DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Applications No. 62408494, 62434537, 62503888, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In fact, Applications No. 62408494, 62434537, 62503888 do not appear to disclose a retrieval feature, a torsion release assembly, and a shuttle assembly translatable between a first shuttle position wherein the retrieval feature is rotationally fixed relative to a housing and a second shuttle position wherein the retrieval feature is free to rotate relative to the housing as required in claims 1, 11 and 17 of the present invention.
Accordingly, the present invention appears to have an effective filing date of 10/13/2017.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 7/10/2024 and 7/28/2024 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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: “retrieval feature” in claims 1, 14 and 17.
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 Objections
Claims 12-14 are objected to because of the following informalities:
In claim 12, there is an apparent minor typographical error in lines 1-2 at “the second shuttle position relives at least a portion of torsion” (wherein a minor amendment such as “the second shuttle position relieves at least a portion of torsion” will moot this objection);
In claim 13, there is an apparent minor typographical error in lines 4-5 at “allowing the first gear to freely rotatable” (wherein a minor amendment such as “allowing the first gear to be freely rotatable” will moot this objection); and
In claim 14, there is an apparent minor instance of rough grammar in lines 3-5 at “to not result in additional torsion applied to the retrieval feature inadvertent over-torsion of the retrieval feature is avoided” (wherein a minor amendment such as (or something similar) “to not result in additional torsion applied to the retrieval feature wherein inadvertent over-torsion of the retrieval feature is avoided” will moot this objection).
Appropriate correction is required.
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 8-10, 14 and 16 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.
Claim 8 recites the limitation "the snare" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 8 recites the limitation "the catheter shaft" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 9 recites the limitation "the IMD" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 10 recites the limitation "the IMD" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 14 recites the limitation "the first gear" in line 1. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 16 recites the limitation "the retrieval system" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
Claim(s) 1-2, 5, 7, 10 and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rydell (US 5,163,942).
Rydell discloses (see Figs. 4 and 7) a surgical instrument with a grasping loop (having the handle embodiment of Fig. 7) and method of use comprising the following claim limitations:
(claim 1) A handle (112, Figs. 4 and 7) of a catheter system (110, Fig. 4) including a sheath (124, Figs. 4 and 7) and a retrieval feature (128/188, Figs. 4 and 7) disposed within the sheath (124) (as shown in Figs. 4 and 7), the handle (112) comprising: a housing (180, Fig. 7); a torsion release assembly including a first gear (194, Fig. 7) supported by a rotational mount (196, Fig. 7) (as shown in Fig. 7), the rotation mount (196) further supported within the housing (180) (as shown in Fig. 7), the first gear (194) fixed to the retrieval feature (188) such that rotation of the first gear (196) results in rotation of the retrieval feature (128/188) (as shown at rotation arrows of loop 130 in Fig. 4; and as shown in movement arrows of belt 188 in Fig. 7); a shuttle assembly (132, Fig. 7) rotationally fixed to the housing (180) (as shown in Figs. 4 and 7, assembly 132 is rotationally fixed relative to housing 180 but is capable of sliding/translating within housing 180) and including a second gear (192, Fig. 7), the shuttle assembly (132) translatable along the housing (180) between a first shuttle position (col. 4, lines 31-34; shuttle assembly 132 in its first/”up” position, wherein the shuttle assembly is locked in place via detent tooth 78 in serrated gear rack 80), and a second shuttle position (col. 4, lines 25-31; col. 5, line 52-col. 6, line 5 shuttle assembly 132 in its second/”down” position wherein the serrated gear rack 80 of the shuttle assembly 132 is disengaged from detent tooth 78 allowing the shuttle assembly to axially slide/translate to tighten/loosen loop 130 and belt 128 is free to rotate within housing 180 (see belt rotation arrows in Fig. 4 and 7)), wherein, when in the first shuttle position, the retrieval feature (128/188) is rotationally fixed relative to the housing (180) (col. 4, lines 31-34; shuttle assembly 132 in its first/”up” position, wherein the shuttle assembly is locked in place via detent tooth 78 in serrated gear rack 80), and, when in the second shuttle position, the retrieval feature (128/188) is free to rotate relative to the housing (180) (col. 4, lines 25-31; col. 5, line 52-col. 6, line 5 shuttle assembly 132 in its second/”down” position wherein the serrated gear rack 80 of the shuttle assembly 132 is disengaged from detent tooth 78 allowing the shuttle assembly to axially slide/translate to tighten/loosen loop 130 and belt 128 is free to rotate within housing 180 (see belt rotation arrows in Fig. 4 and 7));
(claim 2) wherein, when in the first shuttle position, the first gear (194) and the second gear (192) engage each other (as expressly shown in Fig. 7), the second gear (192) coupled to the shuttle assembly (132) which is rotationally fixed relative to the housing (180) such that engagement of the first gear (194) to the second gear (192) results in the first gear (192) and the retrieval feature (128/188) are rotationally fixed relative to the housing (180) (as expressly shown in Fig. 7; col. 4, lines 31-34; when shuttle assembly 132 is in its first/”up” position, the shuttle assembly is locked in place via detent tooth 78 in serrated gear rack 80 and belt is locked and unable to be rotated);
(claim 5) wherein rotation of the handle (112), when the shuttle assembly (132) is in the first shuttle position, results in rotation of each of the shuttle assembly (132), the second gear (192), the first gear (194), and the retrieval feature (128/188) (i.e., as a surgeon rotates their hand holding handle 112 therein about the longitudinal axis of the device 110, results in rotation of the entire device 110 (including all its claimed sub-components));
(claim 7) wherein the retrieval feature (128/188) represents a snare (i.e., loop 130 of Fig. 4, formed by belt 128/188) that extends through the shuttle assembly (132) and is coupled to one of the first gear (194) or the second gear (192) (as shown in Fig 7);
(claim 10) wherein the IMD is a leadless pacemaker and the retrieval feature (128/188) is configured to (i.e., capable of) engage a distal end of the leadless pacemaker (i.e., a leadless pacemaker is not affirmatively claims, and the retractable/contractible loop 130 of belt 128/188 is fully capable of surrounding and capturing a distal end of an implant);
(claim 17) A catheter system (110, Fig. 4), comprising: a handle (112, Figs. 4 and 7) including a housing (180, Fig. 7); a sheath (124, Figs. 4 and 7); a retrieval feature (128/188, Figs. 4 and 7) disposed within the sheath (124) (as shown ion Figs. 4 and 7); a torsion release assembly including a first gear (194, Fig. 7) supported by a rotational mount (196, Fig. 7) (as shown in Fig. 7), the rotation mount (196) further supported within the housing (180) (as shown in Fig. 7), the first gear (194) fixed to the retrieval feature (188) such that rotation of the first gear (194) results in rotation of the retrieval feature (128/188) (as shown at rotation arrows of loop 130 in Fig. 4; and as shown in movement arrows of belt 188 in Fig. 7); a shuttle assembly (132, Fig. 7) rotationally fixed to the housing (180) (as shown in Figs. 4 and 7, assembly 132 is rotationally fixed relative to housing 180 but is capable of sliding/translating within housing 180) and including a second gear (192, Fig. 7), the shuttle assembly (132) translatable along the housing (180) between a first shuttle position (col. 4, lines 31-34; shuttle assembly 132 in its first/”up” position, wherein the shuttle assembly is locked in place via detent tooth 78 in serrated gear rack 80), and a second shuttle position (col. 4, lines 25-31; col. 5, line 52-col. 6, line 5 shuttle assembly 132 in its second/”down” position wherein the serrated gear rack 80 of the shuttle assembly 132 is disengaged from detent tooth 78 allowing the shuttle assembly to axially slide/translate to tighten/loosen loop 130 and belt 128 is free to rotate within housing 180 (see belt rotation arrows in Fig. 4 and 7)), wherein, when in the first shuttle position, the retrieval feature (128/188) is rotationally fixed relative to the housing (180) (col. 4, lines 31-34; shuttle assembly 132 in its first/”up” position, wherein the shuttle assembly is locked in place via detent tooth 78 in serrated gear rack 80), and, when in the second shuttle position, the retrieval feature (128/188) is free to rotate relative to the housing (180) (col. 4, lines 25-31; col. 5, line 52-col. 6, line 5 shuttle assembly 132 in its second/”down” position wherein the serrated gear rack 80 of the shuttle assembly 132 is disengaged from detent tooth 78 allowing the shuttle assembly to axially slide/translate to tighten/loosen loop 130 and belt 128 is free to rotate within housing 180 (see belt rotation arrows in Fig. 4 and 7)); and
(claim 18) wherein, when in the first shuttle position, the first gear (194) and the second gear (192) engage each other (as expressly shown in Fig. 7), the second gear (192) coupled to the shuttle assembly (132) which is rotationally fixed relative to the housing (180) such that engagement of the first gear (194) to the second gear (192) results in the first gear (192) and the retrieval feature (128/188) are rotationally fixed relative to the housing (180) (as expressly shown in Fig. 7; col. 4, lines 31-34; when shuttle assembly 132 is in its first/”up” position, the shuttle assembly is locked in place via detent tooth 78 in serrated gear rack 80 and belt is locked and unable to be rotated).
Allowable Subject Matter
Claims 11-16 are allowed. It is noted that claims 12-14 and 16 respectively remain subject to claim objections and/or 112 rejections that still must be resolved before these claims can be in proper condition for allowance.
Claims 3-4, 6, 8-9 and 19-20 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. It is noted that claims 8-9 respectively remain subject to 112 rejections that still must be resolved before these claims can be rewritten in independent form to be in proper condition for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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