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 .
This action is in response to the amendment filed on 11/05/2025. Claims 1-9 are pending. Claims 1, 4, and 9 are independent. Claim 9 is withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 10, the term “stationary” should be amended to –movable-- because the fifth crimp member is part of the movable jaw.
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.
Claim 4 properly invokes 35 U.S.C. 112(f) by reciting “means for driving the crossbar linearly with respect to the fixed shank to fully crimp the crimp tube and impart multiple crimps on each side of the crimp tube.” Based on the disclosure, the means is a second handle pivotably connected to the fixed shank (see Abstract).
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 1-8 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 recites the limitation "an alignment fiducial" in each of lines 9 and 10 of the claim. The term “fiducial” is an adjective. The term “alignment” is also serving as an adjective in this case. It is unclear what “an alignment fiducial” is because it uses two adjectives without a noun or a structure after that. Therefore, it is unclear what the metes and bounds is for the claim because of the limitation “an alignment fiducial.” For the purpose of examination, the limitation “an alignment fiducial" is considered as “an alignment fiducial structure” which is an alignment reference point. Claims 2-3 are rejected because they depend on claim 1.
Claim 4 recites the limitation "an alignment fiducial" in each of lines 9 and 10 of the claim. The term “fiducial” is an adjective. The term “alignment” is also serving as an adjective in this case. It is unclear what “an alignment fiducial” is because it uses two adjectives without a noun or a structure after that. Therefore, it is unclear what the metes and bounds is for the claim because of the limitation “an alignment fiducial.” For the purpose of examination, the limitation “an alignment fiducial" is considered as “an alignment fiducial structure” which is an alignment reference point. Claims 5-8 are rejected because they depend on claim 4.
The art rejection(s) below is/are made as best understood by the examiner because of the 35 U.S.C. 112 issue(s) stated above.
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, 4, 7, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US Pub. No.: 2021/0015479).
Regarding claim 1, Smith discloses [claim 1] a medical/veterinary suture crimp tool (tool 80, Fig. 10) comprising: a stationary jaw at a distal end of a fixed shank (fixed jaw 84 at a distal end of a fixed shank/structure, Fig. 10. The stationary jaw is 84 with 46 since 46 is engaged with 84) and having across its width and extending at least partially along its length spaced fixed crimp members including at least first, second, and third crimp members (structures of back wall 49 of female component 46, disposed on either side of suture bores 31a and 31b, Fig. 9A; see also Paras. [0043] and [0045], as tool 80 engages the male blade and suture female components); a moveable jaw at a distal end of a linearly driven crossbar (sliding jaw 82 at the distal end of the linearly driven crossbar/structure, Fig. 10. The moveable jaw is 82 with 40 since 40 is engaged with 82) and having across its width and extending at least partially along its length, spaced crimp members including at least fourth, fifth, and sixth crimp members opposing, respectively, the first, second, and third crimp members of the stationary jaw (structures of male blade member 40 disposed between suture clamps 32a and 32b, Fig. 10; see also Paras. [0043] and [0045], as tool 80 engages the male blade and suture female components); an alignment fiducial structure associated with said fifth crimp member for alignment with an alignment fiducial structure of a crimp tube (the horizontal spaces disposed above the suture clamps 32a and 32b, such as the alignment fiducial structure/space shown in the Figure below, as the claim fails to define the structure of the alignment fiducial structure); a first handle connected to the fixed shank (handle connected to and extending from fixed jaw 84, Fig. 10); and a second handle pivotably connected to the fixed shank and configured to drive the crossbar linearly with respect to the fixed shank to fully crimp the crimp tube (remaining handle, Fig. 10; see also Para. [0045], as sliding jaw 82 moves relative to fixed jaw 84 to drive the male blade member deeper into the female suture component).
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Regarding Claims 4, 7, and 8, Smith discloses [claim 4] a crimp tool (tool 80, Fig. 10) comprising: a stationary jaw at a distal end of a fixed shank (fixed jaw 84 at a distal end of a fixed shank/structure, Fig. 10. The stationary jaw is 84 with 46 since 46 is engaged with 84) and having spaced multiple crimp members each configured to provide a deformation on one side of a crimp tube (structures of back wall 49 of female component 46, disposed on either side of suture bores 31a and 31b, Fig. 9A; see also Paras. [0043] and [0045], as tool 80 engages the male blade and suture female components); a moveable jaw at a distal end of a linearly driven crossbar (sliding jaw 82 at the distal end of the linearly driven crossbar/structure, Fig. 10. The moveable jaw is 82 with 40 since 40 is engaged with 82) and having spaced multiple crimp members each configured to provide a deformation on an opposite side of the crimp tube thereby creating multiple crimps in the crimp tube when the stationary and moveable jaws are brought together about the crimp tube (structures of male blade member 40 disposed between suture clamps 32a and 32b, Figures 9A and 10; see also Paras. [0043] and [0045], as tool 80 engages the male blade and suture female components), each deformation on one side of the crimp tube opposing the deformation on the opposite side of the crimp tube (Figures 9A-9C); an alignment fiducial associated with at least one crimp member for alignment with an alignment fiducial of a crimp tube (the horizontal spaces disposed above the suture clamps 32a and 32b, such as the alignment fiducial structure/space shown in the Figure above, as the claim fails to define the structure of the alignment fiducial); a first handle connected to the fixed shank (handle connected to and extending from fixed jaw 84, Fig. 10); a second handle pivotably connected to the fixed shank (remaining handle, Fig. 10); and means for driving the crossbar linearly with respect to the fixed shank to fully crimp the crimp tube and impart multiple crimps on each side of the crimp tube (Fig. 10, as the handles are pivotably joined; see also Para. [0045], as sliding jaw 82 moves relative to fixed jaw 84 to drive the male blade member deeper into the female suture component); [claim 7] wherein crimp tool is fully capable to deform a crimp tube which has an oval cross-sectional shape (crimp tool is fully capable to deform a crimp tube which has an oval cross-sectional shape. Applicant should be noted that the crimp tube is not positively recited as part of the crimp tool); [claim 8] wherein the stationary jaw includes at least partially along its length spaced fixed crimp members including at least first, second, and third crimp members (Fig. 9A, as there are three structures of back wall 49 of female component 46, disposed on either side of suture bores 31a and 31b), the moveable jaw includes at least across its width and partially along its length at least fourth, fifth, and sixth crimp members opposing, respectively, the first, second, and third crimp members of the stationary jaw (Fig. 9A, as there are three structures of male blade member 40 disposed between suture clamps 32a and 32b).
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.
Claim(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US Pub. No.: 2021/0015479) as applied to claims 1 and 4 above, respectively, and further in view of Green (US Pat. No.: 4,354,628).
Regarding claims 2 and 5, Smith discloses substantially all the limitations as taught above but fails to disclose that the second handle includes a distal socket about a drive member on the crossbar to linearly drive the crossbar.
Green teaches, in the field of endeavor (surgical tool with operable jaws), a second handle (lever 110, Fig. 2) that includes a distal socket (socket in which pivotal axis 112 is disposed, Fig. 2) about a drive member on the crossbar to linearly drive the crossbar (metal core 114 of lever 110, Figures 2 and 4; see also col. 6, Ins. 45-48; see also col. 5, Ins. 32-45).
Before the effectively filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the second handle of the tool of Smith to a distal socket about a drive member on the crossbar to linearly drive the crossbar as taught by Green in order to obtain the advantage of providing a driving means that is easy and fast to operate (Green, col. 10, Ins. 63-65; Smith, Para. [0045]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered but are moot in view of new ground(s) of rejection.
In response to the argument(s) on page 6 of the remarks, claim 1 recites the limitation "an alignment fiducial" in each of lines 9 and 10 of the claim. The term “fiducial” is an adjective. The term “alignment” is also serving as an adjective in this case. It is unclear what “an alignment fiducial” is because it uses two adjectives without a noun or a structure after that. Therefore, it is unclear what the metes and bounds is for the claim because of the limitation “an alignment fiducial.” For the purpose of examination, the limitation “an alignment fiducial" is considered as “an alignment fiducial structure” which is an alignment reference point. Claims 2-3 are rejected because they depend on claim 1. Claim 4 recites the limitation "an alignment fiducial" in each of lines 9 and 10 of the claim. The term “fiducial” is an adjective. The term “alignment” is also serving as an adjective in this case. It is unclear what “an alignment fiducial” is because it uses two adjectives without a noun or a structure after that. Therefore, it is unclear what the metes and bounds is for the claim because of the limitation “an alignment fiducial.” For the purpose of examination, the limitation “an alignment fiducial" is considered as “an alignment fiducial structure” which is an alignment reference point. Claims 5-8 are rejected because they depend on claim 4.
In response to the argument(s) on pages 6-8 of the remarks, Smith discloses a medical/veterinary suture crimp tool (tool 80, Fig. 10) comprising: a stationary jaw at a distal end of a fixed shank (fixed jaw 84 at a distal end of a fixed shank/structure, Fig. 10. The stationary jaw is 84 with 46 since 46 is engaged with 84) and having across its width and extending at least partially along its length spaced fixed crimp members including at least first, second, and third crimp members (structures of back wall 49 of female component 46, disposed on either side of suture bores 31a and 31b, Fig. 9A; see also Paras. [0043] and [0045], as tool 80 engages the male blade and suture female components); a moveable jaw at a distal end of a linearly driven crossbar (sliding jaw 82 at the distal end of the linearly driven crossbar/structure, Fig. 10. The moveable jaw is 82 with 40 since 40 is engaged with 82) and having across its width and extending at least partially along its length, spaced crimp members including at least fourth, fifth, and sixth crimp members opposing, respectively, the first, second, and third crimp members of the stationary jaw (structures of male blade member 40 disposed between suture clamps 32a and 32b, Fig. 10; see also Paras. [0043] and [0045], as tool 80 engages the male blade and suture female components); an alignment fiducial structure associated with said fifth crimp member for alignment with an alignment fiducial structure of a crimp tube (the horizontal spaces disposed suture clamps 32a and 32b, such as the alignment fiducial structure/space, as the claim fails to define the structure of the alignment fiducial structure); a first handle connected to the fixed shank (handle connected to and extending from fixed jaw 84, Fig. 10); and a second handle pivotably connected to the fixed shank and configured to drive the crossbar linearly with respect to the fixed shank to fully crimp the crimp tube (remaining handle, Fig. 10; see also Para. [0045], as sliding jaw 82 moves relative to fixed jaw 84 to drive the male blade member deeper into the female suture component). Claims 1 and 4 fail to define the structure of the alignment fiducial structure. The horizontal spaces disposed suture clamps 32a and 32b, such as the alignment fiducial structure/space defines the alignment fiducial structure associated with the fifth crimp member.
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Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JING RUI OU/Primary Examiner, Art Unit 3771