Prosecution Insights
Last updated: April 19, 2026
Application No. 18/226,036

IV MEMBRANE ATTACHMENT SYSTEMS AND METHODS

Non-Final OA §102§103§112
Filed
Jul 25, 2023
Examiner
MENDEZ, MANUEL A
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
BECTON, DICKINSON AND COMPANY
OA Round
1 (Non-Final)
86%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
94%
With Interview

Examiner Intelligence

Grants 86% — above average
86%
Career Allow Rate
1040 granted / 1207 resolved
+16.2% vs TC avg
Moderate +8% lift
Without
With
+8.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
40 currently pending
Career history
1247
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
44.4%
+4.4% vs TC avg
§102
24.0%
-16.0% vs TC avg
§112
12.4%
-27.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1207 resolved cases

Office Action

§102 §103 §112
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 § 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 appl icant regards as his invention. Claim 3 is 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 3 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. Specifically, the claim recites "the adhesive ring". However, the term "the adhesive ring" lacks proper antecedent basis in the claim. Claim 1, from which claim 3 depends, does not introduce an adhesive ring. Claim 2 introduces "an adhesive ring", but claim 3 depends from claim 1, not claim 2. 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)(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. Claims 1 , 7, 8, 9 , 16, and 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ruschke (US 4,521,212 ; hereinafter “ Ruschke ” ) . Independent c laim 1 recites : an intravenous delivery system comprising a drip unit comprising: (a) an exterior wall shaped to at least partially define a drip chamber that receives a liquid from a liquid source, (b) the exterior wall comprising a seat; (c) an anti-run-dry membrane comprising a plurality of pores that are permeable to the liquid, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores, (d) th e anti-run-dry membrane comprising an attachment surface facing towards the seat; and an attachment component that secures the attachment surface to the seat. In relation to independent claim 1 , Ruschke discloses an intravenous delivery system (a "parenteral solution administration set," claim 1) comprising a drip unit (drip chamber 20, col. 3, line 55) comprising: (a) an exterior wall shaped to at least partially define a drip cha mber that receives a liquid from a liquid source: Ruschke teaches a "drip chamber 20" (col. 4 , line 7 and see figures 1 and 2 ) which is the exterior wall. (b) the exterior wall comprising a seat: Ruschke teaches a "filter housing 23 is positioned at the lower end of drip chamber 20 comprising upper housing member 24 and lower housing member 26" (col. 4 , lines 8 - 11 ). The housing members 24 and 26 function as a seat for the filter. (c) an anti-run-dry membrane comprising a plurality of pores that are permeable to the liquid, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores: Ruschke teaches a porous hydrophilic filter having a pore size sufficiently small to prevent air at a predetermined maximum pressure from passing through the filter member when wet, while permitting the flow of parenteral solution therethrough" ( see claim 1; col. 6, lines 11-16 ). (d) the anti-run-dry membrane comprising an attachment surface facing towards the seat: Ruschke discloses a porous hydrophilic filter 28 that is carried between the two housing members 24, 26 (col. 4 , lines 8-1 3 ), meaning its surfaces face the housing members (seat). (e) an attachment component that secures the attachment surface to the seat: Ruschke discloses that the upper and lower housing members (24, 26) are the attachment component. They are "sealed together by adhesive, or by sonic sealing" (col. 4, lines 13-16 ) to secure the filter membrane 28, with its attachment surfaces, to the housing/seat. Thus, Ruschke discloses every element of claim 1. Independent c laim 9 recites : A method for manufacturing an intravenous delivery system, the method comprising: (a) providing a drip unit by: providing an exterior wall shaped to at least partially define a drip chamber that receives a liquid from a liquid source, the exterior wall comprising a seat; (b) providing an anti-run-dry membrane comprising a plurality of pores that are permeable to a liquid to be delivered to a patient, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores, the anti-run-dry membrane comprising an attachment surface; (c) providing an attachment component; and (d) positioning the attachment component to abut the anti-run-dry membrane; and (e) securing the attachment component to the seat of the exterior wall with the attachment component to keep the anti-run-dry membrane in place. In relation to independent claim 9 , Ruschke disclos es a method of manufacturing an intravenous delivery system. The assembly of the device shown and described inherently teaches the method of claim 9: (a) providing a drip unit by: providing an exterior wall shaped to at least partially define a drip chamber that receives a liquid from a liquid source, the exterior wall comprising a seat; Ruschke provides a drip chamber 20 (exterior wall) with a filter housing 23 (seat) (col. 4, 8-11 and see figures 1 and 2) . (b) providing an anti-run-dry membrane comprising a plurality of pores that are permeable to a liquid to be delivered to a patient, wherein the anti-run-dry membrane is formed of a hydrophilic material configured to resist passage of air through the pores, the anti-run-dry membrane comprising an attachment surface; Ruschke provides a porous hydrophilic filter 28. (c) providing an attachment component; and Ruschke provides the housing members 24 and 26, which are the attachment component. (d) positioning the attachment component to abut the anti-run-dry membrane; and Ruschke positions the housing members 24, 26 to carry the filter 28 "between" them (col. 4 , lines 11-13 ). (e) securing the attachment component to the seat of the exterior wall with the attachment component to keep the anti-run-dry membrane in place. Ruschke secures the housing members 24, 26 (attachment component) together via adhesive or sonic sealing, which secures them to the drip chamber 20 (exterior wall) at the filter housing 23 (seat) to keep the membrane in place (col. 4, lines 6-16). Thus, the method of assembling the Ruschke device anticipates the method recited in claim 9. In relation to claim 7 , Ruschke discloses the intravenous delivery system of claim 1. Ruschke further discloses that the seat for the membrane 28 is formed by the housing members 24 and 26. Specifically, Ruschke teaches an "energy-directing ridge 60 is shown, which facilitates the sonic welding of upper housing 24 to lower housing 26" (col. 4, lines 67-68 ). This energy-directing ridge 60 is a ridge on the seat (housing member) on which the membrane rests to facilitate welding. The present application's specification describes a similar feature: "The seat 1020 may have a ridge 1022 on which the surface 1052 of the anti-run-dry membrane 1014 rests; the ridge 1022 may act as an energy director for a welding process such as ultrasonic welding" (para. [0098]). Thus, providing a ridge on the seat is taught by Ruschke . In relation to claim 8 , as established in the rejection of claim 7, Ruschke teaches the structure of claim 7, including a ridge 60 on the seat. Ruschke explicitly teaches that this ridge is an "energy-directing ridge 60... which facilitates the sonic welding of upper housing 24 to lower housing 26" (col. 4, lines 67-68), with the membrane 28 trapped between them. Sonic welding is a type of ultrasonic welding. Therefore, Ruschke teaches ultrasonically welding the components together at the ridge of the seat to secure the membrane, directly anticipating the claimed subject matter. In relation to claim 16 , this rejection follows the same logic as the rejection for claim 7. Ruschke teaches providing a ridge 60 as part of the seat to facilitate sonic welding. In relation to claim 17 , this rejection follows the same logic as the rejection for claim 8. Ruschke explicitly teaches the method of sonic (ultrasonic) welding at the energy-directing ridge 60 to secure the membrane. This directly anticipates the claimed method step. 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. Claims 2 , 3, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ruschke (US 4,521,212 ; hereinafter “ Ruschke ” ) in view Kraus (2003/0220616A1) . In relation to claim 2 , Ruschke discloses the intravenous delivery system of claim 1, as detailed above. Ruschke further teaches that the attachment component (housing members 24, 26) may be "sealed together by adhesive" (col. 4, lines 13-14). Ruschke does not explicitly disclose that the adhesive is in the form of a ring. Kraus teaches bonding a membrane support in a drip chamber "by applying a small amount of adhesive to a bottom surface 19 of DC 5" (para. [0022]). Since the drip chamber and membrane are circular, one of ordinary skill in the art would have understood that applying adhesive to the bottom surface to secure a circular membrane would involve applying the adhesive in an annular or ring shape to ensure a proper seal around the periphery. Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to form the adhesive taught by Ruschke into a ring shape as suggested by Kraus. The motivation to do so would be to provide a uniform and continuous seal around the entire periphery of the membrane, which is a well-known and standard practice for ensuring a leak-proof connection for a circular filter. This would have been a simple and predictable design choice to ensure the efficacy of the adhesive seal. In relation to claim 3 , as established in the rejection of claim 2, the combination of Ruschke and Kraus teaches an intravenous delivery system with an attachment component comprising an adhesive ring. This combination does not explicitly disclose that the adhesive is a pressure-sensitive adhesive secured by compression. However, the use of a pressure-sensitive adhesive (PSA) is a well-known and common type of adhesive in the medical device field. The specification of the present application itself acknowledges this, stating, " The adhesive ring 912 may be formed of a pressure-sensitive adhesive ” (para. [0093]-[0094]). Thus , in response to compression of the adhesive ring, the adhesive ring may adhere to the seat and to the attachment surface of the anti-run-dry membrane . This is an admission that using a PSA secured by compression is a known and conventional method. Therefore, it would have been an obvious matter of design choice for one of ordinary skill in the art to select a pressure-sensitive adhesive from the known types of adhesives for use in Ruschke 's system. The motivation would be to use a clean, easy-to apply, and reliable adhesive that requires no curing time, which are known advantages of PSAs. Securing a PSA via compression is the inherent and standard method of activating its adhesive properties. In relation to claim 10 , as established in the rejection of claim 9, Ruschke teaches the method of claim 9. Ruschke teaches that securing the attachment component can be done with "adhesive". Ruschke does not explicitly teach using a pressure-sensitive adhesive ring and compressing it. As argued for claim 3, it would have been obvious to one of ordinary skill in the art to use a pressure-sensitive adhesive, a common medical device adhesive, and to apply it in a ring shape for a circular filter. The method of securing a PSA is inherently through compression. Therefore, modifying Ruschke 's method to use a PSA ring secured by compression would have been an obvious, c onventional choice to achieve a reliable and easily manufactured seal. Claims 4, 5, 6, 13, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ruschke (US 4,521,212 ; hereinafter “ Ruschke ” ) in view Kraus et al. ( US 5,902,281 ; hereinafter “Jess” ) . In relation to claim 4 , Ruschke discloses the intravenous delivery system of claim 1. Ruschke 's claim 1 further discloses a "parenteral solution administration set having tubular means for conveying solution from a supply source toward the vascular system of a patient," (col. 2, lines 15-19) which teaches the claimed tubing. Ruschke does not explicitly disclose an intravenous access unit connectable to the second end of the tubing. Jess discloses a standard "intravenous infusion set" where liquid flows through an "outlet stem 6 and tube 7 leading to the patient" (col. 3, lines 7-17 ). Jess further clarifies that the connection to the patient is made via "the patient's intravenous cannula" (col. 3 , line s 40-41 ), which is an intravenous access unit. Accordingly, it would have been obvious to one of ordinary skill in the art to provide the parenteral administration set of Ruschke with a conventional intravenous access unit as taught by Jess. The motivation is simple: an intravenous access unit is a fundamental and necessary component to deliver the fluid to the patient's vascular system, which is the stated purpose of Ruschke 's device. Combining these elements results in a complete, functional intravenous delivery system, which is a predictable and intended result. In relation to claim 5 , Ruschke discloses the intravenous delivery system of claim 1, including a drip chamber with an exterior wall. Ruschke does not explicitly disclose that the exterior wall comprises a generally tubular portion, a frustoconical shape, and a shelf disposed in between. Jess discloses a drip chamber that includes these features. Jess teaches a "cylindrical side wall 10" (col. 4 , line s 24-25 ), which is a generally tubular portion. Jess also teaches a "bottom wall member 12" which includes a "circular end wall 20 of conical configuration" (col. 3 , lines 5 7 - 58 ), which is a frustoconical shape. Disposed between the cylindrical side wall and the conical end wall is an "annular wall 21" (col. 3 , line 65 ) which forms a shelf. Based on the above comments, i t would have been obvious to one of ordinary skill in the art to construct the drip chamber of Ruschke with the specific shape taught by Jess. The motivation to do so would be to provide a well-defined, stable, and integrated platform (the shelf) for mounting the filter assembly, which is a known and desirable feature in drip chamber design for ensuring a reliable seal and robust construction. The combination of these references is a predictable amalgamation of known elements to achieve a known function. In relation to claim 6 , as established in the rejection of claim 5, the combination of Ruschke and Jess teaches the structure of claim 5. Jess further discloses that the seat for the filter is on the interior of the shelf. Jess teaches that the "annular wall 21" (the shelf) is "formed with a flat annular seat 22 for receiving the hydrophilic filter 15" (col. 3, lines 59-61). This flat annular seat 22 is an annular surface on the interior of the shelf. Therefore, the claimed feature is taught by the combination of the cited references. In relation to claim 13 , this rejection follows the same logic as the rejection for claim 4. Ruschke teaches a method of making a parenteral administration set which includes "tubular means." Jess teaches a standard infusion set including a tube and an IV cannula for patient access. Therefore, it would have been obvious to complete the manufacturing method of Ruschke by providing the standard tubing and IV access unit taught by Jess to create a complete and functional system. In relation to claim 14 , t his rejection follows the same logic as the rejection for claim 5. I t would have been obvious to manufacture the drip chamber of Ruschke using the conventional shape taught by Jess for the reasons stated previously in the analysis of claim 5 . In relation to claim 15 , this rejection follows the same logic as the rejection for claim 6. As taught by Jess, providing the seat as an annular surface on the interior of the shelf is a known and obvious feature for the reasons stated previously in the analysis of claim 6. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ruschke (US 4,521,212 ; hereinafter “ Ruschke ” ) in view Kraus ( US 2003/0220616A1 ) , as discussed above, and in further view of Jess ( US 4,013,072; hereinafter “Belfort”) . In relation to claim 11 , Ruschke in view of Kraus teaches the method of claim 10, as e stablished above. This combination does not explicitly teach an exterior wall with inwardly protruding interference features that provide radial interference to retain the membrane. Belfort teaches a filter assembly where "the filter 24 can simply be press-fitted into the drip chamber 10" (col. 3 , lines 9-11 ). A press-fit inherently requires interference between the parts. Belfort further teaches that the filter housing has "exterior dimensions correspond to the internal diameter of the drip chamber 10 whereby the filter 24 is capable of establishing a sealing relationship with the interior walls of the drip chamber 10" (col. 3 , lines 4- 9 ). This describes radial interference. While Belfort describes the interference features on the filter housing, the present application describes them on the exterior wall (FIG. 10) as an alternative. The function is the same: to provide a temporary hold during manufacturing. Accordingly, it would have been obvious to one of ordinary skill in the art to add interference features to the interior of Ruschke 's drip chamber wall, as suggested by the press-fit concept in Belfort. The motivation would be to temporarily and securely hold the membrane in place on the seat before the final securing step (e.g., applying the adhesive ring and compressing it), preventing it from shifting. This is a common manufacturing aid, and its application here would yield the predictable result of improved assembly precision. In relation to claim 12 , this claim is rejected for the same reasons as claim 11. Belfort teaches using radial interference to hold a filter in place. The present application acknowledges that the interference features can be on the membrane protruding outward (FIG. 11) or on the wall protruding inward (FIG. 10) to achieve the same result. Belfort shows ribs 34 on the filter housing that protrude outward to engage the inner wall of the drip chamber. Accordingly, it would have been obvious to apply this concept to the membrane assembly in Ruschke for the same reason: to provide a temporary hold during manufacturing. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MANUEL A MENDEZ whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-4962 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Bhisma Mehta can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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
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Prosecution Timeline

Jul 25, 2023
Application Filed
Mar 15, 2026
Non-Final Rejection — §102, §103, §112 (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
86%
Grant Probability
94%
With Interview (+8.0%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 1207 resolved cases by this examiner. Grant probability derived from career allow rate.

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