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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/19/2026 has been entered.
Response to Amendment
In light of Applicant’s amendment, claim(s) 1, 3, 16, and 20 is/are amended. Claim 2 and 10-15 is/are canceled. Claims 21-26 are added. Claims 1, 3-9 and 16-26 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the added limitation “wherein the second proximal wall directs the suture distally” overcomes the previous rejection as written. However, a new grounds of rejection is made over Onuki.
Claim Objections
Claim 25 is objected to because of the following informalities:
Claim 25: “a distal portion have a first diameter” should read “a distal portion having a first diameter”
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.
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: “Actuation mechanism” in claim 1 and 16.
Claim 1 and 16 recite the limitation of a “actuation mechanism”. The term “mechanism” is used as a substitute for “means” and is modified by functional language “actuation”. There is no corresponding structure in the claim, therefore invoking 112(f). Based on the specification, the corresponding structure for “actuation mechanism” is “a pull wire” (Page 18) or equivalents thereof.
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
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, 3, 16-19, 23-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Onuki et al. (US 20030144673 A1).
Regarding claim 1, Onuki discloses a medical device for cutting a suture during a minimally invasive procedure, comprising:
an elongate shaft (4) having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end the distal end (the interpretation of Onuki’s shaft is consistent with Applicant’s use of the term in reference to Figure 10 such that the elongate shaft comprises multiple parts) (Figure 1; Paragraph 0043);
a handle (5) disposed at the proximal end of the elongate shaft, the handle including an actuation mechanism (13) (Figure 1; Paragraph 0045); and
a cutting blade (8) disposed proximate the distal end of the elongate shaft (Figure 3; Paragraph 0046);
wherein the cutting blade is axially translatable within a cutting blade lumen (lumen of 6) formed in the elongate shaft in response to operation of the actuation mechanism (Paragraph 0057; 0064);
wherein the elongate shaft includes a distal port (distal opening of 6) configured to receive a suture (18) therein (Figure 2; Paragraph 0043);
wherein the elongate shaft includes a transverse slot (26a) extending inward from an outer surface of the elongate shaft generally perpendicular to the central longitudinal axis (Figure 6; Paragraph 0050)
wherein the elongate shaft includes a side port (25b) positioned generally opposite the transverse slot relative to the cutting blade (Figure 1, 6; Paragraph 0050);
wherein the elongate shaft includes a suture lumen (7) extending from the distal port axially within the elongate shaft to the transverse slot (Figure 8; Paragraph 0043);
wherein the cutting blade lumen is radially offset from the suture lumen (Figure 2);
wherein the cutting blade intersects the transverse slot adjacent the suture lumen (Figure 4; Paragraph 0049; 0064);
wherein the transverse slot includes a first proximal wall (proximal wall of 26a) facing toward the distal end of the elongate shaft (Figure 1);
wherein the side port includes a second proximal wall (proximal wall of 25b) facing toward the distal end of the elongate shaft (Figure 1); and
wherein the second proximal wall directs the suture distally (Figure 1-3; Paragraph 0051).
Regarding claim 3, Onuki further discloses wherein the second proximal wall is disposed distal of the first proximal wall (Figure 1; Paragraph 0050).
Regarding claim 16, Onuki discloses a medical device for cutting a suture during a minimally invasive procedure, comprising:
an elongate shaft (4) having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end the distal end (the interpretation of Onuki’s shaft is consistent with Applicant’s use of the term in reference to Figure 10 such that the elongate shaft comprises multiple parts) (Figure 1; Paragraph 0043);
a distal tip member (22) fixedly attached to the distal end of the elongate shaft (Figure 1, 6; Paragraph 0049-50); and
a cutting blade (8) non-rotatably disposed within the distal tip member (Figure 1, 3; Paragraph 0046);
wherein the cutting blade is axially translatable within the distal tip member in response to operation of an actuation mechanism (13) disposed proximate the proximal end of the elongate shaft (Paragraph 0043; 0057);
wherein the distal tip member includes a distal port (distal opening of 6) configured to receive a suture (18) therein (Figure 2; Paragraph 0051);
wherein the distal tip member includes a transverse slot (26a) extending radially inward from an outer surface of the distal tip member generally perpendicular to the central longitudinal axis, the transverse slot being at least partially defined by a first proximal wall (proximal wall of 26a) facing distally (Figure 1; Paragraph 0050);
wherein the distal tip member includes a suture lumen (7) extending from the distal port axially within the distal tip member to the transverse slot (Figure 1-2);
wherein the cutting blade is axially translatable in a cutting blade lumen (lumen of 6) that is radially offset from the suture lumen (Figure 3-4; Paragraph 0046);
wherein the distal tip member includes a side port (25b) positioned generally opposite the transverse slot, the side port being at least partially defined by a second proximal wall (proximal wall of 25b) facing distally (Figure 1; Paragraph 0050);
wherein the second proximal wall is configured to direct the suture distally (Paragraph 0051); and
wherein the second proximal wall is axially offset from the first proximal wall along the central longitudinal axis (Figure 6).
Regarding claim 17, Onuki further discloses wherein the second proximal wall is offset distally from the first proximal wall (Figure 6).
Regarding claim 18, Onuki further discloses wherein the second proximal wall is oriented generally parallel to the first proximal wall (Figure 1) (the two proximal walls are generally parallel to each other as they both are “generally” perpendicular to the central axis).
Regarding claim 19, Onuki further discloses wherein the cutting blade is disposed between the first proximal wall and the second proximal wall (Figure 4).
Regarding claim 21, Onuki discloses a medical device for cutting a suture during a minimally invasive procedure, comprising:
an elongate shaft (4) having a proximal end, a distal end, and a central longitudinal axis extending from the proximal end the distal end (Figure 1; Paragraph 0043);
a handle (5) disposed at the proximal end of the elongate shaft, the handle including an actuation mechanism (13) (Figure 1; Paragraph 0045);
a suture lumen (7) defined within the elongate shaft, the suture lumen extending from a distal port (distal opening of 6) formed in the elongate shaft to a transverse slot (26 b) formed in the elongate shaft (Figure 1, 8; Paragraph 0043; 0050);
a side port (25a) formed in the elongate shaft generally opposite of the transverse slot (Figure 1, 6; Paragraph 0050);
a cutting blade lumen (lumen of 6) defined within the elongate shaft, the cutting blade lumen being radially offset from the suture lumen (Figure 2; Paragraph 0057);
wherein the cutting blade lumen includes a first portion (distal end of 8) that overlaps with the suture lumen and a second portion (proximal end of 8) disposed proximal of the suture lumen (Paragraph 0057; 0064) (Paragraph 0057 states the cutting sheath 8 is advanced while it is guided to the inner sheath 7“, meaning at some point at least part of the cutting sheath 8 was located proximal to the inner sheath 7);
a cutting blade (8) slidable disposed within the cutting blade lumen (Figure 1; Paragraph 0043); and
wherein the elongate shaft includes a wall surface (wall of 26b) positioned adjacent to the cutting blade lumen that is configured to direct a suture extending through the suture lumen and through the side port in a distal direction (Figure 1; Paragraph 0051).
Regarding claim 22, Onuki further discloses 22 wherein the side port extends distally of the transverse slot (Figure 1, 8).
Regarding claim 23, Onuki further discloses wherein a proximal end region of the side port axially overlaps with the transverse slot (Figure 2) (the space between the two 23 is considered a proximal end region of the side port and it is connected to the transverse slot).
Regarding claim 24, Onuki further discloses wherein the wall surface includes a distal face (distal wall of 26a) and a tapered surface (proximal wall of 26a) extending proximally from the distal face (Figure 8).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 4-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuki in view of Traynor et al. (US 20080228198 A1).
Regarding claim 4-7, Onuki discloses the medical device of claim 1 but fails to explicitly disclose wherein the cutting blade includes a flattened main body portion oriented substantially parallel to the central longitudinal axis; wherein the cutting blade includes a longitudinally oriented slot extending transversely therethrough; wherein the cutting blade further includes a sharpened cutting edge proximate a distal end of the cutting blade facing toward the proximal end of the elongate shaft and wherein proximal axial translation of the cutting blade relative to the elongate shaft translates the sharpened cutting edge toward the transverse slot.
However, Traynor is directed to a cutting device and teaches the cutting blade (116) includes a flattened main body portion (body of 116) oriented substantially parallel to the central longitudinal axis; wherein the cutting blade includes a longitudinally oriented slot (120) extending transversely therethrough (Figure 8C; Paragraph 0038); wherein the cutting blade further includes a sharpened cutting edge (116a) proximate a distal end of the cutting blade facing toward the proximal end of the elongate shaft (Figure 8C; Paragraph 0038); wherein proximal axial translation of the cutting blade relative to the elongate shaft translates the sharpened cutting edge toward the transverse slot (Paragraph 0031; 0038).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the cutting sheath of Onuki to become the cutting blade of Traynor such that the cutting blade includes a flattened main body portion oriented substantially parallel to the central longitudinal axis; wherein the cutting blade includes a longitudinally oriented slot extending transversely therethrough; wherein the cutting blade further includes a sharpened cutting edge proximate a distal end of the cutting blade facing toward the proximal end of the elongate shaft and wherein proximal axial translation of the cutting blade relative to the elongate shaft translates the sharpened cutting edge toward the transverse slot, as taught by Traynor, as both references and the claimed invention are directed to cutting devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuki with the teachings of Traynor by incorporating the cutting blade includes a flattened main body portion oriented substantially parallel to the central longitudinal axis; wherein the cutting blade includes a longitudinally oriented slot extending transversely therethrough; wherein the cutting blade further includes a sharpened cutting edge proximate a distal end of the cutting blade facing toward the proximal end of the elongate shaft and wherein proximal axial translation of the cutting blade relative to the elongate shaft translates the sharpened cutting edge toward the transverse slot in order to prevent accidental cutting to tissue.
Regarding claim 8, Onuki further discloses wherein the sharpened cutting edge is configured to cooperate with the transverse slot to cut a suture extending through the longitudinally oriented slot of the cutting blade (Figure 4; Paragraph 0051; 0057).
Regarding claim 20, Onuki disclsoes the medical device of claim 16 and further discloses a suture extends within the suture lumen, into the transverse slot, through a longitudinally oriented slot in the cutting blade (lumen of 8), and out the side port (Figure 3-5; Paragraph 0057) and translation of the cutting blade within the distal tip member causes cooperation between a sharpened cutting edge (15) of the cutting blade and the first proximal wall to cut the suture within the distal tip member (Figure 3-5; Paragraph 0057). Onuki fails to explicitly disclose the cutting blade is translated proximally within the distal tip member, the suture is configured to bias biases the cutting blade away from the second proximal wall and toward the first proximal wall such that further proximal translation of the cutting blade within the distal tip member causes cooperation between a sharpened cutting edge of the cutting blade and the first proximal wall to cut the suture within the distal tip member.
However, Traynor teaches wherein when a suture extends within the suture lumen, into the transverse slot, through a longitudinally oriented slot (120) in the cutting blade (116) (Figure 8A-B; Paragraph 0038) and the cutting blade is translated proximally within the distal tip member (112), the suture is configured to bias biases the cutting blade away from the second proximal wall and toward the first proximal wall such that further proximal translation of the cutting blade within the distal tip member causes cooperation between a sharpened cutting edge of the cutting blade and the first proximal wall to cut the suture within the distal tip member (Figure 8A-C; Paragraph 0038).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuki with the teachings of Traynor by incorporating the blade of Traynor with proximal translation to cut the suture in order to prevent inadvertent damage to the tissue during cutting.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuki in view of Gilbert et al. (US 20190357899 A1).
Regarding claim 9, Onuki discloses the medical device of claim 1, but fails to explicitly disclose wherein the elongate shaft includes a rounded distal cap secured to the distal end of the elongate shaft, wherein the rounded distal cap includes the distal port.
However, Gilbert is directed to a suture cutting device and teaches wherein the elongate shaft (14) includes a rounded distal cap (72) secured to the distal end of the elongate shaft, wherein the rounded distal cap includes the distal port (78+38) (Figure 4: Paragraph 0081).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Onuki such that wherein the elongate shaft includes a rounded distal cap secured to the distal end of the elongate shaft, wherein the rounded distal cap includes the distal port, as taught by Gilbert, as both references and the claimed invention are directed to cutting devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuki with the teachings of Gilbert by incorporating wherein the elongate shaft includes a rounded distal cap secured to the distal end of the elongate shaft, wherein the rounded distal cap includes the distal port in order to prevent inadvertent injury to tissue.
Claim(s) 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Onuki in view of Serina (US 20100049213 A1).
Regarding claim 25-26, Onuki discloses the medical device of claim 22, but fails to explicitly disclose wherein the suture lumen includes a distal portion having a first diameter and a second portion having a second diameter smaller than the first diameter; wherein the second portion is curved.
However, Serina is directed to a tether cutter and teaches a suture lumen (1807) includes a distal portion (distal opening of 1807) having a first diameter and a second portion (curved kink of 1807) having a second diameter smaller than the first diameter (Figure 18B; Paragraph 0141); wherein the second portion is curved (Figure 18B; Paragraph 0141).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Onuki such that wherein the suture lumen includes a distal portion having a first diameter and a second portion having a second diameter smaller than the first diameter; wherein the second portion is curved, as taught by Serina, as both references and the claimed invention are directed to tether cutters. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Onuki with the teachings of Serina by incorporating wherein the suture lumen includes a distal portion having a first diameter and a second portion having a second diameter smaller than the first diameter; wherein the second portion is curved in order to be able to releasably secure the suture/wire to prevent migration during cutting.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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/Z.J./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771