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 disclosure is objected to because of the following informalities:
All instances of the word “anhydride” in the specification and abstract should read “anhydrate” where a noun is appropriate or “anhydrous” where an adjective is appropriate. See below 112(a) rejection for explanation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1, 2, 4, 5, 6 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.
Regarding claims 1, 2, 4, 5, and 6, each claim recites the presence of an “anhydride” crystal form. The embodiments of the invention in the specification and drawings use target samples which do not have anhydride forms (e.g. phloroglucinol), as “anhydride” refers to a new compound resulting from dehydrating an acid or base. Rather, (e.g.) phloroglucinol has an “anhydrate” (or “anhydrous” as an adjective) form, which is the crystal form without water. Examiner notes that this discrepancy likely results from a translation error, as the Japanese “無水物” translates both to “anhydride” and “anhydrate”. Therefore, for examination purposes, all instances of “anhydride” will be treated as “anhydrate” or “anhydrous”.
Claims 1, 2, 4, 5, 6 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.
As noted above, the compounds described in the specification on which the claimed methods were tested do not have anhydride forms. Applicant has therefore not disclosed how to perform any step relating to determining the presence of anhydrides from THz spectroscopy measurements.
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, 2, 3, 4, 5, 6, 7, 8, and 9 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.
Regarding claim 1, the use of passive voice in the fourth limitation (“determination is made that a crystal form…”) makes it unclear whether the limitation is itself an action performed as part of the method and how/when that step is performed in relation to the other steps in the method. For examination purposes, the limitation will be read as if it were recited actively (“determining that a crystal form…”).
Claims 2-9 are rejected for using passive tense to describe process limitations according to the same rationale as claim 1 above.
Regarding claim 4, the scope of the claim is unclear. Determining that a hydration or dehydration reaction occurred in the measurement target object based on the presence of two frequency characteristics having different peaks implies that the peaks correspond to an anhydrate and a hydrate, i.e. these two frequency characteristics are the same as those referred to in claim 1. However, the language of claim 4 does not clearly state this, instead referring generally to any two frequency characteristics having peaks at frequencies different from each other. For examination purposes, it is assumed that the two frequency characteristics are those introduced in claim 1, i.e. the “first frequency related to a first peak corresponding to an anhydride and a second frequency related to a second peak corresponding to a hydrate”.
Regarding claims 5 and 6, phloroglucinol does not contain an anhydride form, so the meaning of the claim is unclear. As noted above, for examination purposes, “anhydride” is interpreted to mean “anhydrate”.
Regarding claim 8, the language “the terahertz wave of a broadband wavelength having a frequency in a range of at least 2.65 THz to 2.95 THz” is oxymoronic because “broadband” implies a spectrum of wavelengths rather than a singular wave with a wavelength. For examination purposes, the language is interpreted as a broadband spectrum of terahertz waves in the stated range.
Regarding claim 9, the language “the terahertz wave of a single wavelength having at least one frequency” is unclear because a terahertz wave of a single wavelength can have precisely one frequency. For examination purposes, the language is interpreted to mean at least one terahertz wave, each with a frequency/wavelength discretely separated from the others (as opposed to the continuous broadband spectrum of claim 8).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 2, claim 1 refers to “a first frequency related to a first peak corresponding to an anhydride”, implying that in the process of claim 1 of determining the presence of a crystal form different from the anhydride and the hydrate, it was already determined from the first peak that an anhydride was contained in the measurement target object. Thus, the additional step of claim 2 is implicit in the final limitation of claim 1.
Regarding claim 3, claim 1 refers to “a second frequency related to a second peak corresponding to a hydrate”, implying that in the process of claim 1 of determining the presence of a crystal form different from the anhydride and the hydrate, it was already determined from the second peak that a hydride was contained in the measurement target object. Thus, the additional step of claim 3 is implicit in the final limitation of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Yan et al., “Terahertz signatures and quantitative analysis of glucose anhydrate and monohydrate mixture”, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy (Volume 258), doi: 10.1016/j.saa.2021.119825.
Regarding claim 1, as best understood, Yan teaches a crystal form determination method comprising:
a first process of preparing a measurement target object (Page 2, Section 2.1, second paragraph)
a second process of entering a terahertz wave with respect to the measurement target object and detecting the terahertz wave from the measurement target object (Page 2, Section 2.1, second paragraph) to acquire a plurality of detection results corresponding to a plurality of times separated from each other (Page 4, Fig. 2)
a third process of determining a type of crystal form contained in the measurement target object based on a plurality of frequency characteristics calculated from the plurality of detection results (Page 4, Section 3.2, first paragraph: “the absorption peaks at 1.82 and 1.99 THz dec[r]eased and the absorption peaks at 1.24, 1.44, and 2.08 THz increased over time due to the reduction of glucose monohydrate and augment of anhydrous glucose during the dehydration”);
a first frequency related to a first peak corresponding to an anhydride (Page 4, Section 3.2, first paragraph: any one of the absorption peaks at 1.24, 1.44, or 2.08 THz) and a second frequency related to a second peak corresponding to a hydrate (Page 4, Section 3.2, first paragraph: any one of the absorption peaks at 1.82 and 1.99 THz)
Yan does not teach that when a frequency characteristic having a third peak at a third frequency different from the first frequency and second frequency exists among the plurality of frequency characteristics, determination is made that a crystal form different from the anhydride and the hydrate is contained in the measurement target object.
However, if all peaks in the terahertz spectrum known to correspond to either to an anhydrate or hydrate were identified among the frequency characteristics and a further peak not corresponding to either an anhydrate or hydrate were identified, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose to determine the presence of a different crystal form from a finite number of identified, predictable solutions (determining the presence a different crystal form or determining the presence of noise/measurement error, with the benefit of acquiring more detailed information on the obtained spectra) with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 2, as best understood, Yan teaches in the third process, when a frequency characteristic having the first peak at the first frequency exists among the plurality of frequency characteristics, determination is made that the anhydride is contained in the measurement target object (Page 4, Section 3.2, first paragraph: “the absorption peaks at 1.24, 1.44, and 2.08 THz increased over time due to the… augment of anhydrous glucose during the dehydration”; implicitly, the presence of the anhydrate was inferred from these peaks).
Regarding claim 3, as best understood, Yan teaches in the third process, when a frequency characteristic having the second peak at the second frequency exists among the plurality of frequency characteristics, determination is made that the hydrate is contained in the measurement target object (Page 4, Section 3.2, first paragraph: “the absorption peaks at 1.82 and 1.99 THz dec[r]eased… due to the reduction of glucose monohydrate”; implicitly, the presence of the hydrate was inferred from these peaks).
Regarding claim 4, as best understood, Yan teaches in the third process, when at least two frequency characteristics having peaks at frequencies different from each other exist among the plurality of frequency characteristics, determination is made that a hydration reaction of an anhydride or a dehydration reaction of a hydrate proceeded in the measurement target object (Page 4, Section 3.2, first paragraph: “the absorption peaks at 1.82 and 1.99 THz dec[r]eased and the absorption peaks at 1.24, 1.44, and 2.08 THz increased over time due to the reduction of glucose monohydrate and augment of anhydrous glucose during the dehydration”).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yan.
Regarding claim 5, as best understood, Yan teaches a crystal form determination method comprising:
a first process of preparing a measurement target object (Page 2, Section 2.1, second paragraph);
a second process of entering a terahertz wave with respect to the measurement target object and detecting the terahertz wave from the measurement target object (Page 2, Section 2.1, second paragraph) to acquire a detection result related to the measurement target object (Page 4, Fig. 2);
a third process of determining a type of crystal form contained in the measurement target object based on a frequency characteristic calculated from the detection result (Page 4, Section 3.2, first paragraph: “the absorption peaks at 1.82 and 1.99 THz dec[r]eased and the absorption peaks at 1.24, 1.44, and 2.08 THz increased over time due to the reduction of glucose monohydrate and augment of anhydrous glucose during the dehydration”);
Yan does not teach the measurement target object containing phloroglucinol.
The measurement target object containing phloroglucinol is a simple substitution of one known element (the target sample of Yan, glucose) for another (phloroglucinol, another pharmaceutical), obtaining predictable results (terahertz spectroscopy over time performed on a sample containing phloroglucinol, with the benefit of obtaining terahertz spectral information about phloroglucinol). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yan such that the measurement target object contains phloroglucinol. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Yan does not teach in the third process, when a frequency characteristic has a peak in 2.65 THz to 2.95 THz, determination is made that a crystal form different from the anhydride and the hydrate is contained in the measurement target object.
It is well-known in the art that phloroglucinol has both a hydrous and anhydrous form, e.g. as in Braun et al., “The Complexity of Hydration of Phloroglucinol: A Comprehensive Structural and Thermodynamic Characterization”, The Journal of Physical Chemistry B (Vol 116, Issue 13), pp. 3961-3972, doi: 10.1021/jp211948q. It is well-known in the art to perform terahertz spectroscopy on crystal samples in a broad range containing the interval of 2.65 to 2.95 THz, e.g. as in Zhang et al., “Terahertz spectroscopic investigation of gallic acid and its monohydrate”, Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy (Volume 190), pp. 40-46, doi: 10.1016/j.saa.2017.09.004 (See Fig. 5a). Therefore, a person of ordinary skill in the art would easily be able to perform terahertz spectroscopy over a broad range containing 2.65 to 2.95 THz on anhydrous and hydrous samples of phloroglucinol to determine the peaks in the terahertz spectrum corresponding to hydrous and anhydrous phloroglucinol. The person would notice that neither anhydrous nor hydrous phloroglucinol contain peaks in the range of 2.65 to 2.95 THz. Then, applying the terahertz spectroscopy method of Yan, if a further peak not corresponding to either an anhydrate or hydrate were identified, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose to determine the presence of a different crystal form from a finite number of identified, predictable solutions (determine the presence a different crystal form, or determine the presence of noise/measurement error) with a reasonable expectation of success. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 6, as best understood, performing terahertz spectroscopy over a broad range covering the intervals from 1.7 to 1.9 THz and/or 3.25 to 3.45 THz is well-known in the art (e.g. as in Zhang, Fig. 5a), and doing so to the well-known substance of anhydrous phloroglucinol would reveal peaks in the terahertz spectrum in either interval. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of known elements (the target sample of Yan, glucose; and the measurement interval of Yan, 0 to 2.2 THz) for others (phloroglucinol as the target sample; and 0 to at least 3.45 THz as the measurement range), obtaining predictable results (a process of measuring phloroglucinol over a range including 1.7 to 1.9 THz and 3.25 to 3.45 THz, from which a PHOSITA would easily determine the presence of anhydrate from a peak in either range). See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 7, as best understood, performing terahertz spectroscopy over a broad range covering the interval from 3.1 to 3.25 THz is well-known in the art (e.g. as in Zhang, Fig. 5a), and doing so to the well-known substance of hydrous phloroglucinol would reveal peaks in the terahertz spectrum in the interval. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of known elements (the target sample of Yan, glucose; and the measurement interval of Yan, 0 to 2.2 THz) for others (phloroglucinol as the target sample; and 0 to at least 3.25 THz as the measurement range), obtaining predictable results (a process of measuring phloroglucinol over a range including 3.1 to 3.25 THz, from which a PHOSITA would easily determine the presence of hydrate from a peak in the range). See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 8, as best understood, Yan teaches in the second process, the terahertz wave of a broadband wavelength is entered to the measurement target object (Fig. 2: broadband terahertz spectra of the target object).
Yan does not teach the terahertz wave of a broadband wavelength having a frequency in a range of at least 2.65 THz to 2.95 THz.
Performing terahertz spectroscopy over a broad range covering the interval from 2.65 to 2.95 THz is well-known in the art (e.g. as in Zhang, Fig. 5a). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a simple substitution of a known element (the measurement interval of Yan, 0 to 2.2 THz) for another (an interval covering at least 2.65 to 2.95 THz), obtaining predictable results (a terahertz spectroscopy measurement process where waves covering at least a broadband spectrum of 2.65 to 2.95 THz are entered into the target, with the benefit of obtaining new information about the THz spectrum of phloroglucinol) See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yan in view of Ouchi et al. (WO 2010/074280 A1).
Regarding claim 9, Yan does not teach in the second process, the terahertz wave of a single wavelength having at least one frequency selected from a range of at least 2.65 THz to 2.95 THz (interpreted as at least one discrete terahertz wave selected from a range of at least 2.65 to 2.95 THz) being entered to the measurement target object.
In the same field of endeavor, Ouchi teaches the terahertz wave of a single wavelength having at least one frequency selected from a range of at least 2.65 THz to 2.95 THz being entered to the measurement target object (Last line of page 24 to full page 25: spectrometry of the target using a quantum cascade laser covering a range of 1-150 THz). This provides the benefit of being able to measure the absorption of the target object at specified frequencies, simplifying the setup of the spectrometer and data. In light of the teachings of Ouchi, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yan to use a discrete-wavelength setup for measuring the target object, using a quantum cascade laser as in Ouchi.
Conclusion
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/WILLIAM LAURENCE TAYLOR/Examiner, Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884