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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18100845, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, prior filed application 18100845 does not provide adequate support for “wherein removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point.” Prior-filed application 18100845 discloses a method of removing an anchor device from a penetration point in a patient’s skin comprising removing the first and second anchors from the subcutaneous region of the penetration point ([0044]), but fails to disclose that this removing occurs while the medical instrument remains positioned in the penetration point.
Accordingly, claim 20 of the present application is not entitled to the benefit of the earlier filing dates of the prior-filed application. Pending claim 20 of the present application has the actual filing date of the present application: July 03, 2024.
Information Disclosure Statement
The information disclosure statement filed July 03, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. No copy has been provided for Cite No. 133.
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, the “first body portion and the second body portion are asymmetrical” as required by claim 21 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 disclosure is objected to because of the following informalities:
In paragraph [0023], there appears to be a typo regarding “retainer body 111” as opposed to “retainer body 110”.
In paragraph [0029], there appears to be a typo regarding “retainer body 111” as opposed to “retainer body 110”.
In paragraph [30], there appears to be a typo regarding “in particular embodiments” as opposed to “In particular embodiments”.
In paragraph [0063], there appears to be a typo regarding “the distal portion 328 of medical instrument 420” and “the shaft 328” (see also paragraph [0057]).
Appropriate correction is required.
Claim Objections
Claim 9 is objected to because there is a typo regarding “comprised” as opposed to “comprising” in line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation “wherein removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point” is a recitation of new matter. This disclosure as originally filed on 07/03/24 does not provide support for “removing the first and second anchors while the medical instrument remains positioned in the penetration point.” The originally filed disclosure discloses a method of removing an anchor device from a penetration point in a patient’s skin comprising removing the first and second anchors from the subcutaneous region of the penetration point ([0007], for example), but does not disclose that this removing occurs while the medical instrument remains positioned in the penetration point. This limitation is only found in the preliminary amendment filed 07/29/24, after the disclosure originally filed 07/03/24.
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 10-12 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.
Claim 10 recites the limitation "the anchor body” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the anchor body” is a typo that should be corrected to “the anchor device” as introduced in claim 2, line 2 or if the method incudes the user of both “an anchor device” and a separate “anchor body”. For examination purpose, the limitation "the anchor body” has been interpreted as a typo that should be corrected to “the anchor device”.
Claim 11 is rejected for being dependent upon claim 10.
Claim 12 recites the limitation "the anchor body” in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the anchor body” is a typo that should be corrected to “the anchor device” as introduced in claim 2, line 2 or if the method incudes the user of both “an anchor device” and a separate “anchor body”. For examination purpose, the limitation "the anchor body” has been interpreted as a typo that should be corrected to “the anchor device”.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 2 and 13-14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nowak et al. (USPN 4699616).
Regarding claim 2, Nowak discloses a method of securing a medical instrument (catheter C; “the slitted barrier pad 11 being fitted about a catheter, its slit then being closed, but with squeezing forces being applied at both ends of the respective clamping bars for the purpose of clamping a catheter between the arcuate intermediate portions of the bars.” [Col 5, lines 62-67]), comprising:
securing an anchor device (catheter retention device 10) relative to a penetration point while first and second anchors (ratchet assemblies 130) of the anchor device are in a first configuration (Figure 8-9), the anchor device including a retainer body (clamping bars 125, 126) that comprises:
a first body portion (clamping bar 125) having a first proximal end and a first distal end (Figure 9), the first anchor (ratchet assembly 130) coupled to the first body portion and extending distally from the first distal end (Figure 9);
a second body portion (clamping bar 126) having a second proximal end and a second distal end (Figure 9), the second anchor (ratchet assembly 130) coupled to the second body portion and extending distally from the second distal end (Figure 9); and
adjusting the first body portion relative to the second body portion so that the first and second anchors of the anchor device are adjusted from the first configuration to a second configuration (Figure 7; “The device is used in the same manner already described, with the slitted barrier pad 11 being fitted about a catheter, its slit then being closed, but with squeezing forces being applied at both ends of the respective clamping bars for the purpose of clamping a catheter between the arcuate intermediate portions of the bars.” [Col 5, line 62-67])
wherein the first proximal end of the first body portion and the second proximal end of the second body portion define a cutout region (space between base 21) therebetween when the first and second anchors are in the second configuration to provide visualization and access to a surface under the retainer body (Figure 7; “an improved catheter retention device that is simple in construction and reliable in operation, may be securely attached to a patient…without obstructing visual inspection of the site after the device is in place…exposes the immediate area of the incision or wound for direct visual inspection” [Col 1, lines 50-62]).
Regarding claim 13, Nowak discloses the method of claim 2, wherein the cutout region comprises a U-shaped cutout region (space between base 21) between the first body portion and the second body portion (Figure 5).
Regarding claim 14, Nowak discloses the method of claim 2, wherein the retainer body further comprises a sloped nose region (flexible support arms 24) having a generally planar upper surface (upstanding portion 24a) that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions (Figure 8).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2, 6-13, and 15-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg et al. (US 20100204656) in view of Nowak et al. (USPN 4699616).
Regarding claim 2, Rosenberg discloses a method of securing a medical instrument (Figures 9-13; securing catheter 20 with sleeve 108 and cap assembly 130), comprising:
securing an anchor device (anchor device 100) relative to a penetration point (penetration point 32) while first and second anchors (anchors 140a-b) of the anchor device are in a first configuration (Figures 9-10; “As the anchors 140a and 140b exit the insertion device 150, the tines 145a and 145b may flex against the shafts 141 and 141b of the anchors 140a and 140b due to the force applied by the sides of the opening 174. By resiliently flexing against the anchor shafts 141a and 141b, the tines 145a and 145b can pass through the penetration point 32 in a way that reduces the likelihood of damage to the tissue surrounding the penetration point 32.” [0039]), the anchor device including a retainer body (retainer body 111) that comprises:
a first body portion (left retainer portion 114a) having a first proximal end and a first distal end (Figure 5), the first anchor (anchor 140a) coupled to the first body portion and extending distally from the first distal end (Figure 5);
a second body portion (right retainer portion 114b) having a second proximal end and a second distal end (Figure 5), the second anchor (anchor 140b) coupled to the second body portion and extending distally from the second distal end (Figure 5); and
adjusting the first body portion relative to the second body portion so that the first and second anchors of the anchor device are adjusted from the first configuration to a second configuration (Figures 11-12; “As the anchors 140a and 140b exit the insertion device 150 through the opening 174, the tines 145a and 145b can advance into the subcutaneous layer 34. The tines 145a and 145b can be biased to return toward the deployed configuration, as previously described in connection with FIGS. 2-3.” [0039]),
Rosenberg fails to explicitly disclose the first proximal end of the first body portion and the second proximal end of the second body portion define a cutout region therebetween when the first and second anchors are in the second configuration to provide visualization and access to a surface under the retainer body.
Nowak teaches discloses a method of securing a medical instrument (“the slitted barrier pad 11 being fitted about a catheter, its slit then being closed, but with squeezing forces being applied at both ends of the respective clamping bars for the purpose of clamping a catheter between the arcuate intermediate portions of the bars.” [Col 5, lines 63-67]) comprising: using an anchor device (catheter retention device 10) including a retainer body (clamping bars 125, 126) that comprises: a first body portion (clamping bar 125) and a second body portion (clamping bar 126); wherein the first proximal end of the first body portion and the second proximal end of the second body portion define a cutout region (space between base 21) therebetween when the first and second anchors are in the second configuration to provide visualization and access to a surface under the retainer body (Figure 7; “an improved catheter retention device that is simple in construction and reliable in operation, may be securely attached to a patient…without obstructing visual inspection of the site after the device is in place…exposes the immediate area of the incision or wound for direct visual inspection” [Col 1, lines 50-62]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Rosenberg to include the first proximal end of the first body portion and the second proximal end of the second body portion define a cutout region therebetween when the first and second anchors are in the second configuration to provide visualization and access to a surface under the retainer body based on the teachings of Nowak to allow for visual inspection of the penetration point while the medical instrument is secured (Nowak [Col 1, lines 50-62]).
Regarding claim 6, modified Rosenberg teaches the method of claim 2, wherein the first and second anchors (anchors 140a-b) each comprise flexible tines (tines 145a, b), and the flexible tines of the first and second anchors extend generally in a same direction in the first configuration (Figure 10, showing tines 145a,b, both extending proximally along shafts 141a,b), and the flexible tines of each anchor extend outwardly away from one another in the second configuration (Figures 2 and 12).
Regarding claim 7, modified Rosenberg teaches the method of claim 6, wherein the flexible tines of the first and second anchors have a convex curvature (“The curved shape of the tines 145a and 145” [0040]) facing towards the first body portion and the second body portion (Figure 2).
Regarding claim 8, modified Rosenberg teaches the method of claim 2, further comprising: after adjusting the first body portion relative to the second body portion so that the first and second anchors of the anchor device are adjusted from the first configuration to the second configuration, securing the medical instrument to the retainer body (Figures 12-13; [0041]).
Regarding claim 9, modified Rosenberg teaches the method of claim 8, wherein securing the medical instrument (catheter 20 with sleeve 108 and cap assembly 130) to the retainer body (retainer body 111) further comprised engaging the medical instrument with one or more retention posts (locking tabs 112) of the anchor device, the one or more retention posts extending upward from the retainer body (Figure 3; “the retainer body 111 can include locking tabs 112 that can pass through openings 132 in the cap 131 and positively engage at least a portion of perimeters 134 of the openings 132, thereby removably coupling the cap assembly 130 to the base 110.” [0023]).
Regarding claim 10, modified Rosenberg teaches the method of claim 9, wherein engaging the medical instrument with the one or more retention posts of the anchor body further comprises aligning one or more apertures (openings 132) defined by a hub (sleeve 108 and cap assembly 130) positioned on the medical instrument (shown on catheter 20 in Figure 13) with the one or more retention posts of the anchor device (“the retainer body 111 can include locking tabs 112 that can pass through openings 132 in the cap 131 and positively engage at least a portion of perimeters 134 of the openings 132, thereby removably coupling the cap assembly 130 to the base 110.” [0023]; “o retain the catheter 20 in an operative position, the catheter can be positioned along the channel 122 of the retainer portion 120. The user can decouple the cap assembly 130 from the delivery tool 150 and press the cap assembly 130 to the base 110 to compress the retainer portions 120 and 135 onto the outer surface of the catheter 20 (to provide a frictional holding force thereon), thus transitioning the anchor device 100 to the closed configuration.” [0041]).
Regarding claim 11, modified Rosenberg teaches the method of claim 10, further comprising positioning the hub (sleeve 108 and cap assembly 130) on the medical instrument by opening a longitudinal slit (shown Figure 12) in the hub to receive a portion of the medical instrument (“a flexible sleeve 108 can be fit over the catheter 20 if the outer diameter of the catheter 20 is too small to releasably secure inside the channel 122 of the retainer portion 120. The flexible sleeve 108 may comprise a silicone material or another polymer material so that a compression force applied to the sleeve 108 creates a friction holding force upon the catheter 20.” [0041]).
Regarding claim 12, modified Rosenberg teaches the method of claim 10, wherein engaging the medical instrument with the one or more retention posts of the anchor body further comprises tilting the hub relative to the anchor device to engage the one or more retention posts of the anchor device with the one or more apertures defined by the hub (“the cap assembly 130 can be moved toward the base 110 (e.g., in the direction depicted by arrow 106) to direct the tabs 112 toward to the openings 132. When the diagonal faces of the tabs 112 contact the perimeters 134, the tabs 112 are stressed such that the tips 115 of the tabs 112 move closer to each other. When the face 135 moves beyond the engagement fingers 116, the tabs 112 can outwardly toward their unstressed positions to releasably engage the perimeters 134. When in this closed configuration, the cap assembly 130 and base 110 can apply a compressive force from the gripping members 120 and 135 to the catheter 20 in the channel 122, thereby applying a frictional holding force to the catheter 20 or medical instrument therein.” [0026]).
Regarding claim 13, modified Rosenberg teaches the method of claim 2.
Modified Rosenberg fails to explicitly disclose the cutout region comprises a U-shaped cutout region between the first body portion and the second body portion.
Nowak teaches discloses a method of securing a medical instrument (“the slitted barrier pad 11 being fitted about a catheter, its slit then being closed, but with squeezing forces being applied at both ends of the respective clamping bars for the purpose of clamping a catheter between the arcuate intermediate portions of the bars.” [Col 5, lines 63-67]) comprising: using an anchor device (catheter retention device 10) including a retainer body (clamping bars 125, 126) that comprises: a first body portion (clamping bar 125) and a second body portion (clamping bar 126); wherein the first proximal end of the first body portion and the second proximal end of the second body portion define a U-shaped cutout region (space between base 21) between the first body portion and the second body portion (Figure 7; “an improved catheter retention device that is simple in construction and reliable in operation, may be securely attached to a patient…without obstructing visual inspection of the site after the device is in place…exposes the immediate area of the incision or wound for direct visual inspection” [Col 1, lines 50-62]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Rosenberg to include a U-shaped cutout region between the first body portion and the second body portion based on the teachings of Nowak to allow for visual inspection of the penetration point while the medical instrument is secured (Nowak [Col 1, lines 50-62]).
Regarding claim 15, Rosenberg discloses a method of removing an anchor device (anchor device 100) from a penetration point in a patient's skin (Figures 14-15), the method comprising:
adjusting a first body portion (left retainer body portion 114a) relative to a second body portion (right retainer body portion 114b) of the anchor device so that first and second anchors (anchors 140a,b) of the anchor device are moved from a first configuration (Figure 13) to a second configuration (Figures 14-15; “the body portions 114a and 114b can be pivoted with respect to each other while the anchor tines 145a and 145b are deployed in the subcutaneous region 34 (refer to FIG. 14). Accordingly, the anchors 140a and 140b (including the tines 145a and 145b) can collectively penetrate into the subcutaneous region 34 in a configuration depicted in FIG. 11, and may be pivoted into the removal configuration shown in FIG. 14 for withdrawn from skin penetration point 32” [0043]), the first anchor (anchor 140a) coupled to the first body portion of the anchor device (Figure 2) and the second anchor (anchor 140b) coupled to the second body portion of the anchor device (Figure 2);
removing the first anchor and the second anchor from a subcutaneous region of the penetration point while the first and second anchors of the anchor device are in the second configuration (“the anchor device 100 can be folded such that the anchors 140a and 140b are adjacent to each other and oriented in substantially the same direction (e.g., the tips 146 of the tines 145a and 145b may be shifted proximate to one another). The anchor device 100 can be maneuvered to simultaneously remove the anchors 140a and 140b from the skin 30.” [0044]).
Rosenberg fails to explicitly disclose wherein in the first configuration the first body portion and second body portion define a cutout region therebetween to provide visualization and access to a surface under the anchor device.
Nowak teaches discloses an anchor device (catheter retention device 10) including a first body portion (clamping bar 125) and a second body portion (clamping bar 126); wherein in a first configuration the first body portion and second body portion define a cutout region (space between base 21) therebetween to provide visualization and access to a surface under the anchor device (Figure 7; “an improved catheter retention device that is simple in construction and reliable in operation, may be securely attached to a patient…without obstructing visual inspection of the site after the device is in place…exposes the immediate area of the incision or wound for direct visual inspection” [Col 1, lines 50-62]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Rosenberg to include wherein in the first configuration the first body portion and second body portion define a cutout region therebetween to provide visualization and access to a surface under the anchor device based on the teachings of Nowak to allow for visual inspection of the penetration point while the medical instrument is secured (Nowak [Col 1, lines 50-62]).
Regarding claim 16, modified Rosenberg teaches the method of claim 15, wherein flexible tines (tines 145a, b) of the first and second anchors (anchors 140a, b) extend outwardly away from one another in the first configuration (Figure 13; “the tines 145a and 145b can resiliently return toward the deployed configuration in which the first tine 145a extends outwardly away from the second tine 145b” [0040]), and the flexible tines of each anchor extend generally in a same direction in the second configuration (Figures 14-15; “the anchor device 100 can be folded such that the anchors 140a and 140b are adjacent to each other and oriented in substantially the same direction” [0044]).
Regarding claim 17, modified Rosenberg teaches the method of claim 15, further comprising: prior to adjusting the first body portion relative to the second body portion, disengaging a hub portion (cap assembly 130, catheter 20) of a medical instrument from the anchor device to release the medical instrument from the anchor device (“after a catheter procedure is complete, the cap assembly 130 can be separated from the base 110, thus allowing the catheter 20 to be lifted away from the channel 122 of the flexible portion 120.” [0042]).
Regarding claim 18, modified Rosenberg teaches the method of claim 17, wherein disengaging the hub portion of the medical instrument from the anchor device further comprises extracting one or more retention posts (locking tabs 112) of the anchor device from one or more apertures (openings 132) defined by the hub portion (“the base 110 can be separated from the cap assembly 130 by applying pressure to the locking tabs 112 to move the tips 115 closer to each other. When the engagement portions 116 of the tabs 112 move inside the openings 132 in the cap 131, the retainer portions 120 and 135 force the cap assembly 130 away from the base 110 and the cap assembly 130 becomes decoupled from the base 110, thus transitioning the anchor device 100 to the open configuration (FIGS. 2-3). When the anchor device is in the open configuration, the catheter 20 can be moved relative to the anchor device 100.” [0027]).
Regarding claim 19, modified Rosenberg teaches the method of claim 18, wherein removing the hub portion of the medical instrument from the anchor device further comprises sliding a finger along a relief portion (tips 115) of the one or more retention posts (“To reposition the catheter 20, the cap assembly 130 can be separated from the base 110 by applying pressure to the locking tabs 112 to move the tips 115 closer to each other until the cap assembly 130 is separated from the base 110, thus transitioning the anchor device 100 to the open configuration (refer to FIGS. 2-3)” [0041]).
Regarding claim 20, modified Rosenberg teaches the method of claim 19, wherein removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point (“the anchor device 100 can be folded such that the anchors 140a and 140b are adjacent to each other and oriented in substantially the same direction (e.g., the tips 146 of the tines 145a and 145b may be shifted proximate to one another). The anchor device 100 can be maneuvered to simultaneously remove the anchors 140a and 140b from the skin 30…the anchor device 100 can be removed from the skin 30 (e.g., in a manner similar to that depicted in FIGS. 14-15) while the catheter 20 remains in the skin 30.” [0044])
Claim 14 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg et al. (US 20100204656) in view of Nowak et al. (USPN 4699616) as applied in claim 2 above, and further in view of Rosenberg et al. (US 2010/0016801), hereinafter Rosenberg ‘801.
Regarding claim 14, modified Rosenberg teaches the method of claim 2.
Modified Rosenberg fails to explicitly teach the retainer body further comprises a sloped nose region having a generally planar upper surface that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions.
Rosenberg ‘801 teaches an anchor device (anchor device 100) comprising: a retainer body (retainer body 110 and actuator 130) comprising a first body portion (left side of retainer body 110 and first actuator body portion 131a) and a second body portion (right side of retainer body 110 and second actuator body portion 131b); and wherein the retainer body comprises a sloped nose region (guide channel 132) having a generally planar upper surface (each half of guide channel 132 on each of first and second actuator body portions 131a, 131b; best shown in Figure 6I) that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions (Figures 4 and 6C).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the anchor device of Rosenberg in view of Bierman to include the guide channel as taught by Rosenberg ‘801 based on the teachings of Rosenberg ‘801 to provide a guide for placement of the anchor device and also to provide a guide for removal of the medical instrument to reduce trauma to the surrounding tissue at the penetration site (Rosenberg ‘801 [0037] and [0041]).
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg et al. (US 20100204656) in view of Nowak et al. (USPN 4699616) as applied in claim 15 above, and further in view of Bierman (US 20010039399).
Regarding claim 21, modified Rosenberg teaches the method of claim 15.
Modified Rosenberg fails to explicitly teach the first body portion and the second body portion are asymmetrical.
Bierman teaches an anchor device (anchoring system 10) for securing a medical instrument (catheter 12), the anchor device comprising a first body portion (left side of retainer 20) and a second body portion (right side of retainer 20) that are asymmetrical (Figure 1, due to asymmetric shape of clip 48).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the anchor device used in the method of Rosenberg to include the first body portion and the second body portion are asymmetrical based on the teachings of Bierman to assist in releasably securing the medical device to the anchor device (Bierman [0051]).
Additionally, Claim 20 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rosenberg et al. (US 20140107584)1, hereinafter Rosenberg ‘584, in view of Rosenberg et al. (US 20100204656), hereinafter Rosenberg ‘656.
Regarding claim 20, Rosenberg ‘584 discloses a method of removing an anchor device (anchor device 100) from a penetration point (penetration point 32) in a patient's skin (skin 30; “” [0006]), the method comprising: adjusting a first body portion (first retainer body potion 120a) relative to a second body portion (second retainer body portion 120b) of the anchor device so that first and second anchors (anchors 140a-b) of the anchor device are moved from a first configuration (Figure 2A) to a second configuration (Figure 3A; “The first body portion of the retainer body may be pivotable relative to the second body portion so that the first and second anchors are adjustable from one another to a removal configuration in which the flexible tines extend generally in the same direction.” [0088]), wherein in the first configuration the first body portion and second body portion define a cutout region (cutout region 165) therebetween to provide visualization and access to a surface under the anchor device (“This u-shaped cutout region 165 can more readily provide visualization and access to the skin region under the retainer body 110 for inspection and cleaning of the skin 30 around the skin penetration point 32.” [0039]), the first anchor coupled to the first body portion of the anchor device and the second anchor coupled to the second body portion of the anchor device (Figure 2A; “This u-shaped cutout region 165 can more readily provide visualization and access to the skin region under the retainer body 110 for inspection and cleaning of the skin 30 around the skin penetration point 32.” [0033]); removing the first anchor and the second anchor from a subcutaneous region of the penetration point while the first and second anchors of the anchor device are in the second configuration (“to facilitate both insertion and removal of the anchor device 100 through the skin penetration point 32. For example, the anchor device 100 may have a foldable configuration in which a first portion of the retainer body 110 is pivotably coupled via a flexible hinge portion to a second portion of the retainer body 110.” [0042]); further comprising: prior to adjusting the first body portion relative to the second body portion, disengaging a hub portion of a medical instrument from the anchor device to release the medical instrument from the anchor device; wherein disengaging the hub portion of the medical instrument from the anchor device further comprises extracting one or more retention posts of the anchor device from one or more apertures defined by the hub portion; wherein removing the hub portion of the medical instrument from the anchor device further comprises sliding a finger along a relief portion of the one or more retention posts (“the relief portions 118a-b can help the user decouple the medical instrument 20 from the anchor device 100. Specifically, the relief portions 118a-b can allow the user to slide their finger along the side of the anchor device 100, to better grasp the wings 24a-b between their thumb and forefinger, and to thereafter "peel" the wings 24a-b off the retention posts 112a-b.” [0038]).
Rosenberg ‘584 fails to explicitly disclose wherein removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point.
Rosenberg ‘656 teaches a method of removing an anchor device from a penetration point in a patient’s skin (Figures 14-15), the method comprising removing the first anchor and the second anchor (anchors 140a, 140b) from the subcutaneous region (subcutaneous layer 34) of the penetration point (penetration point 32) comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point (“the anchor device 100 can be removed from the skin 30 (e.g., in a manner similar to that depicted in FIGS. 14-15) while the catheter 20 remains in the skin 30.” [0044]).
At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the method of Rosenberg ‘584 to include removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point based on the teachings of Rosenberg ‘656 to reduce the likelihood of causing additional damage to the skin tissue during removal (Rosenberg ‘656 [0044]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 2-3, 5-6, 8, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 9-10, and 16-17 of U.S. Patent No. 10342954. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 5, 9-10, and 16-17 of the patent disclose all of the limitations of claims 2-3, 5-6, 8, and 15-17 of the present invention (see table below), and therefore claims 2-3, 5-6, 8, and 15-17 are anticipated by USPN 10342954.
Claims 2-3, 5-6, 8, and 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7-8, 11, and 13-16 of U.S. Patent No. 11577051. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-4, 7-8, 11, and 13-16 of the patent disclose all of the limitations of claims 2-3, 5-6, 8, and 15-17 of the present invention (see table below), and therefore claims 2-3, 5-6, 8, and 15-17 are anticipated by USPN 11577051.
Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 16 of U.S. Patent No. 10342954 in view of Rosenberg et al. (US 20100204656), hereinafter Rosenberg ‘656 and over claims 1 and 13 of U.S. Patent No. 11577051 in view of Rosenberg ‘656.
Regarding claim 4, the patented claims disclose substantially the same invention as claim 4, with the exception of “the retainer body further comprises a flexible web portion positioned generally centrally between the first and second body portions and extending longitudinally from a distal end of the retainer body to a proximal face of the retainer body, and wherein the flexible web portion defines the longitudinal fold axis”. Rosenberg ‘656 discloses an anchor device (anchor device 100) having a retainer body (base 110) comprising a flexible web portion (along channel 120) positioned generally centrally between first and second body portions and extending longitudinally from a distal end of the retainer body to a proximal face of the retainer body (Figure 2), and wherein the flexible web portion defines a longitudinal fold axis (fold line 113; Figures 5-7). At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the anchor devices as disclosed in USPN 10342954 and USPN 11577051 to include a flexible web portion positioned generally centrally between the first and second body portions and extending longitudinally from a distal end of the retainer body to a proximal face of the retainer body, and wherein the flexible web portion defines the longitudinal fold axis based on the teachings of Rosenberg ‘656 to permit folding of the retainer body and allow for transition between the first and second configurations (Rosenberg ‘656 [0031]).
Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 16 of U.S. Patent No. 10342954 in view of Rosenberg et al. (US 20090099527), hereinafter Rosenberg ‘527, and over claims 1-4 of U.S. Patent No. 11577051 in view of Rosenberg ‘527. Regarding claim 7, the patented claims disclose substantially the same invention as claim 7, with the exception of “the flexible tines of the first and second anchors have a convex curvature facing towards the first body portion and the second body portion”. Rosenberg ‘527 teaches an anchor device (medical device anchor system 10) including first and second anchors each comprising a flexible tine (subcutaneous anchors 160), the flexible tines of the first and second anchors have a convex curvature facing towards a body portion (“the anchors 160 may include a convex curvature that abuts against the underside of the skin 20” [0025]; Figure 1). At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the anchor devices as disclosed in USPN 10342954 and USPN 11577051 to include that the flexible tines of the first and second anchors have a convex curvature facing towards the first body portion and the second body portion based on the teachings of Rosenberg ‘527 to prevent the anchors from piercing through the underside of the skin (Rosenberg ‘527 [0025]).
Claims 9-13, 18-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3, 11, 15, 18 of U.S. Patent No. 10342954 in view of Bierman (US 20010039399) and over claim 9 and 11-17 of U.S. Patent No. 11577051 in view of Bierman. Regarding claims 9-13 and 18-19, the patent claims disclose substantially the same invention as claims 9-13 and 18-19 (see table below), except for:
The anchor engagement portions being “one or more retention posts extending upward from the retainer body” as required by claim 9-10
“wherein engaging the medical instrument with the one or more retention posts of the anchor body further comprises tilting the hub relative to the anchor device to engage the one or more retention posts of the anchor device with the one or more apertures defined by the hub” as required by claim 11
“the cutout region comprises a U-shaped cutout region between the first body portion and the second body portion” as required by claim 13
The anchor engagement portions being “one or more retention posts” as required by claim 18-19.
“the first body portion and the second body portion are asymmetrical” as required by claim 21
Bierman teaches an anchor device (anchoring system 10) for securing a medical instrument (catheter 12), the anchor device comprising a retainer body (retainer 20), wherein securing the medical instrument comprises engaging the medical instrument with retention posts (posts 30) extending upward from the retainer body (Figures 6-8), wherein engaging the medical instrument with the retention posts further comprises tilting the hub (catheter fitting 14) relative to the anchor device to engage the retention posts with apertures (holes 74) defined by the hub (Figure 7; [0061]); the anchor device comprising a U-shaped cutout region between first and second body portions (“a recess toward the proximal end 24 of the anchor pad 56 proximate to the clip 48.” [0055]; Figure 1); and wherein the first body portion (left side of retainer 20) and the second body portion (right side of retainer 20) are asymmetrical (Figure 1, due to asymmetric shape of clip 48). At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the methods disclosed in USPN 10342954 and USPN 11577051 to include the anchor engagement portions are one or more retention posts, wherein engaging the medical instrument with the one or more retention posts of the anchor body further comprises tilting the hub relative to the anchor device to engage the one or more retention posts of the anchor device with the one or more apertures defined by the hub based on the teachings of Bierman to secure the medical instrument to the retainer body in a manner that inhibits transverse motion of the medical device (Bierman [0061]), to include that the cutout region is a U-shaped cutout region between the first body portion and the second body portion based on the teachings of Bierman to increase contact area and therefore provide greater stability for the anchor device (Bierman [0055]), and to include the first body portion and the second body portion are asymmetrical based on the teachings of Bierman to assist in releasably securing the medical device to the anchor device (Bierman [0051]).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 16 of U.S. Patent No. 10342954 in view of Rosenberg et al. (US 20100016801), hereinafter Rosenberg ‘801 and over claim 1 and 13 of U.S. Patent No. 11577051 in view of Rosenberg ‘801. Regarding claim 14, the patented claims disclose substantially the same invention as claim 14, with the exception of “a sloped nose region having a generally planar upper surface that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions”. Rosenberg ‘801 teaches a system (medical device anchor system 10) comprising an anchor device (anchor device 100) comprising: a retainer body (retainer body 110 and actuator 130) comprising a sloped nose region (guide channel 132) having a generally planar upper surface that is oriented at a decline angle extending distally from generally planar surfaces of first and second body portions (Figures 4 and 6C). At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the system as disclosed in USPN 10342954 and USPN 11577051 to include that a sloped nose region having a generally planar upper surface that is oriented at a decline angle extending distally from generally planar surfaces of the first and second body portions based on the teachings of Rosenberg ‘801 to provide a guide for placement of the anchor device and also to provide a guide for removal of the medical instrument to reduce trauma to the surrounding tissue at the penetration site (Rosenberg ‘801 [0037] and [0041]).
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 10342954 in view of Rosenberg ‘656 over claim 1 and 7 of U.S. Patent No. 11577051 in view of Rosenberg ‘656.
Regarding claim 19, the patented claims disclose substantially the same invention as claim 19, with the exception of “removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point”. Rosenberg ‘656 teaches a method of removing an anchor device from a penetration point in a patient’s skin (Figures 14-15), the method comprising removing the first anchor and the second anchor (anchors 140a, 140b) from the subcutaneous region (subcutaneous layer 34) of the penetration point (penetration point 32) comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point (“the anchor device 100 can be removed from the skin 30 (e.g., in a manner similar to that depicted in FIGS. 14-15) while the catheter 20 remains in the skin 30.” [0044]). At the time of the invention, it would have been obvious to one having ordinary skill in the art to modify the system as disclosed in USPN 10342954 and USPN 11577051 to include removing the first anchor and the second anchor from the subcutaneous region of the penetration point comprises removing the first and second anchors while the medical instrument remains positioned in the penetration point based on the teachings of Rosenberg ‘656 to reduce the likelihood of causing additional damage to the skin tissue during removal (Rosenberg ‘656 [0044]).
Nonstatutory Double Patenting
Present Application
USPN 10342954
USPN 11577051
2
1, 10, 16
1, 13
3
1, 10, 16
1, 13
4
Rosenberg ‘656
Rosenberg ‘656
5
1, 10, 16
1, 13
6
1, 10, 16
1-4
7
Rosenberg ‘527
Rosenberg ‘527
8
2, 10, 17
8, 13-16
9
3, 11, 18 + Bierman
9, 13-16 + Bierman
10
3, 11, 18 + Bierman
9, 13-16 + Bierman
11
15
17
12
Bierman
Bierman
13
Bierman
Bierman
14
Rosenberg ‘801
Rosenberg ‘801
15
1 + 9
1 + 7
16
1 + 9
1 + 7
17
5
11
18
5 + Bierman
11 + Bierman
19
6
12
20
9 + Rosenberg ‘656
7 + Rosenberg ‘656
21
Bierman
Bierman
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
1 Rosenberg et al. (US 20140107584) qualifies as prior art because currently pending Claim 20 is not entitled to the benefit of the earlier filing date of the prior-field applications and has the actual filing date of the present application: July 03, 2024.
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