DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 2-12, 14-15, 17-19, 21-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 2, there is no support in the original disclosure for a circular suture retaining area and thus it constitutes new matter. In particular, the original disclosure is silent regarding a circular suture retaining area. Regarding claim 22, there is no support in the original disclosure for plurality of openings positioned in the suture retaining area only located in the suture retaining area and between the spaced protrusions and thus it constitutes new matter. It is noted that the original disclosure is silent regarding the specific location of the openings in the suture retaining area. Furthermore, note that any negative limitation or exclusionary proviso must have basis in the original disclosure. Regarding claim 23, 25, there is no support in the original disclosure for a second portion which extends inward away from the inner wall into the needle retaining area towards the needle park and thus it constitutes new matter. It is noted that the original disclosure is silent regarding a second portion of the inwardly curved protrusion extending towards the needle park and at best, the figures show the inwardly curved protrusion extending into the needle retaining area.
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 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.
Claim 2, 6, 24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Patent No. 6,047,815 to Cerwin et al. (Cerwin) in view of US Patent No. 5,590,778 to Dutchik.
Regarding claim 2, Cerwin discloses a suture package (Fig 5) comprising a substantially circular suture retaining member including a base (30), an outer wall (40) and an inner wall (90), the outer wall extending from the base (30) about a perimeter of the base, the inner wall being formed from a plurality of spaced protrusions (91) radially spaced from the outer wall and defining a suture retaining area (100) therebetween, the inner wall further defining a needle retaining area (172) interior thereof, the needle retaining area including at least one needle park (at 170), wherein the plurality of spaced protrusions including an inwardly curved protrusion (91, the inner wall is curved) extending from the base, inwardly curved protrusion (91) including a first portion which extends along the inner wall, a cover (200) configured to selectively engage the suture retaining member. Cerwin does not teach the inner wall and cover and suture retaining area being substantially circular; however, Cerwin explicitly discloses that other configurations of the package can be circular (col. 3, ll. 50-55) and one of ordinary skill in the art would have found it obvious to change the shape of the oval Cerwin package with an oval inner wall and oval cover to be a circular Cerwin package with a circular inner wall and circular cover in order to facilitate holding of a suture since it has been held that configuration of a claimed container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Cerwin does not teach the inwardly curved protrusion (91) including second portion which extends inward away from the inner wall into the needle retaining area. However, Dutchik discloses a package (Fig 3) and in particular discloses an inner wall with an inwardly curved protrusion including a first portion (A, Fig 3 below) which extends along the inner wall and a second portion (B, Fig 3 below) which extends inward away from the inner wall into an interior retaining area. In particular, Dutchik discloses the inner wall forming a spiral recess (18) to hold the elongated medical instrument. One of ordinary skill in the art would have found it obvious to curved the inwardly curved protrusion (91) of Cerwin such that it had a second portion extending inwards away from inner wall and into needle retaining area as suggested by Dutchik in order to have a spiral configuration recess to facilitate holding the elongated suture. The modification would have resulted in the second portion extending radially inward away from inner wall and towards the needle park since the needle park is located within the needle retaining area and the second portion is extending into the needle retaining area.
PNG
media_image1.png
813
605
media_image1.png
Greyscale
Regarding claim 6, Cerwin further discloses the base (30) and cover (200) generally planar when cover (200) is selectively engaged with suture retaining member (Fig 6-7).
Regarding claim 24, the modified Cerwin further teaches the substantially circular cover (200) planar when combined with the suture retaining member (30) (Figs 6-7) and configured to be separated from the suture retaining member since they are not integral and made of separate pieces.
Claim 2, 5, 14, 22-23, 25 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US Patent No. 5,655,652 to Sobel et al. (Sobel) in view of Dutchik.
Regarding claim 2, Sobel discloses a suture package (Fig 1) comprising a substantially circular suture retaining member (10, col. 3, ll. 25-30) including a base (20), an outer wall (30) and an inner wall (50), the outer wall extending from the base (20) about a perimeter of the base, the inner wall being formed from a plurality of spaced protrusions (51) radially spaced from the outer wall and defining a suture retaining area (15) therebetween, the inner wall further defining a needle retaining area interior thereof, the needle retaining area including at least one needle park (60), wherein the plurality of spaced protrusions including an inwardly curved protrusion (51, curved wall) extending from the base, the inwardly curved protrusion (51) including a first portion which extends along the inner wall, a cover (70) configured to selectively engage the suture retaining member. Sobel does not teach the inner wall and cover and suture retaining member being substantially circular; however, Sobel explicitly discloses that other configurations of the package can be circular (col. 3, ll. 25-30) and one of ordinary skill in the art would have found it obvious to change the shape of the oval Sobel package with an oval inner wall and oval cover to be a circular Sobel package with a circular inner wall and circular cover in order to facilitate holding of a suture since it has been held that configuration of a claimed container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Sobel does not teach the inwardly curved protrusion (51) including second portion which extends inward away from the inner wall into the needle retaining area. However, Dutchik discloses a package (Fig 3) and in particular discloses an inner wall with an inwardly curved protrusion including a first portion (A, Fig 3 above) which extends along the inner wall and a second portion (B, Fig 3 above) which extends inward away from the inner wall into an interior retaining area. In particular, Dutchik discloses the inner wall forming a spiral recess (18) to hold the elongated medical instrument. One of ordinary skill in the art would have found it obvious to curved the inwardly curved protrusion (51) of Sobel such that it had a second portion extending inwards away from inner wall and into needle retaining area as suggested by Dutchik in order to have a spiral configuration recess to facilitate holding the elongated suture. The modification would have resulted in the second portion extending radially inward away from inner wall and towards the needle park since the needle park is located within the needle retaining area and the second portion is extending into the needle retaining area.
Regarding claim 5, Sobel further discloses cover (70) comprises paper (col. 6, ll. 5-10).
Regarding claim 14, Sobel further discloses base (20) further comprising a plurality of openings (25) configured to engage mounting pins therein the openings radially spaced about the base and positioned within suture retaining area (15) (Fig 4).
Regarding claim 22, the modified Sobel teaches the package of claim 2 and further teaches wherein the base (20) comprises a plurality of openings (25, Sobel) configured to engage mounting pins therein, the openings only located in the suture retaining area and between spaced protrusions (Fig 4). In particular, only the openings between spaced protrusions (51) are considered configured to engage mounting pins since they have the structure as recited.
Regarding claim 23, Sobel discloses a suture package (Fig 1) comprising a suture retaining member (10, col. 3, ll. 25-30) include a base (20), outer wall (30) and inner wall (50), the outer wall extending from the base (20) about a perimeter of the base, the inner wall (50) formed from a plurality of spaced protrusions (51) extending from the base and radially spaced from the outer wall to define a suture retaining area (15) between the outer wall (30) and inner wall (50), the suture retaining area being configured to receive a suture (100) therein, the inner wall (50) further defining a needle retaining area (60) interior thereof, the needle retaining area (60) including at least one needle park (62), wherein the plurality of spaced protrusions include an inwardly curved protrusion (51) extending from the base, the inwardly curved protrusion including a first portion which extends along the inner wall, a cover (70) configured to selectively engage the suture retaining member. Sobel does not teach the inner wall and cover being substantially circular; however, Sobel explicitly discloses that other configurations of the package can be circular (col. 3, ll. 25-30) and one of ordinary skill in the art would have found it obvious to change the shape of the oval Sobel package with an oval inner wall and oval cover to be a circular Sobel package with a circular inner wall and circular cover in order to facilitate holding of a suture since it has been held that configuration of a claimed container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Sobel does not teach the inwardly curved protrusion (51) including second portion which extends inward away from the inner wall into the needle retaining area towards the needle park. However, Dutchik discloses a package (Fig 3) and in particular discloses an inner wall with an inwardly curved protrusion including a first portion (A, Fig 3 above) which extends along the inner wall and a second portion (B, Fig 3 above) which extends inward away from the inner wall into an interior retaining area towards a park (26). In particular, Dutchik discloses the inner wall forming a spiral recess (18) to hold the elongated medical instrument. One of ordinary skill in the art would have found it obvious to curved the inwardly curved protrusion (51) of Sobel such that it had a second portion extending inwards away from inner wall and into needle retaining area towards the park as suggested by Dutchik in order to have a spiral configuration recess to facilitate holding the elongated suture.
Regarding claim 25, Sobel discloses a suture package (Fig 1) comprising a suture retaining member (10, col. 3, ll. 25-30) include a base (20), outer wall (30) and inner wall (50), the outer wall extending from the base (20) about a perimeter of the base, the inner wall (50) formed from a plurality of spaced protrusions (51) extending from the base and radially spaced from the outer wall to define a suture retaining area (15) between the outer wall (30) and inner wall (50), the suture retaining area being configured to receive a suture (100) therein, the inner wall (50) further defining a needle retaining area (60) interior thereof, the needle retaining area (60) including at least one needle park (62), wherein the plurality of spaced protrusions include an inwardly curved protrusion (51) extending from the base, the inwardly curved protrusion including a first portion which extends along the inner wall, a cover (70) configured to selectively engage the suture retaining member to cover at least the suture retaining area (15, Fig 6). Sobel does not teach the inwardly curved protrusion (51) including second portion which extends inward away from the inner wall into the needle retaining area towards the needle park. However, Dutchik discloses a package (Fig 3) and in particular discloses an inner wall with an inwardly curved protrusion including a first portion (A, Fig 3 above) which extends along the inner wall and a second portion (B, Fig 3 above) which extends inward away from the inner wall into an interior retaining area towards a park (26). In particular, Dutchik discloses the inner wall forming a spiral recess (18) to hold the elongated medical instrument. One of ordinary skill in the art would have found it obvious to curved the inwardly curved protrusion (51) of Sobel such that it had a second portion extending inwards away from inner wall and into needle retaining area towards the park as suggested by Dutchik in order to have a spiral configuration recess to facilitate holding the elongated suture.
Claim 2-4, 7, 12, 16, 18-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2004/0050721 to Roby et al. (Roby) in view of Cerwin and Dutchik.
Regarding claim 2, Roby discloses a suture package (Fig 1) comprising a suture retaining member including a base (102), an outer wall (116) and an inner wall (118), the outer wall extending from the base (102) about a perimeter of the base, the inner wall being formed from a plurality of spaced protrusions (118a, 118b) radially spaced from the outer wall and defining a suture retaining area (122) therebetween, the inner wall further defining a needle retaining area interior thereof, the needle retaining area including at least one needle park (130), wherein the plurality of spaced protrusions including an inwardly curved protrusion (118a) extending from the base, the inwardly curved protrusion (118a) including a first portion which extends along the inner wall, a cover (110) configured to selectively engage the suture retaining member. Roby does not teach the package substantially circular with inner wall and cover and suture retaining member also being substantially circular; however, Cerwin explicitly discloses that other configurations of the package can be circular (col. 3, ll. 50-55) and one of ordinary skill in the art would have found it obvious to change the shape of the oval Roby package with an oval inner wall and oval cover to be a circular Roby package with a circular inner wall and circular cover in order to facilitate holding of a suture since it has been held that configuration of a claimed container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Roby does not teach the inwardly curved protrusion (118a) including second portion which extends inward away from the inner wall into the needle retaining area. However, Dutchik discloses a package (Fig 3) and in particular discloses an inner wall with an inwardly curved protrusion including a first portion (A, Fig 3 above) which extends along the inner wall and a second portion (B, Fig 3 above) which extends inward away from the inner wall into an interior retaining area. In particular, Dutchik discloses the inner wall forming a spiral recess (18) to hold the elongated medical instrument. One of ordinary skill in the art would have found it obvious to curved the inwardly curved protrusion (118a) of Roby such that it had a second portion extending inwards away from inner wall and into needle retaining area as suggested by Dutchik in order to have a spiral configuration recess to facilitate holding the elongated suture. The modification would have resulted in the second portion extending radially inward away from inner wall and towards the needle park since the needle park is located within the needle retaining area and the second portion is extending into the needle retaining area.
Regarding claim 3, Roby further discloses suture retaining member is rigid (€0025).
Regarding claim 4, Roby further discloses suture retaining member comprises a polymer (€0025).
Regarding claim 7, Roby further discloses cover (110) generally closes the suture retaining area (122) to retain a suture therein (abstract).
Regarding claim 12, Roby further discloses outer wall (116) further comprising a plurality of inward engaging tabs (114) to engage the cover (110).
Regarding claim 18, Roby further discloses suture (120) including a body portion received in the suture retaining area (122) and a first end portion connected to a needle (128) selectively engaged with the at least one needle park (130) (€0032).
Regarding claim 19, Roby further discloses suture further comprises a second end portion including an end effector (A, Fig 1 below), the second end portion opposite the first end portion.
PNG
media_image2.png
687
792
media_image2.png
Greyscale
Claim 8-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roby in view of Cerwin, Dutchik and US Patent No. 5,230,424 to Alpern.
Regarding claim 8, the modified Roby teaches the package of claim 2 but does not teach cover further comprising a cut-out positioned over needle retaining area and configured for viewing of indicia located on base of suture retaining member. However, Alpern disclose a suture package (Fig 1) and in particular discloses a cutout (56) on cover (50) positioned over a needle area and configured for viewing the base of suture retaining member (20). One of ordinary skill in the art would have found it obvious to incorporate a cutout to the modified Roby cover as suggested by Alpern in order to view contents underneath the cover.
Regarding claim 9, the modified Roby teaches the package of claim 2 but does not teach cover further comprising a cut-out configured for operable engagement by a clinician. However, Alpern disclose a suture package (Fig 1) and in particular discloses a cutout (56) on cover (50) configured for operable engagement by a user. One of ordinary skill in the art would have found it obvious to incorporate a cutout to the modified Roby cover as suggested by Alpern in order to view contents underneath the cover.
Claim 10-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roby in view of Cerwin, Dutchik and US Patent No. 3,885,731 to Mullinix.
Regarding claim 10, the modified Roby teaches the package of claim 2 but does not teach the cover including a tab. However, Mullinix discloses a package (Fig 1) and in particular discloses cover (12) having a tab (22) to facilitate lifting and removing of the cover. One of ordinary skill in the art would have found it obvious to incorporate a tab to the Roby cover as suggested by Mullinix in order to facilitate lifting and separating of the cover from the tray.
Regarding claim 11, the modified Roby teaches the package of claim 10 but does not teach recessed portion on outer wall of the container. However, Mullinix further discloses outer wall (3) include recessed portion (26) configured to receive tab (22). One of ordinary skill in the art would have found it obvious to incorporate a recessed portion to Roby container as suggested by Mullinix in order to receive the tab.
Claim 14-15 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roby in view of Cerwin, Dutchik and Sobel.
Regarding claim 14-15, the modified Roby teaches the package of claim 2 but does not teach base comprising openings radially spaced about the base for aligning with plurality of openings radially spaced about the perimeter of cover and positioned within suture retaining area. However, Cerwin further discloses incorporating openings (120, 130) radially spaced about the base for vertically aligning with plurality of openings (250, 270) radially spaced about perimeter of cover. Sobel discloses a suture package (Fig 1) and in particular discloses base comprising openings (25) positioned within suture retaining area (15). Taken as a whole, one of ordinary skill in the art would have found it obvious to incorporate plurality of openings to the suture retaining area of Roby and to the cover to be aligned as suggested by Cerwin in order to facilitate mounting of suture.
Claim 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roby in view of Cerwin, Dutchik and US Patent No. 6,076,659 to Baumgartner et al. (Baumgartner).
Regarding claim 17, Roby further discloses needle park (130) but does not explicitly teach three aligned need parks. However, Baumgartner discloses a suture package (Fig 1) and in particular discloses a needle park (24) comprising at least three aligned needle parks (22). One of ordinary skill in the art would have found it obvious incorporate additional aligned needle parks to Roby as suggested by Baumgartner in order to hold additional needles since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Roby in view of Cerwin, Dutchik and US 2009/0255836 to Prescott.
Regarding claim 21, the modified Roby teaches the package of claim 19 but does not explicitly teach the suture to be a barbed suture. However, Prescott discloses suture package (Fig 1) and in particular discloses it was known in the art to package barb sutures (€0018). One of ordinary skill in the art would have found it obvious to incorporate barbs on the Roby sutures as suggested by Prescott to facilitate medical procedure since it has been held that simple substitution of one known element for another to obtain predictable results would have been obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982).
Response to Arguments
Applicant's arguments filed 12/22/2025 have been fully considered but they are not persuasive. Initially, it is noted that applicant does not argue the rejection of the dependent claims. Applicant argues that support for the claimed subject matter of a circular suture retaining area is shown in the figures and the inwardly curved protrusions including a second portion extending inward away from inner wall and toward needle park is shown in the figures. Applicant argues that it is not necessary for the written disclosure to describe the claimed limitations and only require the drawings to show support. This is not persuasive because the disclosure only describes the cover being of substantially circular configuration and is silent regarding the shape of the suture retaining area. Applicant argues that the suture retaining member/inner wall is also to be considered circular based on the figures; however, applicant is only assuming that a person of ordinary skill in the art would interpret such figures to show a circular inner wall and retaining member when drawings are not to scale and no such written description is made of the retaining member and inner wall. By definition, to be circular is to have the form of a circle and a circle is defined as a closed plane curve every point of which is equidistant from a fixed point within the curve. The figures show an inner wall that is not a closed plane because there are openings in the inner wall and furthermore there is an inwardly curved protrusion which would prevent every point to be equidistant. In addition, the drawings do not show a planar view of the inner wall and retaining member as to have one of ordinary skill in the art to assume that every point is equidistant from a fixed point within the curve.
Applicant further argues that the drawings show the inwardly projection portion oriented toward the needle park. This is not persuasive because the drawings only show an inwardly curved protrusion configured to form an opening as described in the disclosure. Nowhere does it explicitly state the projection is oriented towards the needle park. Applicant argues that none of the prior art teach an inwardly curved protrusion having a second portion that extends inward away from inner wall and towards the at least one needle park. This is not persuasive because Dutchik discloses an inner wall that is spiral shape and not circular; thus, so long as the protrusion is going inwards, it would be going towards the needle park located within the inner circle. The claims do not require the needle park and protrusion to be aligned as applicant appears to be arguing.
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 ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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, Anthony Stashick can be reached at (571)272-4561. 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.
/ROBERT POON/Examiner, Art Unit 3735