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 .
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 10 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.
The term “high-power laser” in claim 10 is a relative term which renders the claim indefinite. The term “high-power laser” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purpose, examiner interprets that powers disclosed in prior art Cattaneo, applied in the rejection below, is high-power.
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 9-16 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 9 of US 12178395 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because (anticipation analysis).
As per claim 9, US 12178395 B2 also recites a 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 to visualize at least one of heart tissue and calcium deposited on or in heart tissue (US 12178395 B2 Col 15 lines 10-14);
targeting at least one of said calcium and a site to perform a surgical intervention of heart tissue by using visualization information obtained by said performing optical coherence tomography (US 12178395 B2 Col 15 lines 26-30, locating /targeting calcium sites); and
conducting at least one of removal of said targeted calcium and a surgical intervention directed at said targeted site of heart tissue using an ultrafast laser (US 12178395 B2 lines 15-20, calcium removal using ultrafast laser).
As per claim 10, US 12178395 B2 also recites wherein said using an ultrafast laser comprises propagating photons through a hollow core optical fiber, generating a high-power laser beam (US 12178395 B2 claims 2-3).
As per claims 11-12, US 12178395 B2 also recites 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 (US 12178395 B2 Col 15 lines 28-29), 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 (US 12178395 B2 Col 15 lines 33-35), or adjusting at least one of the following properties of said ultrafast laser as a function of visualization information obtained by said performing optical coherence tomography: laser source; wavelength of light generated by said ultrafast laser; and pulse duration of said ultrafast laser (US 12178395 B2 Col 15 lines 33-35).
As per claim 13, US 12178395 B2 further recites inflating a balloon to maintain a heart valve leaflet in an open position (US 12178395 B2 claim 9).
As per claim 14, US 12178395 B2 further recites said method is performed for decalcifying at least one of heart valves and coronary arteries (US 12178395 B2 claim 2 “an ultrafast laser for calcium removal on or in heart valve tissue”).
As per claim 15, US 12178395 B2 further recites 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 (US 12178395 B2 claim 2 “the additional optical fiber for use as part of an ultrafast laser for calcium removal on or in heart valve tissue … said additional optical fiber running along a length of another of said one or more lumens.”).
As per claim 16, US 12178395 B2 further recites further comprising removing pulverized calcium particles through a lumen of a shaft of a catheter, sheath or dilator using a vacuum ( US 12178395 B2 claim 5 “removing pulverized calcium or other debris through said additional lumen, or for securing a valve leaflet in an open position, when said deflectable sheath or dilator or catheter is connected to said vacuum source through said port.”).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9, 12, 14-15 rejected under 35 U.S.C. 102 (a) (1) and 102 (a) (2) as being anticipated by Steinke [US 20130023865 A1].
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 obtained by said performing optical coherence tomography (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).
As per claim 12, Steinke further teaches adjusting at least one of the following properties of said ultrafast laser as a function of visualization information obtained by said performing optical coherence tomography (Steinke ¶0107 “Controlling the dosage may also be facilitated by signals from the analyzer”):
laser source; wavelength of light generated by said ultrafast laser; and pulse duration of said ultrafast laser (Examiner choses pulse duration. Steinke ¶0107 “The pattern of energy delivery can be a single pulse or multiple pulses of varying duration, with the energy delivery optionally being separated by periods of varying duration.”).
As per claim 14, Steinke 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 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).
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 10-11 rejected under 35 U.S.C. 103 as being unpatentable over Steinke as applied to claim 9 above, and further in view of Cattaneo [US 20110218524 A1].
As per claims 10-11, Steinke 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 does not expressly teach wherein said using an ultrafast laser comprises propagating photons through a hollow core optical fiber, generating a high-power laser beam, 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 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 as applied to claim 9 above, and further in view of Rudko [US 20040260322 A1].
As per claim 13, Steinke 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 as applied to claim 9 above, and further in view of Summers [US 5431673 A].
As per claim 16, Steinke 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 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. 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 as applied to claim 9 above, and further in view of Hauck [US 6575971 B2].
As per claim 17, Steinke 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 by integrating coupling mechanisms as in Hauck, so as to provide a mechanism for gripping, securing tissues for cardiac procedures.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Oommen Jacob/Primary Examiner, Art Unit 3797