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 .
Election/Restrictions
Applicant's election with traverse of claims 1-6 in the reply filed on 05/21/2026 is acknowledged. The traversal is on the ground(s) that all the amended claims recite at least one special technical feature that makes a contribution over the prior art in view of Shpaichler (US Pub. No. 2012/0265223). Amended independent claims 1 and 7 recite "a plurality of suture needle paths located in different longitudinal positions for guiding a suture needle to pass therethrough." By contrast, the alleged suture needle paths of Shpaichler appear to be at the same longitudinal position. This is not found persuasive. As shown in Fig. 1 of Shpaichler, the interpreted plurality of suture needle paths 22 define longitudinal paths running axially through the plurality of suture needle guide channels 14A, 14B at four different locations located on the interpreted suture needle guide tube 6. Therefore, the restriction is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/21/2026.
Specification
The disclosure is objected to because of the following informalities:
The specification recites “a plurality of suture needle passing paths located in different positions for guiding a suture needle to pass therethrough” in para. 0007, 0015, 0045, 0054, 0062. However, the claim 1 recites “different longitudinal positions” which is not found in the specification, nor is the term “longitudinal” used in the specification.
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:
“positioning structure” in claim 3. The limitation describing the positioning structure in claim 3 (i.e. configured to lock and unlock the tube body and the suture needle guide) fails to include sufficient structure to perform the recited function of “locking and unlocking”. In the specification, the positioning structure includes “a positioning hole and a pin” (para. 0049: “. For example, a plurality of positioning holes axially spaced apart from each other are formed on the tube body 1, and a pin hole is formed on the suture needle guide 2. After the suture needle guide 2 moves to the predetermined position, the pin passes through the pin hole, and is inserted into the positioning hole in the predetermined position, so that the suture needle guide 2 is held and positioned in the predetermined position”) or “a positioning hole and a locking bolt” (para. 0049: “a positioning hole is formed on the suture needle guide 2, and a locking bolt may be thread-fitted in the positioning hole”). However, para. 0049 further states “Certainly, a plurality of types of positioning structures may be provided”. Therefore, the positioning structure is interpreted as the positioning hole/pin, the positioning hole/locking bolt, or any structural equivalents thereof that is configured to lock and unlock the tube body and the suture needle guide.
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 4-6 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 4 recites the limitation "the other suture needle passing port" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, "the other suture needle passing port" is interpreted as “another suture needle passing port”.
Claim 4 recites the limitation " each pair of suture needle passing ports comprises one suture needle passing port (4) and the other suture needle passing port (4) that are axially spaced apart from each other and circumferentially staggered, an oblique distance between each pair of the two suture needle passing ports (4) forming the suture needle passing path" in lines 2-5. It is unclear to the examiner if the pair of suture needle passing ports are an oblique distance form another pair of suture needle passing ports or if the one suture needle passing port is an oblique distance from the other suture needle passing port. For examination purposes, the limitation is interpreted “as each pair of suture needle passing ports comprises one suture needle passing port (4) and the other suture needle passing port (4) that are axially spaced apart from each other and circumferentially staggered, and an oblique distance between the one suture needle passing port and the other suture needle passing port forming the suture needle passing path”.
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) 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shpaichler et al. (US 20120265223) [hereinafter Shpaichler].
Regarding claim 1, Shpaichler discloses a suture needle guide tube (Fig. 1, para. 0059), comprising:
a tube body 2, 10 for being inserted into a wound to be sutured (Figs. 1-2, para. 0070: “port 10 itself, or one of its parts, functions as body 2 (or part thereof) of the device of the present invention as discussed above, particularly when it serves as the tubular-shaped wall portion of body 2, guides 14 may be positioned in body 2 and oriented by any of many different way”, see intended use in para. 0061-0062) for arranging a handling tube provided with a suture arrangement member and a handling member (Figs. 1-2, para. 0061: “surgical or a diagnostic instrument (not shown) is inserted into abdominal or thoracic cavity 18 through the inner cavity of port 10, a surgical or a diagnostic manipulation is performed, and the instrument is removed”. Therefore, the internal axial channel is capable of arranging or accommodating the handling tube provided with the suture arrangement member and the handling member as claimed), and the tube body 2, 10 being provided with a plurality of suture needle passing paths 22 located in different longitudinal positions for guiding a suture needle to pass therethrough (As shown in Fig. 1 of Shpaichler, the interpreted plurality of suture needle paths 22 define longitudinal paths running axially through the plurality of suture needle guide channels 14A, 14B at four different locations located on the interpreted suture needle guide tube 6, para. 0059); and
a suture needle guide 6 (Fig. 1, para. 0059), provided with a plurality of suture needle guide channels 14A, 14B located in different positions (Fig. 1, para. 0059);
wherein the suture needle guide 6 is provided on the tube body 2, 10 (Fig. 1, para. 0071 states that cap 6 is a form of guide containing member; para. 0072: “ the guide containing member may be made from a separate piece fixed to the port by any of many different types of attachment means known to those skilled in the art, such as screws, clips, or elastic means”), and each suture needle guide channel 14A, 14B respectively communicates with the corresponding suture needle passing path 22 so as to guide the suture needle to move out of the suture needle guide channel 14A and then pass through the suture needle passing path 22 to enter an inner cavity and to allow the suture needle to exit with a suture (Figs. 1-2, para. 0064).
Regarding claim 2, Shpaichler discloses wherein the suture needle guide 6 is configured to be adjusted to a predetermined position by means of axial movement along the tube body 2, 10 so that each of the suture needle guide channels 14A, 14B communicates with the corresponding suture needle passing path 22 in the predetermined position (para. 0071-0072 of Shpaichler: “a guide containing member (not shown) which may be fixably or removably attached to the port…cap 6 of FIG. 1 may be considered to be an example of a guide containing member…the guide containing member may be made from a separate piece fixed to the port by any of many different types of attachment means known to those skilled in the art, such as screws, clips, or elastic means.”. Therefore, Shpaichler discloses that the suture needle guide 6 may be a separate piece that may be attached/detached to the tube body such that the suture needle guide is capable of being adjusted to a predetermined position by means of axial movement along the tube body as claimed).
Regarding claim 3, Shpaichler discloses a positioning structure (interpreted as screws used to attach the suture guide tube to the tubular body; see 112(f) interpretation above) configured to lock and unlock the tube body and the suture needle guide (para. 0071-0072 of Shpaichler: “a guide containing member (not shown) which may be fixably or removably attached to the port…cap 6 of FIG. 1 may be considered to be an example of a guide containing member…the guide containing member may be made from a separate piece fixed to the port by any of many different types of attachment means known to those skilled in the art, such as screws, clips, or elastic means.”), wherein when the positioning structure is unlocked, the suture needle guide is allowed to move axially, and when the suture needle guide moves axially to the predetermined position, the positioning structure is locked (Since the suture needle guide 6 can be removably attached to the tubular body by way of screws as stated above, the screws are capable of having a unlocked position to allow axial movement of the suture guide to the predetermined position and locked. This is further evidenced by para. 0073 which states that when screws are used secure the suture needle guide to the tube body, the suture needle guide can function as a universal guide that can be used for a plurality of different tubes with different sizes).
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.
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 is rejected under 35 U.S.C. 103 as being unpatentable over Shpaichler et al. (US 20120265223) [hereinafter Shpaichler] in view of Malkowski et al. (US 20150038997 [hereinafter Malkowski].
Regarding claim 4, Shpaichler discloses all of the limitations set forth above in claim 1. Shpaichler further discloses wherein a plurality of suture needle passing ports (interpreted as zone “c” which are passing ports comprising a material to be pierced by the suture needle) formed on a tube wall of the tube body (Fig. 1, para. 0059: “The areas of tubular wall 4 located in zone "c" of trajectories 22 of motion of thread-guiding members 16 are made of a material that may be pierced through by thread-guiding members 16, for example, of silicon. Such an arrangement does not require modification of the design of existing ports”), and the plurality of suture needle passing ports C comprise one suture needle passing port and another suture needle passing port that are radially spaced apart from each other (see Fig. 1 of Shpaichler which discloses at least two pairs of suture needle passing ports C). However, Shpaichler fails to disclose the plurality of pairs of suture needle passings ports that are axially spaced apart from each other and circumferentially staggered, and an oblique distance between each pair of the two suture needle passing ports forming the suture needle passing path (interpreted as “an oblique distance between the one suture needle passing port and the other suture needle passing port forming the suture needle passing path”, see 112(b) rejection above).
Malkowski in the same field of endeavor of suture needle guide tubes 200 teaches that it is known in the art for a tube body 202 to include a plurality of pairs of suture needle passing ports 206a, 206b such that one suture needle passing port (interpreted as one of either 206a or 206b) and another suture needle passing port (interpreted as the other 206a or 206b openings) are axially spaced apart from each other and circumferentially staggered (see Figs. 6A-B, para. 0109), and an oblique distance between the one suture needle passing port and the other suture needle passing port 206a, 206b forming a suture needle passing path A-A, B-B (Figs. 6A-B, para. 0109) as a known alternative to ports that are only radially spaced apart from each other (see Fig. 4B of Malkowski).
The substitution of one known port configuration (circumferentially staggered ports as shown in Malkowski) for another (radially spaced ports as shown in modified Shpaichler) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the staggered port configuration shown in Malkowski would have yielded predictable results, namely, an alternative way to orient the pair of plurality of suture needle passing ports along the tubular body (Fig. 6A, para. 0109 of Malkowski); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Shpaichler et al. (US 20120265223) [hereinafter Shpaichler] in view of Malkowski et al. (US 20150038997) [hereinafter Malkowski], as applied to claim 4 above, and further in view of Mohajer-Shojaee (US 20170079639).
Regarding claim 5, modified Shpaichler discloses all of the limitaitons set forth above in claim 4. Modified Shpaichler further discloses wherein the suture needle guide 6 comprises a sleeve (interpreted as the annular body of cap 6, see Fig. 1) and the sleeve 6 being sleeved on the tube body 2, 10 (para. 0072 of Shpaichler).
However, modified Shpaichler fails to disclose a plurality of oblique cylinders and the plurality of oblique cylinders being provided on an outer peripheral surface of the sleeve and circumferentially spaced apart from each other, wherein an internal channel of each oblique cylinder is the suture needle guide channel.
Mohajer-Shojaee in the same field of endeavor of suture needle guides 226 teaches that it is known in the art for the suture needle guide 226 to include a plurality of oblique cylinders 243, 244 and the plurality of oblique cylinders 243, 244 being provided on an outer peripheral surface of the suture needle guide 226 and circumferentially spaced apart from each other (Fig. 16, para. 0051), wherein an internal channel of each oblique cylinder 243, 244 is a suture needle guide channel (see Fig. 15 for example, para. 0051) as a known alternative to a suture needle guide having internal needle guide channels 48, 50 (see the embodiment of Figs. 4-7, para. 0032).
The substitution of one known suture needle guide channel configuration (external suture needle guide channels by way of the plurality of oblique cylinders as shown in Mohajer-Shojaee) for another (internal needle guide channels as shown in modified Shpaichler) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the external suture needle guide channels shown in Mohajer-Shojaee would have yielded predictable results, namely, an alternative way to provide guidance and stability to suture needles during insertion (para. 0051 of Mohajer-Shojaee); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shpaichler et al. (US 20120265223) [hereinafter Shpaichler] in view of Malkowski et al. (US 20150038997) [hereinafter Malkowski], and Mohajer-Shojaee (US 20170079639), as applied to claim 5 above, and further in view of Ravikumar (US 20070213766).
Regarding claim 6, modified Shpaichler discloses all of the limitations set forth above in claim 5. Modified Shpaichler further discloses that the suture needle guide may be joined to the tube by many different attachment means known in the art such as screws, clips, or elastic means (para. 0072-0073 of Shpaichler).
However, Shpaichler fails to disclose wherein a protuberant piece extends axially from an end surface of a sleeve wall at one end of the sleeve, and has a positioning hole, and a positioning column configured to be pressed against a tube body is provided in the positioning hole, wherein when the positioning column is pressed against the tube body, the sleeve is held in a predetermined position, and when the positioning column disengages from the tube body, the sleeve is allowed to move axially.
Ravikumar in the same field of endeavor of fixation mechanisms teaches that it is known in the art for an sleeve 12 to comprise a protuberant piece (interpreted as a handle of sleeve 12, best shown in the embodiment of Fig. 3B; para. 0034: “a screw 54 which extends through a threaded radial hole 55 in the needle 12 or its handle”) extending axially from an end surface of a sleeve wall at one end of the sleeve 12 (see annotated Fig. 3B below), and has a positioning hole 55 (Fig. 3A, para. 0034), and a positioning column (interpreted as shaft of screw 55) configured to be pressed against a tube body 15 is provided in the positioning hole (Fig. 3A, para. 0034), wherein when the positioning column 54 is pressed against the tube body 15, the sleeve 12 is held in a predetermined position by way of positioning column 54 engaging notches 52 of the tube body 15 (Fig. 3A, para. 0034), and when the positioning column 54 disengages from the tube body 15, the sleeve 12 is allowed to move axially (para. 0034).
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Annotated Fig. 3B of Ravikumar
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the suture needle guide and tube body in modified Shpaichler to include the fixation mechanism comprising the protuberant piece, positioning hole, and positioning column engaging with notches of the tube body, as taught by Ravikumar in order to securely position and lock the suture needle guide against the tube body during use (para. 0034 of Ravikumar).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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