DETAILED ACTION
The following Office Action is in response to the Response to Restriction filed on January 20, 2026. Claims 1-20 are currently pending, wherein of the pending claims, claim 19 is withdrawn from further consideration.
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 in the reply filed on January 20, 2026 is acknowledged.
Claim 19 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 January 20, 2026.
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 § 102
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.
Claim(s) 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stiggelbout (US 2015/0351743).
Concerning claim 20, the Stiggelbout prior art reference teaches a system for delivering tissue anchors into an operative space in a body of a patient (Figure 5; 200), comprising: a tissue anchor delivery device comprising a handle (Figure 5; 300) and an elongate shaft extending distally from the handle (Figure 5; 320); and a tissue anchor magazine separate and detached from the tissue anchor delivery device (Figure 5; 400), the tissue anchor magazine having a plurality anchors stored therein ([¶ 0077]), wherein the tissue anchor magazine is configured to be delivered subcutaneously into the operative space separate from the tissue anchor delivery device (Figure 5; cartridge 400 is capable of being inserted percutaneously prior to being coupled to handle).
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.
Claim(s) 1-8, 12-14, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Souls et al. (US 2018/0153550, hereinafter Souls) in view of Thierfelder et al. (US 2002/0028980, hereinafter Thierfelder).
Concerning claim 1, the Souls et al. prior art reference teaches a tissue anchor delivery device (Figure 1A; 100), comprising: a handle (Figure 1A; 110); an elongate shaft extending distally from the handle (Figure 1A; 102); a tissue anchor magazine coupled to the handle in communication with the elongate shaft (Figure 1A; 116), the tissue anchor magazine having a plurality of tissue anchors disposed therein (Figure 14B; 178); and a tissue anchor advancement mechanism configured to advance the plurality of tissue anchors from the tissue anchor magazine out the distal end of the elongate shaft (Figures 4AB); wherein the tissue anchor advancement mechanism is configured to advance only one tissue anchor of the plurality of tissue anchors along the length of the elongate shaft at a time ([¶ 0171]), but does not specifically teach the elongate shaft having a length from the handle to a distal end of the shaft of at least 10 cm.
However, the Thierfelder reference teaches a tissue anchor delivery device, therein being in the same field of endeavor as the Souls reference, the tissue anchor delivery device including a handle (Figure 11; 40) and an elongate shaft (Figure 11; 41), wherein the reference teaches that the elongate shaft may have a length from the handle to a distal end of the shaft of 28 cm or longer ([¶ 0072]).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the elongated shaft of the Souls reference be at least 10 cm as in the Thierfelder reference given the Thierfelder reference teaches such a length being appropriate for a laparoscopic tissue anchor delivery device (Thierfelder; [¶ 0072]).
Concerning claim 2, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches that each actuation of the tissue anchor advancement mechanism may be interpreted as advancing the only one tissue anchor of the plurality of tissue anchors only a portion of the length of the elongate shaft given “each actuation” may be interpreted as a partial turn of the drive wheel.
Concerning claim 3, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches the anchor advancement mechanism including a ratcheting feature (Figure 10AB; 170).
Concerning claim 4, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches the tissue anchor advancement mechanism comprising a pusher coiled within the handle (Figure 10A; 160), the pusher being configured to advance the only one tissue anchor of the plurality of tissue anchors along the length of the elongate shaft (Figures 18A-D; 160).
Concerning claim 5, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 4, wherein the Souls reference further teaches the pusher being configured to uncoil as the only one tissue anchor of the plurality of tissue anchors is advanced along the length of the elongate shaft (Figures 10AB; 160).
Concerning claim 6, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches the tissue anchor advancement mechanism comprising a plurality of gears disposed within the handle (Figure 4A; 124), the plurality of gears being arranged longitudinally relative to each other within the handle.
Concerning claim 7, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 6, wherein the Souls reference further teaches the tissue anchor advancement mechanism comprising a continuously looped element engaged with the plurality of gears (Figure 10AB; 126) and a pusher coupled to the continuously looped element (Figures 10AB; 160), the pusher being configured to advance the only one tissue anchor of the plurality of tissue anchors along the length of the elongate shaft.
Concerning claim 8, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 7, wherein the Souls reference further teaches at least a portion of the pusher being configured to at least partially wrap around the continuously looped element prior to advancing the only one tissue anchor of the plurality of tissue anchors along the length of the elongate shaft (Figure 10A; 160 | [¶ 0181]) and configured to extend away from the continuously looped element after advancing the only one tissue anchor of the plurality of tissue anchors along the length of the elongate shaft (Figure 10B; 160 | [¶ 0181]).
Concerning claim 12, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches the tissue anchor magazine being configured to be removably received within a receptacle formed in the handle ([¶ 0167]).
Concerning claims 13-14, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches the handle comprising a trigger pivotably coupled to the handle and configured to actuate the tissue anchor advancement mechanism (Figure 1A; 112).
Concerning claim 16, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches an automatic retraction apparatus configured to reset the tissue anchor advancement mechanism ([¶ 0057]).
Concerning claim 17, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 1, wherein the Souls reference further teaches the tissue anchor advancement mechanism comprising a pusher configured to engage the only one tissue anchor of the plurality of tissue anchors (Figures 18A-D; 160); wherein the pusher comprises a distal face (Figures 21A-D; 274) and a bevel extending proximally from the distal face to a bottom surface (Figures 21A-D; 268) such that a height of the distal face is less than a thickness of the only one tissue anchor of the plurality of tissue anchors (Figure 22A-D).
Concerning claim 18, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 17, wherein the Souls reference further teaches the bevel capable of engaging a subsequent tissue anchor of the plurality of tissue anchors and bias remaining tissue anchors of the plurality of tissue anchors away from the only one tissue anchor of the plurality of tissue anchors as the only one tissue anchor of the plurality of tissue anchors is advanced distally (Figure 18A-D; fin 175 associated with bevel may push remaining tissue anchors upwards away from pushed tissue anchor).
Claim(s) 9, 10, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Souls et al. (US 2018/0153550, hereinafter Souls) in view of Thierfelder et al. (US 2002/0028980, hereinafter Thierfelder) as applied to claims 1-8, 12-14, and 16-18 above, and further in view of Keating et al. (US 2017/0156723, hereinafter Keating).
Concerning claims 9, 10, and 15, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 6, wherein the Souls reference further teaches a pusher coupled to a drive member engaged with the plurality of gears and extending longitudinally therefrom, the pusher being configured to advance the only one tissue anchor of the plurality of tissue anchors along the length of the elongate shaft (Figures 10AB; 160), but does not specifically teach the tissue advancement mechanism comprising a linear rack engaged with the plurality of gears.
However, the Keating reference teaches a tissue anchor delivery device, therein being in the same field of endeavor as the Souls reference, wherein the Keating reference teaches a handle (Figures 1A-C; 110), an elongate shaft extending distally from the handle (Figures 1A-C; 120); and a tissue advancement mechanism configured to advance a plurality of anchors (Figure 2A), wherein the tissue anchor advancement mechanism comprises a linear rack (Figure 2A; 151) engaged with a plurality of gears (Figure 2A; 132, 136, 134, 139) and a pusher coupled to the linear rack and extending longitudinally therefrom (Figure 2A; 152), the pusher being configured to advance the tissue anchors, wherein the linear rack is configured to engage multiple different gears of the plurality of gears as the tissue anchor is advanced (Figure 2A; rack 152 engages gear wheel 139, which includes a plurality of gears), and wherein the tissue anchor advancement mechanism is further actuated via a trigger slidably coupled to the handle (Figure 2A; 111).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tissue anchor advancement mechanism of the Souls and Thierfelder combination include the rack structure and slidably coupled trigger as in the Keating reference as a simple substitution for one known pusher advancement and trigger structure for a tissue anchor advancement mechanism (the drive wheel and pivotable trigger of Souls) for another known pusher advancement and trigger structure for a tissue anchor advancement mechanism (the rack and slidable trigger of Keating), which would yield the predictable result in effectively functioning in the same manner.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Souls et al. (US 2018/0153550, hereinafter Souls) in view of Thierfelder et al. (US 2002/0028980, hereinafter Thierfelder) as applied to claims 1-8, 12-14, and 16-18 above, and further in view of McAllen, III et al. (US 6,319,258, hereinafter McAllen).
Concerning claim 11, the combination of the Souls and Thierfelder references as discussed above teaches the tissue anchor delivery device of claim 6, but does not specifically teach the tissue anchor magazine being integrally formed with the handle.
However, the McAllen reference teaches a tissue anchor delivery device, therein being in the same field of endeavor as the Souls reference, wherein the McAllen reference teaches a handle (Figure 2; 40); an elongate shaft (Figure 2; 26); a tissue anchor magazine coupled to the handle and in communication with the elongate shaft (Figure 2; 22), and a tissue anchor advancement mechanism (Figure 2; 7), wherein the tissue anchor magazine is integrally formed with the handle (Figure 2; 22).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the tissue anchor magazine of the Souls and Thierfelder combination have a magazine that is integral to the handle as opposed to removable from the handle as a simple substitution of one known tissue anchor magazine structure (removable magazine structure of Souls) for another known tissue anchor magazine structure (the integral magazine structure of McAllen), which would yield the expected result of operating in effectively the same manner.
Furthermore, it is noted that the Specification of the Instant Application presents an integral and removable tissue anchor magazine as being interchangeable, therein presenting them as obvious variants (Specification; Page 44, Lines 13-27).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tormala et al. reference (US 6,010,513) teaches a tissue anchor delivery device including a handle, a shaft, a tissue anchor magazine including a plurality of tissue anchors, and a tissue anchor advancement mechanism for advancing one tissue anchor at a time; the Trott et al. reference (US 6,074,395) teaches a tissue anchor delivery device including a magazine and a tissue anchor advancement magazine including a ratchet mechanism; and the Brown reference (US 2003/0222118) teaches a tissue anchor delivery device including a magazine including a plurality of tissue anchors, and a tissue anchor advancement mechanism for advancing one tissue anchor at a time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN TRUYEN TON whose telephone number is (571)270-5122. The examiner can normally be reached Monday - Friday; EST 10:00 AM - 6:30 PM.
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/MARTIN T TON/Examiner, Art Unit 3771 2/6/2026