DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No.15/733,613, filed on 09/15/2020.
Claim Objections
Claims 1, 4, 9, and 12 are objected to because of the following informalities:
Claim 1 recites the limitation “a stressed state” in line 7. The limitation should be corrected to “the stressed state.”
Claim 1 recites the limitation “lengthwise viscoelastic contraction” in line 7 and line 9, respectively. The limitation should be corrected to “the lengthwise viscoelastic contraction.”
Claim 4 recites the limitations “part” (line 1) and “said part” (line 2), respectively. The limitation should be corrected to “said at least part” and “said at least part,” respectively.
Claim 9 recites the limitation “lengthwise viscoelastic contraction” in lines 4-5 and line 6, respectively. The limitation should be corrected to “the lengthwise viscoelastic contraction.”
Claim 12 recites the limitation “the part” in line 2. The limitation should be corrected to “the at least part.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4, 6-7, 9-12, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Peacock (US 5,272,003 A) in view of Prescott (US 20080093231 A1).
Regarding claim 1, Peacock teaches a method of manufacturing a product comprising a suture thread (col. 1 lines 10-11: syndiotactic polypropylene (SPP) fibers; col. 3 lines 50-52: SPP can be made into surgical sutures; figs. 1-4), the method comprising:
providing a thread having a length (col. 5 line 1- col. 6 line 23 and figs 1, 2: yarn wound up in the end)
applying to the thread a stressed state which gives the thread which gives the thread a tendency to undergo lengthwise viscoelastic contraction (col. 3 line 40-41: SPP fiber thread has elasticity and absorb energy; col. 3 lines 52-56; col. 7 line 55 – col. 8 line 20: Table 1, e.g., force required to deform to 100 %, permanent set immediately after elongation to 100%, and permanent set 24 hours after elongation to 100 %; here, it is implied that the SPP thread which is shrunken immediately after elongation to 100% has a tendency to undergo lengthwise viscoelastic contraction in after 24 hours as much as the variation of the % value between “permanent set immediately after elongation to 100%” and “permanent set 24 hours after elongation to 100 %”); and
[after said application of the stressed state, engaging at least part of the length of the thread with a structure to form an engaged suture thread, said engagement with the structure maintaining the thread in a stressed state by resisting lengthwise viscoelastic contraction of the thread by application of a force to the thread, the structure being disengageable from the thread to allow lengthwise viscoelastic contraction of the thread when it is desired to use the suture to form a surgical suture].
Peacock does not teach the bracketed limitation(s) as presented above, but Prescott teaches the limitation as follows:
Prescott teaches a suture winding device (abstract, fig. 1). Prescott teaches that [after said application of the stressed state] engaging at least part of the length of the thread with a structure to form an engaged suture thread ([0048]: positioned between first member 72 and mounting member 7 is needle 14 with a length of suture 16 attached thereto, and needle park 80 is positioned on first member 72 such that is aligned with needle holder 50 when first member 72 is positioned on plate; [0049-0050]: needle park 80 holding needle 14; [0063]: each needle 14 is positioned in a separate needle channel 64 and attached suture 16 is threaded between interior rods 22 a and exterior rods 22 b such that suture 16 is positioned between at least one interior rod 22 a and at least one exterior rod 22 b, and suture 16 extends through slot 78; figs. 5-6, 17; here, suture thread 16 is engaged with needle 14, and the suture 16 is engaged to the winding device through the engaged needle 14 and several components enclosed in the suture winding device 100),
said engagement with the structure maintaining the thread in a stressed state [by resisting lengthwise viscoelastic contraction of the thread] by application of a force to the thread ([0051, 0058]: a predetermined amount of tension is maintained on suture 16 by a holder 30, and the amount of pressure applied is sufficient to allow suture 16 to be fed from a source to form the loops as base 10 rotates while maintaining the desired amount of tension on suture 16; figs. 5-7), the structure being disengageable from the thread [to allow lengthwise viscoelastic contraction of the thread] when it is desired to use the suture to form a surgical suture (claims 9, 10: releasably engage the needle 14, and thus, the suture thread connected thereon is release from the structure at the same time).
In the same field of endeavor of making sutures available to use (Peacock: col. 3 lines 50-52: for suture treads; Prescott: abstract: a suture winding device). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing invention to modify the suture tread of Peacock to be wound in the suture winding device as taught by Prescott in order to yield known results or a reasonable expectation of successful results of making a suture winding package wherein a suture thread is wound in a predetermined tension and easily removable with minimal handling, preventing the suture thread becoming entangled or damaged before use (Prescott: derived from [0051, 0058] and claims 9, 10).
Prescott does not specifically teach the bracketed limitation(s) as presented above, i.e., the tread engages the structure in the stressed state by resisting lengthwise viscoelastic contraction of the thread, and the contraction is allowed upon disengagement from the structure. However, upon the modification, it would have been also obvious to one of ordinary skill in the art at the time of filing invention to modify the suture tread of modified Peacock to be wound in the suture winding device under the stressed state, e.g., after applying elongation force and following immediate shrinkage (i.e., after “permanent set immediately after elongation to 100%”, see Peacock: Table 1) as taught by modified Peacock in order to obtain known results or a reasonable expectation of successful results of forming a suture thread capable of having appropriate flexibility and elasticity (i.e., absorbing energy/force by elongation during surgical suture or when swelling as well as shrinking in lengthwise to hold the wound closed to cure better) (Peacock: derived from col. 3 line 40-46: SPP fiber thread has elasticity, absorb energy/force, and does not break; Prescott: [0051, 0058]).
Regarding claim 2, modified Peacock teaches the method according to claim 1, wherein said engaging comprises winding said at least part of the length of the thread around a portion of the structure and securing two ends of said at least part of the length of the thread to the structure (Prescott: [0048-0050]: one end attached to needle and the needle is attached to needle holder/park; [0060, 0065]: second member 74 is placed on top of first member 72, thereby forming retainer 70 and securing needle 14 and attached suture 16 within retainer 70, and a free end of suture 16 is positioned along a surface of first member 72; [0061]: first and second members 72, 74 are press fit or joined together using applied pressure or heat; here, the both ends of the suture thread are engaged in the structure of at least retainer 70).
Regarding claim 4, modified Peacock teaches the method according to claim 1, wherein said engaging comprises engaging part of the length of the thread with the structure and the thread is cut to form said part of the length after said application of the stressed state (Prescott: [0060]: while still maintaining the desired tension on suture 16, thereby forming retainer 70 and securing needle 14 and attached suture 16 within retainer 70, and then suture 16 is separated from its source by cutting).
Regarding claim 6, modified Peacock teaches the method according to claim 1, wherein said application of said stressed state comprises applying a tensile force (force required to deform fiber to 50% or 100%) to the thread so that the thread undergoes lengthwise viscoelastic creep (e.g., difference between the elongation to 100 % and “permanent set immediately after elongation to 100 %”) (Peacock: col. 7 line 67 – col. 8 line 8: Table 1).
Regarding claim 7, modified Peacock teaches the method according to claim 6, wherein said application of said stressed state further comprises, after the thread has undergone said viscoelastic creep, releasing the tensile force and allowing the thread to undergo elastic contraction (difference between “permanent set immediately after elongation to 100 %” and “permanent set 24 hours after elongation to 100 %” ) (Peacock: col. 7 line 67 – col. 8 line 8: Table 1).
Regarding claim 9, modified Peacock teaches all the claimed limitations as presented above (see 35 U.S.C. 103 rejection of claim 1).
Regarding claims 10 and 11, modified Peacock teaches the method according to claim 9, wherein the engaging comprises winding the at least part of the length of the thread around a portion of the structure, and further comprising securing at least one end of the at least part of the length of the thread to the structure (Prescott: [0048-0050]: one end attached to needle and the needle is attached to needle holder/park; [0060, 0065]: second member 74 is placed on top of first member 72, thereby forming retainer 70 and securing needle 14 and attached suture 16 within retainer 70, and a free end of suture 16 is positioned along a surface of first member 72; [0061]: first and second members 72, 74 are press fit or joined together using applied pressure or heat; here, the both ends of the suture thread are engaged in the structure of at least retainer 70).
Regarding claim 12, modified Peacock teaches the method according to claim 9, wherein the engaging comprises cutting the thread to form the part of the length while the thread is in the stressed state (Prescott: [0060]: while still maintaining the desired tension on suture 16, thereby forming retainer 70 and securing needle 14 and attached suture 16 within retainer 70, and then suture 16 is separated from its source by cutting).
Regarding claim 16, modified Peacock, as applied to claim 1, teaches a method of manufacturing a suture thread (Peacock: col. 1 lines 10-11: syndiotactic polypropylene (SPP) fibers; col. 3 lines 50-52: SPP can be made into surgical sutures; figs. 1-4), the method comprising:
applying a tensile force (e.g., force required to deform fiber to 50% or 100%) to a thread so that the thread undergoes lengthwise viscoelastic creep (e.g., difference between “the elongation to 50 % or 100 %” and “permanent set immediately after elongation to 50 % or 100 %”) (Peacock: col. 7 line 67 – col. 8 line 8; Table 1);
allowing the thread to undergo elastic contraction resulting in the thread being in a stressed state (id.: e.g., “permanent set 24 hours after elongation to 100 %”); and
engaging at least part of the thread with a structure so as to substantially maintain the thread in the stressed state until the structure is disengaged from the thread ([0051, 0058]: a predetermined amount of tension is maintained on suture 16 by a holder 30, and the amount of pressure applied is sufficient to allow suture 16 to be fed from a source to form the loops as base 10 rotates while maintaining the desired amount of tension on suture 16; figs. 5-7; claims 9, 10: releasably engage the needle 14, and thus, the suture thread connected thereon is release from the structure at the same time).
Thus, modified Peacock teaches all the claimed limitations, and the motivation to combine applied to claim 1 equally applies here.
Regarding claim 17, modified Peacock teaches the method according to claim 16, wherein the engaging comprises winding at least a part of the thread around a portion of the structure and securing at least one end of the thread to the structure (Prescott: [0048-0050]: one end attached to needle and the needle is attached to needle holder/park; [0060, 0065]: second member 74 is placed on top of first member 72, thereby forming retainer 70 and securing needle 14 and attached suture 16 within retainer 70, and a free end of suture 16 is positioned along a surface of first member 72; [0061]: first and second members 72, 74 are press fit or joined together using applied pressure or heat; here, the both ends of the suture thread are engaged in the structure of at least retainer 70).
.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Peacock (US 5,272003 A) and Prescott (US 20080093231 A1) as applied to claim 1, and further in view of Kirsch (US 20100084294 A1).
Regarding claim 3, modified Peacock teaches the method according to claim 1, wherein the engaged thread is packed in a package (Prescott: fig. 17 and [0047]: a suture package or retainer 70), but does not specifically teach that the package is suitable for maintaining sterility of the thread.
Kirsch teaches that suture package 100 may then be removed from the suture loading apparatus and hermetically sealed in sterile packaging (fig. 3 and [0029]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing invention to modify the suture package of modified Peacock to be hermetically sealed in sterile packaging as taught by Kirsch in order to obtain known results or a reasonable expectation of successful results of manufacturing a suture dispenser holding a sterilized thread therein free from contamination.
Claims 5 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Peacock (US 5,272003 A) and Prescott (US 20080093231 A1) as applied to claim 1 or 9, and further in view of Lennard (US 4,911,165).
Regarding claims 5 and 13-14, modified Peacock teaches the method according to claim 1, but does not specifically teach that the method further comprises sterilizing the thread (claims 5, 13), and packing the engaged thread in a package (claim 14).
Lennard teaches polypropylene surgical monofilaments having improved compliance and a process for making them (col. 1 lines 9-11). Lennard discloses that the filaments are fabricated into surgical sutures and can be sterilized (as by using ethylene oxide) and packaged in sterile packs ready for use (col. 4 lines 66 – col 5 line 5).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing invention to modify the suture thread and the suture package of modified Peacock to be sterilized and packed in a sterile pack, respectively, as taught by Lennard in order to obtain known results or a reasonable expectation of successful results of manufacturing a sterilized suture which is ready to use with improved compliance (Lennard: derived from col. 1 lines 9-11).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Peacock (US 5,272003 A) and Prescott (US 20080093231 A1) as applied to claim 1, and further in view of Bogart (US 20100228270 A1).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Peacock (US 5,272003 A), Prescott (US 20080093231 A1), and Lennard (US 4,911,165) as applied to claim 14, and further in view of Bogart (US 20100228270 A1).
Regarding claims 8 and 15, modified Peacock teaches the method according to claim 1 and claim 14, respectively, but does not specifically teach that the method comprises refrigerating the thread in a package (claim 8) or cooling the package (claim 15).
Bogart teaches a suture deployment system including a surgical needle having a flexible suture fixedly attached thereto (abstract). Bogart teaches that the suture thread may be stored in a refrigerator ([0062]: in order to keep the shape of the suture in its temporary shape, the shape memory sutures of the present disclosure should be stored at a temperature which will not cause a transition to the primary shape, e.g., the shape memory suture may be stored in a refrigerator).
In the same field of using syndiotactic polypropylene materials as a suture thread (Peacock: col. 3 lines 50-52: SPP can be made into surgical sutures; Bogart: [0030]: polypropylene can also be utilized to form the suture, and the polypropylene can be isotactic polypropylene or a mixture of isotactic and syndiotactic or atactic polypropylene), it would have been obvious to one of ordinary skill in the art at the time of filing invention to modify the suture threads (i.e., further returning to its original length after elongation, and thus, it can be considered as “a shape memory suture”) or the suture package including the suture threads therein of modified Peacock to be stored in a refrigerator before use as taught by Bogart in order to obtain known results or a reasonable expectation of successful results of delaying or preventing the suture thread from transitioning back to its original shape/dimension after applying a force/stress/tension to deform the original shape/dimension so as to utilize the benefit of the transition or deformed shape/dimension while the suture thread is in use (Bogart: [0061-0062]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eaton (US 5,234,006) teaches a method of manufacturing an adjustable sutures (abstract, col. 7 lines 29-32). The suture thread is stretched upon heating and gentle traction resulting in 25 % increase in length (col. 9 lines 25-30), and the stretched suture tread is shrunken (i.e., reduced in length) when laser energy it is applied in a stressed stretched state (col. 9 line 45 – col. 10 line 13), the thread has a tendency to undergo lengthwise viscoelastic contraction (col. 4 lines 7-30).
Goraltchouk (US 20110125188 A1) teaches that filament 220 may also be heated by magnetic or electrical fields, an electric current passed through filament 220 or simply by bathing the tissue in sterile saline at the transition temperature ([0088]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to INJA SONG whose telephone number is (571)270-1605. The examiner can normally be reached Mon. - Fri. 8 AM - 5 PM.
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/INJA SONG/Examiner, Art Unit 1744