DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
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 limitation(s) is/are:
Claim 8, “actuation component,” which is being interpreted to mean “a spring” and functional equivalents thereof (see Present Specification at Para. [0010]).
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 § 112
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 3 and 4 are 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.
Regarding Claim 3, Claim 3 recites “wherein the coupler is configured to detachably couple to the second body portion with minimal force.” It is grammatically unclear whether the detachment, the coupling, or both is “with minimal force.” It is additionally unclear what is contemplated by “minimal force,” as the Present Specification lists only examples of amounts of force without describing any as the claimed “minimal force” (see Present Specification at Para. [0046]).
Regarding Claim 4, the term “about five projecting members” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 7, 8, 10, 13-19, 21, 24 and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9,216,285 B1 to Boling et al. (“Boling”)1 as evidenced by "Injection molding". 3D Hubs, hubs.com/guides/injection-molding, accessed via waybackmachine, https://web.archive.org/web/20210513001300/https://www.hubs.com/guides/injection-molding/, May 13, 2021 (“3D Hubs”).
Regarding Independent Claim 1, Boling teaches:
A leadless implantable device comprising: (Title, “Leadless implantable medical device having removable and fixed components;” Figs. 1-3, “LIMD 100”);
a first body portion, (Fig. 2; “second end 106”);
the first body portion comprising: a shell, (Col. 5, Ln. 27-36; Fig. 2, “shell 108”);
a housing configured to house at least one electrical component, the housing being arranged at least partially within the shell, (Col. 5, Ln. Ln. 27-36; Fig. 2, “housing 102”);
As shown in Boling’s Fig. 2, “housing 102” houses “power supply 116.”
As shown in Boling’s Fig. 2, “shell 108” extends “between the first end 103 and the second end 106” of housing 102.
and a coupler attached to the housing; (Col. 7, Ln. 46-57, “The first and second body portions 128, 130 are mated to one another at a detachable interface 132. The detachable interface 132 is defined by the distal end 140 of the first body portion 128 and the proximal end 138 of the second body portion 130. In other words, the distal end 140 of the first body portion 128 mates with the proximal end 138 of the second body portion 130 at the detachable interface 132. The first and second body portions 128, 130 are configured to be un-mated or disengaged from one another at the detachable interface 132 in order to separate the first body portion 128 from the second body portion 130. In FIG. 2, the first and second body portions 128, 130 are shown in a mated position.”)
Boling’s “detachable interface” is such a coupler as claimed.
and a second body portion configured to anchor to a surface of a patient's heart, (Fig. 2, “mounting end 104” of LIMD is mounted to the intra-cardiac tissue; Col. 5, Ln. 37-61);
wherein the coupler comprises a base (Col. 10, Ln. 32-35, “The detachable interface 132 includes a core 150 positioned at and extending outward from the distal end 140 of the removable component 128.”);
Boling’s “core 150” is such a “base” as claimed.
and a plurality of projecting members extending from the base, (Col. 12, Ln. 58-59, “…the core 150 includes a set of first threads 190 that extend along an exterior perimeter 192 of the sleeve 158.”);
Boling’s “threads 190” are such “a plurality of projecting members” as claimed.
and wherein the coupler is configured to detachably couple to the second body portion. (Col. 7, Ln. 46-57, “The first and second body portions 128, 130 are mated to one another at a detachable interface 132. The detachable interface 132 is defined by the distal end 140 of the first body portion 128 and the proximal end 138 of the second body portion 130. In other words, the distal end 140 of the first body portion 128 mates with the proximal end 138 of the second body portion 130 at the detachable interface 132. The first and second body portions 128, 130 are configured to be un-mated or disengaged from one another at the detachable interface 132 in order to separate the first body portion 128 from the second body portion 130. In FIG. 2, the first and second body portions 128, 130 are shown in a mated position.”).
Regarding Claim 2, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses:
wherein the coupler is configured to detachably couple to the second body portion at any face-to-face angle between the base of the coupler and the second body portion (Col 9, Ln. 58-65, “To mate the removable component 128 with the fixed component 130, at least one of the components 128, 130 is moved towards the other component along a mating axis 148 until the first inductive coil 144 is proximate to the second inductive coil 146;” Col. 12, In 58-63, “…the core 150 includes a set of first threads 190 that extend along an exterior perimeter 192 of the sleeve 158. The outer wall 152 has a set of second threads 194 that extend along the interior perimeter 170 of the outer wall 152. The first and second threads 190, 194 are helical and complementary. When the core 150 is loaded into the cavity 154, the first threads 190 of the core 150 engage the second threads 194 of the outer wall 152.”).
Regarding Claim 3, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses:
wherein the coupler is configured to detachably couple to the second body portion with minimal force. (Col 13, Ln. 2-6, “To disengage the removable component 128 from the fixed component 130, the removable component 128 is rotated in an opposite direction relative to the fixed component 130, and the helical threads 190,194 push the core 150 out of the cavity 154.”).
Regarding Claim 7, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses:
wherein the shell is moveable relative to the housing between a first position and a second position. (Col. 7, Ln. 38-40; “The first body portion 128 forms the second end 106 of the housing 102. The first and second body portions 128, 130 each form a portion of the shell 108…;” Col. 7, Ln. 46-47, “The first and second body portions 128, 130 are mated to one another at a detachable interface 132.”).
Boling’s shell is movable between a first position wherein first and second body portions are mated and a second position wherein first and second body portions are unmated.
Regarding Claim 8, Boling discloses the entirety of Claim 7 as explained above.
Boling additionally discloses:
wherein the first body portion further comprises an actuation component configured to return the shell from the second position to the first position. (Col. 13, Ln. 24-26, “In another example, the outer wall 152 may include at least one cantilevered deflectable latch that is configured to engage a corresponding catch on the core 150.”)
Boling’s “cantilevered deflectable latch” is such an actuation component as claimed.
Regarding Claim 10, Boling discloses the entirety of Claim 7 as explained above.
Boling additionally discloses:
wherein the projecting members are configured to retract inside the shell when the shell is disposed in the first position. (Fig. 4A, when Boling’s “shell” is in its “first” or “mated” position, Boling’s “projecting members” or “threads 190” are housing entirely in Boling’s “shell”).
Regarding Claim 13, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses:
wherein the coupler is configured to mechanically couple the first body portion to the second body portion (Col. 7, Ln. 46-57, “The first and second body portions 128, 130 are mated to one another at a detachable interface 132. The detachable interface 132 is defined by the distal end 140 of the first body portion 128 and the proximal end 138 of the second body portion 130. In other words, the distal end 140 of the first body portion 128 mates with the proximal end 138 of the second body portion 130 at the detachable interface 132. The first and second body portions 128, 130 are configured to be un-mated or disengaged from one another at the detachable interface 132 in order to separate the first body portion 128 from the second body portion 130. In FIG. 2, the first and second body portions 128, 130 are shown in a mated position.”).
Regarding Claim 14, Boling discloses the entirety of Claim 13 as explained above.
Boling additionally discloses:
wherein the shell is configured to prevent the coupler from mechanically uncoupling the first body portion from the second body portion when the shell is disposed in a first position (Col. 7, Ln. 38-40; “The first body portion 128 forms the second end 106 of the housing 102. The first and second body portions 128, 130 each form a portion of the shell 108…;” Col. 7, Ln. 46-47, “The first and second body portions 128, 130 are mated to one another at a detachable interface 132.”).
Boling’s shell is configured to prevent Boling’s coupler from mechanically uncoupling in that it is formed from the first and second body portions which mate via Boling’s coupler, and thus supports a portion of the device which facilitates coupling.
Regarding Claim 15, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses:
wherein the coupler is configured to provide electrical coupling between the first and second body portions (Col. 8, Ln. 22-28, “In order to provide the electrode 112 with electrical current for stimulation (and sensing), current is provided across the detachable interface 132 from the power supply 116 in the removable component 128 to the electrode 112 in the fixed component 130.”).
Regarding Claim 16, Boling discloses the entirety of Claim 15 as explained above.
Boling additionally discloses:
wherein a portion of the coupler is conductive (Col. 8, Ln. 22-28, “In order to provide the electrode 112 with electrical current for stimulation (and sensing), current is provided across the detachable interface 132 from the power supply 116 in the removable component 128 to the electrode 112 in the fixed component 130.”);
and a portion of the second body portion is conductive. (Col. 13, Ln. 49-52, “The housing 102 … may be programmably selected to act as the return electrode for certain stimulus modes.”).
Regarding Claim 17, Boling discloses the entirety of Claim 16 as explained above.
Boling additionally discloses:
wherein the conductive portion of the coupler is one or more of the projecting members (Col. 8, Ln. 22-28, “In order to provide the electrode 112 with electrical current for stimulation (and sensing), current is provided across the detachable interface 132 from the power supply 116 in the removable component 128 to the electrode 112 in the fixed component 130.”);
Boling’s “projecting members” (i.e., Boling’s threads) are integral with Boling’s coupler (as Boling’s coupler is a screw), and are thus conductive by virtue of the coupler’s conductivity.
Regarding Claim 18, Boling discloses the entirety of Claim 16 as explained above.
Boling additionally discloses:
wherein the conductive portion of the coupler is at least a portion of the base. (Col. 8, Ln. 22-28, “In order to provide the electrode 112 with electrical current for stimulation (and sensing), current is provided across the detachable interface 132 from the power supply 116 in the removable component 128 to the electrode 112 in the fixed component 130;” Col. 12, Ln. 58-59, “…the core 150 includes a set of first threads 190 that extend along an exterior perimeter 192 of the sleeve 158.”););
Boling’s “base” (i.e., Boling’s core) is conductive by virtue of the coupler’s conductivity.
Regarding Claim 19, Boling discloses the entirety of Claim 16 as explained above.
Boling additionally discloses:
wherein each of the projecting members comprises a respective boss. (Col. 12, Ln. 58-59)
Boling’s threads are a boss. See 3D Hubs at Pg. 23/53, explaining that threaded fasteners may be considered bosses.
Regarding Claim 21, Boling discloses the entirety of Claim 16 as explained above.
Boling additionally discloses:
wherein the respective bosses are configured to engage with a corresponding void in the second body portion (Fig. 4A, Boling’s “threads 190” engages with “threads 194”).
Regarding Claim 24, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses:
wherein the at least one electrical component comprises a power source, a pulse generator configured to deliver electrical stimulation, or a controller comprising a processor and a memory. (Fig. 2, “housing 102” is shown as housing “power supply 116”).
Regarding Claim 26, Boling discloses the entirety of Claim 1 as explained above.
Boling additionally discloses
A system comprising: the leadless implantable device according to claim l; (see rejection of Claim 1, above);
and a control device configured to mechanically actuate the first body portion of the leadless implantable device. (Col. 17, Ln. 60-63, “Referring back to FIG. 6, the sheath 202 on the catheter 206 is used to transport the LIMD 100 to the chamber and tissue of interest during implantation and also from the tissue and chamber during extraction;” Col. 17, Ln. 60 through Col. 18, Ln. 51).
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 4-6, 9, 11, 12, 20, 23 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,216,285 B1 to Boling et al. (“Boling”) as applied to Claim 1 above, and further in view of US 2017/0100582 A1 to McEvoy et al. (“McEvoy”).
Regarding Claim 4, Boling discloses the entirety of Claim 1 as explained above.
Boling does not disclose:
wherein the coupler comprises about five projecting members
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein the coupler comprises about five projecting members (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments…”).
The invention of Claim 4 differs from that of Boling in that Boling uses a screw mechanism as its coupler, whereas the invention of Claim 4 uses a different coupling mechanism. McEvoy teaches such a coupling mechanism as recited by Claim 4, with McEvoy’s “segments 63” corresponding to such “projecting members” as claimed.
McEvoy’s range of “at least three” overlaps the claimed range of “about five.” “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). It would have been obvious for a person of ordinary skill in the art to select the claimed range of “about five” from McEvoy’s disclosed range of “at least three,” as doing so constitutes routine optimization and is likely to result in success.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s coupler comprising about five projecting members) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Regarding Claim 5, Boling discloses the entirety of Claim 1 as explained above.
Boling does not disclose:
wherein each of the projecting members is an elongate member
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein each of the projecting members is an elongate member (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments…”).
The invention of Claim 5 differs from that of Boling in that Boling uses a screw mechanism as its coupler, whereas the invention of Claim 5 uses a different coupling mechanism. McEvoy teaches such a coupling mechanism as recited by Claim 5 with McEvoy’s “segments 63” corresponding to such “projecting members” as claimed. McEvoy’s “segments” are elongate members.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s coupler comprising elongate projecting members) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Regarding Claim 6, the combination of Boling and McEboy renders obvious the entirety of Claim 5 as explained above.
The combination of Boling and McEvoy does not disclose:
wherein the elongate member is about 5 millimeters (mm) long by 2 mm wide
However, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Boling and McEvoy such that the elongate member is about 5 millimeters (mm) long by 2 mm wide because such a modification entails only a change in size, which is a common practice which the court has held normally requires only ordinary skill in the art and hence is considered a routine expedient. MPEP 2144.04(IV)(A), citing In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976); Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Regarding Claim 9, Boling discloses the entirety of Claim 8 as explained above.
Boling does not disclose:
wherein the actuation component is a spring.
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein the actuation component is a spring (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments or, alternately, capture members being spring biased outward from a longitudinal axis of the subassembly …;” Para. [0030], “Once outside the constraint of receptacle 530, segments 63 open outward, according to the spring-bias thereof, as shown in FIG. 5B, to provide the enlarged opening 603R into interior 635 of engagement subassembly 630 that allows the operator to initially engage device attachment feature 310…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s spring-biased coupler) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
The Examiner notes that in the proposed modification, McEvoy’s spring biased coupling members serve the same purpose with respect to Boling’s “shell” as does Boling’s “cantilevered deflectable latch,” namely coupling Boling’s first and second body portions in which Boling’s shell is formed.
Regarding Claim 11, the combination of Boling discloses the entirety of Claim 7 as explained above.
Boling does not disclose:
wherein the projecting members are configured to extend outside of the shell when the shell is disposed in the second position.
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein the projecting members are configured to extend outside of the shell when the shell is disposed in the second position. (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments or, alternately, capture members being spring biased outward from a longitudinal axis of the subassembly …;” Para. [0030], “Once outside the constraint of receptacle 530, segments 63 open outward, according to the spring-bias thereof, as shown in FIG. 5B, to provide the enlarged opening 603R into interior 635 of engagement subassembly 630 that allows the operator to initially engage device attachment feature 310…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s spring-biased coupler, in which spring-biased coupler McEvoy’s projecting members are configured to extend outside of the shell when the shell is disposed in Boling’s “second” or “mated” position) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Regarding Claim 12, the combination of Boling and McEvoy renders obvious the entirety of Claim 11 as explained above.
McEvoy additionally teaches:
wherein the projecting members are configured to extend beyond a perimeter of the shell when the shell is disposed in the second position. (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments or, alternately, capture members being spring biased outward from a longitudinal axis of the subassembly …;” Para. [0030], “Once outside the constraint of receptacle 530, segments 63 open outward, according to the spring-bias thereof, as shown in FIG. 5B, to provide the enlarged opening 603R into interior 635 of engagement subassembly 630 that allows the operator to initially engage device attachment feature 310…”).
McEvoy’s “segments 63” are shown in Figs. 5A through 5D as increasing in their collective cross sectional area beginning at the base of McEvoy’s device, reaching maximum collective cross sectional area near their end. As such, McEvoy’s “segments 63” are configured to extend beyond a perimeter of the shell when the shell is disposed in the second position.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s spring-biased coupler, in which spring-biased coupler McEvoy’s projecting members configured to extend beyond a perimeter of the shell when the shell is disposed in Boling’s “second” or “mated” position) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Regarding Claim 20, the combination of Boling discloses the entirety of Claim 19 as explained above.
Boling does not disclose:
wherein each of the projecting members defines a respective first end and a respective second end opposite to the respective first end, wherein the respective first end is arranged in proximity to the base, and wherein the respective boss is arranged in proximity to the respective second end.
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein each of the projecting members defines a respective first end and a respective second end opposite to the respective first end, wherein the respective first end is arranged in proximity to the base, and wherein the respective boss is arranged in proximity to the respective second end. (Fig. 5D, “interlocking edge 631;” see Annotated Fig. 5D, below; see also Paras. [0029] through [0031]).
PNG
media_image1.png
438
791
media_image1.png
Greyscale
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s spring-biased coupler, in which spring-biased coupler McEvoy’s projecting members each comprise a respective boss arranged in proximity to their respective second end) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Regarding Claim 23, the combination of Boling discloses the entirety of Claim 1 as explained above.
Boling does not disclose:
wherein each of the projecting members is formed from a metal.
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein each of the projecting members is formed from a metal. (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments or, alternately, capture members being spring biased outward from a longitudinal axis of the subassembly …;” Para. [0030], “Once outside the constraint of receptacle 530, segments 63 open outward, according to the spring-bias thereof, as shown in FIG. 5B, to provide the enlarged opening 603R into interior 635 of engagement subassembly 630 that allows the operator to initially engage device attachment feature 310…;” Para. [0033], “ Engagement subassembly 630 may be formed from a medical grade Nitinol, for example, having been cut from Nitinol tubing and then heat treated to set the spring-biased condition shown in FIG. 5B; alternately, subassembly 630 may be formed by laser sintering a medical grade Stainless Steel.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s spring-biased coupler, in which spring-biased coupler McEvoy’s projecting members are made of the metal Nitonol or the metal stainless steel) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Regarding Claim 25, the combination of Boling discloses the entirety of Claim 1 as explained above.
Boling does not disclose:
wherein one or more of the projecting members is a flexible projecting member.
McEvoy describes “interventional medical systems, and more particularly to systems, catheters and subassemblies that are useful for retrieving medical devices from implant sites” (Para. [0001]). McEvoy is reasonably pertinent to the problem faced by the inventor, and is thus analogous art.
McEvoy teaches:
wherein one or more of the projecting members is a flexible projecting member. (Figs. 5A through 5D, “segments 63;” Abstract, “An engagement subassembly of a catheter, for retrieving an implanted medical device, may include at least three segments or, alternately, capture members being spring biased outward from a longitudinal axis of the subassembly …;” Para. [0030], “Once outside the constraint of receptacle 530, segments 63 open outward, according to the spring-bias thereof, as shown in FIG. 5B, to provide the enlarged opening 603R into interior 635 of engagement subassembly 630 that allows the operator to initially engage device attachment feature 310…;” Para. [0033], “ Engagement subassembly 630 may be formed from a medical grade Nitinol, for example, having been cut from Nitinol tubing and then heat treated to set the spring-biased condition shown in FIG. 5B; alternately, subassembly 630 may be formed by laser sintering a medical grade Stainless Steel.”).
McEvoy’s projecting members are flexible as evidenced by McEvoy’s description of them as “cut from Nitinol tubing and then heat treated to set the spring-biased condition.”
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of McEvoy (i.e., to replace Boling’s screw mechanism coupler with McEvoy’s spring-biased coupler, in which spring-biased coupler McEvoy’s projecting members are made of the Nitonol that has been heat treated to set McEvoy’s spring-biased condition) in order to increase ease and efficiency of device coupling (McEvoy at Para. [0003]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over US 9,216,285 B1 to Boling et al. (“Boling”) as applied to Claim 1 above, and further in view of US 2018/0228943 A1 to Trotzschel et al. (“Trotzschel”).
Regarding Claim 22, Boling discloses the entirety of Claim 1 as explained above.
Boling does not disclose:
wherein each of the projecting members is formed from a plastic material having a conductive coating
Trotzschel describes “Electrically conductive coating with gradient of particle content, in particular for medical devices” (Title) which medical devices explicitly include pacemakers (Para. [0113]). Trotzschel is analogous art.
Trotzschel teaches:
wherein each of the projecting members is formed from a plastic material having a conductive coating (Claim 1, “A composite comprising as mutually superimposed layers of a series of layers a) a substrate, and b) a first layer; wherein the first layer comprises i) a first layer surface, ii) a polymer, and iii) a plurality of electrically conductive particles; wherein the first layer surface is adjacent to the substrate;…” Claim 7, “…wherein the polymer is selected from the group composed of … an electrically conductive polymer,…;” Claim 8, “…wherein the substrate comprises a substance selected from the group of a plastic,…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of Trotzschel (i.e., to modify Boling’s screw mechanism coupler such that the screw mechanism coupler, inclusive of its projecting members, is formed from a plastic material having a conductive coating such as that taught by Trotzschel) in order to facilitate manufacture of the component via 3D printing methodology (Trotzschel at Para. [0009]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of Trotzschel (i.e., to modify Boling’s screw mechanism coupler such that the screw mechanism coupler, inclusive of its projecting members, is formed from a plastic material having a conductive coating such as that taught by Trotzschel) because such a modification entails only a simple substitution of one known element for another to obtain predictable results.
The prior art contains a device (i.e., Boling’s screw mechanism coupler) which differs from the claimed device by the substitution of some components (i.e., Boling’s screw mechanism coupler formed from an unspecified material) with other components (i.e., a coupler which is formed from a plastic material having a conductive coating).
The substituted components and their functions were known in the art. For example, Trotzschel teaches such a plastic material having a conductive coating at Claims 1, 7 and 8.
One of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over US 9,216,285 B1 to Boling et al. (“Boling”) as applied to Claim 26 above, and further in view of US 2008/0009791 A1 to Cohen et al. (“Cohen”).
Regarding Claim 27, Boling discloses the entirety of Claim 1 as explained above.
Boling does not disclose:
wherein the control device comprises: a motor; a gear system mechanically coupled to the motor; and a plurality of control arms mechanically coupled to the gear system, wherein the control arms are configured to detachably couple to the shell of the first body portion of the leadless implantable device
Cohen describes “A remotely controlled insertion system for a medical device…” (Abstract), which medical device “… could be a catheter, guidewire, introducer sheath, or guide catheter or a pacemaker…” (Para. [0069]). Cohen is analogous art.
Cohen teaches:
wherein the control device comprises: a motor; a gear system mechanically coupled to the motor; and a plurality of control arms mechanically coupled to the gear system, wherein the control arms are configured to detachably couple to the shell of the first body portion of the leadless implantable device (Paras. [0227] through [0232]; Fig. 10; see Annotated Fig. 10, below).
PNG
media_image2.png
731
1132
media_image2.png
Greyscale
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boling with the teachings of Cohen (i.e., to use such a control device as taught by Cohen as the control device of Boling) in order to control insertion intuitively in a manner that conforms to procedures generally taught in medical school (Cohen at Para. [0006]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.J.M./Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
1 US 9,216,285 B1 was disclosed by Applicant in the IDS dated 12/16/2024.
Prosecution Insights