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 .
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 03/03/2025 is acknowledged.
Claims 1-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/03/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: tissue retaining structures of claim 39 which are disclosed as barbs.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 30-31 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 30 recites the limitation "the wire" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 31 recites the limitation "the wire" in 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 23, 34, and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0268375 (Cichocki, Jr. ‘375) in view of US 2009/0209980 (Harris).
23. Cichocki, Jr. ‘375 disclose a method of suturing tissues (P0001), the method comprising:
(a) providing a suturing needle (needle 300), the suturing needle comprising: a needle tip portion having a needle tip (sharpened tip 312) at a distal end for piercing tissue (FIG. 13A; P0140); a needle body having a distal end connected to a proximal end of the needle tip portion (FIG. 13A; P0140); a flexible portion (see annotated FIG. 13A where the portion is “flexible” at P0008 and P0111) having a distal end connected to a proximal end of the needle body; a suture thread (suture 350) attached to a proximal end of the flexible portion by a thread attachment component (attachment post 314); and a tapered ramp (see annotated FIG. 13A where the connector 330 is “tapered” at least because it included rounded end 144) extending from the proximal end of the flexible portion and covering the thread attachment component and at least a portion of the suture thread (FIG. 13B; P0143-P0144).
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Cichocki, Jr. ‘375 discloses the invention substantially as claimed as discussed above and further discloses its method including suturing tissues (P0001) but does not disclose suturing tissues with a roller needle driver. Harris teaches a method in the same field of endeavor where tissues are sutured using a roller needle driver (FIG. 6-7; P0037) for the purpose of mechanically creating a running stitch (FIG. 6-7; P0037). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Cichocki, Jr. ‘375 to suture tissues using a roller needle driver as taught by Harris in order to mechanically create a running stitch. Harris teaches its method including:
(b) grasping, between rollers (gears 119) of the roller needle driver, the suture thread or the tapered ramp distal from the flexible portion (e.g., entirety of needle 11 is grasped between gears 119 as it is actuated in FIG. 6);
(c) loading the needle so that the rollers are positioned on the needle body without opening the rollers (FIG. 7; P0025-P0026);
(d) driving the needle through a tissue being subjected to suture (P0037);
(e) moving the needle through the tissue without releasing the needle from the tissue P0037);
(f) grasping the suture needle at an end exiting from the tissue through which the needle was moved (P0037); and
repeating steps (d) - (f) until completion of the suturing process (P0037).
34. The tapered ramp is formed of a biocompatible material (stainless steel at Abstract).
36. The needle tip portion is formed to become gradually thicker from the needle tip to the proximal end thereof (FIG. 13A).
37. The suture thread is mono-filamentary or multi-filamentary (FIG. 13A; P0061).
Claim(s) 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0268375 (Cichocki, Jr. ‘375) in view of US 2009/0209980 (Harris), as applied above to claim 23, and further in view of DE 3223153 (Beiter).
32. Cichocki, Jr. ‘375 discloses the invention substantially as claimed as discussed above and further discloses a first end of the tapered ramp proximal to the flexible portion has a diameter equal to a needle body diameter (FIG. 13B). However, Cichocki, Jr. ‘375 does not disclose a second end of the tapered ramp opposite the first end of the tapered ramp has a diameter equal to a suture thread diameter, and the tapered ramp provides a smooth transition from the first end to the second end thereof. Beiter teaches a method in the same field of endeavor having a needle with a first end of the tapered ramp proximal to the flexible portion has a diameter equal to a needle body diameter, a second end of the tapered ramp opposite the first end of the tapered ramp has a diameter equal to a suture thread diameter, and the tapered ramp provides a smooth transition from the first end to the second end thereof for the purpose of having an outer diameter with a smooth transition (FIG. 2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second end of the ramp of Cichocki, Jr. ‘375 to have a diameter equal to a suture thread diameter with the ramp providing a smooth transition from the first end to the second end as taught by Harris in order to having an outer diameter with a smooth transition.
Claim(s) 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0268375 (Cichocki, Jr. ‘375) in view of US 2009/0209980 (Harris), as applied above to claim 23, and further in view of US 5,156,615 (Korthoff).
33. Cichocki, Jr. ‘375 discloses the invention substantially as claimed as discussed above but does not disclose the ramp being flexible or cyanoacrylate. Korthoff teaches a method in the same field of endeavor having a flexible ramp including cyanoacrylate for the purpose of securing the needle to the thread with shrinkable tubing (FIG. 1-2; Abstract and col. 9, lns. 18-53). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ramp of Cichocki, Jr. ‘375 to be flexible and include cyanoacrylate as taught by Korthoff in order to secure the needle to the thread with a shrinkable tubing.
Claim(s) 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0268375 (Cichocki, Jr. ‘375) in view of US 2009/0209980 (Harris), as applied above to claim 23, and further in view of US 2013/0226233 (D’Agostino).
38. Cichocki, Jr. ‘375 discloses the invention substantially as claimed as discussed above but does not disclose the suture thread being bioabsorbable. D’Agostino teaches a method in the same field of endeavor having a bioabsorbable suture thread (P0101) for the purpose of breaking down and absorbing the suture after introduction into a tissue (P0101). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suture thread of Cichocki, Jr. ‘375 to be bioabsorbable as taught by D’Agostino in order to break down and absorb the suture after introduction into a tissue.
39-41. Cichocki, Jr. ‘375 discloses the invention substantially as claimed as discussed above but does not disclose the suture thread having barbs. D’Agostino teaches a method in the same field of endeavor having a suture thread with barbs (P0123) for the purpose of allowing movement of the thread in tissue in one direction and resisting movement of the thread in tissue in the opposite direction (P0123). The at least one region of tissue retaining structures is distal from the tapered ramp (FIG. 1). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suture thread of Cichocki, Jr. ‘375 to include barbs as taught by D’Agostino in order to allow movement of the thread in tissue in one direction and resist movement of the thread in tissue in the opposite direction.
Claim(s) 42 is rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0268375 (Cichocki, Jr. ‘375) in view of US 2009/0209980 (Harris), as applied above to claim 23, and further in view of US 2020/0268379 (Cichocki, Jr. ‘379).
42. (New) The method of claim 23, wherein the suturing needle is hardened by at least one of thermal treatment or siliconization.
42. Cichocki, Jr. ‘375 discloses the invention substantially as claimed as discussed above but does not disclose the needle being hardened by thermal treatment. Cichocki, Jr. ‘379 teaches a method in the same field of endeavor having a needle hardened by thermal treatment (P0013 and P0016) for the purpose of strengthening, stiffening, and hardening the needle (P0016). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle of Cichocki, Jr. ‘375 to have been hardened by thermal treatment as taught by Cichocki, Jr. ‘379 in order to strengthen, stiffen, and harden the needle.
Allowable Subject Matter
Claims 18-31 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kelly Bekker can be reached on 571-272-2739. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/ Primary Examiner, Art Unit 3771