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
Applicant’s election without traverse of Group II (Claims 1, 5 – 7, 13, 14, and 17 – 19) in the reply filed on 02/17/2026 is acknowledged.
Claims 2 – 4, 8 – 12, 15, 16, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/17/2026.
Claim Objections
Claims 5, 6, 18, and 19 are objected to because of the following informalities:
Claim 5 recites “wherein the outer sheath is configured to close the pincer by moving distally relative to the inner member and to open the pincer by moving proximally relative to the inner member”, although the line does not rise to the level of being indefinite, as the line is understood by the Examiner, based on Applicant’s disclosure to mean, “wherein each of the outer sheaths is configured to close the respective pincers by moving distally relative to the respective inner members and to open the respective pincers by moving proximally relative to the respective inner member” as each of the sheaths is configured in Applicant’s disclosure to function as claimed, the Examiner suggests the line be amended to read “wherein each of the outer sheaths is configured to close the respective pincers by moving distally relative to the respective inner members and to open the respective pincers by moving proximally relative to the respective inner member” for the purpose of maintaining consistent language throughout the claims;
Claim 6 recites “the line loop” in line 4, although the line does not rise to the level of being indefinite, as the line is understood by the Examiner, based on Applicant’s disclosure wherein the “line loop” is the “loop”, to mean “the loop”, the Examiner suggests the line be amended to read “the loop” for the purpose of maintaining consistent language throughout the claims;
Claim 18 recites “the second end” in lines 3 and 4, although the line is understood by the Examiner to mean “the respective second ends” as there are multiple second ends defined and based on Applicant’s disclosure, the Examiner suggests the line be amended to read “the respective second ends” for the purpose of maintaining consistent language throughout the claims;
Claim 19 recites “the pincer prongs” in lines 2, 3, and 4, although the lines are understood by the Examiner to mean “the respective pair of pincer prongs” based on Applicant’s disclosure and as previously defined, the Examiner suggests the line be amended to read “the respective pair of pincer prongs” for the purpose of maintaining consistent language throughout the claims;
Claim 19 recites “into closed configuration” in line 3, although the line is understood by the Examiner to mean “the closed configuration” as the “closed configuration” was previously defined, the Examiner suggests the line be amended to read “the closed configuration” for the purpose of maintaining consistent language throughout the claims;
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 6, 7, and 14 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 6, the phrase "the pincer includes first and second pincer prongs" renders the claim indefinite because it is unclear whether Applicant is intending for “the pincer” to mean each of the pincers of the first and second proximal element actuators comprise first and second pincer prongs or if Applicant is intending for “the pincer” to mean only one of the pincers of the first or second proximal element actuators comprise the first and second pincer prongs. For the purpose of examination and based on Applicant’s disclosure, the Examiner will read the claim to mean the former such that each of the pincers comprise first and second pincer prongs. Furthermore, if Applicant is intending the claim to mean the former, the Examiner suggests the phrase be amended to read “each of the pincers include first and second pincer prongs configured to couple to the respective loops of the first and second proximal elements when the respective outer sheaths move distally to close the respective pincers and to decouple the corresponding loop when the respective sheaths are moved proximally to open the respective pincers”.
Regarding claim 7, the phrase "the first and second pincer prongs" renders the claim indefinite because it is unclear whether which set of “first and second pincer prongs” Applicant is intending to be made up of the shape memory material. For the purpose of examination, the Examiner will read the claim to mean that both sets of first and second pincer prongs are made up of the shape memory material. It should be understood that the claim phrase is indefinite based on the Examiner’s interpretation for claim 6.
Regarding claim 14, the phrases “the second end portion includes a pincer” renders the claim indefinite because it is unclear Applicant as to which of the first and second proximal element actuators second end portion includes the pincer or if Applicant is intending for both “second end portions” of the first and second proximal element actuators to include a pincer. For the purpose of examination, and based on Applicant’s disclosure, the Examiner will read the claim to mean the latter such that both second end portions include a pincer.
Claim 7 is rendered indefinite for being dependent on an indefinite claim.
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.
Claims 1, 13, and 17 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Dell et al (US 2013/0066342 A1).
Regarding claim 1, Dell discloses a fixation system (interventional tool 10) for engaging tissue of a patient (abstract, paragraphs [0110 – 0111], and Figs. 7,10A), comprising:
an implantable fixation device (fixation device 14) (paragraphs [0119 – 0120] and Figs. 7,10A) comprising:
a first arm and a second arm (left and right arms 53 – when looking in Fig. 7) (paragraph [0120] and Fig. 7) ,
a first proximal element (left proximal element 16) moveable relative to the first arm between a first position and a second position and a second proximal element (right proximal element 16) moveable relative to the second arm between a first position and a second position (paragraphs [0020], [0121 – 0122], [0135], and Figs. 7,9B-11B) ; and
a delivery device (catheter 86 and shaft 12) (paragraph [0128] and Figs. 8A-14) comprising:
a catheter (catheter 86) having a proximal end portion and a distal end portion (paragraph [0128]), the catheter defining at least one lumen (lumen shown in Fig. 10A) extending between the proximal end portion and the distal end portion (paragraph [0128] and Fig. 9A-11B),
a first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the first proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the first proximal element actuator coupled to the first proximal element at the second end portion of the first proximal element actuator and actuatable to move the first proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B) and
a second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the second proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the second proximal element actuator coupled (coupled at loop 48) to the second proximal element at the second end portion of the second proximal element actuator and actuatable to move the second proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B).
Regarding claim 13, Dell discloses a fixation system (interventional tool 10) for engaging tissue of a patient (abstract, paragraphs [0110 – 0111], and Figs. 7,10A), comprising:
an implantable fixation device (fixation device 14) (paragraphs [0119 – 0120] and Figs. 7,10A) comprising:
a first arm and a second arm (left and right arms 53 – when looking in Fig. 7) (paragraph [0120] and Fig. 7) ,
a first proximal element (left proximal element 16) moveable relative to the first arm between a first position and a second position and a second proximal element (right proximal element 16) moveable relative to the second arm between a first position and a second position (paragraphs [0020], [0121 – 0122], [0135], and Figs. 7,9B-11B); and
a delivery device (catheter 86 and shaft 12) (paragraph [0128] and Figs. 8A-14) comprising:
a catheter (catheter 86) having a proximal end portion and a distal end portion (paragraph [0128]), the catheter defining at least one lumen (lumen shown in Fig. 10A) extending between the proximal end portion and the distal end portion (paragraph [0128] and Fig. 9A-11B),
a first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the first proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the second end portion of the first proximal element actuator being releasably coupled (coupled at loop 48) to the first proximal element (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B), and
a second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the second proximal element actuator having a first end portion (end portion within catheter 86, not attached to the proximal element 16) and a second end portion (end portion coupled to the proximal element 16) (paragraph [0130] and Figs. 9A-11B), the second end portion of the second proximal element actuator being releasably coupled (coupled at loop 48) to the second proximal element (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B).
Regarding claim 17, Dell discloses a fixation system (interventional tool 10) for engaging tissue of a patient (abstract, paragraphs [0110 – 0111], and Figs. 7,10A), comprising:
an implantable fixation device (fixation device 14) (paragraphs [0119 – 0120] and Figs. 7,10A) comprising:
a first arm and a second arm (left and right arms 53 – when looking in Fig. 7) (paragraph [0120] and Fig. 7) ,
a first proximal element (left proximal element 16) moveable relative to the first arm between a first position and a second position and a second proximal element (right proximal element 16) moveable relative to the second arm between a first position and a second position (paragraphs [0020], [0121 – 0122], [0135], and Figs. 7,9B-11B); and
a delivery device (catheter 86 and shaft 12) (paragraph [0128] and Figs. 8A-14) comprising:
a catheter (catheter 86) having a proximal end portion and a distal end portion (paragraph [0128]), the catheter defining at least one lumen (lumen shown in Fig. 10A) extending between the proximal end portion and the distal end portion (paragraph [0128] and Fig. 9A-11B),
a first proximal element actuator (left, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the first proximal element actuator having a length extending from a first end (end not attached to the proximal element 16) of the first proximal element actuator and terminating at a second end (end attached to the proximal element 16) of the first proximal element actuator (paragraph [0130] and Figs. 9A,10A,11A), the first proximal element actuator releasably coupled to the first proximal element at the second end of the first proximal element actuator and actuatable to move the first proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B), and
a second proximal element actuator (right, single line, proximal element line 90 – when looking at Fig. 9A-11B) extending through the at least one lumen (paragraph [0130] and Figs. 8A,9A,10A), the second proximal element actuator having a length extending from a first end (end not attached to the proximal element 16) of the first proximal element actuator and terminating at a second end (end attached to the proximal element 16) of the first proximal element actuator (paragraph [0130] and Figs. 9A,10A,11A), the second proximal element actuator releasably coupled to the second proximal element at the second end of the second proximal element actuator and actuatable to move the second proximal element between the first position and the second position (paragraphs [0130], [0133 – 0134], and Figs. 9A-11B).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 6, 7, 14, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Dell et al (US 2013/0066342 A1), as applied to claims 1, 13, and 17 above, and further in view of Rothstein (US 2011/0264191 A1).
Regarding claims 5, 6, 7, 14, 18, and 19, as discussed above, Dell discloses the fixation systems of claims 1, 13, and 17. Additionally, Dell discloses in paragraphs [0130] and [0154 – 0156], wherein the proximal element actuators can be connected to the proximal elements via various means; thereby, teaching wherein the type of means for coupling the proximal element actuators to the proximal elements is not critical to the invention. Furthermore, Dell makes obvious wherein the first and second proximal elements (left and right proximal elements 16) each include a loop (line loop 48) extending therefrom for the purpose of reducing friction on the proximal element lines 90 (i.e., the first and second proximal actuators) (paragraph [0130]).
However, Dell is silent regarding (i) [claim 5] wherein the first proximal element actuator and the second proximal element actuator each comprises an outer sheath axially moveable relative an inner member having a distal pincer, wherein the outer sheath is configured to close the pincer by moving distally relative to the inner member and to open the pincer by moving proximally relative to the inner member, [claim 6] the pincer includes first and second pincer prongs configured to couple to the loop when the outer sheath moves distally to close the pincer and to decouple from the line loop when the sheath is moved proximally to open the pincer, [claim 7] wherein the first and second pincer prongs are formed of a shape memory material such that they are biased outwardly, [claim 14] wherein the second end portion includes a pincer actuatable between a closed and open configuration to respectively couple and decouple the second end portion from the respective first and second proximal elements, [claim 18] wherein the second end of each of the first and second proximal element actuators is defined by a pair of pincer prongs moveable between a closed configuration for coupling the second end to the respective first and second proximal elements and an open configuration for decoupling the second end from the respective first and second proximal elements, and [claim 19] wherein each of the first and second proximal element actuators includes a sheath slidable over the pincer prongs from a distal position in which the outer sheath urges the pincer prongs into closed configuration and a proximal position in which the pincer prongs are in the open configuration.
As to the above, Rothstein teaches an implant delivery system comprising an implantable device (stent 50; which equates to the fixation device 14 of Dell) and a delivery device (delivery system 10) comprising a catheter (sheath 24; which equates to the catheter 86 of Dell) comprising a lumen therethrough (paragraph [0037] and Fig. 1), first and second proximal element actuators (capturing wires 14; which equate to proximal element lines 90 of Dell), wherein each of the first and second proximal actuators comprising an outer sheath (respective sleeves 20) axially moveable relative to an inner member (body portion of capturing wires 14; which equates to the body portion of the proximal element lines 90 of Dell) having a distal pincer (distal end 30 with upper and lower portions 34,36) with a pair of prongs (upper and lower portions 34,36), adjustable between an open and closed configuration (Figs. 18,19), configured to couple to a loop (openings within stent 50; which equates to the line loops 48 of Dell) of the implantable device (stent 10) when the outer sheath (sleeves 20) move distally, over the pincer prongs (upper and lower portions 34,36), to close the pincer (distal end 30) and to decouple from the loop (openings within stent 50; which equates to the line loops 48 of Dell) of the implantable device (stent 10) when the outer sheath (sleeves 20) move proximally relative to the inner member (body portion of capturing wires 14; which equates to the body portion of the proximal element lines 90 of Dell) (paragraphs [0042], [0046], and Figs. 1–7,18,19). Additionally, Rothstein teaches wherein the first and second pincer prongs (upper and lower portions 34,36) are formed of a shape memory material such that they are biased outwardly (paragraph [0038] and Figs. 3,18).
It should be understood that Dell and Rothstein are known references in the art that teach means of coupling an implantable device to the delivery system via multiple elongate members (abstract, paragraphs [0110 – 0111], [0121 – 0122], [0130], [0133 – 0135], and Figs. 7,9B-11B – Dell ; abstract, paragraphs [0037], [0042], [0046], and Figs. 1–7,18,19 – Rothstein); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one coupling mechanism for another (i.e., modifying Dell to incorporate the pincers and slidable sheaths similar to that of Rothstein), and the results of the substitution would have been predictable and resulted in the modified proximal element actuators of Dell being able to function as intended to properly couple and decouple the proximal elements to and from the delivery system. The Examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Qiu et al (US 2020/0330251 A1) teaches pincer prongs, for coupling a delivery system to an implantable device, closable via a slidable sheath.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771