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 Interpretation
Claims 8 and 18 recite the phrase “insertion site.” However, the surrounding claim language does not define where the insertion site is or what is being inserted where. In this examination, Examiner interprets the “insertion site” as the site of the channel of the receptacle where the filament is inserted into.
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 1-3, 5, 7-13, 15, and 17-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bierman (EP 0846013).
Regarding claim 1, Bierman discloses an anchoring system for securing a catheter to the body of a patient (Figs. 2 and 7) comprising: a catheter (see annotated Fig. 7 below) comprising a wing (see annotated Fig. 7 below) having at least one suture hole formed therein (see annotated Fig. 7 below; Fig. 7: 40); and an anchoring apparatus (Fig. 2: 10) comprising: an adhesive member for secure attachment to the body of the patient (Fig. 7: bottom surface of 16; Fig. 2: adhesive layer between 16 and 36; para. [0034], sentence 1 and para. [0035], sentences 1 and 3); a base mounted on the adhesive member (see annotated Fig. 7 below; Fig. 2: 22) and having at least one receptacle (see annotated Fig. 7 below; and Figs. 4 and 6: 20), the at least one receptacle forming a channel through a portion of the base (Fig. 4: channel 34), the channel having a central axis (Figs. 4 and 6: central axis through 34) and a slot through a side of the channel (Fig. 6: slot 44); and at least one filament (see annotated Fig. 7 below, filaments 18) having a proximal end, a distal end, and a midportion therebetween (see annotated Fig. 7 below), the proximal end being coupled to the base (see annotated Fig. 7 below), the distal end being configured to be inserted through the suture hole of the wing (see annotated Fig. 7 below and Fig. 2), the midportion being sized and shaped to be inserted into and subsequently removed from the channel via the slot (para. [0029], specifically last sentence), wherein the at least one filament is inhibited from being withdrawn from the channel in a direction along the central axis towards the wing when the midportion of the at least one filament is in the channel (para. [0040]).
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Annotated Fig. 7, Bierman
Regarding claim 2, Bierman discloses the anchoring system of claim 1, as described above, wherein the central axis is parallel to a lateral direction (see annotated Fig. 7 above).
Regarding claim 3, Bierman discloses the anchoring system of claim 1, as described above, wherein the at least one filament comprises two filaments (see annotated Fig. 7 above), and wherein the at least one receptacle comprises two receptacles (see annotated Fig. 7 above).
Regarding claim 5, Bierman discloses the anchoring system of claim 1, as described above, wherein the at least one filament comprises a protuberance configured to abut a surface of the receptacle when the midportion of the at least one filament is in the channel (Fig. 2: protuberances 28 abut 37 of Fig. 4 when inserted into 34; para. [0040]).
Regarding claim 7, Bierman discloses the anchoring system of claim 1, as described above, wherein the channel has a C-shape (Fig. 6: “C” shape about 34).
Regarding claim 8, Bierman discloses the anchoring system of claim 1, as described above, wherein the slot faces in a longitudinal direction towards an insertion site (Fig. 6: slot 44 cutting through conical channel shown in Fig. 4, being longitudinal to the central axis of the channel where the insertion site of the filament is; this is also illustrated in Fig. 12 for clarity).
Regarding claim 9, Bierman discloses the anchoring system of claim 1, as described above, wherein the base comprises at least one sidewall (Fig. 6: sidewall 42) and wherein the at least one filament extends in a lateral direction from the at least one sidewall (Figs 4, 6 and 7: filament extends through 20, in lateral direction to wall 42).
Regarding claim 10, Bierman discloses the anchoring system of claim 9, as described above, wherein the at least one sidewall is a vertical member or surface (Figs. 4, 6 and 7: 42 of 20 extends vertically from base/16).
Regarding claim 11, Bierman discloses an anchoring device for securing a catheter to the body of a patient (Figs. 2 and 7), the catheter (see annotated Fig. 7 above) having a wing (see annotated Fig. 7 above) having at least one suture hole formed therein (see annotated Fig. 7 above; Fig. 7: 40), the anchoring device comprising: an adhesive member for secure attachment to the body of the patient (Fig. 7: bottom surface of 16; Fig. 2: adhesive layer between 16 and 36; para. [0034], sentence 1 and para. [0035], sentences 1 and 3); a base mounted on the adhesive member (see annotated Fig. 7 above; Fig. 2: 22) and having at least one receptacle (see annotated Fig. 7 above; and Figs. 4 and 6: 20), the at least one receptacle forming a channel through a portion of the base (Fig. 4: channel 34), the channel having a central axis (Figs. 4 and 6: central axis through 34) and a slot through a side of the channel (Fig. 6: slot 44); and at least one filament (see annotated Fig. 7 above, filaments 18) having a proximal end, a distal end, and a midportion therebetween (see annotated Fig. 7 above), the proximal end being coupled to the base (see annotated Fig. 7 above), the distal end being configured to be inserted through the suture hole of the wing (see annotated Fig. 7 above and Fig. 2), the midportion being sized and shaped to be inserted into and subsequently removed from the channel via the slot (para. [0029], specifically last sentence), wherein the at least one filament is inhibited from being withdrawn from the channel in a direction along the central axis towards the wing when the midportion of the at least one filament is in the channel (para. [0040]).
Regarding claim 12, Bierman discloses the anchoring device of claim 11, as described above, wherein the at least one receptacle comprises two receptacles (see annotated Fig. 7 above) and the at least one filament comprises two filaments (see annotated Fig. 7 above), and wherein the midportions of the two filaments extend along a lateral direction when secured in the two receptacles (Figs 4, 6 and 7: filament extends through 20, in lateral direction to wall 42).
Regarding claim 13, Bierman discloses the anchoring device of claim 12, as described above, wherein the midportions of the two filaments extend in opposite lateral directions away from each other when secured in the two receptacles (Fig. 7: ends 32 pointing/extending in opposite directions).
Regarding claim 15, Bierman discloses the anchoring device of claim 11, as described above, wherein the at least one filament comprises a protuberance configured to abut a surface of the receptacle when the midportion of the at least one filament is in the channel (Fig. 2: protuberances 28 abut 37 of Fig. 4 when inserted into 34; para. [0040]).
Regarding claim 17, Bierman discloses the anchoring device of claim 11, as described above, wherein the channel has a C-shape (Fig. 6: “C” shape about 34).
Regarding claim 18, Bierman discloses the anchoring device of claim 11, as described above, wherein the slot faces in a longitudinal direction towards an insertion site (Fig. 6: slot 44 cutting through conical channel shown in Fig. 4, being longitudinal to the central axis of the channel where the insertion site of the filament is; this is also illustrated in Fig. 12 for clarity).
Regarding claim 19, Bierman discloses the anchoring device of claim 11, as described above, wherein the base comprises at least one sidewall (Fig. 6: sidewall 42), and wherein the at least one filament extends in a lateral direction from the at least one sidewall (Figs 4, 6 and 7: filament extends through 20, in lateral direction to wall 42).
Regarding claim 20, Bierman discloses the anchoring device of claim 19, as described above, wherein the at least one sidewall is a vertical member or surface (Figs. 4, 6 and 7: 42 of 20 extends vertically from base/16).
Regarding claim 21, Bierman discloses a method for securing a catheter to a body of a patient, the catheter (see annotated Fig. 7 above) having a wing (see annotated Fig. 7 above) having at least one suture hole formed therein (see annotated Fig. 7 above, 40), the method comprising: aligning the at least one suture hole with an end of a filament (para. [0045], sentences 1-2), the filament being coupled to a base (Fig. 2, 24 coupled to 22; para. [0017], sentence 1) and extending in a transversal direction from the base (Fig. 2: 18 extends transversely from 22), the base comprising at least one receptacle (see annotated Fig. 7 above); threading the end of the filament through the at least one suture hole (para. [0045], sentences 1-2); wrapping the filament around the wing (para. [0045], sentence 2 and Fig. 7 showing 18 wrapped around the wings); and pulling the filament in a lateral direction towards the base to secure a midportion of the filament in the at least receptacle so as to retain the catheter (para. [0045], sentence 2 and Fig. 7).
Regarding claim 22, Bierman discloses the method of claim 21, as described above, wherein pulling the filament comprises pulling the filament taut so as to stretch a length of the filament (para. [0046], sentence 3).
Regarding claim 23, Bierman discloses the method of claim 21, as described above, wherein the at least one receptacle comprises two receptacles (see annotated Fig. 7 above) and the filament comprises two filaments (see annotated Fig. 7 above), and wherein the midportions of the two filaments extend along a lateral direction when secured in the two receptacles (Fig. 7: ends 32 pointing/extending in opposite directions, lateral to structures 20).
Regarding claim 24, Bierman discloses the method of claim 21, as described above, wherein the midportions of the two filaments extend in opposite lateral directions away from each other when secured in the two receptacles (Fig. 7: ends 32 pointing/extending in opposite directions).
Regarding claim 25, Bierman discloses the method of claim 21, as described above, further comprising hand manipulating the filament to disengage the filament from the at least one receptacles (para. [0030]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bierman (EP 0846013) in view of Kessler (US 20050192540).
Regarding claim 4, Bierman discloses the anchoring system of claim 1, as described above, wherein the proximal ends of the filaments are fixed to the base (para. [0017], sentence 1), but fails to explicitly disclose that the filaments comprise a platform that locks to the base.
Kessler teaches an analogous anchoring device, wherein the at least one filament (Fig. 3: filaments 16 and 24) comprises a platform (Fig. 3: platform 14 also shown as the lower platform 33 in Fig. 4: para. [0027]) configured to lock to the base (Fig. 3: base 32; para. [0032] filaments are fixed to the underside of 35 of platform 33 of 14, which locks into base 32, seen in Fig. 4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Bierman device by incorporating the additional platform for fixing the filaments and base to, as taught by Kessler, in order to ensure a more secure locked attachment of the filaments to the base.
Regarding claim 14, Bierman discloses the anchoring device of claim 11, as described above, wherein the proximal ends of the filaments are fixed to the base (para. [0017], sentence 1), but fails to explicitly disclose that the filaments comprise a platform that locks to the base.
Kessler teaches an analogous anchoring device, wherein the at least one filament (Fig. 3: filaments 16 and 24) comprises a platform (Fig. 3: platform 14 also shown as the lower platform 33 in Fig. 4: para. [0027]) configured to lock to the base (Fig. 3: base 32; para. [0032] filaments are fixed to the underside of 35 of platform 33 of 14, which locks into base 32, seen in Fig. 4). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Bierman device by incorporating the additional platform for fixing the filaments and base to, as taught by Kessler, in order to ensure a more secure locked attachment of the filaments to the base.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Bierman (EP 0846013) in view of Bierman (US 9642987), herein referred to as Bierman’17.
Regarding claim 6, Bierman discloses the anchoring system of claim 1, as described above, wherein the base is configured to contact at least a portion of the catheter (see annotated Fig. 7 above, portion of catheter contacts central portion of base). However, Bierman fails to explicitly disclose that the base comprises an adhesive platform that contacts that portion of the catheter.
Bierman’17 teaches an analogous anchoring device, wherein the base (Figs. 1 and 3: base 242) further comprises an adhesive platform (Figs. 1 and 3: platform 22 + 24 having adhesive spot; col. 14, lines 22-27) configured to contact at least a portion of the catheter (col. 14, lines 22-27 and Figs. 7-8). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Bierman anchoring device by incorporating the adhesive platform of the base taught by Bierman’17, in order to ensure the securement of the catheter to the anchoring device and prevent any unwanted axial movement of the catheter (Bierman’17: col. 14, lines 22-24).
Regarding claim 16, Bierman discloses the anchoring device of claim 11, as described above, wherein the base is configured to contact at least a portion of the catheter (see annotated Fig. 7 above, portion of catheter contacts central portion of base). However, Bierman fails to explicitly disclose that the base comprises an adhesive platform that contacts that portion of the catheter.
Bierman’17 teaches an analogous anchoring device, wherein the base (Figs. 1 and 3: base 242) further comprises an adhesive platform (Figs. 1 and 3: platform 22 + 24 having adhesive spot; col. 14, lines 22-27) configured to contact at least a portion of the catheter (col. 14, lines 22-27 and Figs. 7-8). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Bierman anchoring device by incorporating the adhesive platform of the base taught by Bierman’17, in order to ensure the securement of the catheter to the anchoring device and prevent any unwanted axial movement of the catheter (Bierman’17: col. 14, lines 22-24).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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