DETAILED ACTION
This application is being examined under AIA first-to-file provisions.
Status of claims
Canceled:
none
Pending:
1-20
Withdrawn:
none
Examined:
1-20
Independent:
1 and 15
Allowable:
none
Rejections applied
Abbreviations
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
x
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 9/9/2022 filing receipt, this application claims priority to as early as 11/19/2019. All claims have been interpreted as being accorded this priority date.
Withdrawal / revision of objections and/or rejections
In view of the amendment and remarks:
The objection to the presentation of the claims is withdrawn.
The substantive claim objections are withdrawn.
The 112/b rejections are withdrawn.
The 112/a written description rejection is withdrawn.
Rejections and/or objections not maintained from previous office actions are withdrawn. The following rejections and/or objections are either maintained or newly applied. They constitute the complete set applied to the instant application.
Claim rejections - 112/a enablement
The following is a quotation of 112/a:
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Response to arguments
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 7):
The present application describes in one embodiment to use the time-reversal technique on recorded heart electrical activity signals and localize the origin of such signals in a simulation model. This localization can then be transposed to localization on the real heart.
The present application advantageously describes using a precise and effective simulation model of the electrical activity and anatomy of the heart, as the time-reversed signals are applied to such a model to localize the origin(s) of the electrical signals. As mentioned, the location is found on the simulation model first and transposed to real heart subsequently.
Applicant's remarks and the entire specification focus on and provide support only with respect to the heart. The instant claims, except for claims 6-7, are not limited to the heart.
Even regarding claims 6-7 limited to the heart, these claims as well as the rest of the claims are not limited as to the type of anomaly, other than it being "electrical." In a BRI, the recited cells need not be the only cells contributing to the anomaly nor to the obtained electrical signals. As to outputs, the claims comprise detection of convergence locations, thereby allowing locating the cells generating the anomaly. The claims are not limited as to the resolution of the locating.
It may help to overcome the rejection to address the following aspects of the claimed scope:
which body part (except regarding claims 6-7 already limited to the heart),
what type of electrical anomaly and
what resolution of locating within the context of a human body.
Either the claim may be narrowed to particular embodiments within these various aspects, or support may be identified as to the full claim scope relative to each of these aspects, beyond just the disclosed and cited heart literature which does not yet clearly support the entire claim scope.
Applicant may contact the examiner to discuss overcoming the remaining rejections.
Enablement
Claims 1-20 also are rejected under 112/a as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to make and/or use the invention without undue experimentation.
To determine enablement, the Federal Circuit developed "Wands factors" to assess whether required experimentation is "reasonable" or "undue" (In re Wands, Fed. Cir. 1988). MPEP 2164 and particularly 2164.01(a) pertain. Wands factors include: claim breadth, nature of invention, state of prior art, PHOSITA skill level, predictability in the art, inventor-provided direction and working examples.
Instant claim 1, as to claim breadth and inputs, comprises obtaining electrical signals resulting from cells contributing to an anomaly in a body part. The claim is not limited as to the type of anomaly, other than it being "electrical," nor as to the type of body part, the heart being just one disclosed embodiment. In a BRI, the recited cells need not be the only cells contributing to the anomaly nor to the obtained electrical signals. As to outputs, claim 1 comprises detection of convergence locations, thereby allowing locating the cells generating the anomaly. The claim is not limited as to the resolution of the locating.
The prior art teaches that the theory of time reversal analysis is both well-developed and yet challenging in practical application (e.g. Tanter p. 99). Factors complicating application of theory to determine signal sources include inhomogeneity of real media through which signals must propagate and the geometric complexity signal sources themselves. A PHOSITA for the instant inventions would have possessed advanced training in research and development relating to mathematics, medicine and electrical engineering applications. Regarding predictability, the hardware and software of the technology itself is well understood and predictable, however application to the human body is less well understood and less predictable at least due to the above-mentioned media inhomogeneity and source complexity. Importantly, the instant disclosure provides only top-level direction, multiple steps and levels removed from actual reduction to practice and, most importantly, provides no working examples.
As examples regarding the instant disclosure, it is not clear that any, let alone sufficient, particular direction is disclosed as to how to provide the recited "model" (specification: 5:14 - 8:10), e.g. as to what biophysical, physical, electromagnetic, medical, etc. principles should underlie the model, what mathematics should underlie the model, what should be the spatial resolution of the model and what this implies regarding elements of the model, etc. Also, it is not clear that sufficient particular direction is disclosed as to how to ensure the recited "time-reversed electrical signals" "feed" into the "model" so as to necessarily result in the recited "convergence" of a form to "allow... cells generating the... anomaly... to be located" (specification: 8:11-33), e.g. as to what as to what are the particularly enabling mathematics for integration of the input data with the model and operation of the model to arrive at the particularly recited outputs.
Concluding from the above Wands factors analysis, practicing the instant claims would have required undue experimentation, particularly with regard to the recited:
(i) "...a simulation model of the subject's body part, the simulation model being configured to model anatomy and/or electrical activity of the subject's body part, to cause the time-reversed electrical signals when fed into the simulation model to converge in the simulation model at one or more convergence locations" and
(ii) "detecting the one or more convergence locations in the simulation model thereby allowing the one or more cells generating the electrical anomaly in the subject's body part to be located."
Generation of various types of various body part simulation models was known throughout a variety of scientific and medical fields. However, if it is even possible, undue experimentation would have been required to provide the particularly necessary model to enable successfully processing the recited inputs so as to arrive at the recited outputs, particularly with regard to the complexities of achieving the recited convergence at a scale to locate the recited, microscopic anomaly-causing cells. Over two years post-filing of this application and six years since the instant priority date, it remains unclear that the claims are practicable.
The remaining claims are analyzed similarly. Claims 6-7 do limit the recited "body part" to a "heart," however even these claims are not clearly supported as to the other aspects of the overall claim scope as discussed above.
Claim rejections - 101
35 USC 101 reads:
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.
For each rejection below, dependent claims are rejected similarly as not remedying the rejection, unless otherwise noted.
Response to arguments
Applicant states (original emphasis removed, bold emphasis added, applicant remarks: p. 11):
...the present application recognizes and identifies that generating a model using time reversal techniques to locate cells that are causing electrical anomalies within a patient provides an improvement to diagnostic and therapeutical tools. In addition, the improvement of the present application results in less invasive, less time consuming, and more precise identification processes. The present application provides the improvement by combining anatomical models and electrical activity models together with time reversal analysis to identify the cells that are causing the electrical anomalies.
In view of the above enablement rejection, it would not have been clear to PHOSITA that all embodiments within the scope of the claim would deliver the above-asserted improvements.
Judicial exceptions (JE) to 101 patentability
Claims 1-18 and 20 are rejected under 35 USC 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to each claim as a whole, each claim is directed to one or more JEs (i.e. an abstract idea, a natural phenomenon, a law of nature and/or a product of nature), as identified below. Any elements or combination of elements beyond the JE(s) (i.e. "additional elements") are conventional and do not constitute significantly more than the JE(s). Thus, no claim includes additional elements amounting to significantly more than the JE(s), as explained below.
In Alice, citing Mayo and Bilski, two Mayo/Alice questions determine eligibility under 101: First, is a claim directed to a JE? And second, if so, does the claim recite significantly more than the JE?
MPEP 2106 organizes JE analysis into Steps 1, 2A (1st & 2nd prongs) and 2B as follows below.
MPEP 2106 and the following USPTO website provide further explanation and case law citations: www.uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter? -- MPEP 2106.I and 2106.03
[Step 1: claims 1-20: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- abstract idea -- MPEP 2106.I and 2106.04
Preliminarily, in a 1st prong of Step 2A, elements of independent claim 1 are interpreted as directed to the abstract idea of analyzing electrical signal data to calculate cell locations including the JE elements of "time-reversing...," "feeding..." and "detecting...," each of which, including all recitation within each listed element, in at least some embodiments within a BRI, involves only manipulation of data. While manipulation of data is not per se directed to an abstract idea, in this instance the above-identified elements are directed to the abstract ideas identified below.
Claim 15 is analyzed similarly.
BRIs of the claims are analogous to an abstract idea in the form of at least a mental process, at least equivalent to a computer-implemented process, including obtaining and comparing intangible data (e.g. Cybersource, Synopsys and Electric Power Group). In a BRI, it is not clear that the claim embodiments are limited so as to require complexity precluding analogy to a mental process.
BRIs of the claims also are analogous to an abstract idea in the form of a mathematical concept, including mathematical relationships and calculations, as found in the following case law, as cited and discussed above: collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group) and/or obtaining and comparing intangible data (e.g. Cybersource, Ambry and Myriad CAFC) and/or execution of an algorithm to implement mathematical relationships and/or formulas, including image processing (e.g. TLI, Digitech, Benson, Flook, Diehr, FuzzySharp, In re Grams and In re Abele all as cited in MPEP 2106).
Instant examples of math concepts include the recited simulation model and convergence process, as well as relationships inherent in recitations as the only supported embodiments.
The preceding case law examples are cited for the basic form of their identified abstract ideas, and analogy to these example abstract ideas need not be within the same technology field, 101 analysis generally being assumed to be neutral with respect to technology field.
Regarding inherency of abstract ideas, MPEP 2106.04.II.A.1 includes: "the claims in Alice Corp. v. CLS Bank, 'described' the concept of intermediated settlement without ever explicitly using the words 'intermediated' or 'settlement'" (emphasis added, p. 1). Similarly, inherency can effectively be recitation, as in, for example, "By claiming simply 'crystalline paroxetine hydrochloride hemihydrate' with no reference to how it was produced, SKB effectively claimed 'crystalline paroxetine hydrochloride hemihydrate whether non-naturally occurring or arising through natural conversion.' Claim 1, as issued, therefore combines patentable and unpatentable subject matter, and is invalid under Section 101." (capitalization added, SmithKline Beecham Corp. v. Apotex Corp., 365 F.3d 1306, 1321-33, Fed. Cir. 2004).
In the instant type of data processing claims, the specification is not merely adding background explanation as to how a claimed process works, e.g. a physical process based on, involving or further explained by abstract ideas and natural laws. Rather, the specification is detailing the only disclosed way that a programmer may proceed from the recited inputs to the recited outputs, e.g. through actual performance of the disclosed judicial exceptions (JEs).
Regarding the "Meaning of 'Recites,'" MPEP 2106.04.II.A.1 states:
In Prong One examiners evaluate whether the claim recites a judicial exception, i.e. whether a law of nature, natural phenomenon, or abstract idea is set forth or described in the claim. While the terms "set forth" and "described" are thus both equated with "recite", their different language is intended to indicate that there are two ways in which an exception can be recited in a claim. For instance, the claims in Diehr, 450 U.S. at 178 n. 2, 179 n.5, 191-92, 209 USPQ at 4-5 (1981), clearly stated a mathematical equation in the repetitively calculating step, and the claims in Mayo, 566 U.S. 66, 75-77, 101 USPQ2d 1961, 1967-68 (2012), clearly stated laws of nature in the wherein clause, such that the claims "set forth" an identifiable judicial exception. Alternatively, the claims in Alice Corp., 573 U.S. at 218, 110 USPQ2d at 1982, described the concept of intermediated settlement without ever explicitly using the words "intermediated" or "settlement."
While the "set forth" language approximates explicit recitation, it also is fundamental that all recitation must be interpreted and that to be patent eligible a claim must satisfy 101 according to its properly interpreted scope, e.g. for all embodiments on which the claim reads, e.g. according to any inherency pertinent to a given claim and disclosure accompanying that claim, i.e. consistent with the "described" meaning of "recites" as in the MPEP. Thus, within a BRI, the identified abstract idea elements read on one or more embodiments which only involve manipulation of data. It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim.
As in Alice (at 306, as cited in the MPEP above) and Bilski (as cited in Alice, id), an abstract idea may comprise multiple abstract elements or steps (i.e. from Alice: "a series of steps" at 306) and need not be a single equation, relationship or principle.
It is not clear that the identified elements must represent other than an abstract idea according to any relevant analysis or case law.
[Step 2A, 1st prong, abstract idea: claims 1 and 15: YES]
Step 2A, 1st prong: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea? -- law of nature -- MPEP 2106.I and 2106.04
Preliminarily, at this 1st step of the analysis, elements of independent claim 1 are directed to a law relating electrical signals to cell locations, including the JE element of "detecting..."
Claim 15 is analyzed similarly.
A BRI of the instant claims is analogous to a law of nature as found, for example, in Mayo (as cited in the MPEP above). It is not clear than any improvement argument clearly on the record causes a claim not to be directed to a JE for all embodiments within the scope of the claim. It is not clear that the above identified law of nature including the identified elements, taken together and within a BRI, must in all embodiments represent other than a law of nature according to any relevant analysis or case law. Therefore, in answer to the 1st Mayo/Alice question, the above elements are directed to a law of nature.
[Step 2A, 1st prong, natural law: claims 1 and 15: YES]
Step 2A, 2nd prong: If the claims recite a judicial exception under the 1st prong, then is the judicial exception integrated into a practical application? -- MPEP 2106.I and 2106.04(d)
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
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, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
In Step 2A, 1st prong above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In Step 2B below, any remaining steps and/or elements are therefore in addition to the identified JE(s). Any such additional steps and additional elements are further discussed in Step 2B.
Here in Step 2A, 2nd prong, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, 2nd prong considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement (e.g. specification: 1:17-31).
[Step 2A, 2nd prong: claims 1 and 15: NO; claim 19: YES (as described further below)]
Step 2B: Do the claims recite a non-conventional arrangement of additional elements in addition to the identified JEs? -- MPEP 2106.I and 2106.05
Addressing the second Mayo/Alice question, all elements of claims 1 and 15 are part of one or more identified JEs (as described above), except for elements identified here as conventional elements in addition to the above judicial exceptions:
The recited "obtaining..." are conventional elements of a laboratory and/or computing environment and/or conventional data gathering/input elements, as exemplified in MPEP 2106.05(d).II and 2106.05(f-g). Data gathering does not impose any meaningful limitation on the judicial exceptions or on how the judicial exceptions are performed. Data gathering are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)). The recited "obtaining..." reads on data transfer and does not for all embodiments within a BRI require physical signal measurement.
It is emphasized that, outside of an improvement argument, analysis of what is conventional generally pertains to the above-identified additional elements and not to elements identified as part of a JE.
[Step 2B: claims 1 and 15: NO]
Summary and conclusion regarding claims 1 and 15
Summing up the above analysis of claims 1 and 15, each viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the identified JE(s), into patent eligible subject matter, and it is not clear that any claim is sufficiently analogous to controlling case law identifying an example of an eligible claim.
Remaining claims
Claims 2-14, 16-18 and 20 add elements which also are part of the identified JEs for the same reasons described above regarding the independent claims and therefore do not provide the something significantly more necessary to satisfy 101.
Elements of the following claims are additional elements but nonetheless are conventional elements of a laboratory or computing environment, conventional data gathering elements or conventional post-processing elements, as in the following specific examples which also are understood to be well-known and routine:
claims 10 and 12: "sensor system..." is a conventional element of a laboratory and/or computing environment and/or conventional data gathering/input element, as exemplified by Belousov (e.g. "electrocardiogram... signals," p. 429 and entire document, as cited on the attached "Notice of References Cited" form 892) and Tanter (e.g. "Electromagnetic brain mapping using magneto- and electro-encephalography," p. 203 and entire document, as cited on the attached "Notice of References Cited" form 892), and generally it is understood that the examples in the reference are well-known and routine.
claim 11: "wireless communication link..." is a conventional element of a laboratory and/or computing environment, as exemplified at MPEP 2106.05(f), (1), iii and 2106.05(h), 4th para.
None of the dependent claim elements provides the something significantly more than the identified JE(s) necessary to satisfy 101.
Claims satisfying 101 with respect to JEs and therefore not rejected here
Referring to 101 analysis as organized in MPEP 2106, no 101 rejection applies to claim 19, and the claim is patent eligible at least in view of the analysis Step 2A, 2nd prong, 4th consideration relating to a transformation integrating possible judicial exceptions into a practical application (MPEP 2106.04(d) and 2106.05(c)), the transformation in this instance comprising at least the recited "...ablating... located cells" which is an additional element and which implements and/or uses information from the JEs to transform one or more located cells.
Conclusion
No claim is allowed.
Applicant's amendments necessitated the new grounds for rejection in this action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Inquiries
Information regarding the filing, management and status of patent applications which are published (available to all users) or unpublished (available to registered users) may be obtained from the Patent Center: https://patentcenter.uspto.gov. Further is available at https://www.uspto.gov/patents/apply/patent-center, and information about filing in DOCX format is available at https://www.uspto.gov/patents/docx.
The Electronic Business Center (EBC) at 866-217-9197 (toll-free) is available for additional questions, and assistance from a Customer Service Representative is available at 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
The examiner for this Office action, G. Steven Vanni, may be contacted at:
(571) 272-3855 Tu-F 8-7 (ET).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Larry D. Riggs, II, may be reached at (571) 270-3062.
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
Prosecution Insights