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 Arguments
Applicant’s arguments with respect to claims 9-11, 13-17 have been considered but are moot because in view of new grounds of rejection.
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 9, 14-15 rejected under 35 U.S.C. 103 as being unpatentable over Steinke [US 20130023865 A1] in view of Okubo [The relationship between coronary artery calcium density and optical coherence tomography-derived plaque characteristics, Atherosclerosis Volume 311, October 2020, Pages 30-36].
As per claim 9, Steinke method of decalcifying heart tissue or performing a surgical intervention directed at heart tissue comprising:
performing optical coherence tomography using information obtained from light channeled through an optical fiber (Steinke ¶0081 “Optical Coherence Tomography (OCT) utilizes advanced photonics and fiber optics to obtain images and tissue characterization within the human body Infrared light can optionally be delivered to the imaging site through a single optical fiber”) to visualize at least one of heart tissue and calcium deposited on or in heart tissue (Steinke ¶0098 “…embodiments of the catheter devices, systems, and methods described herein may also find applications in the lumens …and/or the heart.” Fig 1 visualizing plaques, ¶0074 “removal of calcified plaque deposits”)
targeting at least one of said calcium and a site to perform a surgical intervention of heart tissue by using visualization information Steinke ¶0071 “to direct the laser energy from laser 22 to the targeted lesion using fiber optics. … In order to bring a sufficient quantity of energy from the laser to the thrombus or plaque…”) and
conducting at least one of removal of said targeted calcium and a surgical intervention directed at said targeted site of heart tissue (Steinke Fig 2, item 22, ¶0072-75 for example laser energy may also be employed for the removal of calcified plaque deposits) using an ultrafast laser (Steinke ¶0079 “Femtosecond lasers may also be adapted and/or used to ablate plaque”. As per applicant spec. this is an ultrafast laser), wherein one or more of pulse duration, wavelength, focal distance, laser source of the ultrafast laser is adjusted (Examiner choses pulse duration. Steinke ¶0075 “Control of pulse duration and repetition rates can maximize the ablative properties”, ¶0100 “embodiments may tune the laser energy directed to a particular patient based on in situ feedback”) based on OCT data (Steinke ¶0104 “specific frequencies may be employed to verify tissue type and/or condition of tissue based … provided using OCT imaging”, ¶0110 “Closed loop control of different types may be included in some embodiments… verify physical changes observed by other intraluminal observation techniques such as OCT implemented in analyzer 24.”)
Steinke does not expressly teach generate calcium density data, said calcium density data, providing information on a location of the site for the surgical intervention or of the calcium and calcium removal based on calcium density.
Okubo in a related field of evaluating coronary artery calcium, teaches generate calcium density data (Okubo sections 2.3-2.4, Table 2, calcification information in relation to calcium density), said calcium density data, providing information on a location of the site for the surgical intervention or of the calcium (Okubo section 2.3 “we first identified the relevant proximal and distal site with the largest lumen area within the same segment as the calcification”, sections 4.1 “We observed 9 additional calcified plaques at the threshold of 90 HU that were confirmed as calcifications by OCT”, calcium density provides information regarding calcium / plaque).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Steinke by utilizing calcium density information from OCT images as in Okubo. As per MPEP 2143.I.A, I. Examples of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results. In the instant case, the claim is only directed to use calcium density for plaque information, which is taught by Okubo as discussed above. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Steinke by utilizing calcium density information from OCT images as in Okubo, to achieve predictable results of gathering plaque characteristics for monitoring coronary health.
Steinke in view of Okubo does not expressly teach a removal based on calcium density. However, the combination discloses how OCT is useful for closed loop control of laser (Steinke ¶0104, ¶0110) and how calcium density is derived from OCT (Okubo). Hence, it would have been obvious to person of ordinary skill to adjust laser parameters based on calcium information associated with coronary plaques, so as to accurately characterize and treat atherosclerosis, or other coronary issues related to calcium.
As per claim 14, Steinke in view of Okubo further teaches wherein said method is performed for decalcifying at least one of heart valves and coronary arteries (Steinke ¶0053 “the signals may be used by an automated signal processing system to selectively transmit laser energy eccentrically from a catheter to an eccentric plaque along (for example) one side of a coronary artery,”).
As per claim 15, Steinke in view of Okubo further teaches wherein said ultrafast laser includes an optical fiber, and wherein said optical fiber of said ultrafast laser is located in a lumen of a shaft of a sheath, catheter or dilator (Steinke ¶0070-¶0070, fibers in the catheter disclosed. Note, some lumen, for example, as that discussed in ¶006, is required for fibers).
Claims 10-11 rejected under 35 U.S.C. 103 as being unpatentable over Steinke in view of Okubo as applied to claim 9 above, and further in view of Cattaneo [US 20110218524 A1].
As per claims 10-11, Steinke in view of Okubo further teaches wherein said performing optical coherence tomography generates distance information pertaining to at least one of said calcium and said site to perform a surgical intervention (Steinke ¶0080 “as monitored by imaging system 24, can be used to enhance ablation depth and targeting control.”).
Steinke in view of Okubo does not expressly teach wherein said using an ultrafast laser comprises propagating photons through a hollow core optical fiber, or further comprising adjusting a focal distance of said ultrafast laser prior to said conducting at least one of removal of said targeted calcium and said surgical intervention.
Cattaneo in a related field of laser-based surgery, teaches wherein said using an ultrafast laser comprises propagating photons through a hollow core optical fiber (Cattaneo ¶0032) comprising adjusting a focal distance of said ultrafast laser prior to said conducting at least one of removal of said targeted calcium and said surgical intervention (Cattaneo ¶0030 “By adjusting the penetration depth of the laser energy, e.g. by adjusting the focus of the irradiating laser beam, deep, yet exacting cuts can be made”).
As per MPEP 2134.I, examples of rationale that may support a conclusion of obviousness include (A) Combining prior art elements according to known methods to yield predictable results. In the instant case, the claim is directed to combine the features of femtosecond laser and control for laser surgery, as in Cattaneo, with the OCT based system in Steinke. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Steinke in view of Okubo by integrating features as in Cattaneo so as to yield predictable results of allowing the destruction of targets with high precision.
Claim 13 rejected under 35 U.S.C. 103 as being unpatentable over Steinke in view of Okubo as applied to claim 9 above, and further in view of Rudko [US 20040260322 A1].
As per claim 13, Steinke in view of Okubo further teaches inflating a balloon (Steinke ¶0053 “with stenting and/or balloon dilation,”)
Steinke does not expressly teach to maintain a heart valve leaflet in an open position.
Rudko, in a related field of catheter-based procedures, teaches to maintain a heart valve leaflet in an open position (Rudko ¶0046 “balloon 100 disposable on the ventricular side of the heart valve under leaflets 102 and 104. Balloon. 100 is connected to inflation conduit 106 which extends within multi-lumen catheter 81.”).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Steinke by integrating balloon for heart valve leaflets, so that space can be provided for laser ablation fiber (Rudko ¶0021, ¶0048).
Claim 16 rejected under 35 U.S.C. 103 as being unpatentable over Steinke in view of Okubo as applied to claim 9 above, and further in view of Summers [US 5431673 A].
As per claim 16, Steinke in view of Okubo further teaches removing pulverized calcium particles through a lumen of a shaft of a catheter, sheath or dilator (Steinke ¶0067 “An outer catheter, the treatment/imaging catheters described herein, and/or a distal balloon-supporting guidewire may include at least one lumen coupled to an aspiration and/or irrigation source”).
Steinke in view of Okubo does not expressly teach using a vacuum.
Summers in a related field of atherectomy catheter teaches using a vacuum (Col 6 lines 34-38).
As per MPEP 2134.I, examples of rationale that may support a conclusion of obviousness include (A) Combining prior art elements according to known methods to yield predictable results. In the instant case, the claim is directed to use a vacuum, as in Summers, with the aspiration /irrigation system of Steinke in view of Okubo. Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Steinke by integrating vacuum, so as to achieve the predictable result of aspiration of plaque.
Claim 17 rejected under 35 U.S.C. 103 as being unpatentable over Steinke in view of Okubo as applied to claim 9 above, and further in view of Hauck [US 6575971 B2].
As per claim 17, Steinke in view of Okubo does not expressly teach securing heart valve tissue to a portion of a catheter, sheath or dilator using a vacuum maintained through a lumen of said catheter, sheath or dilator by a vacuum source.
Hauck, in a related field of a guide catheter teaches, securing heart valve tissue to a portion of a catheter, sheath or dilator using a vacuum maintained through a lumen of said catheter, sheath or dilator by a vacuum source (Hauck Fig 7, Col 7 lines 43-53).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Steinke in view of Okubo by integrating coupling mechanisms as in Hauck, so as to provide a mechanism for gripping, securing tissues for cardiac procedures.
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 OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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/Oommen Jacob/Primary Examiner, Art Unit 3797
