Prosecution Insights
Last updated: April 19, 2026
Application No. 18/615,750

Tube Joining Device With Modular Accessories And Protocol Assurance

Non-Final OA §102§103
Filed
Mar 25, 2024
Examiner
STEPHENS, JACQUELINE F
Art Unit
3781
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Terumo Bct Inc.
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
3y 4m
To Grant
90%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allow Rate
1031 granted / 1361 resolved
+5.8% vs TC avg
Moderate +14% lift
Without
With
+14.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
38 currently pending
Career history
1399
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
54.6%
+14.6% vs TC avg
§102
23.6%
-16.4% vs TC avg
§112
10.5%
-29.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1361 resolved cases

Office Action

§102 §103
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 . Claim Rejections - 35 USC § 102 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 6-16 are rejected under 35 U.S.C. 102(a) as being anticipated by Watanabe USPN 5674741. As to claim 6, Watanabe teaches a method of verifying media combination protocol - a method for manufacture of blood products by transferring blood components from two blood bags 2 to two corresponding blood component bags 6 (col. 3, lines 3-8; col. 57 line 12). The protocol comprises: verifying a first media bag (blood bag 2, col 57,Iine 5-15) including, receiving, with tube 3 joining device (apparatus 1, col 57, lines 8-9. The apparatus including control means 30, a tube connecting device 400 and a data processing device 800, col 11,Iines 37-50. The data processing device 800 includes reader 810 and check reader 860, col 49, in 50-58). The method includes receiving first data associated with the first media bag – where Watanabe teaches a bar code reader 812 is operated to read bar code 25 and the data is input into control means 30 (col 57, In 55-59). The blood bag 2 includes label 23 with bar code 25 (col 49, In 62-67), the receiving includes concurrently scanning, with a scanner – where Watanabe teaches a bar code reader 812 such as a laser scan system (col 50, In 44-46), a first plurality of items – where Watanabe teaches more than one bar code 25 on bag 2 (col 49, In 62-67). The method further includes mapping the first plurality of items to a first plurality of predetermined fields – where Watanbe teaches the data/items read from 25 are input into control means 30 and processed in arithmetic section (col 57, In 55-59); and after the mapping, determining whether a first predetermined condition is met – where Watanabe teaches the data processing device is capable of reading out information concerning the blood held in a given blood bag 2, and therefore enables the work of producing a label and the work of applying the produced label to the bag to and possible selection of the wrong bags or wrong label is precluded. The data processing devices provides an advantage to automate manufacture of blood products hence determining whether each of the predetermined fields match the correct bag fields, (col 55, In 1-12). As to claim 7, Watanabe teaches he method of claim 6, wherein the determining includes determining whether a respective first predetermined condition is met for each of the first plurality of predetermined fields – where Watanabe teaches the data processing device is capable of reading out information concerning the blood held in a given blood bag 2, and therefore enables the work of producing a label and the work of applying the produced label to the bag to and possible selection of the wrong bags or wrong label is precluded. The data processing devices provides an advantage to automate manufacture of blood products hence determining whether each of the predetermined fields match the correct bag fields, (col 55, In 1-12). As to claim 8, Watanabe teaches the method of claim 6, further comprising: verifying a second media bag 6, (col. 58, lines 13-15) including, receiving, with the tube joining device, second data associated with the second media bag – where check reader 860 moves the bar code reader 861 to read the bar code on bag 6 (col 58, In 43-47), , the receiving including concurrently scanning, with a scanner, a second plurality of items – where check reader 860 moves the bar code reader 861 to read the bar code on label 831 of bag 6, col 58, In 43-58. Label 831 bar code corresponds to 25 hence a plurality of barcodes corresponding to plurality of 25 (col 51, in 25-28); mapping the second plurality of items to a second plurality of predetermined fields – where Watanabe teaches the data(items) read by bar code reader 861 are input into control means 30 and processed in the arithmetic section thereof (col. 58 lines 48-51); and after the mapping, determining whether a second predetermined condition is met – where Watanabe teaches the control means 30 examines the bar code of the label 831 tacked to the blood component bag 6 to determine whether or not the bar code is free from such defects as misprint and, at the same times, compares the information symbolized by the bar code on the blood component bag with the data stroed in the memory of the control means 30, namely the information carried by the bar code 25 on the corresponding blood bag 2 to determine whether or not they are identical (col. 58, lines 50-58). As to claim 9, Watanabe teaches the method of claim 8, wherein the determining whether the first predetermined condition is met is based on the first data and data stored in a memory of the tube joining device – where Watanabe teaches reading information concerning the blood held in 2 prevents selection of wrong bag to automate manufacture of blood products hence based on the first data and data stored in memory corresponding to a correct/desired bag, col 55, lines 1-12; memory, col 54, In 45-57). As to claim 10, Watanabe teaches the determining of whether the second predetermined condition is met is based on the first data, the second data, and the data stored in the memory of the tube joining device - determine whether identical hence based on the first data of 25, the second data of label 831 and the data stored in the memory corresponding to a correct/desired bag, col 58, in 48-58). As to claim 11, Watanabe teaches the method of claim 8, further comprising: performing, with the tube joining device, a tube joining process based on a determination that the first predetermined condition and the second predetermined condition are met – where Watanabe teaches identification of the bar codes on bags 2 and 6 is confirmed (col 58, Iines 65-67); and joining of lubes 3 and 7 (col 59, lines 10-30). As to claim 12, Watanabe teaches the method of claim 6, further comprising: storing, in a memory of the tube joining device, at least a portion of the first data associated with the first media bag - where Watanabe teaches the data read out of 25 is stored in memory (col 57, lines 57-59). As to claim 13, Watanabe teaches the method of claim 6, wherein the first plurality of items includes a plurality of one-dimensional barcodes, a plurality of two-dimensional barcodes, a plurality of radiofrequency identifications, or a plurality of near-field communication tags – where Watanabe teaches more than one bar codes 25 on bag 2, (col. 49, Iines 62-67); and one-dimensional barcodes (col.55, Iines 24-25), a plurality of two-dimensional barcodes, a plurality of radiofrequency identifications, or a plurality of near-field communication tags. As to claim 14, Watanabe teaches the method of claim 6, wherein the determining is based on the first plurality of items and data stored in a memory of the tube joining device- where Watanabe teaches reading the information concerning the blood held in 2 prevents selection of wrong bag to automate manufacture of blood products (col. 55, lines 1-12); hence based on the first data and data stored in memory corresponding to a correct/desired bag (col 54, in 45-57). As to claim 15, Watanabe teaches the method of claim 6, further comprising: based on a determination that the first predetermined condition is not met, generating an alert - where Watanabe teaches the display means 870 is electrically connected to the control means 30 and is caused to display various kinds of information in response to signals output by the control means, including errors to be displayed based on information carried by bar code 25 be read by the bar code reader 812 (col 54, Iines 17-32). As to claim 16, Watanabe teaches the method of claim 6, wherein the first data associated with the first media bag 2 includes media bag identification, storage solution, sex of donor, viral status of media, blood type, quantity of media units. unit identification, process step, or any combination thereof (col 49, line 62 through col. 50 line 11). Claims 17, 18, and 20 are rejected under 35 U.S.C. 102(a) as being anticipated by Luoma, II et al. USPN 4461951. As to claim 17, Luoma teaches a method of performing a tube joining process (Luoma Abstract; col. 3, lines 15-18) comprising: applying a current to a wafer - where Luoma teaches cutting-heating means including a resistor, current is supplied to the resistor (col. 3, lines 48-68 and col. 5, lines 34-35); determining a temperature of the wafer during the applying – where Luoma teaches the voltage of the resistor and time are measured after current is supplied (col. 5, lines 34-65) and used to monitor a temperature of the heating element/wafer (col 2, lines 62-68 and col 3, lines 1-18); determining whether the temperature is within a predetermined temperature range – where Luoma teaches determining if a temperature of the cutting means reaches operating temperature of 2320C to 3430C (col. 5, line 54 through col. 6, line 1); and based on a determination that the temperature is within the predetermined temperature range, performing, with a tube joining device, a tube joining process – where Luoma teaches that when the voltage reflects the desired temperature, the device initiates the lubing cut and joining sequence (col. 6 lines 30-34). As to claim 18, Luoma teaches the method of claim 17, wherein the determining the temperature includes, detecting an electrical resistance of the wafer – where Luoma teaches the empirical relationship for calculating the resistance (col. 5, lines 17-26), and calculating the temperature based on the electrical resistance - used to monitor a temperature of the heating element/wafer (col 2, lines 62-68 and col 3, lines 1-18). As to claim 20, Luoma discloses the method of claim 17, further comprising: based on a determination that the temperature is outside of the predetermined temperature range, replacing the wafer (col 5, Iines 43-46). 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. Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bollinger et al. US Patent Application Publication 2007/0142960 in view of Holtz et al. US Patent Application Publication 2021/0386115. As to claim 1, Bollinger teaches a method of initiating a tube joining process (Abstract) comprising: receiving, with a tube joining device – where Bollinger teaches a communication module 120, such as a scanner 130 and lubing welder 160, (Fig 1. para 0027), data associated with a cartridge 120 – where the communication module 120 supports connection process steps including wafer cassette identification (para 0060); Bollinger does not specifically teach determining whether the cartridge is authentic based on the data; and in response to determination that the cartridge is authentic, initiating the tube joining process. Bollinger does teach the cartridge is for welding wafers (wafer cassette, para (0060), and the wafers involved in the welding process (para 010), wherein the data is for identifying the cartridge (wafer cassette identification, para 0060), and wherein the method involves using a communication module 120 such as a scanner 130 (para. 0027). Bollinger teaches the communication module 120 is capable of reading any type of barcode labels from the scanner 130 (para. 044), and the communication module 120 features ensure any scanned information matches with any applicable barcode matching rules (para 0048); and further wherein the communication module 120 may be used to determine when a tube joining process may be initiated in that the communication module 120 can also control when the sterile tubing welder 160 perform a weld (para. 0043). Bollinger teaches that if any error is detected during the weld process by the communication module 120, then the weld process will not continue (para 0062). What Bollinger does not teach is the method of determining whether the cartridge is authentic and based on that data, initiating the joining process. Holtz teaches a method of authenticating a cartridge for an electronic device (Holtz Abstract; electronic vaping device (Holtz para 0088) comprising: receiving, with the device, data associated with a cartridge (controller receives identification data such as an Identification label 170 read by a cartridge reader 260 (Holtz para 0093): cartridge 120 includes an identification label 170 (Holtz para. 0051) by reading a barcode of the cartridge - where identification label 170 may be a barcode on the cartridge 120 readable by a reader, (Holtz para 0051); identification data obtained from 170 is read by cartridge reader 260, (Holtz para 0093); determining whether the cartridge is authentic based on the data - where the controller authenticates the cartridge 120 by comparing the Identification data with reference Identification data (Holtz para 0094); an authorized cartridge may be referred to as an authentic cartridge (Holtz para 0095); and in response to a determination that the cartridge is authentic, enabling use of the electronic device – where Holtz teaches if the controller 264 provides an indication that the cartridge 120 is not authentic, the controller 264 maintains the battery section 140 in a locked state so that it is not permitted to provide power to the cartridge 120 (Holtz para. 0102). Likewise If the controller 264 determines that the cartridge 120 is authentic (the authentication process for the cartridge 120 was successful), then the controller 264 determines whether the battery section 140 has sufficient charge for powering the cartridge 120 (Holtz para. 0106-1017), if the controller determines that the cartridge 120 is authentic, a battery is permitted to power the cartridge (Holtz para 0105-0107), and the device is enabled for use (Holtz para 0109, 0113). It would have been obvious to a person having ordinary skill in the art before the invention was originally filed to modify the method of Bollinger with the authentication and initiating methods taught in Holtz. Doing so would allow use when a cartridge or communication module is authenticated. The combination of Bollinger/Holtz allows use of the device and further comprises initiating the tube joining process after data authentication. As to claim 2, Bollinger/Holtz teach the determining includes comparing the data to a predetermined list of data – where Holtz teaches identification data is compared to reference Identification data stored in memory of a controller (Holtz para 0093-0095), and determining that the cartridge is authentic when the data is included in the predetermined list of data – where Holtz teaches authentication of the cartridge 120 is successful if the received authentication data matches the reference identification data (Holtz para 0099). As to claim 3, Bollinger/Holtz teach the receiving includes scanning, with a scanner, an item – where Holtz teaches the cartridge 120 may further include an identification label 170 which may include one or more of a barcode, a quick response (QR) code, a Near Field Communication (NFC) tag, a special (e.g. magnetic) ink, or any other type of identification label readable by a reader such as a laser a MICR reader, combination thereof , or other reading device (Holtz para. 0051). Holtz further teaches the identification data may be obtained from or included in the identification label 170 read by the cartridge reader 260 (Holtz para 0093). As to claim 4, Bollinger/Holtz teach the method of claim 3, wherein the item is a one-dimensional barcode, a two dimensional barcode, a radiofrequency identification, a near-field communication tag, or any combination thereof - where Holtz teaches the cartridge 120 may further include an identification label 170 which may include one or more of a barcode, a quick response (QR) code, a Near Field Communication (NFC) tag, a special (e.g. magnetic) ink, or any other type of identification label readable by a reader such as a laser a MICR reader, combination thereof , or other reading device (Holtz para. 0051). As to claim 5, Bollinger/Holtz teach the method of claim 1, further comprising: in response to a determination that the cartridge is not authentic, generating an alert – Holtz teaches if the authentication process for the cartridge fails a display may output a visual indication such as "unauthorized cartridge (Holtz para 0103). Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Luoma II et al. USPN 4461951. As to claim 19, Luoma teaches the present invention substantially as claimed. Luoma teaches determination that a temperature is within a predetermined temperature range as discussed in claim 17 above, but does not teach generating an alert based on a determination that the temperature is outside of the predetermined temperature range. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the method of Luoma to provide a signal or alert when the temperature is outside of a predetermined temperature range. Doing so would alert the user to replace the wafer. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00. 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, Sarah Al-Hashimi can be reached at 571-272-7159. 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.. /JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
Read full office action

Prosecution Timeline

Mar 25, 2024
Application Filed
Feb 23, 2026
Non-Final Rejection — §102, §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
76%
Grant Probability
90%
With Interview (+14.3%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 1361 resolved cases by this examiner. Grant probability derived from career allow rate.

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