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 7, 8, 10 and 12 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.
Claims 7, 10 and 12 recites the limitation " a 3-D model of the heart" in the claims which seems indefinite as there is already “a model of the heart” recited in claim 6 and it seems unclear whether or not “a 3-D model of the heart” of claims 7, 10 and 12 is the same as “a model of the heart” in claim 6. There is insufficient antecedent basis for this limitation in the claim. Claim 8, which depends from claim 7, is also being rejected for the same reason set forth for claim 7.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 6-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 6-19 recite a system, and therefore is a product. Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claim 6 recites limitations of “receive intracardiac electrophysiological signal waveforms” and “determine relative spatial locations of the probe positions within the heart, identify, based on the signal waveform measurements, a position and orientation of a region between the atrial side and the ventricular side, the region being positioned at the heart valve annulus along the atrioventricular axis, and oriented to include opposite circumferential sides of the heart valve annulus, and produce a model of the heart.” The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitation in the mind except for the recitation of “system comprising a processor, memory, and display”, which reads on a computer. That is, other than reciting that a system is performing these tasks, nothing in the claim precludes the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. For example, aside from the recitation of “system comprising a processor, memory, and display”, the claim encompasses a user receiving ECG data and tracking location within heart and making notes of the tracked positions with pen and paper. As such, these limitations are mental process.
For the limitation of “probe positions extending between an atrial side and a ventricular side of a heart valve annulus, including, for each side, a respective plurality of probe positions”, the probe recited in claim 6 is not part of the system and system is only receiving electrophysiological signal waveform from the probe. As such, system is not performing the measuring of the signal waveform.
Step 2A Prong 2:
The claims recite “system comprising processor, memory, and display” to perform the abstract steps. These components read on a computer implemented system and are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A Prong 2, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification (p61, line 24-p62, line 2) does not provide any indication that the computer is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim, as a whole, amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claims 7, 9, 11, and 13-19 further limit the abstract idea already indicated in independent claim 6 and they are ineligible for the same reasons provided for claim 6 above.
Regarding claims 8, 10, and 12, the additional limitation of displaying 3-D model of the heart is nothing more than post-solution activity of displaying results of performing abstract idea steps.
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 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.
Claim(s) 6-19 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Markowitz et al. US 2009/0262980 alone or alternatively in view of Paskar 2014/0088684.
For claim 6 Markowitz teaches a processor and a memory with instructions (38) in Fig. 1 and para. [0070]). The processor is configured to provide a model of a heart (fig. 28) with sensed egm/ecg data. See for instance “Rendering of the instruments, such as the electrodes 108,110 of the mapping catheter 100, can also be presented with the same classification so the representation of physical position is in the same context as the rendered image of the heart chambers/vessels” in para. [0346].
The processor receives intracardiac electrophysiological signal waveforms measured from a plurality of probe positions extending between an atrial side and a ventricle side of the heart valve annulus (see figure 28 map with probe positions mapped) and on both sides of the tricuspid valve and the pulmonary valve. The processor determines the relative spatial positions of the surface potentials as well as those of the instruments (probe) and maps them to the model of the heart (see para. [0346]). The processor determines a position and an orientation region between the atrial side and the ventricle side along the atrioventricular axis as the heart valve region corresponding to the heart valve annulus and produces a model of the heart 58, as shown in figure 28.
It seems that Fig. 28 and [0320] of Markowitz illustrates the catheter position mapping along the heart to include going through annulus of tricuspid valve (TCV), which would read on claim limitation of “atrial and ventricular side of the annulus.” and thus Markowitz would seem to anticipate the claims.
Although the heart valve annulus position and orientation is likely approximated in Markowitz due to the linearity of the catheter, as claimed, the system only produces the information based upon the heart data received. However, if additional information were needed in order to meet the claim language by mapping the heart rate annulus directly using a bendable or curved catheter (I.e. see Applicant’s figures 2a-2g) that can directly reach the annulus rather than by a linear catheter of Markowitz, it would have been obvious to provide a catheter of the Paskar type that maps the annulus itself above and below the annulus (see fig. 7c and paras. [0018] and [0053] of Paskar and describing the mapping above and below the heart annulus. Thus, the processor of Markowitz is fully capable of performing all of the steps of the claims depending on the probe placement. Thus, the system of Markowitz is considered to anticipate the system of claim 6 as being capable of performing all of the tasks claimed, or obvious, it would have been obvious to use a probe of the Paskar type for mapping the valve annulus by direct contact or close proximity.
For claim 7, the spatial locations correspond to locations with a 3-D model of the heart. See para. [0131] for 3D model 58 in fig. 28
For claim 8, the processor is capable of producing positions along the heart valve and annulus when the received data has such probe position information concerning the annulus EGMs. See para. [160] for 3D mapping of model 58.
For claim 9, the system of Markowitz identifies atrial chambers and ventricle chambers on the map in part by the type of waveform measure, P or R. See para. [0322] and [315]
For claim 10 see positions in RA region of the heart model fig. 28 of the heart along the av axis extending through the valves, the positions identified by p wave detection.
For claim 11 and 12, see positions with region RV region of the heart model fig. 29 of the heart along the av axis extending through the valve, the region identified by the detection of R Waves. See para. [160] for 3D mapping of model 58.
For claim 13, relatives amplitudes para. [0315] and [0322] of p waves and R waves are used to identify RA and RV regions along the atrioventricular axis.
For claim 14 and 15, the limitations are the properties of atria and ventricular chambers as to the type of wave is produced since atrial depolarizations generate the P wave portion of the EGMs and ventricles generate the QRS portion of the EGMs. Thus, if one detects a surface potential in the atrium, it would detect a P wave and if one detects a surface potential in the ventricle, one would be detecting a ventricular wave.
For claim 16, the mapping system of Markowitz is capable of interpolating map points when to determine where the R waves stop and P waves start (see block 431) fig. 20 and para. [0150]
For claim 17, the mapping system processor is capable of identifying a position along the AV axis by identifying a planar region of the annulus TCV which is shown in 3D model 58 of fig. 28 as a planar region intersecting the entire circumference of the valve annulus and which is identified as TCV which is short for “tri-cuspid valve” (or alternatively the pulmonary valve PV.
For claims 18 -19, data from the Markowitz probe can used to determine landmarks and more clearly distinguish landmarks or render an anatomical surface more clearly (see para. [0067]). Valve information may be collected via the ECGs received by the mapping catheter (paras. [0150]-[151]) to provide the physician information about the valves which valves and information are presented by torroids (figure 6 ) to provide the physician guidance. The torroid markers may include valve information such as the area of the valve and the orientation of the valve. Para. [0153]. While the reference does not explicitly state the detection of a non-planar region intersecting an entire circumference of the valve annulus (which is due to a deformity), it would reasonable to conclude that the Markowitz detects whatever size and orientation the valve under inspection takes, including a non-planar saddle shape due to a geometry deformity of the valve. Claim 19 provides for a result based upon a specific application of the device, specifically, the use of the system on a person with a valve deformity. Presumably the mapping system outputs a map that is representative of whatever anatomical structure it is presented. If it is presented with a deformed valve, it will map a deformed valve. If not inherent, it would have been obvious at the time of Applicant’s invention to have substituted the Paskar catheter system to gather additional information concerning the details of the annulus of the valve at the top and bottom of the valve annulus to provide additional information about the size, orientation and shape of the valve for generation to be included in the torroids of Markowitz (fig. 6) to provide additional guidance to the physician using the apparatus of Markowitz.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK W. BOCKELMAN whose telephone number is (571)272-4941. The examiner can normally be reached Monday -Friday 8:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK W. BOCKELMAN/ Primary Examiner, Art Unit 3792
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