powders, as Kojima et al teaches wherein the pharmaceutical preparation is contrast media (paragraph [0005]). Ghuge teaches a method wherein a pharmaceutical preparation is one of tablets and powders (paragraph [0009]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pharmaceutical preparation, of the method of Kojima et al, to be one of tablets and powders, as taught by Ghuge, as such are commonly known forms of pharmaceutical preparations, further including pellets and liquid, in order to provide a plurality of doses (paragraph [0009]).
In regards to claim 17, Kojima et al does not teach wherein the pharmaceutical preparation is one of capsules, tablets, granules, and powders, as Kojima et al teaches wherein the pharmaceutical preparation is contrast media (paragraph [0005]). Ghuge teaches a device wherein a pharmaceutical preparation is one of tablets and powders (paragraph [0009]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pharmaceutical preparation, of the device of Kojima et al, to be one of tablets and powders, as taught by Ghuge, as such are commonly known forms of pharmaceutical preparations, further including pellets and liquid, in order to provide a plurality of doses (paragraph [0009]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kojima et al, as applied to claim 1 above, and further in view of Pitts et al (US 9,375,568).
In regards to claim 9, Kojima et al teaches causing a computer (22) to execute the dose sensation evaluation method of a pharmaceutical preparation according to claim 1 (Figure 1); however, Kojima et al is silent about a non-transitory computer readable storage medium storing a program for causing the computer to execute the dose sensation evaluation method of a pharmaceutical preparation according to claim 1. Pitts et al teaches a non-transitory computer readable storage medium storing a program causing a computer to execute a method (column 2, lines 23-24). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Kojima et al, with a non-transitory computer readable storage medium storing a program causing the computer to execute the method, as taught by Pitts et al, as such will provide a processor of the computer the program configured for the method to be executed (column 2, lines 23-33).
Allowable Subject Matter
Claims 3-5 and 12-14 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.
In regards to claim 3, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a dose sensation evaluation method of a pharmaceutical preparation, as claimed, specifically including generating third data by adopting points from the second data, the points corresponding to the second data and exceeding an average value of a baseline plus twice a standard deviation when not dosing the pharmaceutical preparation; and generating the dose sensation evaluation information when dosing the pharmaceutical preparation based on the third data.
Kojima et al is silent about after acquiring the measurement data, performing a root-mean-square process of first data contained in the measurement data to generate second data; generating third data by adopting points from the second data, the points corresponding to the second data and exceeding an average value of a baseline plus twice a standard deviation when not dosing the pharmaceutical preparation; and generating the dose sensation evaluation information when dosing the pharmaceutical preparation based on the third data.
Fujiwara et al (JP 2021032770) teaches a dose sensation evaluation method, comprising: after acquiring measurement data, performing a root-mean-square process of first data contained in the measurement data to generate second data (The parameter calculation unit 30 analyzes the waveform data generated by the waveform data generation unit 20 and calculates parameters related to swallowing. Examples of parameters for swallowing include temporal factors, quantitative factors, and frequency factors… Examples of the quantitative factors include… the root mean square (RMS)… The root mean square (RMS) indicates the amount of muscle activity).
Fujiwara et al is silent about generating third data by adopting points from the second data, the points corresponding to the second data and exceeding an average value of a baseline plus twice a standard deviation when not dosing the pharmaceutical preparation; and generating the dose sensation evaluation information when dosing the pharmaceutical preparation based on the third data.
Thus, claim 3 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1. Claims 4-5 are objected to by virtue of being dependent upon claim 3.
In regards to claim 12, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a dose sensation evaluation device, as claimed, specifically including generating third data by adopting points from the second data, the points corresponding to the second data and exceeding an average value of a baseline plus twice a standard deviation when not dosing the pharmaceutical preparation; and generate the dose sensation evaluation information when dosing the pharmaceutical preparation based on the third data.
Kojima et al is silent about wherein the program causes the processor to after acquiring the measurement data, perform a root-mean-square process of first data contained in the measurement data to generate second data; generating third data by adopting points from the second data, the points corresponding to the second data and exceeding an average value of a baseline plus twice a standard deviation when not dosing the pharmaceutical preparation; and generate the dose sensation evaluation information when dosing the pharmaceutical preparation based on the third data.
Fujiwara et al teaches a dose sensation evaluation device (Figure 1), wherein a program causes a processor (of personal computer (PC)) to after acquiring measurement data, perform a root-mean-square process of first data contained in the measurement data to generate second data (The parameter calculation unit 30 analyzes the waveform data generated by the waveform data generation unit 20 and calculates parameters related to swallowing. Examples of parameters for swallowing include temporal factors, quantitative factors, and frequency factors… Examples of the quantitative factors include… the root mean square (RMS)… The root mean square (RMS) indicates the amount of muscle activity).
Fujiwara et al is silent about generating third data by adopting points from the second data, the points corresponding to the second data and exceeding an average value of a baseline plus twice a standard deviation when not dosing the pharmaceutical preparation; and generate the dose sensation evaluation information when dosing the pharmaceutical preparation based on the third data.
Thus, claim 12 is objected to as being dependent upon a rejected base claim 10, but would be allowable if rewritten in independent form including all of the limitations of the base claim 10. Claims 13-14 are objected to by virtue of being dependent upon claim 12.
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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