DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Effective Filing Date
The instant application contains the following priority data:
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Claims 1-20 are directed to subject matter that was introduced for the first time in U.S. Application 13/539,661, filed 7/21/2012. The features of the distal end of the flexible actuation member extending through and into the transition portion of the tissue-engaging helical coil member such that the windings of the transition portion are not available for engaging or receiving tissue is disclosed for the first time in Fig. 104 of this parent application. The earliest disclosure for the subject matter of claims 1-20 and thus the effective filing date for the subject matter of is 7/21/2012.
Drawings
The drawings are objected to under 37 CFR 1.84 for the following reasons: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. See replacement drawings filed 11/18/2021 in parent application 17/396,021 which provides acceptable and clear lines. See CFR 1.84(l) which states “All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 7, 8, 15 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.
Claims 7 and 15 recite the term “near”. This is a relative term which renders the claims indefinite. The term “near” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 8 recites “a bearing sleeve” twice. It is unclear if the second recitation in line 4 is referring to the same bearing sleeve first introduced in line 3, or if it is an additional bearing sleeve. Lines 4-5 further recite “the bearing sleeve”. If the previously mentioned bearing sleeves are two different sleeves, it is then unclear which bearing sleeve lines 4-5 is referring to.
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 1-4, 9-12, 16-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Saadat et al (US 2005/0250985) in view of McPherson et al (US 5437266).
Claim 1. Saadat et al discloses a tissue-grasping instrument sufficiently flexible for insertion and use through a body endoscopically ([0011], [0135]; an example of an endoscope shown in Fig. 67A), the tissue-grasping instrument comprising:
a flexible tubular member (12) having a proximal end (end closer to user) and a distal end (end closer to treatment site) and defining a lumen extending between the proximal end and the distal end ([0139], [0140]);
a flexible actuation member (28) extending through the flexible tubular member lumen and having a proximal end and a distal end (Figs. 1-2); and
a tissue-engaging helical coil member (30) coupled to the distal end of the flexible actuation member and including a plurality of windings including a transition portion (see annotated figure below) having a non-constant pitch (Figs. 4A, 4B; [0141], [0143], [0162], [0163]);
wherein: the flexible tubular member and the flexible actuation member are sufficiently flexible for being advance through a curved passage (Fig. 67A illustrates the curvature the instrument may take on; [0139]).
Saadat discloses the flexible actuation member (28) may be fastened to the helical coil member (30) through any suitable fastening method, such as adhesives, solder, etc. ([0162]). However, Saadat et al fails to illustrate the fastening method or details of the attachment and therefore fails to disclose the distal end of the flexible actuation member (28) extends through and into the transition portion of the tissue-engaging helical coil member (30) such that the windings of the transition portion are not available for engaging or receiving tissue.
However, in a similar field of endeavor of a tissue-grasping instrument, McPherson teaches a helical coil (30) for grasping onto tissue, wherein an actuation member (38) is attached to the helical coil by extending through the transition portion of the plurality of windings and fastened thereto using an adhesive (44) (see annotated figures below; wherein the annotated transition portion of McPherson is equivalent to the transition portion of Saadat et al as the interpretated transition portion of Saadat is up to the first open coil; similarly, the transition portion of McPherson is up to the first open coil). The actuation member includes a distal end (42) that extends through the transition portion such that the windings are not available for engaging or receiving tissue as the space within the winding is occupied by the distal end (42) of the actuation member and filled with an adhesive (44).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the adhesive attachment disclosed in Saadat et al (0162]) to the adhesive attachment as taught by McPherson, wherein the distal end of the actuation member extends through and into the transition portion of the tissue-engaging helical coil member such that the windings of the transition portion are not available for engaging or receiving tissue, to increase the surface area of adhesion between the helical coil member and the flexible actuation member for an improved securement. In other words, extending the distal end of the actuation member through and into the transition portion of the coil member for fastening increases the surface area for attachment as opposed to, for example, when only the proximal face of the most proximal coil is fastened to the distal face of the flexible actuation member.
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Claim 2. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses windings of a distal portion of the tissue-engaging helical coil member distal to the transition portion have a constant pitch (Figs. 4A, 4B).
Claim 3. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses the tissue-engaging helical coil member ends in a sharpened distal tip (Figs. 4A, 4B).
Claim 4. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses the plurality of windings of the tissue-engaging helical coil member includes open distal windings (see annotated figure from claim 1).
Claim 9. Saadat et al discloses a tissue-grasping instrument configured for insertion through an instrument channel of an endoscope ([0011], [0135]; an example of an endoscope shown in Fig. 67A), the tissue-grasping instrument comprising:
a flexible tubular member (12) having a proximal end (end closer to user) and a distal end (end closer to treatment site) and defining a lumen extending between the proximal end and the distal end ([0139], [0140]);
a flexible actuation member (28) extending through the flexible tubular member lumen and having a proximal end and a distal end (Figs. 1-2); and
a tissue-engaging helical coil member (30) coupled to the distal end of the flexible actuation member and including a plurality of windings including a transition portion (see annotated figure from claim 1) having a non-constant pitch (Figs. 4A, 4B; [0141], [0143], [0162], [0163]);
wherein: the flexible tubular member and the flexible actuation member are sufficiently flexible for being advance through a curved passage (Fig. 67A illustrates the curvature the instrument may take on; [0139]).
Saadat discloses the flexible actuation member (28) may be fastened to the helical coil member (30) through any suitable fastening method, such as adhesives, solder, etc. ([0162]). However, Saadat et al fails to illustrate the fastening method or details of the attachment and therefore fails to disclose the distal end of the flexible actuation member (28) extends through and into the transition portion of the tissue-engaging helical coil member (30) such that the windings of the transition portion are not available for engaging or receiving tissue.
However, in a similar field of endeavor of a tissue-grasping instrument, McPherson teaches a helical coil (30) for grasping onto tissue, wherein an actuation member (38) is attached to the helical coil by extending through the transition portion of the plurality of windings and fastened thereto using an adhesive (44) (see annotated figures from claim 1; wherein the annotated transition portion of McPherson is equivalent to the transition portion of Saadat et al as the interpretated transition portion of Saadat is up to the first open coil; similarly, the transition portion of McPherson is up to the first open coil). The actuation member includes a distal end (42) that extends through the transition portion such that the windings are not available for engaging or receiving tissue as the space within the winding is occupied by the distal end (42) of the actuation member and filled with an adhesive (44).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the adhesive attachment disclosed in Saadat et al (0162]) to the adhesive attachment as taught by McPherson, wherein the distal end of the actuation member extends through and into the transition portion of the tissue-engaging helical coil member such that the windings of the transition portion are not available for engaging or receiving tissue, to increase the surface area of adhesion between the helical coil member and the flexible actuation member for an improved securement. In other words, extending the distal end of the actuation member through and into the transition portion of the coil member for fastening increases the surface area for attachment as opposed to, for example, when only the proximal face of the most proximal coil is fastened to the distal face of the flexible actuation member.
Claim 10. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses windings of a distal portion of the tissue-engaging helical coil member distal to the transition portion have a constant pitch (Figs. 4A, 4B).
Claim 11. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses the tissue-engaging helical coil member ends in a sharpened distal tip (Figs. 4A, 4B).
Claim 12. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses the plurality of windings of the tissue-engaging helical coil member includes open distal windings (see annotated figure from claim 1).
Claim 16. Saadat et al discloses an endoscopic tissue suturing system ([0011], [0135]; an example of an endoscope shown in Fig. 67A) comprising:
an endoscopic suturing device (18) configured to translate a needle (48) through tissue to pull a suture (76) through the tissue (Figs. 2A-2D, 3A-3B; [0147]-[0149]); and
a tissue-grasping instrument comprising:
a flexible tubular member (12) having a proximal end (end closer to user) and a distal end (end closer to treatment site) and defining a lumen extending between the proximal end and the distal end ([0139], [0140]);
a flexible actuation member (28) extending through the flexible tubular member lumen and having a proximal end and a distal end (Figs. 1-2); and
a tissue-engaging helical coil member (30) coupled to the distal end of the flexible actuation member and including a plurality of windings including a transition portion (see annotated figure from claim 1) having a non-constant pitch (Figs. 4A, 4B; [0141], [0143], [0162], [0163]);
wherein: the flexible tubular member and the flexible actuation member are sufficiently flexible for being advance through a curved passage (Fig. 67A illustrates the curvature the instrument may take on; [0139]).
Saadat discloses the flexible actuation member (28) may be fastened to the helical coil member (30) through any suitable fastening method, such as adhesives, solder, etc. ([0162]). However, Saadat et al fails to illustrate the fastening method or details of the attachment and therefore fails to disclose the distal end of the flexible actuation member (28) extends through and into the transition portion of the tissue-engaging helical coil member (30) such that the windings of the transition portion are not available for engaging or receiving tissue.
However, in a similar field of endeavor of a tissue-grasping instrument, McPherson teaches a helical coil (30) for grasping onto tissue, wherein an actuation member (38) is attached to the helical coil by extending through the transition portion of the plurality of windings and fastened thereto using an adhesive (44) (see annotated figures from claim 1; wherein the annotated transition portion of McPherson is equivalent to the transition portion of Saadat et al as the interpretated transition portion of Saadat is up to the first open coil; similarly, the transition portion of McPherson is up to the first open coil). The actuation member includes a distal end (42) that extends through the transition portion such that the windings are not available for engaging or receiving tissue as the space within the winding is occupied by the distal end (42) of the actuation member and filled with an adhesive (44).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the adhesive attachment disclosed in Saadat et al (0162]) to the adhesive attachment as taught by McPherson, wherein the distal end of the actuation member extends through and into the transition portion of the tissue-engaging helical coil member such that the windings of the transition portion are not available for engaging or receiving tissue, to increase the surface area of adhesion between the helical coil member and the flexible actuation member for an improved securement. In other words, extending the distal end of the actuation member through and into the transition portion of the coil member for fastening increases the surface area for attachment as opposed to, for example, when only the proximal face of the most proximal coil is fastened to the distal face of the flexible actuation member.
Claim 17. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses windings of a distal portion of the tissue-engaging helical coil member distal to the transition portion have a constant pitch (Figs. 4A, 4B).
Claim 18. The tissue-grasping instrument of claim 16, wherein the tissue-engaging helical coil member ends in a sharpened distal tip (Figs. 4A, 4B) to engage tissue to be able to bring the tissue into the path of the needle of the endoscopic suturing device (Figs. 2A-2D, 3A-3B; [0147]-[0149])
Claim 19. The combination discloses the invention substantially as claimed above, wherein Saadat et al discloses the plurality of windings of the tissue-engaging helical coil member includes open distal windings (see annotated figure from claim 1).
Allowable Subject Matter
Claims 5, 6, 13, 14 and 20 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: In regards to dependent claims 5, 13 and 20, the closest prior art of record, Saadat et al in view of McPherson et al, discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed tissue-grasping instrument comprising, inter alia, the plurality of windings of the tissue-engaging helical coil member includes open distal windings and proximal closed windings, with the transition portion positioned between the open distal windings and the proximal closed windings. Instead, as annotated above, the helical coil terminates proximally in the non-constant pitch transition portion. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Wilson et al (US 6544195) teaches extending a distal end of an actuation member through a proximal and middle portion of a helical coil member which results in the proximal and middle portion being unavailable for engaging or receiving tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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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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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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