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 INTERPRETATION
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: structure permitting displacement of the needle assembly in claim 13.
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 13 function: ‘permitting displacement of the needle assembly’ and ‘resisting displacement of the needle assembly’.
Corresponding structure: barbs, catch surface;(Fig. 19;[0075]). The claim is construed to cover this structure and equivalents.
If applicant believes ‘structure permitting displacement of the needle assembly connotes sufficient structure, applicant is invited to amend or provide evidence that the term is understood as structural by a POSITA. If the specification lacks structure linked to the function, claims 13-15 are further rejected under 35 U.S.C. 112(b) as indefinite for failure to disclose corresponding structure for a §112(f) limitation. See MPEP § 2181(II)(B).”
Double Patenting
This is an actual non-statutory double patenting rejection over U.S. Patent No. 10,639,028, which is commonly owned with the present application (Boston Scientific).Claims 1, 2, 6-9, 11, 12, 16, 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 6, 8, 10, 13 of U.S. Patent No. 10,639,028. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 6-9, 11, 12, 16, 18 under examination are anticipated by claims 1, 3, 4, 6, 8, 10, 13 of the reference patent. Every limitation in the application under examination is recited in the conflicting reference patent claims, and the differences between the claims are highlighted below by bolding all limitations that differ, italicizing additional limitations, and underlining limitations that will be addressed below.
Instant claims of Application 19/029145
Corresponding claims of U.S. Patent No. 10,639,028
A needle assembly for use in association with a suturing device having a movable needle holder arm and a length of suture, the needle assembly comprising: needle body extending along an axis and having a first end and a second end a side wall extending between the first end and the second ends; a needle tip extending from the first end of the needle body; a suture segment extending from the needle body at a transverse orientation relative to the axis of the needle body and defining an opening for slidably receiving a length of suture so that the needle body is displaceable along through the length of suture passage during use of the needle assembly.
A needle assembly for use in association with a suturing device having a movable needle holder arm, comprising: a) a needle including, a needle tip with a sharp end and a circumferential capture groove adjacent the sharp end, and a straight, tubular needle body having a first end adjacent the needle tip, a second end opposite the needle tip, a side wall extending between the first and second ends, and an axis extending between the first and second ends, the second end provided with retaining structure into which the needle holder arm is received so that the needle body can be removably retained on the needle holder arm; and b) a short length of first suture having a first end, a second end, and an opening for receiving a second suture therethrough, the first suture fixed at least the first end within the needle body, the first suture extending out of the side wall of the needle body at a transverse orientation relative to the axis.
2 and 12. The needle assembly of claim 1, wherein the opening defined by the suture segment is adjustable in size.
5.The needle assembly of claim 1, wherein: the opening is a suture loop at the second end of the first suture. The needle assembly of claim 5, wherein: the loop is adjustable in dimension.
6. The needle assembly of claim 1, wherein the opening defined by the suture segment is a looped portion of the suture segment.
4. The needle assembly of claim 1, wherein: the opening is a looped portion of the first suture.
7 and 8. The needle assembly of claim 6, wherein the suture segment has first and second ends fixed within the needle body to define the looped portion of the suture segment.
3. The needle assembly of claim 1, wherein: the first and second ends of the first suture are fixed within the needle body, and the first suture defines a loop between the two ends.
9 and 16. The needle assembly of claim 1, wherein the opening is defined within a latch mechanism.
8.The needle assembly of claim 1, wherein: the opening is defined within a latch mechanism fixed at the second end of the first suture.
10. The needle assembly of claim 9, the suture segment has a first end fixed with respect to the needle body, and a second end with the latch mechanism coupled thereto.
8. The needle assembly of claim 1, wherein: the opening is defined within a latch mechanism fixed at the second end of the first suture.
11. A suture and needle assembly comprising: a length of suture; and a needle assembly comprising: a needle body extending along an axis and having a first end and a second end and a side wall extending between the first end and the second end; a needle tip extending from the first end of the needle body; and a suture segment extending from the needle body at a transverse orientation relative to the axis of the needle body and defining an opening for slidably receiving the length of suture so that the needle body is displaceable along the length of suture during use of the needle assembly.
10.A needle assembly for use in association with a suturing device having a movable needle holder arm, comprising: a) a needle including, a needle tip with a sharp end and a circumferential capture groove adjacent the sharp end, and a straight, tubular needle body having a first end adjacent the needle tip, a second end opposite the needle tip, a side wall extending between the first and second ends, and an axis extending between the first and second ends, the second end provided with retaining structure into which the needle holder arm is received so that the needle body can be removably retained on the needle holder arm; and b) a short length of first suture having a first end, a second end, and an opening for receiving a second suture therethrough, the first suture fixed at least the first end within the needle body, the first suture extending out of the side wall of the needle body at a transverse orientation relative to the axis.
18. A needle system comprising: a first needle assembly comprising: a first needle assembly needle body extending along an axis and having a first end and a second end and a side wall extending between the first end and the second end; and a first needle assembly needle tip extending from the first end of the needle body; and a second needle assembly comprising: as second needle assembly needle body extending along an axis and having a first end and a second end and a side wall extending between the first end and the second end; a second needle assembly needle tip extending from the first end of the second needle assembly needle body; and a second needle assembly suture segment extending from the second needle assembly needle body at a transverse orientation relative to the axis of the second needle assembly needle body and defining an opening for slidably receiving a length of suture so that the second needle assembly needle body is displaceable along the length of suture during use of the needle system
The needle system for use in association with a suturing device having a movable needle holder arm, comprising: a) a first needle including, a needle tip with a sharp end, a straight needle body having a first end adjacent the needle tip, a second end opposite the needle tip, and an axis extending between the first and second ends, the second end provided with retaining structure at which the needle holder arm is couplable so that the needle body can be removably retained to the needle holder arm, and a first suture extending from the needle body, the first suture having a free proximal end, and a distal end fixed relative to the needle body; and b) at least one second needle, the at least one second needle including, a needle tip with a sharp end, a straight needle body having a first end adjacent the needle tip, a second end opposite the needle tip, and an axis extending between the first and second ends, the second end provided with retaining structure at which the needle holder arm is couplable so that the needle body can be removably retained to the needle holder arm, and a second suture extending from the needle body, the second suture provided with or defining an opening at which the at least one second needle is advanceable over the proximal end of the first suture toward the distal end of the first suture.
As shown in the mapping above, claim 1 of the reference includes all the limitations of claim 1 of the instant application, while also reciting further limitations. Claim 1 of the instant application differs from claim 1 of the reference patent in that it recites a “suture segment” rather than a “short length of first suture.” However, the instant disclosure at paragraph [0022-0023] shows that “short length of first suture” falls within the broadest reasonable interpretation of the category encompassed by suture segment. Thus, the “short length of first suture” of the reference patent claim 1 anticipates the suture segment of claim 1 of the instant application.
Allowable Subject Matter
Claims 3-5, 13-15, 17, 19, and 20 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bielefeld (US 2014/0214152A1) discloses a repair device that includes a body with an opening through which a suture extends but the body does not include a needle nor does the suture define the opening. Proto (US 6,056,771) discloses a needle having a needle tip and a suture disposed within an opening but the suture does not define an opening nor a loop.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOCELIN C TANNER whose telephone number is (571)270-5202. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571)272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOCELIN C TANNER/Primary Examiner, Art Unit 3771
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