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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/21/2026 has been entered.
This office action is responsive to the amendment filed on 05/21/2026. As directed by the amendment: claims 1-4 and 6-10 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 Thus, claims 1-20 are presently pending in this application with claims 5 and 11-20 withdrawn.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. 7, filed 05/21/2026, with respect to the rejection of claims 1-4 and 6-10 under 35 U.S.C. 103 have been fully considered and are persuasive. The rejection of claims 1-4 and 6-10 under 35 U.S.C. 103 has been withdrawn.
Applicant's arguments filed 05/21/2026 have been fully considered but they are not persuasive. Applicant argues that Yoon and Butwell do not disclose all of the amended claim features. The Office respectfully disagrees. As set forth below, Yoon and Butwell do teach all of the amended claim features. The Office notes that the recommendation made in the interview was to focus on the structure of the preform as shown in fig. 2, specifically a preform having a center point where four needles extend radially outward from the center portion with their ends being connected at that center point but their bodies and tips not being connected. The submitted claim language was much broader simply claim a plurality of needle tips and bases (which can be only 2) connected at a point. This broader language is taught by Butwell as set forth below.
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 claims 1 and 3 Yoon discloses (fig. 1-3) a unitary, bio-dissolvable (see col. 4 ln. 55-60), needle preform (form entering mold in fig. 3, see col. 5 ln. 16-21), comprising:
a of needle tip 38 (see fig. 1 and col. 4 ln. 55-66); a of needle base 36 (see fig. 1 and col. 4 ln. 32-59);
suturing material 34, wherein the suturing material is contiguously formed with the base as a continuous extension of the respective e needle tip and a connected needle base (see fig. 2 and col. 4 ln. 55 – col. 5 ln. 45), such that the suturing material 34, the needle base, and the needle tip are made of a same bio-dissolvable material (see col. 8 ln. 28-46), and wherein the suturing material is bio-dissolvable (see col. 4 ln. 55 – col. 5 ln. 45).
Yoon is silent regarding the needle preform being muilti-needle preform with a plurality of needle tips and a plurality of needle bases, each needle base in the plurality of needle bases connected to a needle tip in the plurality of needle tips; and a connecting point interconnecting the plurality of needle bases.
However Butwell, in the same field of endeavor, teaches (fig. 1-7) of a method of forming multiple suture needles, using a muilti-needle preform 40 with a plurality of needle tips 18 and a plurality of needle bases 20 (see col. 5 ln. 25-42), each needle base 20 in the plurality of needle bases connected to a needle tip 18 in the plurality of needle tips (see fig. 7); and a connecting point interconnecting the plurality of needle bases (portion between 2 of the needle bases as a plurality requires a minimum of 2).
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 preform being muilti-needle preform with a plurality of needle tips and a plurality of needle bases, each needle base in the plurality of needle bases connected to a needle tip in the plurality of needle tips; and a connecting point interconnecting the plurality of needle bases 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 as modified further teaches each base on the plurality of needle bases base is configured to couple to bio-dissolvable or non-dissolvable suturing material (see Yoon col. 4 ln. 55 – col. 5 ln. 45; and Butwell col. 4 ln. 31-53).
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 as modified further teaches a tip extends at a same angle as a body of the bio-dissolvable suturing needle (fig. 1 of Yoon shows the needle tip extending at the same angle as the body, also see fig. 7 of Butwell).
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 unitary, bio-dissolvable, multi-needle preform 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 unitary, bio-dissolvable, multi-needle preform 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 each tip in the plurality of needle tips 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 each tip in the plurality of needle tips 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 a tip in the plurality of needle tips extends at an angle different from a connected body.
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 a tip in the plurality of needle tips extends at an angle different from a connected body 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
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
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