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 .
Response to Amendment
This office action is responsive to the amendment filed on 02/04/2026. As directed by the amendment: claims 1, 6, 7, 9, and 10 have been amended. Thus, claims 1-20 are presently pending in this application with claims 5 and 11-20 withdrawn.
Response to Arguments
Applicant’s arguments, see pg. 6, filed 02/04/2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections have been withdrawn.
Applicant’s arguments, see pg. 6, filed 02/04/2026, with respect to the rejection of claims 7, 9, and 10 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 7, 9, and 10 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pg. 7, filed 02/04/2026, with respect to the rejection(s) of claim(s) 1-3, 6, 8, 10 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Butwell.
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.
Claims 1-4 and 6-10 are 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 1 recites “A bio-dissolvable suturing needle…wherein the base comprises a remaining portion where the bio-dissolvable suturing needle was separated from at least one other bio-dissolvable suturing needle”. This claim is an apparatus claim directed to a single needle. The claim limitation “a remaining portion where the bio-dissolvable suturing needle was separated from at least one other bio-dissolvable suturing needle” requires a second needle in order to exist rendering the scope of the claim unclear.
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 1-3, 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (US 4,932,962) in view of Butwell et al. (US 5,928,268).
Regarding claim 1 Yoon discloses (fig. 1-2) a bio-dissolvable suturing needle 32, comprising: a tip 38; and a base 36 (see fig. 1 and col. 4 ln. 32-59).
Yoon does not expressly disclose the base comprises a remaining portion where the bio-dissolvable suturing needle was separated from at least one other bio-dissolvable suturing needle.
However Butwell, in the same field of endeavor, teaches (fig. 1-7) of a method of forming multiple suture needles, each comprising a tip 18 and a base 14 (see fig. 1 and col. 4 ln. 31-53), wherein the needles are attached to one another prior to separating to form individual needles (see fig. 7 and col. 5 ln. 24-42), wherein the base comprises a remaining portion (extra material on the base before polishing, see col. 5 ln. 34-42) where the needle was separated from at least one suturing needle (see col. 5 ln. 34-42).
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 Yoon to have the needle manufacture in a sheet of multiple needles such that it has a remaining portion where the bio-dissolvable suturing needle was separated from at least one other bio-dissolvable suturing needle as taught by Butwell, for the purpose of decreasing production time that it takes to produce multiple needles (see Butwell col. 3 ln. 20-30).
Regarding claim 2, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon further discloses (fig. 1-2) the base is configured to couple to bio-dissolvable or non-dissolvable suturing material.
Regarding claim 3, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon further discloses (fig. 1-2) further comprising: suturing material, wherein the suturing material is contiguously attached to the base, and wherein the suturing material is one of bio-dissolvable or non- dissolvable.
Regarding claim 6, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon further discloses (fig. 1-2) the bio-dissolvable suturing needle is made of at least one of: PLA and Polyglycolic Acid (PGA) (see col. 8 ln. 27-45).
Regarding claim 8, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon further discloses (fig. 1-2) the tip comprises a cutting needle (the needle is for penetrating tissue, therefore it is a cutting needle; see col. 4 ln. 32-54).
Regarding claim 10, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon further discloses (fig. 1-2) the tip extends at a same angle as a body of the bio-dissolvable suturing needle (fig. 1 shows the needle tip extending at the same angle as the body).
Claim 4 is rejected under 35 U.S.C. 103 as unpatentable over Yoon in view of Butwell.
Regarding claim 4, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1.
Yoon as modified teaches a needle made of a bio-dissolvable material by making a sheet of needles and separating them. Yoon as modified however is silent as to 3D printing the sheet of needles. The claimed phrase “the bio-dissolvable suturing needle is manufactured using 3-D printing” is being treated as a product by process limitation; that is, that the needle is made by 3-D printing. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113.
Thus, even though Yoon as modified is silent as to the process used to make the needle sheet, it appears that the product in Yoon would be the same or similar as that claimed; especially since both applicant’s product and the prior art product is made of a Polyglycolic Acid.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Butwell, as applied to claim 1 above, and further in view of Chen et al. (US 20170246472 A1).
Regarding claim 4, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1.
Yoon as modified teaches a needle made of a bio-dissolvable material by making a sheet of needles and separating them. Yoon as modified however is silent as to 3D printing the sheet of needles. The claimed phrase “the bio-dissolvable suturing needle is manufactured using 3-D printing” means that the needle is made by 3-D printing, as explained in the instant application.
Chen teaches that 3-D printing is a known method to form a needle out of (see [0118]).
Therefore, even if “3-D printing” results in different structural characteristics of the end product than other manufacturing methods, it still would have been prima facie obvious before the effective filing date of the claimed invention to use a “3-D printed” material in Yoon as claimed since Chen teaches that 3-D printing is recognized as a useful technique for forming needles.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Butwell, as applied to claim 1 above, and further in view of Matsutani et al. (JP H1170113 A).
Note that all references to Matsutani herein refer to the attached English translation.
Regarding claim 7, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon as modified is silent regarding the tip comprises a trussed point.
However Matsutani, in the same filed of endeavor, teaches a needle tip comprises a trussed point (see 112b rejection above, the needle tip has grooves; see fig. 3-5 and [0022] lines 20-32 which is the bottom half of pg. 9).
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 Yoon as modified to have the needle tip comprise grooves as taught by Matsutani, for the purpose of reducing the force needled to pierce tissue with the needle (see Matsutani [0022] lines 20-32 which is the bottom half of pg. 9).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yoon in view of Butwell, as applied to claim 1 above, and further in view of McGregor et al. (US 4,524,771).
Regarding claim 9, Yoon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Yoon as modified is silent regarding the tip extends at an angle different from a body of the bio-dissolvable suturing needle.
However McGregor, in the same filed of endeavor, teaches a needle tip that extends at an angle different from a body of the bio-dissolvable suturing needle (the needle tip has an angle that differs from the body; see fig. 1 and col. 3 ln. 40-53).
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 Yoon as modified to have the needle tip extend at an angle different from a body of the bio-dissolvable suturing needle as taught by McGregor, for the purpose of limiting feedback required from the needle to improve placement of the needle and allow suturing delicate tissue (see McGregor col. 2 ln. 28-38).
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771