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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 21-40 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.
Claim 21 recites the limitation "the received and transmitted sound waves" in Line 13. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the sound waves’.
Claim 21 recites ‘sound signals’ after reciting ‘sound waves’ making it unclear if each recitation refers to the same element or not. For examination purposes they will be treated as the same element.
Claim 22 recites ‘a patient’s digestive tract’ making it unclear if this is the same patient as recited in claim 21 or not. For examination purposes it will be treated as the same patient.
Claim 28 recites the limitation "the received and transmitted sound waves" in Line 3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the sound waves’.
Claim 31 recites the limitation "the received and transmitted sound waves" in Lines 14-15. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the sound waves’.
Claim 31 recites ‘sound signals’ after reciting ‘sound waves’ making it unclear if each recitation refers to the same element or not. For examination purposes they will be treated as the same element.
Claim 33 recites ‘a patient’s digestive tract’ making it unclear if this is the same patient as recited in claim 31 or not. For examination purposes it will be treated as the same patient.
Claim 34 recites the limitation "the received or analyzed sound data" in Lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the sound data’.
Claim 40 recites the limitation "the received sound waves" in Line 3. There is insufficient antecedent basis for this limitation in the claim. It appears this should read ‘the sound waves’.
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 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claimed invention in claims 21-40 are directed to statutory subject matter as the claims recite a system (claims 21-30) and a method (claims 31-40).
Step 2A, Prong One
Regarding claims 21 and 31, the recited steps are directed mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Specifically from claim 21:
receive sound data corresponding with the received and transmitted sound waves, and
analyze the received sound data to determine whether the distal end of the catheter is positioned within the patient's digestive tract based, at least in part, on at least one of an attenuation of sound signals, detection of resonance frequencies, or a frequency and amplitude response associated with a location of the catheter.
Specifically from claim 31:
receiving…sound data corresponding with the received and transmitted sound waves;
analyzing…the sound data to determine whether the distal end of the catheter is positioned within the patient's digestive tract based, at least in part, on at least one of an attenuation of sound signals, detection of resonance frequencies, or a frequency and amplitude response associated with a location of the catheter
These limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Step 2A, Prong Two
This judicial exceptions (abstract ideas) in claims 21-40 are not integrated into a practical application because:
•The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for performing the abstract ideas merely invoke a computer as a tool.
•The data-gathering steps do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
•There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for performing the abstract ideas
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a medical measurement.
•The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer to perform the abstract ideas. The claims do not apply the obtained measurements to a particular machine. Rather, the data is merely output in a post-solution step.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Step 2B
The additional elements are identified as follows:
“a processor; an external acoustic transducer positioned in proximity to a patient's body; and a tubing assembly comprising: a catheter having a proximal end and a distal end and extending in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and an internal acoustic transducer in bi-directional communication with the external acoustic transducer; wherein the processor is configured to: transmit control signals in real-time to cause the external acoustic transducer and the internal acoustic transducer to continuously receive or transmit sound waves to one another” in claim 21
“inserting a distal end of a tubing assembly into an orifice of the patient's body, wherein the tubing assembly comprises: the catheter, wherein the catheter has a proximal end and a distal end and extends in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and an internal acoustic transducer in bi-directional communication with an external acoustic transducer, wherein the internal acoustic transducer and the external acoustic transducer are in electronic communication with a processor; placing the external acoustic transducer in proximity to the patient's body; causing, by the processor, the internal acoustic transducer and the external acoustic transducer to continuously receive or transmit sound waves to one another;” in claim 31
“a display device” in claims 22 and 33-34, “microphone or MEMS microphone: in claims 25 and 37, “transmitter” and “speaker or piezoelectric transducer” in claims 27 and 39, “receiver” in claims 28 and 40.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
The prior art provided by the Applicant in the IDS and by the Examiner in PTO-892 which disclose each of the elements as being known and conventional in the art elements;
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception into a practical application or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b). Placement of the catheter with the sensors is merely implying field of use, of where the data is to be collected from and the conventional equipment used for the extra-solutionary data gathering.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 22 and 33-34 is additional data output
Claims 22, 25-28, 32-34, and 37-40 recites additional elements at a high level of generality which are conventional in the art
Claims 23-24, 28-30, 35-36, and 40 are steps that are also abstract as a mental process through additional data gathering or analysis
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
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.
Claim(s) 21-22, 25-27, 31-34, and 37-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al. (US 2018/0078195) in view of Emery (US 2015/0080926).
Regarding claim 21, Sutaria teaches a system (Abstract) comprising:
a processor (monitor 110; Paragraph 0123; ‘It should be noted that use of the noun “monitor” herein refers to a computer’);
an external acoustic transducer (sound emitter 118) positioned in proximity to a patient's body (Figure 1C); and
a tubing assembly (Figures 1B and 1C; Paragraph 0123) comprising:
a catheter (102) having a proximal end (Figures 1B and 1C) and a distal end (Figures 1B and 1C) and extending in a longitudinal direction (Figures 1B and 1C), wherein the proximal end and the distal end define a lumen therebetween (Paragraph 0123; ‘the acoustic sensor 104 and the wire are connected into a single and separate component that is placed inside the main lumen of the feeding tube 102’); and
an internal acoustic transducer (104)
wherein the processor is configured to:
transmit control signals in real-time to cause the external acoustic transducer and the internal acoustic transducer to continuously receive or transmit sound waves to one another (Paragraph 0128; Figures 1B-1C),
receive sound data corresponding with the received and transmitted sound waves (Paragraph 0123; ‘The acoustic sensor 104 may be designed to detect certain vibrations, such as audible sounds, non-audible sounds or both audible and non-audible sounds.’; Further see Paragraphs 0135-0139), and is configured for stationary placement on a patient’s body (Paragraph 0128; ‘In step 203, the clinician attaches the two electrodes 118, 120 to the body, with 118 being ideally placed on the abdomen just caudal to the left costal margin’; Paragraph 0123; ‘The acoustic sensor 104 may be designed to detect certain vibrations, such as audible sounds, non-audible sounds or both audible and non-audible sounds.’; Further see Paragraphs 0135-0139), and
analyze the received sound data to determine whether the distal end of the catheter is positioned within the patient's digestive tract based, at least in part, on at least one of an attenuation of sound signals, detection of resonance frequencies, or a frequency and amplitude response associated with a location of the catheter (Paragraph 0123: ‘Such a computer can be configured to track a patient's condition, other data of a patient, medical instruments or equipment used to assist a patient, etc. The monitor can preferably but optionally include a display (e.g., monitor screen) or other indicator (e.g., audible alarm) for a clinician.’; Further see Paragraphs 0135-0139; Paragraph 0132: ‘the monitor can indicate a visual alarm, and/or an auditory alarm, to warn the clinician that the tube may be located within the lower respiratory tract, such as the larynx, trachea or a bronchus. The clinician can then stop tube insertion and withdraw the tube.’; Given that all types of frequency ranges are sensed they are all being compared in some way to determine the placement, as further seen in Paragraphs 0130, 0135, and 0156-0157 Sutaria explains how groupings of certain frequency ranges can show or be indicative of certain things/locations).
Sutaria is silent on an internal acoustic transducer in bi-directional communication with the external acoustic transducer.
Emery teaches an internal acoustic transducer and external acoustic transducer in bidirectional communication with each other (Paragraph 0107).
It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Emery because it is beneficial for targeting (Paragraph 0107 of Emery).
Regarding claim 22, Sutaria teaches wherein the processor is further configured to: responsive to determining that the distal end of the catheter is positioned within or outside a patient's digestive tract, generate an alert via a display device in electronic communication with the processor (Paragraph 0123; ‘Such a computer can be configured to track a patient's condition, other data of a patient, medical instruments or equipment used to assist a patient, etc. The monitor can preferably but optionally include a display (e.g., monitor screen) or other indicator (e.g., audible alarm) for a clinician.’; Further see Paragraphs 0135-0139).
Regarding claim 25, Sutaria teaches wherein the external acoustic transducer or internal acoustic transducer comprises a microphone or a MEMS microphone (Paragraph 0123; ‘A number of other exemplary sensors can be used to measure acoustic signals, including but not limited to an electret, condenser, piezoelectric crystal, piezoelectric ceramic, piezoelectric film, fiber optic microphone’).
Regarding claim 26, Sutaria teaches wherein the internal acoustic transducer is positioned within the lumen of the catheter or the tubing assembly (Paragraph 0123; ‘the acoustic sensor 104 and the wire are connected into a single and separate component that is placed inside the main lumen of the feeding tube 102’).
Regarding claim 27, Sutaria and Emery teach wherein the internal acoustic transducer is a transmitter that transmits the sound waves from the distal end of the catheter to the external acoustic transducer, and wherein the internal acoustic transducer comprises a speaker or a piezoelectric transducer (Sutaria: Paragraphs 0024 and 0123 and Emery: Paragraph 0107). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Emery because it is beneficial for targeting (Paragraph 0107 of Emery).
Regarding claim 31, Sutaria teaches a method for determining if a catheter is placed within a digestive tract of a patient's body (Abstract), the method comprising:
inserting a distal end of a tubing assembly (Figures 1B and 1C; Paragraph 0123) into an orifice of the patient's body (step 204; Figure 2; Paragraph 0129), wherein the tubing assembly comprises:
the catheter (102), wherein the catheter has a proximal end (Figures 1B and 1C) and a distal end (Figures 1B and 1C) and extends in a longitudinal direction(Figures 1B and 1C), wherein the proximal end and the distal end define a lumen therebetween (Paragraph 0123; ‘the acoustic sensor 104 and the wire are connected into a single and separate component that is placed inside the main lumen of the feeding tube 102’); and
an internal acoustic transducer (104) in communication with an external acoustic transducer (sound emitter 118), wherein the internal acoustic transducer and the external acoustic transducer are in electronic communication with a processor (monitor 110; Paragraph 0123; ‘It should be noted that use of the noun “monitor” herein refers to a computer’; Figures 1B-1C);
placing the external acoustic transducer in proximity to the patient's body (Figure 1C; Step 203; Paragraph 0128);
causing, by the processor, the internal acoustic transducer and the external acoustic transducer to continuously receive or transmit sound waves to one another (Paragraph 0128; Step 203);
receiving, by the processor, sound data corresponding with the received and transmitted sound waves (bottom two thirds of flow chart of Figure 2; Paragraphs 0129-0130) ;
analyzing, by the processor, the sound data to determine whether the distal end of the catheter is positioned within the patient's digestive tract based, at least in part, on at least one of an attenuation of sound signals, detection of resonance frequencies, or a frequency and amplitude response associated with a location of the catheter (Paragraph 0123: ‘Such a computer can be configured to track a patient's condition, other data of a patient, medical instruments or equipment used to assist a patient, etc. The monitor can preferably but optionally include a display (e.g., monitor screen) or other indicator (e.g., audible alarm) for a clinician.’; Further see Paragraphs 0135-0139; Paragraph 0132: ‘the monitor can indicate a visual alarm, and/or an auditory alarm, to warn the clinician that the tube may be located within the lower respiratory tract, such as the larynx, trachea or a bronchus. The clinician can then stop tube insertion and withdraw the tube.’; Given that all types of frequency ranges are sensed they are all being compared in some way to determine the placement, as further seen in Paragraphs 0130, 0135, and 0156-0157 Sutaria explains how groupings of certain frequency ranges can show or be indicative of certain things/locations).
Sutaria is silent on an internal acoustic transducer and external acoustic transducer in bidirectional communication.
Emery teaches an internal acoustic transducer and external acoustic transducer in bidirectional communication with each other (Paragraph 0107).
It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Emery because it is beneficial for targeting (Paragraph 0107 of Emery).
Regarding claim 32, Sutaria teaches further comprising: advancing the distal end of the catheter inside the patient's body in a direction away from the orifice while the external acoustic transducer is activated via the processor (Figure 2; Paragraphs 0126-0129)
Regarding claim 33, Sutaria teaches further comprising: responsive to determining, by the processor, that the distal end of the catheter is positioned within or outside a patient's digestive tract, generating an alert via a display device (Paragraph 0123; ‘Such a computer can be configured to track a patient's condition, other data of a patient, medical instruments or equipment used to assist a patient, etc. The monitor can preferably but optionally include a display (e.g., monitor screen) or other indicator (e.g., audible alarm) for a clinician.’; Further see Paragraphs 0135-0139).
Regarding claim 34, Sutaria teaches further comprising: causing, by the processor, display of at least a portion of the received or analyzed sound data by the display device (Paragraph 0123; ‘Such a computer can be configured to track a patient's condition, other data of a patient, medical instruments or equipment used to assist a patient, etc. The monitor can preferably but optionally include a display (e.g., monitor screen) or other indicator (e.g., audible alarm) for a clinician.’; Further see Paragraphs 0135-0139; Figure 5).
Regarding claim 37, Sutaria teaches wherein the external acoustic transducer or internal acoustic transducer comprises a microphone or a micro-electromechanical systems (MEMS) microphone (Paragraph 0123; ‘A number of other exemplary sensors can be used to measure acoustic signals, including but not limited to an electret, condenser, piezoelectric crystal, piezoelectric ceramic, piezoelectric film, fiber optic microphone’).
Regarding claim 38, Sutaria teaches wherein the internal acoustic transducer is positioned within the lumen of the catheter or the tubing assembly (Paragraph 0123; ‘the acoustic sensor 104 and the wire are connected into a single and separate component that is placed inside the main lumen of the feeding tube 102’).
Regarding claim 39, Sutaria and Emery teach wherein the internal acoustic transducer is a transmitter that transmits the sound waves from the distal end of the catheter to the external acoustic transducer, and wherein the internal acoustic transducer comprises a speaker or a piezoelectric transducer (Sutaria: Paragraphs 0024 and 0123 and Emery: Paragraph 0107). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Emery because it is beneficial for targeting (Paragraph 0107 of Emery).
Claim(s) 23-24 and 35-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al. (US 2018/0078195) in view of Emery (US 2015/0080926) as applied to claims 21 and 31 above in further view of Ingold et al. (US 2012/0083702).
Regarding claim 23, Sutaria is silent on the filtering. Ingold teaches wherein the processor is configured to determine whether the distal end of the catheter is positioned within the patient's digestive tract by: filtering out at least a portion of the sound waves captured by at least one of the external acoustic transducer and the internal acoustic transducer (Paragraph 0035). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Ingold because it would aid in removing noise (Paragraph 0035 of Ingold) as is conventional in the art to provide a higher quality signal.
Regarding claim 24, Sutaria is silent on the filtering. Ingold teaches wherein filtering out at least a portion of the sound waves comprises: removing frequencies below a predetermined threshold that are associated with inspiration or expiration breathing sounds (Paragraph 0035). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Ingold because it would aid in removing noise (Paragraph 0035 of Ingold) as is conventional in the art to provide a higher quality signal.
Regarding claim 35, Sutaria is silent on the filtering. Ingold teaches further comprising: filtering out, by the processor, at least a portion of the sound waves captured by at least one of the external acoustic transducer and the internal acoustic transducer (Paragraph 0035). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Ingold because it would aid in removing noise (Paragraph 0035 of Ingold) as is conventional in the art to provide a higher quality signal.
Regarding claim 36, Sutaria is silent on the filtering. Ingold teaches wherein filtering out at least a portion of the sound waves comprises: removing frequencies below a predetermined threshold that are associated with inspiration or expiration breathing sounds (Paragraph 0035). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Ingold because it would aid in removing noise (Paragraph 0035 of Ingold) as is conventional in the art to provide a higher quality signal.
Claim(s) 28-29 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al. (US 2018/0078195) in view of Emery (US 2015/0080926) as applied to claims 21 and 31 above in further view of Curran et al. (US 2014/0257071).
Regarding claim 28, Sutaria is silent on the sum and temporal match. Curran teaches wherein the internal acoustic transducer or the external acoustic transducer, when functioning as a receiver, is configured to: sum and temporally match frequency patterns of the received or transmitted sound waves (Paragraph 0050). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Curran because it enables only acquiring desired data (Paragraph 0054 of Curran).
Regarding claim 40, Sutaria is silent on the sum and temporal match. Curran teaches wherein the internal acoustic transducer or the external acoustic transducer, when functioning as a receiver, is configured to: sum and temporally match frequency patterns of the received sound waves (Paragraph 0050). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Curran because it enables only acquiring desired data (Paragraph 0054 of Curran).
Claim(s) 29-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutaria et al. (US 2018/0078195) in view of Emery (US 2015/0080926) as applied to claim 21 above in further view of Curran et al. (US 2014/0257071) and Viswanathan (US 2003/0171673).
Regarding claim 29, Sutaria is silent on the frequency sweep. Curran and Viswanathan teach wherein the received or transmitted sound waves between the internal acoustic transducer and the external acoustic transducer include a sweep of frequencies (Paragraph 0050 of Curran, Paragraph 0036 of Viswanathan). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Curran because it enables only acquiring desired data (Paragraph 0054 of Curran). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Viswanathan because it aids in the accuracy of the localization (Paragraph 0006 of Viswanathan).
Regarding claim 30, Sutaria in view of Curran is silent on the frequency sweep range. Viswanathan teaches wherein a range of the sweep of frequencies is between 20 hertz and 500 kilohertz (Paragraph 0036). It would have been obvious to one of ordinary skill in the art to have modified Sutaria with Viswanathan because it aids in the accuracy of the localization (Paragraph 0006 of Viswanathan). The applicant' s specification provides no specifical reasoning or critical functionality for the use of a range of the sweep of frequencies is between 20 hertz and 500 kilohertz, thus claimed limitation is a design choice. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to use the range of the sweep of frequencies is between 20 hertz and 500 kilohertz as desired by the user as a matter of routine engineering design choice to yield predictable results.
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12036063 in view of Emery (US 2015/0080926). The chart below details the similarities between the instant application and the conflicting patent. The difference is merely the bi-directional communication between the internal acoustic transducer and external acoustic transducer. Emery teaches an internal acoustic transducer and external acoustic transducer in bidirectional communication with each other (Paragraph 0107). It would have been obvious to one of ordinary skill in the art to have modified the patent with Emery because it is beneficial for targeting (Paragraph 0107 of Emery).
Instant Application 18/773,360
Conflicting US Patent No. 12036063
A system comprising:
a processor;
an external acoustic transducer positioned in proximity to a patient's body; and
a tubing assembly comprising:
a catheter having a proximal end and a distal end and extending in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and
an internal acoustic transducer in bi-directional communication with the external acoustic transducer;
wherein the processor is configured to:
transmit control signals in real-time to cause the external acoustic transducer and the internal acoustic transducer to continuously receive or transmit sound waves to one another,
receive sound data corresponding with the received and transmitted sound waves, and
analyze the received sound data to determine whether the distal end of the catheter is positioned within the patient's digestive tract based, at least in part, on at least one of an attenuation of sound signals, detection of resonance frequencies, or a frequency and amplitude response associated with a location of the catheter.
1. A catheter guidance system comprising: (a) a processor;
(b) a power source;
(c) a display device;
(d) an external acoustic transducer; and
(e) a tubing assembly comprising:
a catheter having a proximal end and a distal end and extending in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and
an internal acoustic transducer;
wherein the internal acoustic transducer receives sound waves as controlled by the processor in real-time via an electrical connection;
wherein the external acoustic transducer transmits the sound waves, wherein the internal acoustic transducer communicates acquired sound data to the processor in real-time via an electrical connection, and further wherein the external acoustic transducer is contained within a speaker and is configured for stationary placement on a body of a patient;
wherein the display device is coupled to the processor and displays a graph of the sound data communicated by the internal acoustic transducer or the external acoustic transducer; and
wherein the catheter guidance system is configured to alert a user as to placement of the catheter in a digestive tract of the patient or alert the user as to placement of the catheter in a respiratory tract of the patient by distinguishing between a frequency response associated with the placement of the catheter in the digestive tract of the patient or the placement of the catheter in the respiratory tract of the patient, wherein the frequency response associated with the placement of the catheter in the digestive tract exhibits an initial peak in amplitude followed by a gradual decrease in amplitude as frequency is increased, and wherein the frequency response associated with the placement of the catheter in the respiratory tract of the patient exhibits an initial peak in amplitude followed by an overall decrease in amplitude with spikes of increased amplitude at one or more harmonic frequencies as frequency is increased.
31. A method for determining if a catheter is placed within a digestive tract of a patient's body, the method comprising:
inserting a distal end of a tubing assembly into an orifice of the patient's body, wherein the tubing assembly comprises:
the catheter, wherein the catheter has a proximal end and a distal end and extends in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and
an internal acoustic transducer in bi-directional communication with an external acoustic transducer, wherein the internal acoustic transducer and the external acoustic transducer are in electronic communication with a processor;
placing the external acoustic transducer in proximity to the patient's body;
causing, by the processor, the internal acoustic transducer and the external acoustic transducer to continuously receive or transmit sound waves to one another;
receiving, by the processor, sound data corresponding with the received and transmitted sound waves;
analyzing, by the processor, the sound data to determine whether the distal end of the catheter is positioned within the patient's digestive tract based, at least in part, on at least one of an attenuation of sound signals, detection of resonance frequencies, or a frequency and amplitude response associated with a location of the catheter.
7. A method for determining if a catheter is placed within a digestive tract of a body of a patient via a catheter guidance system comprising a processor, a power source, a display device, an external acoustic transducer, and a tubing assembly, the method comprising:
(a) inserting a distal end of the tubing assembly into an orifice of the body of the patient, wherein the tubing assembly comprises: the catheter, wherein the catheter has a proximal end and a distal end and extends in a longitudinal direction, wherein the proximal end and the distal end define a lumen therebetween; and an internal acoustic transducer;
(b) electrically connecting the internal acoustic transducer to the processor via a wired connection or a wireless connection;
(c) placing the external acoustic transducer on or adjacent to the patient's throat or chest, wherein the external acoustic transducer is electrically connected to the processor via a wired connection or a wireless connection;
(d) activating the internal acoustic transducer, wherein the internal acoustic transducer receives sound waves as controlled by the processor in real-time via an electrical connection;
(e) advancing the distal end of the catheter inside the body of the patient in a direction away from the orifice while the external acoustic transducer is activated;
(f) activating the external acoustic transducer to transmit the sound waves, wherein the internal acoustic transducer acquires sound data from the sound waves and communicates the sound data to the processor in real-time, wherein the external acoustic transducer is contained within a speaker and is configured for stationary placement on the body of the patient; and
(g) observing a graph of the sound data on the display device coupled to the processor, wherein the catheter guidance system is configured to alert a user as to placement of the catheter in the digestive tract of the patient or alert the user as to placement of the catheter in a respiratory tract of the patient by distinguishing between a frequency response associated with the placement of the catheter in the digestive tract of the patient or the placement of the catheter in the respiratory tract of the patient, wherein the frequency response associated with the placement of the catheter in the digestive tract exhibits an initial peak in amplitude followed by a gradual decrease in amplitude as frequency is increased, and wherein the frequency response associated with the placement of the catheter in the respiratory tract of the patient exhibits an initial peak in amplitude followed by an overall decrease in amplitude with spikes of increased amplitude at one or more harmonic frequencies as frequency is increased.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Tunay et al. (US 2016/0143686)
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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