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
Claims 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/03/2025.
Applicant’s election without traverse of claims 1-21 in the reply filed on 11/03/2025 is acknowledged.
Claim Objections
Claims 1-21 are objected to because of the following informalities:
Throughout the claims there is a comma missing after the claim numbers such as “The device of claim 1”. For grammatical purposes, the examiner suggests to include a comma after the claim number i.e. “The device of claim 1, “.
Claim 11, line 1: “the tubular segment second end” which should recite “the second end of the tubular segment”.
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 4-5, 7-8 and 17 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.
Claims 4 and 5 recite the limitation "the projection" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the projection” is interpreted as “a projection”
Claims 7 and 8 recite the limitation "the shaft end" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the shaft end” is interpreted as “a shaft end”.
Claim 17 recites “wherein the aperture has an aperture diameter substantially equal to an inner diameter of the sheath”. It is unclear to the examiner the scope of the claimed diameters recited that would be considered as “substantially equal” to meet the claim language. Under broadest reasonable interpretation, “substantially” is defined as “being largely but not wholly that which is specified” (see attached Merriam-Webster dictionary definition of “substantial”). For examination purposes, the limitation will be interpreted as “wherein the aperture has an aperture diameter being largely but not wholly equal to an inner diameter of the sheath”.
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:
“indexing structure” in claim 19. The limitation describing the indexing structure (to enable controllable rotation of an object engaged with the foot and the shaft; functional language) fails to include sufficient structure to perform the recited function of "enabling control". The specification describes the indexing structure as a structure that can includes “a portion raised above a jaw face of the foot” (page 6, lines 13-14) and/or “a sidewall or a polygonal stud” (page 3, lines 14-15). Therefore, the indexing structure is interpreted as a structure that can includes “a portion raised above a jaw face of the foot”, “a sidewall”, “a polygonal stud” or any structural equivalent thereof that enables controlled rotation of an object engaged with the foot and the shaft.
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 § 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) 1-16 and 18--21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Torrie et al. (US 20220104804) [hereinafter Torrie].
Regarding claim 1, Torrie discloses a device 100 (Fig. 5, para. 0046) comprising:
a tubular segment (interpreted as working end 104 which is a segment of tubular shaft 103) having a first end face (see annotated Fig. 6A below, para. 0047), a second end (see annotated Fig. 6A below, para. 0047), a center axis L-L (Fig. 6A, para. 0047), and a sidewall (see annotated Fig. 6A below, para. 0047), the first end face contiguous with the second end and aligned on the center axis (see Fig. 6A, para. 0047), the sidewall having an aperture 125 disposed proximate to the first end face and between the first end face and the second end (Fig. 6A, para. 0047); and
a shaft 110 configured for axial movement relative to the tubular segment 104 and within a portion of the tubular segment 104 (Figs. 6A-C, para. 0047), the shaft 110 configured to exert a clamping force between a distal end of the shaft 110 and a portion of the first end face (Fig. 6C, para. 0050).
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Annotated Fig. 6A Torrie
Regarding claim 2, Torrie discloses wherein the first end face is cantilevered to the sidewall (See Figs. 6A-B, 6D which illustrates the first end face affixed to the sidewall, para. 0051. The examiner notes that the interpretation is in light of page 2, lines 9-11 of the instant application’s specification).
Regarding claim 3, Torrie discloses further including a projection affixed to a portion of the first end face (see annotated Fig. 6A [1] of Torrie below).
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Annotated Fig. 6A [1] of Torrie
Regarding claim 4, Torrie discloses wherein the projection includes a linear dimension aligned with a segment of the sidewall (see annotated Fig. 6A [1] of Torrie above).
Regarding claim 5, Torrie discloses wherein the projection includes a cross section (see Fig. 6D, para. 0050-0051) configured to control rotary motion about the center axis (see note below).
Note: “configured to control rotary motion about the center axis” is interpreted as functional language and intended use of the device. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Torrie discloses all of the structural components (i.e. a projection having a cross-section) required for the functional limitation, Torrie thereby discloses the functional limitation such that the projection is capable of controlling rotary motion about the center axis. For example, the cross-section of the projection triangular such that it supports needle 110 (see Fig. 6D, para. 0051). Depending on the size of the needle, the cross-section of the projection is capable of allowing rotation of the needle about the center axis. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 6, Torrie discloses wherein the first end face is oblique relative to the center axis.
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Annotated Fig. 6A [2] of Torrie
Regarding claim 7, Torrie discloses wherein the shaft end (interpreted as a shaft end, see 112(b) rejection above) is oblique relative to the center axis (see annotated Fig. 6A [3] of Torrie below).
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Annotated Fig. 6A [3] of Torrie
Regarding claim 8, Torrie discloses wherein the shaft end (interpreted as a shaft end, see 112(b) rejection above) is rounded (see Figs. 6C which illustrates a rounded tubular body of the shaft such that a proximal end of the shaft is rounded).
Regarding claim 9, Torrie discloses wherein the aperture 125 includes an edge having a non- perpendicular angle relative to the center axis (see annotated Fig. 6A [4] of Torrie below).
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Annotated Fig. 6A [4] of Torrie
Regarding claim 10, Torrie discloses wherein a proximal end of the shaft 110 is configured to engage with a manual actuator tool (interpreted as needle actuator 102).
Regarding claim 11, Torrie discloses wherein the tubular segment 104 second end is configured to engage with a manual actuator tool (interpreted as needle actuator 102).
Regarding claim 12, Torrie discloses a device comprising:
a shaft 110 within a sheath 103 (Figs. 5, 6A-C, para. 0046-0047), wherein the shaft 110 is configured for axial movement relative to the sheath (para. 0047, 0050-0052); and
a foot affixed to the sheath 103 (Fig. 5, see annotated Fig. 6A [5] below, para. 0046), wherein a portion of the foot is aligned with a longitudinal axis L-L of the shaft 110 (Figs. 5, see annotated 6A [5] below, para. 0046-0047), and wherein the sheath 103 includes a throat portion 126 adjacent the foot (see annotated Fig. 6A [5] below, para. 0047).
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Annotated Fig. 6A [5] of Torrie
Regarding claim 13, Torrie discloses wherein the throat portion 126 includes an aperture 125 in a sidewall of the sheath (see annotated Fig. 6A [5] above, para. 0047).
Regarding claim 14, Torrie discloses wherein the foot includes a clamp face aligned oblique with the longitudinal axis (see annotated Fig. 6A [6] of Torrie below).
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Annotated Fig. 6A [6] of Torrie
Regarding claim 15, Torrie discloses wherein the shaft 110 is configured to exert a compressive force in a direction of the clamp face (Figs. 6A-6D, para. 0047, 0050-0051).
Regarding claim 16, Torrie discloses wherein the foot includes an aperture 140 aligned with the longitudinal axis (Figs. 6A-6F, para. 0049, 0051).
Regarding claim 18, Torrie discloses wherein the foot includes a tooth aligned parallel with the longitudinal axis.
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Annotated Fig. 6A [7] of Torrie
Regarding claim 19, Torrie discloses wherein the foot includes an indexing structure (interpreted as projection formed by spring arms 31, see 112(f) interpretation above) to enable controllable rotation of an object engaged with the foot and the shaft (Fig. 6D, para. 0050-0051, note below).
Note: “to enable controllable rotation of an object engaged with the foot and the shaft” is interpreted as functional language and intended use of the device. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Since Torrie discloses all of the structural components (i.e. a foot having an indexing structure) required for the functional limitation, Torrie thereby discloses the functional limitation such that the indexing structure is capable of controlling rotation of an object engaged with the foot and the shaft. For example, the cross-section of the indexing structure is triangular such that it supports needle 110 (see Fig. 6D, para. 0051). Depending on the size of the needle, the cross-section of the projection is capable of allowing rotation of the needle about the longitudinal axis such that an object, like a leaflet 10a, may rotate when engaged with the foot and the shaft (Fig. 6C, para. 0050). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 20, Torrie discloses wherein the indexing structure includes a sidewall 133a (Fig. 6D, para. 0051).
Regarding claim 21, Torrie discloses wherein the shaft 110 includes a conical end profile (see Figs. 7C-D, para. 0048).
Additional claim 12 rejection to reject claim 17
Claim(s) 12 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sinnott et al. (US 20130158570).
Regarding claim 12, Sinnott discloses a device 100 (Fig. 1, para. 0052) comprising:
a shaft 350 within a sheath 430 (Figs. 8A-C, para. 0054-0055), wherein the shaft 350 is configured for axial movement relative to the sheath 430 (Figs. 8A-C, para. 0056-0057); and
a foot 468 affixed to the sheath 430 (Figs. 8A-B, 10A, para. 0055, 0058), wherein a portion of the foot 468 is aligned with a longitudinal axis of the shaft 350 (Figs. 8B-C, 10A, para. 0055-0057), and wherein the sheath 430 includes a throat portion (interpreted as portion comprising elbow 462 having a first, proximal portion 464) adjacent the foot 468 (Fig. 10A, para. 0058).
Regarding claim 16, Sinnott discloses wherein the foot 468 includes an aperture 472 aligned with the longitudinal axis (Figs. 8B-8C, 9-10A, para. 0060).
Regarding claim 17, Sinnott discloses wherein the aperture 472 has an aperture diameter substantially equal to an inner diameter of the sheath 430 (see 112b rejection above, Figs. 8B-C, 19-20A, para. 0055, 0060).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771