DETAILED ACTION
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 action is in response to amendments filed on 12/11/2025. Claims 1, 8, 10-11 have been amended. Claims 1-11 are pending and examined below.
Election/Restrictions
Newly submitted claims 21-24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions are distinct, each from the other because of the following reasons:
Inventions I, II, and III are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j).
In the instant case, the inventions as claimed have materially different design and mode of operation as the product of Invention I is a retrieval apparatus having a stylet with a proximal and distal stylet ends separated by a lumen and a retrieval sheath having proximal and distal sheath ends longitudinally separated by a sheath lumen, the sheath lumen being configured to selectively and concurrently directly laterally surround the microdevice and the stylet therewithin for removal from the body tissue, and Invention II is an apparatus having a medical microdevice, an anchoring apparatus, and a retrieval apparatus including a stylet having proximal and distal stylet ends longitudinally separated by a stylet lumen configured to selectively accept the guidewire, and a retrieval sheath having proximal and distal sheath ends longitudinally separated by a sheath lumen, the sheath lumen being configured to selectively and concurrently laterally surround the microdevice and the stylet therewithin for removal from the body tissue.. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21-24 withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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) 1-11, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 5353804 A (cited in the IDS; hereinafter referred to as “Kornberg”).
Regarding claim 1, Kornberg, an apparatus for removing tissue, teaches a retrieval apparatus for selectively retrieving a medical microdevice and associated anchoring apparatus from a target implantation site of a body tissue (48; column 8, lines 43-63; Figure 9), the microdevice including a body having longitudinally spaced proximal and distal device ends and a guidewire extending proximally from the proximal device end, and the anchoring apparatus including an anchor having longitudinally spaced proximal and distal anchor ends, a selected one of the proximal and distal anchor ends being connected to a respective one of the distal and proximal device ends, the anchoring apparatus being selectively expandable between a collapsed insertion condition and an expanded anchoring condition within the body tissue (the limitation is not positively claimed), the microdevice beinq selectively implanted in a body tissue with the quidewire protruding proximally through a skin surface from the body tissue into ambient space adjacent the skin surface and beinq selectively maintained in the implanted position via resistance of the anchorinq apparatus, in the expanded anchorinq condition, to longitudinal motion of the microdevice, the retrieval apparatus comprising:
a stylet having proximal and distal stylet ends longitudinally separated by a stylet lumen configured to selectively accept the guidewire (58; column 8, lines 43-63; Figure 9); and
a retrieval sheath having proximal and distal sheath ends longitudinally separated by a sheath lumen, the sheath lumen being configured to selectively and concurrently laterally surround the microdevice and the stylet therewithin for removal from the body tissue (54; column 8, lines 43-63; Figure 9).
Regarding claim 2, Kornberg teaches wherein the distal stylet end includes a device notch for selectively longitudinally accepting a portion of the proximal device end in a predetermined orientation (62; column 8, lines 43-63; Figure 9, 14).
Regarding claim 3, Kornberg teaches wherein at least one of the distal stylet end and the distal sheath end includes a tapered nosecone for atraumatically engaging the body tissue (tapered puncturing end 60; column 8, lines 63-68; Figure 9, 14).
Regarding claim 4, Kornberg teaches wherein the distal sheath end includes a concentric cutting edge for coring through the body tissue (56; column 11, lines 24-41; Figure 15).
Regarding claim 5, Kornberg teaches wherein the stylet and sheath are mutually coaxially concentric (stylet 58 and sheath 54 are concentric; Figure 12).
Regarding claim 6, Kornberg teaches including a housing operatively connected to the proximal stylet end and the proximal sheath end, the housing being configured for selective manipulation by a user to independently longitudinally move the stylet and the sheath (64; column 8, lines 43-63; Figure 9).
Regarding claim 7, Kornberg teaches wherein the housing includes a clamp for grasping at least a portion of guidewire to maintain the device body in relative longitudinal spacing from the housing (spacing cylinder 102; column 9, lines 61-65; Figure 12).
Regarding claim 8, Kornberg teaches wherein wherein the stylet is configured for initial engagement with the guidewire in the ambient space and guidance by the guidewire toward the body tissue immediately adjacent the proximal device end (as shown in Figures 12).
Regarding claim 9, Kornberg teaches being configured to retrieve a biopsy sample portion of the body tissue immediately adjacent the microdevice by at least partially directly laterally surrounding the biopsy sample within the sheath lumen concurrently with the sheath lumen laterally surrounding the microdevice and stylet (as shown in Figures 30C and 30D).
Regarding claim 10, Kornberg teaches wherein the sheath lumen is smaller than the anchoring apparatus, when in the expanded anchoring condition (as shown in Figures 9-14).
Regarding claim 11, Kornberg teaches wherein the sheath lumen is configured to concurrently at least partially surround the anchoring apparatus, the microdevice and the stylet (as shown in Figures 9-14).
Regarding claim 20, Kornberg teaches A retrieval apparatus for selectively retrieving a medical microdevice and associated anchoring apparatus from a target implantation site of a body tissue (48; column 8, lines 43-63; Figure 9), the microdevice including a body having longitudinally spaced proximal and distal device ends and a guidewire extending proximally from the proximal device end, and the anchoring apparatus including an anchor having longitudinally spaced proximal and distal anchor ends, a selected one of the proximal and distal anchor ends being connected to a respective one of the distal and proximal device ends, the anchoring apparatus being selectively expandable between a collapsed insertion condition and an expanded anchoring condition within the body tissue (the limitation is not positively claimed), the retrieval apparatus comprising:
a stylet having proximal and distal stylet ends longitudinally separated by a stylet lumen configured to selectively accept the guidewire, the stylet lumen being configured not to accept the proximal device end thereinto (58; column 8, lines 43-63; Figure 9);
a retrieval sheath having proximal and distal sheath ends longitudinally separated by a sheath lumen, the distal sheath end being configured for selective contact with the anchoring apparatus, the distal sheath end including a concentric cutting edge for coring the body tissue, and the sheath lumen being configured to selectively and concurrently directly laterally surround the microdevice, the stylet, and a biopsy sample portion of the body tissue immediately adjacent the microdevice therewithin for removal from the body tissue (54; column 8, lines 43-63; Figure 9); and
a housing operatively connected to the proximal stylet end and the proximal sheath end, the housing being configured for selective manipulation by a user to independently longitudinally move the stylet and the sheath (64; column 8, lines 43-63; Figure 9).
Response to Arguments
Applicant’s arguments, filed 12/11/2025, with respect to the 35 USC 112(b) and (d) rejections have been fully considered and are persuasive. The 35 USC 112(b) and (d) rejections have been withdrawn.
Applicant's arguments filed 12/11/2025 with regards to the prior art rejection have been fully considered but they are not persuasive.
Applicant traverses the prior art rejection of claims 1 and 20
Specifically, Applicant argues that the prior art fails to teach or suggest the sheath lumen configured to selectively and concurrently directly laterally surround the microdevice and the stylet therewithin for removal from the body tissue.
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 ABID A MUSTANSIR whose telephone number is (408)918-7647. The examiner can normally be reached M-F 10 am to 6 pm Pacific Time.
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/ABID A MUSTANSIR/Examiner, Art Unit 3791