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 .
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: first and second joint coupling structures in claim 1 which are disclosed as openings 48A, 48B.
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, 5-8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0121193 (Bob).
1. A combination tissue manipulation and cutting device (instrument 10), the device comprising:
(a) a first elongate member (first jaw 11) comprising a first handle (handle 15), a first jaw (first tool part 17), and a first joint coupling structure (e.g., opening at first jaw 11 in FIG. 5 for hinge 13 which is the same as disclosed in this application) disposed between the first handle and the first jaw (FIG. 5; P0044 and P0063);
(b) a second elongate member (second jaw 12) comprising a second handle (handle 23), a second jaw (second tool part 20), and a second joint coupling structure (e.g., opening/connection at second jaw 12 in FIG. 5 for hinge 13 which is the same as disclosed in this application) disposed between the second handle and the second jaw (FIG. 5; P0044 and P0063);
(c) a rotatable joint (hinge 13) disposed at the first and second coupling structures such that the first and second elongate members are rotatable in relation to each other at the rotatable joint (FIG. 5; P0044 and P0063);
(d) a blade guide housing (housing 26) disposed along a length of the first elongate member (FIG. 1; P0048-P0049), the blade guide housing comprising a distal opening (e.g., distal opening of inner space 27), a proximal opening (e.g., proximal opening of inner space 27), and a lumen (inner space 27) defined through the blade guide housing from the distal opening to the proximal opening (FIG. 1; P0048-P0049); and
(e) a blade drive body (knife 30) slidably disposable within the lumen of the blade guide housing, the blade drive body comprising a blade attachment component (e.g., end of knife adjacent to blade 32) at a distal end of the blade drive body (FIG. 5; P0049).
5. The blade drive body comprises a finger contact structure (tappet 37 and recess 38) associated with a proximal portion of the blade drive body (FIG. 1; P0051 and P0059).
6. The finger contact structure comprises ribs or protrusions (e.g., tappet 37) (FIG. 1; P0051 and P0059).
7. The blade guide housing and the blade drive body are removable (FIG. 1; P0053 and P0061).
8. The device has a removable blade coupleable to the blade attachment component (FIG. 1; P0053 and P0061).
10. The blade drive body is slidable between a retracted position and a deployed position along a length of the first elongate member (FIG. 1; P0051, P0059, and P0071).
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.
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) 2-4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0121193 (Bob), as applied to claim 1 above, and further in view of US 6,146,399 (Lee).
2-3. Bob discloses the invention substantially as claimed as discussed above but does not disclose the blade drive body having a detent. Lee teaches a device in the same field of endeavor having a blade drive body (blade 13) with a detent (detent 14 and/or handle 16) for the purpose of controlling distal/proximal movement of the blade drive body relative to the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). The detent is disposed on the blade drive body, wherein the detent extends beyond the cross-sectional width or height of the blade drive body such that the detent cannot fit within the lumen of the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). The detent contacts a proximal end of the blade guide housing as the blade drive body is urged distally through the blade guide housing, thereby preventing the blade drive body from moving further distally through the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bob to include the blade drive body detent as taught by Lee in order to control distal/proximal movement of the blade drive body relative to the blade guide housing.
4. Bob discloses the invention substantially as claimed as discussed above but does not disclose the blade drive body having a channel with the blade guide housing having a detent. Lee teaches a device in the same field of endeavor having a blade drive body (blade 13) with a channel (detent 14) and the blade guide housing having a detent (projection 24) for the purpose of controlling distal/proximal movement of the blade drive body relative to the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). The channel defined along the length of the blade drive body, and the detent disposed on the blade guide housing such that the at least one detent is disposed within the at least one channel when the blade drive body is disposed within the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bob to include the blade drive body channel and blade guide housing detent as taught by Lee in order to control distal/proximal movement of the blade drive body relative to the blade guide housing.
9. Bob discloses the invention substantially as claimed as discussed above but does not disclose the first elongate member having a guide slot. Lee teaches a device in the same field of endeavor having a first elongate member (11) with a channel (channel 19) for the purpose of guiding longitudinal movement of the blade drive body via the first elongate member (FIG. 7-8; col. 3, lns. 41-51). The guide slot defined within and disposed along a length of the first elongate member, wherein the blade drive body is slidably disposed adjacent to or within the guide slot (FIG. 7-8; col. 3, lns. 41-51). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bob to include the first elongate member channel as taught by Lee in order to guide longitudinal movement of the blade drive body via the first elongate member.
Claim(s) 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0121193 (Bob) in view of US 6,146,399 (Lee).
11. A combination tissue manipulation and cutting device (instrument 10), the device comprising:
(a) a first elongate member (first jaw 11) comprising a first handle (handle 15) and a first jaw (first tool part 17) (FIG. 5; P0044 and P0063);
(b) a second elongate member (second jaw 12) comprising a second handle (handle 23) and a second jaw (second tool part 20), wherein the second elongate member is rotatably coupled to the first elongate member at a rotatable joint (hinge 13)(FIG. 5; P0044 and P0063);
(c) a blade guide housing (housing 26) disposed along a length of the first elongate member (FIG. 1; P0048-P0049), the blade guide housing comprising a distal opening (e.g., distal opening of inner space 27), a proximal opening (e.g., proximal opening of inner space 27), and a lumen (inner space 27) defined through the blade guide housing from the distal opening to the proximal opening (FIG. 1; P0048-P0049); and
(d) a blade drive body (knife 30) slidably disposable within the lumen of the blade guide housing, the blade drive body comprising a blade attachment component (e.g., end of knife adjacent to blade 32) at a distal end of the blade drive body (FIG. 5; P0049); wherein the blade drive body is slidable between a proximal position and a distal position (FIG. 1; P0051, P0059, and P0071); and
(e) a removable blade (blade 32)(e.g., “removable” at least because it can be removed along with knife 30 at FIG. 1, P0053, and P0061) operably coupled to the blade attachment component (FIG. 1; P0053 and P0061).
Bob discloses the invention substantially as claimed as discussed above but does not disclose the first elongate member having a guide slot. Lee teaches a device in the same field of endeavor having a first elongate member (11) with a channel (channel 19) for the purpose of guiding longitudinal movement of the blade drive body via the first elongate member (FIG. 7-8; col. 3, lns. 41-51). The guide slot defined within and disposed along a length of the first elongate member, wherein the blade drive body is slidably disposed adjacent to or within the guide slot (FIG. 7-8; col. 3, lns. 41-51). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bob to include the first elongate member channel as taught by Lee in order to guide longitudinal movement of the blade drive body via the first elongate member.
Bob discloses the invention substantially as claimed as discussed above but does not disclose the blade drive body having a detent. Lee teaches a device in the same field of endeavor having a blade drive body (blade 13) with a detent (detent 14 and/or handle 16) for the purpose of controlling distal/proximal movement of the blade drive body relative to the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). The detent is disposed on the blade drive body, wherein the detent extends beyond the cross-sectional width or height of the blade drive body such that the detent cannot fit within the lumen of the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). The detent contacts a proximal end of the blade guide housing as the blade drive body is urged distally through the blade guide housing, thereby preventing the blade drive body from moving further distally through the blade guide housing (FIG. 6-7; col. 3, lns. 4-13; col. 4, lns. 11-19; col. 4-5, lns. 66-11). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bob to include the blade drive body detent as taught by Lee in order to control distal/proximal movement of the blade drive body relative to the blade guide housing.
13. The blade drive body comprises a finger contact structure (tappet 37 and recess 38) associated with the blade drive body (FIG. 1; P0051 and P0059). The finger contact structure comprises ribs or protrusions (e.g., tappet 37) (FIG. 1; P0051 and P0059).
14. The blade guide housing and the blade drive body are removable and replaceable (FIG. 1; P0053 and P0061).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0121193 (Bob) in view of US 6,146,399 (Lee), as applied to claim 14 above, and further in view of US 2013/0018372 (Sims).
Bob discloses the invention substantially as claimed as discussed above and further discloses the blade guide housing and blade drive body being removable and replaceable (FIG. 1; P0053 and P0061) but does not disclose the device having an additional blade guide housing and an additional blade drive body. Sims teaches a device in the same field of endeavor having additional blade guide housing and additional blade drive body (P0003 and P0044) for the purpose of reusing sterilizable elongate members with disposable blade guide housings and blade drive bodies (P0003 and P0044). The additional blade guide housing and additional blade drive body are interchangeable with the blade guide housing and the blade drive body, respectively (P0003 and P0044). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Bob to include an additional blade drive body and an additional blade guide housing as taught by Sims in order reuse sterilizable elongate members with disposable blade guide housings and blade drive bodies.
Allowable Subject Matter
Claims 21-25 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights