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 .
Response to Amendment
The amendments to the claims and drawings filed 04/13/2026 have been entered. Claims 1-6, 8-11, 16-24, 27 are pending in the application.
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.
Claims 1-6, 8-11, 17-18, 20, 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chiu (US 2017/0232121) in view of Vassallo (US 2016/0030288) and further in view of Solomon (US 20160144118) and further in view of in view of Daneluzzi (US 2016/0213912) as evidenced by Raulerson (US 2006/0030827) and Sansoucy (US 2012/0083750).
Regarding claim 1, Chiu discloses a device (device of Fig 35) for connection to a medical connector, the device comprising: a cap (20, Fig 35) comprising an integral body (71, Fig 38), a closed end (closed base of cap 20, Fig 38), an annular wall (wall of cap 20, Fig 38) having a length Lc extending from the closed end to an open end (end defined by ring 72, Fig 38) and defining a chamber (See Fig 38) containing an absorbent material (50, Fig 35) and disinfectant or antimicrobial agent (Para 0075), the open end having a peripheral ledge (73, Fig 38) extending radially inward from the open end defining an end face and an engagement surface (top surface of ledge 73, Fig 42), the peripheral ledge is adapted and sized to allow a male luer connector to rest on the peripheral ledge (the male luer connector rests on the peripheral ledge at least indirectly through the membrane flange 81, See Fig 42; Para 0072); the annular wall having an exterior wall surface and an interior wall surface (See Fig 42); one or more internal threads (39, Fig 37) are adapted and sized to engage a female luer connector (Para 0076), the internal thread disposed adjacent the closed end that partially extend along a length of the interior wall surface (Para 0069, liens 29-31); an opening therethrough sized and adapted to receive either a male luer connector, a female luer connector or a hemodialysis connector (Para 0043); a locking lid (81, Fig 37) having perforations (80, Fig 36) configured to engaged with the engagement surface and secure the elastic sealing ring to the open end (See Fig 42, Para 0071; the perforations and extrusions are intended to form a permanent connection), the locking lid having an end surface (top surface of membrane flange 81, Fig 36); and a peelable seal (10, Fig 35) on the end surface of the locking lid to prevent the disinfectant or the antimicrobial agent from exiting the chamber (Para 0073).
Chiu is silent to an elastic sealing ring having a dilatable opening therethrough sized and adapted to receive a male luer connector, a female luer connector and a hemodialysis connector, wherein the elastic seal ring is configured to frictionally engage a male luer connector upon insertion into the elastic sealing ring and the locking lid having a peripheral sidewall extending perpendicularly from a base, one or more threads disposed on an interior surface of the peripheral sidewall of the locking lid configured to engage with the engagement surface.
Vassallo teaches a locking lid (20, Fig 2) having a peripheral sidewall (28, Fig 2) extending perpendicularly from a base (98, Fig 2), one or more threads (118, Fig 8) disposed on an interior surface of the peripheral sidewall of the locking lid configured to engage with the engagement surface and engaging the elastic seal (16, Fig 2) to the open end (Para 0051).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the perforations of the locking lid and the extrusions 75 of the cap disclosed by Chiu to be the threads and retention lugs 120 taught by Vassallo in order to more easily form a permanent connection between the locking lid and cap since the lugs form a permanent lock as soon as the lid is seated onto the cap (Para 0051 -Vassallo). Chiu further teaches that the lid and cap can be affixed by other mechanical means (Para 0049), therefore, one of ordinary skill would have ample motivation to modify the rivets with locking threads.
The modified invention of Chiu and Vassallo disclose all of the elements of the invention, however, is silent regarding an elastic sealing ring having a dilatable opening therethrough sized and adapted to receive a male luer connector, a female luer connector and a hemodialysis connector, wherein the elastic seal ring is configured to frictionally engage a male luer connector upon insertion into the elastic sealing ring.
Solomon teach an analogous device (device of Fig 7) for connection to a medical connector comprising: a cap (16) comprising a closed end (12, Fig 7), an open end (10, Fig 7), and a chamber (30, Fig 7) containing a disinfectant (antiseptic liquid, Para 0052), the open end having a peripheral ledge (ledge that the elastic sealing ring 20 rest on, Fig 7); an elastic sealing ring (20, Fig 7) having a dilatable opening (14, Fig 7) therethrough sized and adapted to receive connectors of varying dimensions (Para 0003), wherein the elastic seal ring is configured to frictionally engage a male luer connector upon insertion into the elastic sealing ring (Para 0055 and Para 0057).
Daneluzzi teaches an elastic ring (3, Fig 2) having a dilatable opening therethrough sized and adapted to receive and frictionally engage any connector present on the market (Para 0055, Para 0062, claim 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Chiu to include an elastic sealing ring dimensioned to receive and engage a male luer, a female luer, and a hemodialysis connector as taught by Solomon and Daneluzzi in order to have a universal cap that can be removably held on connectors of varying dimensions by a compression fit (Para 0003 -Solomon; Para 0055 -Daneluzzi).
Examiner notes that a hemodialysis connector can be a luer connector as evidenced by Raulerson (US 2006/0030827) and Sansoucy (US 2012/0083750) in Para 0003 and Para 0029, respectively.
Regarding claim 2, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the female luer connector is selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors (Para 0043 -Chiu).
Regarding claim 3, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the dilatable opening (14, Fig 7 -Solomon) is sized to frictionally engage a male luer connector (Para 0003-Solomon).
Regarding claim 4, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the male connector is an intravenous tubing end, stopcock or male lock luer (Para 0043 -Chiu).
Regarding claim 5, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the elastic sealing ring (20, Fig 7 -Solomon) is in contact with the peripheral ledge (ledge that the elastic sealing ring 20 rest on, Fig 7 -Solomon).
Regarding claim 6, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses a dilatable opening (14, Fig 7 -Solomon), however, is silent regarding a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm.
The instant specifications indicates that the dilatable opening is sized to receive a male luer connector, a female luer connector, or a hemodialysis connector. Since Chiu, Solomon, and Daneluzzi are sized to receive male and female luer connectors, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the dilatable opening to be dilatable from 7-9mm to 9-12mm since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 8, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the peripheral ledge (ledge that the elastic sealing ring 20 rest on, Fig 7 -Solomon) is sized and adapted to receive the elastic sealing ring (20, Fig 7 -Solomon).
Regarding claim 9, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses all of the elements of the invention as discussed above, however, is silent regarding the cap comprises a polypropylene or polyethylene material.
Solomon further teaches the cap comprises a polypropylene material (Para 0068).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap to be made of polypropylene as taught by Solomon in order to for the cap to be IPA impermeable (Para 0068).
Regarding claim 10, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the elastic sealing ring (20, Fig 7 -Solomon) comprises an elastomeric material (Para 0068 -Solomon).
Regarding claim 11, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the elastomeric material comprises a thermoplastic elastomer (Para 0068 -Solomon).
Regarding claim 17, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses a compression of the absorbent material toward the closed end of the chamber occurs upon connection to the female luer connector or the male luer connector (Para 0075, lines 1-4 -Chiu).
Regarding claim 18, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses compression of the absorbent material disinfects the female luer connector or the male luer connector (Para 0075, lines 1-4 -Chiu).
Regarding claim 20, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof (Para 0046, lines 3-6 -Chiu).
Regarding claim 22, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the disinfectant or antimicrobial agent is a fluid or a gel (Para 0046, lines 6-8 -Chiu)
Regarding claim 23, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the peelable seal comprises an aluminum or multi-layer polymer film peel back top (Para 0073, lines 17-19).
Claims 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chiu (US 2017/0232121) in view of Vassallo (US 2016/0030288) and further in view of Solomon (US 20160144118) and further in view of in view of Daneluzzi (US 2016/0213912) and further in view of Gardner (US 2016/0045629).
Regarding claim 19, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses all of the elements of the invention as discussed above, however, is silent regarding the absorbent material is under radial compression by the internal threads to retain the absorbent material in the chamber.
Gardner teaches an analogous device (1010, Fig 26), wherein the absorbent material (1032, Fig 26) is under radial compression by the internal threads (1030, Fig 26) to retain the absorbent material in the chamber (Para 0103, lines 5-8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to include retaining rings as taught by Gardner to provide internal threads for better retaining the absorbent material (Para 0103, lines 5-8).
Regarding claim 21, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses all of the elements of the invention as discussed above, however, is silent regarding the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.
Gardner teaches an analogous device (310, Fig 6), wherein the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate (Para 0052, lines 2-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the isopropyl alcohol as taught by Chiu to instead be chlorhexidine gluconate as Gardner teach that isopropyl alcohol and chlorhexidine gluconate could be used to achieve the same result (disinfect a connector as described in Para 0052, lines 2-5) and thus were art-recognized equivalents at the time the invention was made. it has been held that substituting parts of an invention involves only routine skill in the art.
Claims 16 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chiu (US 2017/0232121) in view of Vassallo (US 2016/0030288) and further in view of Solomon (US 20160144118) and further in view of in view of Daneluzzi (US 2016/0213912) and further in view of Kerr (US 2014/0366914).
Regarding claim 16, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses all of the elements of the invention as discussed above, however, is silent regarding the absorbent material has slits.
Kerr teaches an analogous device (20, Fig 1), wherein the absorbent material (110, Fig 19) has slits (111, 19) (Para 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the absorbent material to comprise slits as taught by Kerr in order to increase the surface area for scrubbing to provide a more effective disinfecting (Para 0093).
Regarding claim 24, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses all of the elements of the invention as discussed above, however, is silent regarding the peelable seal is heat-sealed or induction sealed to the engagement surface.
Kerr teaches an analogous device (20, Fig 1), wherein the peelable seal is heat-sealed to the engagement surface (Para 0066, lines 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peelable seal to be heat sealed as taught by Kerr in order easily seal the cap while still being able remove it when needed (Para 0066).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Chiu (US 2017/0232121) in view of Vassallo (US 2016/0030288) and further in view of Solomon (US 20160144118) and further in view of in view of Daneluzzi (US 2016/0213912) and further in view of Raulerson (US 2006/0030827).
Regarding Claim 27, the modified invention of Chiu, Vassallo, Solomon, and Daneluzzi discloses the opening adjacent the open end of the interior wall surface is sized and adapted to receive the elastic sealing ring (See Fig 7 -Solomon), however, is silent regarding the opening adjacent the open end of the interior wall surface is sized and adapted to receive an elastic sealing ring in a press-fit connection.
Raulerson teaches a ring (152, Fig 3) and a cap (108, Fig 3) having an interior wall; wherein the opening adjacent the open end of the interior wall surface is sized and adapted to receive a ring in a press-fit connection (Para 0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cap and elastic sealing ring to be coupled via a press-fit connection as taught by Raulerson as Raulerson teaches that a press-fit or interference fit is a common form of coupling elements in a medical device (Para 0027).
Response to Arguments
Applicant’s arguments filed 04/13/2026, on pages 5-6, regarding Chiu not disclosing a cap and absorbent material that are configured to continuously disinfect male, female, and hemodialysis connectors for seven days have been fully considered but are not persuasive. This is not a claimed limitation and therefore has not been addressed in the rejections above.
Applicant’s arguments filed 04/13/2026, on page 6, regarding Vassallo does not disclose a disinfection cap and does not disclose a locking lid that engages with an engagement surface of a cap and secures an elastic sealing ring to an open end of a cap, or a locking lid that has a base and an end surface with no walls have been fully considered but are not persuasive. While Vassallo is not directed to a disinfection cap, it is analogous art under prong two (the reference is reasonably pertinent to the problem faced by the inventor…A reference outside of the field of endeavor is reasonably pertinent if a person of ordinary skill would have consulted it and applied its teachings when faced with the problem that the inventor was trying to solve (MPEP 2141.01(a)(I))) since Vassallo addresses mechanical means to attach a lid to a cup or container. Applicant argues Vassallo does not disclose a locking lid that engages with an engagement surface of a cap and secures an elastic sealing ring to an open end of a cap, or a locking lid that has a base and an end surface with no walls. As detailed in the rejection of claim 1 above, Vassallo teaches a locking lid (20, Fig 2) that engages with an engagement surface of a cap (“container”) and secures an elastic seal (16, Fig 2) to an open end of a cap (Para 0051). Vassallo does not disclose an end surface with no walls, however, the claim explicitly requires “a locking lid having a peripheral sidewall”. Thus, it is unclear what limitation Applicant is referring to in this argument.
Applicant’s arguments filed 04/13/2026, on page 7, regarding Solomon does not receive a compliant wall, the compliant wall is part of the proximal portion of the cap have been fully considered but are not persuasive. Para 0057 of Solomon describes the cap body 16 as one component and the compliant wall 20 as a separate component received within the body as illustrated in Fig. 7. This is further highlighted by the fact that cap body 16 and compliant wall 20 have differing crosshatching in Fig 7. Applicant further mentions that the compliant walls in Solomon are not dilatable. Para 0057 also details that the “compliant wall 20 deforms when a NIS is inserted into the opening 14 so that the compliant wall 20 engages threading elements on the outer diameter of the NIS”. Deforming to accommodate the threads is synonymous with dilating or widening. Thus, Solomon still reads on the claim language and obviates the claims as detailed in the rejection of claim 1 above.
Applicant’s arguments filed 04/13/2026, on page 7-8, regarding Daneluzzi’s sponge-like element not being separate from the absorbent material have been fully considered, but is not persuasive. As detailed in the rejection of claim 1 above, Daneluzzi is not relied upon to teach specific structural elements, but that a compliant wall (similar to that taught in Solomon) can be sized to accommodate male luer connectors, female luer connector, and hemodialysis connectors to have a universal cap. Thus, the sponge-like element not being separate from the absorbent material is not really relevant to the combination as Chiu and Solomon both teach having elastic sealing rings separate from the disinfectant/absorbent material.
Applicant’s arguments filed 04/13/2026, on page 9-11, regarding Gardner, Kerr, and Raulerson failing to remedy the deficiencies of references relied upon to rejection the independent claim have been fully considered but are not persuasive for the reasons outlines in the response to Applicant’s arguments above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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