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 .
Claims 4, 11-14, and 19-20 are amended.
Claims 1-20 are being examined in this office action.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show belt 80 as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 disclosure is objected to because of the following informalities: Elements 33, 37 and 39 are shown in the drawings, but are not mentioned within the specification.
Appropriate correction is required.
Claim Objections
Claims 8, 11 and 14-16 are objected to because of the following informalities:
Claim 8 recites "The system of claim 7 wherein said compressible part includes a plurality of fingers surrounding said pathway, said fingers flexible radially to engage with the catheter and hold the catheter when said fingers are flexed towards said catheter." should read "The system of claim 7 wherein said compressible part includes a plurality of fingers surrounding said pathway, said fingers flex radially to engage with the catheter and hold the catheter when said fingers are flexed towards said catheter".
Regarding Claim 11, the limitation “a complementary two part hook and loop fastener” should read “a complementary two-part hook and loop fastener”.
Regarding Claim 14, the limitations “a first portion” and “a second reference portion” are not consistent, as lines 4 and 6 later recite “said second portion” creating a lack of antecedent basis for this limitation in the claim.
All remaining claims are objected to by virtue of their dependance on objected claims.
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.
(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.
Claim(s) 1 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bierman (US 7223256 B2).
Regarding Claim 1, Bierman discloses a system for securing a portion of a catheter (abstract, Fig. 1), the system comprising in combination:
a grip (400), said grip configured to be attached to and hold to a portion of the catheter (Col. 16 Lines 39-51, Fig. 9B);
an anchor pad (110); and
a fastener (120) interposed between said grip and said anchor pad for removable attachment of said grip and the catheter to said anchor pad (Fig. 1, Col. 18 Lines 19-30), and holding of said catheter relative to said anchor pad (Fig. 11, Col. 18 Lines 31-42).
Regarding Claim 12, Bierman discloses the system of claim 1 wherein said fastener (120) includes a mechanical fastener (Col. 10 Lines 28-43) mounted upon said anchor pad (110, Fig. 1), said mechanical fastener configured to releasably engage said grip (400 being released from retainer 120 in Fig. 10).
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.
Claim(s) 2-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Orr et al. (US 5382239 A, herein Orr).
Regarding Claim 2, Bierman discloses the system of claim 1.
Bierman does not expressly disclose wherein said grip includes a pathway through said grip for location of a portion of the catheter passing therethrough.
Orr teaches wherein said grip (10, Fig. 1) includes a pathway (14) through said grip for location of a portion of the catheter passing therethrough (catheter tubing 12 running through length of fixation device 10 in Fig. 1).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said grip includes a pathway through said grip for location of a portion of the catheter passing therethrough as taught by Orr so that the catheter may be easily fastened to the securing device (Orr, Col. 4 Lines 3-11).
Regarding Claim 3, modified Bierman in view of Orr discloses the system of claim 2 wherein said grip (Orr, 10) includes a slit (Orr, opposite 52) extending laterally into said pathway (Orr, Figs. 2-4), said slit allowing said catheter to pass into said pathway (Orr, Col. 2 Lines 21-25, Fig. 1).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said grip includes a slit extending laterally into said pathway, said slit allowing said catheter to pass into said pathway as taught by Orr so that the securement device may receive the catheter in an open position and secure the catheter in a closed position. (Orr, Col. 1 Lines 29-36).
Regarding Claim 4, modified Bierman in view of Orr discloses the system of claim 2 wherein said grip (Orr, 10) includes a first end (Orr, 40) with an entry into said pathway (Orr, 14) and a second end (Orr, 42) opposite said first end with an exit from said pathway (Orr, Fig. 1), said entry and said exit sized to accommodate passage of the catheter into said pathway at said entry and out of said pathway at said exit (Orr, Col. 1 Lines 45-48, Fig. 1).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said grip includes a first end with an entry into said pathway and a second end opposite said first end with an exit from said pathway, said entry and said exit sized to accommodate passage of the catheter into said pathway at said entry and out of said pathway at said exit as taught by Orr so that a length of the catheter can be gripped by the securement device (Orr, Col. 1 Lines 45-51).
Regarding Claim 5, modified Bierman in view of Orr discloses the system of claim 2 wherein said grip (Orr, 10) includes a catheter engagement (Orr, 60, 62) holding said grip firmly to said catheter (Orr, Col. 2 Lines 53-59).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said grip includes a catheter engagement holding said grip firmly to said catheter as taught by Orr so that gripping of the catheter may be facilitated (Orr, Col. 2 Lines 54-58).
Regarding Claim 6, modified Bierman in view of Orr discloses the system of claim 5 wherein said catheter engagement (Orr, 60, 62) removably attaches to the catheter through at least two parts of said grip which move relative to each other to releasably engage the catheter (Col. 2 Lines 57-59, Figs. 2-4, 6 show liners 60 and 62 in a released state, while Fig. 1 shows liners 60 and 62 joined together to engage with the catheter 12).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said catheter engagement removably attaches to the catheter through at least two parts of said grip which move relative to each other to releasably engage the catheter as taught by Orr so that the catheter may be easily fastened to the securing device (Orr, Col. 4 Lines 3-11).
Regarding Claim 7, modified Bierman in view of Orr discloses the system of claim 5 wherein said catheter engagement (Orr, 60, 62) includes a compressible part (Orr, liners 60 and 62 are able to be made of silicone, which is able to be compressed Col. 2 Lines 53-57) which is compressed against the catheter to hold the catheter to said grip when said compressible part of said grip is compressed between two portions of said grip (Orr, Liners 60 and 62 meet to compress catheter 12 in Fig. 1).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said catheter engagement includes a compressible part which is compressed against the catheter to hold the catheter to said grip when said compressible part of said grip is compressed between two portions of said grip as taught by Orr so that a surface of high friction is provided to grip the catheter (Orr, Col. 2 Lines 57-59).
Regarding Claim 10, modified Bierman in view of Orr discloses the system of claim 5 wherein said catheter engagement (Orr, 60, 62) of said grip (Bierman, 400) includes a first threaded part (Bierman, 490) which is rotatable relative to a second threaded part (Bierman, 430, Col. 18 Lines 12-15, Fig. 9B), with rotation of said first threaded part relative to said second threaded part causing radial inward gripping forces to be applied by said grip upon the catheter located along said pathway of said grip (examiner interprets spin nut 480 is moved over tapered end 450 and engages with screw threads 430, applying an inward force to connector fitting 400 and medical line 420).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman wherein said catheter engagement of said grip includes a first threaded part which is rotatable relative to a second threaded part, with rotation of said first threaded part relative to said second threaded part causing radial inward gripping forces to be applied by said grip upon the catheter located along said pathway of said grip as taught by Orr so that the catheter may be easily fastened to the securing device (Orr, Col. 4 Lines 3-11).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Orr further in view of Mihalcik (Pub. No. US 20040034311 A1).
Regarding Claim 8, modified Bierman in view of Orr discloses the system of Claim 7.
Modified Bierman in view of Orr does not expressly disclose wherein said compressible part includes a plurality of fingers surrounding said pathway, said fingers flexible radially to engage with the catheter and hold the catheter when said fingers are flexed towards said catheter.
Mihalcik teaches a plurality of fingers (204) surrounding a pathway (203), said fingers flexible radially to engage with the catheter (10) and hold the catheter when said fingers are flexed towards said catheter (Fig. 3, Paragraph [0038]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said compressible part includes a plurality of fingers surrounding said pathway, said fingers flexible radially to engage with the catheter and hold the catheter when said fingers are flexed towards said catheter as taught by Mihalcik so that the fingers engage the catheter and lock it in a position (Mihalcik, Paragraph [0038]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Orr further in view of Helm, JR. (Pub. No. US 20110106014 A1).
Regarding Claim 9, modified Bierman in view of Orr discloses the system of claim 7.
Modified Bierman in view of Orr does not expressly disclose wherein said compressible part includes a compressible washer with a hole therein which hole is adapted to have the catheter pass therethrough before said compressible washer is compressed, and which compressible washer deforms and compresses against the catheter at said hole when forces are applied to said compressible washer to squeeze said compressible washer.
Helm, JR. teaches a compressible washer (16, “flexible gasket ring” – Paragraph [0111]) with a hole (ring having a hole) therein which hole is adapted to have the catheter (24) pass therethrough before said compressible washer is compressed (Fig. 3), and which compressible washer deforms and compresses against the catheter at said hole when forces are applied to said compressible washer to squeeze said compressible washer (Fig. 5A, Paragraph [0111]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said compressible part includes a compressible washer with a hole therein which hole is adapted to have the catheter pass therethrough before said compressible washer is compressed, and which compressible washer deforms and compresses against the catheter at said hole when forces are applied to said compressible washer to squeeze said compressible washer as taught by Helm, JR. so that a sealing element may be provided with the catheter (Helm, JR., Paragraph [0111]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Orr further in view of Watson (Pub. No. US 20160206856 A1).
Regarding Claim 11, modified Bierman in view of Orr discloses the system of claim 1.
Modified Bierman in view of Orr does not expressly disclose wherein said fastener includes a complementary two part hook and loop fastener between said anchor pad and said grip. Watson teaches wherein said fastener (212) includes a complementary two part hook and loop fastener (“The clip may comprise hook and loop material, and the collar comprise complimentary hook and loop material, so that the collar can be releasably coupled to the clip.” – Paragraph [0020]) between said anchor pad (226) and said grip (216, Fig. 5).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said fastener includes a complementary two part hook and loop fastener between said anchor pad and said grip as taught by Watson so that the grip can be easily released from the anchor pad (Watson, Paragraph [0020]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Bierman et al. (Pub. No. US 20080249476 A1, herein Bierman '476).
Regarding Claim 13, Bierman discloses the system of claim 12
Bierman does not expressly disclose wherein said mechanical fastener includes a belt sized to gird the catheter and said belt closable upon the catheter to hold the catheter to said anchor pad.
Bierman ‘476 teaches wherein said mechanical fastener (20) includes a belt (24) sized to gird the catheter (8, Fig. 8) and said belt closable upon the catheter to hold the catheter to said anchor pad (Fig. 9, strap 24 closes around catheter 8 via latch mechanism 80).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said mechanical fastener includes a belt sized to gird the catheter and said belt closable upon the catheter to hold the catheter to said anchor pad as taught by Bierman ‘476 so that the system may stop axial movement of the catheter (Bierman ‘476, Paragraph [0044]).
Claim(s) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Zhang et al. (CN 208660106 U, herein Zhang).
Regarding Claim 14, Bierman discloses the system of claim 12.
Bierman does not expressly disclose wherein said mechanical fastener includes a clasp which includes a spring which biases at least a first portion of said clasp toward a tight position, with a second reference portion of said clasp fixed to said anchor pad and with said first portion movable relative to said second portion to store energy in said spring and release said clasp from the catheter, and said first portion movable relative to said second portion to release energy in said spring and engage the catheter.
Zhang teaches wherein said mechanical fastener (Fig. 2) includes a clasp (left clamping piece 5 and right clamping piece 6) which includes a spring (10) which biases at least a first portion (5) of said clasp toward a tight position (spring 10 shows tensioning of left post 5 to catheter in Fig. 2), with a second reference portion (6) of said clasp fixed to said anchor pad (right clamping piece fixed to bottom plate 4 in Fig. 2) and with said first portion movable relative to said second portion to store energy in said spring and release said clasp from the catheter, and said first portion movable relative to said second portion to release energy in said spring and engage the catheter (guide chute 7 contains compression spring 10 allowing left clamping piece 5 to move toward and from right clamping piece 6).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said mechanical fastener includes a clasp which includes a spring which biases at least a first portion of said clasp toward a tight position, with a second reference portion of said clasp fixed to said anchor pad and with said first portion movable relative to said second portion to store energy in said spring and release said clasp from the catheter, and said first portion movable relative to said second portion to release energy in said spring and engage the catheter as taught by Zhang so that a catheter with varying thickness may be secured (Zhang, Page 2 Paragraph 3).
Regarding Claim 15, modified Bierman in view of Zhang discloses the system of claim 14 wherein said spring includes a compression spring (Zhang, compression spring 10).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said spring includes a compression spring as taught by Zhang so that the mechanical fastener is constantly tensioned (Zhang, Page 3 Paragraph 7).
Regarding Claim 16, modified Bierman in view of Zhang discloses the system of claim 14 wherein said first portion (Zhang, 5) and said second portion (Zhang, 6) engage the catheter (Zhang, Figure 2) through said grip (Bierman, 400).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said first portion and said second portion engage the catheter through said grip as taught by Zhang so that the grip may be secured via mechanical fastener (Zhang, Page 2 Paragraph 3).
Claim(s) 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Watson (Pub. No. US 20160206856 A1).
Regarding Claim 17, Bierman discloses the system of claim 12.
Bierman does not expressly disclose wherein said mechanical fastener includes a clip which has a pair of resilient leaves spaced apart by a distance which receives and holds the catheter resiliently therein.
Watson teaches wherein said mechanical fastener (200) includes a clip (212) which has a pair of resilient leaves spaced apart by a distance (clip 212 demonstrates leave shaped extensions spaced apart in Fig. 5) which receives and holds the catheter resiliently therein (Paragraph [0058]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said mechanical fastener includes a clip which has a pair of resilient leaves spaced apart by a distance which receives and holds the catheter resiliently therein as taught by Watson so that a catheter can be easily replaced within the securement device (Watson, Paragraph [0059]).
Regarding Claim 18, Bierman in view of Watson discloses the system of claim 17 wherein said leaves are spaced apart by a distance which receives both the catheter and said grip therebetween (Watson, Paragraph [0059], Fig. 5).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said leaves are spaced apart by a distance which receives both the catheter and said grip therebetween as taught by Watson so that a catheter can be easily replaced within the securement device (Watson, Paragraph [0059]).
Regarding Claim 19, Bierman discloses the system of claim 12
Bierman does not expressly disclose wherein said fastener includes both said mechanical fastener and complementary hook and loop fasteners between said anchor pad and said grip.
Watson teaches wherein said fastener (200) includes both said mechanical fastener (212) and complementary hook and loop fasteners between said anchor pad and said grip (Paragraph [0070]).
Therefore, it would be obvious to one of ordinary skill within the art before the effective filing date of the invention to modify the system as disclosed by Bierman in view of Orr wherein said fastener includes both said mechanical fastener and complementary hook and loop fasteners between said anchor pad and said grip as taught by Watson so that the catheter can be releasably coupled to the clip (Watson, Paragraph [0070]).
Regarding Claim 20, modified Bierman in view of Watson discloses the system of claim 19 wherein said grip (Watson, 210) includes a complementary one of a loop or hook fastener (Watson, Paragraph [0070])
Modified Bierman in view of Watson does not expressly disclose for attachment to a hook or loop fastener of said complementary hook and loop fasteners that is upon said anchor pad.
Watson teaches a hook and loop fastener that is on the grip (210) and mechanical fastener (212, Paragraph [0070]).
It would have been obvious to one of ordinary skill within the art before the effective filing date of the invention to move a hook and loop fastener wherein said grip includes a complementary one of a loop or hook fastener for attachment to a hook or loop fastener of said complementary hook and loop fasteners that is upon said anchor pad as taught by Watson, since rearranging parts of invention involves only routine skill within the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). The motivation being to provide an easily releasable coupling (Watson, Paragraph [0070]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri. off.
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/MARK GOLOVAN/ Patent Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783