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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitation “said housing for receiving a hub of a luer connector, in claim 1; the limitation “... a blockage feature for fluidly blocking the hub of the luer connector” in claim 16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Note: the drawings should be included a hub of the luer connector, as recited in the claims 1 & 16
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 & 14-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tennican (US 10,894,153)
Regarding claim 1, Tennican discloses a disinfection cap 100 comprising:
a housing 100 having a top wall (opposite to an open end 104) and a cylindrical sidewall having an inner surface (at inner threads) defining a cavity, and an outer surface;
an open bottom 104 formed by the cylindrical sidewall with an opening 104 to the cavity within said housing for receiving a hub of a luer connector 306, Fig. 5C;
an open cell foam structure 110 disposed within the cavity, the open cell foam structure 110 abutting a top wall of the cavity, the open cell foam structure 110 being impregnated with disinfectant fluid (antimicrobial composition) in a pre-activated state; and
a closed cell foam structure 112 disposed against the open cell foam structure 110, wherein the open cell foam structure 110 and the closed cell foam structure 112 are configured to be immobilized within the cavity in a pre-activated state, see Figs. 1A-1B.
Regarding claim 14, wherein a removable peelable seal 102 covers an opening to the cavity, see Fig. 1A
Regarding claim 15, wherein the open cell foam structure 110 is bonded to the closed cell foam structure 112, see Fig. 1A.
Regarding claim 16, wherein the closed cell foam structure 112 being configured as a blockage feature for fluidly blocking the hub of the luer connector 306, col. 3, lines 4-8.
Claims 1 & 14-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Jiang et al. (US 2022/0331575).
Regarding claim 1, Jiang discloses a disinfection cap 10, in Figs. 1-9, comprising:
a housing 10 & 30 having a top wall and a cylindrical sidewall 26 having an inner surface 31 defining a cavity, and an outer surface 26. See Figs. 1-2;
an open bottom 27 formed by the cylindrical sidewall with an opening 28 to the cavity within said housing for receiving a hub of a luer connector (e.g., male/female luer connector via threads 26 *38, para [0068]);
an open cell foam structure 50 disposed within the cavity, the open cell foam structure 50 abutting a top wall of the cavity, the open cell foam structure 50 being impregnated with disinfectant fluid in a pre-activated state, para [0070]; and
a closed cell foam structure 55 (para [0072]) disposed against the open cell foam structure, wherein the open cell foam structure 50 and the closed cell foam structure 55 are configured to be immobilized within the cavity in a pre-activated state, see Fig. 8.
Regarding claim 2, as best as understood, the open cell foam structure 110 has a non-circular cross-section shape, i.e., cylindrical shape (in cross-section, in vertical direction).
Regarding claim 7, as best as understood, the closed cell foam structure 112 has a non-circular cross-section shape, i.e., cylindrical shape (in cross-section, in vertical direction).
Regarding claim 14, wherein a removable peelable seal 60 covers an opening to the cavity, see Fig. 7.
Regarding claim 15, wherein the open cell foam structure 50 is bonded (via a bond surface 58) to the closed cell foam structure 55, para [0073].
Regarding claim 16, wherein the closed cell foam structure 55 being configured as a blockage feature for fluidly blocking the hub of the luer connector (not shown, in para [0074], ... As a needless connector is threadably secured to the inner threads 36 or outer threads 38, the sealing foam 55 applies pressure to the lumen of a luer connector. The pressure applied to the lumen of the connector by the sealing foam 55 blocks the lumen and mitigates the potential of disinfectant ingress into the luer connectors).
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 2-11, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 10,894,153) in view of Shaw et al. (US 2010/0000040).
Note: incase applicant disagrees with the rejection in claims 2 & 7 above, the claims 2 & 7 are alternatively being rejected as below.
Regarding claims 2-6, Tennican discloses all the claimed subject matter as required. Assuming that Tennican does not disclose that the open cell feam structure has a non-circular cross-sectional shape, i.e., polygonal shape; wherein the closed cell foam structure has one of a multitude of corners which engage the inner surface of the housing in an interference fit; wherein a gap is formed between one of a multitude of corners and the inner surface of the housing, the gap creating a pathway for disinfectant to flow through upon compression of the open cell foam structure; wherein insertion of the luer connector into the cavity causes compression of the open cell foam structure, thereby releasing the disinfectant fluid through the gap.
Note: Tennican discloses that the applicator 108, including the open cell foam 110 may take on other shapes, col. 3, lines 15-17. Therefore, the applicator 108 (including the open cell foam 110 and the closed cell foam 112) can be formed in polygonal shape.
Shaw discloses a disinfection cap 60 in Figs. 12-13 comprising: a housing; an applicator 64 (or open cell foam 30/64, para [0065, 0072]) has a non-circular cross-sectional shape, i.e., a polygonal shape; wherein the closed cell foam structure has one of a multitude of corners which engage the inner surface of the housing in an interference fit. Therefore, a gap is formed between one of a multitude of corners of the polygonal shape and the inner surface of the housing, the gap creating a pathway for disinfectant to flow through upon compression of the open cell foam structure. Therefore, insertion of the luer connector into the cavity causes compression of the open cell foam structure, thereby releasing the disinfectant fluid through the gap.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Tennican with obtaining a polygonal shape in the applicator (e.g., the open cell foam structure is in polygonal shape), as taught by Shaw, in order to create a gap or a pathway in between the inner surface of the housing and the corners of the polygonal shape to enhance of disinfectant liquid flow through upon compression of the open cell foam structure.
Regarding claims 7-11, similar to the analysis as discussed in the claims 2-6 above. As said the above, the closed cell foam 112 in Tennican is a part of applicator 108 can be formed in any shape. The applicator 64 in Shaw has a polygonal shape. Therefore, the closed cell foam 112 is also having a polygonal shape; wherein the closed cell foam structure has one of a multitude of corners (of the polygonal shape) which engage the inner surface of the housing in an interference fit; wherein a gap is formed between one of a multitude of corners and the inner surface of the housing, the gap creating a pathway for disinfectant to flow through upon compression of the open cell foam structure; wherein insertion of the luer connector into the cavity causes compression of the open cell foam structure, thereby releasing the disinfectant fluid through the gap.
Regarding claims 17-20, similar to the analysis as discussed in the claims 2-11 above. Tennican discloses the applicators (e.g., open cell foam or closed cell foam can be formed in any shape) and Shaw discloses that the applicator being in the polygonal shape.
Therefore, it would have been an obvious matter of design choice to obtain a hexagonal, or pentagonal or start shape or four-point start shape or five-point star shape, since applicant has not disclosed that the shapes (e.g., hexagonal, or pentagonal or start shape or four-point start shape or five point star shape) solves any stated problem or is for any particular purpose that is different with respect to the polygonal shape, and it appears that the invention would perform equally well with polygonal shape or any shape in the open/closed cell foam structure.
In addition, the shapes (e.g., hexagonal, or pentagonal or start shape or four-point start shape or five-point star shape) are considered as polygonal shape.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 10,894,153) in view of Rogers et al. (US 2014/0150832).
Regarding claim 12, Tennican discloses all the claimed subject matter except for the limitation that at least one thread on said outer surface of the housing, said at least one thread being sufficient to interlock with a mating feature of the luer connector.
Rogers discloses a disinfection cap 1 in Fig. 1 comprising a housing 1, at least one thread 40 on said outer surface of the housing, said at least one thread being sufficient to interlock with a mating feature of a male-luer connector, para [0027].
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Tennican with providing at least one thread located at outer surface of the housing, as taught by Hitchcok, in order to interlock with a luer connector tightly.
Regarding claim 13, Tennican in view of Rogers discloses all the claimed subject matter. Tennican discloses that the hub 306 is secured within said inner surface of said cavity by interlocking at least a portion of at least one thread (inner threads inside the cap 100/106, see Fig. 1B) with a mating feature, i.e., outer flange, on said hub of said luer connector, see Fig. 3 & 4C.
Claims 2-11, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2022/0331575) in view of Tennican (US 9,527,660).
Note: incase applicant disagrees with the rejection in claims 2 & 7 above, the claims 2 & 7 are alternatively being rejected as below.
Regarding claims 2-5, Jiang discloses all the claimed subject matter as required except for the limitations that the open cell foam structure has a non-circular cross-sectional shape; wherein the open cell foam structure has a polygonal shape; wherein the closed cell foam structure has one of a multitude of corners which engage the inner surface of the housing in an interference fit; wherein a gap is formed between one of a multitude of corners and the inner surface of the housing, the gap creating a pathway for disinfectant to flow through upon compression of the open cell foam structure.
Tennican discloses a disinfection cap comprising: a housing 500/504; an open cell foam 510; a closed cell foam 508 (Note: the applicator material 508 can be made of cellulosic gel, polyurethan, silicon, silicon rubber, polyethylene, polypropylene..., col. 6, lines 11-15. These materials are considered as closed cell foam); wherein the open cell foam structure 510 has a non-circular cross-sectional shape, i.e., a polygonal shape, col. 4, lines 21-25. In addition, Tennican states that: the applicator material (508/510) may include a closed-cell region on one or both axial ends of the applicator material. The closed cell region may have difference surface... or contours, col. 6, lines 23-26;
wherein the closed cell foam structure 508 has one of a multitude of corners (of the polygonal shape) which engage the inner surface of the housing in an interference fit; wherein a gap is formed between one of a multitude of corners (of the polygonal shape) and the inner surface of the housing 500, the gap creating a pathway for disinfectant to flow through upon compression of the open cell foam structure.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Jiang with obtaining a polygonal shape in the open cell foam structure & in the closed cell foam structure, as taught by Tennican, in order to create a gap or a pathway in between the inner surface of the housing and the corners of the polygonal shape to enhance of disinfectant liquid flow through upon compression of the open cell foam structure.
Note: As seen in Fig. 8 in Jiang, the open cell foam 50 and the closed cell foam 55 are now modified to polygonal shape, as suggested by Tennican. Therefore, Jiang in view of Tennican discloses all the claimed subject matter, as required in claims 2-5.
Regarding claims 6-11, Jiang in view of Tennican discloses all the claimed subject matter. Jiang (or Jiang in view of Tennican) discloses that insertion of the luer connector into the cavity causes compression of the open cell foam structure 50, thereby releasing the disinfectant fluid through the gap (that created in between the multitude corner of the polygonal shape of the open cell foam and the inner surface of the housing); wherein the closed cell foam structure has a non-circular cross-sectional shape (polygonal shaped, as modified by Tennican); wherein the closed cell foam structure has a polygonal shape; wherein the closed cell foam structure has one of a multitude of corners (in the polygonal shape) which engage the inner surface of the housing in an interference fit; wherein a gap is formed between one of a multitude of corners and the inner surface of the housing, the gap creating a pathway for disinfectant to flow through upon compression of the open cell foam structure; wherein insertion of the luer connector into the cavity causes compression of the open cell foam structure, thereby releasing the disinfectant fluid through the gap.
Regarding claims 17-20, similar to the analysis as discussed in the claims 2-11 above. Tennican discloses the applicators (e.g., open cell foam or closed cell foam can be formed a polygonal shape or the like, col. 4, lines 21-24, which means that the open/closed cell foam can be formed in any shape.
Therefore, it would have been an obvious matter of design choice to obtain a hexagonal, or pentagonal or start shape or four-point start shape or five-point star shape, since applicant has not disclosed that the shapes (e.g., hexagonal, or pentagonal or start shape or four-point start shape or five point star shape) solves any stated problem or is for any particular purpose that is different with respect to the polygonal shape, and it appears that the invention would perform equally well with polygonal shape in the open/closed cell foam structure.
In addition, the shapes (e.g., hexagonal, or pentagonal or start shape or four-point start shape or five-point star shape) are considered as polygonal shape.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (US 2022/0331575) in view of Hitchcock et al. (US 10,589,080).
Regarding claim 12, Jiang discloses all the claimed subject matter except for the limitation that at least one thread on said outer surface of the housing, said at least one thread being sufficient to interlock with a mating feature of the luer connector.
Hitchcok discloses a disinfection cap 104 comprising a housing 150, at least one thread 143 on said outer surface of the housing, said at least one thread being sufficient to interlock with a mating feature (inner threds) of a male-luer connector, col. 3, lines 20-23.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device of Jiang with providing at least one thread located at outer surface of the housing, as taught by Hitchcok, in order to interlock with a luer connector tightly.
Regarding claim 13, Jiang in view of Hitchcock discloses all the claimed subject matter. Jiang discloses that wherein said hub of the luer connector is secured within said inner surface of said cavity by interlocking at least a portion of at least one thread with a mating feature on said hub of said luer connector.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 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, Michael Tsai can be reached on 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights