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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 2, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on June 18, 2026. As directed by the amendment: claim 1 has been amended and claim 14 has been added. Thus, claims 1-14 are presently pending in this application.
Response to Arguments
Applicant’s arguments, filed June 18, 2026, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 have been fully considered and are persuasive, specifically in regards to the prior art not teaching or disclosing the newly added limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
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.
Claim 13 is 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 13, the claim recites that the graspable portion is molded/extruded as part of the tubing. The tubing is a functional limitation of the claimed device due to the “configured to be disposed within a lumen of a tubing” language in claim 1. As such, it is unclear if this claim now requires the tubing to be part of the claimed device or if the tubing is still intended to be functional so that the graspable portion merely needs to be capable of being molded or extruded as part of the tubing. For examination purposes, the second interpretation was used.
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) 1-7 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biche (US 5944697).
Regarding claim 1, Biche discloses a tubular surgical device comprising:
a grasper receiving section (housing 12 in fig. 1) comprised of a biocompatible material (3:39-43 discloses polycarbonate), the grasper receiving section including
a distal portion (see below) comprising diversion holes to provide an alternative fluid pathway during suction (see below; a suction device can be attached to hole 1 below to allow suction through hole 1 and a tube can be inserted through seal 20 to allow suction through hole 2 below), and
a proximal portion co-aligned with the distal portion (see below), the proximal portion including a male adaptor having a smaller outer diameter than the distal portion (see below), wherein the male adaptor is configured to be disposed within a lumen of a tubing (the examiner notes that the tubing is functional; the adaptor below is capable of being disposed within a lumen of a tube); and
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a graspable portion (suture ring 14 and sheath 16 in fig. 3) comprising a mounting section mounted around the grasper receiving section (suture ring 14 in fig. 3) wherein the mounting section has a cylindrical shape (fig. 1), and
at least one of a flexible wing or a flag attached to the mounting section (tab 40 is a flag in fig. 3 and 3:53-55 discloses that the suture portion 14 is made from an elastomeric material so that tab 40 is also a flexible wing) and extending along a longitudinal axis of the tubular surgical device (fig. 3 shows a dimension of the wing/flag extending in the longitudinal direction).
Regarding claim 2, Biche discloses the grasper receiving section comprises a material selected from polyurethanes, aliphatic or semialiphatic polyamides, polysulfone, silicone, polycarbonate, polyvinyl chloride, acrylonitrile butadiene styrene (ABS), acrylic, and block copolymers made up of rigid polyamide blocks and soft polyether blocks (PEBAX®) (3:39-43 discloses polycarbonate).
Regarding claim 3, Biche discloses the tubing comprises a suction tube, an irrigation tube, or both, and the male adaptor is configured to be in fluid communication with the tubing (the examiner notes that the tubing is functional; the device of Biche is capable of being used with the claimed tubing so that the male adaptor is in fluid communication with the tubing).
Regarding claim 4, Biche discloses the graspable portion is friction fit over the grasper receiving section (claim 5).
Regarding claim 5, Biche discloses the graspable portion is bonded to the grasper receiving section (3:60-62 discloses the sheath 16, which is part of the graspable portion, molded to main body 12 so as to be “bonded” to the main body 12).
Regarding claim 6, Biche discloses the graspable portion is overmolded to the grasper receiving section (4:1-8 discloses the sheath 16, which is part of the graspable portion, is coupled to the main body 12 via overmolding).
Regarding claim 7, Biche discloses the graspable portion is of a lower durometer than is the grasper receiving section (3:39-43 discloses housing, equated to the grasper receiving section, is made from polycarbonate and 3:53-55 discloses that suture ring 14, equated to the graspable portion, is made from an elastomer).
Regarding claim 12, Biche discloses the graspable portion comprises a cylindrical section positioned outside the tubing and the distal portion of the grasper receiving section (the examiner notes that the tubing is functional so that the graspable portion of Biche is capable of being used with tubing as claimed).
Regarding claim 13, Biche discloses the graspable portion is molded or extruded as part of the tubing (in view of the 112(b) rejection/interpretation above; the graspable portion is capable of being molded or extruded as part of the tubing since the tubing is functional).
Regarding claim 14, Biche discloses a tubular surgical device comprising:
a grasper receiving section (housing 12 in fig. 1) comprised of a biocompatible material (3:39-43 discloses polycarbonate), the grasper receiving section including
a distal portion (see below) comprising diversion holes to provide an alternative fluid pathway during suction (see below; a suction device can be attached to hole 1 below to allow suction through hole 1 and a tube can be inserted through seal 20 to allow suction through hole 2 below), and
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a proximal portion co-aligned with the distal portion (see above), the proximal portion including a male adaptor having a smaller outer diameter than the distal portion (see above), wherein the male adaptor is configured to be disposed within a lumen of a tubing (the examiner notes that the tubing is functional; the adaptor below is capable of being disposed within a lumen of a tube); and
a graspable portion comprising a mounting section mounted around the grasper receiving section (suture ring 14 in fig. 3) wherein the mounting section has a continuous cylindrical shape (fig. 1 shows the ring as entirely cylindrical; the examiner notes that the structure is also denoted as a “ring”), and
at least one of a flexible wing or a flag attached to the mounting section (tab 40 is a flag in fig. 3 and 3:53-55 discloses that the suture portion 14 is made from an elastomeric material so that tab 40 is also a flexible wing).
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.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biche, as applied to claim 1 above, and further in view of Pinchuk (US 5360397).
Regarding claim 8, Biche discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the grasper receiving section has a Shore durometer of between 30D and 70D.
Pinchuk teaches a similar grasper receiving section (adaptor 52 in fig. 2) which is made from polycarbonate and has a Shore durometer between 30D and 70D (6:22-25). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the grasper receiving section to be within the claimed durometer range as Pinchuk teaches these are known durometers for polycarbonate.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biche.
Regarding claim 9, Biche discloses all of the claimed limitations set forth in claim 1, as discussed above, but does not teach or disclose the grasper receiving section has an outer diameter of 0.3 to 0.8 inch.
There is no evidence that changing the maximum inner diameter of the grasper receiving section would result in a difference in function of the device of Biche. Further, PHOSITA, being faced with modifying the outer diameter of the grasper receiving section, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed outer diameters. Lastly, Applicant has not disclosed that the claimed range solves any stated problem, stating in paragraph 112 of the Specification that dimensions are "illustrative and various alternatives are contemplative", and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result. Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the outer diameter of the grasper receiving section of Biche to be between 0.3 to 0.8 inch as an obvious matter of design choice within the skill of the art.
Allowable Subject Matter
Claims 10 and 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, the closest prior art is Biche which does not teach or disclose at least one of the diversion holes are longitudinal slots. The first hole of Biche denoted above is intended to connect to a tubing (tubing 62 in fig. 2) and the second hole of Biche is intended to receive a dilator (4:28-29). As such, PHOSITA would not be motivated to modify either diversion hole to be a longitudinal slot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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