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 .
Status of Claims
Claims 1-9 and 12-20 are currently pending
Claims 10-11 are currently withdrawn from consideration
Claims 3, 6, 8, 10, 12, 15, 17 and 20 are currently amended
Claims 1-9 and 12-20 are currently rejected
Information Disclosure Statement
The Information Disclosure Statement filed on 12/18/2024 is in compliance with the provisions of 37 CFR 1.97 and has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Election/Restrictions
Applicant’s election without traverse of species corresponding to claims 1-9 and 12-20 in the reply filed on 10/30/2025 is acknowledged.
Specification
Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract should be on a separate page. 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
Claim 1 is objected to because of the following informalities: Line 3 states “the sample” and instead should state “the test sample” for further clarity. FURTHERMORE, lines 6 and 8-9 each state “the two or more separated buffers or excipients” and “the separated two or more buffers or excipients.”, respectively. Examiner suggests to amend the limitations to have both written the exact same way for consistent claim language. Appropriate corrections are required.
Claim 6 is objected to because of the following informalities: Lines 3-4 state “the two or more excipients run on the same HPLC column;” and instead should state “the two or more buffers or excipients run on the HPLC column;” for further clarity and consistency. FURTHERMORE, line 7 states “converting the integrated areas” and instead should state “converting the integrated peak areas” for further clarity. Appropriate corrections are required.
Claim 9 is objected to because of the following informalities: Line 2 states “of 40 to 70 ºC, a pressure of 30 to 70 psi,” and instead should state “of 40 ºC to 70 ºC, a pressure of 30 psi to 70 psi,” for further clarity. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Line 2 states “the HPLC is” and instead should state “the HPLC column is” for further clarity. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Line 1 states “wherein mobile phase A” and instead should state “wherein the mobile phase A” for further clarity. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: Line 1 states “wherein mobile phase A” and instead should state “wherein the mobile phase A” for further clarity. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: Line 2 states “wherein mobile phase B” and instead should state “wherein the mobile phase B” for further clarity. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: Line 1 states “wherein mobile phase B” and instead should state “wherein the mobile phase B” for further clarity. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: Line 2 states “wherein performing chromatography” and instead should state “wherein performing the chromatography” for further clarity. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: Line 1 states “the equilibration step flow rate” and instead should state “the equilibration step flow” for further clarity and to maintain consistency. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: Line 1 states “the equilibration step flow rate” and instead should state “the equilibration step flow” for further clarity and to maintain consistency. Appropriate correction is required.
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 1-9 and 12-20 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.
Claim 1 recites the limitation "the HPLC column effluent” on lines 6-7. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 and 12-20 are also rejected since these claims depend on claim 1.
Claim 6 recites the limitation "a concentration or amount” on lines 7-8. It is unclear and confusing whether Applicant is trying to refer to the same ‘a concentration or an amount’ as recited on line 5 of claim 6, or a different concentration or an amount? Claim 7 is also rejected since this claim depends on claim 6.
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 1-9 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Phoebe, Jr. et al. (U.S. 2019/0092800 A1) (hereinafter “Phoebe”) in view of ANTOCHSHUK et al. (U.S. 2015/0329628 A1) (hereinafter “Anto”).
Regarding Claim 1:
Phoebe teaches a method for analytically separating two or more components in a single assay (see FIGS. 1-3) (see paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102), the method comprising:
performing chromatography on a test sample (see FIGS. 1-3) (see paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102), the test sample comprising the two or more components, on a chromatography column to separate the two or more components (see FIGS. 1-3) (see paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102);
detecting the two or more separated components in the chromatography column effluent (see FIGS. 1-3) (see paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102); and
generating a chromatogram having peaks corresponding to the separated two or more components (see FIGS. 1-3) (see paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102).
Phoebe does not explicitly teach analytically separating two or more buffers or excipients in a single assay, and performing chromatography on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as recited in independent claim 1.
Anto further teaches a similar chromatography system and method including separating two or more buffers or excipients in a single assay (see Anto paragraphs 33-36, 40, 57, 60, 105-106, 108-109, 119-121, 123, and 126-130), and performing chromatography on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 2:
The combination of Phoebe in view of Anto teaches the method according to claim 1, wherein Anto further teaches the two or more buffers or excipients are selected from the group consisting of 2-hydroxypropyl-beta-cyclodextrin, sucrose, sodium phosphate, sodium citrate, potassium phosphate, histidine, trehalose, and mannitol (see Anto paragraphs 33-36, 40, 57, 60, 105-106, 108-109, 119-121, 123, and 126-130).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 3:
The combination of Phoebe in view of Anto teaches the method according to claim 1, wherein Anto further teaches the two or more buffers or excipients are sugars or sugar-based molecules (Examiner’s note: this claim limitation is in an alternative form and therefore only one has to occur) (see Anto paragraphs 33-36, 40, 57, 60, 105-106, 108-109, 119-121, 123, and 126-130).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 4:
The combination of Phoebe in view of Anto teaches the method according to claim 3, wherein Anto further teaches the two or more buffers or excipients are sugars (see Anto paragraphs 33-36, 40, 57, 60, 105-106, 108-109, 119-121, 123, and 126-130).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 5:
The combination of Phoebe in view of Anto teaches the method according to claim 3, wherein Anto further teaches the two or more buffers or excipients are selected from the group consisting of 2-hydroxypropyl-beta-cyclodextrin, sucrose, trehalose, and mannitol (see Anto paragraphs 33-36, 40, 57, 60, 105-106, 108-109, 119-121, 123, and 126-130).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 6:
The combination of Phoebe in view of Anto teaches the method according to claim 1, wherein Anto further teaches:
obtaining standard calibration chromatographic data for the two or more excipients run on the same HPLC column (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139); and
calculating a concentration or an amount of the two or more buffers or excipients in the test sample by determining from the chromatogram integrated peak areas of the two or more buffers or excipients and converting the integrated areas to a concentration or amount based on the obtained standard calibration chromatographic data (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 7:
The combination of Phoebe in view of Anto teaches the method according to claim 6, wherein Anto further teaches the conversion includes a linear regression fit to the standard calibration chromatographic data (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 8:
The combination of Phoebe in view of Anto teaches the method according to claim 1, wherein Phoebe further teaches the two or more buffers or excipients are detected using an evaporative light scattering detector (ELSD) (see Phoebe FIGS. 1-3) (see Phoebe paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102).
Regarding Claim 9:
The combination of Phoebe in view of Anto teaches the method according to claim 8, wherein Phoebe further teaches the ELSD is set at an evaporative temperature of 40 to 70 °C, a pressure of 30 to 70 psi, a gain of 0.5 to 2, and filter set at 0.5 to 1 (see Phoebe FIGS. 1-3) (see Phoebe paragraphs 6-7, 9-10, 58, 64, 76-77, 89, 92-93 and 102).
Regarding Claim 12:
The combination of Phoebe in view of Anto teaches the method according to claim 1, wherein Anto further teaches the HPLC is run using mobile phase A and mobile phase B (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 13:
The combination of Phoebe in view of Anto teaches the method according to claim 12, wherein Anto further teaches mobile phase A is selected from the group consisting of 100% H20, formic acid in H20, and trifluoroacetic acid in H20 (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 14:
The combination of Phoebe in view of Anto teaches the method according to claim 13, wherein Anto further teaches mobile phase A is selected from the group consisting of 0.5% formic acid in H20 and 0.05% trifluoroacetic acid in H20 (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 15:
The combination of Phoebe in view of Anto teaches the method according to claim 12, wherein Anto further teaches mobile phase B comprises acetonitrile (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 16:
The combination of Phoebe in view of Anto teaches the method according to claim 15, wherein Anto further teaches mobile phase B is 100% acetonitrile (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 17:
The combination of Phoebe in view of Anto teaches the method according to claim 12, wherein Anto further teaches performing chromatography comprises an equilibration step having a flow of 100% mobile phase A through the HPLC column at a rate of 0.1 ml/minute to 1.0 ml/minute (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 18:
The combination of Phoebe in view of Anto teaches the method according to claim 17, wherein Anto further teaches the equilibration step flow rate is 0.25 ml/minute (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 19:
The combination of Phoebe in view of Anto teaches the method according to claim 17, wherein Anto further teaches the equilibration step flow rate is 0.5 ml/minute (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Regarding Claim 20:
The combination of Phoebe in view of Anto teaches the method according to claim 17, wherein Anto further teaches the equilibration step is between 0.5 minutes and 10 minutes (see Anto paragraphs 41-43, 60, 62, 64, 86, 89, 102, 131 and 138-139).
Phoebe and Anto are analogous inventions in the art of teaching a separation system and method via chromatography. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skilled in the art to modify the chromatography system and method of Phoebe to include separating buffers and excipients on a pentafluorophenyl (PFP) high performance liquid chromatography (HPLC) column, as taught by Anto, for optimization purposes and to achieve the desirable result of purifying a liquid source efficiently and effectively (see Anto paragraphs 33-36, 41-43, 57, 60, 62, 64, 86, 89, 102, 105-106, 108-109, 119-121, 123, 126-131 and 138-139).
Other References Considered
Sosic et al. (U.S. 2009/0227039 A1) (hereinafter “Sosic”) teaches a detection and quantification of cyclodextrins.
Rabausch et al. (U.S. 2019/0203240 A1) (hereinafter “Rabausch”) teaches and system and method for the production of flavonoids.
Wang (U.S. 2017/0212128 A1) (hereinafter “Wang”) teaches a system and method for mass spectrometry analysis.
Kedrowski et al. (U.S. 2014/0004214 A1) (hereinafter “Kedro”) teaches a system and method of extracting fruit seeds.
Conclusion
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/AKASH K VARMA/Primary Examiner, Art Unit 1773