UpDETAILED 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/30/26 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-5 have been considered but are moot because the new ground of rejection over Singh et al. US 2013/0178865, in view of Evans et al. US 2004/0144395, in view of Esser US 5,222,977 and in view of Rousseau et al. US 2013/0139828.
Singh et al. discloses a solid, elongated static needle having a first angle angled away from the central axis and second angle from the central axis, the second angle at least partially receiving the insertion and extraction hook, the body and the head formed together as one piece, as shown in annotated figure 16a, and as further discussed below.
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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.
Claims 1 and 3-5 are 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.
Claim 1 discloses “said insertion hook and said extraction hook positioned on a side of said body toward which said head section is angled” lines 11-13. Examiner notes this language is indefinite as the amendment claims both a first angle and a second angle. It is unclear as to whether the insertion hook and extraction hook are positioned toward the first angle or the second angle.
Claim 3 recites the limitation “said instrument” on line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to “said single unitary instrument” to be consistent with the claim language.
Claim 4 recites the limitation “said instrument” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to “said single unitary instrument” to be consistent with the claim language.
Claim 5 recites the limitation “said instrument” on lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending to “said single unitary instrument” to be consistent with the claim language.
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, 3, 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. US 2013/0178865, in view of Evans et al. US 2004/0144395, in view of Esser US 5,222,977 and in view of Rousseau et al. US 2013/0139828.
Regarding claim 1, Singh et al. discloses a suture passer device comprising:
a solid elongated static needle (62i, figure 16a, paragraph 0133) like single unitary instrument having a body with an external surface (see annotated figure 16a below), and a second end with a needle tip (see annotated figure 16a below); said single unitary instrument includes a head section angled away from a central axis of said instrument body at a first angle (see annotated figures 16a below); said single unitary instrument having a second angle on said single unitary instrument between said body of said single unitary instrument and said head section (see annotated figure 16a below); said body and said head section formed together as one piece (figure 16a, body and head of shaft 62i are one piece; Examiner further notes that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e -said body and head section formed together as one piece, does not depend on its method of production, i.e. In re Thorpe, 227 USPQ 964, 966 (Federal Circuit 1985)).
said single unitary instrument having an insertion hook for securing a suture for insertion and an extraction hook for securing a suture during extraction (see annotated figure 16a below); said insertion hook and said extraction hook positioned on a side of said body toward which said head section is angled (see annotated figures 16a below);
said insertion hook and said extraction hook defined by an open mouth area 64 located between said insertion hook and said extraction hook (see annotated figure 16a below), said open mouth area having a length (length of open mouth area, see annotated figure 16a), and a continuous internal surface extending from the external surface of the body adjacent to said insertion hook to said external surface of the body adjacent to said extraction hook to form an opening (slot 81) in the body of said suture passer device which receives the suture when said suture is placed into said mouth area (see annotated figure 16a below); said opening in said body having a length larger than said length of said open mouth area (figure 16a, slot 81 is wider than suture opening or mouth area 64); said insertion hook and said extraction hook positioned on said body within said second angle (see annotated figure 16a);
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said insertion hook securing said suture for delivering an insertion of said suture by said single unitary instrument and said extraction hook securing said suture for extraction of said suture by said single unitary instrument (paragraph 0134).
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Singh et al. discloses a stabilizer piece to connect with a handle 12 (figures 1, 2), needle comprises a coupling portion 58b which may be connected to a coupling portion 58a on distal end of rod connected to a handle (figures 1, 2, 16b), the coupling parts may be complementary screw threads or any other forms such as luer lock couplers (paragraph 0100), the linkage 40 is received within the handle to engage the handle with the instrument (paragraph 0092), but fails to explicitly disclose the first end received by a handle section with a stabilizer piece inside said handle section, said stabilizer piece receiving said first end of said instrument.
Evans et al. discloses an instrument for inserting a sling or suture comprising an elongate needle (figure 2) attached to a handle 4 (figure 3A) and with a stabilizer piece inside said handle section (figures 3B or 4A, needle end is received within the distal end of handle with stabilizer piece for example, paragraph 0139 with latch mechanism 33), said stabilizer piece receiving said first end of said instrument (figures 3B, 4A, 4B).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Singh et al. with a stabilizer piece inside said handle section for receiving the needle, as taught by Evans et al. as a known substitute coupler as known in the art to provide a releasable mechanism for attaching or releasing the needle directly from a handle.
Singh et al. discloses said single unitary instrument having a second angle the instrument or needle having a straight or curved shaft 62i (paragraph 0014, 0109; figure 16a), but fails to explicitly disclose the second angle of 18 to 22 degrees on said single unitary instrument between said body of said single unitary instrument and said head section.
Esser discloses a suture passer device (figure 1) comprising a needle having an open mouth and opening (figure 1), the shaft being straight or curved and a head section angled away from the central axis of the instrument body (column 4, lines 9-13, curvature of head on the distal end of the shaft), the angle formed between 15 to 45 degrees, which is overlapping in scope, and further discloses the curvature is not critical and may be varied (column 4, lines 13-16).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Singh et al. with a head curvature between 18 and 22 degrees, as taught by Esser, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Singh et al. discloses the opening has a length in the order of 4mm and width of approximately .6mm or 1mm (paragraph 0133), the open mouth area 64 being a smaller opening than the length of the entire slot 81 (figure 16a), but fails to explicitly disclose said open mouth area having a length of 0.5 millimeters to 4 millimeters. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an open mouth area having a length of .5 millimeters to 4 millimeters, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Singh et al. fails to explicitly disclose at least one of said insertion hook or said extraction hook is marked for visual aid.
Rousseau et al. teaches a suture passing device 100 having an elongated shaft and hook elements within an opening for receiving a suture (filament 200, figure 19a-19c), the shaft having a marker on the device for directional location of the opening 108 (figure 9a) on the shaft 106 relative to the filament or suture (paragraph 0059). Examiner notes that although the explicit hook portions are located within the opening 108 of the shaft, and the visual aid marking is located to position the opening or hooks within the opening adjacent the filament to be grasped (figures 19a, 19b), and further any suitable marker may be present to indicate to the surgeon the directional location of the side opening relative to the suture or filament (paragraph 0059).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Singh et al. with a visual aid marker on the device at the insertion or extraction hook position surrounding the opening on the shaft or needle, as taught by Rousseau et al., in order to provide relative directional location information of the shaft opening relative to the filament or suture and corresponding hook elements within the opening.
Regarding claim 3, Singh et al. discloses wherein said insertion hook is located on said instrument at a position proximal to said handle section relative to said extraction hook (see annotated figure 16a below).
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Regarding claim 4, Singh et al. discloses wherein said body of said instrument has a cylindrical shape (shaft 62i, figure 16b, similar cylindrical shaped shafts shown for example, fig. 5a, 5b, 8b, 10b 12, 14).
Regarding claim 5, Singh et al. discloses a body 62i, but fails to explicitly disclose wherein said body of said instrument has an oval shape.
Esser discloses a suture passer device (figure 1) comprising a needle (figure 3A) having an open mouth and opening (defined by opening 3, figure 3A), having a body 1 (figure 1), the body having a generally circular shape or an ovoid shape cross section at the eye (column 3, line 63-column 4, line 2). Esser further discloses wherein the cross-sectional shape may vary and is not critical (column 3, line 63-64).
Therefore, it would have been an obvious matter of design choice to modify Singh et al. to have a cylindrical or oval shape, since applicant has not disclosed that having an oval shape or a cylindrical shape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design (present invention, paragraph 0008, any other shapes are within the scope of the invention). Furthermore, absent a teaching as to criticality of the oval or cylindrical shape, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975). Additionally, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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