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 .
Applicant’s submission of a Response
Applicant’s submission of a response was received on 12/01/2025. Presently, claims 1-10, and 15-23 are pending in this application.
Response to Arguments
Applicant's arguments filed on 12/01/2025 have been fully considered but they are not persuasive. Applicant’s representative asserts that the amended claims limitations are not met. However, the rejection of claim 1-10, and 15-23 is maintained as presented below.
Applicant’s representative alleges the following:
In regards to rejections under 35 U.S.C. § 103, applicant respectfully disagrees with the assertion that Kramer teaches or suggests "the flexible part has an area larger than the opening of the interventricular septum (area of foam plug 243)".
Regarding point (1), the examiner notes that does teach or disclose this limitation in the instant rejection.
Applicant’s representative argues that the newly added claim limitations requiring "a holder being detachably installed inside the main body and including a flexible part capable of locking the catheter, wherein: the holder can be installed at a position of an interventricular septum provided inside the main body, and the flexible part has an area larger than an opening of the interventricular septum" is not met. Kramer states that "Plug 242 has a cylindrical shape and is sized to fit within the opening 244 in carrier 240. In one embodiment, plug 242 may have a diameter of about 0.350 inches and thickness of about 0.250 inches, although plugs having smaller or larger diameter and thickness are contemplated herein." (Kramer [0036]) And it further states "[c]arrier 240 is configured to enable plug 242 to be easily removed after use and replace with a different plug of the same or different material." (Kramer [0036]) Kramer does not provide any dimensions or surface area for opening 244 or carrier 240, nor does Kramer disclose any comparison between the plug's area and the opening's area. Therefore, Kramer does not reasonably teach or suggest a structure where "the flexible part has an area larger than an opening." In fact, Kramer emphasizes that plug 242 is designed to fit precisely within a small carrier opening for targeted training at the His bundle region, which is a very narrow area of the interventricular septum.
In response to the arguments above, when talking about the area of the flexible part (foam plug 242), it refers to the full area of the foam plug as shown in Fig 5A. If we are only comparing the upper circular area of the foam plug 242 in Fig 5A in comparison to the opening 244 in carrier 240, then this assessment is correct. However, the claim does not limit what area of the flexible part can be used, and as shown in Fig 5A, the full area of the foam plug 242 is larger than the opening 244 in carrier 240.
Applicant’s representative argues that Claims 2-6, 8-10, 15, and 18-23 depend from claim 1 and are allowable for at least their dependency and also by virtue of the additional features it recites. However, in light of the remarks and standing rejection below, the examiner asserts the prior art of record teaches all the elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
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.
Claims 1-10, 14-15, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over OKAYAMA et al. (US 20180018904 A1 see-IDS; hereinafter Okayama) in view of Kramer et al. (US 20190172372 A1; hereinafter Kramer).
Regarding claim 1, Okayama discloses a heart model (Fig 3) comprising: a main body having one or more cavities in the inner part (four-chamber heart model; ¶20); a simulated blood vessel passage being contiguous to the main body and allowing insertion therethrough of a catheter (abstract). Okayama does not explicitly disclose a holder being detachably installed inside the main body and including a flexible part capable of locking the catheter; wherein the holder can be installed at a position of an interventricular septum provided inside the main body, and the flexible part has an area larger than an opening of the interventricular septum.
However, Kramer focuses on providing a heart model with the capability of inserting catheters and His pacing leads, which relates to Okayama because it provides a heart model with a catheter simulator.
Kramer teaches a holder being detachably installed inside the main body (carrier 240; ¶43 and Fig 5A-5C) and including a flexible part capable of locking the catheter (foam plug 242; ¶43 and Fig 5A-5C); wherein the holder can be installed at a position of an interventricular septum provided inside the main body (¶4 and ¶51), and the flexible part has an area larger than an opening of the interventricular septum (the full area all around the foam plug 242 as shown in Fig 5A is larger than the opening 244 in carrier 240).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer for the benefit of having a way to attach a leadless pacemaker to the inside of the heart model.
Regarding claim 2, Kramer teaches wherein the flexible part has surface unevenness on a surface thereof (foam plug is inherently uneven because of the multiple pores on the surface; Fig 5A).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer for the benefit of mimicking the real structure of a heart model.
Regarding claim 3, Kramer teaches wherein the flexible part is formed from a hollow material mounted on the holder (hollow material is defined like a porous sponge, therefore a foam plug would fit this description because both are materials filled with hollow spaces; ¶43).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer for the benefit of mimicking the real structure of a heart model.
Regarding claim 4, Okayama discloses wherein a hole allowing passage of a liquid is formed in the holder (liquid being passed to the inside of the heart model will need a hole for the liquid to pass; ¶7)
Regarding claim 5, Okayama discloses wherein in an outer shell of the main body (outer shell seen in Fig 2), an inflow port opened to an outside is formed (opening of the inflow tube 31a; Fig 4) in addition to the simulated blood vessel passage.
Regarding claim 6, Okayama discloses wherein in the outer shell of the main body, the inflow port opened to a left ventricle side and protruding to the outside is formed (opening of the inflow tube 31a; Fig 4), a pulmonary artery communicating with a right ventricle is provided (pulmonary artery 24; ¶67), and in the pulmonary artery, a liquid communication part opened to the left ventricle or an aorta, or both of them is formed (¶67).
Regarding claim 8, Okayama discloses wherein each of the one or more cavities include a right atrium, and the right ventricle and the left ventricle divided by the interventricular septum, a superior vena cava or an inferior vena cava constituting the simulated blood vessel passage, or both of them communicate with the right atrium (¶67), in the interventricular septum. Okayama does not explicitly disclose an opening detachably fitting the holder is formed such that the flexible part is exposed inside the right ventricle, and in the outer shell of the main body, an opening part for holder attachment and detachment is formed to allow the holder to be installed in the opening of the interventricular septum.
However, Kramer teaches an opening detachably fitting the holder is formed such that the flexible part is exposed inside the right ventricle (¶4), and in the outer shell of the main body, an opening part for holder attachment and detachment is formed to allow the holder to be installed in the opening of the interventricular septum (central opening 244; ¶43 and Fig 5A).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer for the benefit of having a way to attach a leadless pacemaker to the inside of the heart model.
Regarding claim 9, Kramer teaches wherein the heart model is used at a time of performing a simulation of an operation for installing a leadless pacemaker (attachment of a pacemaker; ¶3) or a simulation of a myocardial biopsy maneuver.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer because the present invention lacks any clear distinguishable physical features, the structure as taught by Kramer is inherently performing the function of attaching a pacemaker to a heart model.
Regarding claim 10, Okayama discloses wherein in an outer shell of the main body, cutting lines (lines in figure 4 could represent cutting lines) for forming an opening region (opening through cutting is implied the use of a heart model for surgical operation; ¶153) allowing visual recognition of a movement of a catheter inserted inside the main body are created (making an opening would allow for visual recognition of the catheter inside the main body).
Regarding claim 15, Kramer teaches wherein any one or more of a recess, a pit, and a protrusion are formed on a surface of the flexible part (a recess, pit, or protrusion are inherent to the surface because of the multiple pores on the surface of the foam plug) correspondingly to a shape of the leadless pacemaker (the surface of the foam plug can correspond to a pacemaker; see Fig 5A).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer for the benefit of having a way to attach a leadless pacemaker to the inside of the heart model.
Regarding claim 18, Kramer teaches wherein when a recess is formed on the surface of the flexible part, the recess is accompanied by one or more pits (recess with one or more pits is inherent to the foam plug material along with the sliding or bouncing movement necessary for the placing the pacemaker on the foam plug).
Regarding claim 19, Kramer teaches wherein a knob is formed in the holder (pair of legs 248 and 246).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Okayama to implement the teachings of Kramer for the benefit of having a way to attach a leadless pacemaker to the inside of the heart model.
Regarding claim 20, Okayama discloses wherein a hole allowing passage of a liquid is formed in the holder (there is liquid being passed to the inside of the heart model, therefore you will need a hole for the liquid to pass; ¶7).
Regarding claim 21, Okayama discloses a catheter simulator comprising: a container equipped with an accommodation part capable of accommodating the heart model according to claim 1 in a state of being filled with a liquid (container 10; Fig 2); a connection part provided in the container and holding the heart model (heart being held in Fig 2); and an introduction part provided in the container and allowing insertion therethrough of the catheter (shown in Fig 2), wherein the container includes a holding part for holding the heart model such that the simulated blood vessel passage is connected to the introduction part (connections to the heart and tubes; Fig 2).
Regarding claim 22, Okayama discloses wherein the catheter simulator includes a pump for circulating the liquid filled in the container (pump 60; ¶43), and the pump generates a pulsatile flow to an internal space of the heart model held in the container in the state of being filled with the liquid (¶43).
Regarding claim 23, Okayama discloses wherein the catheter simulator includes a pump for circulating the liquid filled in the container (pump 60; ¶43), in an outer shell of the main body, an inflow port opened to the outside is formed in addition to the simulated blood vessel passage, and a flow of the liquid inside the main body to be discharged to the outside is generated by a flow circulating an outside of an outflow port (¶63).
Allowable Subject Matter
Claims 16-17 would be allowable if rewritten 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 to include all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 JOSE ANGELES whose telephone number is (703)756-5338. The examiner can normally be reached Mon-Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dmitry Suhol can be reached at (571) 272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSE ANGELES/Examiner, Art Unit 3715
/STEVE ROWLAND/Primary Examiner, Art Unit 3715
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