DETAILED ACTION
This Office Action is in response to Applicant’s amendment filed 8 September 2025.
Notice of 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 .
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 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.
Response to Arguments
Claim 1
Applicant argues the amendment to claim 1 overcomes the 35 USC 102 rejection under Flagg’330 because Flagg’330 does not disclose the suture thread extends at last to the suture thread viewing port, as required amended claim 1. This argument is persuasive because Flagg’330’s viewing port has a catch 11 intended to engage with abutment 8 on the proximal end of the needle. If suture 1 extended to the catch 11, it would interfere with the engagement between the abutment 8 and catch 11. The rejection to claim 1 under Flagg’330 is withdrawn.
Applicant argues the amendment to claim 1 overcomes the 35 USC 102 rejection under Cichocki’375 because Cichocki’375 fails to disclose “a needle body having…a proximal end including a suture thread viewing port”, as required by amended claim 1. This argument is persuasive because Cichocki’375 does not teach a suture thread viewing port. However, upon further consideration, a new rejection under 35 USC 103 under Cichocki’375 in view of Grainger358 follows below.
Applicant argues the amendment to claim 1 overcomes the 35 USC 103 rejection under DE’153 in view of Grainger’358 because DE’153’s element 19, identified as the thread attachment component, is not hollow, because there space between the lug 14 and lug 17 is filled with plastic. Under broadest reasonable interpretation, the term “hollow” is interpreted to mean “having an unfilled or hollowed out space within” (Merriam Webster Online). DE’153’s element 19 is hollow because the ends which receive lugs 14, 17 are unfilled when the lugs are not attached creating a hollow structure The existence of plastic in the area between lugs 14, 17 does not preclude element 19 from being considered hollow.
Applicant argues DE’153 in view of Grainger’358 does not teach a “suture thread viewing port”, as recited by claim 1, because Grainger’358’s lance member 23, which forms the viewing port, does not allow viewing of the suture thread until it is bent inward to compress and capture the suture thread. Applicant argues this would undermine the benefit of the viewing port, which is to visualize the suture prior to attachment to the needle. This argument is not persuasive. MPEP 2144 Section IV states “It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” In this case, providing DE’153 with the viewing port (and lance 23) taught by Grainger’358 provides the advantage of more secure attachment between the needle and the suture. Because the suture can be viewed through Grainger’358’s port, it renders the claim obvious despite having a different purpose.
Applicant argues there is no reason to combine Grainger’358’s lance member 23 (which creates the claimed viewing port) with DE’153 because it would defeat the design of DE’153, which is to allow detachment of the suture from the needle. This argument is not persuasive because DE’153 teaches the needle is detached from the connecting piece 19 (and therefore the suture, as well). A secure connection between the connector piece 19 and the suture, which is what the modification by Grainger’358 would provide, does not preclude the needle from detaching from the connecting piece 19.
For these reasons, the rejection under DE’153 in view of Grainger’358 is maintained.
Claim 30
Claim 30 requires the limitations of claim 1. Therefore, for the reasons discussed above, the rejection under Flagg’330 in view of Harris’980 is withdrawn. However, upon further consideration, a new rejection der DE’153 in view of Grainger’358 in view of Harris’980 follows below.
Claim 31
Applicant argues the amended to claim 31 reciting a proximal end of the needle body includes a suture thread viewing port overcomes Cichocki’375. This argument is persuasive because Cichocki’375 does not teach a viewing port. However, upon further consideration, a new rejection under DE’375 in view of Grainger’358 follows below.
Claim 32
Applicant argues the amendment to claim 32 overcomes the 35 USC 103 rejection under Cichocki’375 because Cichocki’375 does not describe “a hollow, elongated, flexible, metal or metallic component”, as required by amended claim 32. Under broadest reasonable interpretation, the term “hollow” is interpreted to mean “having an unfilled or hollowed out space within” (Merriam Webster Online). DE’153’s element 230 is hollow because element 234 provides a hollowed-out space. The rejection is updated to address the claim amendment but otherwise maintained.
Applicant argues the amendment to claim 32 overcomes the 35 USC 103 rejection under Bach’476 because Bach’476 fails to disclose “a middle portion extending from and exterior to the proximal end of the suturing needle”. This argument is not persuasive because (1) the suturing needle is not a positively recited element in the claim – it is only functionally recited “a distal end configured for coupling to a…needle”; and (2) Bach’476 discloses a needed and the middle portion, as identified below, is exterior to Bach’476’s disclosed needle in Figure 1.
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Claim Objections
Claim 11 is objected to because of the following informalities: Claim 11 recites “the needle body curved.” This appears to be a typographical error and should read “the needle body is curved.” Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 9-11, 22, 23 are rejected under 35 U.S.C. 103 as being unpatentable over DE 3223153 C1 (hereafter “DE’153”) in view of Granger et al. (US Patent 5,116,358).
Claim 1: DE’153 discloses a suturing needle (Figure 1) comprising:
a needle tip portion having a needle tip (tapered tip near 11 in Figure 1) at a distal end for piercing tissue;
a needle body (10) having a distal end connected to a proximal end of the needle tip portion (Figure 1);
a hollow thread attachment component (19) having a distal end (see annotated copy of Figure 2 below) attached to a proximal end (12) of the needle body (10), a hollow extension ramp portion (16) having a distal end (17) and a tapered portion at a proximal end (Figure 2 shows the proximal opening of element 16 is tapered), the distal end of the hollow extension ramp portion attached to a proximal end of the thread attachment component (16 is connected to proximal end of thread attachment component 19); and
a suture thread (13) attached to the thread attachment component (Figure 2).
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DE’153 does not disclose a suture thread viewing port on the connection mechanism.
Like DE’153, Granger’358 teaches a connection mechanism (20) which has a view port (opening formed around 23) in order to provide further securement of the suture to the connector. In order to function as taught by Granger’358, the suture will extend to the view port to allow for the lance 23 to contact the suture.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by DE’153 with a view port, as taught by Granger’358, in order to provide an additional securement of the needle to the connector.
Claim 2: DE’153 teaches the distal end of the hollow extension ramp portion (at 17) has a diameter equal to a diameter of the needle body (at 14). The proximal end of the hollow extension ramp portion has a diameter equal to the diameter of the suture (13) to provide a smooth transition between the from the hollow extension ramp portion to a distal end thereof (Figure 2).
Claim 3: In the combination of DE’153 in view of Granger’358, the thread attachment component (19) is configured for attachment of the suture by swaging when the suture thread is visible through the viewing port (opening around 23 of Granger’358) because DE’153 could be further deformed/swaged to the suture after lance 23 is pushed into suture.
Claim 4, 5: DE’153 does not specifically disclose the suture is monofilament or multi-filament or bioabsorbable.
Monofilament, multi-filament and bioabsorbable sutures are exceedingly well known in the art. For example, like Flagg’330, Granger’358 teaches a mechanism for attaching a suture (30) to a needle (10). Granger’358 teaches the suture attached to the needle can be braided or monofilament and absorbable or non-absorbable (column 5, lines 7-10).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by DE’153 with a different suture, such as a monofilament or braided suture or a bioabsorbable suture, as suggested by Granger’358 because the use of such sutures is well documented in the art as a routine decision made by the surgeon depending on the part of the body being sutured, strength requirements and expected time needed for healing.
Claim 9: DE’153 teaches the needle tip portion is formed become gradually thicker from the needle tip to the proximal end of the needle tip portion (Figure 1).
Claim 10: DE’153 does not specifically teach a straight needle body.
Granger’358 teaches the needle can be curved, like DE’153, or straight (column 5, lines 10-11).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by DE’153 with a straight needle, as suggested by Granger’358, because the use of such suturing needles is well documented in the art as a routine decision made by the surgeon depending on the location and type of tissue being sutured.
Claim 11: DE’153 teaches a curved needle body (Figure 1).
Claim 22: DE’153 further teaches a hollow flexible extension component (the boxed part of element 15/19 in the annotated copy of Figure 2 above; it is flexible because it will have to accommodate 17 and specification indicates it is more flexible than the needle) having a distal end (left side, with respect to the figure) and a proximal end (right side, with respect to the figure). The distal end is attached to the proximal end of the thread attachment component. The proximal end is attached to the distal end of the tapered extension ramp portion (Figure 2).
Claim 23: DE’153 teaches the hollow flexible extension component has a diameter equal to the needle body diameter (Figure 2).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over DE’153 in view of Granger’358, as applied to claim 1, further in view of Leung et al. (US Patent Publication 9,248,580).
Claims 6-8: DE’153 does not teach the sutures thread includes tissue retaining structures.
Providing sutures with tissue retaining structures is exceedingly well known in the art. For example, Leung’580 teaches a suture (S2) attached to a needle (N2) (Figure 13b). Leung’580 teaches providing the suture with tissue retaining structure in the form of barbs (column 28, lines 21-23; Figure 1a shows suture 2 with barbs 7). Leung’580 teaches barbed sutures are advantageous because they only move through tissue in one direction and prevent slipping of the suture out of tissue such that they do not need to be knotted like conventional sutures (column 1, lines 39-50).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by DE’153 with a barbed suture instead of a non-barbed suture, as taught by Leung’580, in order to provide the stated advantages.
Regarding claim 8: Leung’580 at Figure 13b shows that the tissue retaining structures are distal from the portion which is connected to the needle.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention that the barbs taught by Leung’580 are distal from the hollow thread attachment component so that the barbs on the suture do not interfere with the connecting of the suture to the needle.
Claims 12, 13 are rejected under 35 U.S.C. 103 as being unpatentable over DE’153 in view of Granger’358, as applied to claim 1, further in view of Kim (US Patent 5,433,728).
DE’153, as modified, teaches the limitations of claims 12, 13 but does not disclose the needle body has a circular cross-section or a smooth profile.
Smooth, round suturing needles are exceedingly well known in the art. For example, Kim’728 teaches a suturing needle (10) which has a smooth profile and circular cross section (Figure 1 and column 3, lines 50-52) which is adapted to be gripped by a forceps (Figure 3-6).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the needle taught by DE’153 such that the cross-section is circular and the outer surface is smooth, as taught by Kim’728 in order to allow the needle to be gripped by a forceps adapted for gripping round needles and to allow the tissue to move through tissue more easily.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over DE’153 in view of Granger’358 in view of Harris (US Patent Publication 2009/0209980).
Claim 30: DE’153 in view of Granger’358 teaches a suturing needle, as recited in the claim – see the rejection to claim 1 above for details.
DE’153 in view of Granger’358 does not teach how the suture needle is used.
Harris’980 teaches a method of suturing using a roller needle driver that includes:
grasping, between rollers (121a, 121b, 121e, 121f, 121k, 121l) of the roller needle driver (Figure 1), the ramp portion of a needle (Harris’980 teaches needle 11 is connected to a suture at paragraph [0021]; the entire body of the needle 11 is contained with a head section 7 – see Figure 5. Therefore, in the resulting device, at least during use, will require grasping the connection portion between the suture and the needle);
loading the needle (11) so the rollers are positioned on the needle body without opening the rollers (rollers 121a, 121b, 121e, 121f, 121k, 121l do not open);
driving the needle through tissue (paragraph [0037]);
moving the needle through tissue without releasing the needle from tissue (paragraph [0026], [0037], Figure 9);
grasping the needle at an end exiting from the tissue through which the needle was moved (needle exits the head 7 through opening 65, passes through tissue, then enters the head through opening 67 when moving in the direction a1, see Figure 9, as well);
these steps are repeated until the suturing process is complete (paragraph [0037]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use the needle of DE’153 in view of Granger’358 in combination with a suturing instrument as taught by Harris’980 in order to perform a suturing operation in order to allow the surgeon to more quickly and efficiently perform a suturing operation (paragraph [0003], [0004]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over DE’153 in view of Granger’358.
Claim 31: DE’153 discloses a suturing needle (Figure 1) comprising:
a needle tip portion having a needle tip (tapered tip near 11 in Figure 1) at a distal end for piercing tissue;
a needle body (10, 19) having a distal end connected to a proximal end of the needle tip portion (Figure 1);
an extension component (16) having a distal end (17) attached to a proximal end of the needle body (Figure 2), the distal end of the extension component (17) comprising a cross section smaller than a cross section of the proximal end of the needle body (see annotated copy of Figure 2 below), the extension component having a hollow proximal end (Figure 2) ; and
a suture thread (13) positioned in and coupled to the hollow proximal end of the extension component (Figure 2).
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DE’153 does not disclose a suture thread viewing port on the proximal end of the needle body.
DE’153 does not disclose a suture thread viewing port on the connection mechanism.
Like DE’153, Granger’358 teaches a needle (10, 20) which has a view port (opening formed around 23) in order to provide further securement of the suture to the needle.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by DE’153 with a view port, as taught by Granger’358, in order to provide an additional securement of the needle to the suture.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Cichocki’375.
Claim 32: Cichocki’375 discloses a device (230; Figure 9a) comprising:
elongated, flexible, metal or metallic component (230; paragraph [0014] – this element is considered flexible because it is not completely rigid or brittle) comprising:
a distal end (end towards element 236 in Figure 9a) configured for coupling to a hollow proximal end (214) of a suturing needle (202), wherein the distal end (236) comprises a cross section smaller than a cross section of the hollow proximal end of the suturing needle (Figure 9a);
a middle portion (between distal end and proximal end – Figure 9a) extending from and exterior to the proximal end of the suturing needle ; and
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a proximal end (end opposite distal end 236), wherein the middle portion extends between the distal end and the proximal end, wherein the proximal end comprises a hollow portion (234), and wherein the hollow portion is configured for coupling to a suture thread (250 – Figure 9c).
Furthermore, it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Bach (US Patent 877,476).
Bach’476 teaches a device (b) comprising:
elongated, flexible component (b, which is considered flexible because it moves resiliently when inserted into needle a, as described on page 1, lines 72-90; it is hollow because there is a longitudinal passage b’ passing through it ) comprising:
a distal end (towards b4 as shown in Figure 4) configured for coupling to a hollow proximal end (a3) of a suturing needle (a), wherein the distal end (at b3) comprises a cross section smaller than a cross section of the hollow proximal end (a3) of the suturing needle (Figure 1);
a middle portion (between distal end and proximal end – Figure 4) extending from and configured to be exterior to a proximal end of a suture needle (a) ; and
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a proximal end (end opposite distal end b3, b4), wherein the middle portion extends between the distal end and the proximal end, wherein the proximal end comprises a hollow portion (longitudinal passage b1), and wherein the hollow portion is configured for coupling to a suture thread (c).
Bach’476 does not specifically disclose the device (b) is made of metal. However, It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to construct Bach’476’s device (b) of metal because it is deemed to be within the level of ordinary skill in the art to use a known material. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Double Patenting
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The claims of the patent "anticipate" the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claim. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-12, 22-23, 25-28, 30 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 26-38 of copending Application No. 17/945,812. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent "anticipate" the claims of the application.
Specifically, the claims of the ‘454 application are anticipated by the claims of the ‘812 application as outlined in the chart below:
Present claims 17/826,454
Anticipated by claims of 17/945,812
1
1
2
2
3
28
4
29
5
30
6
31
7
32
8
33
9
34
10
35
11
36
12
37
22
1
23
3
25
26
26
27
28
27
30
38
31
4
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 24-29 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY BACHMAN whose telephone number is (571)272-6208. The examiner can normally be reached Monday-Friday 9am-5pm and alternating Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 10 October 2025
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771