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 .
Response to Amendment
In response to the amendment filed on 2/6/2026, claims 1-3, 7, 8 and newly added claims 16-18 are pending, while claims 4-6, 9-15 remain withdrawn.
Response to Arguments
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive.
Applicant indicates a replacement sheet of Fig. 2 was filed with the amended phrase “Prior Art”. However, no such drawing appears to have been filed, as further evidenced by the Electronic Acknowledgement Receipt dated 2/6/2026. Therefore, the drawing objection is maintained.
Applicant’s arguments with respect to the rejection as being anticipated by Kim et al has been fully considered but are unpersuasive. Applicant argues Kim et al fails to disclose claim 1 as amended due to the through-hole 16 in blade 10. The Examiner respectfully disagrees. The embodiment with through-hole 16 is in reference to Fig. 8. However, in regards to claim 1, the Examiner had previously also relied upon Figs. 3 and 4. It is the Examiner’s position that the embodiment of Figs. 3 and 4 still disclose claim 1 as amended, as detailed below. The details of which are provided in the annotated figure below. Therefore, Kim et al is maintained as disclosing at least claim 1.
Drawings
Figure 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 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 17 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.
Newly added claim 17 recites “the blade holder comprises a flat surface configured to abut a corresponding flat surface of the distal end of the shaft”. However, the original disclosure has not discussed the distal end of the shaft (120) having a flat surface for abutting the blade holder. Therefore, this limitation is considered new matter.
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) 1, 2, 8 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al (KR 101811272; citation No. 67 in the IDS filed 12/30/2024 and a copy provided by Applicant. The English machine translation cited in the attached PTO-892 is cited below).
Kim et al discloses the following limitations:
Claim 1. A myectomy instrument (abstract; Figs. 3, 4) comprising:
a handle (30) (p. 3, paragraphs 2 and 10);
a shaft (see annotated figure below) extending distally from the handle (p. 3, paragraph 5);
a blade mounting portion (20) affixed to a distal end of the shaft; and
a cutting blade (10) coupled to the blade mounting portion, the cutting blade attached at two attachment portions (left and right sides of blade 10) and having a middle cutting portion extending between the two attachment portions, wherein a proximal-facing edge (12) of the middle cutting portion is sharpened for cutting tissue (Fig. 4; p. 3, paragraph 4), wherein the middle cutting portion is spaced away from the distal end of the shaft to define an open space between the middle cutting portion and the blade mounting portion for receiving a strip of the tissue (see the dashed double-headed arrow in the annotated figure below. The U-shaped configuration of blade 10 defines an open space between the middle cutting portion of the blade and the annotated blade mounting portion to receive tissue).
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Claim 2. The myectomy instrument of claim 1, wherein the cutting blade (10) is releasably coupled to the blade mounting portion coupled to the distal end of the shaft (p. 3, paragraph 9; “[a]ccording to the drawings, the blade portion 10 and the connecting portion 20 [cited blade mounting portion] are fixed to each other, but they can be fastened so as to be detachable from each other” indicating the releasable coupling and fixed coupling are alternatives to one another).
Claim 8. The myectomy instrument of claim 1, wherein middle cutting portion is U-shaped (Fig. 3; p. 3, paragraph 4; e.g. hemispherical).
Claim 18. The myectomy instrument of claim 1, wherein the middle cutting portion is U-shaped (Fig. 3; p. 3, paragraph 4; e.g. hemispherical), and the two attachment portions are substantially parallel to a longitudinal axis of the shaft (attachment portions can be seen in annotated figure from claim 1 above as extending along the left and right side of the ‘ladder’, extending substantially parallel to a longitudinal axis of the shaft).
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.
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) 3 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al in view of Nakamura (US 2013/0066164).
Claim 3. Kim et al discloses the invention substantially as claimed above, but fails to disclose the myectomy instrument further comprising a plurality of cutting blades that have differing cutting-depths or cutting-widths1.
In a similar field of endeavor of adjustable cutting instrument, Nakamura teaches a medical cutting knife, having a plurality of different shape cutting blades (41A) that may be attached (these different shapes result in different cutting-depths or widths) (Figs. 1-3; [0032], [0036]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kim et al to have a plurality of cutting blades that have differing cutting-depths or cutting-widths based upon the teachings of Nakamura to permit the surgeon to select the appropriate blades for a given patient.
Claim 16. Kim et al discloses the invention substantially as claimed above, including the blade (10) is releasable from the remainder of the instrument (p. 3, paragraph 9; “[a]ccording to the drawings, the blade portion 10 and the connecting portion 20 [cited blade mounting portion] are fixed to each other, but they can be fastened so as to be detachable from each other” indicating the releasable coupling and fixed coupling are alternatives to one another) but fails to disclose the mechanism for doing so, specifically the myectomy instrument further comprising a blade holder releasably coupled to the blade mounting portion coupled to the distal end of the shaft, wherein the cutting blade is attached to the blade holder at the two attachment portions.
However, in a similar field of endeavor of adjustable cutting instrument, Nakamura teaches a medical cutting knife, having a blade (41A) coupled to a blade holder (42A), wherein the blade holder is releasably coupled to the blade mounting portion (distal end of shape memory portion 30), wherein the cutting blade is attached to the blade holder at the attachment portion (Fig. 1; [0031], [0032]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to before the effective filing date of the invention to modify Kim et al with a blade holder as claimed based upon the teachings of Nakamura to allow for the user to handle the blade portion when attaching and detaching the blade (rather than handling the blade directly) to minimize inadvertent injury/cutting. The combination would result in the blade of Kim et al attached to a blade holder at the two attachment portions as the blade of Kim et al requires two portions for attachment (left and right side of blade 10).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al in view of Conklin et al (US 2013/0158600).
Claim 7. Kim et al discloses the invention substantially as claimed above, but fails to disclose the shaft is malleable to facilitate user adjustment of a shape of the shaft. Instead, Kim et al discloses the material of the shaft is not limited to the disclosure (p. 3, paragraph 5).
In a field reasonably pertinent to the particular problem with which Applicant was concerned with, namely delivering a tool into the heart of a patient, Conklin et al teaches a device for insertion into the heart for a surgical procedure, wherein the shaft (402) of the instrument is malleable or bendable into various shapes for insertion into the heart ([0114]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the shaft of Kim et al such that it is malleable to facilitate user adjustment of a shape of the shaft as taught by Conklin et al to enhance the ability of a surgeon to correctly the position of the distal end of the instrument at the target location ([0114]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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
1 Applicant’s plurality of cutting blades are essentially blades of a kit that can be interchanged with the shaft and cutting blade of the instrument (Fig. 5). The differing blades are not all coupled to the shaft at the same time. Therefore, for examination purposes, the Examiner is interpreting the prior art in the same manner.