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 Objections
Claim 1 is objected to because of the following informalities: the phrase “covering and receiving” is grammatically incorrect and should be amended to say “cover and receive”. Appropriate correction is required.
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)(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 1-6, 8-9, 11-12 are rejected under 35 U.S.C. 102a1 as being anitcipated by EP 0671182 to Jerlow (Jerlow).
Regarding claim 1, Jerlow teaches A central line protector apparatus (abstract, see fig. 1, 2) comprising: (a) a central venous catheter (1, Col. 3 ln. 53); (b) a site protector (see ex fig. 1) providing a viewing shield surrounded by a protective frame (see ex. fig.1, Col. 4 ln. 5-14, Col. 4 ln. 33-45); (c) an inlet (8) provided on the site protector configured to covering and receiving the catheter (Col. 4 ln. 5-14); and (d) a protective sleeve (7; see ex. fig. 1) attached to the site protector at the inlet and extending a predetermined length away from the site protector and configured to reduce undesired tampering of the CVC (col. 4 ln. 5-21) ; wherein the protective sleeve is configured to provide a passage for the catheter into the site protector, and into an entry point of the patient (see fig. 1-2).
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Regarding claim 2, Jerlow teaches the claim limitations of claim 1, and teaches further comprising an adhesive element connected to the site protector configured to secure the apparatus to a patient for the CVC (Col. 4 ln. 8-14).
Regarding claim 3, Jerlow teaches the claim limitations of claim 2, and teaches wherein the adhesive element is integrated with site protector (Col. 4 ln. 8-14, note integral does not require that the elements be structurally integral, but can be secured and integral in a functional sense).
Regarding claim 4, Jerlow teaches the claim limitations of claim 1, and further teaches wherein the viewing shield is surrounded circumferentially by the protective frame (see fig. 2- where the lower component of the viewing shield at the attachment point at 10 surrounds the shield base Col. 5 ln. 33-39).
Regarding claim 5, Jerlow teaches the claim limitations of claim 1, and further teaches wherein the viewing shield is made from a semi-rigid material (Col. 4 ln. 54- Col. 5 ln. 7).
Regarding claim 6, Jerlow teaches the claim limitations of claim 1, wherein the viewing shield is substantially flat (see fig. 1) to prevent air or any foreign substance from entering (bottom at 12 can be sealed to prevent elements from entering).
Regarding claim 8, Jerlow teaches the claim limitations of claim 1, wherein wherein the viewing shield is configured to promote breathability at a catheterization site while in use and reduce or prevent condensation or perspiration accumulating at a catheterization site by preventing the viewing shield from being in constant contact with a patient's skin (Col. 5 ln. 21-39).
Regarding claim 9, Jerlow teaches the claim limitations of claim 1, wherein the viewing shield is relatively transparent and made of a clear material to enable a clear view of a catheterization site while in use without removing the site protector (Col. 5 ln. 4-6).
Regarding claim 11, Jerlow teaches the claim limitations of claim 1, wherein the inlet is configured to receive the CVC and define a path for any tubing to remain accessible (Col. 4 ln. 15-21; see fig. 1, the inlet is capable of receiving the catheter and defining a path).
Regarding claim 12, Jerlow teaches the claim limitations of claim 11, wherein the inlet is configured to cover and protect the CVC as it extends towards an insertion point (see fig. 1, the inlet is capable of covering and protecting the catheter).
Regarding claim 19, Jerlow teaches the claim limitations of claim 11, wherein the protective sleeve defines an access hole at a distal end configured to allow for insertion of CVC through the protective sleeve and into the site protector before insertion into a patient and the access hole is covered by a closing mechanism (12; Col. 4 ln. 5-21).
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 1, 4, 13-14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2022/0054217 to Valdez et al. (Valdez) in view of U.S. Publication No. 2022/0062613 to Beckerman et al. (Beckerman).
Regarding claim 1, Valdez teaches a central line protector apparatus (abstract, see fig. 1, 2) comprising: (a) a central venous catheter (abstract, 0029) (b) a site protector (DS) (c) an inlet provided on the site protector configured to covering and receiving the catheter (see fig. 3b); and (d) a protective sleeve (310) attached to the site protector at the inlet and extending a predetermined length away from the site protector and configured to reduce undesired tampering of the CVC (0076); wherein the protective sleeve is configured to provide a passage for the catheter into the site protector, and into an entry point of the patient (abstract, see fig. 3b), but fails to explicitly teach the use of a viewing shield surrounded by a protective frame.
Beckerman teaches the use of a viewing shield (40) surrounded by a protective frame (12; 0022-0023).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the viewing shield surrounded by a protective frame of Beckerman with the device of Valdez in order to allow the port to be visible to a user during use while inhibiting bacterial from accessing the site.
Regarding claim 4, Valdez and Beckerman teaches the claim limitations of claim 1, where Beckerman teaches wherein the viewing shield (40) is surrounded circumferentially by the protective frame (12; see fig. 1, 5; 0023-0024).
Regarding claim 7, Valdez and Beckerman teach the claim limitations of claim 1, where Beckerman teaches wherein the viewing shield defines a convex bubble or dome shape (abstract, 0020, 0023) extending out and away from a patient while preventing air or any foreign substance from entering while in use (0023).
Regarding claim 13, Valdez and Beckerman teach the claim limitations of claim 1, where Valdez teaches further comprising an attachment tab (320a) configured to secure the protective sleeve to the site protector (see fig 3b, 0036, 0076).
Regarding claim 14, Valdez and Beckerman teach the claim limitations of claim 1, where Valdez teaches wherein the protective sleeve is configured to receive and cover any external tubes that extend outside a patient while the CVC is inserted into the patient, wherein the protective sleeve surrounds the external tubes and provides protection external to the patient and decreases or prevents ingress of debris or microbes (abstract, 0076).
Regarding claim 19, Valdez and Beckerman teach the claim limitations of claim 1, where Valdez teaches wherein the protective sleeve defines an access hole at a distal end configured to allow for insertion of CVC through the protective sleeve and into the site protector before insertion into a patient and the access hole is covered by a closing mechanism (see fig. 3b, 320b, 0076).
Regarding claim 20, Valdez and Beckerman teach the claim limitations of claim 1, where Valdez teaches wherein the protective sleeve further includes an elastic band (0060) interposed between an attachment tab (320a) and an access hole (0060), wherein the elastic band is configured to wrap around a circumference of the protective sleeve to cinch it closed and wherein the elastic band is placed near a distal end of the protective sleeve during delivery of medicine or blood draws and external ports on a distal end of one or more external tubes are accessible by exposing the ports through the access hole and the cinching effect of the elastic band is configured to hold the protective sleeve in place and prevent it from slipping beyond the exterior ports (0060).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jerlow.
Regarding claim 10, Jerlow teaches the claim limitations of claim 1, wherein an alternative embodiment of Jerlow teaches the viewing shield is formed of a material that is breathable and configured to prevent undesired contamination to a catheterization site while in use (Col. 5 ln. 55- Col. 6 ln. 14).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included a breathable material in order to help reduce the condensation that can gather in the shield during use.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Valdez and Beckerman and in further view of U.S. Publication No. 2004/0049145 to Flick (Flick).
Regarding claim 15, Valdez and Beckerman teach the claim limitations of claim 14, where Valdez teaches wherein the protective sleeve has antibacterial properties on top or embedded within the sleeve (0036, 0037, 0047-0050), however Valdez fails to explicitly teach the sleeve is made from a breathable bacteriostatic cloth.
Flick teaches a catheter sleeve made from a breathable bacteriostatic cloth (0071, 0072, 0075, 0149).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included breathable bacteriostatic cloth of Flick with the device of Valdez and Beckerman in order to prevent bacterial growth and promote pain relief.
Regarding claim 16, Valdez, Beckerman and Flick teach the claim limitations of claim 15, where Flick teaches wherein the protective sleeve is made from silver impregnated fibers (0071, 0072, 0075, 0149).
Regarding claim 17, Valdez, Beckerman, and Flick teach the claim limitations of claim 15, where Valdez teaches wherein the protective sleeve is removable and interchangeable to allow for replacement with a clean and/or unused sleeve (Fig. 3b, 0059).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Valdez and Beckerman and Flick and in further view of U.S. Patent No. 3,335,723 to Waldman Jr. (Waldman).
Regarding claim 18, Valdez, Beckerman, and Flick teach the claim limitations of claim 15, but fails to explicitly teach wherein the protective sleeve is pleated or accordion shaped configured to expand and contract in length to accommodate varying lengths of external tubes.
Waldman teaches the protective sleeve is pleated or accordion shaped configured to expand and contract in length to accommodate varying lengths of external tubes (see fig. 1-3, Col. 3 ln. 16-20).
It would have been obvious to one of ordinary skill in the art at the time of filing to have included the accordion shaped sleeve of Waldman with the device of Valdez, Beckerman and Flick in order to readily fit a variety of sizes of catheters within the sleeve.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA E EISENBERG whose telephone number is (571)270-5879. The examiner can normally be reached M-F 8-5.
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REBECCA E. EISENBERG
Supervisory Patent Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781