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 .
Response to Arguments
This Office action is in response to the applicant’s communication filed on 2/6/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant's arguments regarding the pending double patenting rejections, see page 6, allege that “the claims of the instant application are patentably distinct from those of the ‘318 patent and the ‘271 patent for at least the reason discussed below”. However, distinctions between the claims of the instant invention and those of both the ‘318 patent and the ‘271 patent are never expressly argued or disclosed. For that reason, Applicant’s arguments (i.e., one mere conclusory statement) have been fully considered but they are not persuasive.
Applicant’s arguments, see page 6, with respect to Applicant’s amendments to the specification made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant's arguments, see pages 6-7, alleging that an (or at least one) “electrically conductive element” in claims 1 and 9 conveys sufficient structure have been fully considered but they are not persuasive. Applicant’s arguments allege that “element”, “being in electrical communication”, “a distal portion”, and/or “a proximal portion” expressly recite sufficient structure to preclude interpretation under 35 U.S.C. 112(f). The Examiner respectfully disagrees. It is the Examiner’s position that the claim limitation at issue meets all three prongs. First, the term “element” is a generic placeholder and is not a term of art. Second, the term “element” is modified by functional language (i.e., “electrically conductive”). Third, the term “element” is not modified by sufficient structure for performing the claimed function. Applicant’s arguments that the term “element” itself and/or the element having a “portion” (either proximal or distal) expressly provides sufficient structure falls short. The term “element” is generic and convey no specific structure, and every known solid object can have designated proximal and/or distal portions (i.e., fails to convey any specific structure). For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 6-7, alleging that “rinsing device” in claim 6 being connected to the insertion sheath or to the surgical intervention device conveys sufficient structure have been fully considered but they are not persuasive. Applicant’s arguments allege that having a connection to another component expressly recite sufficient structure to preclude interpretation under 35 U.S.C. 112(f). The Examiner respectfully disagrees. It is the Examiner’s position that the claim limitation at issue meets all three prongs. First, the term “device” is a generic placeholder and is not a term of art. Second, the term “device” is modified by functional language (i.e., “rinsing”). Third, the term “device” is not modified by sufficient structure for performing the claimed function. Applicant’s arguments that having a connection to another component expressly provides sufficient structure falls short. A “connection” is a separate generic limitation/structure that fails to add or convey any specific structure to the original “device”. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 6-7, alleging that “a discrete electrically conductive aspect” in claim 7 being in contact with tissue and/or in electrical communication with a guide wire conveys sufficient structure have been fully considered but they are not persuasive. Applicant’s arguments allege that contact with tissue and/or being in electrical communication with a guide wire expressly recites sufficient structure to preclude interpretation under 35 U.S.C. 112(f). The Examiner respectfully disagrees. It is the Examiner’s position that the claim limitation at issue meets all three prongs. First, the term “aspect” is a generic placeholder and is not a term of art. Second, the term “aspect” is modified by functional language (i.e., “electrically conductive”). Third, the term “aspect” is not modified by sufficient structure for performing the claimed function. Applicant’s arguments that having contact with tissue and/or being in electrical communication with a guide wire expressly provides sufficient structure falls short. Having contact with tissue and/or being in electrical communication with another component fails to add or convey any specific structure to the original “aspect”. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant's arguments, see pages 8-9, alleging that the guide wire of Mokelke is not “intended to be introduced into the tubular sheath of the introducer for advancing an artificial valve intended to replace the heart valve” have been fully considered but they are not persuasive. With regard the statement of intended use and other functional statements (i.e., “intended to”), they do not impose any structural limitations on the claims distinguishable over Mokelke which is capable of being used as claimed if one so desires to do so ([0023]; the dimensions of the components of the system of Mokelke expressly disclosed to be changeable as needed; [0036]; the system of Mokelke is expressly disclose to be used in procedures such as angioplasty and stent implant delivery). In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Furthermore, the law of anticipation does not require that the reference “teach” what the subject patent teaches, but rather it is only necessary that the claims under attack “read on” something in the reference. Kalman v. Kimberly Clark Corp., 218 USPQ 781 (CCPA 1983). Furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987). For at least these reasons, Applicant’s arguments are not persuasive.
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: “an electrically conductive element” in claim 1, “a rinsing device” in claim 6, “a discrete electrically conductive aspect” in claim 7, and “at least one electrically conductive element” in claim 9.
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
Claim(s) 9-10 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mokelke et al. (US 2009/0299443).
Mokelke discloses (see Figs. 1 and 3) a guide catheter system with electrodes comprising the following claim limitations:
(claim 9) an introducer comprising at least one tubular insertion sheath (12, Fig. 1; 50, Fig. 3), intended to be introduced into an artery of a human body ([0006]) and to allow passage of a surgical intervention device ([0029]; [0036]; lumen of guide catheter allows for passage of other instruments therein); at least one electrically conductive element ([0030]; i.e. connecting wires electrically connect electrode 18 with external wire 24) comprising a distal portion (18, Fig. 1; 52, Fig. 3) configured to (i.e., capable of) contact subcutaneous tissue of the body or the artery (as shown in Figs. 1 and 3; [0030]; [0036]-[0038]; sheath tip fully capable of contacting subcutaneous tissue if one so desires), and a proximal portion (at 20/24, Fig. 1) accessible from the outside of the body in such a way as to serve as a connection to one electrode of a cardiac stimulator (14) (as shown in Fig. 1); and at least one guide wire (56, Fig. 3; [0004]; [0008]; [0036]-[0038]) intended to be introduced into the tubular sheath (12,50) of the introducer for advancing an artificial valve intended to replace the heart valve ([0004]; [0036]; sheath 12,50 capable of being inserted over guidewire allowing for deployment of vascular stents and the like as desired), the guide wire (56) having an electrically insulated covering on a central portion of a length of the guide wire (56) ([0004]; [0008]; guidewire is expressly covered except for an exposed distal end conducting portion), a distal end of the guide wire (56) able to contact a wall of a left ventricle of the patient's heart being not electrically insulated ([0004]; [0008]; as shown in Fig. 3, guidewire 56 expressly comprises an exposed conducting portion 58 at its distal end that is fully capable of contacting the wall of the left ventricle if one so desires) and having an increased flexibility than the central portion ([0030]; [0037]; electrodes at the distal tip of the guide wire expressly may be composed of a flexible open mesh), the guide wire (56) comprising a metallic part electrically connected to or providing at least a portion of a distal tip ([0030]; [0037]; electrodes expressly may comprise any electrically conductive materials including metal), and serving as a connection to another electrode of the cardiac stimulator to provide electrical contact at the distal end ([0004]; [0008]; catheter electrode 18/52 and guidewire electrode 58 connecting to stimulator expressly disclosed), wherein the distal end of the guide wire (56) and the at least one electrically conductive element are in electrical communication with one another only through the patient’s body and through the cardiac stimulator ([0004]; [0008]; [0036]-[0039]; guidewire 56 (with return electrode 58) is expressly disclosed as passable through the catheter 12/50 (with electrode 18/52) to provide an electrical pathway when energized by the stimulator/electrical signal generator);
(claim 10) wherein the electrode (18/52) of the cardiac stimulator (14) connected to the electrically conductive element is an anode ([0008]), and the electrode (58) connected to the metallic part of the guide wire (56) is a cathode ([0008]; electrode of conductive catheter 12 expressly may serve as either the anode or cathode, and the electrode of the guidewire 56 may comprise the other half of the bipolar electrode); and
(claim 13) wherein the distal end (58) of the guide wire (56) and the at least one electrically conductive element are in electrical communication with one another only through tissue of the patient’s heart and through the cardiac stimulator (14) ([0008]; guidewire 56 (with return electrode 58) is expressly disclosed as passable through the catheter 12/50 (with electrode 18/52) to provide an electrical pathway when energized by the stimulator/electrical signal generator).
Claim Rejections - 35 USC § 103
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mokelke as applied to claim 10 above, and further in view of Twiss et al. (US 5,375,596).
Mokelke, as applied above, discloses a guide catheter system with electrodes comprising all the limitations of the claim except for the guide wire and the at least one electrically conductive element each comprising a respective notch external to the body that are configured to be connected to separate clips in electrical communication with the electrodes of the cardiac stimulator.
However, Twiss teaches (see Fig. 1A-2B) a similar surgical catheter and guidewire system comprising the guide wire (22, Fig. 1A) and the at least one electrically conductive element (at catheter 30, Fig. 1A) each comprising a respective notch (i.e., notches expressly taught at terminal ends 42/48 for housing respective pads 44146,50,52; col. 5, line 54-col. 6, line 33) external to the body (as shown in Fig. 1A) that are configured to be (i.e., capable of) connected to separate clips (18, Fig. 1A) in electrical communication with the electrodes of the cardiac stimulator (at 2, Fig. 1A) in order to beneficially provide for quick and convenient electrical interface between electrical pathways within catheters and guidewires to an electrical system located external to a patient’s body (col. 5, line 54-col. 6, line 33). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Mokelke to have the guide wire and the at least one electrically conductive element each comprising a respective notch external to the body that are configured to be connected to separate clips in electrical communication with the electrodes of the cardiac stimulator in order to beneficially provide for quick and convenient electrical interface between electrical pathways within catheters and guidewires to an electrical system located external to a patient’s body, as taught by Twiss.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Mokelke as applied to claim 9 above, and further in view of Corbett et al. (US 2015/0328383).
Mokelke, as applied above, discloses a guide catheter system with electrodes comprising all the limitations of the claim except for the distal end of the guide wire being configured to coil upon contact with tissue within a patient’s body.
However, Corbett teaches (see Fig. 8) a similar heart delivery system comprising the distal end (806) of the guide wire being configured to (i.e., capable of) coil upon contact with tissue within a patient’s body ([0037]; pigtail configuration expressly taught) in order to beneficially provide a flexible distal end configured in the form of an atraumatic tip for contact with the ventricle wall and to allow for guidewire loading as needed ([0037]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Mokelke to have the distal end of the guide wire being configured to coil upon contact with tissue within a patient’s body in order to beneficially flexible distal end configured in the form of an atraumatic tip for contact with the ventricle wall and to allow for guidewire loading as needed, as taught by Corbett.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,045,318. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,045,318
9
1-14
10
2
11
5
12
12,14
13
1-14
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 16-17 of U.S. Patent No. 11,911,271. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,911,271
1
1-9
2
2
3
3
4
6
5
7
6
8
7
16
8
17
Allowable Subject Matter
Claims 1-8 contain allowable subject matter. However, it is noted that claims 1-8 remain subject to double patenting rejections are set forth above, that must be resolved before these claims can be in proper condition for allowance.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
If there are any inquiries that are not being addressed by first contacting the Examiner or the Supervisor, you may send an email inquiry to TC3700_Workgroup_D_Inquiries@uspto.gov.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771