Prosecution Insights
Last updated: April 19, 2026
Application No. 17/973,638

SYSTEMS AND METHODS FOR GENERATING LABORATORY WATER AND DISTRIBUTING LABORATORY WATER AT DIFFERENT TEMPERATURES

Final Rejection §103
Filed
Oct 26, 2022
Examiner
GURTOWSKI, RICHARD C
Art Unit
1773
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Regeneron Pharmaceuticals, Inc.
OA Round
2 (Final)
72%
Grant Probability
Favorable
3-4
OA Rounds
2y 10m
To Grant
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
541 granted / 755 resolved
+6.7% vs TC avg
Strong +39% interview lift
Without
With
+39.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
35 currently pending
Career history
790
Total Applications
across all art units

Statute-Specific Performance

§101
2.4%
-37.6% vs TC avg
§103
43.7%
+3.7% vs TC avg
§102
19.8%
-20.2% vs TC avg
§112
29.3%
-10.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 755 resolved cases

Office Action

§103
DETAILED ACTION For this Office action, Claims 1-2, 15, 17, 18, 24, 26-29, 35-36, 38-39, 55-59, 75, 77-78, 84-89, 93-96, 101-102, 104 and 107-110 are pending. Claims 55-59, 75, 77-78, 84-89, 93-96, 101-102, 104 and 107-110 are withdrawn from consideration due to a previous restriction requirement, and Claims 3-14, 16, 19-23, 25, 30-34, 37, 40-44, 60-74, 76, 79-83, 97-100, 103, 105 and 106 are canceled. 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 03 February 2026 have been fully considered but they are not persuasive. Applicant has amended independent Claims 1 and 24 to further clarify and narrow the scope of the invention, including limitations regarding the second temperature range exceeding the first temperature range, wherein the sub distribution loop is configured to maintain the laboratory water in the sub distribution loop at the second temperature range. The claims have also been amended to further require a heat exchanger within the sub distribution loop. Applicant further argues that the cited prior art does not disclose these limitations, as Arai et al. (herein referred to as “Arai”, US Pat Pub. 2013/0292330; the secondary reference in the previous grounds of rejection) allegedly does not teach or discuss maintaining a water temperature after heating or cooling. Upon further consideration, the examiner respectfully disagrees. Arai discloses heating (or cooling) the water with a heat exchanger to a predetermined temperature (Abstract; Paragraph [0022]; Paragraph [0040]), including a suggested range to maintain the temperature (Paragraph [0040])—suggesting the water is maintained at the predetermined temperature throughout the process. Arai does disclose that no heating is necessary on the occasion that the water is produced at the temperature range (Paragraph [0040]; as referenced by applicant); however, this situation is a conditional alternative, and Arai accounts for situations when this is not the case (see above). The grounds of rejection are maintained in view of the arguments for these reasons, wherein the only adjustments are made in view of the amendments. 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 1-2, 15, 17-18, 24, 26-29, 35-36 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Nagai et al. (herein referred to as “Nagai”, US 5614088) in view of Arai et al. (herein referred to as “Arai”, US Pat Pub. 2013/0292330). Regarding instant Claim 1, Nagai discloses a laboratory water generation and distribution system capable of distributing laboratory water at different temperatures (Abstract; Figure 1; Col. 1, Lines 30-56; Col. 4, Lines 9-33; water purifier with pure water production system 1; subsystem 4 and supply subpipes 10 a-c, taking purified water to points of use 11-17, wherein water at different points of use is capable of being provided at different temperatures), wherein the system comprises: (A) a laboratory water generation section configured to treat potable water to generate laboratory water (Figure 1; Col. 1, Lines 30-56; Col. 4, Lines 9-33; primary pure water producing system 2); (B) a laboratory water distribution section (Figure 1; Figure 2; Col. 1, Lines 30-56; Col. 4, Lines 9-33; see piping downstream of system 2 in Figure 1, including subsystem 4 and subpipes 7 and return pipes 14a-c) comprising: (1) a laboratory water storage tank (Figure 2; Col. 1, Lines 30-56; Col. 4, Lines 9-52; see that subsystem 4 must retreat water since outputted ultrapure water must constantly being flowing to avoid contamination, water must be stored within subsystem 4 when not in use); (2) a main distribution loop in fluid communication with the laboratory water storage tank and configured to receive the laboratory water therefrom to distribute though at least one outlet laboratory water at a first temperature range (Figure 1; Col. 1, Lines 30-56; Col. 4, Lines 9-52; supply main pipe 6 from and to subsystem 4 to extra pure water production systems; temperature range would be the ambient temperature of the water produced in main pipe 6); (3) a sub distribution loop operatively connected to the main distribution loop via a valve and configured to receive the laboratory water therefrom to distribute through at least one outlet laboratory water, wherein the sub distribution loop also can return the laboratory water to the main distribution loop (Figure 1; Col. 4, Lines 9-52; see subpipes 10a-c with point of use branch pipes at 11, with valve at point of uses 11p-r and return pipes 13/12/16 with pipes at point of use); (D) an Operational Interface Terminal (OIT) (Figure 3; Col. 5, Lines 5-16; control panel 33); and (E) one or more processors (Col. 2, Line 63-Col. 3, Line 67; Col. 5, Lines 18-51; automatic control and control panel 33 demonstrate processors involved in the system). However, the reference is silent on temperature control, in particular providing outputted laboratory water from the sub distribution loop at a second temperature range, the second temperature range exceeding the first temperature range, wherein the sub distribution loop is configured to maintain the laboratory water in the sub distribution loop at the second temperature range and wherein the sub distribution loop comprises a heat exchanger. Arai discloses an ultrapure water producing method in the same field of endeavor as the instant application, as it solves the mutual problem of producing ultrapure water (Abstract; Paragraph [0001]). Arai further discloses the ability to distribute water at a second temperature different from a first temperature at production in order to ensure a desired, predetermined temperature for the water, the second temperature range exceeding a first temperature range, and wherein said second temperature range is maintained via a heat exchanger (Abstract; Figure 1; Paragraph [0022]; Paragraph [0040]; heat exchanger 2 can provide discretional temperature control, including heating water at low temperatures and cooling water at high temperatures; temperature is heated and maintained within a desired, predetermined temperature range). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the storage tank and sub distribution loop of Nagai to further comprise a heat exchanger that maintains the temperature in the sub distribution loop at a higher, second temperature range as taught by Arai because Arai discloses doing so will own an operator to have water at a predetermined temperature when said water is output (Arai, Paragraph [0022]; Paragraph [0040]). Regarding instant Claim 2, Claim 1, upon which Claim 2 is dependent, has been rejected above. The combined references further disclose wherein the laboratory water generation section comprises a multimedia filter (Nagai, Col. 1, Lines 58-63; coagulo-settling filter), a cartridge filter (Nagai, Figure 2; Col. 4, Lines 53-68; ultrafiltration device 31), a water softening medium (Nagai, Figure 2; Col. 4, Lines 53-68; cartridge demineralizer 29 removes hardness ions), an activated carbon bed (Nagai, Col. 1, Lines 58-63; activated carbon filter), a reverse osmosis unit (Nagai, Col. 1, Lines 58-63; reverse osmosis unit), a UV light (Nagai, Col. 1, Line 64-Col. 2, Line 2; ultraviolet sterilizer), an ion exchange bed vessel (Nagai, Col. 1, Line 64-Col. 2, Line 2; ion exchanger for high degree purity), and a mixed bed ion exchange vessel (Nagai, Col. 1, Line 64-Col. 2, Line 2; ion exchanger for lower grade pure water, which would require higher degree of ion exchange). Regarding instant Claim 15, Claim 1, upon which Claim 15 is dependent, has been rejected above. The combined references further disclose wherein the laboratory water in the main distribution loop is maintained at a temperature between about 18⁰C to about 25⁰C (Arai, Paragraph [0040]; reference teaches normal operation range at around 20⁰C). Regarding instant Claim 17, Claim 1, upon which Claim 17 is dependent, has been rejected above. The combined references further wherein it would be obvious to one of ordinary skill in the art at the time the invention was filed to heat and maintain the laboratory water in the sub distribution loop to a temperature between about 53⁰C to about 57⁰C because Arai discloses such high temperatures improve decomposition efficiency, the range could be obvious to the one of ordinary skill in the art based on his desired predetermined temperature (Paragraph [0040]; see that removing efficiency may be decreased, but removal of bacteria would be higher). Regarding instant Claim 18, Claim 17, upon which Claim 18 is dependent, has been rejected above. The combined references further disclose wherein the sub distribution loop is configured to cool the laboratory water in the sub distribution loop to a temperature between about 18⁰C to about 25⁰C prior to dispensing the laboratory water to the main distribution loop (Nagai, Figure 1; Col. 1, Lines 30-57; Arai, Paragraph [0040]; reference teaches normal operation range at around 20⁰C; water is returned via branch pipes 13p-13r, etc.). Regarding instant Claim 24, Nagai discloses a method of generating laboratory water and distributing water (Abstract; Figure 1; Col. 1, Lines 30-56; Col. 4, Lines 9-33; water purifier with pure water production system 1; subsystem 4 and supply subpipes 10 a-c, taking purified water to points of use 11-17, wherein water at different points of use is capable of being provided at different temperatures), the method comprising the steps of: (A) treating potable water using laboratory water generation section to generate laboratory water (Figure 1; Col. 1, Lines 30-56; Col. 4, Lines 9-33; primary pure water producing system 2); and (B) distributing water using a laboratory water distribution section Figure 1; Figure 2; Col. 1, Lines 30-56; Col. 4, Lines 9-33; see piping downstream of system 2 in Figure 1, including subsystem 4 and subpipes 7 and return pipes 14a-c) comprising: (1) a laboratory water storage tank (Figure 2; Col. 1, Lines 30-56; Col. 4, Lines 9-52; see that subsystem 4 must retreat water since outputted ultrapure water must constantly being flowing to avoid contamination, water must be stored within subsystem 4 when not in use); (2) a main distribution loop in fluid communication with the laboratory water storage tank and configured to receive the laboratory water therefrom to distribute though at least one outlet laboratory water at a first temperature range (Figure 1; Col. 1, Lines 30-56; Col. 4, Lines 9-52; supply main pipe 6 from and to subsystem 4 to extra pure water production systems; temperature range would be the ambient temperature of the water produced in main pipe 6); (3) a sub distribution loop operatively connected to the main distribution loop via a valve and configured to receive the laboratory water therefrom to distribute through at least one outlet laboratory water, wherein the sub distribution loop also can return the laboratory water to the main distribution loop (Figure 1; Col. 4, Lines 9-52; see subpipes 10a-c with point of use branch pipes at 11, with valve at point of uses 11p-r and return pipes 13/12/16 with pipes at point of use), wherein the distributing is controlled by a at least one processor (Col. 2, Line 63-Col. 3, Line 67; Col. 5, Lines 18-51; automatic control and control panel 33 demonstrate processors involved in the system). However, the reference is silent on temperature control, in particular providing outputted laboratory water from the sub distribution loop at a second temperature range, the second temperature range exceeding the first temperature range, wherein the sub distribution loop is configured to maintain the laboratory water in the sub distribution loop at the second temperature range and wherein the sub distribution loop comprises a heat exchanger. Nagai is also silent on receiving heating input related to a set point temperature for water; heating a first quantity of water within the sub distribution loop from a baseline temperature to the set point temperature; and maintaining the first quantity of water at the set point temperature; and maintaining the first quantity of water at the set point temperature for a period of time. Arai discloses an ultrapure water producing method in the same field of endeavor as the instant application, as it solves the mutual problem of producing ultrapure water (Abstract; Paragraph [0001]). Arai further discloses the ability to distribute water at a second temperature different from a first temperature at production in order to ensure a desired, predetermined temperature for the water, the second temperature range exceeding a first temperature range, and wherein said second temperature range is maintained via a heat exchanger (Abstract; Figure 1; Paragraph [0022]; Paragraph [0040]; heat exchanger 2 can provide discretional temperature control, including heating water at low temperatures and cooling water at high temperatures; temperature is heated and maintained within a desired, predetermined temperature range). Arai further discloses receiving heating input related to a set point temperature for water (Paragraph [0040]; predetermined temperature); heating a first quantity of water from a baseline temperature to the set point temperature (Paragraph [0040]; temperature is raised via heat exchanger) and maintaining the first quantity of water at the set point temperature for a period of time (Paragraph [0040]; water may stay at temperature for predetermined period of time). It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention to modify the processor, the storage tank and sub distribution loop of Nagai to further comprise a heat exchanger that maintains the temperature in the sub distribution loop at a higher, second temperature range—along with the other process steps performed by the heat exchanger and processor—as taught by Arai because Arai discloses doing so will own an operator to have water at a predetermined temperature when said water is output (Arai, Paragraph [0022]; Paragraph [0040]). Regarding instant Claim 26, Claim 24, upon which Claim 26 is dependent, has been rejected above. The combined references further comprising steps that are controlled by a processor: preserving a second quality of water within the amin distribution loop at the baseline temperature for the period of time (Arai, Paragraph [0040]; water not heated may stay at baseline/ambient temperature); cooling the first quantity of water from the set point temperature to the baseline temperature in response to a trigger (Arai, Paragraph [0040]; heat exchanger may reduce/cool temperature of water based on demand). Regarding instant Claim 27, Claim 24, upon which Claim 27 is dependent, has been rejected above. The combined references further disclose wherein the heating input comprises a request for heated water at the set point (Arai, Paragraph [0040]; see predetermined temperature). Regarding instant Claim 28, Claim 24, upon which Claim 27 is dependent, has been rejected above. The combined references further disclose wherein the trigger comprises that the period for time has reached a predetermined time limit (Arai, Paragraph [0040]; Nagai, Figure 3; Col. 5, Lines 5-16; control panel 33 would comprise notification of heat exchanger/temperature function). Regarding instant Claim 29, Claim 24, upon which Claim 29 is dependent, has been rejected above. The combined references further disclose wherein the heating input comprises a time limit, wherein the trigger comprises a notification that the period of time has reached the time limit (Paragraph [0040]; Figure 3; Col. 5, Lines 5-16; heater would only heat water for time to reach predetermined temperature, which would be displayed with the control panel 33). Regarding instant Claim 35, Claim 24, upon which Claim 35 is dependent, has been rejected above. The combined references further disclose wherein the laboratory water generation section comprises a multimedia filter (Nagai, Col. 1, Lines 58-63; coagulo-settling filter), a cartridge filter (Nagai, Figure 2; Col. 4, Lines 53-68; ultrafiltration device 31), a water softening medium (Nagai, Figure 2; Col. 4, Lines 53-68; cartridge demineralizer 29 removes hardness ions), an activated carbon bed (Nagai, Col. 1, Lines 58-63; activated carbon filter), a reverse osmosis unit (Nagai, Col. 1, Lines 58-63; reverse osmosis unit), a UV light (Nagai, Col. 1, Line 64-Col. 2, Line 2; ultraviolet sterilizer), an ion exchange bed vessel (Nagai, Col. 1, Line 64-Col. 2, Line 2; ion exchanger for high degree purity), and a mixed bed ion exchange vessel (Nagai, Col. 1, Line 64-Col. 2, Line 2; ion exchanger for lower grade pure water, which would require higher degree of ion exchange). Regarding instant Claim 36, Claim 24, upon which Claim 36 is dependent, has been rejected above. The combined references further disclose wherein the laboratory water in the main distribution loop is maintained at a temperature between about 18⁰C to about 25⁰C (Arai, Paragraph [0040]; reference teaches normal operation range at around 20⁰C). Regarding instant Claim 38, Claim 24, upon which Claim 38 is dependent, has been rejected above. The combined references further wherein it would be obvious to one of ordinary skill in the art at the time the invention was filed to heat and maintain the laboratory water in the sub distribution loop to a temperature between about 53⁰C to about 57⁰C because Arai discloses such high temperatures improve decomposition efficiency, the range could be obvious to the one of ordinary skill in the art based on his desired predetermined temperature (Paragraph [0040]; see that removing efficiency may be decreased, but removal of bacteria would be higher). Regarding instant Claim 39, Claim 38, upon which Claim 39 is dependent, has been rejected above. The combined references further disclose wherein the sub distribution loop is configured to cool the laboratory water in the sub distribution loop to a temperature between about 18⁰C to about 25⁰C prior to dispensing the laboratory water to the main distribution loop (Nagai, Figure 1; Col. 1, Lines 30-57; Arai, Paragraph [0040]; reference teaches normal operation range at around 20⁰C; water is returned via branch pipes 13p-13r, etc.). Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD C GURTOWSKI whose telephone number is (571)272-3189. The examiner can normally be reached 9:00 am-5:30pm MT. 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. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571) 272-0475. The 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. /RICHARD C GURTOWSKI/Primary Examiner, Art Unit 1773 02/27/2026
Read full office action

Prosecution Timeline

Oct 26, 2022
Application Filed
Oct 30, 2025
Non-Final Rejection — §103
Feb 03, 2026
Response Filed
Feb 27, 2026
Final Rejection — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+39.2%)
2y 10m
Median Time to Grant
Moderate
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