CTNF 18/492,656 CTNF 70292 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 § 112 07-30-02 AIA 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. 07-34-01 Claims 28 and 29 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 28 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the applicant regards as the invention. Claim 28 recites “wherein the drip feature comprises a top membrane retainer retains an upper end of the anti-run-dry membrane.” The clause is grammatically incomplete (missing a required connector such as “that” before “retains”). This renders the metes and bounds of the claimed structure unclear. See MPEP § 2173.05(m). Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-03-aia AIA Claim s 18, 19, 21, and 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jess (US 4,013,072) . Independent claim 18 recites an intravenous delivery system, comprising: a drip unit; a drip feature that delivers a liquid to an interior of the drip unit; an exterior wall that defines a drip chamber to contain the liquid, wherein the exterior wall comprises a bottom portion; a tubing interface extending from the bottom portion; and an anti-run-dry membrane within the drip chamber, wherein the anti-run-dry membrane extends from the drip chamber to the bottom portion. PNG media_image1.png 646 160 media_image1.png Greyscale In relation to independent claim 18 , Kraus discloses an intravenous delivery system comprising: a drip unit: see Figure 1 [above], “drip chamber 10” (col. 2, lines 46-51). “a drip feature that delivers a liquid to an interior of the drip unit” : a drip feature that delivers a liquid to an interior of the drip unit (“inlet tubing 14”, col. 2, lines 46-51). “an exterior wall that defines a drip chamber to contain the liquid, wherein the exterior wall comprises a bottom portion”: an exterior wall that defines a drip chamber to contain the liquid ("generally cylindrical housing", col. 2, lines 46-51), wherein the exterior wall comprises a bottom portion ("closed at its bottom portion 16", col. 2, line 46-51). “a tubing interface extending from the bottom portion”: a tubing interface extending from the bottom portion (“outlet tubing 18”, col. 2, lines 46-51). “an anti-run-dry membrane within the drip chamber, wherein the anti-run-dry membrane extends from the drip chamber to the bottom portion”: an anti-run-dry membrane within the drip chamber ("hydrophilic filter element 26", col. 2, line 59, which acts as an anti-run-dry membrane because "hydrophilic filter elements are capable of passing therethrough liquid while simultaneously blocking air", col. 2, lines 67-68), wherein the anti-run-dry membrane extends from the drip chamber to the bottom portion ("ribs 34 extend below the bottom panel 32 so as to support the bottom panel 32 above the base of the drip chamber", col. 3, lines 37-40, and the filter element 26 is mounted on the ribs 34, col. 3, lines 20-21). In relation to claim 19 , Jess discloses the exterior wall comprises a peripheral portion with a tubular or frustoconical shape ("drip chamber 10 formed of a generally cylindrical housing", col. 2, Line 47). In relation to claim 21 , Jess discloses the anti-run-dry membrane is retained within the drip chamber directly by a plurality of components that define the drip chamber ("filter 24 is capable of establishing a sealing relationship with the interior walls of the drip chamber 10", col. 3, lines 7-9). In relation to claim 22 , Jess discloses the anti-run-dry membrane is retained at a lower end of the anti-run-dry membrane by the bottom portion of the exterior wall ("ribs 34 extend below the bottom panel 32 so as to support the bottom panel 32 above the base of the drip chamber", col. 3, lines 37-40) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 20, 23, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Jess (US 4,013,072) in view of Kraus (US 2003/0220616A1) . In relation to claim 20 , Jess discloses the anti-run-dry membrane has a tubular shape ("cylindrical walls of the housing 28. Mounted on the ribs 34 is the hydrophilic filter element 26", col. 3, lines 17-19). Jess does not disclose that the liquid flows from the drip chamber through the anti-run-dry membrane to reach an interior of the anti-run-dry membrane; rather, Jess discloses liquid flows from the interior to the exterior ("liquid contained in the drip chamber 10 passes through the top opening 30 into the interior 36 of the filter 24... passes through the hydrophilic filter element 26 into the space 31", col. 3, lines 45-52). However, Kraus discloses a membrane support where liquid flows from the drip chamber through the membrane to reach an interior of the membrane support ("Filtrate can flow from drain outlet 28 via a conduit 30 to an outlet 32", paragraph [0027]). Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the tubular filter of Jess to have the liquid flow from the outside of the filter to the interior, as taught by Kraus, in order to increase the effective surface area of the membrane exposed to the fluid in the drip chamber, thereby enabling higher liquid throughputs ("The increased membrane area is a significant advantage because it enables use of bacterially retentive membranes with good liquid throughputs", Kraus, paragraph [0026]). In relation to claim 23 , Jess discloses the membrane is retained at the bottom portion, but Jess does not disclose the bottom portion comprises a tubular collar that retains the lower end of the anti-run-dry membrane. However, Kraus discloses a membrane support comprising a tubular collar that retains the membrane ("Membrane support 10 includes a support member 7 preferably constructed of a short, open-ended cylinder", paragraph [0020]). Based on the above comments, it would have been obvious to one of ordinary skill in the art to modify Jess to include a tubular collar at the bottom portion to retain the membrane, as taught by Kraus, to provide a secure and simple mounting structure for the membrane that prevents adhesive from contacting and damaging the membrane ("The adhesive is never in close contact with membrane 16 and possible damage is minimized", Kraus, paragraph [0022]). In relation to claim 31 , Jess discloses the tubing extending from the tubing interface ("outlet tubing 18", col. 2, line 50), wherein the liquid flows downwardly into the tubing. Jess does not disclose the liquid flows from the drip chamber through the anti-run-dry membrane to reach an interior of the anti-run-dry membrane. Kraus discloses the flow from the drip chamber through the membrane to the interior ("Filtrate can flow from drain outlet 28 via a conduit 30 to an outlet 32", paragraph [0027]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the flow direction of Jess as taught by Kraus for the same reasons as set forth in the rejection of Claim 20 . 07-21-aia AIA Claim s 24, 25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Jess (US 4,013,072) in view of Haydel (US 6,149,631A) . In relation to claim 24 , Jess discloses an anti-run-dry membrane within the drip chamber, but Jess does not disclose the anti-run-dry membrane is retained at an upper end of the anti-run-dry membrane by the drip feature. Haydel discloses an internal member that is retained at its upper end by the drip feature ("Sleeve member 30 includes a base 32 and a fine bore tube 34 mounted to the base 32 for support... Attached to the base 32 and extending downward in spaced relation to the fine bore tube 34 is an impinging member noted generally be reference numeral 40", col. 4, lines 24-31). Based on the above comments, it would have been obvious to one of ordinary skill in the art to modify the drip chamber of Jess to have the upper end of the filter/membrane retained by the drip feature, as taught by Haydel, in order to securely position the internal member centrally within the fluid flow path and simplify the manufacturing and assembly of the drip chamber components. In relation to claim 25 , Jess does not disclose the drip feature comprises a top membrane retainer that retains the upper end of the anti-run-dry membrane. Haydel discloses the drip feature comprises a top retainer that retains the upper end of the internal member ("Attached to the base 32 and extending downward... is an impinging member", col. 4, lines 28-30). Accordingly, it would have been obvious to one of ordinary skill in the art to modify Jess to include a top membrane retainer as part of the drip feature, as taught by Haydel, for the same reasons as set forth in the rejection of Claim 24. In relation to claim 26 , Jess does not disclose the top membrane retainer comprises a tubular collar. Haydel discloses the top retainer comprises a tubular collar ("Sleeve member 30", col. 4, Lines 21-22) that retains the upper end of the internal member. Therefore, it would have been obvious to one of ordinary skill in the art to modify Jess to utilize a tubular collar as the top retainer, as taught by Haydel, to provide a secure structural connection to the upper end of the membrane . 07-21-aia AIA Claim s 27, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Jess (US 4,013,072) in view of Haydel (US 6,149,631A), as discussed above, and in further view of Carlsson (WO 1996/004944A1) . In relation to claim 27 , Jess and Haydel do not disclose the top membrane retainer is offset from a central axis of the drip unit such that the drip feature delivers the liquid proximate the central axis. However, Carlsson discloses a drip chamber head where the drip feature is arranged eccentrically ("the drip tube 17 is arranged to one side, i.e. eccentrically within the head 1", page 5, lines 11-12). Accordingly, it would have been obvious to one of ordinary skill in the art to offset the top retainer as taught by Carlsson to allow space for other connections or features at the top of the drip chamber while still delivering liquid effectively proximate the central axis. In relation to claim 28 , Jess discloses the bottom portion comprises a bottom membrane retainer. Jess does not disclose the drip feature delivers the liquid offset from a central axis, nor does it disclose the drip feature comprises a top membrane retainer. Additionally, Haydel discloses the drip feature comprises a top membrane retainer ("Attached to the base 32... is an impinging member", col. 4, lines 28-30). Finally, Carlsson discloses the drip feature delivers the liquid offset from a central axis ("the drip tube 17 is arranged to one side, i.e. eccentrically within the head 1", page 5, lines 11-12). Based on the above comments, it would have been obvious to one of ordinary skill in the art to combine these features and align the top and bottom retainers as a matter of obvious design choice to maintain a straight, vertical orientation of the membrane within the chamber for uniform fluid flow and structural stability. In relation to claim 29 , aligning the top and bottom retainers, as rendered obvious in the rejection of claim 28, inherently positions the membrane parallel to the central axis of the drip unit . 07-21-aia AIA Claim 30 are rejected under 35 U.S.C. 103 as being unpatentable over Jess (US 4,013,072) in view of Alisantoso et al. (US 8,974,414B2; hereinafter “Alisantoso”) . In relation to claim 30 , Jess discloses a tubular membrane parallel to the axis. Jess does not disclose the membrane is at an oblique angle. Alisantoso discloses an anti-run-dry membrane that is at an oblique angle with respect to a central axis of the drip unit ("drip chamber 100 alternatively comprises a conical air filter 230", col. 6, lines 52-53). Based on the above comments, it would have been obvious to one of ordinary skill in the art to modify the membrane of Jess to be at an oblique angle, as taught by Alisantoso, in order to reduce the coefficient of friction between bubbles and the filter, thereby assisting in dislodging air bubbles during a priming procedure ("The conical shape of filter 230 further provides an angled surface to assist in dislodging air bubbles 40 as part of a priming procedure", Alisantoso, col. 7, lines 12-14). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM. 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, Bhisma Mehta can be reached at 571-272-3383. 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. Respectfully submitted, /MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783 Application/Control Number: 18/492,656 Page 2 Art Unit: 3783 Application/Control Number: 18/492,656 Page 3 Art Unit: 3783 Application/Control Number: 18/492,656 Page 4 Art Unit: 3783 Application/Control Number: 18/492,656 Page 5 Art Unit: 3783 Application/Control Number: 18/492,656 Page 6 Art Unit: 3783 Application/Control Number: 18/492,656 Page 7 Art Unit: 3783 Application/Control Number: 18/492,656 Page 8 Art Unit: 3783 Application/Control Number: 18/492,656 Page 9 Art Unit: 3783