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 .
Drawings
The drawings are objected to because: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. This applies to shading. Solid black shading areas are not permitted, expect when used to represent bar graphs or color. See for example, Figures 1-10. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 suture thread positioning segment in claims 9 and 17, a positioning structure in claim 16 and a plurality of locking structures in claim 19.
The suture thread position segment is interpreted under 112(f) as an elastomer or a cone and equivalents thereof (claims 10, 13). The locking structures are interpreted under 112(f) as locking bolts and radial holes 27 and equivalents thereof ([0062]).
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 7, 9-13 and 16-17 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 7 recites the limitation "the guide segment (4) of each of the suture needles (8) is configured to be located in the respective corresponding channel hole" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim because there is only one guide segment claimed, not one associated with each of the needles. Further, the guide segment (4) is not configured to be located in channel holes, as the channel holes (4) extend through the guide segment (4) as shown in Fig. 2.
Claims 9-10 recite the limitation "the outward-moving puncture needle segment" in lines 2 and 3, respectively. There is insufficient antecedent basis for this limitation in the claim. While antecedent basis is provided for a puncture needle segment, there is no basis for the puncture needle segment being outward-moving.
Claim limitation “a positioning structure” in claim 16 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of adequate structure to perform the claimed function. In particular, the specification merely states a positioning structure is arranged therebetween the sleeve 21 and the guide segment 4. There is no disclosure of any particular structure, either explicitly or inherently, to perform the positioning. The use of the term “structure” is not adequate for preforming the positioning function because it does not describe a particular structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 17 recites the limitation "the suture thread position segment" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claims 11-13 depend from rejected claims 9 and 10; therefore, are also rejected.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. As described above, the disclosure does not provide adequate structure to perform the claimed function of positioning. The specification does not demonstrate that applicant has made an invention that achieves the claimed function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention.
Allowable Subject Matter
Claims 1-6, 8, 14-15 and 18-20 are allowed.
Claims 7, 9-13 and 16-17 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and/or the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art of record, Kronner (US 5,817,110) or Nobles (US 2020/0214694 A1), does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of independent claim 1, which recites, inter alia “the plurality of the suture needles (8) are configured to be arranged in the suture needle channel, and the puncture needle segments (10) are configured to carry the suture thread and be located in the accommodating cavity (7); wherein each of the suture needles (8) is configured to move toward the proximal end and the distal end along the suture needle channel such that the puncture needle segment (10) is configured to return to the accommodating cavity (7) alone after passing with the suture thread through a tissue wall (5).”
Kronner teaches a tissue suturing device (suturing apparatus 20), comprising: a body (body of 20), comprising a guide segment (plunger 44 and/or sleeve 72) at a proximal end for extending into a wound to be sutured (Fig. 6A) and a tube segment (plug 74) at a distal end (Fig. 1), wherein the guide segment (44, 72) is provided with a suture needle channel (channel shown in Fig. 2), and the tube segment (74) is provided therein with an accommodating cavity (closed-ended opening of sheath 82; Fig. 2) communicated with the suture needle channel (Fig. 2); a suture needle (needle 22), each of which comprising a main needle segment (shaft 24) and a puncture needle segment (pointed end 34) connected with and spaced apart from the main needle segment (Fig. 2), wherein the suture needle (22) is used to connect a suture thread (suture 118), the main needle segment (24) is configured to be arranged in the suture needle channel (Fig. 2), and the puncture needle segment (34) is configured to carry the suture thread (Fig. 6F) and be located in the accommodating cavity (82; Fig. 6L); wherein the suture needle (22) is configured to move toward the proximal end and the distal end along the suture needle channel such that the puncture needle segment (34) can return is configured to return to the accommodating cavity (82) alone after passing with the suture thread through a tissue wall (Figs. 6L-6M).
Kronner fails to disclose a plurality of suture needles, wherein two of the suture needles are used as a group of suture needles to connect a suture thread releasably between the puncture needle segments of the two suture needles, the main needle segments of the plurality of the suture needles are configured to be arranged in the suture needle channel, and the puncture needle segments are configured to carry the suture thread and be located in the accommodating cavity; wherein each of the suture needles is configured to move toward the proximal end and the distal end along the suture needle channel such that the puncture needle segment is configured to return to the accommodating cavity alone after passing with the suture thread through a tissue wall. Instead, Kronner teaches a single suture needle.
Nobles teaches a tissue suturing device (suturing device 100; Figs. 2-8B) with a guide segment (elongated body 32) and a tube segment (needle sheath 24) at a distal end, wherein the guide segment is provided with a suture needle channel (lumen within 32), and the tube segment is provided therein with an accommodating cavity (guides 124) communicated with the suture needle channel (Figs. 8A-8B); and a plurality of needles (needles 120), each of which comprise a main needle segment (body of 120) and a puncture needle segment (tip 130) connected with and spaced apart from the main needle segment, wherein two of the sutures are used as a group of suture needles to connect a suture thread (suture portion 52) releasably between the puncture needle segments (Fig. 11), the main needle segments are configured to be arranged in the suture needle channel (Fig. 8A), and the puncture needle segments (130) are configured to carry the suture thread (via 132) and be located in the accommodating cavity (Fig. 8A).
Nobles fails to disclose wherein each of the suture needles is configured to move toward the proximal end and the distal end along the suture needle channel such that the puncture needle segment is configured to return to the accommodating cavity alone after passing with the suture thread through a tissue wall. Instead, the puncture needle segments carry the suture into the accommodating cavity as the needles are retracted into the elongate body 32 ([0062]-[0063]).
It would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kronner to have a plurality of needles configured as claimed as doing so would require a substantial reconstruction and redesign of the elements shown in Kronner as well as change the basic way the suture is pulled through tissue under which the device of Kronner was designed to operate.
Because none of the prior art documents teach the tissue suturing device as claimed, it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the technical solutions of claim 1 according to the prior art documents or a combination thereof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kumar et al. (US 10,966,707 B2) is noted for teaching a tube segment. Bhalla et al. (US 2018/0221015 A1) is noted for teaching a guide segment. Debbas (US 2003/0171764 A1) is noted for teaching a plurality of needles.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH A LONG/Primary Examiner, Art Unit 3771