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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Response to Amendment
The Amendment filed on 12/23/2025 has been entered. Claims 1-12 and 15-20 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(a) and 112(b) rejection previously set forth in the final Office Action mailed 10/23/2025.
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 4-6, 8, 11, 17, 19 and 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 4 recites “a hose” and claim 1 already recites “a hose” and therefore, claim 4 is unclear if the hose is the same or different from the hose recited in claim 1. Claim 20 is rejected by virtue of their dependence on a rejected base claim.
Claim 5 recites “a locating column” and claim 1 already recites “a locating column” and therefore, claim 5 is unclear if the locating column is the same or different from the locating column recited in claim 1.
Claim 6 recites “a stepper motor” and claim 1 already recites “a stepper motor” and therefore, claim 4 is unclear if the stepper motor is the same or different from the stepper motor recited in claim 1.
Claim 8 recites “a two-way solenoid valve” and claim 1 already recites “a two-way solenoid valve” and therefore, claim 4 is unclear if the two-way solenoid valve is the same or different from the two-way solenoid valve recited in claim 1.
Claim 11 recites “a peristaltic pump” and claim 1 already recites “a peristaltic pump” and therefore, claim 4 is unclear if the peristaltic pump is the same or different from the peristaltic pump recited in claim 1.
Claim 17 recites “a hose” and claim 1 already recites “a hose” and therefore, claim 17 is unclear if the hose is the same or different from the hose recited in claim 1.
Claim 19 recites “a locating column” and claim 1 already recites “a locating column” and therefore, claim 19 is unclear if the locating column is the same or different from the locating column recited in claim 1.
Claim 20 recites “a locating column” and claim 1 already recites “a locating column” and therefore, claim 20 is unclear if the locating column is the same or different from the locating column recited in claim 1.
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 4 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 4 recites that the connecting pipeline is a hose and claim 1 already specified that the connecting pipeline is a hose. 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 6 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 4 recites that the second drive unit is a stepper motor and claim 1 already specified that the second drive unit is a stepper motor. 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 11 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 11 recites that the first drive unit is a peristaltic pump and claim 1 already specified that the first drive unit is a peristaltic pump. 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 12 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 12 recites that the second drive unit is a motor and claim 1 already specified that the second drive unit a stepper motor and as a motor is broader than a stepper motor, claim 12 has broadened the scope of claim 1. 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 17 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 4 recites that the connecting pipeline is a hose and claim 1 already specified that the connecting pipeline is a hose. 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
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) 1, 3-12, 15-17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 205333386, hereinafter Lai in view of United States Application Publication No. 2013/0313197, hereinafter Ritchie, United States Application Publication No. 2019/0270086, hereinafter Harding and United States Patent No. 5,141,871, hereinafter Kureshy with or without United States Application Publication No. 2007/0056910, hereinafter Ramaprasad.
Regarding claim 1, Lai teaches a fully-automatic protein purification system device (figure 1), comprising a chromatography unit (item 7), a first drive unit (item 6), a first container (one of item 1), a second container (another of item 1), a first valve (one of item 3), a second valve (another of item 3), and a control unit (item 2); the first container (one of item 1) is connected to an upper part of the chromatography unit with a first pipeline through the first valve (figure 1), and the second container (another of item 1) is connected to the upper part of the chromatography unit with a second pipeline through the second valve (figure 1); each of the first valve and second valve is a two-way solenoid valve (page 3, second paragraph from the bottom) and is opened, by a circuit board control system (the circuit board control system is not positively recited (MPEP § 2115)), only after being powered up (intended use MPEP § 2114 (II)), and at any time only one of the first valve and second valve is opened by the circuit board control system (intended use MPEP § 2114 (II)), the first drive unit is a peristaltic pump (page 3, third paragraph from the bottom) that drives a solution in the first container to flow through the chromatography unit (figure 1).
Lai fails to teach a connecting pipeline, wherein the connecting pipeline has a first end connected to an outlet of the chromatography unit and a second end connected to a container and a liquid flowing out is collected in the second container located below the connecting pipeline through the connecting pipeline.
Ritchie teaches a chromatography device in which the eluate is recycles back to the inlet of the same column so that components of a sample which has not been adequately separated can be fed into the column again and subjected to further chromatography to further separate the components (Ritchie, paragraph [0125]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a connecting pipeline connected to the outlet end of the chromatography unit and a container because it would allow the outlet to be subjected to further chromatography to further separate the components (Ritchie, paragraph [0125]).
Lai and Ritchie fail to teach a locating unit which comprises a locating column configured to rotate 360 degrees, a second drive unit, wherein the connecting pipeline has a second end connected to the locating unit; wherein the locating unit causes the connecting pipeline to rotate, the second drive unit drives the locating unit and the connecting pipeline rotates with the locating unit, such that an outlet of the connecting pipeline is located above the second container. The examiner is interpreting the locating unit as being a shaft which rotates to put the connecting pipeline in the position above each of the containers.
Harding teaches a sample preparation system which has a locating unit (Harding, item 5), a second drive unit (Harding, item 4), wherein the connecting pipeline has a second end connected to the locating unit the second drive unit drives the locating unit (Harding, figure 2) and the connecting pipeline rotates with the locating unit (Harding, figure 2), such that an outlet of the connecting pipeline is located above the second container (Harding, figure 2) which allows for the outlet to be positioned above a selected container (Harding, paragraph [0030]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a locating unit, a second drive unit with the connecting pipeline connected to the locating unit and the second drive unit drive the locating unit because it would allow for the outlet to be positioned above a selected container (Harding, paragraph [0030]).
Lai teaches all of the connections used are rubber hoses (page 2, paragraph 6) and therefore the connecting pipeline would be made from a rubber hose.
Lai, Ritchie and Harding are silent with regards to specific second drive unit, therefore, it would have been necessary and thus obvious to look to the prior art for conventional drive units. Kureshy provides this conventional teaching showing that it is known in the art to use a stepper motor (Kureshy, column 2, lines 23-25). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the second drive unit from a stepper motor motivated by the expectation of successfully practicing the invention of Kureshy. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the second drive unit from a stepper motor because it can provide positional accuracy for a pipette (Kureshy, column 2, lines 23-25).
If it is determined that Lai fails to teach the two-way solenoid valves of the first and second valve are not opened only after being powered up, then Lai, Ritchie, Harding and Kureshy fail to teach this limitation.
Ramaprasad provides a conventional teaching that it is known in the art to use a chromatography system which utilizes normally closed solenoid valves which are opened and closed in a sequential and systematic manner (Ramaprasad, paragraph [0058]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the two-way solenoid valves from normally closed solenoid valves motivated by the expectation of successfully practicing the invention of Ramaprasad. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the first and second solenoid valves from normally closed solenoid valves because it would allow the valves to be opened and closed in a sequential and systematic manner (Ramaprasad, paragraph [0058]).
Regarding claim 3, Lai teaches wherein the chromatography unit is a chromatography column (item 7).
Regarding claim 4, Lai teaches all of the connections used are rubber hoses (page 2, paragraph 6) and therefore the connecting pipeline would be made from a rubber hose.
Regarding claim 5, Lai teaches wherein the locating unit is a locating column (see supra); and the locating unit is configured to rotate 360° (see supra).
Regarding claim 6, Lai, Ritchie and Harding are silent with regards to specific second drive unit, therefore, it would have been necessary and thus obvious to look to the prior art for conventional drive units. Kureshy provides this conventional teaching showing that it is known in the art to use a stepper motor (Kureshy, column 2, lines 23-25). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the second drive unit from a stepper motor motivated by the expectation of successfully practicing the invention of Kureshy. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the second drive unit from a stepper motor because it can provide positional accuracy for a pipette (Kureshy, column 2, lines 23-25).
Regarding claim 7, Lai teaches further comprising: a third container, a fourth container, a fifth container and a sixth container (items 1 and 8).
Regarding claim 8, Lai teaches further comprising: a third container, a fourth container, a fifth container (items 1), a third valve, a fourth valve and a fifth valve (items 3), wherein the third container, the fourth container, and the fifth container are connected to the upper part of the chromatography unit with third pipelines through the third valve, the fourth valve and the fifth valve, respectively (figure 1); the third valve is a third two-way valve; the fourth valve is a fourth two-way valve; the fifth valve is a fifth two-way valve (figure 1); and each of the first two-way valve, the second two-way valve, the third two-way valve, the fourth two-way valve, and the fifth two-way valve is a two-way solenoid valve (page 3, second paragraph from the bottom).
Lai, Ritchie and Harding disclose the claimed invention except for a sixth container and sixth valve connected in the same way as the other containers and valves. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a sixth container and sixth valve, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04(VI)(B). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a sixth container and sixth valve because it would allow for additional functional solutions to be utilized (page 2, paragraph 13).
Regarding claim 9, Lai teaches wherein the first valve and the second valve are normally-closed valves and are opened only after being powered up (intended use MPEP § 2114 (II) and is taught in figure 1); and, at any time point, only one valve of the first valve and the second valve is opened and the remaining one of the first valve and the second valve is closed (intended use MPEP § 2114 (II)).
Regarding claim 10, Lai teaches a method of use of the fully-automatic protein purification system device according to claim 1 in a purification of a protein (abstract).
Regarding claim 11, Lai teaches wherein the first drive unit is a peristaltic pump (page 3, third paragraph from the bottom).
Regarding claim 12, Lai, Ritchie and Harding are silent with regards to specific second drive unit, therefore, it would have been necessary and thus obvious to look to the prior art for conventional drive units. Kureshy provides this conventional teaching showing that it is known in the art to use a stepper motor (Kureshy, column 2, lines 23-25). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the second drive unit from a stepper motor motivated by the expectation of successfully practicing the invention of Kureshy. Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the second drive unit from a stepper motor because it can provide positional accuracy for a pipette (Kureshy, column 2, lines 23-25).
Regarding claim 15, Lai teaches wherein the chromatography unit is a chromatography column (item 7).
Regarding claim 16, Lai teaches all of the connections used are rubber hoses (page 2, paragraph 6) and therefore the connecting pipeline would be made from a rubber hose.
Regarding claim 17, Lai teaches all of the connections used are rubber hoses (page 2, paragraph 6) and therefore the connecting pipeline would be made from a rubber hose.
Regarding claim 19, Lai teaches wherein the locating unit is a locating column (see supra); and the locating unit is configured to rotate 360° (see supra).
Regarding claim 20, Lai teaches wherein the locating unit is a locating column (see supra); and the locating unit is configured to rotate 360° (see supra).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lai, Ritchie, Harding and Kureshy as applied to claim 1 above, and further in view of United States Application Publication No. 2006/0118472, hereinafter Schick with or without Ramaprasad.
Regarding claim 2, Lai, Ritchie, Harding and Kureshy with or without Ramaprasad teach all limitations of claim 1; however, they fail to teach the chromatography unit comprises a liquid level detector.
Schick teaches a chromatography column with a conductivity sensor to monitor the conductivity levels of the solution entering the column so that the controller can modify the operation of the pump unit and control various valves (Schick, paragraph [0083]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a liquid level detector (conductivity sensor) because it would allow for the controller can modify the operation of the pump unit and control various valves (Schick, paragraph [0083]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lai, Ritchie, Harding and Kureshy with or without Ramaprasad as applied to claim 4 above, and further in view of CN 106461606A, hereinafter Goto.
Regarding claim 18, Lai, Ritchie, Harding and Kureshy with or without Ramaprasad are silent with regards to specific hose material, therefore, it would have been necessary and thus obvious to look to the prior art for conventional hose materials. Goto provides this conventional teaching showing that it is known in the art to use a silicone flexible soft material (Goto, page 9, paragraph 1). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the hose from silicone motivated by the expectation of successfully practicing the invention of Goto.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., to distribute fractions into containers) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim only specifies that the device has a locating column that rotates 360 degrees, and collecting the solution into the second contained located below the connecting column. There is nothing in the claim about distributing fractions into containers.
Regarding applicant’s argument that Harding does not teach connecting a rotating outlet specifically to a chromatography column’s outlet, the examiner agrees that Harding does not specifically teach connecting the rotating outlet to a chromatography columns outlet. However, Harding does teach utilizing a device which has a rotating column with the outlet of a device connected to the rotating column so that the of the connecting pipeline is located above the second container (Harding, figure 2) which allows for the outlet to be positioned above a selected container (Harding, paragraph [0030]). Based upon this teaching one of ordinary skill in the art would have combined the rotating column of Harding and connected it to the outlet of a chromatography column, thereby arriving at the claimed features.
In response to applicant's argument that Harding does not disclose coordinating rotation with a solenoid-valve regime in which only one normally-closed two-way inlet valve is opened, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the circuit board control system is not positively claimed and therefore how the circuit board control system controls the valves is regarded as the intended use of the valves and the valves would be able to be controlled in the manner specified in the claims.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., fraction collection) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claim only specifies that the device has a locating column that rotates 360 degrees, and collecting the solution into the second contained located below the connecting column. There is nothing in the claim about distributing fractions into containers. Therefore, as the claim does not specify fraction collection, Ritchie would not teach away from fraction collection. Additionally, Ritchie does teach to return eluate to the inlet to enhance separation however, this process in Ritchie would not be continuously performed and at some point the return of eluate would stop after a desired separation occurs and then after this, the fluid could be fractionally collected and would not teach away from Ritchie.
Regarding applicant’s argument that the office has not articulated why a conductivity sensor would be substituted is not found persuasive. As shown above in the rejection it would have been obvious to added a liquid level detector because it would allow for the controller can modify the operation of the pump unit and control various valves (Schick, paragraph [0083]).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding applicant's argument that the combination destroys the intended functionality of Lai is not found persuasive. The modifications which is done to Lai with Ritchie, Harding, Schick and Goto add features to the reference of Lai without changing the intended functionality of Lai. For example, Lai is still performing chromatography as described in Lai and then Ritchie is adding the recycle to the reference of Lai. This recycle doesn't destroy the intended functionality of Lai as modified Lai would still be performing chromatography, but just with a recycle step which improves the chromatography ability. Similarly, the combination also does not change the principal of operation of Lai with the modifications described in the final office action mailed on 10/23/2025.
Regarding applicant's argument that the inventor identified a problem others did not is not found persuasive. The applicant argues that the office has not articulated why a skilled artisan would modify the references a described to arrive at the claimed invention. The final office action mailed on 10/23/2025 details the modifications which are performed along with the reasons for combining the references to arrive at the claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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