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 Amendment
The amendments filed on 08/11/2026 have been entered. Claims 1-14 and 16-20 remain pending in the application
Claim Objections
Claim 9 is objected to because of the following informalities: In lines 1-2, “further comprising the obturator” should be removed from the claim because claim 1 already recites the implant delivery instrument comprising an obturator. Appropriate correction is required.
Allowable Subject Matter
Claims 18-20 are allowed.
The following is an examiner’s statement of reasons for allowance: Regarding claim 18, the prior art of record fails to teach or render obvious “the tab… is one of angled or curved so that a portion of the tab is received partially in the groove of the shaft of the obturator along a section of the shaft that projects out of the discharge opening” in combination with the remaining limitations of the claim.
Modification of the device of Jin would not have been obvious to achieve any of the above limitations because doing so would require substantial reconstruction of the portion of the device interpreted as comprising the tab.
Claims 5 and 9-11 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.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments filed 08/11/2026 with respect to the rejection(s) of claim(s)1 and 13 under 35 USC 102(a)(1) 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 Therefore, the rejection has been withdrawn.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 Bardy (US 2010/0331868).
With respect to claim 13, the amended claim incorporates subject matter of claim 6, which was previously indicated as allowable subject matter. However, because the subject matter of claim 1 (from which claim 6 depends) and 13 differs, incorporating claim 6 into claim 13 does not necessarily arrive at an allowable claim. As such, a rejection in view of Bardy is presented below.
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) 1-4, 6-8, 12-14, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bardy (US 2010/0331868).
Regarding claim 1, Bardy discloses an implant delivery instrument (FIG 31A) comprising: an obturator (286, FIG 31C, [0139]) having a distal tip (Distal end shown in FIG 31C); and a housing (284) having a main body section (FIG 31A, wherein 284 is equivalent to 261 better illustrated in FIG 30) that defines a passage therethrough from a front end of the main body section to a back end of the main body section (See lumen/passage which houses 288, 286, 285), the passage configured to receive the obturator through an opening at the back end (FIG 31A), the passage also configured to receive an implant device (288, [0139]), the housing including a discharge opening at the front end (Covered by 290 in FIGs 31A-31C, best viewed in FIG 30 as cutout/cavity opening 276), wherein movement of the obturator through the passage is configured to push the implant device through the discharge opening at the front end and through an incision into a subdermal pocket of the patient (FIG 31A-31C, [0138-0144]), the housing including a tab (290, equivalent to 271 shown in FIG 30) connected to and projecting from the front end of the main body section (FIG 31A-C; understood to be connected in a manner similar to hinge 274), wherein the tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision (Shown as 271 in FIG 30, [0135-0136]; the tab is blunt and not configured for creating or enlarging the incision), wherein the tab extends beyond the discharge opening (FIG 31A-31C show the tab is connected to and extends beyond the discharge opening), and the tab is configured to surround the implant device moving through the discharge opening along only one side of the implant device (As the implant 288 moves from the position of FIG 31B to 31C, tab 290 only interfaces with the top side of the implant); wherein the distal tip of the obturator is configured to extend beyond the tab (FIG 31C shows 286 extending beyond the tab); and wherein the tab has a planar lower surface (Best shown in FIG 30, the bottom side of the distal end of the tab forms a planar surface).
Regarding claim 2, Bardy discloses a thickness of the tab tapers along a length of the tab from a proximal end of the tab connected to the main body section to a distal end of the tab (FIG 30 shows the tab 271 has a greater thickness at the region of 274 which connects to the many body, than at the distal tip, which tapers to a flat lip).
Regarding claim 3, Bardy discloses a width of the tab, along at least 90% of a length of the tab, is no greater than a width of the discharge opening (The tab tapers from the width of the opening to a narrower width, therefore it is not greater than the opening for at least 90% of its length, FIG 30).
Regarding claim 4, Bardy discloses the front end of the main body section includes a leading edge that defines a hard stop surface, and the tab is connected to the leading edge (Distal edge of the top side of 284 that 290 is connected to, best shown in FIG 30 as the top leading edge of 261 which connects to the hinge 274 of 271).
Regarding claim 6, Bardy discloses the main body section has a top side (Top side as oriented in FIG 31A) and a bottom side opposite the top side (Bottom side as oriented in FIG 31A), the bottom side configured to face towards skin of the patient as the implant device is pushed through the discharge opening into the subdermal pocket (FIG 31C shows the implant being pushed through the discharge opening and at least some portion of the bottom side of 284 faces the skin of the patient), wherein the tab is disposed along a top edge of the discharge opening (FIG 31C) between the discharge opening and the top side of the main body section (The hinge connection is formed on the leading edge of the main body in between the discharge opening and the top side).
Regarding claim 7, Bardy discloses the main body section of the housing includes at least one device support wall (Bottom wall of as shown in FIG 31B-31C) proximate to the front end, the at least one device support wall defining a ceiling of the passage (This wall forms the wall of the passage and therefore is interpreted as the ceiling) to engage the implant device and inhibit tilting of the implant device in a direction away from the tab as the obturator pushes the implant device through the discharge opening (As the implant travels out of the discharge opening, as least a rear portion of the implant is still received within the passage and therefore engages with the support wall. This engagement prevents tilting of the implant and ensures straight delivery into the tissue, see movement between FIG 31B-31C).
Regarding claim 8, Bardy discloses a lower surface of the tab is one of angled or curved so that a distal end of the tab is closer to a center of the passage than a proximal end of the tab connected to the main body section (FIG 31A shows the side profile of the tab is curved such that the proximal end attached to the main body is further from a center of the passage than a distal end).
Regarding claim 12, Bardy discloses the main body section of the housing defines a receptacle cavity (Interpreted as a proximal most region of the main body/passage) in communication with the passage 9Because the form part of a continuous lumen), the receptacle cavity exposed to an external environment through a cavity opening (Open proximal end through which 291 is inserted) along a side of the main body section (The back side/proximal side), the receptacle cavity configured to receive the implant device through the cavity opening (The implant 288 can be loaded into the cavity through the proximal opening).
Regarding claim 13, Bardy discloses an implant delivery instrument (FIG 31A) comprising: an obturator (286, FIG 31C, [0139]) including an elongated shaft (Body shown in FIG 31A connecting at proximal end of plunger handle 295, [0142]) with a distal tip (Distal end shown in FIG 31C); and a housing (284) having a main body section (FIG 31A, wherein 284 is equivalent to 261 better illustrated in FIG 30) that has a top side (Top surface of the rectangular structure viewed in FIG 30 and 31A) and a bottom side opposite the top side (Bottom surface of the rectangular structure viewed in FIG 30 and 31A), the main body section defining a passage therethrough from a front end of the main body section to a back end of the main body section (See lumen/passage which houses 288, 286, 285), the passage configured to receive the obturator through an opening at the back end (FIG 31A), the passage also configured to receive an implant device (288, [0139]), the housing including a discharge opening at the front end (Covered by 290 in FIGs 31A-31C, best viewed in FIG 30 as cutout/cavity opening 276), wherein movement of the obturator through the passage is configured to push the implant device through the discharge opening at the front end and through an incision into a subdermal pocket of the patient (FIG 31A-31C, [0138-0144]), the housing including a tab (290) connected to and projecting from the front end of the main body section (FIG 31A-C), wherein the bottom side of the main body section is configured to face towards skin of the patient as the implant device is pushed into the subdermal pocket (FIG 31C), and the tab connects to the front end at a location between the discharge opening and the top side of the main body section (FIG 31C); wherein the tab is disposed along a top edge of the discharge opening between the discharge opening and the top side of the main body section (FIG 31C, connection best shown in FIG 30); wherein the tab extends beyond the discharge opening (FIG 31A-31C show the tab is connected to an extends beyond the discharge opening); wherein the distal tip is configured to extend beyond the tab (FIG 31C shows 286 extending beyond the tab).
Regarding claim 14, Bardy discloses the tab has a blunt dissection tip for maintaining the incision in an open state without creating or enlarging the incision (Shown as 271 in FIG 30, [0135-0136]; the tab is blunt and not configured for creating or enlarging the incision).
Regarding claim 16, Bardy discloses a width of the tab, along at least 90% of a length of the tab, is no greater than a width of the discharge opening (The tab tapers from the width of the opening to a narrower width, therefore it is not greater than the opening for at least 90% of its length, FIG 30).
Regarding claim 17, Bardy discloses the main body section of the housing includes at least one device support wall (Bottom wall of as shown in FIG 31B-31C) proximate to the front end, the at least one device support wall defining a ceiling of the passage (This wall forms the wall of the passage and therefore is interpreted as the ceiling) to engage the implant device and inhibit tilting of the implant device in a direction away from the tab as the obturator pushes the implant device through the discharge opening (As the implant travels out of the discharge opening, as least a rear portion of the implant is still received within the passage and therefore engages with the support wall. This engagement prevents tilting of the implant and ensures straight delivery into the tissue, see movement between FIG 31B-31C).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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, 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
