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 3/3/2025 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “a diameter of the large-diameter section (211) is smaller than or equal to a diameter of the knotted structure (A3) to allow at least a part of the knotted structure (A3) to be detachably held in the large-diameter section (211)” must be shown or the feature(s) canceled from the claim(s) (emphasis added). Figs. 8a-8b depict the diameter of the large diameter section (211) being larger than (i.e., not smaller than or equal to) the diameter of the knotted structure (A3). No new matter should be entered.
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.
Currently no claims are 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 2-6, 8-12 and 14-18 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 2 (and thereby dependent claims 3, 5-6, 8-9, 11-12, 14-15 and 17-18) is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: the “a knotted structure” of line 2 in claim 2 omitting essential structural cooperative relationships of elements (i.e., it appears to be (and is currently interpreted as being) a sub-component of the suture (A), e.g., such as “the suture further comprising a knotted structure”). The knotted structure is not affirmatively connected to or related to any other structure, other than the knotted structure claimed to be stopped adjacent the rear end of the through hole (21). Appropriate correction is required.
Claim 4 (and thereby dependent claims 10 and 16) recites the limitation "the knotted structure" in line 4. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claims 4-6 (and thereby each of claims 4-6 respective dependent claims 10-12 and 16-18), the phrase "a diameter of the large-diameter section (211) is smaller than or equal to a diameter of the knotted structure (A3) to allow at least a part of the knotted structure (A3) to be detachably held in the large-diameter section (211)" renders the claim(s) indefinite because the claimed scope appears to be opposite the structures disclosed in the present application, thereby rendering the scope of the claim(s) unascertainable. As shown in Figs. 8a-8b, when the knotted structure (A3/A31) is held in the large diameter section (211) the diameter of the larger diameter section (211) is depicted as being larger than the diameter of the knotter structure (A3) but smaller than the through hole (21). 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, 7 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tu (US 2016/0000427).
Tu discloses (see Figs. 1-6) a suturing device comprising the following claim limitations:
(claim 1) A capsule knotting module (10, Fig. 2), characterized in that the capsule knotting module comprises: a knotting member (20, Fig. 6) having a through hole (21, Fig. 5) formed through the knotting member (20) (as shown in Fig. 5), two ends of the through hole (21) defined respectively as a front end (i.e., right side end of passage 31, as shown in Fig. 5) and a rear end (i.e., left side end of passage 21, as shown in Fig. 5), and a shaft (25, Fig. 5) extending through the through hole (21) and protruding from the front end (i.e., right side end) of the through hole (21) (as shown in Figs. 5-6); a suture (40, Fig. 6) extending through the through hole (21) and the shaft (25) (as shown in Figs. 3 and 5-6) and having two ends defined respectively as an operating end (401, Figs. 3 and 5) and a knotting end (i.e., end at knot 41 with needle 45, as shown in Fig. 3), and the operating end and the knotting end respectively exposed out of the rear end of the through hole (21) and a front end of the shaft (25) (as shown in Figs. 3 and 5), wherein at least a part of the knotting end of the suture (40) is wrapped around an outer circumference of the shaft (25) and forms a pre-knot (41) (as shown in Fig. 3 and 5-6), and a sliding loop (42, Figs. 5-6) is formed between the shaft (25) and the pre-knot (41) (as shown in Figs. 5-6); and a size of the sliding loop (42) is varied according to a distance between an operating member (50, Fig. 2) and the knotting member (20) ([0033]; [0038]; [0056]; [0059]; [0060]);
(claim 7) wherein at least a part of the shaft (25) is securely held in the through hole (21) (as shown in Fig. 5; [0036]), wherein: during an operation (the following language is interpreted as intended use and/or functional language statements, with regard the statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over Tu which is capable of being used as claimed if one so desires to do so, In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963); furthermore, the manner in which a device is intended to be employed does not differentiate the claimed apparatus from prior art apparatus satisfying the claimed structural limitations, Ex parte Masham, 2 USPQ2d 1647 (1987)), at least a part of the suture (40) extends through the sliding loop (42) (as shown in Figs. 12C-12D and 13B; [0056]-[0057]; needle 45 and suture 40 expressly disclosed to pass through loop 42), and the sliding loop (42) is pulled to be shrunk and abuts with the outer circumference of the shaft (25) (as shown in Figs. 13C-13E; [0058]-[0059]); the operating member (50) is continuously pulled to make the pre-knot (41) to move toward the front end of the capsule knotting module until the pre-knot (41) is detached from the shaft (25) (as shown in Figs. 13F-13G; [0059]-[0060]); and the pre-knot (41) is detached from the shaft (25) and is tied with the sliding loop (42) and at least a part of the suture (40), and a secure knot is formed (as shown in Figs. 13F-13G; [0059]-[0060]); and
(claim 13) wherein the knotting end of the suture (40) is connected with a surgical needle (45) (as shown in Figs. 1-2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 7 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/108,379. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Present Invention
U.S. App. No. 19/108,379
1
1-18
7
15,19
13
19
Allowable Subject Matter
Dependent claims 2 and 4 are objected to (as the claims are currently being interpreted) and appear to contain allowable subject matter if the pending respective 112 rejections (as set forth above) are resolved. The pending 112 rejections must be resolved before any of these claims can be rewritten into proper independent 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)270-3952. 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
