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 without traverse of Group II, claims 1-9 and 13, and opaque/non-transparent column of Species I and UV absorption detector of Species II in the reply filed on 17 February 2026 is acknowledged. Claims 10-12 are withdrawn from consideration as being directed to non-elected Group I. New dependent claims 16-19 are withdrawn from consideration due to the recited “flow cell detector” which is directed to non-elected Group I. Claims 10-12 are withdrawn from consideration.
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 recited “first column, ” “at least one additional column” (note, “at least one” encompasses more than one column which is not depicted in the instant drawings as well), “module input port,” “module output port,” “first electrical port,” “second electrical port,” “LC input port” and “LC output port” must be shown with associated reference numbers or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Recited limitations of “a first column” and “at least one additional column.” In addition, the recited claim limitations of: “module input port,” “module output port,” “first electrical port,” “second electrical port,” “LC input port” and “LC output port” must include reference numbers within the specification.
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 13-19 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. Instant independent claims 1, 4, 7 and 13 all recite the limitation “first column” and instant dependent claims 3, 6, 9 and 15 all recite the limitation “at least one additional column.” The instant filed specification fails to employ the limitation “first column” or “at least one additional column,” thus it is unclear as to which column is specifically being recited in the instant claims, rendering the claims indefinite. In addition, the claim limitations of “at least one additional column” includes more than one “additional column,” and it is unclear, based on the instant disclosure, where a second, third or more “additional columns” are employed in regards to the claimed invention, and their connections to other recited elements, rendering the claims indefinite. All other pending claims are similarly rejected due to their dependency from the rejected claims.
Instant independent claims 1, 7 and 13 recite a module that comprises: “at least one detector.” The instant filed specification states in para 0034: “the detector 74 is a UV absorption flow cell detector. It is too large to fit inside the module 40, and is therefore disposed outside the module (emphasis added)” In view of Applicant’s election of a UV absorption detector species, and specifically recited in instant dependent claims 2, 5 and 8, it is unclear how the elected UV absorption detector can be recited within the module, since it is too large to fit inside the module. The instant filed specification fails to provide any details and/or guidance in regards to a UV absorption detector being modified to fit within the module, rendering the claims indefinite. All dependent claims from these independent claims are similarly rejected due to their dependency.
Claim 4 recites the limitation "the output port" in line 6. There is insufficient antecedent basis for this limitation in the claim. It appears, but it is unclear, the recited “output port” is the previously recited “LC output port.” Claims 8 and 9 are similarly rejected due to their dependency.
Claim 7 recites the limitation "the output port" in line 6. There is insufficient antecedent basis for this limitation in the claim. It appears, but it is unclear, the recited “output port” is the previously recited “LC output port.” Claims 5 and 6 are similarly rejected due to their dependency.
Claim 7 recites the limitation "the module output port" in line 14-15. There is insufficient antecedent basis for this limitation in the claim. Claims 5 and 6 are similarly rejected due to their dependency.
Instant independent claim 4 recites an LC device that comprises: “at least one detector coupled to the LC input port” and subsequently recites: “wherein the results of separating, identifying and quantifying of substances are transmitted from the module to a computing device using the first and the second electrical ports.” The instant disclosure indicates the “LC device” has reference number “38.” As such, it is unclear how the recited “module,” which does not include the “at least one detector,” is capable of determining any “results of separating, identifying and quantifying of substances” to be “transmitted” from the recited “module,” rendering the claim indefinite. All dependent claims from independent claim 4 are similarly rejected due to their dependency.
In additional regards to instant dependent claims 3, 6, 9 and 15, the phrase "may be" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
As best understood, claim(s) 1-3 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0265215 to Xie et al., U.S. 2019/0383777 to Inoue and U.S. 2002/0155033 to Strand et al. Xie et al. disclose a liquid chromatography (LC) system (see entire reference), including an LC device (38) including: a pump, a solvent and a sample (see paras 0029-0030); an injector (14) for delivering the sample in the solvent (see para 0057); a connection dock (80) (see Figs 6-8 and paras 0038-0059) for providing an LC output port (48) to enable the injector to deliver the sample in the solvent to the output port (see paras 0040-0063) and a first electrical port (see para 0057); and a separate module (40) that is attached to the LC device (see Fig. 3), the module including: a module input port (46) for forming a high pressure compression connection to the output port and receiving the sample in the solvent; a second electrical port (44) that is coupled to the first electrical port; a first column (50) coupled at a first end to the module input port (see para 0037) for receiving the sample in the solvent, a heating unit (see paras 0029, 0054 and 0071); at least one detector (52) being a UV absorption detector (see para 0067) (as recited in instant dependent claim 2) for performing detection/identification of substances in the sample in the solvent based on how the sample interacts with sorbent material in the column (see para 0002 and claim 11), wherein the first column and detector perform separating, identifying and quantifying of substances (see paras 0029 and 0058); wherein the results of separating, identifying and quantifying of substances are transmitted from the module to the LC device which inherently includes a computing device to process the signals using the first and second electrical ports (as recited in instant independent claim 1) and wherein the column is further comprised of at least one additional column coupled to the first column (see para 0053) (as partially recited in instant dependent claim 3).
Xie et al. do not explicitly disclose the first column and the at least one additional column is opaque or transparent (as recited in instant independent claim 1 and instant dependent claim 3), or that the heating unit includes a column oven disposed around the heating unit and at least a portion of the column (as recited in instant independent claim 1). Inoue discloses a liquid chromatography system (see entire reference) having a heating unit/heater disposed in a column oven (5) surrounding at least a portion of two columns (53, 54) (see paras 0022, i.e. a first column and at least one additional column). It would have been obvious to employ a column oven disposed around the heater unit surrounding the first column disclosed by Xie et al., as taught by Inoue, since it is known to one having ordinary skill in the art as of the effective filing date that column ovens maintain stable thermal conditions within columns, commonly employing circulating heated air to control the temperature of the column during separation within the column. In addition, the instant disclosure fails to disclose any criticality in employing a column oven, that the column oven employed in the instant invention solves any particular engineering design problem or purpose, and as such, it would have been obvious to one having ordinary skill in the art as of the effective filing date to employ a column oven with heating unit disclosed by Xie et al., or any other type of column temperature control means to control the column temperature, meeting the limitations regarding a column oven recited in instant independent claim 1.
As to the remaining limitations of the first column and at least one additional column are opaque or transparent recited in instant independent claim 1 and instant dependent claim 3, Strand et al. disclose a liquid chromatography system (see entire reference) employing a cartridge/module (see Figs. 1 and 2 and associated text in Strand et al.), wherein the column/separation conduit (20) is opaque, since stainless steel is inherently opaque, and may be made of other materials, such as fused silica (which is a highly transparent material), or polymeric compositions (see para 0004). It would have been obvious to one having ordinary skill in the art as of the effective filing date to employ an opaque material for the first column and the at least one additional column, such as stainless steel, modifying the liquid chromatography system disclosed by Xie et al., as taught by Strand et al., thus the columns being able to withstand high pressures, and maintaining original efficiency of the columns (see para 0003). In addition, the instant disclosure fails to disclose any criticality in employing an opaque or transparent material for the first column and at least one additional column, or that the columns being opaque employed in the instant invention solves any particular engineering design problem or purpose, and as such, it would have been obvious to one having ordinary skill in the art as of the effective filing date to employ an opaque or transparent material forming the columns by Xie et al., or any other type of suitable material capable of withstanding the high pressures within a liquid chromatography system. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to employ an opaque or transparent material forming the columns disclosed by Xie et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). In the instant case, a material that can withstand high pressures within a liquid chromatography system. As such, all the limitations regarding the recited columns, and all the limitations of claims 1-3 have been met.
As to claims 13-15, a method of performing liquid chromatography for separating, identifying and quantifying substances in a sample, the system disclosed by Xie et al., Inoue and Strand et al. is capable of performing all of the recited method steps recited in instant claims 13-15.
As best understood, claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0265215 to Xie et al., U.S. 2019/0383777 to Inoue and U.S. 2002/0155033 to Strand et al. Xie et al. disclose a liquid chromatography (LC) system (see entire reference), including an LC device (38) including: a pump, a solvent and a sample (see paras 0029-0030); an injector (14) for delivering the sample in the solvent (see para 0057); a connection dock (80) (see paras 0038-0059) for providing an LC output port (48) to enable the injector to deliver the sample in the solvent to the output port (see paras 0040-0063); an LC input port (see Fig. 13 embodiment, and para 0073), and a first electrical port (see para 0057); at least one detector (112) coupled to the LC input port for receiving the sample in the solvent and for performing detection of substances in the sample in the solvent; and a separate module (114) that is attached to the LC device, the module including: a module input port (46) for forming a high pressure compression connection to the LC output port and receiving the sample in the solvent; a second electrical port (44) that is coupled to the first electrical port; a first column (50) coupled at a first end to the module input port (see para 0037) for forming a high pressure compression connection to the LC output port for receiving the sample in the solvent and wherein the first column is coupled at a second end to the module output port (see Fig. 13 embodiment), a heating unit (see paras 0029, 0054 and 0071); the at least one detector (52) being a UV absorption detector (see para 0067) (as recited in instant dependent claim 5) for performing detection of substances in the sample in the solvent, wherein the first column and detector perform separating, identifying and quantifying of substances (see paras 0029 and 0058); wherein the results of separating, identifying and quantifying of substances are transmitted from the module to the LC device which inherently includes a computing device to process the signals using the first and second electrical ports (as recited in instant independent claim 4) and wherein the column is further comprised of at least one additional column coupled to the first column (see para 0053) (as partially recited in instant dependent claim 6).
Xie et al. do not explicitly disclose the first column and the at least one additional column is opaque or transparent (as recited in instant independent claim 4 and instant dependent claim 6), or that the heating unit includes a column oven disposed around the heating unit and at least a portion of the column (as recited in instant independent claim 4). Inoue discloses a liquid chromatography system (see entire reference) having a heating unit/heater disposed in a column oven (5) surrounding at least a portion of two columns (53, 54) (see paras 0022, i.e. a first column and at least one additional column). It would have been obvious to employ a column oven disposed around the heater unit surrounding the first column disclosed by Xie et al., as taught by Inoue, since it is known to one having ordinary skill in the art as of the effective filing date that column ovens maintain stable thermal conditions within columns, commonly employing circulating heated air to control the temperature of the column during separation within the column. In addition, the instant disclosure fails to disclose any criticality in employing a column oven, that the column oven employed in the instant invention solves any particular engineering design problem or purpose, and as such, it would have been obvious to one having ordinary skill in the art as of the effective filing date to employ a column oven with heating unit disclosed by Xie et al., or any other type of column temperature control means to control the column temperature, meeting the limitations regarding a column oven recited in instant independent claim 4.
As to the remaining limitations of the first column and at least one additional column are opaque or transparent recited in instant independent claim 4 and instant dependent claim 6, Strand et al. disclose a liquid chromatography system (see entire reference) employing a cartridge/module (see Figs. 1 and 2 and associated text in Strand et al.), wherein the column/separation conduit (20) is opaque, since stainless steel is inherently opaque, and may be made of other materials, such as fused silica (which is a highly transparent material), or polymeric compositions (see para 0004). It would have been obvious to one having ordinary skill in the art as of the effective filing date to employ an opaque material for the first column and the at least one additional column, such as stainless steel, modifying the liquid chromatography system disclosed by Xie et al., as taught by Strand et al., thus the columns being able to withstand high pressures, and maintaining original efficiency of the columns (see para 0003). In addition, the instant disclosure fails to disclose any criticality in employing an opaque or transparent material for the first column and at least one additional column, or that the columns being opaque employed in the instant invention solves any particular engineering design problem or purpose, and as such, it would have been obvious to one having ordinary skill in the art as of the effective filing date to employ an opaque or transparent material forming the columns by Xie et al., or any other type of suitable material capable of withstanding the high pressures within a liquid chromatography system. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to employ an opaque or transparent material forming the columns disclosed by Xie et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). In the instant case, a material that can withstand high pressures within a liquid chromatography system. As such, all the limitations regarding the recited columns, and all the limitations of claims 4-6 have been met.
As best understood, claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2019/0265215 to Xie et al., U.S. 2019/0383777 to Inoue and U.S. 2002/0155033 to Strand et al. Xie et al. disclose a liquid chromatography (LC) system (see entire reference), including an LC device (38) including: a pump, a solvent and a sample (see paras 0029-0030); an injector (14) for delivering the sample in the solvent (see para 0057); a connection dock (80) (see paras 0038-0059) for providing an LC output port (see Fig. 14 embodiment) to enable the injector to deliver the sample in the solvent to the output port (see paras 0040-0063); an LC input port (see Fig. 14 embodiment, and para 0073), and a first electrical port (see para 0057); a separate module (114) that is attached to the LC device, the module including: a module input port (46) for forming a high pressure compression connection to the LC output port and receiving the sample in the solvent; a second electrical port (44) that is coupled to the first electrical port; a first column (50) coupled at a first end to the module input port (see para 0037) for receiving the sample in the solvent, wherein the first column is coupled at a second end to the module output (see Fig. 14 embodiment); a heating unit (see paras 0029, 0054 and 0071); at least one detector (52) being a UV absorption detector (see para 0067) (as recited in instant dependent claim 8) coupled to the module output port for receiving the sample in the solvent, for performing detection of substances in the sample in the solvent, wherein the first column and detector perform separating, identifying and quantifying of substances (see paras 0029 and 0058); wherein the results of separating, identifying and quantifying of substances are transmitted from the module to the LC device which inherently includes a computing device to process the signals using the first and second electrical ports (as recited in instant independent claim 7) and wherein the column is further comprised of at least one additional column coupled to the first column (see para 0053) (as partially recited in instant dependent claim 9).
Xie et al. do not explicitly disclose the first column and the at least one additional column is opaque or transparent (as recited in instant independent claim 7 and instant dependent claim 9), or that the heating unit includes a column oven disposed around the heating unit and at least a portion of the column (as recited in instant independent claim 7). Inoue discloses a liquid chromatography system (see entire reference) having a heating unit/heater disposed in a column oven (5) surrounding at least a portion of two columns (53, 54) (see paras 0022, i.e. a first column and at least one additional column). It would have been obvious to employ a column oven disposed around the heater unit surrounding the first column disclosed by Xie et al., as taught by Inoue, since it is known to one having ordinary skill in the art as of the effective filing date that column ovens maintain stable thermal conditions within columns, commonly employing circulating heated air to control the temperature of the column during separation within the column. In addition, the instant disclosure fails to disclose any criticality in employing a column oven, that the column oven employed in the instant invention solves any particular engineering design problem or purpose, and as such, it would have been obvious to one having ordinary skill in the art as of the effective filing date to employ a column oven with heating unit disclosed by Xie et al., or any other type of column temperature control means to control the column temperature, meeting the limitations regarding a column oven recited in instant independent claim 7.
As to the remaining limitations of the first column and at least one additional column are opaque or transparent recited in instant independent claim 7 and instant dependent claim 9, Strand et al. disclose a liquid chromatography system (see entire reference) employing a cartridge/module (see Figs. 1 and 2 and associated text in Strand et al.), wherein the column/separation conduit (20) is opaque, since stainless steel is inherently opaque, and may be made of other materials, such as fused silica (which is a highly transparent material), or polymeric compositions (see para 0004). It would have been obvious to one having ordinary skill in the art as of the effective filing date to employ an opaque material for the first column and the at least one additional column, such as stainless steel, modifying the liquid chromatography system disclosed by Xie et al., as taught by Strand et al., thus the columns being able to withstand high pressures, and maintaining original efficiency of the columns (see para 0003). In addition, the instant disclosure fails to disclose any criticality in employing an opaque or transparent material for the first column and at least one additional column, or that the columns being opaque employed in the instant invention solves any particular engineering design problem or purpose, and as such, it would have been obvious to one having ordinary skill in the art as of the effective filing date to employ an opaque or transparent material forming the columns by Xie et al., or any other type of suitable material capable of withstanding the high pressures within a liquid chromatography system. In addition, it would have been obvious to one having ordinary skill in the art at the time the invention was made to employ an opaque or transparent material forming the columns disclosed by Xie et al., since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). In the instant case, a material that can withstand high pressures within a liquid chromatography system. As such, all the limitations regarding the recited columns, and all the limitations of claims 7-9 have been met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant is invited to review PTO form 892 accompanying this Office Action listing Prior Art relevant to the instant invention cited by the Examiner.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Primary Examiner John Fitzgerald whose telephone number is (571) 272-2843. The examiner can normally be reached on Monday-Friday from 7:00 AM to 3:30 PM E.S.T. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor John Breene, can be reached at telephone number (571) 272-4107. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. The central fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN FITZGERALD/Primary Examiner, Art Unit 2855