DETAILED ACTION
Claim 1 is amended. A complete action on the merits of pending claims 1-10, 12-16, and 18-35 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/24/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/24/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. However, Examiner notes that the IDS was annotated to address some minor discrepancies. Firstly, reference number 19 on the IDS, which corresponds to US 9,675,341 and reference number 31 on the IDS, which corresponds to US 2013/0226233, had typographical errors (typos) in the last name of the Patentee, as such the IDS was annotated to address that issue. Lastly, the Foreign reference numbered 46 on the IDS and corresponds to JP 3140508 had an incorrect publication date listed on the IDS which did not correspond to the publication date in the document provided by Applicant which was 03/05/2001, the IDS was annotated to reflect the correct date.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 11/24/2025 which are now entered.
Claim Rejections - 35 USC § 103
Claim(s) 1-10, 18-24, 26, 31-32, and 34-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGregor (US Patent No. 5683416), in view of Cabezas (US PGPUB No. 20100036415 A1).
Regarding claim 1, McGregor discloses, a taper point surgical needle. McGregor teaches, a needle (Figure 1, needle (10); Col. 3, line 21-22), comprising:
a needle tip portion (Figure 1, tip portion (16); Col. 3, line 22-26) having a needle tip (Figure 4, tip (18)) at a distal end for piercing tissue (Col. 3, line 58-60);
a curved trunk portion (Figure 1, main body portion (14); Col. 3, line 22-26) having a distal end connected to a proximal end of the needle tip portion (As seen in Figures 1 and 4, main body portion (14) does indeed possess a distal end that is connected to a proximal end (Proximal end (35) seen in Figure 4 and disclosed in Col. 3, line 60-62) of tip portion (16));
a thread attachment portion (Figure 1, hole (20)) connected to a proximal end of the trunk portion (As seen in Figure 1, hole (20) is indeed connected to the proximal end of main body portion (14)) for connecting a suturing thread (Figure 1, suture (22)) (Col. 3, line 27-33);
a suture thread (Figure 1, suture (22)) connected to the thread attachment portion (Col. 3, line 27-33); and
a tapered transition portion (Figure 1, suture mounting portion (12)) providing a taper from the curved trunk portion (main body portion (14)) and past the thread attachment portion (hole (20)) to the suture thread (suture (22)) (Col. 3, line 31-33, discloses, “A suture (22) is inserted at one end portion into hole (20) and then the suture mounting portion (12) is deformed or compressed to hold the suture (22).” Where as seen in Figure 1, once mounting portion (12) is deformed or compressed it does indeed provide a taper from main body portion (14) and past hole (20) seeing as how Col 3, line 29-31, discloses, “The length of the suture mounting portion (12) is generally equal to or slightly greater than the length of the hole (20).” Further, the compression of the suture mounting portion (12) around the suture (22) creates a direct interface and transition to the attached thread), the tapered transition portion extending from the proximal end of the curved trunk portion and over the thread attachment portion and at least a portion of the suture thread (As seen in Figure 1, suture mounting portion (12) is indeed extending from the proximal end of the main body portion (14) and over hole (20) and a portion of suture (22) located inside hole (20)), and configured to provide a gradual transition from a first diameter about equal to a diameter of the suture thread to a second diameter about equal to a diameter of the curved trunk portion (Col. 3, line 31-33, discloses, “A suture (22) is inserted at one end portion into hole (20) and then the suture mounting portion (12) is deformed or compressed to hold the suture (22).” Where to hold the suture (22) as seen in Figure 1 by simply compressing suture mounting portion (12) involves that suture mounting portion (12) have a diameter about equal to a diameter of the suture (22). Further, as seen in Figure 1, suture mounting portion (12) at its distal end, where it meets main body portion (14), does indeed have a diameter about equal to a diameter of the main body portion (14), where Col. 3, line 24-25, “a contiguous main body portion 14 having a generally uniform cross-sectional area throughout an entire length thereof”. Thus, there is indeed a transition from a first diameter about equal to a diameter of the suture thread (suture (22)) to a second diameter about equal to a diameter of the curved trunk portion (main body portion (14)) and where indeed that transition is gradual given that the term "gradual" is considered an inherent or obvious characteristic of a functional taper designed for surgical use, which seeks to minimize force and tissue trauma, a goal explicitly discussed in the background of McGregor (Col. 1, line 30-35)), and
wherein the needle tip portion (tip portion (16)) is formed to become gradually thicker from the needle tip (tip (18)) to the proximal end thereof (Figure 4; Col. 3, line 52-67).
McGregor fails to teach, wherein the curved trunk portion is formed to have a shaped cross-section having a non-smooth profile.
Cabezas discloses, a needle for use during surgical procedures including a reduced surface area to facilitate advancement of the needle through tissue. Cabezas teaches, the curved trunk portion (Figure 1, shaft (206); Paragraph [0027]) is formed to have a shaped cross-section having a non-smooth profile (Figure 2; Paragraphs [0029]-[0032]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the needle of McGregor such that the outer surface of the curved trunk portion includes topographical variation as taught by Cabezas allowing the curved trunk portion to have a shaped cross-section having a non-smooth profile, as both references and the claimed invention are directed to surgical needles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of McGregor such that the outer surface of the curved trunk portion includes topographical variation as taught by Cabezas allowing the curved trunk portion to have a shaped cross-section having a non-smooth profile, as such a modification would have been predictable, namely, to decrease the surface area of the needle that is in contact with tissue during use. Thus, by decreasing the surface area of the needle that is in contact with tissue, the topographical variations reduce the force necessary to advance the needle, and facilitate the atraumatic insertion and removal thereof (Paragraph [0029] of Cabezas).
Regarding claim 2, modified McGregor teaches, wherein the non-smooth profile (Figure 2 of Cabezas) comprises a plurality of equally spaced indentations (Figure 2 of Cabezas, protrusions (214); Paragraph [0030]) extending longitudinally along a portion of the length of the curved trunk portion (Figure 1 of Cabezas; Paragraphs [0031]-[0032]).
Regarding claim 3, modified McGregor teaches, wherein the indentations extend along a portion of the trunk that is less than the entire trunk (Figure 1 of Cabezas; Paragraphs [0031]-[0032]).
Regarding claim 4, modified McGregor teaches, wherein the non-smooth profile comprises from 2 to about 500 equally spaced circumferential indentations forming ridges (Figure 1 of Cabezas; Paragraphs [0030]-[0031]).
Regarding claim 5, modified McGregor teaches, wherein the circumferential indentations extend along a full length of the curved trunk portion (Paragraph [0032] of Cabezas).
Regarding claim 6, modified McGregor teaches, wherein the circumferential indentations are angled on the curved trunk portion to form a spiral thereon (Figures 1-20 of Cabezas; Paragraph [0031]).
Regarding claim 7, modified McGregor teaches, wherein the spiral is right-handed or left-handed (Figures 6 and 15 of Cabezas; Paragraphs [0031] and [0035]).
Regarding claim 8, modified McGregor teaches, comprising at least two regions of circumferential indentations having different angles on the curved trunk portion (Figure 6 and Paragraphs [0009] and [0031] of Cabezas).
Regarding claim 9, modified McGregor teaches, wherein the ridges are flat, pointed, rounded, or bumpy (Figures 1-20 of Cabezas; Paragraphs [0009] and [0031]).
Regarding claim 10, modified McGregor teaches, wherein a surface of the needle is ridged, grooved, roughened, smooth, bumpy, ribbed, tacky, or polished (Figures 1-20 of Cabezas; Paragraphs [0009] and [0029]-[0031]).
Regarding claim 18, McGregor further teaches, wherein the tapered transition portion (suture mounting portion (12)) is flexible (Col. 3, line 31-33, discloses, “A suture (22) is inserted at one end portion into hole (20) and then the suture mounting portion (12) is deformed or compressed to hold the suture (22).” Where being capable of deformation or compression is a clear indication that suture mounting portion (12) is flexible).
Regarding claim 19, modified McGregor teaches, the claimed invention except for, “wherein the tapered transition portion comprises a biocompatible material”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the tapered transition portion comprise a biocompatible material, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin.
Regarding claim 20, modified McGregor teaches, the claimed invention except for, “wherein the biocompatible material comprises a cyanoacrylate”. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the tapered transition portion comprise a biocompatible material which is cyanoacrylate, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin.
Regarding claim 21, McGregor further teaches, wherein the tapered transition portion is configured to provide a steep transition from the first diameter about equal to the diameter of the suture thread to the second diameter about equal to the diameter of the curved trunk portion (As discussed previously in claim 1, McGregor discloses a suture mounting portion (12) that is deformed or compressed to hold the suture (22) (Col. 3, line 31-33). As seen in Figure 1, the suture mounting portion (12) provides a transition in diameter from a diameter about equal to the suture to a diameter about equal to that of the main body portion (14). The deformation or compression of the mounting portion (12) is directed to securely fix the suture, which reasonably indicates the inherency of a localized, abrupt or steep change in diameter rather than a gradual taper, this is of course directly related to the degree or extent of compression applied to the mounting portion (12), where it inherently affects how quickly the outer profile narrows from the larger curved trunk diameter to the smaller suture-engaging diameter. That is, a greater degree of localized compression results in a sharper or steeper taper, while a more gradual deformation results in a gentler taper. Accordingly, the steepness of the transition is not a structurally distinct feature, but rather a predictable and controllable outcome of the know compression process taught in McGregor).
Regarding claim 22, McGregor further teaches, wherein the needle tip portion (tip portion (16)) and curved trunk portion (main body portion (14)) comprise a biocompatible material (Col. 3, line 48-51).
Regarding claim 23, McGregor further teaches, wherein the biocompatible material comprises steel wire, a martensitic stainless steel, or an austenitic stainless steel (Col. 3, line 48-51).
Regarding claim 24, McGregor further teaches, wherein the needle tip portion (tip portion (16)) and curved trunk portion (main body portion (14)) are non-hollow (As seen in Figures 1-4, the tip portion (16) and the main body portion (14) are indeed non-hollow/solid, the only component of needle (10) that is hollow as seen in Figure 1 and disclosed in Col. 3, line 27-28 is suture mounting portion (12)).
Regarding claim 26, McGregor further teaches, wherein the curved trunk portion (main body portion (14)) is formed to have at least one of a circular, an oval, a triangular, a square, a rectangular, a pentagonal, a hexagonal, a heptagonal, an octagonal, a nonagonal, a decagonal, or a polygonal cross sectional shape (Figures 2-3; Col. 3, line 35-37).
Regarding claim 31, McGregor further teaches, wherein at least one of the needle tip portion (tip portion (16)) and curved trunk portion (main body portion (14)) are magnetizable (Col. 3, line 48-51, where it is discloses that needle (10) is formed of surgical grade steel or martensitic stainless steel then it is inherently magnetizable. Particularly, martensitic stainless steel is ferromagnetic due to its body-centered tetragonal (BCT) crystal structure).
Regarding claim 32, McGregor further teaches, wherein the tapered transition portion (suture mounting portion (12)) includes: a proximal side that overlaps the proximal end of the curved trunk portion in a direction of the needle tip; and a distal side that extends to a point overlapping the suture to form a taper (McGregor discloses a tapered transition portion (suture mounting portion (12)) that overlaps the proximal end of the curved trunk portion (main body portion (14)) and extends over at least a portion of the suture (22), forming a taper (see Fig. 1; Col. 3, lines 24–33). As seen in Figure 1, the deformed suture mounting portion (12) begins at the proximal end of main body portion (14) (i.e., the curved trunk portion) and extends over hole (20) and suture (22), thereby forming a taper on both sides of the thread attachment site).
Regarding claim 34, McGregor further teaches, wherein the tapered transition portion extends over the at least a portion of the suture thread at a distance from the end of the curved trunk portion in a range from 0.1 cm to 20 cm (McGregor discloses a tapered transition portion (suture mounting portion (12)) extending from the end of the curved trunk portion (main body portion (14)) and over a portion of the suture (22) inserted into the hole (20) (see Fig. 1). While McGregor does not explicitly recite the exact length of this extension, it is a design parameter that would have been an obvious matter of optimization to a skilled artisan based on the intended surgical use and desired hold strength of the suture-needle junction).
It has been held that “where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art.” In re Aller. Accordingly, the recited range of 0.1 cm to 20 cm represents an obvious design choice and does not impart patentable weight in the absence of unexpected results or criticality, which is not alleged.
Regarding claim 35, McGregor further teaches, wherein the tapered transition portion is configured to provide a gradual transition from the first diameter about equal to the diameter of the suture thread to the second diameter about equal to the diameter of the curved trunk portion (As previously discussed, McGregor discloses a suture mounting portion (12) that is deformed or compressed to hold the suture (22) and provides a transition from the diameter of the suture to that of the main body portion (14) (Col. 3, lines 24–33). The compression of the mounting portion inherently causes a gradual transition, as shown in Figure 1, where the outer profile appears smoothly tapered between the compressed suture and the main body portion. Moreover, the level of compression applied to the suture mounting portion would control the sharpness or gradualness of the taper, and selecting a more gradual taper would have been an obvious modification to reduce drag during tissue penetration. As such, it would have been obvious to a skilled artisan to configure the transition to be gradual based on surgical preferences or procedural requirements.).
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGregor, in view of Cabezas, and further in view of D’Agostino (US Patent No. 9675341).
Regarding claim 12, McGregor teaches, aspects of the needle according to claim 1 (See above rejection of claim 1).
McGregor does not explicitly teach, wherein the suture thread is mono-filamentary or multi-filamentary.
Cabezas teaches, other aspects of the needle according to claim 1 (See above rejection of claim 1).
D’Agostino discloses, filaments for surgical procedures, methods of manufacturing filaments for surgical procedures, and uses thereof. D’Agostino teaches, the suture thread is mono-filamentary or multi-filamentary (Col. 14, line 7-9).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the needle of McGregor such that the suture thread is mono-filamentary or multi-filamentary as taught by D’Agostino, as all the references and the claimed invention are directed to suturing devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of McGregor such that the suture thread is mono-filamentary or multi-filamentary as taught by D’Agostino, as such a modification would have been predictable, namely, enhance the sutures’ strength, resilience, longevity, or other qualities.
Regarding claim 13, modified McGregor teaches, wherein the suture thread is bioabsorbable (Col. 14, line 22-54 of D’Agostino).
Regarding claim 14, modified McGregor teaches, wherein the suture thread comprises at least one region of tissue retaining structures (Col. 12, line 46-Col. 13, line 61 of D’Agostino).
Regarding claim 15, modified McGregor teaches, wherein the tissue retaining structures are barbs (Col. 12, line 46-Col. 13, line 61 of D’Agostino).
Regarding claim 16, modified McGregor teaches, wherein the at least one region of tissue retaining structures are distal from the thread attachment region (Figure 7 of D’Agostino, retainers (703a or 703b); Col. 21, line 34-59).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGregor, in view of Cabezas, and further in view of Kawada (US Patent No. 4890614).
Regarding claim 25, McGregor teaches, aspects of the needle according to claim 1 (See above rejection of claim 1).
McGregor fails to teach, wherein at least one of the needle tip portion or curved trunk portion is hollow.
Cabezas teaches, other aspects of the needle according to claim 1 (See above rejection of claim 1).
Kawada discloses, a suture needle and its manufacturing processes. Kawada teaches, at least one of the needle tip portion or curved trunk portion is hollow (Figure 1; Col. 3, line 67-Col. 4, line 2).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the needle of McGregor such that at least one of the needle tip portion or curved trunk portion is hollow as taught by Kawada, as all the references and the claimed invention are directed to surgical needles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of McGregor such that at least one of the needle tip portion or curved trunk portion is hollow as taught by Kawada, as such a modification would have been predictable, namely, lowering production costs but maintaining a needle unit that is uniform and stable. Further, the resilience of the needle unit is increased.
Claim(s) 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGregor, in view of Cabezas, and further in view of Almodovar (US PGPUB No. 20180116653 A1).
Regarding claim 27, McGregor teaches, aspects of the needle according to claim 1 (See above rejection of claim 1).
McGregor fails to teach, a method, comprising:(a) grasping the curved suture needle with a roller needle driver so that the non-smooth profile of the curved trunk portion fits securely within grooves of a plurality of rollers of the needle driver;(b) driving the curved suture needle through a tissue being subjected to suture;(c) moving the curved suture needle through the tissue without releasing the needle from the tissue;(d) grasping the curved suture needle at an end exiting from the tissue through which the curved suture needle was moved; and repeating steps (a) - (d) until completion of the suturing process.
Cabezas teaches, other aspects of the needle according to claim 1 (See above rejection of claim 1).
Almodovar discloses, a surgical suturing device. Almodovar teaches, a method, comprising:
(a) grasping the curved suture needle (needle) with a roller needle driver (100) so that the non-smooth profile of the curved trunk portion (outer surface of needle) fits securely within grooves (grooves of driver) of a plurality of rollers of the needle driver (The configured surface of the distal end may comprise several groves having particular configuration in order to hold the needle in a particular angle while it is drive or pushed by the rotational motion of the rod or tip, Almodovar, col 3 line 5-18 and col 6 line 4-22);
(b) driving the curved suture needle through a tissue being subjected to suture (driving the suturing needle through the tissue, Almodovar, col 1 line 15-30);
(c) moving the curved suture needle through the tissue without releasing the needle from the tissue (Almodovar, col 3 line 18-25);
(d) grasping the curved suture needle at an end exiting from the tissue through which the curved suture needle was moved (Almodovar, claim 7); and
repeating steps (a) - (d) until completion of the suturing process (repeating the method, through a plurality of tissues until completion of the suturing process, Almodovar, claim 9).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the needle of McGregor such that it operates using a method, comprising:(a) grasping the curved suture needle with a roller needle driver so that the non-smooth profile of the curved trunk portion fits securely within grooves of a plurality of rollers of the needle driver;(b) driving the curved suture needle through a tissue being subjected to suture;(c) moving the curved suture needle through the tissue without releasing the needle from the tissue;(d) grasping the curved suture needle at an end exiting from the tissue through which the curved suture needle was moved; and repeating steps (a) - (d) until completion of the suturing process as taught by Almodovar, as all the references and the claimed invention are directed to suturing devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of McGregor such that it operates using a method, comprising:(a) grasping the curved suture needle with a roller needle driver so that the non-smooth profile of the curved trunk portion fits securely within grooves of a plurality of rollers of the needle driver;(b) driving the curved suture needle through a tissue being subjected to suture;(c) moving the curved suture needle through the tissue without releasing the needle from the tissue;(d) grasping the curved suture needle at an end exiting from the tissue through which the curved suture needle was moved; and repeating steps (a) - (d) until completion of the suturing process as taught by Almodovar, as such a modification would have been predictable, namely, allows for the performance of the surgical suturing procedure in a less complicated and more secure way by allowing more control over the angled suturing needle and the area to be stitched, even when the suturing area is small, deep, and/or restricted.
Regarding claim 28, modified McGregor teaches, wherein the curved suture needle (needle) is grasped by the roller needle driver (100) between the plurality of rollers (rollers seen in fig 3A-3C) so that the needle is perpendicular to the rollers (The configured surface of the distal end may comprise several groves having particular configuration in order to hold the needle in a particular angle while it is drive or pushed by the rotational motion of the rod or tip, Almodovar, col 3 line 5-18 and col 6 line 4-22).
Regarding claim 29, modified McGregor teaches, wherein the curved suture needle (needle) is grasped by the roller needle driver between the plurality of rollers so that the needle is parallel to the rollers (Also the rotational driver comprises several configurations at the interactive portion ends to provide selected angles for the needle during the suturing procedure and figure 4A-4G shows cross-sections that is parallel or at right angles to the drive, Almodovar, abstract, col 3 line 5-18 and col 6 line 4-22).
Regarding claim 30, modified McGregor teaches, wherein the curved suture needle is grasped by the roller needle driver between the plurality of rollers so that the needle is at an angle from 0 degrees (parallel) to 90 degrees (perpendicular) with respect to the rollers (Almodovar, abstract, col 3 line 5-18 and col 6 line 4-22).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGregor, in view of Cabezas, and further in view of Dumanian (US PGPUB No. 20180078255 A1).
Regarding claim 33, McGregor teaches, the tapered transition portion is built up from a diameter of the suture material to a diameter of the curved trunk portion (McGregor discloses a tapered transition portion (suture mounting portion (12)) providing a diameter transition between the suture (22) and main body portion (14) via deformation or compression of the mounting portion (Col. 3, lines 29–33)).
McGregor fails to teach, wherein the tapered transition portion is a coating or filament material built up.
Cabezas teaches, aspects of the needle according to claim 1 (See above rejection of claim 1).
Dumanian discloses, attaching a macroporous mesh suture to a standard-sized surgical needle. Dumanian teaches, a transition portion (Figure 1, intervening segment (107); Paragraph [0017]) that is a coating or filament material built up (Paragraph [0022], discloses in part, “With either drilled or channeled needles, it is also possible to incorporate additional or alternative retention means between the needle (102) and intervening segment (107) such as adhesive, welding, staking, swaging, etc.” and Paragraph [0023], discloses in part, “And in any configuration, the intervening segment (107) could include surface texture defined by the external geometry of the plurality of fibers (111) bundled together, barbs, or adhesive chemical elements to draw the filaments towards each other.”)
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the needle of McGregor such that the tapered transition portion is a coating or filament material as taught by Dumanian built up from a diameter of the suture material to a diameter of the curved trunk portion once compressed or deformed as taught by McGregor, as all the references and the claimed invention are directed to surgical needles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of McGregor such that the tapered transition portion is a coating or filament material as taught by Dumanian built up from a diameter of the suture material to a diameter of the curved trunk portion once compressed or deformed as taught by McGregor, as such a modification would have been predictable, namely, to draw the filaments of the suture towards each other. Further, it enhances securement and retention of the suture and prevents suture pull-through (Paragraph [0002] of Dumanian).
Response to Arguments
Applicant's arguments filed on 11/24/2025 have been fully considered but they are not persuasive.
Thread Attachment Portion and Tapered Transition Portion Argument:
The Examiner maintains the position that the claimed "thread attachment portion" and "tapered transition portion" are disclosed by McGregor.
Thread Attachment Portion: The Applicant argues that a "hole" cannot be a "portion" (pages 1-3 of the Remarks filed on 11/24/2025). However, a person of ordinary skill in the art would understand that the "hole (20)" within the "suture mounting portion (12)" in McGregor functions as the structure to which the suture (22) is attached, as explicitly described in the reference (Col. 3, lines 27-33). The claimed function is met by the disclosed structure.
Tapered Transition Portion: The Applicant further argues McGregor fails to describe a separate, gradual "tapered transition portion" (pages 1-3 of the Remarks filed on 11/24/2025). McGregor discloses that the "suture mounting portion (12)" is compressed to hold the suture (22) (Col. 3, line 31-33). This compression inherently creates a transition from the diameter of the main body portion (14) to a diameter about equal to that of the suture thread (22). The degree of taper ("steep" vs. "gradual") is a matter of obvious design choice for a skilled artisan seeking to optimize the needle for a specific application (e.g., minimizing force, improving strength). The general desirability for ease of penetration is known in the art (Col. 1, line 27-35 in the Background of McGregor discusses this).
Lastly, the final limitation, "wherein the curved trunk portion is formed to have a shaped cross-section having a non-smooth profile," remains the distinguishing feature taught by Cabezas.
Cabezas specifically teaches topographical variations (protrusions or indentations) on the surface of the needle shaft to reduce surface area, decrease the force required to advance the needle, and facilitate atraumatic insertion.
The motivation to combine the teachings of McGregor and Cabezas remains strong and explicit: both references concern surgical needles, and a person of ordinary skill in the art would have been motivated to combine the features to achieve the known and predictable benefit of reduced insertion force and tissue trauma.
Therefore, all elements of the amended claim are present in the combined prior art references, and the modification would have been obvious to one of ordinary skill in the art. See updated rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OSAMA NEMER whose telephone number is (571)272-6365. The examiner can normally be reached Monday-Friday 7:30-5:00.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/O.N./Examiner, Art Unit 3771
/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771