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 .
Election/Restrictions
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05 August 2026.
Information Disclosure Statement
The listing of references in the specification (e.g., paragraph 0055, Scientific Working Group for Forensic Toxicology (SWGTOX) Standard Practices for Method Validation in Forensic Toxicology) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s):
Claim 1: a mass spectrometer adjacent to the DART device (emphasis added); a computer processor and a memory; and comparing a known standard mass spectrum with the sample mass spectrum.
No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
FIG. 1: element SA
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The use of the following terms, which are trade names or marks used in commerce, has been noted in this application:
Orbitrap®
IonSense®
VAPUR®
Applied Biosystems®
SCIEX®
QTRAP®
Analyst®
The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
Paragraph 0056 refers to Supplementary Table 1; there is no supplementary table included in the specification or elsewhere in the disclosure.
Paragraph 0078 refers to “the HPLC method”; HPLC is not referenced elsewhere in the disclosure, so it is unclear what is meant by “the HPLC method.”
Appropriate correction is required.
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.
Claims 9, 10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada (U.S. Patent Application Publication No. 2015/0380225 A1), hereinafter Yamada, in view of Maher et al. (U.S. Patent Application Publication No. 2025/0362316 A1), hereinafter Maher.
Regarding claim 9, Yamada discloses a platform of screening a compound, comprising:
a carrier (FIG. 1, element 12);
an ion source (FIG. 1, element 21) adjacent to the carrier (FIG. 1);
a mass spectrometer (FIG. 1, elements 22, 23) adjacent to the ion source (FIG. 1, element 21), wherein a sample in the carrier and ionized by the ion source is analyzed by the mass spectrometer to obtain a sample mass spectrum (paragraph 0045); and
a compound screening model comprising a computer processor (FIG. 1, element 31) and a memory (FIG. 1, element 32), the memory storing a plurality of computer program instructions that, when executed by the computer processor, cause the computer processor to implement following steps (paragraphs 0046-0049), comprising:
importing the sample mass spectrum (paragraph 0046, acquisition unit 31a); and
comparing a known standard mass spectrum with the sample mass spectrum (paragraph 0062), wherein when a profile of the known standard mass spectrum is the same as a profile of the sample mass spectrum (paragraph 0062, matched peaks), and the known standard mass spectrum is not exactly the same as the sample mass spectrum (paragraph 0062, unmatched peaks), the sample is determined to be the compound (paragraph 0089).
Yamada fails to disclose that the compound is a new psychoactive substance; the carrier loads at least one chromatographic paper; and the ion source is a DART device.
However, Maher discloses a platform of screening a new psychoactive substance (paragraph 0041);
a carrier (paragraphs 0033-0035 and FIG. 2(a): the carrier is the strip connecting the paper arrows 0-10) loading at least one chromatographic paper (paragraphs 0033-0035, the triangular tip of the paper arrow); and
a DART device (paragraph 0063).
The disclosure of Maher demonstrates that the functions of chromatographic paper and DART devices are known in the art of mass spectrometry. Maher also shows that substituting chromatographic paper for another sample carrier in mass spectrometry yields the predictable result of separating the analytes on the chromatographic paper (paragraph 0035), and that substituting a DART device for another ion source in mass spectrometry yields the predictable result of direct analysis of raw samples without requiring dilution or a more complex system (paragraph 0220). “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” United States v. Adams, 383 U.S. 39 (1966). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamada to include that the carrier loads at least one chromatographic paper; and the ion source is a DART device, because it is not inventive to substitute one known element for another which yields predictable results to one of ordinary skill in the art. See MPEP 2143 I (B).
Furthermore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamada to include that the compound is a new psychoactive substance, based on the teachings of Maher that the platform comprising a carrier loading at least one chromatographic paper and a DART device is beneficial for non-invasive diagnoses of overdose related to new psychoactive substances (Maher, paragraph 0041).
Regarding claim 10, Yamada in view of Maher as applied to claim 9 discloses the platform of claim 9.
In addition, Maher discloses that the at least one chromatographic paper is a plurality of chromatographic papers (FIG. 2(a)), wherein the carrier comprises a body (FIG. 2(a): the carrier body is the strip connecting the paper arrows 0-10) and a plurality of paper modules sequentially disposed on the body (paragraph 0035: the paper modules are the rectangular strips), wherein the plurality of chromatography papers are respectively disposed on the plurality of paper modules (FIG. 1 shows the triangular chromatography paper disposed on the rectangular strip).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamada in view of Maher to include that the at least one chromatographic paper is a plurality of chromatographic papers, wherein the carrier comprises a body and a plurality of paper modules sequentially disposed on the body, wherein the plurality of chromatography papers are respectively disposed on the plurality of paper modules, based on the additional teachings of Maher that this provides simpler, cheaper, and/or faster mass spectrometry analysis (Maher, paragraphs 0029 and 0067).
Regarding claim 13, Yamada in view of Maher as applied to claim 9 discloses the platform of claim 9.
In addition, Yamada discloses that the profile of the known standard mass spectrum comprises one or more than one mass to charge ratio (m/z) (paragraph 0050).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Maher as applied to claim 9 above, and further in view of Clarke et al. (U.S. Patent Application Publication No. 2015/0346183 A1), hereinafter Clarke.
Regarding claim 11, Yamada in view of Maher as applied to claim 9 discloses the platform of claim 9.
Yamada in view of Maher fails to disclose that the mass spectrometer comprises a high-resolution mass spectrometer or a low-resolution mass spectrometer, wherein the high-resolution mass spectrometer provides a mass accuracy level below 5 ppm and a mass resolution above 10,000 m/Δm; the low-resolution mass spectrometer provides a mass accuracy level above or equal to 5 ppm and a mass resolution below or equal to 10,000 m/Δm.
However, Clarke discloses that the mass spectrometer comprises a high-resolution mass spectrometer or a low-resolution mass spectrometer, wherein
the high-resolution mass spectrometer provides a mass accuracy level below 5 ppm and a mass resolution above 10,000 m/Δm (paragraph 0105);
the low-resolution mass spectrometer provides a mass accuracy level above or equal to 5 ppm and a mass resolution below or equal to 10,000 m/Δm (paragraph 0125).
When a claimed range “overlap[s] or lie[s] inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05 I; In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the case at hand, Clarke teaches a mass spectrometer with a mass accuracy level below 3 ppm and a mass resolution above 25,000, which overlaps with the claimed ranges of a mass accuracy level below 5 ppm and a mass resolution above 10,000, respectively. Clarke further teaches a mass spectrometer with a mass accuracy level of 50 ppm and a mass resolution of 10,000, which overlaps with the claimed ranges of a mass accuracy level above or equal to 5 ppm and a mass resolution below or equal to 10,000, respectively. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamada in view of Maher to meet the claimed ranges of mass accuracy levels and mass resolutions.
Regarding claim 12, Yamada in view of Maher and Clarke as applied to claim 11 discloses the platform of claim 11, including the low-resolution mass spectrometer (Clarke, paragraph 0125).
In addition, Yamada discloses that the mass spectrometer (FIG. 1, elements 22, 23) comprises a triple quadrupole linear ion trap mass spectrometer (paragraph 0044).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yamada in view of Maher as applied to claim 9 above, and further in view of Wang et al. (CN Patent No. 115963165 A) hereinafter Wang (English machine translation provided).
Regarding claim 14, Yamada in view of Maher as applied to claim 9 discloses the platform of claim 9.
Yamada in view of Maher fails to disclose that a known standard of the known standard mass spectrum comprises a known drug.
However, Wang discloses that a known standard of the known standard mass spectrum comprises a known drug (page 12, Experimental Example 7 paragraph 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamada in view of Maher to include that a known standard of the known standard mass spectrum comprises a known drug, based on the teachings of Wang that using a known drug as a known standard improves the simplicity, efficiency, and flexibility of the platform (Wang, page 4, paragraph labeled 2).
Regarding claim 15, Yamada in view of Maher and Wang as applied to claim 14 discloses the platform of claim 14.
In addition, Wang discloses that the known drug comprises ketamine (page 12, Experimental Example 7 paragraph 1).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamada in view of Maher and Wang to include that the known drug comprises ketamine, based on the additional teachings of Wang that ketamine is one of the most common drugs which may need to be detected and identified (Wang, page 2, Background paragraph 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lee et al. (U.S. Patent Application Publication No. 2020/0240964 A1), hereinafter Lee, teaches a high-resolution mass spectrometer providing a mass accuracy level below 10 ppm and a mass resolution above 10,000 m/Δm.
D’Aloia et al. (U.S. Patent Application Publication No. 2016/0047799 A1), hereinafter D’Aloia, teaches determining that a profile of a known standard mass spectrum is the same as a profile of the sample mass spectrum.
Chang et al. (U.S. Patent No. 10,041,962 B1), hereinafter Chang, teaches identifying an unknown sample using a known standard comprising methamphetamine.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALINA R KALISZEWSKI whose telephone number is (703)756-5581. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/A.K./Examiner, Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881
