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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 29, 2026 has been entered.
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:
-“holder” in claims 45-47 . Since there is no disclosure for holder, Examiner will interpret holder to mean anything capable of supporting the arm member.
-“connector” in claim 51 will be interpreted according to para. [0046] as having internal engaging and disengaging elements.
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.
Claim 49 is 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.
Specifically it is unclear whether Applicant is intending to recite that both tubes completely overlap the bendable tube or whether each tube overlaps a portion of the bendable tube. It appears that Applicant is intending to recite that each tube entirely overlaps the bendable member as disclosed in claim 48, but it is unclear how that is possible in light of Applicant’s figures. Specifically, Fig. 5B shows bendable tube 58 and a first tube 59 overlapping the bendable tube and further para. [0039] discloses a second tube covering 58c. However, claim 49 recites that the first tube is longer than the bendable tube and the second tube and as such it is unclear how the first tube can be “entirely disposed between a distal end and a proximal end of the bendable tube” while also being longer than the bendable tube. Additionally, Applicant discloses in Claim 43, that the bendable tube is located at a distal end of the first rigid tube and a second rigid tube is located at a distal end of the bendable tube, so it is unclear what Applicant is intending to recite especially in light of Fig. 8 of Applicant’s drawings. For purposes of this Office Action, Examiner will interpret claims 48 and 49 and the dependents thereof to mean that at least a portion of each tube overlaps the proximal and distal ends of the bendable member.
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.
Claims 43-50, 52-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mueller (US 2012/0179151 A1).
Regarding claim 43, Mueller discloses a clip delivery device (Fig. 1), comprising: a sheath 20 including: a first tube 24, a bendable tube 28 located at a distal end of the first tube (Fig. 2), and a second tube 22a located at a distal end of the bendable tube (Fig. 2) and a clip unit 16 including an arm member (i.e., 30, 32) and detachably connected to the sheath (i.e., by way of pin as shown in Fig. 4 which can be detachably connected at least during assembly and disassembly), wherein: the bendable tube is more flexible than the first tube and the second tube (i.e., as shown in Fig. 4), each of the first tube and the second tube overlaps the bendable tube and is fixed to the bendable tube (para. [0032] discloses a reduced diameter coupling the flexible portion 28 between the end effector support tube 22a and the outer tubular member 24 (Fig. 2) such that the first and second tube at least partially overlap the bendable tube).
Regarding claim 44, Mueller discloses the clip delivery device according to claim 43. Mueller also discloses wherein the bendable tube is fixed to the first tube to maintain a position of the bendable tube relative to the first tube in a longitudinal direction of the bendable tube (para. [0032]; see also Fig. 1).
Regarding claim 45, Mueller discloses the clip delivery device according to claim 44. Mueller also discloses wherein the clip unit includes a holder (i.e., pin as shown in Fig. 4 will be interpreted according to 112f above which is capable of supporting the arm member) that supports the arm member (i.e., by coupling it to 22a), and the clip unit is detachably engaged with the sheath (i.e., as shown in Fig. 2).
Regarding claim 46, Mueller discloses the clip delivery device according to claim 44. Mueller also discloses wherein the clip unit includes a holder (i.e., pin as shown in Fig. 4 will be interpreted according to 112f above which is capable of supporting the arm member) that supports the arm member (i.e., by coupling it to 22a), and the clip unit detachably abuts the sheath (i.e., as shown in Fig. 2).
Regarding claim 47, Mueller discloses the clip delivery device according to claim 44. Mueller also discloses wherein the clip unit includes a holder (i.e., pin as shown in Fig. 4 will be interpreted according to 112f above which is capable of supporting the arm member) that supports the arm member (i.e., by coupling it to 22a), and the clip unit detachably connected to the second tube (i.e., as shown in Fig. 2).
Regarding claim 48, Mueller discloses the clip delivery device according to claim 44. Mueller also discloses wherein the first tube and the second tube are each
Regarding claim 49, Mueller discloses the clip delivery device according to claim 48. Mueller also discloses wherein the first tube is longer than the bendable tube and the second tube (Fig. 1).
Regarding claim 50, Mueller discloses the clip delivery device according to claim 48. Mueller also discloses further comprising a wire 60 located within the sheath (Fig. 2), wherein the wire is configured to operate the arm member and wherein, when the arm member is opened, a distal end of the wire is located distally relative to the bendable tube and is located in the second tube (para. [0029]; Fig. 2)).
Regarding claim 52, Mueller discloses the clip delivery device according to claim 44. Mueller also discloses further comprising: a wire 60 located within the sheath (Fig. 2) and configured to operate the arm member (para. [0029]), and a handle 46 connected to the sheath and the wire (Fig. 1; para. [0029])), wherein the bendable tube is connected to the handle (i.e., indirectly by way of 24).
Regarding claim 53, Mueller discloses a clip delivery device (Fig. 1), comprising: a sheath 20 including: a first portion 24, a bendable portion 28 located at a distal end of the first portion (Fig. 2), and a second portion 22a located at a distal end of the bendable portion (Fig. 2); and a clip unit 16 including an arm member 30, 32 and detachably connected to the second portion (i.e., by way of pin as shown in Fig. 4 at least upon assembly/disassembly), wherein: the bendable portion is more flexible than the first portion and the second portion (i.e., as shown in Fig. 4), and the first portion comprises a bendable tube (i.e, portion of 28) and a first tube 24 covering the bendable tube (i.e., para. [0032]), the bendable portion is the bendable tube, and the second portion comprises the bendable tube and a second tube covering the bendable tube (para. [0032]).
Regarding claim 54, Mueller discloses the clip delivery device according to claim 53. Mueller also discloses wherein the bendable tube is fixed to the first tube to maintain a position of the bendable tube relative to the first tube in a longitudinal direction of the bendable tube (para. [0032]; Fig. 1).
Regarding claim 55, Mueller discloses the clip delivery device according to claim 54. Mueller also discloses wherein the first tube and the second tube each
Regarding claim 56, Mueller discloses the clip delivery device according to claim 54. Mueller also discloses further comprising: a wire 60 located within the sheath (Fig. 2) and configured to operate the arm member (para. [0029]), and a handle 46 connected to the sheath and the wire (Fig. 1; para. [0029]), wherein the bendable tube is connected to the handle (i.e., indirectly via 24).
Regarding claim 57, Mueller discloses the clip delivery device according to claim 54. Mueller also discloses wherein the bendable tube is formed by a coil (i.e., as shown in Fig. 2).
Regarding claim 58, Mueller discloses a clip delivery device (Fig. 1), comprising: a clip unit 16 including an arm member 30, 32; a wire 60 configured to operate the arm member (para. [0029]); a sheath 18 through which the wire is inserted (Figs. 1-4; para. [0023]); and a handle 46 connected to the sheath (Fig. 1), wherein the clip unit is detachably connected to the sheath (i.e., by way of pin as shown in Fig. 4 at least upon assembly and disassembly), wherein the sheath includes: a first portion 20, a second portion (i.e., at 22) located distal to the first portion (Fig. 2), and a bendable portion 28 located between the first portion and the second portion (Fig. 2), wherein the first portion is covered by a first tube 24 (para. [0023]), wherein the second portion is covered by a second tube 22a (i.e., note also that alternatively the bendable piece 28 that is covered by 22a may be interpreted as the second portion), and wherein the bendable portion is more flexible than the first portion and the second portion (Fig. 4).
Regarding claim 59, Mueller discloses the clip delivery device according to claim 58. Mueller also discloses wherein the clip unit is detachably engaged with the sheath (i.e., by way of pin as shown in Fig. 4).
Regarding claim 60, Mueller discloses the clip delivery device according to claim 58. Mueller also discloses wherein the clip unit detachably abuts the sheath (Fig. 4).
Regarding claim 61, Mueller discloses the clip delivery device according to claim 58. Mueller also discloses wherein the clip unit detachably connected to the second portion (Fig. 4).
Regarding claim 62, Mueller discloses the clip delivery device according to claim 58. Mueller also discloses wherein the sheath is formed by a coil (i.e, at least part of the sheath (i.e., 28) is formed by a coil as shown in Figs. 1-4).
Claim Rejections - 35 USC § 103
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 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 51 is rejected under 35 U.S.C. 103 as being unpatentable over Mueller in view of Dunki-Jacobs et al. (US 20090036734 A1).
Regarding claim 51, Mueller discloses the clip delivery device according to claim 50. Mueller doesn’t directly disclose further comprising a connector located at the distal end of the wire, wherein the connector is configured to be connected to the arm member, and wherein, when the arm member is opened, the connector is located distally relative to the bendable tube and is located in the second tube.
In the same field of endeavor of devices and methods for introducing a device into the anatomy, Dunki-Jacobs discloses a similar device to Mueller including a handle 169, an arm 166, 167, a wire 174, and further discloses a connector (i.e., suitable endoscopic actuating mechanism is being interpreted according to 112f as disclosed above which includes engaging and disengaging elements) located at the distal end of the wire (para. [0070]), wherein the connector is configured to be connected to the arm member (para. [0030]), and wherein, when the arm member is opened, the connector is located distally relative to the bendable tube and is located in the second tube (i.e, the resulting device would teach this since the connector is coupled to the arms as disclosed by para. [0070] and would therefore be located in the second tube).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the device of Mueller to have a connector as disclosed by Dunki-Jacobs for the purpose of coupling the wire to the arm for purposes of opening and closing the jaw (para. [0070]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771