DETAILED ACTION
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 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 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.
Election/Restrictions
Applicant’s election without traverse of species A and sub-species A (claims 1-6 and 9) in the reply filed on 3/9/26 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(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 2-3 and 5-11 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2:
The claim is unclear because of the limitation “the drain tube includes a flexible tube, a 3-way valve, and connectors that connect the 3-way valve to the flexible tube” in lines 2-3. This limitation further modifies the drainage tube which claim 1 establishes as outside the scope of the claim since it is mentioned in the preamble of the claim. For this reasons, further modifications to the structure of the drainage tube is unclear since the structure of the drainage tube is not required structure of the claim. For the sake of examination, the office has assumed that the drainage tube is required by the claim however the applicant should amend claim 1 to clarify.
Claims 3 and 5-11 are rejected due to their dependence on claim 1.
Regarding claim 9:
The claim is unclear because of the limitation “the connector” in lines 2-3 of the claim. The limitation is unclear because a plurality of connectors have been established in line 2 of claim 2 (on which this claim depends) raising a question of if this connector is part of the plurality of connectors established in claim 2 or a different connector. For the sake of examination, the office has assumed that this connector is part of the plurality established in claim 2 however the applicant should amend the claim to clarify.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4626246 A to Verkade in view of US 20140188079 A1 to Simons et al. (Simons).
Regarding claim 1:
Verkade discloses:
A plaster (as shown in figure 2) for fixing a drainage tube (16), which fixes the drainage tube (16) that is inserted into a patient's body (as shown in figures 1 and 2) and discharges liquid inside the patient's body to the outside of the patient's body (column 2, lines 1-10), the plaster comprising:
a plurality of support pads (32/23) attached to the patient's body to be spaced apart from each other, each of the plurality of support pads (32/23) having a certain thickness (as shown in figure 2);
a support band (22) fixed to respective upper surfaces (under the broadest reasonable interpretation, the support band 22 attached to the upper surface of 23/32 since the two structures are coupled together) of the support pads (32/23) to cover the skin (as shown in figure 2); and
a holder (29) coupled to the support band (22) to hold and fix the drainage tube (16).
Verkade fails to disclose:
A plurality of holders detachably coupled to an upper surface of the support band to hold and fix the drainage tube.
Simons teaches:
A plaster (100) for supporting a tube (404) on a patient’s body (400). Further, the plaster includes a support band (102) and a plurality of holders (110 and 112) on the top of the support band that support the tube (as shown in figure 4). Further, the plurality of holders are detachably coupled (172/170/168/166 or 156/157/154/155)(¶0025) to allow for the folding and unfolding of the holders (as shown in figure 3) when the tubes are attached.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Verkade to replace the holder in Verkade with the foldable and detachable holders as taught by Simons to hold the drainage tube. This is a simple substitution of one known element (holder in Verkade) for another (plurality of holders in Simons) to obtain predictable results (to hold the tubes to the support band and therefore support and secure the drainage tubing). Further, the plurality of holders would be connected to the upper surface of the support band in the same way the plurality of holders (110/112) are mounted to the support band (102) in Simons.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4316461 A to Marais et al. (Marais) in view of US 20140188079 A1 to Simons et al. (Simons).
Regarding claim 1:
Marais discloses:
A plaster (figures 1 and 7) for fixing a drainage tube (interpreted as intended use however this reference does show a tube 42 connected to the plaster), which fixes the drainage tube that is inserted into a patient's body (see abstract) and discharges liquid inside the patient's body to the outside of the patient's body (interpreted as intended use since this structure is not required by the claim and further since the plaster of the reference is capable of this function), the plaster comprising:
a plurality of support pads (11/12) attached to the patient's body to be spaced apart from each other (as shown in figure 1), each of the plurality of support pads having a certain thickness (as shown in figures 3 and 4);
a support band (10) fixed to respective upper surfaces (on top of the supporting pads 11/12) of the support pads to cover the skin (as shown in figure 6); and
a plurality of holders (25/25’/27/25’’) coupled to an upper surface (as shown in figures 3 and 4) of the support band to hold and fix the drainage tube (interpreted as intended use since the structure is beyond the scope of the claim).
Marais fails to disclose:
A plurality of holders detachably coupled to an upper surface of the support band.
Simons teaches:
A plaster (100) for supporting a tube (404) on a patient’s body (400). Further, the plaster includes a support band (102) and a plurality of holders (110 and 112) on the top of the support band that support the tube (as shown in figure 4). Further, the plurality of holders are detachably coupled (172/170/168/166 or 156/157/154/155)(¶0025) to allow for the folding and unfolding of the holders (as shown in figure 3) when the tubes are attached.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Verkade to replace the holder in Verkade with the foldable and detachable holders as taught by Simons to hold the drainage tube. This is a simple substitution of one known element (holder in Verkade) for another (plurality of holders in Simons) to obtain predictable results (to hold the tubes to the support band and therefore support and secure the drainage tubing). Further, the plurality of holders would be connected to the upper surface of the support band in the same way the plurality of holders (110/112) are mounted to the support band (102) in Simons.
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4626246 A to Verkade and US 20140188079 A1 to Simons et al. (Simons) as applied to claim 1 above, and further in view of US 5037398 A to Buchanan.
Regarding claim 2:
Verkade discloses:
The plaster of claim 1, wherein
the drain tube (16) includes a flexible tube (see accordion portion 14 and 15), and
the support band (22) has a support (25 as shown in figure 2) that supports the drain tube and separates drain tube from the skin (as shown in figure 2).
Verkade and Simons fails to disclose:
the drain tube includes a 3-way valve, and connectors that connect the 3- way valve to the flexible tube, and
the support band has a support that supports the 3-way valve and the connectors and separates the 3-way valve and the connectors from the skin.
Buchanan teaches:
A plaster (figures 2, 3 and 5) includes a drainage tube (20/50/46/44) including a 3 way valve (44) and connectors (50/44/64). The three way valve allows for the addition of a vent port (64) to allow for the venting of bubbles (column 2, lines 5-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Verkade and Simons to further include a three way valve and connectors as taught by Buchanan to allow for venting of the drainage tube (Buchanan, column 2, lines 5-20).
Regarding claim 9:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Verkade and Simons:
The plaster of claim 2, wherein each of the holders comprises:
a folding sheet (see the folding sheet 110 and 112 of Simons incorporated into Verkade) having a certain thickness (as shown in figure 3 of Simons), being foldable, and accommodating the connector in a folded state (as shown in 4 of Simons); and
a folding holding portion (172/170/168/166 or 156/157/154/155 of Simons incorporated into Verkade) mounted on the folding sheet to maintain a state in which the folding sheet is folded (as shown in figure 4 of Simons).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4626246 A to Verkade and US 20140188079 A1 to Simons et al. (Simons) as applied to claim 1 above, and further in view of US 5018534 A to Grant.
Regarding claim 4:
Verkade discloses:
The plaster of claim 1, wherein
each of the support pads (32/23) is a sheet-type member (as shown in figure 2) having a certain thickness (as shown in figure 2), and
the support band (22) is detachably coupled to the respective upper surfaces (32 is adhesive tape that can be removed from the pads 32/23 and under the broadest reasonable interpretation since the two structures are coupled then the support band is coupled to the upper surface) of the support pads (32/23).
Verkade and Simons fail to disclose:
The support band is detachably coupled to the respective upper surfaces of the support pads through adhesive cloths.
Grant teaches:
A retainer (figure 1) for a catheter that includes bands (52) that are connected via Velcro (column 2, lines 55-62). This reference demonstrates that it is well known to connect different structures via Velcro connections (adhesive cloth as indicated in the applicant’s specification page 6, lines 8-12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Verkade Simons to use Velcro connections to connect the support band to the support pads instead of adhesive as taught Grant. This is a simple substitution of one known element (adhesive connection between the support band and support pads) for another (Velcro connection (adhesive cloth) between the support band and support pads as taught by Grant) to obtain predictable results (to connect the support band and support pads).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4626246 A to Verkade, US 20140188079 A1 to Simons et al. (Simons) and US 5037398 A to Buchanan as applied to claim 2 above, and further in view of US 5018534 A to Grant.
Regarding claim 5:
Verkade, Simons and Buchanan fail to disclose:
The plaster of claim 2, wherein a protective housing that covers and protects the 3-way valve supported by the support is detachably mounted on the support.
Grant teaches:
A retainer (figure 1) for a catheter that includes bands/support (52) that are connected via Velcro (column 2, lines 55-62). This reference further includes a protective housing (14) that can be connected or removed (detached) via the hinge (70) from the support to protect the arm and catheter (column 1, lines 40-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Verkade, Simons and Buchanan to further include a protective housing over the 3-way valve and drainage tube that can be detached from the support as taught by Grant in order to protect the valve and drainage tube (Grant, column 1, lines 40-50).
Allowable Subject Matter
Claims 3 and 6 would be allowable if rewritten to overcome the rejection(s) 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-8425467-B1
Haak
See the support bands 20 and support band 62
US-4484913-A
Swauger
See the support pad 34 and band 18
US-20180311474-A1
Tyler
See the support pad 124 and band 108
US-20070265571-A1
Utterberg
See the support pad 40 and band 20
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WESLEY G HARRIS/Examiner, Art Unit 3783