DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 8/16/2023. Claims 1-20 are currently pending.
Claim Rejections - 35 USC § 101
3. 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.
3.1. Claims 1-20 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1, 14 and 18, and their respective dependent claims are directed, in part, to method, system and medium for pre-planning a left atrial appendage (LAA) closure.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 1, 14 and 18, as a whole, are directed to pre-planning a LAA closure by receiving images of a LAA of a patient, receiving an indication of a landing zone of a closure device, simulating a deployment of the closure device in the LAA of the patient, simulating a sealing of the deployed closure device against the LAA of the patient, simulating an anchoring of the closure device in the LAA of the patient, generating a graphical representation of the sealing and anchoring of the closure device in the LAA of the patient, etc. which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, the claims are also directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper. For example, a human can receive images, perform simulations, and generate graphical representations in their mind and/or with pen and paper using observation, evaluation, judgment and/or opinion.
CLAIM 1
A method of pre-planning a left atrial appendage (LAA) closure, comprising:
receiving, at a computing device, images comprising indication of an LAA of a patient;
receiving, at the computing device, an indication of a landing zone of a closure device;
simulating, by the computing device, a deployment of the closure device in the LAA of the patient;
simulating, by the computing device, a sealing of the deployed closure device against the LAA of the patient;
simulating, by the computing device, an anchoring of the closure device in the LAA of the patient; and
generating, by the computing device, a graphical representation of the sealing and anchoring of the closure device in the LAA of the patient.
CLAIM 2
The method of claim 1, comprising generating a graphical representation of the deployed closure device in the LAA of the patient.
CLAIM 3
The method of claim 2, generating a graphical representation of the deployed closure device in the LAA of the patient comprising overlaying the simulated deployed closure device with a graphical representation of the LAA of the patient.
CLAIM 4
The method of claim 1, comprising determining a recommended size of the closure device based on the received images.
CLAIM 5
The method of claim 4, comprising:
identifying a diameter of the ostium of the LAA of the patient based on the received images;
selecting from a set of closure device sizes a closure device size within a threshold expanded diameter to the diameter of the ostium; and
identifying the selected closure device size as the recommended closure device.
CLAIM 6
The method of claim 4, comprising simulating the deployment of the closure device in the LAA of the patient for a closure device having the recommended size.
CLAIM 7
The method of claim 6, comprising simulating a deployment of the closure device in the LAA of the patient for a closure device having a size different from the recommended size.
CLAIM 8
The method of claim 7, comprising generating a graphical representation of the deployed closure device in the LAA of the patient comprising overlaying the simulated deployed closure device having the recommended size with the graphical representation of the LAA of the patient and overlaying the simulated deployed closure device having a different size with the graphical representation of the LAA of the patient.
CLAIM 9
The method of claim 1, generating the graphical representation of the sealing of the deployed closure device in the LAA of the patient comprising generating a plurality of images comprising an indication of the LAA of the patient and an indication of a contact surface, the contact surface representative of a contact between the deployed closure device and the LAA of the patient.
CLAIM 10
The method of claim 9, the plurality of images comprising the indication of the LAA of the patient, the indication of the contact surface and an indication of a leak path.
CLAIM 11
The method of claim 10, comprising generating a rotatable model from the plurality of images.
CLAIM 12
The method of claim 1, generating the graphical representation of the anchoring of the closure device in the LAA of the patient comprising generating an image of the simulated deployed closure device comprising indications of anchors of the closure device and a representation of an engagement of the anchors with tissue of the LAA of the patient.
CLAIM 13
The method of claim 12, wherein the representation of the engagement of the anchors comprises a color map.
CLAIM 14
A computing system, comprising:
a processor; and
memory comprising instructions, which when executed by the processor cause the computing system to:
receive images comprising indication of an LAA of a patient;
receive an indication of a landing zone of a closure device;
simulate a deployment of the closure device in the LAA of the patient;
simulate a sealing of the deployed closure device against the LAA of the patient;
simulate an anchoring of the closure device in the LAA of the patient; and
generate a graphical representation of the sealing and anchoring of the closure device in the LAA of the patient.
CLAIM 15
The computing system of claim 14, the instruction, when executed by the processor, cause the computing system to generate a graphical representation of the deployed closure device in the LAA of the patient.
CLAIM 16
The computing system of claim 15, the instruction, when executed by the processor, cause the computing system to generate a graphical representation of the deployed closure device in the LAA of the patient comprising overlaying the simulated deployed closure device with a graphical representation of the LAA of the patient.
CLAIM 17
The computing system of claim 14, the instruction, when executed by the processor, cause the computing system to determine a recommended size of the closure device based on the received images.
CLAIM 18
A computer readable storage medium comprising instructions, which when executed by a processor of a computing device cause the processor to:
receive images comprising indication of an LAA of a patient;
receive an indication of a landing zone of a closure device;
identifying a diameter of the ostium of the LAA of the patient based on the received images;
selecting from a set of closure device sizes a closure device size within a threshold expanded diameter to the diameter of the ostium;
identifying the selected closure device size as the closure device;
simulate a deployment of the closure device in the LAA of the patient;
simulate a sealing of the deployed closure device against the LAA of the patient;
simulate an anchoring of the closure device in the LAA of the patient; and
generate a graphical representation of the sealing and anchoring of the closure device in the LAA of the patient.
CLAIM 19
The computer readable storage medium of claim 18, the instruction, when executed by the processor, cause the computing system to simulate the deployment of the closure device in the LAA of the patient for a closure device having the recommended size.
CLAIM 20
The computer readable storage medium of claim 19, the instruction, when executed by the processor, cause the computing system to simulate a deployment of the closure device in the LAA of the patient for a closure device having a size different from the recommended size.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., computing device, closure device, computing system, processor, memory, medium, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “by the computing device”, “cause the processor to”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0067]-[0068] of applicant's specification (US 2024/0058071) recites that the system/method/medium can be implemented using a server computer, a client computer, a personal computer (PC), a tablet computer, a laptop computer, a netbook, a set-top box (STB), a PDA, an entertainment media system, a cellular telephone, a smart phone, a mobile device, a wearable device (e.g., a smart watch), a smart home device (e.g., a smart appliance), other smart devices, a web appliance, a network router, a network switch, a network bridge, or any machine capable of executing the instructions which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination 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.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
3.2. Claims 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 18-20 are directed toward "A computer readable storage medium comprising instructions". A computer program not explicitly stored in a non-transitory computer readable storage medium is non-statutory. The Examiner could not immediately find within the specification any recitation that would define said computer readable medium. The computer readable medium could read on both statutory (such as a non-transitory computer readable storage medium) and non-statutory subject matter (such as forms of computer readable transmissions). Without evidence to the contrary and given its broadest reasonable interpretation, a computer program or code is merely a set of instructions capable of being executed by a computer, the computer program or code itself does not fall within any of the statutory categories of invention (i.e., a process, article of manufacture, machine and a composition of matter); thus, since the claim language is interpreted to read on non-statutory subject matter, the claims are rejected as being directed to a non-statutory subject matter.
Claim Rejections - 35 USC § 102/103
4. 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.
4.1. 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 –
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.
4.2. 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.
4.3. Claims 1-20 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 Camus et al. (US 2019/009095).
CLAIM 1
Camus teaches a method of pre-planning a left atrial appendage (LAA) closure (Camus: abstract; ¶¶ [0016] “LAA closure guidance”, [0017] “planning”), comprising:
receiving, at a computing device, images comprising indication of an LAA of a patient (Camus: abstract; ¶¶ [0024]-[0028] “an ultrasound scanner scans the LAA of a patient”; FIGS. 1-6);
receiving, at the computing device, an indication of a landing zone of a closure device (Camus: abstract; ¶¶ [0041] “detected locations of the ostium of the LAA”; FIGS. 1-6);
simulating, by the computing device, a deployment of the closure device in the LAA of the patient (Camus: abstract; ¶¶ [0057] “the image processor generates an implantation plan. The implantation plan includes the placement of the closure device relative to the LAA of the patient”; FIGS. 1-6);
simulating, by the computing device, a sealing of the deployed closure device against the LAA of the patient (Camus: abstract; ¶¶ [0058] “image processor simulates interactions of one or more of the closure devices with the anatomy model. The interaction provides more than geometric fit or geometric information. The interaction uses a biomechanical model derived from the anatomy model. The biomechanical model uses material properties and physics to model the distortions and/or effects of forces due to interaction between the closure device and the LAA”; FIGS. 1-6);
simulating, by the computing device, an anchoring of the closure device in the LAA of the patient (Camus: abstract; ¶¶ [0058] “image processor simulates interactions of one or more of the closure devices with the anatomy model. The interaction provides more than geometric fit or geometric information. The interaction uses a biomechanical model derived from the anatomy model. The biomechanical model uses material properties and physics to model the distortions and/or effects of forces due to interaction between the closure device and the LAA”; FIGS. 1-6); and
generating, by the computing device, a graphical representation of the sealing and anchoring of the closure device in the LAA of the patient (Camus: abstract; ¶¶ [0079]-[0083] “the image processor outputs an image. The image is used as part of modeling, simulating, characterizing geometry, calculating geometric metrics, or other action”; FIGS. 1-6).
CLAIM 2
Camus teaches the method of claim 1, comprising generating a graphical representation of the deployed closure device in the LAA of the patient (Camus: abstract; ¶¶ [0081]; FIGS. 1-6).
CLAIM 3
Camus teaches the method of claim 2, generating a graphical representation of the deployed closure device in the LAA of the patient comprising overlaying the simulated deployed closure device with a graphical representation of the LAA of the patient (Camus: abstract; ¶¶ [0081]; FIGS. 1-6).
CLAIM 4
Camus teaches the method of claim 1, comprising determining a recommended size of the closure device based on the received images (Camus: abstract; ¶¶ [0070]-[0071]; FIGS. 1-6).
CLAIM 5
Camus teaches the method of claim 4, comprising: identifying a diameter of the ostium of the LAA of the patient based on the received images; selecting from a set of closure device sizes a closure device size within a threshold expanded diameter to the diameter of the ostium; and identifying the selected closure device size as the recommended closure device (Camus: abstract; ¶¶ [0043]; FIGS. 1-6).
CLAIM 6
Camus teaches the method of claim 4, comprising simulating the deployment of the closure device in the LAA of the patient for a closure device having the recommended size (Camus: abstract; ¶¶ [0061]; FIGS. 1-6).
CLAIM 7
Camus teaches the method of claim 6, comprising simulating a deployment of the closure device in the LAA of the patient for a closure device having a size different from the recommended size (Camus: abstract; ¶¶ [0058]; FIGS. 1-6).
CLAIM 8
Camus teaches the method of claim 7, comprising generating a graphical representation of the deployed closure device in the LAA of the patient comprising overlaying the simulated deployed closure device having the recommended size with the graphical representation of the LAA of the patient and overlaying the simulated deployed closure device having a different size with the graphical representation of the LAA of the patient (Camus: abstract; ¶¶ [0018], [0055], [0081]-[0087]; FIGS. 1-6).
CLAIM 9
Camus teaches the method of claim 1, generating the graphical representation of the sealing of the deployed closure device in the LAA of the patient comprising generating a plurality of images comprising an indication of the LAA of the patient and an indication of a contact surface, the contact surface representative of a contact between the deployed closure device and the LAA of the patient (Camus: abstract; ¶¶ [0066]; FIGS. 1-6).
CLAIM 10
Camus teaches the method of claim 9, the plurality of images comprising the indication of the LAA of the patient, the indication of the contact surface and an indication of a leak path (Camus: abstract; ¶¶ [0067]-[0069]; FIGS. 1-6).
CLAIM 11
Camus teaches the method of claim 10, comprising generating a rotatable model from the plurality of images (Camus: abstract; ¶¶ [0075]; FIGS. 1-6).
CLAIM 12
Camus teaches the method of claim 1, generating the graphical representation of the anchoring of the closure device in the LAA of the patient comprising generating an image of the simulated deployed closure device comprising indications of anchors of the closure device and a representation of an engagement of the anchors with tissue of the LAA of the patient (Camus: abstract; ¶¶ [0074]; FIGS. 1-6).
CLAIM 13
Camus teaches the method of claim 12, wherein the representation of the engagement of the anchors comprises a color map (Camus: abstract; ¶¶ [0041], [0047], [0074], [0083]; FIGS. 1-6).
CLAIM 14-20
Claims 14-20 repeat substantially the same limitations as those in claims 1-13. As such, claims 14-20 are rejected for substantially the same reasons given for claims 1-13 and are incorporated herein.
Conclusion
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
Prosecution Insights