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 I, claims 10-18, drawn to a device for inserting suture in the reply filed on 09/23/2026 is acknowledged. Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 15, 17 and 18 are objected to because of the following informalities:
In claim 15 “said barbed anchor articles” should read “said plurality of barbed anchor articles for consistency.
Claim 17 should read “each of said plurality of barbed anchor articles comprises…”
Claim 18 should read “said plurality of barbed anchor articles comprises…”
Appropriate correction is required.
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.
Claim Rejections - 35 USC § 112
Claims 10-18 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 10 recites the limitation "said drawn through said plurality of barbed anchor articles" in line 7. There is insufficient antecedent basis for this limitation in the claim. It appears that the word “said” is a typo and that claim 10 should read “said length of suture material is moved with respect to [[said]] and drawn through said plurality of barbed anchor articles” based on the specification (see paragraph [0119]). The Examiner has interpreted the limitations of claim 10 this way for examination purposes.
Claims 11-18 are similarly rejected by virtue of their dependency from claim 10.
Claim limitation “means to draw said suture material” recited in claim 11 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
The specification merely states that “[s]ome embodiments of the device may additionally comprise means to draw said suture material so that it is drawn through said plurality of barbed anchor articles once placed into tissue, so as to approximate said opposed tissue surfaces” (see paragraph [0026]). However, it is unclear what corresponding structure of the device performs the function of drawing the suture material.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For examination purposes, “means to draw said suture material” in claim 11 has been
interpreted as any structure capable of drawing suture material.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gambale et al. (US 20040138704 A1).
Regarding claim 10, Gambale discloses a device (472, see Fig. 24A-24F) for inserting a suture material (470, see Fig. 23A-23B) adapted to be anchored into opposed tissue surfaces (306), and to approximate said opposed tissue surfaces (see Fig. 23B and [0075]), said device comprising: a. a containment portion (474) adapted to contain and dispense a length of an elongate suture material, said length of an elongate suture material having a plurality of barbed anchor articles slidingly disposed along said length of an elongate suture material, and shaped so as to resist the withdrawal from tissue once placed into tissue as said length of suture material is moved with respect to and drawn through said plurality of barbed anchor articles once placed into tissue (suction chamber 474 contains tether 470 with darts 460 slidingly arranged along the length of the tether and capable of resisting migration from the tissue after implantation, see [0075] and Fig. 24A); and b. an insertion portion (478) adapted to insert at least one of said plurality of barbed anchors in a series into each of said opposed tissue surfaces (auger spring 478 drives darts 460 into tissue, see [0076]).
Regarding claim 11, Gambale discloses the device according to claim 10 additionally comprising means to draw said suture material (480, see Fig. 24A) so that it is drawn through said plurality of barbed anchor articles once placed into tissue, so as to approximate said opposed tissue surfaces (torque cable 480 is considered a means to draw the suture material since spring 478 rotates under motion from the torque capable and spring 478 can be rotated to tighten the tether 470 between two darts 460, see [0076]).
Regarding claim 12, Gambale discloses the device according to claim 10 wherein each of said plurality of barbed anchor articles comprise barbs of sufficient number and length so as to resist the withdrawal once placed into tissue (darts 460 are configured to resist withdrawal from tissue and include a plurality of barbs, where each point of the distal tip 462 can be considered a barb, see Fig. 23A).
Regarding claim 13, Gambale discloses the device according to claim 10 wherein each of said plurality of barbed anchor articles comprise barbs numbering from 2 to 10 (darts 462 each have 3 barbs, see Fig. 23A).
Regarding claim 14, Gambale discloses the device according to claim 10 wherein each of said plurality of barbed anchor articles comprises an aperture (466) adapted to allow said length of an elongate suture (470) to slidingly pass (see Fig. 23A-23B).
Regarding claim 15, Gambale discloses the device according to claim 14 wherein each of said plurality of barbed anchor articles comprise barbs numbering at least 3 (darts 462 each have 3 barbs, see Fig. 23A).
Regarding claims 16, 17 and 18, while Gambale expressly discloses the device (472) is configured to contain and insert a length of an elongate suture material having a plurality of barbed anchor articles as claimed in claim 10, it is noted that the suture material and plurality of barbed anchor articles are not positively recited in claim 10 and are therefore not structural requirements of the claimed device.
The language “wherein each of said barbed anchor articles has a perimeter and a geometric center, and a slot extending from said perimeter toward said geometric center, said slot of sufficient width to accommodate the sliding engagement of said length of said elongate suture material passing therethrough, once said barbed anchor article is placed into tissue,” “wherein each of said barbed anchor articles comprises at least 2 barbs on a first side thereof and said slot on a second side thereof” and “wherein said plurality of barbed anchor articles comprises a resorbable material” therefore constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim is an apparatus claim and is to be limited by structural limitations. The Office submits that the device of Gambale meets the structural limitations of the claims and is capable of being used with a suture material having a plurality of barbed anchor articles having the claimed features.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Evans et al. (US 20090137862 A1), Shelton et al. (US 20040138683 A1) and Akopov et al. (US 5484451 A) teach barbed anchor articles having a perimeter and a geometric center, and a slot extending from said perimeter toward said geometric center, said slot of sufficient width to accommodate the sliding engagement of a length of said elongate suture material passing therethrough and each of said barbed anchor articles comprises at least 2 barbs on a first side thereof and said slot on a second side thereof (see Evans Fig. 9A-11, Shelton Fig. 5H and Akopov Fig. 1-13).
Shelton et al. (US 20040138683 A1) also teaches a related device for inserting a suture (see Fig. 12 and [0069]]).
James et al. (US 20040210241 A1) teaches a related device for inserting a suture (see Fig. 2, steps 7-12) and anchors made of resorbable material (see [0013]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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