DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 4 and 18 are objected to because of the following informalities:
Claim 4, line 3 recites “the cavity marker”, however claim 1 recites “at least one site marker”. It is recommended that this limitation be amended to recite “the site marker” instead to match the antecedent basis for the structure.
Claim 18 recites the limitation “inserting the delivery system” on page 4, line 11, however this term lacks antecedent basis in the claim. It is recommended that claim 18 be amended to recite “the surgical site marker system” instead, which has basis in the line 2 of the claim.
Appropriate correction is required.
Specification
The abstract of the disclosure is objected to because:
Line 6 recites “configured to selectively retain site marker”, which is missing an article. It is recommended this line be amended to recite “configured to selectively retain the site marker” instead.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a/the retention member” in claims 1, 4, 6, 9-10, and 17, which can be interpreted as “a/the member for retaining”
the retention member is being interpreted to cover the corresponding structure of “an angled protrusion” as described in the specification (see PP [0045]), which enables retention of a site marker
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 5, 7-8, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischvogt et al. (US PGPub 2023/0346378 A1).
With respect to claim 1, Fischvogt et al. discloses a system (300 in Fig. 5) for deploying one or more site markers (318 in Fig. 8) within a surgical site, the system comprising:
at least one site marker (318, upon implantation the implant 318 effectively marks the fastening site by its presence and can be considered to be a site marker); and
an applicator device (300 in Fig. 5) comprising:
a housing (302);
a carousel (304) rotatably coupled to the housing (PP [0065]: “a cartridge 304, such as, for example, a carousel or wheel, movably supported within a cavity 306 of the housing 302”, PP [0071]: “The cartridge 304 is configured to move (e.g., rotate), in response to an activation of the motor 314 or via a manual actuation, between a first position and at least one second position. In the first position, one of the slots 324 of the cartridge 304 is coaxial with the longitudinal channel 312 of the housing 302 allowing for the free translation of the surgical instrument 50 therethrough”) and configured to retain the at least one marker (see 318 within 304 in Fig. 5);
a shaft assembly (50 in Fig. 9A) that extends through the housing (302) and slidingly engages the housing (302) and the carousel (304, see 50 slide relative to 302 and 304 in Figs. 9A-D), wherein the shaft assembly (50) comprises:
a drive member (shaft portion of 50, see annotated Fig. 9A below) configured to engage the at least one site marker (318, the shaft of 50 engages the site marker 318 via the end effector jaws 55), and
a retention member (55 in Fig. 9D, see unmarked end effector jaws of 50 in Fig. 9A, this structure reads on the 112(f) interpretation of “retention member” because the jaws comprise unmarked grooves and protrusions for mating with a geometry of the clip, see Figs. 9A-C) configured to selectively retain the at least one site marker (318, see retention in Fig. 9B); and
a sheath (200 in Fig. 9A) coupled to the housing (200 couples to housing 302 via sterile interface 400), wherein the sheath (200) is disposed around the shaft assembly (50, see shaft assembly extending through sheath 200 in Fig. 9D, with end effector jaws 55 extending out the distal end) which comprises a distal end having an opening sized and shaped to permit the at least one site marker to exit the applicator device (see unmarked distal opening of 200 in Fig. 9D, PP [0074]: “in step 1000 (FIG. 10), the surgical instrument 50 may be passed through the longitudinal channel 312 of the reloading module 300, through the trocar 200, and into a surgical site, as shown in FIG. 9D. After firing a surgical implant 318 from the surgical instrument 50 into tissue, in step 1002, the now spent surgical instrument 50 may be translated proximally out of the surgical site, through the trocar 200, and stop when the end effector 55 of the surgical instrument 50 is within the reloading module 300 and proximal of the cartridge 304, as shown in FIG. 9A”).
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Regarding claim 2, Fischvogt et al. further discloses wherein the applicator device (300 in Fig. 5, see also Fig. 9A) is movable between a retracted state (see Fig. 9A) and a deployment state (see Fig. 9D) by retracting or advancing the drive member (shaft of 50, see annotated Fig. 9A above, PP [0075]: “With the surgical implant 318 captured between the jaws of the end effector of the surgical instrument 50, in step 1008, the surgical instrument 50 is retracted to dislodge the surgical implant 318 from the cartridge 304, as shown in FIG. 9C. The surgical instrument 50, with the surgical implant secured thereto, is retracted a sufficient distance from the cartridge 304, without exiting the reloading module 300”).
Regarding claim 5, Fischvogt et al. further discloses wherein, when in the retracted state (see Fig. 9A), the drive member (shaft of 50, see annotated Fig. 9A above) is retracted in a proximal direction such that it is capable of sufficiently disengaging the carousel (304) to permit rotation of the carousel (PP [0073]: “upon the end effector of the surgical instrument 50 moving proximally through the reloading module 300 to a position proximal of the cartridge 304, the sensor 320 causes the motor 314 to rotate the cartridge 304 from the first position to the second position to allow for reloading the end effector with the surgical implant 318”).
Regarding claim 7, Fischvogt et al. further discloses wherein:
the carousel (304 in Fig. 9A) retains a plurality of the site markers (318, see also isolated view of carousel 304 in Fig. 8); and
when in the retracted state (see Fig. 9A), the carousel (304) is rotatable to permit selection of one of the plurality of site markers (318, PP [0073]: “upon the end effector of the surgical instrument 50 moving proximally through the reloading module 300 to a position proximal of the cartridge 304, the sensor 320 causes the motor 314 to rotate the cartridge 304 from the first position to the second position to allow for reloading the end effector with the surgical implant 318”).
Regarding claim 8, Fischvogt et al. further discloses wherein the carousel (304 in Fig. 7) further comprises a plurality of windows (326) corresponding to the plurality of site markers (318), whereby the site markers (318) are visible through the corresponding windows (326) while the site markers (318) are in the carousel (304, see Figs. 5 and 9A, the clips are visible through the open side of housing 302 within their pocket windows 326).
With respect to claim 17, Fischvogt et al. discloses an applicator device (300 in Fig. 5) for applying a surgical site marker (318 in Fig. 8, upon implantation the implant 318 effectively marks the fastening site by its presence and can be considered to be a site marker) comprising:
a housing (302 in Fig. 5);
a carousel (304) rotatably coupled to the housing (PP [0065]: “a cartridge 304, such as, for example, a carousel or wheel, movably supported within a cavity 306 of the housing 302”, PP [0071]: “The cartridge 304 is configured to move (e.g., rotate), in response to an activation of the motor 314 or via a manual actuation, between a first position and at least one second position. In the first position, one of the slots 324 of the cartridge 304 is coaxial with the longitudinal channel 312 of the housing 302 allowing for the free translation of the surgical instrument 50 therethrough”) and configured to retain at least one site marker (see 318 within 304 in Figs. 5 and 8);
a shaft assembly (50 in Fig. 9A) that extends through the housing (302) and slidingly engages the housing (302) and carousel (304, see 50 slide relative to 302 and 304 in Figs. 9A-D), the shaft assembly (50) comprising:
a drive member (shaft portion of 50, see annotated Fig. 9A below) configured to engage the site marker (318, the shaft of 50 engages the site marker 318 via the end effector jaws 55); and
a retention member (55 in Fig. 9D, see unmarked end effector jaws of 50 in Fig. 9A, this structure reads on the 112(f) interpretation of “retention member” because the jaws comprise unmarked grooves and protrusions for mating with a geometry of the clip, see Figs. 9A-C) configured to selectively retain the site marker (318, see retention in Fig. 9B); and
a sheath (200 in Fig. 9A) coupled to the housing (200 couples to housing 302 via sterile interface 400), disposed around the shaft assembly (50, see shaft assembly 50 extending through sheath 200 in Fig. 9D, with end effector jaws 55 extending out the distal end), and comprising an opening a distal end sized and shaped to permit the site marker to exit the applicator device (see unmarked distal opening of 200 in Fig. 9D, PP [0074]: “in step 1000 (FIG. 10), the surgical instrument 50 may be passed through the longitudinal channel 312 of the reloading module 300, through the trocar 200, and into a surgical site, as shown in FIG. 9D. After firing a surgical implant 318 from the surgical instrument 50 into tissue, in step 1002, the now spent surgical instrument 50 may be translated proximally out of the surgical site, through the trocar 200, and stop when the end effector 55 of the surgical instrument 50 is within the reloading module 300 and proximal of the cartridge 304, as shown in FIG. 9A”).
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With respect to claim 18, Fischvogt et al. discloses a method of applying a site marker to tissue of a patient (PP [0074]: “firing a surgical implant 318 from the surgical instrument 50 into tissue”, upon implantation the implant 318 effectively marks the fastening site by its presence and can be considered to be a site marker), the method comprising:
providing a surgical site marker system (300 in Fig. 5, see also Fig. 9A) comprising:
a plurality of surgical site markers (318 in Fig. 9A); and
an applicator device (300 in Fig. 5) comprising:
a housing (302);
a carousel (304) rotatably coupled to the housing (PP [0065]: “a cartridge 304, such as, for example, a carousel or wheel, movably supported within a cavity 306 of the housing 302”, PP [0071]: “The cartridge 304 is configured to move (e.g., rotate), in response to an activation of the motor 314 or via a manual actuation, between a first position and at least one second position. In the first position, one of the slots 324 of the cartridge 304 is coaxial with the longitudinal channel 312 of the housing 302 allowing for the free translation of the surgical instrument 50 therethrough”), wherein the plurality of site markers (318) are retained within the carousel (304), and
a shaft assembly (50 in Fig. 9A) that extends through the housing (302) and slidingly engages the housing (302) and carousel (304, see 50 slide relative to 302 and 304 in Figs. 9A-D), the shaft assembly (50) comprising a drive member (50 with end effector 55) configured to engage one of the plurality of site markers (see 55 engage 318 in Fig. 9B);
retracting the drive member (50) of the applicator device (300, PP [0073]: “the end effector of the surgical instrument 50 moving proximally through the reloading module 300 to a position proximal of the cartridge 304”);
rotating the carousel to select one of the plurality of site markers (PP [0073]: “upon the end effector of the surgical instrument 50 moving proximally through the reloading module 300 to a position proximal of the cartridge 304, the sensor 320 causes the motor 314 to rotate the cartridge 304 from the first position to the second position to allow for reloading the end effector with the surgical implant 318”);
inserting the delivery system into the patient proximate an area of tissue in a surgical site (PP [0064]: “the surgical trocar 200 of the surgical robotic system 10 is configured for guiding the surgical instrument 50 through a natural or artificial (e.g., percutaneous) opening in a patient and into a surgical site or internal body cavity of the patient”); and
advancing the drive member (50 in Fig. 9D) distally to engage the selected site marker (PP [0075]: “the surgical instrument 50 is translated distally to engage the jaws of the end effector 55 with the surgical implant 318, as shown in FIG. 9B”) and secure the site marker to the area of tissue (PP [0074]: “the surgical instrument 50 may be passed through the longitudinal channel 312 of the reloading module 300, through the trocar 200, and into a surgical site, as shown in FIG. 9D. After firing a surgical implant 318 from the surgical instrument 50 into tissue, in step 1002, the now spent surgical instrument 50 may be translated proximally out of the surgical site”).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fischgvogt et al. (US PGPub 2023/0346378 A1), as applied to claim 1 above, and further in view of Shellenberger et al. (US PGPub 2021/0007751 A1).
Regarding claim 3, Fischvogt et al. fails to disclose wherein the shaft assembly further comprises a spring-loaded guide member.
In the related field of clip applier devices (abstract), which is relevant to the present disclosure as it also pertains to the implantation of legged surgical clip-like implants into target tissue, Shellenberger et al. teaches a shaft assembly (100 in Fig. 1) comprising a drive member (104) and a retention member (102, see protrusions 124 and 134 in Figs. 6-7 for retaining a site marker or implant), wherein the shaft assembly (100) further comprises a spring-loaded guide member (142 in Figs. 6-7, PP [0029]: “the pivoting of the jaw assembly 102 may be biased into the open configuration by at least one leaf spring 140 and actuated by longitudinal movement of the tubular member 114… a pair leaf springs 140 on opposing lateral sides of a vertical beam or connector 142, and a proximal end of the leaf springs 140 may be fixed (e.g., welded) to the connector 142 in a cantilever configuration”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Fischvogt et al. device according to the teachings of Shellenberger et al. to include a spring-loaded guide member in the shaft assembly. One of ordinary skill in the art would have been motivated to perform this modification as doing so is a simple substitution of shaft assemblies that would have yielded predictable results, as Fischvogt et al. contemplates that “the surgical instrument 50 may be a surgical clip applier, a surgical stapler, an electrosurgical forceps, or the like” (PP [0044], emphasis added). Furthermore, the substitution as proposed would not alter the main operating principle of the Fischvogt et al. assembly, as the shaft assembly of Shellenberger et al. (100 in Fig. 1, see also drive member 104 and retention member 102 in Figs. 6-7) is also configured with retention protrusions (see distal protrusions defined by recesses 124 and 134) for retaining implants similar to that disclosed by the Fischvogt et al. reference and would operate in the same way as the Fischvogt et al. shaft assembly for actuating the surgical implants.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fischgvogt et al. (US PGPub 2023/0346378 A1), as applied to claim 1 above, and further in view of Castro (US PGPub 2021/0212689 A1).
Regarding claim 6, Fischvogt et al. fails to disclose wherein:
the drive member further comprises a wedge portion; and
when in the deployment state, the wedge portion is configured to engage the retention member and cause the retention member to release one site marker.
In the related field of clip applier devices (abstract), which is relevant to the present disclosure as it also pertains to the implantation of legged surgical clip-like implants into target tissue, Castro teaches a shaft assembly (10 in Fig. 1) comprising a drive member (30) and a retention member (20, see also 102 and 104 in Figs. 4-5, see protrusions defined by recesses 114 for retaining a surgical implant as seen in Figs. 4-5), wherein the drive member (30) further comprises a wedge portion (106 in Figs. 3-5, stabilizing member 106 has a wedge shape as it has a wider proximal end and a narrow); and
when in the deployment state, the wedge portion (106) is configured to engage the retention member (102 and 104, 106 engages 102 and 104 via slots 126 and pins 128, since the pins and slots always connect the retention member 102/104 to the wedge portion 106 the wedge portion engages the retention member in the deployment state) and cause the retention member (102 and 104) to release one implant (50, PP [0037]: “The retraction of the stabilizing member 106, 206 also facilitates release of the surgical clip 50 after closing and/or latching of the surgical clip 50”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Fischvogt et al. device according to the teachings of Castro to include the wedge portion as claimed. One of ordinary skill in the art would have been motivated to perform this modification as doing so is a simple substitution of shaft assemblies that would have yielded predictable results, as Fischvogt et al. contemplates that “the surgical instrument 50 may be a surgical clip applier, a surgical stapler, an electrosurgical forceps, or the like” (PP [0044], emphasis added). Furthermore, the substitution as proposed would not alter the main operating principle of the Fischvogt et al. assembly, as the shaft assembly of Castro is also configured with retention protrusions (see protrusions defined by recesses 114 for retaining a surgical implant as seen in Figs. 4-5) for retaining implants similar to that disclosed by the Fischvogt et al. reference and would operate in the same way as the Fischvogt et al. shaft assembly for actuating the surgical implants.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fischgvogt et al. (US PGPub 2023/0346378 A1), as applied to claim 1 above, and further in view of Huitema (US PGPub 2003/0225423 A1).
Regarding claim 15, Fischgvogt et al. fails to disclose wherein the site marker is scan-detectable.
In the related field of surgical clips (abstract), which is relevant to the present disclosure as it relates to inserting clip-like implants into a target tissue of a patient, Huitema teaches a clip (14 in Fig. 2), wherein the clip is scan-detectable (see Fig. 5, PP [0028]: “The second layer of material 40 may be preferably made from a linear elastic material, such as iron, stainless steel or titanium linear elastic nitinol. The second layer could also be made from a material which would impart radiopaque qualities to the clip so it could be seen better under x-ray”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Fischvogt et al. according to the teachings of the Huitema reference to include wherein the site marker is scan-detectable. One of ordinary skill in the art would have been motivated to perform this modification because doing so constitutes the use of a known technique (constructing clips/implants using radiopaque materials to enable scan detection) to improve a similar device (the implants of Fischvogt et al.) in order to yield the predictable result of enabling the implants of Fischvogt et al. to “be seen better under x-ray” (PP [0028] of Huitema). The modification as proposed would not alter the main operating principle of the Fischvogt et al. device, since the respective implants of Fischvogt et al. and Huitema are both intended to be inserted into target tissue (Huitema PP [0019]: “The closing of first jaw 142 and second jaw 144 by firing trigger 114 causes clips to form and deploy from clip applier 100 around the tissue positioned therebetween”, Fischvogt et al. PP [0074]: “After firing a surgical implant 318 from the surgical instrument 50 into tissue”) and furthermore because Fischvogt et al. does not offer any statements of criticality requiring the implants to be constructed from a specific material.
Regarding claim 16, Fischgvogt et al. as modified by Huitema further discloses wherein the site marker (318 in Fig. 9A of Fischvogt et al.) is radiopaque (Huitema PP [0028]: “The second layer of material 40 may be preferably made from a linear elastic material, such as iron, stainless steel or titanium linear elastic nitinol. The second layer could also be made from a material which would impart radiopaque qualities to the clip so it could be seen better under x-ray”).
Allowable Subject Matter
Claims 4, 9-10, and 11-14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the claims 4, 11-14 filed on 2/21/2025 could either not be found or was not suggested in the prior art of record.
With respect to claim 4, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein the drive member is configured to push the cavity marker along a length of the shaft assembly, or wherein at least a portion of the at least one site marker is disposed between the drive member and the guide member, in combination with the other limitations of the claim.
The closest prior art is Fischvogt et al. (US PGPub 2023/0346378 A1) which discloses wherein, in order to move the applicator device (see 300 and 50 in Figs. 5 and 9A) from the retracted state (Fig. 9A) to the deployment state (Fig. 9D):
the drive member (shaft of 50 in Fig. 9B) is configured to push the cavity marker (318) out of the carousel (304, see Figs. 9B and D, the drive member is retracted proximally to Fig. 9C before pushing distally to deposit the cavity marker 318 into tissue in Fig. 9D),
the site marker (318 in Figs. 9A-C) is configured to engage with the retention member (end effector 55 of shaft assembly 50, see the site marker 318 being engaged within the jaws of 55 in Fig. 9B).
However, Fischvogt et al. fails to disclose wherein the drive member is configured to push the cavity marker along a length of the shaft assembly, or wherein at least a portion of the at least one site marker is disposed between the drive member and the guide member. Furthermore, the prior art of record does not suggest any motivation to modify the Fischvogt et al. disclosure to arrive at these features since the drive member (shaft of 50) does not move relative to the shaft assembly (50 as a whole) while distally moving the cavity
With respect to claims 9-10, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein, when in the deployment state, the retention member is configured to contact a stop of the sheath, wherein the stop prevents motion of the retention member relative to the sheath in a distal direction biased by a spring, in combination with the other limitations of the claim.
The closest prior art is Fischvogt et al. (US PGPub 2023/0346378 A1), which discloses each of the limitations as described above regarding claim 1.
However, Fischvogt et al. fails to disclose the sheath stop as claimed. Furthermore, the prior art of record does not suggest any motivation to modify the Fischvogt et al. disclosure to arrive at these features since the shaft assembly and retention member as disclosed by Fischvogt et al. is actuatable by hand to move proximally and distally through the sheath. A distal stop engageable with the retention member to prevent distal motion would therefore not have been obvious.
With respect to claims 11-14, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein the distal end of the sheath further comprises a first deflection surface configured to contact a first arm of the site marker and bend the site marker such that the first arm moves closer to a second arm of the site marker, in combination with the other limitations of the claim.
The closest prior art is Fischvogt et al. (US PGPub 2023/0346378 A1), which discloses wherein:
a proximal end (202 in Fig. 9A) of the sheath (200) is coupled to a distal end of the housing (302 in Fig. 5, see unmarked 302 in Fig. 9A, 200 is coupled to a bottom distal end of housing 302 via interface 400).
However, Fischvogt et al. fails to disclose wherein the sheath includes the deflection surfaces for bending the site marker as claimed. Furthermore, the prior art of record does not suggest any motivation to modify the Fischvogt et al. disclosure to arrive at these features, since bending of the site markers (318 in Figs. 9A-C) is already accomplished by actuation of the end effector (55 in Fig. 9D) of the shaft assembly (50).
Claims 12-14 depend from claim 11 and inherit the same allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure
Fiebig et al. (US PGPub 2015/0157417 A1) discloses a biopsy device (10 in Fig. 1) with a rotatable carousel (140 in Figs. 3-4, PP [0140]: “rotatable manifold (140) comprises a plurality of chambers (150) positioned about a central hub (142) where each of the plurality of chambers (150) extend through rotatable manifold (140)”) with a plurality of chambers (150). There’s a shaft assembly (90 of needle 40, see also Fig. 1), but no retention member or drive member because the device uses a vacuum suction force to suck tissue samples proximally into each of the chambers (150, PP [0036]: “a vacuum may be applied to cutter lumen (98) while atmospheric air is provided through a vent fluidly coupled to first lumen (94) and/or second lumen (96). The combination of vacuum on one side of the tissue sample and atmospheric air on the other may cooperatively urge the tissue sample proximally through tubular cutter (90) and towards tissue sample holder (100)”).
Sussman (US PGPub 2025/0302622 A1) discloses a rotatable carousel (120 in Figs. 3A-C) for holding fasteners (140) and a driver rod (134 in Figs. 3A-5C, Figs. 4A-C show the retracted rod and Figs. 5A-C show the rod advanced to push an anchor/fastener distally) for deploying the fasteners (140). Figs. 10-13E also show another embodiment with a rotatable carousel (206), however the filing date for this reference renders it unusable as prior art.
Cavanagh et al. (US PGPub 2025/0000607 A1) discloses a marker delivery device (10 in Fig. 1) with a rotatable cartridge for holding markers (452 in Figs. 10 and 11A-C) that rotates into engagement with a push rod (470), however the cartridge (452) is not a “carousel” because it rotates around a fulcrum rod (461) that is perpendicular to the longitudinal axis of the device, and doesn’t rotate a full 360 degrees. Cavanagh et al. also fails to disclose the retention and drive members, since it only discusses a singular pushrod.
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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771
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