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 of Group II, claims 10-15, in the reply filed on 1/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-9 and 16-20 are withdrawn.
Specification
The disclosure is objected to because of the following informalities: “handle 112” should recite - - handle 114 - - in [0035] to remain consistent with the reference numbers.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: suture transfer location 110 and thread securing stage 214 ([0039]). 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. 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 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 and 15 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 14 recites the limitation "the first side of the suture pass needle". There is insufficient antecedent basis for this limitation in the claim. Only a first side of a suture pass needle mount has been introduced in claim 10. Therefore, for examination purposes and as best understood by the Examiner in light of the disclosure, the Examiner will interpret claim 14 as - - the first side of the suture pass needle mount- -.
Claim(s) 15 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim Rejections - 35 USC § 102
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) 10-12, 14 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weiss (US 2007/0049952).
Weis discloses the following limitations:
Claim 10. A tensioning device operable to tension a suture during a medical procedure, the tensioning device comprising:
a suture pass needle (26) (Fig. 7) coupled to a first side (distal side) of a suture pass needle mount (23) (Fig. 3);
an eyelet (30) disposed in the suture pass needle (within lumen 58) to receive a thread of the suture (36) (Figs. 7-1; [0051]1), the suture operable to secure to a distal end of tissue (4B) internal to a patient (Figs. 10-14);
a gripping portion (66) coupled to the eyelet (30) for moving the eyelet relative to the suture pass needle (26) (Fig. 14; [0052]); and
a tension meter (200) operable to measure a tension value of the thread when the tensioning device pulls the suture to a suture transfer location (base location 21 - at exterior surface of heart 3 where suture exits the heart tissue) spaced a distance from the distal end of the tissue internal to the patient (Figs. 5-6; [0059]; the tension meter 200 is also capable of being placed at ends 90 of the suture (which extend to surgical drapes not shown and discussed in [0057]) to measure the tension while the remainder of the tensioning device is still connected to the suture in Fig. 5).
Claim 11. The tensioning device of claim 10, further comprising: a tensioning bar (40) operable to connect to the tension meter (200) and receive the thread (36) of the suture from a side of the suture pass needle mount (proximal side) opposite the suture pass needle (23) (the tension meter 200 can be placed at ends 90 of the suture (which extend to surgical drapes not shown and discussed in [0057]) and would therefore be connected to the tensioning bar 40 via thread 36; Applicant has not claimed how the tensioning bar is to connect to the tension meter and thus the indirection connection by thread 36 encompasses the claimed limitation).
Claim 12. The tensioning device of claim 11, wherein, the tensioning bar (40) is removably couplable to the suture pass needle mount (23) via the thread (36) of the suture passing through the suture pass needle mount (23) (the tensioning bar 40, which is a sheath as disclosed by Weiss, is not permanently attached to suture pass needle mount 23, the tensioning bar 40 can be proximally slid off the thread 36 to be removed from the suture pass needle mount 23).
Claim 14. The tensioning device of claim 10, wherein, the suture pass needle (26) is a first suture pass needle, the eyelet (30) is a first eyelet, and the thread (36) is a first thread of the suture, and the tensioning device further includes a second suture pass needle (24) coupled to the first side (distal side) of the suture pass needle mount (23).
Claim 15. The tensioning device of claim 14, further comprising: an indicator (202) operable to indicate whether the tension value is within a predetermined tension range ([0060]; the display will show the measured tension values and thus the value can indicate to the surgeon if it is within the desired predetermined tension or not).
Allowable Subject Matter
Claim 13 is 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Weiss, discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed tensioning device comprising, inter alia, the tensioning bar includes a screw-type clamp for receiving the thread of the suture. Instead, Weiss discloses a securement ring (92), separate from the tensioning bar (40), having locking teeth (98) disposed in channels for receiving the thread of the suture ([0058]).
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Taber et al (US 2018/0008330) discloses a tensioning device having a tensioning bar having a screw-type clamp (730) for receiving the thread of the suture (Figs. 12-15; [0044]).
Spence et al (US 2008/0228267) discloses a tensioning device having a tension gauge mechanism (188) for allowing the user to mention the tension of sutures (106, 115, 126) extending out of an eyelet (130/134) (Figs. 18, 18A, 18B; [0073]). Suture tensioning mechanisms (164, 166, 168) are provided in the form of rotatable spools (Fig. 18; [0076]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771