DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/14/2026 has been entered.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sterile packaging” in claim 26 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 22-23, 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 22, there is no support in the original disclosure for plurality of openings positioned in the suture retaining area only located within spaces 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 and aligned with 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.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 26, the scope of the claims is unclear because the preamble recites a suture package and a sterile packaging is not part of the suture package. It is unclear whether applicant is reciting the combination of a sterile packaging and suture package or subcombination of a suture package capable of functioning with sterile packaging. For purposes of examination, claims will be given their broadest reasonable interpretation and be treated as directed towards the subcombination; however, clarification of the scope of the claims is required.
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, 26 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 annular 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 an annular 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.
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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.
Regarding claim 26, as best understood, Cerwin discloses the suture package capable of being hermetically sealed in sterile packaging since it has the structure as recited.
Claim 2, 5, 14, 18, 22-23, 25-26 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 annular 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 an annular 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 18, Sobel further discloses a suture (102) including a body portion received in the annular suture retaining area (Fig 4) and a first end portion connected to a needle (110) selectively engaged with the needle park (60), the first end portion of the suture wound around the inwardly curved protrusion, the curved protrusion capable of preventing the first end portion of the suture from creasing near the needle while selectively engaged within the needle park since it has the structure as recited (col. 5, ll. 15-25).
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 within spaces 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 annular 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 single annular 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 and aligned with 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 annular 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.
Regarding claim 26, as best understood, Sobel discloses the suture package capable of being hermetically sealed in sterile packaging since it has the structure as recited.
Claim 2-4, 7, 12, 26 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 annular 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 26, as best understood, Roby discloses the suture package capable of being hermetically sealed in sterile packaging since it has the structure as recited.
Claim 19, 21 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sobel in view of Dutchik and US Patent No. 5,053,047 to Yoon.
Regarding claim 19, the modified Sobel teaches the suture package of claim 18 but does not teach the suture with a second end portion including an end effector opposite the first end portion. However, Yoon discloses a barbed suture (Fig 10b) and in particular discloses an end effector (68b) on second end of the suture opposite the first end with the needle (66b). One of ordinary skill in the art would have found it obvious to incorporate an end effector to the opposite end of the modified Sobel suture as suggested by Yoon in order to incorporate a stop to the suture.
Regarding claim 21, the modified Sobel teaches the package of claim 19 but does not teach the suture being a barb suture. However, Yoon further discloses barbed sutures (Fig 10b) were known in the art and one of ordinary skill in the art would have found it obvious to substitute the sutures of Sobel with functionally equivalent sutures having barbs as suggested by Yoon in order to facilitate grip.
Response to Arguments
Applicant's arguments filed 4/14/2026 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 the drawings support the second portion extending radially inward away from the inner wall into the needle retaining area and towards the at least one needle park. However, the drawings are not to scale and the written disclosure only describes the second portion extending radially inward away from the inner wall into the needle retaining area. The original disclosure is silent regarding the second portion extending towards the needle park and thus it constitutes new matter. Similarly, there is no support in the original disclosure for the second portion aligned with the needle park. Applicant relies solely on the drawings to show this limitation and provides a marked-up drawing with a line showing alignment; however, the drawings alone cannot be relied upon to show support because they are not drawn to scale.
Applicant argues that none of the prior art teach inwardly curved protrusion extends inward away from inner wall into retaining area and towards needle park. This is not persuasive because Dutchik discloses package for an elongated medical device comprising an inner wall having inwardly curved protrusion that extends inward away from inner wall into a retaining area (22) and towards a park (26) to hold medical device. In particular, Dutchik discloses one of the protrusions forming the inner wall to extend inwards away from the inner wall into the retaining area and towards the park holding the elongated medical device in similar manner to applicant’s invention. One of ordinary skill in the art would have found it obvious to also have one of the protrusions of the prior art inner walls to extends inwards as suggested by Dutchik in order to have a spiral configuration to facilitate holding the elongated suture.
Conclusion
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/ROBERT POON/Examiner, Art Unit 3735
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