DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/21/2026 has been entered.
Response to Arguments
Applicant’s amendments have overcome the previously applied prior art rejections for claim 25.
Applicant’s arguments with respect to claim(s) 35 and 44 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.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 35, 37-39, and 42-45 is/are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by US 2005/0251093 (Abou-Kansoul).
In regards to claim 35, 38, 39, and 44, Abou-Kansoul discloses a surgical implantation device and method (see title and abstract). The surgical device (figures 1- 5; paragraphs [0040]-[0050]) has the following components:
a finger sheath (tube clamp 22 and 24; see figures 2 and 3), adapted for mounting on a finger (36) of a user, the finger sheath having an opening on a distal end (see figures 3-5; finger extends through the tube clamp), wherein the finger sheath is configured so as to enable a user to palpate a tissue via the finger (fingers are free so are enabled to palpate); and
at least one rigid guide tube (28) attached to the finger sheath (tube is attached via a clamp),
wherein the at least one rigid guide tube is attached to the finger sheath such that the distal opening of the at least one rigid guide tube extends beyond a distal end of a finger in the finger sheath (figure 4 shows an instance where the guide tube extends beyond a distal end of the user’s finger).
It is noted that the art only requires a sheath and a guide tube. No other structural limitations are presented. The limitations regarding the guide tube being configured for guiding a tissue repair implant comprising a tissue anchor and suture are not being claimed as part of the device. Instead, they appear to be directed to an intended use of the guide tube. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The tube used in the prior art can be used to guide a tissue repair implant from the proximal opening to the distal opening (tube provides the traveling path). Further defining the invention by including the implant or better defining how the guide tube performs the claimed function can be used to overcome the current rejection.
In regards to claim 37, Abou-Kansoul discloses the limitations of claim 35. In addition, depending on how one orients the arm, there would be some configurations where the proximal opening of the guide tube is positioned above a back hand of the user when the finger sheath is mounted (Ex. anytime the hand is placed vertically relative to the floor, the proximal opening would be above the hand).
Claims 42 and 43 are directed towards limitations pertaining to intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim 45 limits a component that is not being claimed as part of the device. The current limitation, appears to limit a component related to the intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Thus, Abou-Kansoul would meet the limitation of the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 45, 47-48 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2005/0251093 (Abou-Kansoul), as applied to claims 35 and 44 above, and further in view of US 2007/0239208 (Crawford).
In regards to claims 45, 47, and 48, Abou-Kansoul discloses the limitations of claims 35 and 44 but does not disclose the presence of an anchor. In a related area, Crawford discloses a surgical implantation device and method (see title and abstract). The surgical device (figures 1- 9A-B; paragraphs [0040]-[0067]) has the following components:
a finger sheath (glove garment 4), adapted for mounting on a finger of a user, the finger sheath having an opening on a distal end (window 18), wherein the finger sheath is configured so as to enable a user to palpate a tissue via the finger (paragraph [0042]-[0045]); and
at least one guide tube (conduit 6) attached to the finger sheath,
a tissue anchor (50) coupled to a suture (44), where the anchor comprises a material configured to return to an expanded state from a compressed state (tissue anchor has a frame that expands once it is advanced through the tube and is in tissue; paragraph [0053]);
the at least one guide tube being configured for guiding a tissue repair implant including both a tissue anchor (50) and a suture (44) from a proximal opening of the at least one rigid guide tube to a distal opening of the at least one rigid guide tube.
Crawford states that anchors are used for securing materials and grafts to positions over the rectum and beneath the vaginal vault for pelvic floor surgeries (paragraph [0062]-[0063]). Thus, it would be obvious to one of ordinary skill in the art, before the claimed invention was made, to modify the device of Abou-Kansoul to include anchors as taught by Crawford in order to hold materials and grafts in place to resolve pelvic floor issues.
Allowable Subject Matter
Claims 25, 27-34, and 45 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
In regards to claim 25, the prior art of record does not teach or suggest a device with a combination of components, as claimed by Applicant, that includes housing for mounting on a portion of a finger of a user, a tube, tissue repair implant, and at least one rigid guide tube, where the rigid guide tube is attached to a cylindrical housing and guides the tissue repair implant via the rigid guide tube where the distal opening of the rigid guide tube extends past a distal end of the finger of the user when the finger is in the elongate housing.
Claims 27-34 and 45 are dependent on allowed matter from claim 25 and are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA DARYL DEANON LANNU whose telephone number is (571)270-1986. The examiner can normally be reached Monday-Thursday 8 AM - 5 PM, Friday 8 AM -12 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA DARYL D LANNU/Examiner, Art Unit 3791 /CARRIE R DORNA/Primary Examiner, Art Unit 3791
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