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 .
Response to Arguments
Applicant’s arguments filed 26 May 2026 have been fully considered. Claims 1-5 are pending. Claim 5 has been amended.
Applicant’s efforts to address the rejection under 35 U.S.C. 112(d) have been considered but are not persuasive. As written, claim 5 recites a computer program stored on a non-transitory medium, which may cause a computer to function as the data processing system in the system of claim 3. Infringement of claim 5 would occur if one had possession of a flash drive containing such a program, even if that person did not have possession of the system of claim 3. This is problematic because claim 5 is written to depend from claim 3, and if one did not infringe claim 3, one should be able to conclude that they do not infringe any claim depending from claim 3, as dependent claims are required to further limit the claims they depend from. To fix this issue, the examiner suggests writing claim 5 in independent form. See 112(d) rejection below.
Applicant’s arguments regarding the rejections under 35 U.S.C. 101 are persuasive. In particular, the examiner agrees that actual analytical data must be obtained from a liquid chromatograph in order to perform the limitations of claim 1, thus use of a liquid chromatograph is required for infringement. All 101 rejections are therefore withdrawn.
Applicant’s arguments regarding the rejections under 35 U.S.C. 103 have been considered. The examiner considers that some of the arguments were persuasive. However, new grounds of rejection have been submitted. See 103 rejections below.
Claim Rejections - 35 USC § 112
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 1-5 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.
Claims 1 and 3 recite “a first chromatogram data” and “a second chromatogram data” then later refer to “the first chromatogram” and “the second chromatogram”. These later references have no antecedent basis, and from context it appears to the examiner that these later references intend to refer to the first and second chromatogram data, respectively. This will be the interpretation used for examination purposes.
Claims 2 and 4-5 depend from claims 1 and 3, respectively, therefore they inherit the same issues and are rejected for the same reasons.
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.
Claim 5 is 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.
Claim 5 recites a computer program stored on a non-transitory medium, which may cause a computer to function as the data processing system in the system of claim 3. Infringement of claim 5 would occur if one had possession of a flash drive containing such a program, even if that person did not have possession of the system of claim 3. This is problematic because claim 5 is written to depend from claim 3, and if one did not infringe claim 3, one should be able to conclude that they do not infringe any claim depending from claim 3, as dependent claims are required to further limit the claims they depend from. To fix this issue, the examiner suggests writing claim 5 in independent form.
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.
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 1, 3, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Ortmann (DE 102020114618 A1; the following references to Ortmann refer to the English translation submitted along with this document) in view of Cui (“An improved independent component analysis model for 3D chromatogram separation and its solution by multi-areas genetic algorithm”).
Regarding claim 1, Ortmann discloses a data processing method for creating a simulation data of a chromatogram (¶31: a user can input a selection parameter into an input device, which enables them to modify a results diagram; ¶19: a result diagram refers to a chromatogram; ¶32: the input device can include a GUI. A user can provide input in an intuitive way to investigate and visually capture the interplay of selected parameters and their influence on an expected actual result of a sample separation. ¶13: the sample separation device can be a liquid chromatogram. ¶19: selection parameters refer to chromatographic separation results desired by a user), the data processing method comprising:
a data extracting step of extracting a first chromatogram data of a first component and a second chromatogram data of a second component (the subsequent steps require that an action be taken on chromatogram data of one or more components, implying a data extraction step; as seen in ¶31 below, there can be two or more components);
a parameter determining step of determining, based on a user input, concentration values of the first and second components and separation degree of a first peak of the first component and a second peak of the second component (¶31: “the input device can be designed to allow the user to vary at least one selection parameter for setting a shape and/or a position and/or a mutual distance of peaks”; varying peak shape would vary concentration; also, since Ortmann’s method can be applied to multiple peaks, one is free to define two of the multiple peaks as the first and second component);
a data adjusting step of adjusting peak areas of the first peak in the first chromatogram data and the second peak in the second chromatogram data based on the first and second concentration values to obtain adjusted peak areas of the first and second peaks, and peak positions of the first peak in the first chromatogram data and the second peak in the second chromatogram data based on the separation degree to obtain adjusted peak positions of the first and second peaks (¶32: “a user only needs to move one or more sliders (for example, within predefined value ranges) to obtain a preview of the expected actual result…it is also possible, for example, to enter discrete numerical values to specify selection parameters”. The preview would be an expected chromatogram with the user-defined selection parameters; from this it follows that the peak areas and peak positions would actually be adjusted by acting on the chromatogram data according to the user-defined concentration and peak separation values);
a creating step of creating the simulation data of the chromatogram for the sample using the adjusted peak areas of the first and second peaks and the adjusted peak positions of the first and second peaks (see ¶32 above; the expected actual result is given, which means that the simulated chromatogram was created); and
a displaying step of displaying the created simulation data on a display (see above; also from ¶32: “Adjustment using software controllers offers a particularly intuitive and user-friendly way to investigate and visually capture the interplay of selected parameters and their influence on the expected actual result”).
Ortmann does not explicitly disclose that the simulation is for a sample containing a first component and a second component; or a data obtaining step of obtaining, from a liquid chromatograph, a first analytical data of the first component and a second analytical data of the second component, or a third analytical data of a sample including the first and second components; or extracting the first and second chromatogram data from the first and second analytical data or from the third analytical data.
The above is met by acquiring a multi-component chromatogram from a liquid chromatograph, taking in some manner data of two components (the data itself would be analytical data since a chromatograph performs analysis of samples), and extracting in some manner chromatogram data for the first and second components.
Ortmann teaches that one use of its invention is to acquire a chromatogram and modify properties of one or more peaks to focus on information of interest in the chromatogram (¶31: “In a pharmaceutical application, for example, a user may only be interested in exactly one of several peaks relating to a pharmaceutical active ingredient, or only in a ratio of two peaks out of a large number of peaks. By allowing a user to modify the shape, position and/or distance of peaks in a results diagram and analyze their interplay, the user can focus the result display on the specific sub-information of interest to the user. By mapping, it can then be determined how this user-defined partial information of interest, i.e., a corresponding user-defined target result, can be achieved.”). As previously referenced, Ortmann also teaches that its sample separation device may be a liquid chromatogram (¶13).
Therefore, it would have been obvious to one of ordinary skill in the art practicing the invention of Ortmann to cause the simulation to be for a sample containing a first component and a second component; and to include a data obtaining step of obtaining, from a liquid chromatograph, a first analytical data of the first component and a second analytical data of the second component, or a third analytical data of a sample including the first and second components; and to include a step of extracting the first and second chromatogram data from the first and second analytical data or from the third analytical data. Doing so would enable one to simulate modifications to a previously obtained chromatogram in order to learn how to set up a chromatograph to produce a desired configuration. An example of this would be if a user wishes to analyze two peaks out of a large number of peaks relating to a pharmaceutical active ingredient.
In light of the above, Ortmann does not teach that the simulation is for a three-dimensional chromatogram.
Cui teaches simulating a 3D chromatogram (Fig. 5 takes chromatographic and spectral data for compounds and simulates a 3D chromatogram. See also the paragraph under "Simulations and discussion" on page 6: "As illustrated in Figure 5, five compounds' chromatogram peaks…are constructed in the simulation dataset."). Cui teaches that a 3D chromatogram provides more information by displaying chromatographic intensity over multiple wavelengths (Background, page 1: 2D chromatography "is chosen from only one specific wavelength which misses much information from other wavelength[s]").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Cui with the invention of Ortmann by causing the simulation to be for a three-dimensional chromatogram, and thus to include:
extracting a first spectrum data of the first component and a second spectrum data of the second component from the first and second analytical data or from the third analytical data in the data-extracting step; and
creating the simulation data of the three-dimensional chromatogram using the first and second spectrum data. Doing so would extend Ortmann’s invention to the existing field of 3D chromatogram simulation, which provides more information than 2D chromatograms by displaying chromatographic intensity over multiple wavelengths.
Regarding claim 3, claim 3 recites a system including a liquid chromatograph and a data processing system encompassed by a general-purpose computer, which together implements the method of claim 1. Since Ortmann in view of Cui teaches use of a liquid chromatograph and general-purpose computer (see rejection of claim 1 and interface device 100 and sample separation device 10 in Fig. 1 of Ortmann), the limitations of claim 3 are rejected for the same reasons as given in the rejection of claim 1.
Regarding claim 5, claim 5 is rejected for the same reasons as claim 3 (also see ¶12 of Ortmann: “Exemplary embodiments of the present invention can be implemented…by means of a computer program”).
Claims 2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Ortmann (DE 102020114618 A1) in view of Cui (“An improved independent component analysis model for 3D chromatogram separation and its solution by multi-areas genetic algorithm”), and further in view of Pogue (US 20080071164 A1).
Regarding claims 2 and 4, Ortmann in view of Cui teaches the limitations of claims 1 and 3, respectively, but does not explicitly teach the limitations of claim 2 and 4.
Pogue teaches adding noise to simulated data to replicate experimental conditions (¶45: “Noise…was added to simulated data to better replicate experimental conditions.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to incorporate the teachings of Pogue with the invention of Ortmann in view of Cui by imparting predetermined noise to the first and second chromatogram data and/or the first and second spectrum data in the data adjusting step. Doing so would make the simulation more realistic.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ETHAN WESLEY EDWARDS whose telephone number is (571)272-0266. The examiner can normally be reached Monday - Friday, 7:30am-5pm.
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ETHAN WESLEY EDWARDS
Examiner
Art Unit 2857
/E.W.E./ Examiner, Art Unit 2857
/ANDREW SCHECHTER/ Supervisory Patent Examiner, Art Unit 2857
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