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 .
This action is in response to the amendment filed on 03/10/2026. Claims 1-6 and 8-20 are pending. Claims 1 and 17 are independent. Claims 17-20 are withdrawn. Claim 7 is canceled.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 7, the limitation “each have” should be amended to --each has--
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
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) 1-6 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoffman et al. (US Pub. No.: 2008/0071310).
Regarding claims 1-6 and 8-11, Hoffman discloses [claim 1] an implant (800 shown in Figs. 8 and 9 with barbs on the suture rod shown in Fig. 10D and Paras. [0079] and [0113]-[0117]) for closing a tissue opening, the implant comprising: a barbed suture (suture rod connecting 820 and 870, Figs. 8, 9, and 10D) having a first end (distal end of the suture rod, Fig. 8 and 9) and a second end (proximal end of the suture rod, Fig. 8 and 9 and Para. [0012]); a first disc (820, Fig. 8 and 9) statically coupled to the first end of the barbed suture at a center of the first disc; and a second disc (870, Figs. 8 and 9) having a through-hole (a through-hole arranged at the center of 870, Figs. 8 and 9 and Paras. [0079] and [0113]-[0117]; also see other figures, e.g. Figs. 11 and 12) arranged in a center of the second disc, wherein the second disc is moveably coupled to the barbed suture via the through-hole (Figs. 8 and 9 and Paras. [0079] and [0113]-[0117]); wherein the first disc and the second disc each has a convex face and a concave face in a deployment condition (Fig. 9);
[claim 2] wherein the barbed suture has a plurality of barbs (the structural elements / barbs arranged on the suture rod, Fig. 10D) arranged unidirectionally such that the second disc is configured to be advanced in a single direction toward the first disc (Paras. [0079] and [0113]-[0117]);
[claim 3] wherein the first disc and the second disc have a delivery condition and a deployment condition (the first disc and the second disc have a delivery condition and a deployment condition similar to what is shown in Fig. 7, Para. [0113]);
[claim 4] wherein the first disc and the second disc are collapsed or compressed toward a central axis of each respective disc in the delivery condition (Fig. 7 and Para. [0113]) and wherein the first disc and the second disc expand radially outward away from a central axis of each respective disc in the deployment condition (Figs. 8 and 9 and Paras. [0113]-[0117]);
[claim 5] wherein the first disc and the second disc have the same diameter in the deployment condition (Fig. 9);
[claim 6] wherein the diameter of the first disc and the second disc is fully capable to be 0.5 mm to 1 mm larger than a widest point of the tissue opening (he diameter of the first disc and the second disc is fully capable to be 0.5 mm to 1 mm larger than a widest point of the tissue opening depending on the size of the opening because the diameter of first and second disc can be as big as 50 mm or 100 mm, Fig. 9 and Para. [0055]);
[claim 8] wherein the convex face of the first disc is arranged facing the first end of the barbed suture and the concave face of the first disc is arranged facing the second disc, and wherein the convex face of the second disc is arranged facing the second end of the barbed suture and the concave face of the second disc is arranged facing the first disc (Figs. 8, 9, and 10D and Paras. [0079] and [0113]-[0117]);
[claim 9] wherein the first disc, the second disc, and the barbed suture are biodegradable (Paras. [0012], [0053], and [0061]);
[claim 10] wherein the first disc and the second disc are self-expanding such that the first disc and the second disc are outwardly biased towards the deployment condition (Paras. [0112]-[0117], [0056] and [0057] and Figs. 8 and 9); and
[claim 11] wherein the second disc is spaced apart from the first disc along the barbed suture to permit deployment of the first disc on a first side of the tissue opening and deployment of the second disc on the second side of the tissue opening (Figs. 8, 9, and 10D and Paras. [0079] and [0113]-[0117]).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman et al. (US Pub. No.: 2008/0071310) as applied to claim 12 above, and further in view of Fortson et al. (US Pub. No.: 2014/0364900).
Regarding claim 12, Hoffman discloses a surgical system for closing a tissue opening comprising: the implant according to claim 1; and a delivery device (810, Figs. 8 and 9) having an inner diameter (inner diameter of 810, Figs. 8 and 9), and an outer diameter (outer diameter of 810, Figs. 8 and 9); and defining a lumen with a first end having a delivery opening (distal end of 810 with the distal opening, Figs. 8 and 9) and a second end (proximal end of 810), , wherein the implant is disposed in the lumen of the delivery device such that the first disc is arranged adjacent to the delivery opening of the lumen (Fig. 7 and Para. [0113]) and the second disc is arranged in the lumen between the first disc and the second end of the lumen (Fig. 7 and Para. [0113]). However, Hoffman does not disclose that the second end of the lumen is coupled to a force-imparting guide.
Fortson teaches, in the same field of endeavor (implant for closing a tissue opening), a force-imparting guide (1020, Figs. 2A) coupled to a second/proximal end of a lumen of a delivery device (1010, Fig. 3A).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Hoffman to include a force-imparting guide coupled to the second/proximal end of the lumen of the delivery device as taught by Fortson in order to facilitate the delivery of the discs (Fortson, Para. [0043]).
Regarding claim 13, Hoffman discloses when the first disc and the second disc are in a deployment condition, a diameter of each of the first disc and the second disc is larger than the inner diameter of the lumen of the delivery device (Fig. 9);
Regarding claim 14, Hoffman discloses that the inner diameter of the lumen is consistent along a portion of the lumen in which the implant is arranged (Fig. 9), and the inner diameter of the lumen and the diameter of the delivery opening are the same (Fig. 9); and
Regarding claim 15, Hoffman in view of Fortson discloses all the limitations of claim 12 as taught above. Hoffman fails to disclose that the first end of the lumen is taper.
Fortson teaches, in the same field of endeavor (implant for closing a tissue opening), a first/distal end of the lumen of the delivery device is tapered (Fig. 3).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the first/distal end of the lumen of the delivery device of system of Hoffman to be tapered as taught by Fortson in order to facilitate the entry of the delivery device into a body lumen (Fortson, Para. [0041]).
Regarding claim 16, Hoffman discloses that the delivery device comprises a catheter or a cannula (Figs. 8 and 9).
Claim(s) 1-5, 8-13, 15, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fortson et al. (US Pub. No.: 2014/0364900) in view of Hoffman et al. (US Pub. No.: 2008/0071310).
Regarding claims 1-5, 8-13, 15, and 16, Fortson discloses [claim 1] an implant (100, Fig. 1) for closing a tissue opening, the implant comprising: a barbed suture (120, Fig. 1) having a first end and a second end; a first disc (110a, Fig. 1 and Para. [0022]) statically coupled to the first end of the barbed suture at a center of the first disc; and a second disc (110b, Fig. 1) having a through-hole (Fig. 1 and Para. [0022]) arranged in a center of the second disc, wherein the second disc is moveably coupled to the barbed suture via the through-hole (Fig. 1 and Para. [0022]). Fortson further discloses that first disc and the second disc (cap members 101a and 101b) can have other shapes and/or configurations (Para. [0027]). However, Fortson does not explicitly disclose that the first disc and the second disc (cap members 101a and 101b) has a configuration such that each has a convex face and a concave face in a deployment condition.
Hoffman teaches, in the same field of endeavor (an implant for closing a tissue opening), a first disc and a second disc each can have different shapes (flat or umbrella shape, Para. [0064]), such as an umbrella shape, such that each of the first disc and the second disc has a convex face and a concave face in a deployment condition (Para. [0064] and Fig. 9).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the shape of the first disc and the second disc of Fortson to be umbrella shape such that each of the first disc and the second disc has a convex face and a concave face in a deployment condition as taught by Hoffman in order to obtain the advantage of selecting the suitable shape appropriate for sealing the puncture of the opening (Hoffman, Para. [0064]).
[claim 2] wherein the barbed suture has a plurality of barbs (barbs 125, Fig. 1) arranged unidirectionally such that the second disc is configured to be advanced in a single direction toward the first disc (Fig. 1 and Para. [0033]);
[claim 3] wherein the first disc and the second disc have a delivery condition and a deployment condition (Fig. 3A);
[claim 4] wherein the first disc and the second disc are collapsed or compressed toward a central axis (a central radial axis, Fig. 3A) of each respective disc in the delivery condition and wherein the first disc and the second disc expand radially outward away from a central axis of each respective disc in the deployment condition (Fig. 3A);
[claim 5] wherein the first disc and the second disc have the same diameter in the deployment condition (Para. [0029]);
[claim 8] Hoffman discloses the convex face of the first disc is arranged facing the first end of the barbed suture and the concave face of the first disc is arranged facing the second disc, and wherein the convex face of the second disc is arranged facing the second end of the barbed suture and the concave face of the second disc is arranged facing the first disc (Hoffman, Figs. 8, 9, and 10D and Paras. [0079] and [0113]-[0117]);
[claim 9] wherein the first disc, the second disc, and the barbed suture are biodegradable (Paras. [0023] and [0030]);
[claim 10] wherein the first disc and the second disc are self-expanding such that the first disc and the second disc are outwardly biased towards the deployment condition (Paras. [0021] and [0052]);
[claim 11] wherein the second disc is spaced apart from the first disc along the barbed suture to permit deployment of the first disc on a first side of the tissue opening and deployment of the second disc on the second side of the tissue opening (Para. [0033]);
[claim 12] a surgical system (1000, Fig. 3A and Para. [0039]) for closing a tissue opening comprising: the implant according to claim 1 (Para. [0039]); and a delivery device (1010, Fig. 3A) having an inner diameter (Fig. 3A), and an outer diameter (Fig. 3A) and defining a lumen (lumen of 1010, Fig. 3A) with a first end (distal end of the lumen of 1010, Fig. 3A) having a delivery opening (1015, Fig. 3A) a second end (proximal end of the lumen of 1010, Fig. 3A), wherein the implant is disposed in the lumen of the delivery device such that the first disc is arranged adjacent to the delivery opening of the lumen and the second disc is arranged in the lumen between the first disc and the second end of the lumen (Para. [0039] and Fig. 3A), and wherein the second end of the lumen is coupled to a force-imparting guide (1020, Fig. 3A);
[claim 13] when the first disc and the second disc are in a deployment condition, a diameter of each of the first disc and the second disc is larger than the inner diameter of the lumen of the delivery device (Para. [0029]);
[claim 15] wherein the first end of the lumen is tapered (Fig. 3A); and
[claim 16] wherein the delivery device comprises a syringe, a catheter, or a cannula (Fig. 3A).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 and 8-16 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on pages 9-10 of the remarks, the claim objection and the 35 USC 112(b) rejection(s) have been withdrawn in light of the amendment.
In response to the argument(s) on pages 10-13, the rod filament of Hoffman that connects disc members 820 and 870 is a suture. First, it is bendable/flexible as shown from Fig 7 to Fig. 8. Furthermore, the rod is a slender filament as shown in Fig. 7 and 8 and is described that it can have a diameter of 0.01 mm or 0.1 mm (Para. [0082]). Also, it is biocompatible because it is designed to be deployed in the body. As described in Para. [0079] of Hoffman, “at least a portion of the rod may be in a form of a `tie-wrap.` As shown in FIG. 10D, the rod or at least a portion of the rod may have a form of oriented fibers. These beads, fibers or tie-wrap-like elements may be integral with the rod or may be separate structures that are attachable to the rod 100 in a permanent or non-permanent manner.” Applicant should be noted that sutures can be made from wires, such suture wires. More importantly, Hoffman specifically disclose that the “rod” may be “a string” or “a thread” in Para. [0073]. Therefore, the rod extending from the first disc to the second disc and connecting the first disc to the second disc is a barbed suture.
In response to the argument(s) on pages 13 of the remarks, the diameter of the first disc and the second disc of Hoffman is fully capable to be 0.5 mm to 1 mm larger than a widest point of the tissue opening (the diameter of the first disc and the second disc is fully capable to be 0.5 mm to 1 mm larger than a widest point of the tissue opening depending on the size of the opening because the diameter of first and second disc can be as big as 50 mm or 100 mm , Fig. 9 and Para. [0055]). The limitation “wherein the diameter of the first disc and the second disc is configured to be 0.5 mm to 1 mm larger than a widest point of the tissue opening” is a functional limitation or recitation of the intended use. 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.
In response to the argument(s) on pages 13-15 of the remarks, Fortson discloses an implant (100, Fig. 1) for closing a tissue opening, the implant comprising: a barbed suture (120, Fig. 1) having a first end and a second end; a first disc (110a, Fig. 1 and Para. [0022]) statically coupled to the first end of the barbed suture at a center of the first disc; and a second disc (110b, Fig. 1) having a through-hole (Fig. 1 and Para. [0022]) arranged in a center of the second disc, wherein the second disc is moveably coupled to the barbed suture via the through-hole (Fig. 1 and Para. [0022]). Fortson further discloses that first disc and the second disc (cap members 101a and 101b) can have other shapes and/or configurations (Para. [0027]). However, Fortson does not explicitly disclose that the first disc and the second disc (cap members 101a and 101b) has a configuration such that each has a convex face and a concave face in a deployment condition.
Hoffman teaches, in the same field of endeavor (an implant for closing a tissue opening), a first disc and a second disc each can have different shapes (flat or umbrella shape, Para. [0064]), such as an umbrella shape, such that each of the first disc and the second disc has a convex face and a concave face in a deployment condition (Para. [0064] and Fig. 9).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the shape of the first disc and the second disc of Fortson to be umbrella shape such that each of the first disc and the second disc has a convex face and a concave face in a deployment condition as taught by Hoffman in order to obtain the advantage of selecting the suitable shape appropriate for sealing the puncture of the opening (Hoffman, Para. [0064]).
In response to the argument(s) on pages 15-18 of the remarks, Hoffman discloses a surgical system for closing a tissue opening comprising: the implant according to claim 1; and a delivery device (810, Figs. 8 and 9) having an inner diameter (inner diameter of 810, Figs. 8 and 9), and an outer diameter (outer diameter of 810, Figs. 8 and 9); and defining a lumen with a first end having a delivery opening (distal end of 810 with the distal opening, Figs. 8 and 9) and a second end (proximal end of 810), , wherein the implant is disposed in the lumen of the delivery device such that the first disc is arranged adjacent to the delivery opening of the lumen (Fig. 7 and Para. [0113]) and the second disc is arranged in the lumen between the first disc and the second end of the lumen (Fig. 7 and Para. [0113]). However, Hoffman does not disclose that the second end of the lumen is coupled to a force-imparting guide.
Fortson teaches, in the same field of endeavor (implant for closing a tissue opening), a force-imparting guide (1020, Figs. 2A) coupled to a second/proximal end of a lumen of a delivery device (1010, Fig. 3A).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the system of Hoffman to include a force-imparting guide coupled to the second/proximal end of the lumen of the delivery device as taught by Fortson in order to facilitate the delivery of the discs (Fortson, Para. [0043]). The motivation/advantage for modifying the system of Hoffman to include a force-imparting guide coupled to the second/proximal end of the lumen of the delivery device as taught by Fortson is to facilitate the delivery of the discs.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JING RUI OU whose telephone number is (571)270-5036. The examiner can normally be reached M-F 9:00am -5:00pm.
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, Jackie Ho can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JING RUI OU/Primary Examiner, Art Unit 3771
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