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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 1/27/2025 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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 wiring structure” in claim 41.
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 14, 28 and 44-45 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.
Regarding claim 14, the phrase "a plurality of stabilizers (4)" in line 2 renders the claim(s) indefinite because “stabilizers (4)” (i.e., introduced as plural, not a single stabilizer) were already introduced in line 2 of claim 7, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the stabilizers of claim 7 or introduce a new, additional stabilizers. To move prosecution forward, the examiner assumed applicant intended to refer back to the stabilizers of claim 7. Appropriate correction is required.
Claim 28 improperly depends from a cancelled claim (i.e., canceled claim 27). To move prosecution forward, the Examiner assumed Applicant intended to have claim 28 depend from claim 25. Appropriate correction is required.
Regarding claim 44 (and thereby dependent claims 45), the phrase "at least two ends of the suture thread" in line 4 renders the claim(s) indefinite because with the claim language being open-ended (e.g., “at least two”) it is unclear how a single suture thread can comprise more than two opposed ends, thereby rendering the scope of the claim(s) ambiguous and/or unascertainable (see also, lines 1-2 in claim 45). Appropriate clarification and/or correction is required.
Regarding claim 45, the phrase "with needle outlet channels" in line 3 renders the claim(s) indefinite because “two needle outlet channels” were already introduced in lines 4-5 of claim 44, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the needle outlet channels of claim 44 or introduce a new, additional needle outlet channels. To move prosecution forward, the examiner assumed applicant intended to refer back to the needle outlet channels of claim 44. Appropriate correction is required.
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 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shafi et al. (US 2008/0033459).
Shafi discloses (see Figs. 1-5) a suturing apparatus and method for closing tissue comprising the following claim limitations:
(claim 1) A tissue closure device, comprising: a tube body (5, Figs. 1A-1B) in which a plurality of needle outlet channels (12, Fig. 1B) are formed; a plurality of suture needles (13, Fig. 1B) located in the tube body (5) (as shown in Fig. 1A-1B); and a needle manipulator (1, Figs. 1A-1B) disposed on the tube body (5) and movable between a needle initial position and a needle triggering position ([0039]-[0040]; [0047]; reciprocal movement of needle actuator 1 in both the proximal and distal directions to drive an retracted needle is expressly disclosed); wherein the needle manipulator (1) can drive the plurality of suture needles (13) to simultaneously move so as to simultaneously extend obliquely from respective corresponding needle outlet channels (12) to a puncture position (as shown in Figs. 3A-3C; [0039]-[0040]; [0047]; distal movement of needle actuator 1 is expressly disclosed to distally drive needles 13); and the needle manipulator (1) allows the plurality of suture needles (13) to simultaneously move so as to simultaneously retract into the respective corresponding needle outlet channels (12) (as shown in Figs. 1A-1B, 2E and 3C-3E; [0031]; [0039]-[0040]; [0047]-[0049]; proximal movement of needle actuator 1 is expressly disclosed to proximally retract needles 13);
(claim 2) wherein a plurality of independent suture needle channels (14) are provided in the tube body (5) (as expressly shown in Figs. 1B, 3E and 5), each of the suture needles (13) is movably located in a respective suture needle channel (14), and each of the suture needle channels (14) comprises a curvilinear channel section (i.e., curved section shown adjacent outlets 12 in Figs. 1B, 3E and 5) to guide the plurality of suture needles (13) so that the needles (13) can simultaneously extend obliquely from the respective corresponding needle outlet channels (12) to the puncture position (as shown in Figs. 3A-3C; [0039]-[0040]; [0047]; distal movement of needle actuator 1 is expressly disclosed to distally drive needles 13);
(claim 3) wherein each of the suture needle channels (14) comprises a rectilinear channel section (i.e., rectilinear section shown in the proximal region of tube body 5 in Figs. 1B) and the curvilinear channel section (i.e., curved section shown adjacent outlets 12 in Figs. 1B, 3E and 5);
(claim 4) wherein in a radial direction of the tube body (5), the rectilinear channel section is located on one side of the tube body (5), the curvilinear channel section extends from the one side of the tube body (5) to the other side, and one end of the curvilinear channel section serves as the needle outlet channel (2) (as expressly shown in Figs. 3E and 5);
(claim 7) wherein the tissue closure device comprises stabilizers (8, Figs. 1A-1B) and a driver (4/21, Fig. 1B), wherein the stabilizers (8) are disposed on the tube body (5) and movable between an unfolded position (as shown in Figs. 2E-3E) and a folded position (as shown in Fig. 2B) ([0040]; [0044]; [0050]; actuation between folded and unfolded positions expressly disclosed); wherein the driver (4/21) is disposed in the tube body (5) and movable between a stabilizer initial position and a stabilizer triggering position ([0040]; [0044]; [0050]; actuation of handle 4 and push rod 21 axially within tube body 5 to move pivoting extensions 8 between folded and unfolded positions expressly disclosed); and wherein the driver (4/21) can drive the stabilizers (8) to move, and in the stabilizer initial position, the stabilizers (8) are in the folded position (as shown in Fig. 2B), and in the stabilizer triggering position, the stabilizers (8) are in the unfolded position (as shown in Figs. 2E-3E) ([0040]; [0044]; [0050]);
(claim 19) wherein the needle manipulator (1) is disposed at a proximal end position on the tube body (5) (as shown in Figs. 1A-1B), and a manual operation portion (i.e., exposed plunger portion shown in Figs. 1A-1B) of the needle manipulator (1) extends from a proximal end port of the tube body (5) (as shown in Figs. 1A-1B; [0039]-[0040]; [0047]; needle actuator 1 (e.g., shown having a plunger exposed at the proximal end of the tube body 5) expressly moves axially within the tube body 5 to drive and retract the needles 13); and
(claim 20) wherein the needle manipulator (1) is movable between the needle initial position and the needle triggering position in an axial direction of the tube body (5) (see Figs. 1A-1B; [0039]-[0040]; [0047]; needle actuator 1 (e.g., shown having a plunger configuration) expressly moves axially within the tube body 5 to drive and retract the needles 13).
Claim(s) 44 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lemke (US 2011/0270282).
Lemke discloses (see Figs. 1a-4d) a suturing apparatus and method for closing a tissue opening comprising the following claim limitations:
(claim 44) A tissue closing method, comprising: arranging a suture thread (21, Fig. 1b) on the exterior of a tube body (3, Fig. 1c) of a tissue closure device (as shown in Figs. 1a-1c), and positioning at least two ends of the suture thread (21) at two needle outlet channels (6’ in Fig. 1a; and 7’ in Fig. 1c) of the tube body (3) (as shown in Fig. 1c; [0036]), respectively; unfolding, by means of a driver (17, Fig. 1a) on the tube body (3), stabilizers (19/20, Fig. 3a) in an inner cavity of tissue (26, Fig. 3b) to be sutured, and abutting the stabilizers (19/20) against an inner cavity wall of the tissue (26) (as shown in Figs. 3a-4b; [0037]-[0038]); driving, by means of a needle manipulator (2, Fig. 1a), a plurality of suture needles (8/9, Figs. 1a and 4b) in the tube body (3) to simultaneously extend obliquely from corresponding needle outlet channels (6’/7’), such that two ends of the suture thread (21) are drawn to pass through the tissue (26) to be sutured and suture thread fixing portions of the stabilizers (19/20) and then move to a puncture position (as expressly shown in Figs. 4b-4c; [0036]; [0043]-[0044]); driving, by means of the needle manipulator (2), the plurality of suture needles (8/9) back into the tube body (3), and retaining the two ends of the suture thread (21) on the corresponding suture thread fixing portions (on 19/20), respectively; and folding the stabilizers (19/20) by means of the driver (17) on the tube body (3) to draw out the two ends of the suture thread (21) from a wound to be sutured (26) (as expressly shown in Figs. 4c-4d; [0044]).
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) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Shafi as applied to claim 20 above, and further in view of Chu et al. (US 2015/0327878).
Shafi, as applied above, discloses a suturing apparatus and method for closing tissue comprising the following claim limitations:
(claim 21) wherein a movement guidance structure (i.e., the opening and interior wall of the lumen at the proximal end of tube body 5) is provided between the needle manipulator (1) and the tube body (5), the movement guidance structure defining the needle initial position and the needle triggering position of the needle manipulator (1) (see Figs. 1A-1B; [0039]-[0040]; [0047]; needle actuator 1 (e.g., shown having a plunger configuration) expressly moves axially within the tube body 5 to drive and retract the needles 13).
Shafi fails to expressly disclose wherein the movement guidance structure comprises an axially extending guide slot on an outer surface of the needle manipulator and a guide bump on an inner surface of the tube body, and the guide bump is fitted in the guide slot.
However, Chu teaches a similar surgical instrument comprising a movement guidance structure (i.e., keyed tab 1120, Fig. 12) comprising an axially extending guide slot on an outer surface of the needle manipulator (i.e., plunger 1114, Fig. 12) and a guide bump (i.e., corresponding keyed structure to compliment keyed tab 1120) on an inner surface of the tube body (1108, Fig. 12), and the guide bump is fitted in the guide slot (i.e., complimentary keyed structures) in order to beneficially provide for limited two-way movement while further limiting rotational movement of the actuation plunger relative to the instrument body ([0135]; [0137]; [0139]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Shafi to have a movement guidance structure comprising an axially extending guide slot on an outer surface of the needle manipulator and a guide bump on an inner surface of the tube body, and the guide bump is fitted in the guide slot in order to beneficially provide for limited two-way movement while further limiting rotational movement of the actuation plunger relative to the instrument body, as taught by Chu.
Allowable Subject Matter
Claims 5, 8-9, 14, 18, 23-25, 28, 30-32, 34, 36, 41 and 45 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that claims 14, 28 and 44-45 remain subject to 112 rejections that must be resolved before these claims can be put into proper form for allowance.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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