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 .
Response to Amendment
This office action is responsive to the amendment filed on 01/05/2026. As directed by the amendment: claims 1-3, 5, and 9 have been amended. Thus, claims 1-19 are presently pending in this application with claims 6-8 and 10-19 have been amended.
Response to Arguments
Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
Applicant argues that for the interpretation of “connection member for fixation”, “nothing in the claims would require or limit the claims to solely a slot and structural equivalents thereof. The Office agrees that there is nothing in the claim to limit “connection member for fixation”. However, since the limitation is interpreted under 112(f), the specification is referenced for interpretation. One of the examples given is a slot in [0018]. The interpretation covers “structural equivalents thereof” which can include the other examples given by applicant in the specification.
Applicant argues that “a connection member for separation” should not be interpreted under 112(f) because claim 1 recites “when the end of each of the at least two side clipping arms is at the proximal end of the clipping portion, the connection member for separation is adapted to the releaser or each of the at least two side clipping arms, so that the end of each of the at least two side clipping arms and the releaser are in a separable connection state." For similar reasons as the "connection member for fixation”. The Office respectfully disagrees. This further limitation of “connection member for separation” does not recite the structure of the connection member and thus does not take it out of interpretation under 112(f).
Applicant argues that “Tamura fails to teach ‘the clipping portion is provided with a connection member for fixation and a connection member for separation’ ” because “Tamura teaches that both the ‘connection member for fixation’ and the ‘connection member for separation’ are provided/formed in the guide tube 55 of the delivery portion, that is, both the ‘connection member for fixation’ and the ‘connection member for separation’ are provided in the delivery portion” The Office respectfully disagrees. The claim language recites “clip device…comprising: a clipping portion… the clipping portion is provided with a connection member for fixation and a connection member for separation”. There is nothing in this claim language that would exclude the connection member for fixation and the connection member for separation being formed in / a part of the same guide tube. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the connection member for fixation and the connection member for separation are not formed in / a part of the same guide tube) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that “Tamura fails to teach… ‘when the end of the side clipping arm is at the proximal end of the clipping portion, the connection member for separation is adapted to the releaser or the side clipping arm, so that the end of the side clipping arm and the releaser are in a separable connection state’ Instead, Tamura teaches when the end of the side clipping arm is at the proximal end of the clipping portion, the end of the side clipping arm and the releaser are still in a fixed connection state”. The Office respectfully disagrees. Fig. 15 of Tamura shows the configuration when the proximal end of the side clipping arm (21, 22) is at the proximal end of the of the clipping portion (10). At this position the connection member for separation (cavity of 55) is adapted to the releaser (170) or the side clipping arm, so that the end of the side clipping arm (21, 22) and the releaser are in a separable connection state (Tamura states “When the distal-end portion 172a of each jaw 172 reaches the proximal-end opening 30b, each claw portion 173 rotates due to the force received from the proximal-end portion 20a, and the distal-end portions 172a are separated from each other. After that, each link 175 is deformed and the pair of jaws 172 are further separated from each other, and as shown in FIG. 15, the engagement between the hook 170 and the arm portion 20 is released”). Therefore, The Office maintains that Tamura discloses claim 1.
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:
“a connection member for fixation” in claim 1; for examination purposes, the limitation is being interpreted based on [0018] as a slot and structural equivalents thereof;
“a connection member for separation” in claim 1; for examination purposes, the limitation is being interpreted based on [0018] as a cavity and structural 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 § 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 1-5 and 9 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 1, line 15 recites “the end of the side clipping arm”. Since at least two side clipping arms are claimed it is unclear which side clipping arm is being referred to in this limitation. For examination purposes, the limitation will be interpreted as “the end of each of the at least side clipping arms”. Appropriate correction is required.
Claims 2 recites “a separable connection state”. Independent claim 1 already recites a separable connection state rendering it unclear if “a separable connection state” in claim 2, and 9 is the same as that recited in claim 1 or different. For examination purposes, the limitation will be interpreted as “the separable connection state”. Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5 and 9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tamura et al. (WO 2021210091 A1).
Note that all references to Tamura herein refer to the attached English translation.
Regarding claim 1 Tamura discloses (fig. 1-3 and 13-15) a clip device with separable connection and having variable connection force, comprising: a clipping portion 10 and a delivery portion 51, a proximal end of the clipping portion being detachably connected to a distal end of the delivery portion (pg. 37, 6th paragraph from the bottom and fig. 15);
wherein the clipping portion comprises at least two side clipping arms (21, 22; see fig. 2 and pg. 37, 4th paragraph from the bottom) and a clipping base 30 (pg. 37, last paragraph); the delivery portion comprises a handle 52, a control wire 52 and a sheath tube 51 (see fig. 1 and pg. 38, 4th paragraph); a proximal end of the sheath tube 51 is connected to the handle 50 (see fig. 1), and the control wire 52 is provided inside the sheath tube (see fig. 1 and 14);
wherein each of the at least two side clipping arms (21, 22) are provided in the clipping base 30 (see fig. 3 and pg. 37 last paragraph - pg. 38 first paragraph), and a proximal end 20a of each of the at least two side clipping arm is connected to the control wire 52 (see fig, 14 and pg. 42, 7th paragraph); the handle 50 drives the control wire 52 to move in the sheath tube 51 (see pg. 38, 7th paragraph), so that each of the at least two side clipping arms (21, 22) move relative to the clipping base 30 to open and close each of the at least two side clipping arms (pg. 39, 5th – 6th paragraphs);
wherein the clipping portion is provided with a connection member for fixation (channel of 30, meeting the interpretation under 112f; see fig. 13) and a connection member for separation (cavity of 55, meeting the interpretation under 112f; see fig. 13-15), a distal end of the control wire 52 is provided with a releaser 170, and an end of each of the at least two side clipping arm is connected to the releaser (see fig. 13-14 and pg. 42 7th paragraph);
when the end of each of the at least two side clipping arm is at the distal end of the clipping portion (fig. 13), the connection member for fixation (channel of 30) constrains a separation action between the releaser 170 and the end of each of the at least two side clipping arm, so that the end of each of the at least two side clipping arm and the releaser are in a fixed connection state (see fig. 13 and pg. 42 9th – 10th paragraph); and
when the end of each of the at least two side clipping arm is at the proximal end of the clipping portion (fig. 15), the connection member for separation (cavity of 55) is adapted to the releaser or each of the at least two side clipping arm, so that the end of each of the at least two side clipping arm and the releaser are in a separable connection state (see fig. 15 and pg. 42, 11th paragraph).
Regarding claim 3 Tamura further discloses (fig. 1-3 and 13-15) the connection between the releaser 170 and the end of each of the at least two side clipping arm is a deformable connection (via 175; see pg. 42, 2nd to the last paragraph); when the end of each of the at least two side clipping arm is at the distal end of the clipping portion (fig. 13), the connection member for fixation (channel of 30) limits the deformation of the end of the releaser 170 (see fig. 13), so that the end of each of the at least two side clipping arm and the releaser are in a fixed connection state (see fig. 13 and pg. 42 9th – 10th paragraph); when the end of each of the at least two side clipping arm is at a proximal end of the clipping portion (fig. 15), the control wire 52 drives the releaser 170 to disengage from the connection member for fixation, so as to separate the end of each of the at least two side clipping arm from the releaser (see fig. 15 and pg. 42, 11th paragraph).
Regarding claim 4 Tamura further discloses (fig. 1-3 and 13-15) the connection member for fixation is of a slot structure (see fig. 13-14, the channel of 30 is of a slot structure), the connection member for separation is a release cavity (see fig. 15, the cavity of 55 is a release cavity), a width of the slot is less than that of the connection member for separation, and the connection member for fixation and the connection member for separation form a stepped groove (see fig. 14).
Regarding claim 5 Tamura further discloses (fig. 1-3 and 13-15) a first connection hole is provided on the releaser 170 (see annotated fig. 14 below), the first connection hole is connected to a first connection shaft 20a at the end of each of the at least two side clipping arm (see fig. 14), and a first release port is provided at one side of a distal end of the first connection hole (see annotated fig. 14 below); wherein the releaser 170 is clamped in the connection member for fixation (see fig. 13), and after the releaser moves from the connection member for fixation to the connection member for separation, the first release port is compressed and deformed and releases the first connection shaft (see fig. 13-15 and pg. 42 9th – 11th paragraph).
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Regarding claim 9 Tamura further discloses (fig. 1-3 and 13-15) the releaser is clamped in the end of each of the at least two side clipping arm (see fig. 13); when the end of each of the at least two side clipping arm is at the distal end of the clipping portion (fig. 13), the connection member for fixation is connected to the end of each of the at least two side clipping arm, and the releaser 170 is clamped, so that the end of each of the at least two side clipping arm and the releaser are in a fixed connection state (see fig. 13 and pg. 42, 9th – 10th paragraph); and when the end of each of the at least two side clipping arm is at a proximal end of the clipping portion (fig. 15), the connection member for separation cooperates with the releaser 170, and the end of each of the at least two side clipping arm and the releaser are in a separable connection state (see fig. 15 and pg. 42, 11th paragraph).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tamura.
Regarding claim 2, Tamura discloses the claimed invention substantially as claimed, as set forth above for claim 1. Tamura further discloses (fig. 1-3 and 13-15) the connection force between the end of each of the at least two side clipping arm and the releaser is a separable connection force when the end of each of the at least two side clipping arm and the releaser are in a separable connection state (see pg. 42, 9th – 11th paragraph); wherein the connection force between the end of each of the at least two side clipping arm and the releaser is a fixed connection force when the end of each of the at least two side clipping arm and the releaser are in a fixed connection state (see pg. 42, 9th – 11th paragraph); and wherein the fixed connection force is greater than the separable connection force (the arms of 170 cannot freely expand in the fixed connection state thus the force required to separate them would be greater than when they are in the separable connection state and can freely expand).
Tamura is silent regarding the separable connection force is greater than or equal to 5N.
At the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art have the separable connection force of Tamura greater than or equal to 5N because Applicant has not disclosed criticality for the claimed range simply indicating the force is “optionally” and “in an embodiment” in the claim range (see [0015]-[0017] and [0067]). One of ordinary skill in the art, furthermore, would have expected Tamura’s device, and applicant’s invention, to perform equally well with either the force of Tamura or the force claimed by applicant because both forces dimensions would serve to disconnect the releaser from the clip.
Therefore, it would have been prima facie obvious to modify Tamura to obtain the invention as specified in claim 2 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Tamura.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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