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 amendment filed 08 December 2025 has been entered. Claim(s) 1-11 remain pending in the application. Applicant’s amendments to the claims have overcome each and every rejection under 35 U.S.C. 102/103 previously set forth in the Office Action mailed 08 August 2025.
Claim Objections
Claim 1 is objected to because of the following informalities: "actuato" in line 10 should be --actuator--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification fails to describe “removing the funnel from said end prior to insertion of said end of the introducer tube into a patient”. The closest references to this limitation merely describe the funnel as being removeable, generally, and that the funnel “may be removed and discarded” after insertion and use of the device (Page 6, line 1-3 of the instant specification).
Claim Rejections - 35 USC § 103
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) 1, 4, and 6-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bates (US 6179859 B1) in view of Baril (US 20210361307 A1).
Regarding claim 1, Bates teaches a medical specimen retrieval device (10) comprising:
an introducer tube (capture ring 36);
a funnel (Struts 32 and hoop 38; Fig. 2A),
wherein the funnel has a proximal end and a distal end and the funnel tapers from a smaller cross-section at the proximal end to a larger cross-section at the distal end (See Fig. 2a—struts extend to titanium hoop along perimeter 38 which has a larger cross-section than the proximal end at capture ring 36);
wherein said proximal end attaches over said end of the introducer tube so as to form a fixed engagement (See Fig. 2A—the proximal ends of the struts extend over the end of the capture ring 36 to form a fixed engagement) thereto;
a retracting element extending from an interior of the funnel, in an extended condition (guide wire 11, 50; see Fig. 3B)
wherein the retracting element is retractable through the funnel and into an interior of the introducer tube to a retracted condition by an actuator (Col. 3, line 58-60--guide wire 11 and distal region 12 may comprise a mechanism, such as are known in the art, for steering distal region 12 through a patient's vasculature) where, in moving the retracting element to the retracted condition (Figs. 3A-3E show movement of the guidewire 11 beyond an end of the capture ring 36 to deploy the struts and sac, followed by retraction of the guidewire 11 back through the capture ring to capture specimens and remove the device), the funnel remains attached to and fixed relative to said end of the introducer tube by way of the fixed engagement (Figs. 3A-3E, the struts remain in a fixed position relative to the capture ring throughout the process); and
a medical specimen bag removably coupled to retracting element (Sac 31).
However, Bates does not explicitly disclose the funnel is removably attached to an end of the introducer tube.
Baril, in the same field of endeavor of a medical specimen retrieval device, discloses struts for guiding the deployment and retraction of a bag for medical specimen retrieval are removably attached to an end of a tube (Fig. 4—the shaft 112 includes slots 117a/b and windows 119a/b configured to allow attachment and pivoting of the arms 150a/b and 151 a/b; paragraph 0027-0029).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Bates with the particular attachment of Baril in order to predictably improve the device by allowing for the replacement of parts in case of damage or a need for different sized parts to accommodate different patient or target area anatomy.
Regarding claim 4, the combination of Bates and Baril discloses the device of claim 1. However, Baril does not explicitly disclose wherein the funnel removably attaches to the end of the introducer tube by a friction fit.
Baril, in the same field of endeavor of a medical specimen retrieval device, discloses struts for guiding the deployment and retraction of a bag for medical specimen retrieval are removably attached to an end of a tube by a friction fit (Fig. 4—the shaft 112 includes slots 117a/b and windows 119a/b configured to allow attachment and pivoting of the arms 150a/b and 151 a/b; paragraph 0027-0029).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Bates with the particular attachment of Baril in order to predictably improve the device by allowing for the replacement of parts in case of damage or a need for different sized parts to accommodate different patient or target area anatomy.
Regarding claim 6, the combination of Bates and Baril discloses the device of claim 1. Bates additionally teaches wherein the distal end is a non-rectilinear shape (Fig. 2A distal end formed by ring 38).
Regarding claim 7, the combination of Bates and Baril discloses the device of claim 1. However, Baril does not explicitly disclose wherein the retractable element comprises at least one biasing arm.
Baril, in the same field of endeavor of a medical specimen retrieval device, discloses a retractable element comprises at least one biasing arm (Arm 134).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device of Bates to include a biased retractable element as described by Baril in order to predictably improve the device by allowing for the use of bias to ensure that deployment of the bag occurs smoothly while still allowing for retraction and thus collection of all capture specimens.
Regarding claim 8, the combination of Bates and Baril discloses the device of claim 1. Bates additionally teaches wherein the retractable element comprises at least one non-biasing appendage (guide wire 11).
Regarding claim 9, the combination of Bates and Baril discloses the device of claim 1. Bates additionally teaches wherein the retractable element comprises a wire (guide wire 11).
Regarding claim 10, the combination of Bates and Baril discloses the device of claim 1. Bates additionally teaches a method for preparing the device of claim 1 for use, the method comprising:
retracting the retracting element through the funnel and into the introducer tube (Figs. 3A-3E—the guide wire 11 is retracted from its most distal position back through the capture ring 36), whereby the funnel remains attached to said end, by way of the fixed engagement when the retracting element is in the retracted condition (Figs. 3A-3E—the struts remain attached to the capture ring in all steps of use);
deflating the medical specimen bag by a retraction of the retracting element by the actuator (Fig. 2A and 3A-3C show the sac at its most expanded configuration; Fig. 3E shows the sac deflated by retracting the guide wire 11); and
retracting the bag (Col. 5, line 56-59-- As the guide wire continues to be pulled proximally, struts 32 cause sac 31 to collapse inward to its contracted position and the filter element is retracted into lumen 24 of catheter 21).
However, Bates does not explicitly disclose retracting the bag into the introducer tube.
Baril, in the same field of endeavor of a medical specimen retrieval device, discloses retracting a bag into the introducer tube (paragraph 0028--In the retracted configuration, the bag brim 140 is collapsed to fit within the inner peripheral surface of shaft 112 and the distal ends 154a, 154b of hook members 150a, 150b are sandwiched between the distal end of shaft 122 and the inner peripheral surface of the distal end 116 of shaft 112; paragraph 0031--Bag brim 140 may include features that close off the opening of the bag brim 140 when fully retracted.).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the device and method of Bates to retract the bag into the introducer tube as disclosed by Baril in order to predictably improve the device by allowing for some amount of sealing of the bag by retracting the ends of the bag into the introducer tube, which would close of the opening of the bag and prevent the escape of any specimens being collected.
Allowable Subject Matter
Claims 2-3 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.
In particular, in spite of teaching limitations of claims 2-3 and 5, prior art of the record Middleman (US 7722626 B2) and Baril (cited above) teach away from “said proximal end attaches over said end of the introducer tube so as to form a fixed engagement thereto” and “where, in moving the retracting element to the retracted condition, the funnel remains attached to and fixed relative to said end of the introducer tube by way of the fixed engagement” of claim 1. The prior art of Bates (cited above) teaches away from the limitations of “wherein the proximal end is cylindrical” of claims 2-3 and the limitation of “wherein the introducer tube is cylindrical with an external diameter between 5 millimeters to 15 millimeters” of claim 5, as Bates specifically requires multiple struts to allow for a particular expanding and collapsing behavior of the funnel and requires a smaller size to allow use of the device in a vessel of a user.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Claim 11 is not currently rejected under 35 U.S.C. 102/103 as each of the pertinent prior art references fails to teach and/or reasonably suggest “removing the funnel from said end prior to insertion of said end of the introducer tube into a patient”.
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 ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791