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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 15, 2025 has been entered.
Claims 1-17 are currently pending in the above identified application.
Claims 1-13 have been withdrawn from consideration
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 14-17 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.
Specifically the limitations (A) “the plurality of cogs being axially deformed and permanently included to one side with respect to a virtual central line of biodegradable thread” and (B) “a cut-out area of the biodegradable thread extending along a direction of the virtual central line of the biodegradable thread”.
Regarding limitation (A), the amendment filed March 18, 2025, introduced “permanently inclined in to one side” in place of biased. In the originally filed disclosure, there is no mention of “permanently inclined” and therefore there is no explicit support for this limitation, especially in combination with the plurality of cog being axially deformed. The originally filed disclosure teaches “the cogs are biased to one side with respect to a virtual central line of the biodegradable thread so as to partially protrude without returning to their original positions even if the biodegradable thread is wound” (see para 0001, 0010 of published application). This supports the cogs being partially protruding without returning to their original positions. Permanently inclined limits the position to always being inclined which differs in scope from not returning to the original position or being biased.
Regarding limitation (B), a cut-out region is discussed in para 0044-0045 and 0051 of the published application. These portions teach “conventionally, cogs 11 are formed on a biodegradable thread 10 and rolled into a roll type, and then, the biodegradable thread 10 is unrolled when being used for a procedure. In this case, the cogs 11 may be inserted into an original cut-out region 11 a of the biodegradable thread 10 while the biodegradable thread 10 is wound. So, there is inconvenience to withdraw the cogs 11 from a body of the biodegradable thread 10 for a procedure. Accordingly, in the present embodiment, the cogs 11 formed on the biodegradable thread 10 are biased to one side, thereby preventing the cogs 11 from being inserted into the original cut-out area 11 a even if the biodegradable thread 10 is wound. So, the manufacturing apparatus 100 according to the present embodiment further includes a cog axially deforming unit 140 to deform the position of the cogs 11… the cogs 11 are biased to one side with respect to the virtual central line 10S of the biodegradable thread 10 by the hitting of the hitting member 143. So, since the cogs are not reinserted into the cut-out region 11 a even if the biodegradable thread 10 is wound.” The original file disclosure teaches the inventive cogs not being reinserted into the cut-out regions to avoid having to withdraw the cogs from the body of the thread prior to use. The originally filed disclosure does not provide teachings nor guidance for the cut-out area extending along a direction of the virtual central line of the biodegradable thread.
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 15 is 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.
Claim 15 recites the limitation “wherein the biodegradable thread is formed by a process comprising: heating the biodegradable thread to reach a softening point to soften the biodegradable thread; applying an external force to cogs formed on the biodegradable thread axially deform the cogs to one side with respect to a virtual central line; and cooling the biodegradable thread so that the cogs do not return to their original positions”. It is unclear if the virtual central line of claim 15 is the same or different from the virtual central line of the biodegradable thread of claim 14. It is also unclear how the previously recited process of forming the scratches by a plurality of prong portions arranged along an inner wall of a rotating penetrating part falls within the process claim 15. This process in claim 14 appears to be part of the process of form the claimed biodegradable thread, however, is absent nor specified in process placement in claim 15. For the purpose of prior art application, Examiner will interpret claim 15 as encompassing the virtual central line of claim 15 can be the same as the virtual central line in claim 14 but not require and the scratches being formed form a plurality of prong portions arranged along an inner wall of a rotating penetrating part can be complete at any point in the process of forming the thread.
The remaining claims are rejected based upon their dependency on rejected claims.
Claim Rejections - 35 USC § 102 / 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 14-17 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US Pub. No. 2011/028284 to Odermatt.
Regarding claims 14-17, Odermatt teaches a suture material (thread) comprising barbs (plurality of cogs) cut into an undrawn suture material fiber (integrally formed on an outer surface of the thread) that is then drawn to form the surgical suture material having protruding barbs and being formed of resorbable polymer, including polylactide and poly-para-dioxane (biodegradable) (Odermatt, abstract, para 0025, 0037, 0047, 0055-0060, 0074-0081), reading on the suture material being a biodegradable thread. Odermatt teaches the cut in, undrawn suture material fiber being twisted simultaneously during drawing (Id., para 0059) and teaches the undrawn suture being drawn with the application of heat in particular in a temperature range of between 20 and 80°C above the glass transition temperature of the suture material (heating the biodegradable thread to reach a softening point to soften the biodegradable thread, claim 15) (Id., para 0068). This would result in axial force being subjected to the fiber, axially deformation of the barbs (plurality of cogs), and permanent inclination of the barbs relative to a virtual central line of the suture material (biodegradable thread), absent evidence to the contrary. Examiner would like to note that any permanent inclination to one side with respect to a virtual central line of the thread and any degree of deformation is within the broadest reasonable interpretation of the claim. The twisting and drawing of the fiber, especially under heat as described in Odermatt would change the molecular structure of the fiber and cause the barbs to raise from the surface as well as deform. As the thread is cut prior to twisting and drawing, the portion of the thread above the cut forming the barbs would undergo different stresses then the thread body that is twisted, resulting in the axial deformation and inclination. Odermatt teaches area of the cut surface extending in the longitudinal direction of the suture material and the barbs no longer fully fitting into undercuts formed by cuts made in the suture material (Id., para 0041), reading on a cut-out area of the biodegradable thread extending along a direction of the virtual central line of the biodegradable thread and the barbs, or cogs, not returning to their original position (claim 15). Additionally, as the drawing and twisting are completed simultaneously, thread is formed by a process comprising heating the threads to a soften point to soften the biodegradable thread and applying an external force to the bars (cogs) through the twisting of the thread to axially deform the cogs to one side with respect to a virtual central line. This also supports the axial deformation and inclination when the drawing and twisting are completed simultaneously. As the surface is cut to form the barb, there are scratches on the outer surface of the biodegradable thread. Odermatt also teaches the cross-sectional shape being formed with the aid of suitable extrusion dies (Id., para 0044) and teaches the barbs can be designed in different shapes and geometries (Id., para 0036).
The limitations “the scratches being formed form a plurality of prong portions arranged along an inner wall of a rotating penetrating part” (claim 14), “wherein the biodegradable thread is formed by a process comprising: heating the biodegradable thread to reach a softening point to soften the biodegradable thread; applying an external force to cogs formed on the biodegradable thread axially deform the cogs to one side with respect to a virtual central line; and cooling the biodegradable thread so that the cogs do not return to their original positions” (claim 15), “wherein the plurality of cogs are formed through a molding process of applying pressure to the biodegradable thread” (claim 16), and “wherein the molding process is performed in a vacuum state, and wherein after the molding process, a cutting process using press punching is performed” (claim 17) are interpreted as product-by-process limitations. Absent a showing to the contrary, it is Examiner's position that the article of the applied prior art is identical to or only slightly different than the claimed article. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). The burden has been shifted to Applicant to show unobvious difference between the claimed product and the prior art product. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983). The applied prior art either anticipated or strongly suggested the claimed subject matter. The suture, or thread, of the prior art is formed from a biodegradable polymer and contains a plurality of barbs, or cogs, that protruding from the main body of the suture material formed by cutting in the undrawn suture material, thereby forming scratches on the surface, and then drawing and twisting under heat such that the barbs are shaped different then the cut out area and thereby subjecting the barbs to axially deformation, which would result in permanent inclination relative to a virtual central line of the suture material (thread). The degree of inclination or axial deformation has not been specified or claimed. The scratches have not been specified as different from cuts forming the cogs or location specified apart from on the outer surface of the biodegradable thread. It is noted that if Applicant intends to rely on Examples in the specification or in a submitted declaration to show unobviousness, Applicant should clearly state how the Examples of the present invention are commensurate in scope with the claims and how the Comparative Examples are commensurate in scope with the applied prior art.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. 2021/0077781 to Cichocki teaches a barbed microcatheter having a barbs and fluid egress opening cut into the side. US Pub. No. 2004/0060409 to Leung teaches a barbed suture comprising a plurality of barbs projecting from the body that may be staggered, twist cut, overlapping, or random and teaches a corrugated barb underside.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER ANN GILLETT whose telephone number is (571)270-0556. The examiner can normally be reached 7 AM- 4:30 PM EST M-H.
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/JENNIFER A GILLETT/Examiner, Art Unit 1789
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