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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 May 2026 has been entered.
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.
Claim(s) 1-2, 4-6, 8-10, 12-14, 28, 30-31, 33, and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Pre-Grant Publication 2010/0063445 to Sternberg et al. (Sternberg hereinafter) in view of US Pre-Grant Publication 2010/0179488 to Spiegel et al. (Spiegel).
Regarding claim 1, Sternberg teaches a prime tube (Fig. 2) a sidewall (20) defining an internal volume (with 24 therein), a connector (8) configured to reversibly engage a reservoir (6) and disposed at a proximal (rightward in Fig. 2) end of the sidewall, and a closure (24) which is disposed at a distal (leftward in Fig. 2) end of the sidewall and which is permeable to air and not the fluid (paragraph 44). Sternberg does not teach an expandable volume. Spiegel teaches another medical fluid device generally, and particularly teaches an expandable volume (14) whose expansion indicates pressure (paragraph 45). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an expansible chamber to the prime tube of Sternberg in order to indicate pressure. Thus provided, the expandable volume would be configured to increase as the medical fluid enters the internal chamber, that is, as the pressure therein rises.
Regarding claim 2, Spiegel teaches that the chamber includes a bellows (14) which would have been obvious to include as the pressure indicating device, the bellows expanding when filled to a larger volume.
Regarding claims 4 and 36, Spiegel teaches that the bellows expands to a greater axial length (Xb).
Regarding claims 5 and 37, Spiegel teaches an elastomeric material (paragraph 62) having beneficial properties for this application. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to form the bellows of silicone rubber or the like as taught by Spiegel in order to take advantage of the beneficial properties of that substance in the pressure sensing application.
Regarding claims 6, 10, 28 and 38, Spiegel teaches transitioning from a contracted state to an expanded state (paragraph 46) and that the bellows may be rolled over (see Fig. 5c) when contracted and partially unrolled when expanded (see Fig. 5b, i.e. rolling is partial in both states).
Regarding claim 8, Spiegel teaches radial inversion of the bellows in response to fluid pressure increasing therein.
Regarding claim 9, Spiegel teaches a flaccid configuration and a rigid, extended configuration in the absence and presence of pressure respectively.
Regarding claim 12, Sternberg teaches a porous material (paragraph 16).
Regarding claim 13, by definition, Sternberg teaches porousness sufficient for air passage and not liquid (see e.g. paragraph 50).
Regarding claim 14, Sternberg teaches that the membrane may provide an audible sound dependent on presence or absence of flow therethrough (paragraph 20).
Regarding claim 30, Sternberg teaches a prime tube (Fig. 2) a sidewall (20) defining an internal volume (with 24 therein), a connector (8) configured to reversibly engage a reservoir (6) and disposed at a proximal (rightward in Fig. 2) end of the sidewall, and a closure (24) which is disposed at a distal (leftward in Fig. 2) end of the sidewall and which is permeable to air and not the fluid (paragraph 44).. Sternberg further teaches a processor (paragraph 20, “controller”) programmed to determine priming status (so as to emit an alarm). Sternberg does not teach an expandable volume. Spiegel teaches another medical fluid device generally, and particularly teaches an expandable volume (14) whose expansion indicates pressure (paragraph 45). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide an expansible chamber to the prime tube of Sternberg in order to indicate pressure. Thus provided, the expandable volume would be configured to increase as the medical fluid enters the internal chamber, that is, as the pressure therein rises.
Regarding claim 31, Sternberg teaches a processor (controller, paragraph 20) configured to determine priming status. Sternberg teaches that this is done based on a signal from a sensing system (300). However, as Spiegel is directed to ensuring safety via pressure measurement, it would have been equally obvious to use a pressure sensor (or the visual sensor 354 of Sternberg in combination with the bellows of Spiegel) to determine bellows status as the mere substitution of one known sensing method for another according to the known construction and operational methods evinced by both references.
Regarding claim 33, Sternberg teaches an actuator determination of prime based on sensor output, including a visual sensor (354) which measures state changes in the tube. Spiegel teaches detection of pressure based on shape changes (of Xb). One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use the shape changes indicated by Spiegel to determine priming in the system of Sternberg as the mere substitution of one known state detection method for another.
Claim(s) 32 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sternberg in view of Spiegel as applied to claim 30 above, and further in view of US Pre-Grant Publication 2007/0233003 to Radgowski et al. (Radgowski).
Regarding claims 32 and 35, Sternberg does not explicitly teach prime determination based on current draw or sensed force. Radgowski teaches another medical fluid apparatus and particularly teaches that prime may be determined from motor current (see e.g. claim 3), which is tantamount to a force reading. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to detect prime as taught by Radgowski as the mere substitution of one known prime determination method for another according to the known construction and operational methods evinced by both references.
Response to Arguments
Applicant's arguments filed 10 December have been fully considered but they are not persuasive.
With respect to the argument that Sternberg does not teach the proximal and distal orientations relative to a downstream or upstream direction, the examiner notes that the claim is silent to fluid flow direction and as such contains no limitation to predicate this argument. In other words, the distal and proximal ends of the sidewall are not necessarily upstream or downstream as argued because there is no upstream and downstream direction of the claim. Furthermore, the claim is silent to any overall function of the prime tube or of the fluid reservoir containing a medical fluid. Accordingly, the examiner finds no patentable distinction between the claimed invention and the combined apparatus of Sternberg and Spiegel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 23 June 2026
Prosecution Insights