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
Applicant's election with traverse of group I comprising claims 1 – 11 in the reply filed on 5/27/2026 is acknowledged. The traversal is on the ground(s) that each of the inventions are not independent and distinct (e.g., they share the same and/or overlapping subject matter) and that there would be no serious burden placed on the examiner during examination. This is not found persuasive because, as indicated in the previous restriction requirement, the inventions are indeed independent and distinct and have been accordingly separately classified. The primary classification of claimed subject matter is merely one indication of the burdensome nature of the search requirements and a serious burden on the examiner may also be shown by appropriate explanation of the field of search (see MPEP § 803). The restriction requirement merely refers to the primary classification for the inventions, not the complete scope of the prior art search in additional art class and subclass classifications or electronic database resources, or employing different search queries, that would be required in determining patentability. Furthermore, each of the inventions are drawn to different statutory classes of invention. Clearly, since each of the inventions comprise different features (e.g., additional distinct apparatus structure and/or method steps), different searches and patentability determination issues are involved in the examination of each invention group.
Invention groups I and II are characterized as product and process of use, wherein the product can be used in a materially different process of using that product. Applicant alleges that this characterization is improper. Examiner respectfully disagrees. The term “subject” can be broadly defined and interpreted as “a person or thing,” not just a biological individual person. The term “subject” can include essentially any sample being subjected to chemical analysis. The term “metabolite” can be broadly defined and interpreted as “a substance formed in or necessary for metabolism” or a biomarker for example. Thus, the terms of art “subject” and “metabolite” are not necessarily restricted to the biological analysis of an individual person as asserted by the Applicant. Applicant is advised that the claims must be given their broadest and reasonable interpretation (see MPEP § 2111). Applicant is also advised that it is improper to import limitations from the specification during examination (see MPEP § 2111.01, part II). Applicant’s arguments are simply not commensurate in scope to the claim language. Therefore, in addition to environmental monitoring as indicated in the restriction requirement, the system of group I could potentially also be utilized in the analysis of a cell culture system, a bioreactor or fermentation reactor, in which biological cells, which can be either human, non-human animal, bacterial or plant cells, not in the form of a biological human person, are analyzed for their expressed metabolic products or metabolites.
The requirement is still deemed proper and is therefore made FINAL.
Applicant canceled non-elected claims 12 – 19.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 3, the term “configured” should be inserted prior to the term “for” to positively recite the functionality of the sample receiving area. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in line 4, the term “configured” should be inserted prior to the term “for” to positively recite the functionality of the at least one mass spectrometer. Appropriate correction is required.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the Applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 5 and 8 – 11 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Goodnough et al. (WO 01/57518 A2; hereinafter “Goodnough”).
Regarding claim 1, Goodnough teaches throughout the publication a system for non-targeted analysis of a metabolome in a sample (Abstract; page 2, lines 21 – 29; claim 1), comprising:
a sample receiving area for receiving at least one sample from a subject (e.g., samples are introduced to the Fourier Transform Mass Spectrometer (FTMS) via an autosampler; page 13, lines 1 – 5; page 12, lines 8 – 16);
at least one mass spectrometer for performing at least one mass spectrometry, operatively connected to the sample receiving area for receiving at least a portion of the at least one sample therefrom (e.g., samples are introduced to the Fourier Transform Mass Spectrometer (FTMS) via an autosampler; page 12, lines 22 – 32; page 13, lines 1 – 5);
means to further perform at least one of spectroscopy, high-throughput mass spectrometry and nuclear magnetic resonance (NMR), operatively connected to the sample receiving area for receiving at least a portion of the at least one sample therefrom (e.g., samples are introduced to the Fourier Transform Mass Spectrometer (FTMS) via an autosampler; page 13, lines 1 – 5);
wherein the at least one mass spectrometry and at least one of spectroscopy, high- throughput mass spectrometry and NMR identify a plurality of metabolites corresponding to the subject's metabolome (e.g., page 11, line 29 – page 12, line 6; page 13, lines 1 – 20); and
wherein the system is configured to output a metabolomic profile of the subject comprising all detected metabolites (e.g., page 6, line 1 – page 7, line 10; page 13, lines 1 – 20).
Regarding claim 2, Goodnough teaches the system according to claim 1, wherein the system is configured to analyze a plurality of samples (e.g., samples are introduced to the Fourier Transform Mass Spectrometer (FTMS) via an autosampler; page 13, lines 1 – 5).
Regarding claim 3, Goodnough teaches the system according to claim 2, wherein the system is configured to analyze the plurality of samples in parallel (e.g., all of the analytes or metabolites within the complex mixture are analyzed simultaneously; page 13, lines 15 – 20).
Regarding claim 4, Goodnough teaches the system according to claim 2, wherein the system is configured to analyze the plurality of samples in sequence (e.g., samples are introduced to the Fourier Transform Mass Spectrometer (FTMS) via an autosampler; page 13, lines 1 – 5).
Regarding claim 5, Goodnough teaches the system according to claim 1, wherein the at least one sample is provided on an absorbent substrate (MALDI FTMS is taught, which implicitly uses absorbent substrates in sample preparation for analysis; page 9, lines 26 – 31).
Regarding claim 8, Goodnough teaches the system according to claim 1, wherein the at least one sample comprises a urine sample (page 12, lines 8 – 16).
Regarding claim 9, Goodnough teaches the system according to claim 1, wherein the at least one sample comprises a blood sample (page 12, lines 8 – 16).
Regarding claim 10, Goodnough teaches the system according to claim 9, wherein the blood sample is a capillary blood sample (page 12, lines 8 – 16).
Regarding claim 11, Goodnough teaches the system according to claim 1, wherein the at least one sample comprises a saliva sample (implicit in page 12, lines 8 – 16: human body fluids such as blood and urine samples are taught, but also implicitly would include saliva fluid).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodnough et al. (WO 01/57518 A2; hereinafter “Goodnough”) in view of Liepold et al. (US 2014/0276217 A1; hereinafter “Liepold”).
Regarding claim 6, Goodnough does not specifically teach the system according to claim 5, further comprising mechanical separation means for mechanically separating at least a portion of the absorbent substrate. However, the use of a separation means, such as a hole punch, for mechanically separating a portion of an absorbent substrate comprising paper containing a sample for preparation for analysis is well known in the art as evidenced by Liepold (paragraphs 4, 17, 31 and 33). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide a mechanical separation means for mechanically separating at least a portion of the absorbent substrate. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Regarding claim 7, Goodnough does not specifically teach the system according to claim 1, further comprising solvent provision means for providing a solvent to extract, solubilize, dissolve, or dilute at least a portion of the at least one sample. Goodnough does teach an extraction method for samples prior to analysis (e.g., page 12, lines 8 – 21). Liepold does teach the use of on-line liquid extraction devices in preparing sample prior to analysis (paragraph 4). The combination of familiar elements is likely to be obvious when it does no more than yield predictable results (see MPEP § 2143, A.). Furthermore, the Supreme Court decision in KSR International Co. v. Teleflex Inc., 550 U.S. 82 USPQ2d 1385 (2007) has affirmed that the threshold requirement for a prima facie case of obviousness is “demonstrating that each element was, independently, known in the prior art.” Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide further comprising solvent provision means for providing a solvent to extract, solubilize, dissolve, or dilute at least a portion of the at least one sample prior to sample analysis. Examiner submits that these arguments are in line with the Supreme Court unanimous opinion, KSR International v. Teleflex, Inc., 127 S. Ct. 1727, 1741 (2007), in which the Court stated that “[a] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” Id. at 1731.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
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