DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Advisory Notice
The examiner of the Application has changed. Please direct your correspondence to the Examiner whose information is set forth below.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-13 and 17-20 in the reply filed on 20 January 2026 is acknowledged.
Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 20 January 2026.
Formal Matters
Claims 1-20 are pending. Claims 14-16 are withdrawn without traverse. Claims 1-13 and 17-20 are under examination.
Benefit
The application claims benefit as a Continuation to 16/949,579 (11/4/2020) issued as US 12,097,106, which claims benefit as a Continuation to 15/967,004 (4/30/2018) issued as US 10,856,959, which claims benefit as a Continuation to 14/707,554 (5/8/2015) issued as US 9,974,637, which claims benefit as a Continuation to 12/623,857 (11/23/2009) issued as US 9,028,509, which claims benefit to US Provisional Application 61/193,542 (12/5/2008).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/20/2024 (3x) and 11/4/2025 has been considered by the examiner. Signed copies are attached.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Non-Statutory Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
These are non-provisional obviousness-type double patenting rejections. Terminal Disclaimers may be filed in order to overcome the rejections, but they must be accompanied with a reply requesting reconsideration of the prior Office action.
Claims 1, 2, and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No.9,028,509.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘509 patent overlap with the claims of the application as shown in the comparison chart below. For example, claim 1 of the ‘509 patent anticipates all of the limitations of claim 1 of the application. The underlined portion of claim 1 of the ‘509 patent in the chart shows a species of location between the first ridge and the second ridge anticipates the generic recitation of the distal end portion (of the stylet) in claim 1 of the application (emphasized for ease of comparison). Claims 2 of the ‘509 patent anticipates claim 2 of the application. Portions of claim 1 of the ‘509 patent anticipate claim 6 of the application as indicated below. Accordingly, a Terminal Disclaimer is required to overcome the rejection.
Patent 9,028,509
Application 18/809753
1. An apparatus, comprising: an elongate member having a proximal end portion, a distal end portion, and defining a lumen therethrough; a base portion coupled to the proximal end portion of the elongate member, the base portion defining a lumen; a tissue anchor having a length, the tissue anchor defining a lumen; a stylet having a distal end portion, a proximal end portion, and being slidably coupled to the elongate member, the stylet being configured to move from a first position to a second position with respect to the elongate member, the distal end portion of the stylet having a first ridge extending radially from and at an angle with respect to a longitudinal axis of the stylet, the distal end portion of the stylet having a second ridge extending radially from and at an angle with respect to the longitudinal axis of the stylet, the distal end portion of the stylet being configured to removably couple the tissue anchor between the first ridge and the second ridge such that the distal end portion of the stylet extends through the lumen of the tissue anchor, the first ridge being distally disposed a distance from the second ridge, the distance being greater than the length of the tissue anchor, a portion of the stylet between the first ridge and the second ridge being disposed outside of the lumen of the elongate member when the stylet is in its first position, the portion of the stylet being disposed within the lumen when the stylet is in its second position, the distal end portion of the stylet includes a tip and a tapered portion extending between the first ridge and the tip; and a handle coupled to the stylet, the proximal end portion of the stylet being slidable within the lumen of the base portion.
1. An insertion device, comprising: an elongate member having a proximal end portion, a distal end portion, and defining a lumen therethrough; and a stylet having a distal end portion, a proximal end portion, and being slidably coupled to the elongate member, the stylet being configured to move from a first position to a second position with respect to the elongate member, the distal end portion of the stylet being configured to removably couple a tissue anchor thereto, a portion of the distal end portion of the stylet being disposed outside of the lumen of the elongate member when the stylet is in its first position, the portion of the stylet being disposed within the lumen when the stylet is in its second position.
2. The apparatus of claim 1, wherein the stylet includes a curved portion.
2. The insertion device of claim 1, wherein the stylet includes a curved portion.
1. (from above) the distal end portion of the stylet extends through the lumen of the tissue anchor,
6. The insertion device of claim 1, wherein the distal end portion of the stylet is configured to extend through a lumen defined by the tissue anchor.
Claims 1-3, 5, 6, and 8-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-10 of U.S. Patent No. 10,856,959.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘959 patent overlap with the claims of the application as shown in the comparison chart below. For example, claim 1 of the ‘959 patent anticipates all of the limitations of claim 1 of the application. Claim 5 of the application is anticipated by portions of claim 1 of the ‘959 patent not otherwise already provided in claim 1 of the application. Claims 2 and 3 of the ‘959 patent anticipate claims 2 and 3 of the application. Claim 5 of the ‘959 patent anticipates claim 6 of the application. Claim 7 of the ‘959 patent anticipates claim 9 of the application. Claim 8 of the ‘959 patent anticipates claim 10 of the application. Claim 9 of the ‘959 patent anticipates claim 11 of the application. Claim 10 of the ‘959 patent anticipates claims 12 and 13 of the application. Accordingly, a Terminal Disclaimer is required to overcome the rejection.
Patent 10,856,959
Application 18/809753
1. An insertion device, comprising: an elongate member having a proximal end portion, a distal end portion, and defining a lumen therethrough; and a stylet having a distal end portion, a proximal end portion, and being slidably coupled to the elongate member, the stylet being configured to move from a first position to a second position with respect to the elongate member, the distal end portion of the stylet being configured to removably couple a tissue anchor thereto, the distal end portion of the stylet defines a ridge configured to be disposed outside of and contact an exterior surface of a distal end portion of the tissue anchor, a portion of the distal end portion of the stylet being disposed outside of the lumen of the elongate member when the stylet is in its first position, the portion of the distal end portion of the stylet being disposed within the lumen when the stylet is in its second position.
1. An insertion device, comprising: an elongate member having a proximal end portion, a distal end portion, and defining a lumen therethrough; and a stylet having a distal end portion, a proximal end portion, and being slidably coupled to the elongate member, the stylet being configured to move from a first position to a second position with respect to the elongate member, the distal end portion of the stylet being configured to removably couple a tissue anchor thereto, a portion of the distal end portion of the stylet being disposed outside of the lumen of the elongate member when the stylet is in its first position, the portion of the stylet being disposed within the lumen when the stylet is in its second position.
2. The insertion device of claim 1, wherein the stylet includes a curved portion.
2. The insertion device of claim 1, wherein the stylet includes a curved portion.
3. The insertion device of claim 1, wherein the distal end portion of the stylet has a first diameter and the proximal end portion of the stylet has a second diameter, wherein the second diameter is greater than the first diameter.
3. The insertion device of claim 1, wherein the distal end portion of the stylet has a first diameter and the proximal end portion of the stylet has a second diameter, wherein the second diameter is greater than the first diameter.
1. (from above) the distal end portion of the stylet defines a ridge configured to be disposed outside of and contact an exterior surface of a distal end portion of the tissue anchor,
5. The insertion device of claim 1, wherein the distal end portion of the stylet defines a ridge configured to be disposed outside of and contact a distal end portion of the tissue anchor.
5. The insertion device of claim 1, wherein the distal end portion of the stylet is configured to extend through a lumen defined by the tissue anchor.
6. The insertion device of claim 1, wherein the distal end portion of the stylet is configured to extend through a lumen defined by the tissue anchor.
6. The insertion device of claim 1, wherein the proximal end portion of the elongate member includes a base portion having at least one protrusion, the proximal end of the stylet having a stopping portion configured to engage the at least one protrusion of the base portion.
8. The insertion device of claim 1, wherein the proximal end portion of the elongate member includes a base portion having at least one protrusion, the proximal end of the stylet having a stopping portion configured to engage the at least one protrusion of the base portion.
7. The insertion device of claim 1, wherein the proximal end portion of the stylet includes a stopping portion having lip, the lip configured to engage a protrusion of the elongate member when the stylet is moved from its first position to its second position.
9. The insertion device of claim 1, wherein the proximal end portion of the stylet includes a stopping portion having lip, the lip configured to engage a protrusion of the elongate member when the stylet is moved from its first position to its second position.
8. The insertion device of claim 1, wherein the distal end portion of the elongate member is configured to contact the tissue anchor when the stylet is moved from its first position to its second position.
10. The insertion device of claim 1, wherein the distal end portion of the elongate member is configured to contact the tissue anchor when the stylet is moved from its first position to its second position.
9. The insertion device of claim 1, wherein the distal end portion of the elongate member is configured to contact a proximal end portion of the tissue anchor to decouple the tissue anchor from the stylet when the stylet is moved from its first position to its second position.
11. The insertion device of claim 1, wherein the distal end portion of the elongate member is configured to contact a proximal end portion of the tissue anchor to decouple the tissue anchor from the stylet when the stylet is moved from its first position to its second position.
10. An insertion device comprising: an elongate member having a proximal end portion, a distal end portion, and defining a lumen therethrough; a stylet having a distal end portion and a proximal end portion, and being configured to move from a first position to a second position, the distal end portion being configured to removably couple a tissue anchor thereto, the distal end portion being coupled to the tissue anchor when the stylet is in its first position, the elongate member being configured to contact the tissue anchor and decouple the tissue anchor from the distal end portion of the stylet when the stylet is moved from its first position to its second position, the distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip, the ridge being configured to interact with the tissue anchor.
12. An insertion device comprising: an elongate member having a proximal end portion, a distal end portion, and defining a lumen therethrough; a stylet having a distal end portion and a proximal end portion, and being configured to move from a first position to a second position, the distal end portion being configured to removably couple a tissue anchor thereto, the distal end portion being coupled to the tissue anchor when the stylet is in its first position, the elongate member being configured to contact the tissue anchor and decouple the tissue anchor from the distal end portion of the stylet when the stylet is moved from its first position to its second position.
10. (from above) the distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip, the ridge being configured to interact with the tissue anchor.
13. The insertion device of claim 12, wherein the distal end portion of the stylet defines a ridge, a tip, and a tapered portion extending between the ridge and the tip, the ridge being configured to interact with the tissue anchor.
Claims 17 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,974,637.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘959 patent overlap with the claims of the application as shown in the comparison chart below. For example, claim 1 of the application is fully disclosed and anticipated by claim 1 of the ‘637. Claim 2 of the ‘637 patent is the same as claim 18 of the application. Accordingly, a Terminal Disclaimer is required to overcome the rejection.
Patent 9,974,637
Application 18/809753
1. A method, comprising: coupling a tissue anchor to a distal end portion of a stylet of an insertion device, the distal end portion of a stylet including a first ridge and a second ridge, the tissue anchor defining a lumen, a portion of the stylet being disposed within the lumen of the tissue anchor between the first ridge and the second ridge, the stylet being movably coupled to an elongate member, the stylet including a proximal end portion having an engagement member, the elongate member including a proximal end portion and a distal end portion, the proximal end portion of the elongate member including a base member, the base member including an engagement member; inserting the insertion device into a body of a patient; moving the stylet with respect to the elongate member from a first position to a second position in a proximal direction to decouple the tissue anchor from the stylet of the insertion device, the engagement member on the proximal end portion of the stylet contacting the engagement member on the base member of the elongate member in response to the stylet being in the second position to assist with preventing further movement in the proximal direction; and removing the insertion device from the body.
17. A method, comprising: coupling a tissue anchor to a distal end portion of a stylet of an insertion device, the stylet being movably coupled to an elongate member; inserting the insertion device into a body of a patient; moving the stylet with respect to the elongate member from a first position to a second position to decouple the tissue anchor from the stylet of the insertion device; and removing the insertion device from the body.
2. The method of claim 1, wherein the coupling of the tissue anchor includes moving the stylet to the first position such that the distal end portion of the stylet extends beyond the distal end portion of the elongate member.
18. The method of claim 17, wherein the coupling of the tissue anchor includes moving the stylet to its first position such that a distal end portion of the stylet extends beyond a distal end portion of the elongate member.
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.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 1-13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bonutti, US 20020193830 (19 December 2002).
Regarding claim 1, Bonutti teaches an insertion device (FIGs 1-4), comprising:
an elongate member (94) having a proximal end portion, a distal end portion, and defining a lumen therethrough (FIGs 1, 2); and
a stylet (92) having a distal end portion (76), a proximal end portion (22), and being slidably coupled to the elongate member (94) (FIG 2; ¶76),
the stylet (92) being configured to move from a first position to a second position with respect to the elongate member (94) (¶78, retracted and extended positions),
the distal end portion (76) of the stylet (92) being configured to removably couple a tissue anchor (30) thereto (¶76),
a portion of the distal end portion (76) of the stylet (92) being disposed outside of the lumen of the elongate member (94) when the stylet is in its first position (FIG 2),
the portion of the stylet (92) being disposed within the lumen when the stylet is in its second position (FIG 4).
Regarding claim 2, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the stylet (92) includes a curved portion (FIG 3).
Regarding claim 3, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (76) of the stylet (92) has a first diameter and the proximal end portion of the stylet (92) has a second diameter, wherein the second diameter is greater than the first diameter (FIG 2, point 76 of stylet 92 has a first diameter at the distal end and a second diameter at the proximal end that is greater than the first diameter; point 76 is conical in shape).
Regarding claim 4, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (76) of the stylet (92) defines a ridge (proximal end groove 106), a tip (point at distal end 76), and a tapered portion extending between the ridge and the tip (FIG 2, slope 80), the ridge being configured to interact with the tissue anchor (30) (¶91).
Regarding claim 5, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (76) of the stylet (92) defines a ridge (slope 80) configured to be disposed outside of and contact a distal end portion of the tissue anchor (30) (¶66).
Regarding claim 6, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (76) of the stylet (92) is configured to extend through a lumen defined by the tissue anchor (FIG 2; ¶66).
Regarding claim 7, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (76) of the stylet (92) is configured to extend outside of a distal end portion of the tissue anchor (30) (FIG 4).
Regarding claim 8, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the proximal end portion (handle 22) of the elongate member (94) includes a base portion (110, ¶81) having at least one protrusion (FIG 1, knob 112; ¶81), the proximal end of the stylet (92) having a stopping portion (FIG 1, ¶¶81, 86) configured to engage the at least one protrusion (112) of the base portion (¶81).
Regarding claim 9, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the proximal end portion (handle 22) of the stylet (92) includes a stopping portion (FIG 1, ¶¶81, 86) having lip (¶72, circumferentially extending grooves to facilitate firm gripping of the handle), the lip configured to engage a protrusion (24) of the elongate member (94) when the stylet (92) is moved from its first position to its second position (FIG 4; ¶78).
Regarding claim 10, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (pusher surface 98) of the elongate member (94) is configured to contact the tissue anchor (30) when the stylet is moved from its first position to its second position (FIG 4; ¶¶78, 80).
Regarding claim 11, Bonutti teaches the insertion device of claim 1, as set forth above, wherein the distal end portion (98) of the elongate member (94) is configured to contact a proximal end portion of the tissue anchor (FIG 4, trailing end surface 42, ¶56) to decouple the tissue anchor from the stylet (92) when the stylet is moved from its first position to its second position (FIG 4; ¶83).
Regarding independent claim 12, Bonutti teaches an insertion device (FIGs 1-4), comprising:
an elongate member (94) having a proximal end portion, a distal end portion, and defining a lumen therethrough (FIGs 1, 2); and
a stylet (92) having a distal end portion (76) and a proximal end portion (FIG 2), and being configured to move from a first position to a second position (¶78, retracted and extended positions),
the distal end portion (76) being configured to removably couple a tissue anchor (30) thereto (¶76),
the distal end portion (76) being coupled to the tissue anchor (30) when the stylet (92) is in its first position (FIG 2),
the elongate member (94) being configured to contact the tissue anchor (30) and decouple the tissue anchor (30) from the distal end portion (76) of the stylet (92) when the stylet (92) is moved from its first position to its second position (¶83).
Regarding claim 13, Bonutti teaches the insertion device of claim 12, as set forth above, wherein the distal end portion (76) of the stylet (92) defines a ridge (proximal end groove 106), a tip (point at distal end 76), and a tapered portion extending between the ridge and the tip (FIG 2, slope 80), the ridge being configured to interact with the tissue anchor (30) (¶91).
Claims 17, 18, and 20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Benderev, US 7,387,634 (17 June 2008).
Regarding independent claim 17, Benderev teaches a method (FIGs 20A-C, 21; col 16, line 42 to col 18, line 7), comprising:
coupling a tissue anchor (808a, FIG 20A) to a distal end portion of a stylet (816, FIG 20) of an insertion device (804, FIG 20B), the stylet being movably coupled to an elongate member (818, FIG 20); inserting the insertion device into a body of a patient (within 820, FIG 21); moving the stylet with respect to the elongate member from a first position to a second position to decouple the tissue anchor from the stylet of the insertion device (col 17, lines 51-67) and removing the insertion device from the body (FIG 21; col 18, lines 1-7).
Regarding claim 18, Benderev teaches the method of claim 17, as set forth above, wherein the coupling of the tissue anchor (808a) includes moving the stylet (816) to its first position such that a distal end portion of the stylet (816) extends beyond a distal end portion of the elongate member (818) (col 16, lines 49-60).
Regarding claim 20, Benderev teaches the method of claim 17, as set forth above, wherein the moving of the stylet (816) to its second position includes moving the stylet in a distal direction (col 17, lines 51-58).
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.
Claim 19 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Benderev, US 7,387,634 (17 June 2008) in view of Hart et al., US 8,192,458 (5 June 2012).
Regarding claim 19, Benderev teaches the method of claim 17, as set forth above, wherein the coupling of the tissue anchor (808a) includes inserting the stylet (816) into a lumen defined by the tissue anchor (808a, a hole at the proximal end of the anchor).
Benderev does not specifically teach that a ridge defined by the distal end of the stylet interacts with the tissue anchor.
Hart teaches a stylet (80, FIG 4) of an insertion device (75, FIG 7) wherein the distal end of the stylet defines a ridge (tool shoulder 115, FIGs 4, 7) interacting with tissue anchor (5, FIG 1) (FIG 10-12; col 6, line 65 to col 7, line 15).
Benderev and Hart both teach stylets as surgical deployment mechanisms. Although, Benderev discloses the claimed method of using a stylet, Benderev does not expressly disclose that that a ridge defined by the distal end of the stylet interacts with the tissue anchor. Hart specifically addresses the ridge stating that the surgical fastener (5) and the installation tool (75) are sized so that when the surgical fastener’s proximal end surface (35) engages the installation tool’s shoulder (115), the surgical fastener’s distal end surface (30) will sit completely within the inserter’s bore (120) withdrawn from the installation tool’s sharp point.” Hart explains that “this construction ensures that surgical fastener (5) can enter and exit the inserter’s recess 105 only via the distal end of the recess, adjacent to the tool’s sharp point 100.” (col 6, line 65 to col 7, line 10). Because Benderev discloses that “actuator 814, and more particularly the shaft 816 thereof may be selectively coupled to an anchor mechanism such as 808a depicted in FIG 20 to thus direct and position the anchor mechanism 808a at a target site within the body and that deployment member 818 may be configured to have a variety of sizes and shapes, and may be specifically configured for deployment of an implant 802 at a particular target site within the body,” (col 16, lines 51-64) a person of ordinary skill in the art, seeking to insure fit compliance and ease of insertion of the surgical fastener would reasonably consult Hart’s ridge solution. Hart’s ridge can be incorporated alongside Benderev’s stylet using known assembly methods without redesigning Benderev’s stylet or method of delivery. Because the references address the same engineering problem (successful delivery of surgical fasteners via a stylet insertion device) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a ridge to the distal end of the stylet), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Walshe, US 7,056,333 (6 June 2006) teaches a tissue anchor system.
Sharpe et al., US 5,433,722 (18 July 1995) teaches a ligature carrier for endoscopic use.
Zaddem, et al., US 7,527,588 (5 May 2009) teaches a system and method for surgical implant placement.
Knapp, et al., teach US 8,480,559 (9 July 2013, benefit to 20 March 2008) teaches a urethral support system.
Hamel et al., US 8,944,990 (3 February 2015, benefit to 9 April 2007) teaches surgical needle and anchor system with retractable features.
Ostrovsky, US 9,301,750 (5 April 2016, with benefit to 3 November 2009) teaches device and methods for delivery of mesh-based devices.
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771