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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
Claims 1-19 drawn to a monolithic framework for an end effector of a medical device, classified in A61B 18/1492.
Claim 20 drawn to a method of manufacturing a monolithic framework for a medical device, classified in A61B 5/150519.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as the product made and the process of making. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2)
that the product as claimed can be made by another and materially different process
(MPEP § 806.05(f)). In the instant case the product as claimed can be made by another materially different process which may not involve heat setting the plurality of spines.
Restriction for examination purposes as indicated is proper because all the
inventions listed in this action are independent or distinct for the reasons given above
and there would be a serious search and/or examination burden if restriction were not
required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classifications and the
inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or
search queries).
Applicant is advised that the reply to this requirement to be complete must
include (i) an election of an invention to be examined even though the requirement
may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
the elected invention.
The election of an invention may be made with or without traverse. To reserve a
right to petition, the election must be made with traverse. If the reply does not distinctly
and specifically point out supposed errors in the restriction requirement, the election
shall be treated as an election without traverse. Traversal must be presented at the time
of election in order to be considered timely. Failure to timely traverse the requirement
will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
the election, applicant must indicate which of these claims are readable upon the
elected invention.
Should applicant traverse on the ground that the inventions are not patentably
distinct, applicant should submit evidence or identify such evidence now of record
showing the inventions to be obvious variants or clearly admit on the record that this is
the case. In either instance, if the examiner finds one of the inventions unpatentable
over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.
103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected
invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one
or more of the currently named inventors is no longer an inventor of at least one claim
remaining in the application. A request to correct inventorship under 37 CFR 1.48(a)
must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that
identifies each inventor by his or her legal name and by the processing fee required
under 37 CFR 1.17(i).
During a telephone conversation with Korbin Blunck on 12/22/2025 a provisional election was made without traverse to prosecute the invention of Invention I, claims 1-19. Affirmation of this election must be made by applicant in replying to this Office action. Claim 20 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 third arcuate bend being proximal to the spine terminal end as described in claim 9, must be shown or the feature(s) canceled from the claim(s). Moreover, the drawings fail to show the plurality of spines comprising a generally spheroidal shape when in the collapsed configuration, as described in claim 18. 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: The following sentence should be amended to read, “The second arcuate bend 204B extends from the first arcuate bend 204A in a second radial direction R2” [pa. 0070].
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 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a third arcuate bend 204C of respective spine, which extends from a second arcuate bend 204B, to be distal to a respective spine terminal end 230 (see figure 12), does not reasonably provide enablement for the third arcuate bend to be specifically located proximal the spine distal end. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Regarding claim 9, the claim recites “a third arcuate bend, proximal the spine terminal end and extending from the second arcuate bend, in the first radial direction” (Emphasis added by Examiner). Parent claim 1 has set forth that the spines “are configured to bow outwardly relative to the longitudinal axis” and for each spine to extend “from the crown to a spine terminal end configured to connect to a connecting hub”. Parent claim 8 sets forth for a first arcuate bend is “proximal the crown, in a first radial direction perpendicular to the longitudinal axis” and for a second arcuate that is “extending from the first arcuate bend, in a second radial direction perpendicular to the longitudinal axis”.
The Examiner has reviewed the instant disclosure for discussion with respect to
each of these noted limitations. As a preliminary matter, the Examiner notes that Applicant has specifically defined the term “proximal” in the instant Specification in [0026] to be defined as “a location closer to the operator or physician”. Thus, the Examiner is of the position that the use of claim language of “proximal the spine terminal end” in the at-issue language in claim 9 requires the third arcuate bend to be placed closer to the operator or physician than the spine terminal end.
The Examiner, in light of this definition in [0026] of the term “proximal”, has further review the Specification for the existence of description or a working example of such an arrangement for the first, second and third acruate bends. Paragraph [0071] of the filed Specification sets forth disclosure with respect to figure 12, and substantially reiterates the at-issue claim language in reciting “the third arcuate bend 204C extends from the second arcuate bend 204B and is proximal the spine terminal ends 230” (emphasis added). While [0071] of the Specification notes for the same specific location of the third arcuate bend in relation to the spine terminal end as in the at-issue language in claim 9, such description in not consistent with the balance of the disclosure in the Specification nor the depiction of the third arcuate bend in figure 12. Figure 12, rather, depicts each third acruate bend at 204C to be located distal to its respective spine terminal end at 230. Neither figure 12 nor any other figure display an arrangement where any arcuate bend, let alone the specific third arcuate bend is placed in a position that is proximal the spine terminal end as required in claim 9.
The Examiner has further failed to find any structural or functional description which provides for the third arcuate bend to be proximally located in relation to the spine terminal end as required by claim 9, while also being contained between “the crown to a spine terminal end” as set forth in claim 1. It is unclear to Examiner based on the Specification and Drawings how a third arcuate bend would be able to be physically located proximal to a respective spine terminal end given that the arcuate bend is a structural feature of the spine itself, and any structure located proximal to the spine terminal end would therefore not be considered part of the spine.
Accordingly, while the Examiner can find general description in the Specification for the features of claim 9 in [0071], the Examiner has failed to find any description or working example that would enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate with the scope of claim 9 where the third arcuate bend would be proximal the spine terminal end. To this end, while the invention involves spline/basket structures that are well established in the surgical instruments arts and the general level of skill and predictability in this art is high, the Examiner is of the position that the achievement of such a claimed physical arrangement of these framework components as required by the combination of features in claim 9 would require undue experimentation to achieve by one of ordinary skill in the art given that the achievement of the monolithic framework of claim 9 would not be physically possible to achieve as described. Said differently, Applicant’s own definition of “proximal” in [0021] would preclude each third arcuate bend from being located as shown in figure 12 (at a located distal to the spine terminal end), and the provision of the third arcuate bend proximal to the spine terminal end would structurally place the third arcuate bend at a location both off of its respective spine and in a location in conflict with the requirements of claim 1.
It is, therefore, in view of at least the reasoning set forth above that the Examiner is of the position that claim 9 fails to comply with the enablement requirement of 35 U.S.C. 112(a). Appropriate correction is required.
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.
Claims 1-2, 5-6, 8, 10-12, and 16-18, are rejected under 35 U.S.C. 103 as being unpatentable over Marrs (U.S. Application No. 20170065227 A1), and further in view of Schneider (U.S. Application No. 20200155194 A1).
Regarding independent claim 1, and claim 2, Marrs discloses a multi-piece framework for an end effector (12) for a medical device (10) (pa. 0051 & Figs. 1-2), the end effector comprising:
a crown (28) (pa. 0053) extending along a longitudinal axis (24), defining a crown lumen (104) (pa. 0060), and defining a plurality of crown recesses (118 a 1-d 2) (pa. 0061 & Fig. 10A) configured to connect to an annulus (26) (pa. 0056 & Figs. 4-5B). Examiner is interpreting the word “connect to” as bringing together/two objects touching, either directly or indirectly. In this case, the annulus is brought together/connected to the inner surfaces of the crown, as illustrated in Fig. 26, where the side walls of the annulus touch at least a portion of the crown recesses; and
a plurality of spines (30 a-d) extending along the longitudinal axis and configured to bow outwardly relative to the longitudinal axis (pa. 0053), each spine extending from the crown to a spine terminal end (130 a) (pa. 0064 & Fig. 11) and being configured to connect to a connecting hub (32, specifically a combination of retainer ring 186, constraining ring 182, and torsion ring 184) (pa. 0053, 0068 & Fig. 17).
However, Marrs does not disclose the end effector being a monolithic framework comprising cylindrical stock.
Schneider, in the same field of endeavor, teaches a catheter (10) including an end effector (12) comprising a tubular body (32) being made up of a plurality of spines (34) and a crown (42) (pa. 0114), wherein the tubular body and the crown can be a single, one-piece component that is integrally, monolithically formed from a single piece of material, such as a sheet stock. In other examples, the tubular body and the crown can be formed separately and secured to one another in any suitable way (pa. 0114 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the multiple-piece manufacturing method of the medical device of Marrs to be a single piece, monolithic framework as taught by Schneider, since either manufacturing technique would yield the same predictable results of creating an end effector with a plurality of splines with a crown.
Regarding claim 5, Marrs/Schneider combination discloses each spine defining a plurality of spine recesses (140 a, 142 a, 144 a, 146 a) (Marrs, pa. 0065 & Fig. 15) in at least one lateral side of the spine, the plurality of spine recesses being configured to interface with the connecting hub (Marrs, pa. 0069, 0071).
Regarding claim 6, Marrs/Schneider combination discloses each plurality of spine recesses comprising a first set of spine recesses defined in a first lateral side of the respective spine (Marrs, top portion of the spine as seen in Fig. 15) and a second set of spine recesses defined in a second lateral side of the respective spine (Marrs, bottom portion of the spine as seen in Fig. 15).
Regarding claim 8, Marrs/Schneider combination discloses each spine comprising:
a first arcuate bend (see annotated Fig. 12 below), proximal the crown, in a first radial direction (i.e., in a counterclockwise direction) perpendicular to the longitudinal axis; and
a second arcuate bend (see annotated Fig. 12 below), extending from the first arcuate bend, in a second radial direction (i.e., in a clockwise direction) perpendicular to the longitudinal axis.
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Regarding independent claim 10, Marrs discloses an end effector (12) for a medical device (10) (pa. 0051 & Figs. 1-2), the end effector comprising:
A multi-piece framework comprising:
a crown (28) (pa. 0053) extending along a longitudinal axis (24) and defining a plurality of crown recesses (118 a 1-d 2) (pa. 0061 & Fig. 10A); and
a plurality of spines (30 a-d) extending along the longitudinal axis and configured to bow outwardly relative to the longitudinal axis (pa. 0053), the plurality of spines being movable between a collapsed configuration and an expanded configuration (pa. 0053);
an annulus (26) connected to the plurality of crown recesses (pa. 0056 & Figs. 4-5B). Examiner is interpreting the word “connected to” as bringing together/two objects touching, either directly or indirectly. In this case, the annulus is brought together to the inner surfaces of the crown, as illustrated in Fig. 26, where the side walls of the annulus touch at least a portion of the crown recesses;
a connecting hub (32, specifically a combination of retainer ring 186, constraining ring 182, and torsion ring 184) (pa. 0068) connected to the plurality of spines (pa. 0053 & Fig. 17); and
one or more electrodes (40) connected to each spine of the plurality of spines (pa. 0055 & Fig. 3).
However, Marrs does not disclose the end effector being a monolithic framework comprising cylindrical stock.
Schneider, in the same field of endeavor, teaches a catheter (10) including an end effector (12) comprising a tubular body (32) being made up of a plurality of spines (34) and a crown (42) (pa. 0114), wherein the tubular body and the crown can be a single, one-piece component that is integrally, monolithically formed from a single piece of material, such as a sheet stock. In other examples, the tubular body and the crown can be formed separately and secured to one another in any suitable way (pa. 0114 & Fig. 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the multiple-piece manufacturing method of the medical device of Marrs to be a single piece, monolithic framework as taught by Schneider, since either manufacturing technique would yield the same predictable results of creating an end effector with a plurality of splines with a crown.
Regarding claim 11, Marrs/Schneider combination discloses the crown defining a crown lumen (104), and the annulus extending through the crown lumen (Marrs, pa. 0060 & Fig. 9).
Regarding claim 12, Marrs/Schneider combination discloses the annulus comprising an atraumatic tip portion (58), a polygonal portion (combination of a cylindrical portion 64 and tapered portion 66) frictionally engaging an inner surface of the crown, and a tube portion (Marrs, pa. 0056-0057 & Figs. 7 and 26).
Regarding claim 16, Marrs/Schneider combination discloses further comprising a connector tube (46) extending generally parallel to or coaxial with the longitudinal axis and connected to the annulus (Marrs, pa. 0054, 0056).
Regarding claim 17, Marrs/Schneider combination discloses each spine of the plurality of spines having a shaped end defining at least one recess (140 a, 142 a, 144 a, 146 a) (Marrs, pa. 0065 & Fig. 15), the connecting hub defining a plurality of hub reliefs (194 a 1-d 2, , 206 a 1-d 2) and each hub relief being shaped to receive a respective shaped end of each spine (Marrs, pa. 0069, 0071).
Regarding claim 18, Marrs/Schneider combination discloses the plurality of spines comprising a generally spheroidal shape when in the collapsed configuration (Marrs, pa. 0053).
Claims 3-4, 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claims 1 and 10 above, and further in view of Conlon (W.O. Application No. 2017066087 A1).
Regarding claim 3, Marrs/Schneider combination discloses a crown terminal end (Marrs, i.e., bottom/lower section where circumferential wall 106 is located in Fig. 10A).
However, they do not disclose each crown recess comprising a first portion defined in the crown terminal end and extending parallel to the longitudinal axis; and a second portion extending from and generally perpendicular to the first portion.
Conlon, in the same field of endeavor, teaches a medical assembly (3710) comprising a first coupling member (3010) (analogous to the annulus) and second coupling member (3730) (analogous to the crown) (pa. 000345-000346 & Figs. 103-106). The first coupling member comprises a plurality of bayonet mount tabs (3014) (pa. 000345, 000348), and the second coupling member comprises a plurality of bayonet slots (3732) (analogous to the crown recess) (pa. 000349), wherein the bayonet mount tabs rotatably engage the bayonet slots in a nonpermanent locking fashion, as demonstrated in Figs. 107A-107E). The plurality of bayonet slots further comprise a longitudinally extending portions (3736) (i.e., a first portion defined in a crown terminal end and extending parallel to the longitudinal axis) and angularly extending portions (3738) (i.e., a second portion extending from and generally perpendicular to the first portion) (pa. 000349).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the bayonet mount tabs of Conlon to the annulus of Marrs and to have added additional crown recesses (i.e., the bayonet slots of Conlon) to the crown terminal end of Marrs for the purpose of providing an additional method of frictionally securing these two elements together.
Regarding claim 4, Marrs/Schneider/Conlon combination discloses a plurality of crown holes (defined by screws which extend through circumferential wall 110 of crown 28 into cylindrical portion 64 of annulus 26 used to retain the crown and the annulus) extending generally perpendicular to the longitudinal axis (see Fig. 26), each crown hole being located between adjacent recesses of the plurality of crown recesses (Marrs, pa. 0075).
Regarding claim 13, Marrs/Schneider combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not disclose the polygonal portion comprising a plurality of locking protrusions protruding radially outwards away from the longitudinal axis, each locking protrusion engaging in a respective crown recess of the plurality of crown recesses.
Conlon, in the same field of endeavor, teaches a medical assembly (3710) comprising a first coupling member (3010) (analogous to the annulus) and second coupling member (3730) (analogous to the crown) (pa. 000345-000346 & Figs. 103-106). The first coupling member comprises a plurality of bayonet mount tabs (3014) (i.e., a plurality of locking protrusions protruding radially outwards away from the longitudinal axis) (pa. 000345, 000348), and the second coupling member comprises a plurality of bayonet slots (3732) (analogous to the crown recess) (pa. 000349), wherein the bayonet mount tabs rotatably engage the bayonet slots in a nonpermanent locking fashion, as demonstrated in Figs. 107A-107E).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the bayonet mount tabs of Conlon to the annulus of Marrs and to have added the additional crown recesses (i.e., the bayonet slots of Conlon) to the crown of Marrs for the purpose of providing an additional method of frictionally securing these two elements together.
Regarding claim 14, Marrs/Schneider/Conlon combination discloses the polygonal portion defining a plurality of annulus holes (defined by screws which extend through circumferential wall 110 of crown 28 into cylindrical portion 64 of annulus 26 used to retain the crown and the annulus), each annulus hole being positioned proximal a respective locking protrusion of the plurality of locking protrusions (Marrs, pa. 0075). Examiner is interpreting the term proximal as being in a location closer to the operator or as being adjacent to, as described in the Specification of the instant application pa. 0057.
Regarding claim 15, Marrs/Schneider/Conlon combination discloses the crown defining a plurality of crown holes extending perpendicular to the longitudinal axis (the screws may extend through circumferential wall 110 of the crown 28 into the polygonal portion 64 of annulus 26), each crown hole axially aligning with a respective annulus hole of the plurality of annulus holes (Marrs, pa. 0075 & Fig. 26).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claim 1 above, and further in view of Marecki (U.S. Application No. 20150342491 A1).
Regarding claim 7, Marrs/Schneider combination discloses the connecting hub (32) including retainer ring (186), wherein the retainer ring comprises a plurality of apertures (222) which may be configured to be filled with epoxy or adhesive to allow for greater bond strength (Marrs, pa. 0073 & Fig. 17).
However, they do not disclose each spine defining at least one spine hole defined through the spine and extending perpendicular to the longitudinal axis, the at least one spine hole being positioned between the first set of spine recesses and the second set of spine recesses.
Marecki, in the same field of endeavor, teaches an electrode assembly catheter (30) comprising a plurality or splines (60, 160) (see Fig. 3B), wherein terminal end of each splines comprises a locking feature (198) defined by a geometrical shape having a first portion (202) and a second portion (204) (the first and second portions being analogous to the spine recesses of Marrs) located on both lateral sides of each splines, and an aperture (201), extending perpendicular to a longitudinal axis and positioned between the first and second portions, that is filled with adhesive in order to provide further means of securing the terminal ends to a cap (pa. 0074 & Figs. 5A-5B).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the aperture of Marecki to each of the spines of Marrs in order to provide further means of securing the terminal ends to the connecting hub (Marecki, pa. 0074 & Figs. 5A-5B).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Marrs and Schneider as applied to claims 10 and 18 above, and further in view of Olson (U.S. Application No. 20200375657 A1).
Regarding claim 19, Marrs/Schneider combination discloses each spine of the plurality of spines having a proximal half (i.e., bottom-most half) and a distal half (i.e., top half including a middle section), and the plurality of electrodes being distributed on both halves (Marrs, see Fig. 3).
However, they do not disclose the one or more electrodes being disposed on only the distal half.
Olson, in the same field of endeavor, teaches a catheter (60A) comprising an expandable basket (62A) comprising a plurality of splines (66A) and electrodes (70B) (pa. 0046 & Fig. 3A), wherein the electrodes may be distributed along each spline in a variety of ways, one such method including the electrodes located on only the distal and equatorial portions of the spline (pa. 0050).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the location of the electrodes on the splines of Marrs since this specific distribution pattern of electrodes on the splines can be used to accommodate specific physiological features in a body (Olson, pa. 0050).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA VERUSKA GUERRERO ROSARIO whose telephone number is (571)272-6976. The examiner can normally be reached Monday - Thursday 7:00 - 4:30 PM EST.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794