Detailed Action1
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 8, 2026 has been entered.
America Invents Act Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 USC 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis 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.
Rejections under 35 USC 112
The following is a quotation of 35 U.S.C. 112:
(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.
Claims 1-2, 4-11, 13-18, and 21-31 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 applicant regards as the invention.
Regarding claims 1 and 10, the preambles respectively recite: A method of providing a water soluble antimicrobial composition to a transdermal catheter, and, A method of providing an inside portion of a transdermal catheter with an antimicrobial agent. However, the bodies of claims 1 and 10 only recite the step of providing a cap. Due to the disconnect between the preamble and body of the claims it is unclear what is required to infringe the claim. For purposes of examination, the claims will be interpreted as only comprising one step: providing a cap, and not including using the cap with a catheter. If this interpretation is correct, the examiner recommends amending the preamble of the claims to recite something similar to: A method of providing a cap configured to provide a water soluble antimicrobial composition to a transdermal catheter.
Claim 10 also recites the solid elongate portion of the cap is insertable into the hub and is configured to form a restriction within the interior channel at the distal end of the tapered portion when the cap is fully threaded onto the transdermal catheter. It is unclear how the solid elongate portion can form the restriction if it is the distal end of the tapered portion that forms the restriction. For purposes of examination, this limitation will be interpreted as: the solid elongate portion of the cap is insertable into the hub, and the cap is configured to form a restriction within the interior channel at the distal end of the tapered portion when the cap is fully threaded onto the transdermal catheter.
Claims 8 and 17 each recite two caps are installed on the two hubs. Since no installation step was previously recited, it is unclear if these claims require the two caps installed on the hubs, or if two caps are required to be provided that are capable of being installed on the hubs. For purposes of examination, the latter interpretation will be used.
The rest of the claims are rejected for depending from one of claims 1 and 10.
Rejections under 35 USC 1032
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious3 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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, 4, 6-10, 14-18, 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over DE-3515665-C1 (“Gerhard”) in view of USPGPub No. 2005/0124970 (“Kunin”).
Claim 1 recites a method comprising, providing a cap that is insertable into the transdermal catheter, the cap comprising an end wall at a proximal end of the cap, a tapered portion (18) extending in a distal direction from the end wall, and a solid elongate portion (30) extending in the distal direction away from a distal end of the tapered portion (figs. 1-2, ¶ [0004]-[0005], wherein all references to the Gerhard specification refer to the machine translation submitted herewith).
Gerhard fails to explicitly teach the cap comprises the water soluble antimicrobial composition located on at least a portion of the cap so that the cap is configured to provide a water soluble antimicrobial composition to a transdermal catheter. However, this would be obvious in view of Kunin.
Kunin is also directed to a closure of a medical catheter or connector (figs. 3-5, paras. [0016]-[0017] & [0023]-[0024]). Kunin teaches the cap comprising a male luer portion 116 with another elongated portion 220 extending distally therefrom (fig. 5, paras. [0018] & [0025]). Kunin teaches that risk of infection of medical catheters or connectors is one of the biggest obstacles and that it is possible for pathogens to grow within the catheter/connector since locking solutions are minimally successful as an antibacterial agent (paras. [0004]-[0005]). Thus, Kunin teaches the cap/closure to provide antibacterial properties within the catheter/connector by providing antibacterial agents on the male luer portion and the elongated portion 220 extending therefrom (fig. 5, paras. [0017] & [0024]-[0025]). When inserting the elongated portion into a catheter/connector with a locking solution, the antibacterial agent diffuses into the solution to provide antibacterial properties (para. [0024]). Kunin teaches the antibacterial agent being a silver that allows silver ions to diffuse into the liquid (paras. [0023] & [0024]). However, Kunin teaches the antimicrobial agent can be other agents such as a lyophilized antimicrobial agent (para. [0017]).
In this case, each of Gerhard and Kunin teach a closure of a medical catheter or connector comprising a male luer portion with another elongated portion extending distally therefrom. Kunin teaches one of skill in the art that there is a reasonable expectation of success of providing a lyophilized antimicrobial agent on the elongated portion in order to provide antibacterial properties within the catheter/connector. The examiner is taking Official Notice that it is well known in the art for antimicrobial agents to be water soluble.4 Thus, in order to prevent infection by preventing pathogen growth within the catheter/connector, it would be obvious in view of Kunin to provide a lyophilized water soluble antimicrobial agent (wherein lyophilization is a drying process) on the outer surface of the elongated member so that the antimicrobial agent is configured to diffuse into the locking solution.
With respect to the below limitations, the claim only positively recites the cap, thus the transdermal catheter is not a required element—the cap merely has to be capable of being used with a hypothetical catheter as claimed. As illustrated in annotated fig. 2 of Gerhard, below, the cap of Gerhard et al. is capable of being used with a catheter, wherein the transdermal catheter having a proximal region that is configured to be located outside of a patient and a distal region that is configured to be located at least partially within the patient, the transdermal catheter including a hub located at a proximal end of the transdermal catheter and an interior channel leading from an opening at the proximal end of the transdermal catheter, the method comprising; wherein: the tapered portion and the solid elongate portion are insertable into the hub of the transdermal catheter to displace a solution that is within the transdermal catheter; the cap is configured such that, when the tapered portion is inserted into a first region of the interior channel of the transdermal catheter and the cap is fully threaded onto the transdermal catheter, the tapered portion is configured to displace at least a first portion of the solution initially within a first region of the interior channel (wherein the hub can have threads on an exterior surface while still allowing ribs 26 & 28 to move past them via elastic deformation, see ¶ [0006] of Gerhard; the hub can also be filled with a locking solution prior to insertion of the cap); the first region extends between the proximal end of the transdermal catheter and the distal end of the tapered portion of the cap when the cap is fully threaded onto the transdermal catheter; the cap is configured to form a restriction between the interior channel of the transdermal catheter and the tapered portion when the cap is fully threaded onto the transdermal catheter (¶ [0008]-[0009]); the cap is configured such that insertion of the solid elongate portion of the cap into the hub of the transdermal catheter displaces at least a second portion of the solution initially within a second region of the interior channel of the transdermal catheter; the second region is located axially beyond the first region, the second region extending distally from a distal end of the first region to a constriction in the interior channel of the transdermal catheter when the cap is fully threaded onto the transdermal catheter; the water soluble antimicrobial composition located on at least a portion of the cap is configured to be dispersed into the solution after insertion of at least the solid elongate portion of the cap into the hub of the transdermal catheter (wherein when a lock solution is in the hub, the water soluble antimicrobial agent is configured to be released therein); a third region of the interior channel is axially beyond the second region, the third region extends distally from the constriction in the interior channel of the transdermal catheter to a distal tip of the solid elongate portion; a fourth region of the interior channel is axially beyond the third region, the fourth region extends distally from the distal tip of the solid elongate portion.
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As further illustrated above, since there would be minimal amount of lock solution in the first region due to the seal between the tapered portion 18 and inner wall of the hub, a first volume of the solution in the first region, when the cap is fully threaded onto the transdermal catheter, is less than a second volume of the solution in the second region, when the cap is fully threaded onto the transdermal catheter; the second volume of the solution in the second region, when the cap is fully threaded onto the transdermal catheter, is greater than a third volume of the solution in the third region when the cap is fully threaded onto the transdermal catheter. Further, since solution can flow from the second region to the fourth region via the third region, the volume within the second region can disperse in the third and fourth regions over time, thus reading on: a portion of the water soluble antimicrobial composition disperses and diffuses axially beyond the second region and to the third region and the fourth region after a period of time.
Claim 10 has a lot of overlap with claim 1. Limitations also found in claim 1 will not be repeated again and are taught by Gerhard in view of Kunin as detailed in the rejection to claim 1, above. Gerhard et al. further teach an outer shroud (20) extending in a distal direction from the end wall (figs. 1-2 of Gerhard), the solid elongate portion extending distally beyond the outer shroud (figs. 1-2 of Gerhard); the first portion of the solution adjacent to the opening (figs. 1-2 of Gerhard, wherein the first portion/region extends from the proximal end/opening to the distal end of the tapered portion).
Claim 10 also recites a concentration of the water soluble antimicrobial composition in the second region is higher than the fourth region after a period of time; and the restriction is adapted to reduce an amount of diffusion of the water soluble antimicrobial composition in the solution in the hub proximal to the second region to kill organisms. Since the tapered portion forms a seal with the catheter, the restriction created by the distal end of the tapered portion reduces the amount of diffusion of the composition proximal to the second region. With respect to the concentration of the antimicrobial composition, since the second region overlaps with the elongate portion having the antimicrobial composition therein, and the fourth region is entirely distal from the elongate portion, one of skill in the art will reasonably infer that for a period time after the initial insertion of the elongate portion within the catheter that a concentration of the antimicrobial composition within the second region will be higher than the fourth region because more of the antimicrobial composition will disperse from the elongate portion directly into the second region than disperse directly into the fourth region.
Claims 4 and 16 each recites the cap is configured to be retained entirely proximal to a clamp connected to the transdermal catheter. The cap of Gerhard et al. is capable of being inserted into a catheter proximal to a clamp it is possible to use the cap of Gerhard et al. with a catheter configured to be clamped.
Claims 6 and 15 each recite the water soluble antimicrobial composition is coated on the cap. See rejection to claim 1, above, wherein the lyophilization process results in the antimicrobial composition coated on the cap.
Regarding claim 7, Gerhard further teaches a length of the cap from the proximal end of the cap to the distal end of the tapered portion is greater than a length of the solid elongate portion (figs. 1-2).
Claims 8 and 17 each recite the transdermal catheter is a hemodialysis catheter having two hubs, and wherein two caps are installed on the two hubs. As noted above, the catheter is not a positively recited element. It would be obvious to provide multiple caps in order to close multiple catheters. Further, MPEP 2144.04(VI(B) states mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In this case, duplicating the cap of Gerhard et al. produces the expected result of allowing multiple catheters/hubs to be closed.
Since multiple caps are provided, two caps are capable of being installed on respective hubs of a transdermal catheter.
Claims 9 and 18 each recite upon insertion, the cap displaces a volume of at least 0.03 mL of the solution out of the hub. The cap of Gerhard et al. is capable of being inserted into a catheter that is completely filled with lock solution. Thus, this imitation is met if the tapered portion and elongate portion have a volume capable of displacing at least 0.03 mL. One of skill in the art will reasonably infer than the tapered portion and elongate portion can displace at least .03 mL of lock solution given the standard size of catheters and caps. Assuming arguendo that one of skill in the art would not reasonably infer this, MPEP 2144.04(IV)(A) states that mere scaling up of a prior art process capable of being scaled up does not establish patentability in a claim to an old process so scaled. In this case, merely scaling up the size of the catheter/cap so that the cap displaces more than 0.03 mL of solution of the hub does not establish patentability.
Claim 14 recites upon insertion of the cap into the hub, the water soluble antimicrobial composition does not enter a distal region of the transdermal catheter or a patient. Since the cap is inserted into the proximal end of the catheter, one of skill in the art will reasonably infer that it will take some time for the antimicrobial composition to reach the distal region of the catheter or a patient. The cap can also be used with a catheter having a clamp so that the antimicrobial composition never reaches the patient or distal region of the catheter.
Claims 21-24 recite one of the following limitations: a concentration of the water soluble antimicrobial composition in the second region is at least ten times higher than the fourth region after the period of time, and, the concentration of the water soluble antimicrobial composition in the second region is at least ten times greater than the fourth region after forty eight hours. These limitations are dependent upon the structure of the catheter—which is not a positively recited element. Specifically, these limitations are dependent upon the size of the constriction of the catheter (i.e. gap between the elongate portion and the inner wall of the catheter at the constriction), location of the constriction with respect to the elongate portion, and orientation and movement of the catheter after insertion of the cap (wherein movement of the catheter and/or orientation can allow greater fluid flow between the second region and fourth region). If the cap of Gerhard et al. is used with a catheter having the constriction proximal to the distal end of the elongate portion, a minimal clearance/gap between the elongate portion and the inner surface of the catheter at the constriction, and the catheter is held stationary after insertion of the cap, one of skill in the art will reasonably infer that the limitations of claims 21-24 will be met since there will be much more of the antimicrobial composition that disperses directly into the second region than the fourth region, and there will be minimal fluid flow between the second and fourth regions.
The examiner also notes that an end point for the fourth region is not defined by the claims. Thus, the fourth region can be interpreted as a region with a significantly smaller axial length than the second region.
Regarding claim 25, Gerhard further teaches the solid elongate portion is solid along an entire length thereof (see figs. 1-2 of Gerhard).
Regarding claims 26 and 28, Gerhard further teaches the restriction is a seal (see fig. 2 & ¶ [0008] of Gerhard).
Regarding claim 27 and 29, Gerhard further teaches the tapered portion extends distally beyond a threaded portion of the cap (see figs. 1-2 of Gerhard, wherein tapered portion 18 extends distally beyond thread 24).
Claims 2, 5, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Gerhard et al. as applied to claim 1 above, and further in view of USPGPub No. 2012/0302997 (“Gardner”).
Regarding claims 2 and 11, Gerhard et al. fail to explicitly teach a precipitate is configured to be formed through a chemical reaction involving chlorhexidine ions and chlorine ions, wherein the precipitate of the water soluble antimicrobial composition is positioned on at least a portion of a wall in the proximal region, wherein the precipitate possesses antimicrobial properties. However, this would have been obvious in view of Gardner.
Gardner is also directed to an antiseptic cap for a medical connector (para. [0001]). Gardner teaches that the cap can have an elongate rod 34 & 211 that is coated with an antimicrobial configured to be released to disinfect the connector (figs. 1 & 6, paras. [0037]- [0039] & [0049]). Gardner teaches the antimicrobial can be in liquid or solid form and can comprise silver compounds such as silver acetate, silver oxide, silver sulfate, or can comprise chlorhexidine, chlorhexidine gluconate, or chlorhexidine acetate (paras. [0099]-[0102]).
In this case, each of Gerhard et al. and Gardner are directed to a catheter cap having an elongate portion coated with an antimicrobial agent to disinfect the catheter. Gerhard in view of Kunin teaches the antimicrobial agent can be a silver compound or a lyophilized antimicrobial agent (para. [0017] of Kunin). Gardner teaches that chlorhexidine gluconate or chlorhexidine acetate is a known substitute for silver compounds. Further, one of skill in the art appreciates that chlorhexidine gluconate or chlorhexidine acetate can be lyophilized. Thus, it would be obvious to modify Gerhard et al. so that the antimicrobial agent is lyophilized chlorhexidine gluconate or chlorhexidine acetate.
Claims 5 and 13 each recite the water soluble antimicrobial composition comprises chlorhexidine. This is obvious in view of Gardner for the same reasons detailed in the rejection to claims 2 and 11, above.
Allowable Subject Matter
Claims 30 and 31 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Claims 30 and 31 are interpreted as positively reciting the catheter since the catheter is required for the inserting step.
Response to Arguments
Applicant's arguments filed January 8, 2026 (“the remarks”) have been fully considered. The examiner agrees that the amendments to claim 10 overcome the previous prior art rejections over Rogers et al. Thus, the previous prior art rejections are withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Cook whose telephone number is 571-272-2281. The examiner’s fax number is 571-273-3545. The examiner can normally be reached on Monday-Friday 9AM-5PM EST.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner's supervisor Thomas Hong (571-272-0993). The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A COOK/Primary Examiner, Art Unit 3726
1 The following conventions are used in this office action. All direct quotations from claims are presented in italics. All information within non-italicized parentheses and presented with claim language are from or refer to the cited prior art reference unless explicitly stated otherwise.
2 In 103 rejections, when the primary reference is followed by “et al.”, “et al.” refers to the secondary references. For example, if Jones was modified by Smith and Johnson, subsequent recitations of “Jones et al.” mean “Jones in view of Smith and Johnson”.
3 Hereafter all uses of the word “obvious” should be construed to mean “obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.”
4 A specific water soluble antimicrobial agent, i.e. chlorhexidine gluconate, is used in the rejections to claims 2, 5, 11, and 13.