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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 2/24/2025, 7/30/2025, 11/25/2025 and 4/1/2026 have been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numerals “56” and “62” in at least Fig. 4, and “556” in at least Fig. 10B. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 18-21 are objected to because of the following informalities:
In claim 18 (and thereby dependent claims 19-21), there is an instance of rough grammar in line 2 at “in a side wall of aperture” (wherein a minor amendment such as “in a side wall of the aperture” will moot this objection); and
In claim 19 (and thereby dependent claim 20), there is an instance of rough grammar in line 2 at “in a side wall of aperture” (wherein a minor amendment such as “in a side wall of the aperture” will moot this objection).
Appropriate correction is required.
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 11-14 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 11 recites the limitation "the through hole" in line 2. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 (and thereby dependent claims 13-14) recites the limitation "the reduced thickness region" in line 3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 14 recites the limitation "the through hole" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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.
Claim(s) 1-7, 15-17 and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zenz-Olson et al. (US 2019/0175328).
Zenz-Olson discloses (see Figs. 6, 12A and 12E) a medical implant delivery system comprising the following claim limitations:
(claim 1) An implant delivery system (40, Fig. 6), the implant delivery system comprising: a delivery shaft (44, Fig. 6) including a proximal portion (not shown, but located above the truncated line on sheath 42 in Fig. 6) and a distal portion (50, Fig 6); and a frame (46, Fig. 6) coupled to the distal portion (50) of the delivery shaft (44) (as shown in Fig. 6), wherein the frame (46) includes a body portion (56, Fig. 6) and a plurality of attachment arms (64, Fig. 6) extending away from the body portion (56) (as shown in Fig. 6); and at least one soft tissue anchor (94, Fig. 12A/694, Fig. 12E) (see Abstract; [0059]; [0142]-[0145]; [0158]-[0164]; a variety of tack members are disclosed and may be used) releasably secured to a free end (free end shown adjacent apertures 70 in Fig. 6) of at least one of the plurality of attachment arms (64) (as shown in Fig. 6); and an implant (12, Fig. 6) releasably secured to the frame (46) via the at least one soft tissue anchor (94, Fig. 12A/694, Fig. 12E);
(claim 2) wherein the at least one soft tissue anchor (94, Fig. 12A/694, Fig. 12E) is configured to (i.e., capable of) remain in a body with the implant (12) (see claim 41; [0029]; [0142]; tack members expressly di9sclsoed to remain engaged with the bony structure);
(claim 3) wherein the at least one tissue anchor (94, Fig. 12A/694, Fig. 12E) comprises a proximal head portion (640, Fig. 12E), a distal fixation end (654, Fig. 12E), and an intermediate connecting portion (652, Fig. 12E) extending between the proximal head portion (640) and the distal fixation end (660) (as shown in Fig. 12E);
(claim 4) wherein the proximal head portion (640) is generally disc-shaped (as shown in annotated Fig. 12E below);
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(claim 5) wherein the distal fixation end (654) comprises a first barb (653A, Fig.12E) and a second barb (653B, Fig.12E) (as shown in Fig. 12E);
(claim 6) wherein the intermediate connection portion (652) comprises an elongate rod (as expressly shown in Fig. 12E; shaft 652 is depicted as an elongate rod);
(claim 7) further comprising a recess (70, Fig. 6) formed in the at least one of the plurality of attachment arms (64) adjacent to the free end thereof (as shown in Fig. 6);
(claim 15) wherein the proximal head portion (640) further comprises one or more radially extending tabs (as shown in annotated Fig. 12E below);
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(claim 16) further comprising an aperture (70, Fig. 6) formed through the at least one of the plurality of attachment arms (64) adjacent the free end thereof (as shown in Fig. 6; [0091]-[0093]);
(claim 17) where the aperture (70) extends through a thickness of the at least one of the plurality of attachment arms (64) (as shown in Fig. 6; [0091]-[0093]; apertures 70 expressly may comprises holes/openings extending all the way through entire thickness arm 64);
(claim 22) wherein the proximal head portion (640) further comprises one or more radially extending detents (circumferential detent shown in annotated Fig. 12E below);
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(claim 23) wherein the detent extends about a circumference of the proximal head portion (640) (as expressly shown in annotated Fig. 12E above);
(claim 24) further comprising an aperture (70, Fig. 6) formed through the at least one of the plurality of attachment arms (64) adjacent the free end thereof (as shown in Fig. 6; [0091]-[0093]); and
(claim 25) where the aperture (70) extends through a thickness of the at least one of the plurality of attachment arms (64) (as shown in Fig. 6; [0091]-[0093]; apertures 70 expressly may comprises holes/openings extending all the way through entire thickness arm 64).
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bouduban et al. (US 2018/0036003).
Bouduban discloses (see Figs. 1-3 and 5-9) a medical implant delivery system comprising the following claim limitations:
(claim 1) An implant delivery system (40, Figs. 5-9), the implant delivery system comprising: a delivery shaft (42, Fig. 5) including a proximal portion (i.e., attached to handle 57 in Fig. 5) and a distal portion (i.e., adjacent to plate 13 in Fig. 5 ); and a frame (13, Figs. 1-3) coupled to the distal portion of the delivery shaft (42) (as shown in Fig. 7), wherein the frame (13) includes a body portion (i.e., sidewalls surrounding central hole 31, Figs. 1-3) and a plurality of attachment arms (i.e., each of the four triangular arm portions extending from the central hole 31 walls to a hole 32, as shown in Fig. 1) extending away from the body portion (i.e., adjacent 31) (as shown in Fig. 1); and at least one soft tissue anchor (14, Figs. 1-3) releasably secured to a free end (free triangular ends shown adjacent apertures 32 in Figs. 1-2) of at least one of the plurality of attachment arms (as shown in Figs. 1-2); and an implant (72, Figs. 8-9) releasably secured to the frame (13) via the at least one soft tissue anchor (14) (as shown in Figs. 8-9);
(claim 2) wherein the at least one soft tissue anchor (14) is configured to (i.e., capable of) remain in a body with the implant (72) (as shown in Figs. 8-9; [0037]-[0038]; [0055]);
(claim 3) wherein the at least one tissue anchor (14) comprises a proximal head portion (i.e., proximal end of cylindrical anchor shaft 14 that is adjacent to staple body 12 in Fig. 1), a distal fixation end (i.e., distal end portion of leg 14, as shown in Figs. 1-3), and an intermediate connecting portion (i.e., intermediate shaft portion of leg 14, as shown in Figs. 1-3) extending between the proximal head portion and the distal fixation end (as shown in Figs. 1-3);
(claim 4) wherein the proximal head portion is generally disc-shaped (i.e., upper cylindrical anchor shaft 14 that is adjacent to staple body 12 in Fig. 1 is generally round and disc-shaped);
(claim 5) wherein the distal fixation end comprises a first barb (i.e., first tooth 18, Fig. 3) and a second barb (i.e., a second tooth 18, Fig. 3);
(claim 6) wherein the intermediate connection portion comprises an elongate rod (as expressly shown in Figs. 1-3; intermediate portion of shaft 13 is depicted as an elongate rod);
(claim 7) further comprising a recess (28, Fig. 1) formed in the at least one of the plurality of attachment arms adjacent to the free end (free triangular ends shown adjacent apertures 32) thereof (as shown in Figs. 1 and 3);
(claim 8) wherein the recess (28) extends partially through a thickness of the at least one of the plurality of attachment arms to define a reduced thickness region (as best shown in Figs. 1 and 3; recess 28 has a reduced thickness region as compared to the lateral sides 26a/26b/26c/26d);
(claim 9) further comprising a through hole (32, Fig. 1) extending through the reduced thickness region (28) (as shown in Fig. 1);
(claim 10) wherein the recess (28) is configured to (i.e., capable of) receive the proximal head portion (i.e., upper portion of shaft 14) of the at least one soft tissue anchor (14) therein (as shown in Figs. 2-3); and
(claim 11) wherein the intermediate connection portion (i.e., intermediate portion of shaft 14) extends through the through hole (32) (as shown in Figs. 2-3).
Allowable Subject Matter
Claims 12-14, 18-21 and 26-30 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. It is noted that claims 12-14 remain subject to 112 rejections and claims 18-21 remain subject to claim objections that must be resolved before any of these claims can be re-written into proper form for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, 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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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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