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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-19) in the reply filed on July 1, 2026, is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 1, 2026.
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, “a hydrophobic and antistatic material” (claim 1, line 1) and “a coating of a hydrophobic and antistatic material” (claim 10, line 2) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Specification
The abstract of the disclosure is objected to because:
In line 1, “tubing has” should be changed to “tubing, wherein the connector has”
In line 2, “thereof” should be changed to “of the connector”
In line 3, “line may” should be changed to “line, the method may”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 4, 7, 9, 11-13, 15, and 17-18 are objected to because of the following informalities:
In regards to claim 1, line 1, “line, having” should be changed to “line, the connector having”.
In regards to claim 1, line 2, “thereof” should be changed to “of the connector”.
In regards to claim 4, line 2, “the group” should be changed to “a group”.
In regards to claim 7, line 2, “isopropyl alcohol” should be changed to “the isopropyl alcohol”.
In regards to claim 9, line 1, “the connector” should be changed to “the luer connector”.
In regards to claim 11, line 1, “providing” should be changed to “the providing”.
In regards to claim 12, line 1, “providing” should be changed to “the providing”.
In regards to claim 13, line 1, “providing” should be changed to “the providing”.
In regards to claim 15, line 2, “the group” should be changed to “a group”.
In regards to claim 17, line 1, “providing” should be changed to “the providing”.
In regards to claim 17, lines 1-2, “a coating” should be changed to “the coating”.
In regards to claim 18, line 1, “comprises” should be changed to “comprising”.
In regards to claim 18, line 2, “providing” should be changed to “the providing”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 10-11, 14-15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto et al (US 11,066,745).
In regards to claim 1, Yamamoto et al teaches a connector (Figures 2-2A, labeled in Figure 2 below) for an infusion line, having a hydrophobic and antistatic material (column 4, line 27: coating 42 has an antistatic surface 48)(column 4, lines 34-35 states “the coating may optionally be… SiCOH”, which is known to be hydrophobic) coated on an external surface (46) thereof, the hydrophobic and antistatic material being non-reactive to isopropyl alcohol and chlorhexidine (column 4, lines 34-35 states “the coating may optionally be… SiCOH”, which is known to be non-reactive to isopropyl alcohol and chlorhexidine).
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In regards to claim 2, Yamamoto et al teaches wherein the hydrophobic and antistatic material comprises an organosilicate (column 4, lines 34-35 states “the coating may optionally be… SiCOH”, which is known to be an organosilicate).
In regards to claim 3, Yamamoto et al teaches wherein the hydrophobic and antistatic material has a thickness in a range from 10 nm to 1 µm (column 4, lines 35-41: the vapor deposited coating 42 has a thickness of… optionally 10 nm to 100 nm, optionally 10 nm to 75 nm, optionally 10 nm to 50 nm).
In regards to claim 4, Yamamoto et al teaches wherein the connector comprises a polymer material selected from the group consisting of polyvinyl chloride and polycarbonate (column 2, lines 64-67, to column 3, lines 1-13).
In regards to claim 5, Yamamoto et al teaches wherein the connector has a flexural modulus of at least about 700 MPa (column 2, lines 64-67, to column 3, lines 1-13 states “the polymeric resin compositions can be injection moldable resin compositions, which are preferred because injection molded containers can be made inexpensively… Several specific examples of the polymers from which thermoplastic compositions can be made, any of which are contemplated for any embodiment, are:… polyvinyl chloride (PVC); polycarbonate”, which are known to have a flexural modulus of at least about 700 MPa).
In regards to claim 10, Yamamoto et al teaches a method of treating a connector (Figures 2-2A, labeled in Figure 2 above) for an infusion line, the method comprising:
providing a coating (42) of a hydrophobic and antistatic material (column 4, line 27: coating 42 has an antistatic surface 48)(column 4, lines 34-35 states “the coating may optionally be… SiCOH”, which is known to be hydrophobic) that is non-reactive to isopropyl alcohol and chlorhexidine on an external surface (46) of the connector (column 4, lines 34-35 states “the coating may optionally be… SiCOH”, which is known to be non-reactive to isopropyl alcohol and chlorhexidine)
In regards to claim 11, Yamamoto et al teaches wherein providing the coating comprises applying the hydrophobic and antistatic material using a plasma enhanced chemical vapor deposition (PECVD) process (column 4, lines 28-34).
In regards to claim 14, Yamamoto et al teaches wherein the hydrophobic and antistatic material comprises an organosilicate material (column 4, lines 34-35 states “the coating may optionally be… SiCOH”, which is known to be an organosilicate).
In regards to claim 15, Yamamoto et al teaches wherein the connector comprises a polymer material selected from the group consisting of polyvinyl chloride and polycarbonate (column 2, lines 64-67, to column 3, lines 1-13).
In regards to claim 17, Yamamoto et al teaches wherein providing the coating comprises applying a coating of the hydrophobic and antistatic material having a thickness in a range from 10 nm to 1 µm (column 4, lines 35-41: the vapor deposited coating 42 has a thickness of… optionally 10 nm to 100 nm, optionally 10 nm to 75 nm, optionally 10 nm to 50 nm).
Claim Rejections - 35 USC § 103
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al, as applied to claim 1 above.
In regards to claim 6, Yamamoto et al does not teach wherein the hydrophobic and antistatic material is selected to have a water contact angle of at least 95º, as Yamamoto et al teaches the hydrophobic and antistatic material to be SiCOH (column 4, lines 34-35), which is known to have a water contact angle between 70º and 90º. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the hydrophobic and antistatic material, of the connector of Yamamoto et al, to be selected to have a water contact angle of at least 95º, as Applicant does not disclose that such a water contact angle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the hydrophobic and antistatic material being SiCOH, as taught by Yamamoto et al, which is known to have a water contact angle between 70º and 90º, as a person having ordinary skill in the art would have known how to select the hydrophobic and antistatic material to allow for reducing static charge of the plastic connector.
In regards to claim 7, in the modified connector of Yamamoto et al, Yamamoto et al is silent about wherein the water contact angle is not reduced by more than 10% after interaction with isopropyl alcohol. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the water contact angle, of the modified connector of Yamamoto et al, to be not reduced by more than 10% after interaction with isopropyl alcohol, as Applicant does not disclose that such a water contact angle provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the hydrophobic and antistatic material being SiCOH, as taught by Yamamoto et al, which is known to have a water contact angle between 70º and 90º and to be non-reactive to isopropyl alcohol, as a person having ordinary skill in the art would have known how to select the hydrophobic and antistatic material to allow for reducing static charge of the plastic connector.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al, as applied to claims 1 and 10 above, and further in view of Thiagarajan et al (US 2016/0287758).
In regards to claim 8, Yamamoto et al is silent about wherein the connector is a luer connector. Thiagarajan et al teaches a connector (Figures 4-5) wherein the connector is a luer connector (19). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector, of Yamamoto et al, to be a luer connector, as taught by Thiagarajan et al, as such will enable a syringe or other device to operably connect therewith during fluid carrying (paragraph [0028]).
In regards to claim 16, Yamamoto et al is silent about wherein the connector is a luer connector. Thiagarajan et al teaches a method, wherein the connector is a luer connector (19) (Figures 4-5). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector, of the method of Yamamoto et al, to be a luer connector, as taught by Thiagarajan et al, as such will enable a syringe or other device to operably connect therewith during fluid carrying (paragraph [0028]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al and Thiagarajan et al, as applied to claim 8 above, and further in view of Liu et al (US 9,039,989).
In regards to claim 9, in the modified connector of Yamamoto et al and Thiagarajan et al, Yamamoto et al and Thiagarajan et al are silent about wherein the connector is a male luer connector. Liu et al teaches a connector (Figure 5B) wherein the connector is a male luer connector (110). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified connector, of Yamamoto et al and Thiagarajan et al, to be a male luer connector, as taught by Liu et al, as such will allow for a syringe to be connected therewith during medication infusion therapy (column 1, lines 8-14).
Claims 12-13 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al, as applied to claim 10 above, and further in view of Williams et al (US 5,510,155).
In regards to claim 12, Yamamoto et al does not teach wherein providing the coating comprises applying the hydrophobic and antistatic material by dipping the connector in a liquid comprising the hydrophobic and antistatic material, as Yamamoto et al instead teaches wherein providing the coating comprises applying the hydrophobic and antistatic material using a plasma enhanced chemical vapor deposition (PECVD) process (column 4, lines 28-34). Williams et al teaches a method, wherein providing a coating (30) comprises applying a material by dipping a connector (Figure 1) in a liquid comprising the material (column 4, lines 33-39). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify providing the coating, of the method of Yamamoto et al, to comprise applying the material by dipping the connector in a liquid comprising the material, as taught by Williams et al, as such is a convenient and conventional solution coating technique (column 4, lines 33-39). In the combination of Yamamoto et al and Williams et al, the material is the hydrophobic and antistatic material, as taught by Yamamoto et al.
In regards to claim 13, Yamamoto et al does not teach wherein providing the coating comprises applying the hydrophobic and antistatic material by spraying an aerosol comprising the hydrophobic and antistatic material, as Yamamoto et al instead teaches wherein providing the coating comprises applying the hydrophobic and antistatic material using a plasma enhanced chemical vapor deposition (PECVD) process (column 4, lines 28-34). Williams et al teaches a method, wherein providing a coating (30) comprises applying a material by spraying an aerosol comprising the material (column 4, lines 33-40). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify providing the coating, of the method of Yamamoto et al, to comprise applying the material by spraying an aerosol comprising the material, as taught by Williams et al, as such is a convenient and conventional solution coating technique (column 4, lines 33-39). In the combination of Yamamoto et al and Williams et al, the material is the hydrophobic and antistatic material, as taught by Yamamoto et al.
In regards to claim 18, Yamamoto et al is silent about pretreatment of the external surface of the connector prior to providing the coating. Williams et al teaches a method, comprising pretreatment of an external surface of a connector (Figure 1) prior to providing a coating (30) (column 6, lines 66-67, to column 7, lines 1-7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method, of Yamamoto et al, with pretreatment of the external surface of the connector prior to providing the coating, as taught by Williams et al, as such will expose the external surface of the connector to glow discharge plasma in order to coat the plastic connector with a silicon oxide based film (column 6, lines 60-67, to column 7, lines 1-15).
In regards to claim 19, in the modified method of Yamamoto et al and Williams et al, Yamamoto et al is silent about wherein the pretreatment comprises exposing the external surface to a plasma. Williams et al teaches wherein the pretreatment comprises exposing the external surface to a plasma (column 6, lines 66-67, to column 7, lines 1-7). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the pretreatment, of the modified method of Yamamoto et al and Williams et al, to comprise exposing the external surface to a plasma, as taught by Williams et al, as such will allow for coating the plastic connector with a silicon oxide based film (column 6, lines 60-67, to column 7, lines 1-15).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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