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 .
Claim Rejections - 35 USC § 112
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 3 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 3 recites “the plurality of the bundles of the bio-composites of the fibers made from the Agave americana plant leaf has a high density, approximately following U.S.P. sizes from 0, 00, 3-0, 4-0, 5-0 and 6-0”. First, the scope of “high density” is unclear as it is not know what densities constitute “high”. Second, it is unclear if the density is a result of the suture size or how it is related thereto. For examination purposes, the claim will be interpreted as sutures with the claimed sizes 0, 00, 3-0, 4-0, 5-0 and 6-0 have a high density.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Schmieding (US 20060178701 A1) in view of Gonzalez-Quevedo et al. (CU 22398 A1).
Note that all references to Gonzalez-Quevedo refer to the attached English translation.
Regarding claim 1 Schmieding discloses (fig. 1-2) a surgical suture assembly comprising: a surgical suture 2, the surgical suture comprising an elongated core 6 (see fig. 2 and [0021]) covered by a plurality of bundles of fibers 10+12 (se fig. 1 and [0021]).
Schmieding further teaches the plurality of fibers can be natural fibers including silk (see [0010]). Schmieding is silent regarding the plurality of bundles of fibers are bio-composites of fibers from an Agave americana plant leaf.
However Gonzalez-Quevedo, in the same filed of endeavor, teaches a plurality of fibers forming a suture are a plurality of bundles of fibers are bio-composites of fibers from an Agave americana plant leaf (see pg. 1 second full paragraph).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Schmieding to have the plurality of bundles of fibers are bio-composites of fibers from an Agave americana plant leaf as taught by Gonzalez-Quevedo, for the purpose of reducing patient rejections, and allowing them to be in place longer term (see Gonzalez-Quevedo pg. 1 second full paragraph).
Regarding claim 2, Schmieding as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schmieding further discloses (fig. 4A-4B) a surgical needle mechanically connected to the plurality of the bundles of the bio-composites of the fibers made from the Agave americana plant leaf (see fig. 4A-4B and [0038]).
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Ohi (US 4,946,467 A1) in view of Gonzalez-Quevedo
Note that all references to Gonzalez-Quevedo refer to the attached English translation.
Regarding claim 1 Ohi discloses (fig. 1-2) a surgical suture assembly comprising: a surgical suture, the surgical suture comprising an elongated core 2 (see fig. 1-2 and col. 4 ln. 13-16) covered by a plurality of bundles of fibers 1 (se fig. 1-2 and col. 4 ln. 13-16).
Ohi further teaches the plurality of fibers can be natural fibers including silk (see col. 4 ln. 13-16). Ohi is silent regarding the plurality of bundles of fibers are bio-composites of fibers from an Agave americana plant leaf.
However Gonzalez-Quevedo, in the same filed of endeavor, teaches a plurality of fibers forming a suture are a plurality of bundles of fibers are bio-composites of fibers from an Agave americana plant leaf (see pg. 1 second full paragraph).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Ohi to have the plurality of bundles of fibers are bio-composites of fibers from an Agave americana plant leaf as taught by Gonzalez-Quevedo, for the purpose of reducing patient rejections, and allowing them to be in place longer term (see Gonzalez-Quevedo pg. 1 second full paragraph).
Regarding claim 3, Ohi as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Ohi as modified further teaches the plurality of the bundles of the bio-composites of the fibers made from the Agave americana plant leaf has a high density, approximately following U.S.P. sizes from 0, 00, 3-0, 4-0, 5-0 and 6-0 (see 112b interpretation above; Ohi table 1 and Gonzalez-Quevedo pg. 1 third full paragraph).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Schmieding in view of Gonzalez-Quevedo as applied to claim 1 above, and further in view of Clark (US 861,231) and Boyden et al. (US 20110275912 A1).
Regarding claim 4, Schmieding as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schmieding as modified is silent regarding a Potassium permanganate (KMnO4) 0.1% solution mechanically adhered to the surgical suture.
However Clark, in the same filed of endeavor, teaches dipping a surgical suture in an antiseptic solution (see col. 1 ln. 20-35).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Schmieding as modified to dip the surgical suture in an antiseptic solution as taught by Clark, for the purpose of providing an antiseptic property to the patient through the suture (see Clark col. 1 ln. 20-35).
Boyden, in the analogous art, of coating for medical devices, teaches the antiseptic can be Potassium permanganate (see [0153]).
Therefore, the substitution of one known salt (potassium permanganate as taught in Boyden) for another (bismuth carbonate as taught in Schmieding as modified) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the potassium permanganate as taught in Boyden would have yielded predictable results, namely, an antiseptic solution that the suture can be dipped in. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Schmieding as modified does not expressly disclose the solution is 0.1% potassium permanganate solution.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the solution be 0.1% potassium permanganate solution because applicant has not disclosed that 0.1% is critical simply stating that it provides an antiseptic property (which any antiseptic solution would do). One of ordinary skill in the art, furthermore, would have expected Schmieding as modified’s solution, and applicant’s invention, to perform equally well with either the amount taught by Schmieding as modified or applicant’s because both amounts would perform the same function of coating the suture with an antiseptic.
Therefore, it would have been prima facie obvious to modify Schmieding as modified to obtain the invention as specified in claim 4 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Schmieding as modified.
Regarding claim 5, Schmieding as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schmieding further discloses a method of manufacturing the surgical suture of claim 1 (see [0034]).
Schmieding as modified is silent regarding chemically curing the surgical suture by immersion with a Potassium permanganate (KMnO4) 0.1% solution.
However Clark, in the same filed of endeavor, teaches dipping a surgical suture in an antiseptic solution (see col. 1 ln. 20-35).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Schmieding as modified to dip the surgical suture in an antiseptic solution as taught by Clark, for the purpose of providing an antiseptic property to the patient through the suture (see Clark col. 1 ln. 20-35).
Boyden, in the analogous art, of coating for medical devices, teaches the antiseptic can be Potassium permanganate (see [0153]).
Therefore, the substitution of one known salt (potassium permanganate as taught in Boyden) for another (bismuth carbonate as taught in Schmieding as modified) would have been obvious to one of ordinary skill in the art at the time of the invention since the substitution of the potassium permanganate as taught in Boyden would have yielded predictable results, namely, an antiseptic solution that the suture can be dipped in. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Schmieding as modified does not expressly disclose the solution is 0.1% potassium permanganate solution.
Before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person of ordinary skill in the art to have the solution be 0.1% potassium permanganate solution because applicant has not disclosed that 0.1% is critical simply stating that it provides an antiseptic property (which any antiseptic solution would do). One of ordinary skill in the art, furthermore, would have expected Schmieding as modified’s solution, and applicant’s invention, to perform equally well with either the amount taught by Schmieding as modified or applicant’s because both amounts would perform the same function of coating the suture with an antiseptic.
Therefore, it would have been prima facie obvious to modify Schmieding as modified to obtain the invention as specified in claim 4 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Schmieding as modified.
Schmieding as modified teaches the suture is chemically cured. Applicant discloses that dipping the suture into the potassium permanganate solution chemically sures the suture and Schmieding is modified to be dipped in a potassium permanganate solution.
Regarding claim 6, Schmieding as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Schmieding as modified further teaches the fibers of Agave americana is dip coated in the Potassium permanganate (KMnO4) 0.1% solution (see Clark col. 1 ln. 20-35 and claim 5 above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771