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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/31/2025 has been entered.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 12/01/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Schatz (US 7,803,136) to teach the newly recited limitations.
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, 6, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schatz (US 7,803,136).
Regarding claims 1, Schatz discloses a surgical device (10, FIG 1) for felting an implant to soft tissue of a patient (The device comprises a reciprocating needle and therefore is interpreted as at least capable of being used in the claimed manner) comprising: at least one felting needle (18, FIG 3A-3C; examiner notes the claim does not provide any structural limitations which would distinguish a felting needle from an injection needle. “felting” is interpreted as an intended use of the needle. While the specification of the present invention discloses “A felting needle may be understood as a needle including barbs that catch the fibers of the felt and move the fibers through the felt and which entangles the fibers of the felt further” this does not constitute a special definition of a felting needle and thus, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993)) configured to move reciprocally (col 4 lines 33-48 disclose advancing and retracting the needle, thereby achieving reciprocal motion), the at least one felting needle configured to entangle the implant with the soft tissue (The needle is at least configured to puncture and therefore entangle an implant if driven through an implant prior to piercing the tissue); a connection interface (Attachment between the proximal end of the needle and the needle hub, col 3 lines 52-56) for connecting the at least one felting needle to an actuator (col 4 lines 33-38 discloses linear advancement of the needle by pushing the needle hub relative to the catheter) and for transferring a reciprocal motion from the interface to the at least one felting needle (The assembly of the needle and the needle hub transfers reciprocal motion), and a needle protection mechanism (22’’, FIGs 3A-3C, col 3 line 52-col 4 line 46) wherein the needle protection mechanism is configured to modify a maximal penetration depth of the at least one felting needle (protection mechanism 22’’ extends out of 30 and radially expands to define a penetration depth for the needle. The protection mechanism can be extended out of catheter 12 to any position between FIG 3A and 3B thereby allowing it to modify a maximal penetration depth of the needle because each position of 22’’ would allow for a larger or smaller penetration depth. Col 4 lines 1-6 discloses preferably, the needle tip 20 extends between 3 and 7 millimeters beyond the distal portion 34 of the abutment member 22''. Thus teaching there is a range of depths which can be set as the maximal penetration depth) to prevent the at least one needle from being damaged due to a contact with rigid structure during the reciprocal motion (by limiting the penetration depth, the protection mechanism acts to prevent damage. For example, if the needle were inserted too deep it could contact a rigid structure which damages the needle. By shortening and limiting the penetration depth, the protection mechanism prevents potential damage to the needle).
Regarding claim 6, Schatz discloses the at least one felting needle has a maximal penetration depth and wherein the maximal penetration depth is adjustable (the maximal penetration depth is set by the distance which the needle protrudes beyond the needle protection mechanism 22’’. The protection mechanism can be extended out of catheter 12 to any position between FIG 3A and 3B thereby adjusting a maximal penetration depth of the needle because each position of 22’’ would allow for a larger or smaller penetration depth. Col 4 lines 1-6 discloses preferably, the needle tip 20 extends between 3 and 7 millimeters beyond the distal portion 34 of the abutment member 22''. Thus teaching there is a range of depths which can be set as the maximal penetration depth).
Regarding claim 13, Schatz discloses the needle protection mechanism includes a predetermined breaking point wherein the predetermined breaking point breaks, if a force on the at least one needle exceeds a predetermined threshold (The needle protection mechanism has a breaking point defined by a structural property of the material used to form the element. This structure will break at some failure point for example if a shear force were applied to the needle, and therefore the needle protection mechanism which surrounds the needle, that exceeds a threshold of force which the structure can handle).
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.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Schatz (US 7,803,136) in view of Hsueh et al. (US 2015/0231368).
Regarding claim 2, Schatz discloses the invention substantially as claimed, as set forth above for claim 1.
Schatz is silent regarding the diameter of the needle and therefore fails to teach the width or diameter of the needle being less than 0.8mm.
However, Hsueh et al. teaches in the same field of endeavor an injection needle (504, FIG 5, [0058]) for reciprocal delivery into a tissue (heart tissue, [0063]) wherein the width or diameter of the needle is less than 0.8mm ([0058] discloses a 0.016'' outer diameter, which is equal to 0.4 mm).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the diameter of the needle to be less than 0.8mm, as taught by Hsueh et al., for the purpose of selecting a needle gauge commonly known in the art of affecting a desired treatment to a body tissue without causing unnecessary trauma to the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771
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