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 .
Status of the Claims
Claims 1, 5-14 and 25-27 are examined; claims 2-4, 15-24 and 28-36 are cancelled.
Priority
This US Application 17/768,148 (04/11/2022) is a 371 of PCT/BR2019/050440 (10/09/2019); as reflected in the filing receipt mailed on 12/27/2022. The claims to the benefit of priority are acknowledged and the effective filing date of claims 1, 5-14 and 25-27 is 10/09/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/11/2022 was considered by the examiner.
Claim objections
Claims 1, 5-14 and 25-27 are objected to because of the following informalities. Appropriate correction is required.
The following issues are objected to:
Claim
Recitation
Comment
1, 5-14 and 25-27
A COMPUTER...
Generally, a claim begins with a capital letter, and capitalization should only be used when grammatically required, e.g. for abbreviations and proper nouns.
1
COMPUTER IMPLEMENTED
Should be hyphenated
6
includes
Subject-verb agreement: should read "include[[s]]"
8
plurality... are
Subject-verb agreement: should read "[[are]]is"
Claim Rejections - 35 USC § 112(b)
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.
Claim 7 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter of the invention.
The following issues cause the respective claims to be rejected under 112(b) as indefinite:
Claim
Recitation
Comment (suggestions in bold)
1,5-14 and 25-27
METHOD (1000)
In claim 1, it is not clear that the cited "1000" corresponds to the actually recited claim. Any inconsistency causes the claim to be indefinite. This same issue also renders dependent claims 5-14 indefinite, noting that not all of the different claims can correspond to the one method depicted in FIG. 2 and labeled there as "1000." Similarly in claim 1, it is not clear which if any of the recited "1010," "1020," etc. correspond to the actually recited steps, including all associated recitation. The same issues occur in claims 25-27.
1, 25
standard human organism
It is unclear whether "standard" refers to any standard or some particular standard. To the extent that it refers to some particular standard, then the recited "standard" is a term of relative or vague degree or form of association, neither defined in the specification (p. 7, lines 12-14) nor having a well-known and sufficiently particular definition in the art and in the instant context. (MPEP 2173.05(b) pertains.)
1, 25
feedback information from at least one target
The relationship is unclear between this instance and that in the preceding two steps. Possibly the two instances should be recited as "first" and "second" "feedback information."
1, 25
the effect of the at least one final dose
Requires but lacks clear antecedent
1, 25
the volumetric energy density
Requires but lacks clear antecedent
1, 25
In the formula for Vm, the relationship is unclear between the "t" of "dt" and the previously recited "predetermined exposure time t." Also, the "Ω" of "dΩ" must be defined in the claim.
1, 25
the variation in the concentration
Each requires but lacks antecedent
1, 25
the susceptibility ...
the production
Each requires but lacks antecedent
1, 25
the stimuli
Requires but lacks clear antecedent
1, 25
tissue Cn
Inconsistent with previous recitation of "wherein Cn is the variation in the concentration..."
1, 25
the total variation
Requires but lacks clear antecedent
5
if variations...
The relationship is unclear between this instance and those recited earlier. Possibly this instance should read "if the variations..." Also, possibly this instance, like the previous should recite "total." Also, generally, conditional expressions are more easily readable if the conditional precedes and if the action to be taken is preceded by "then," i.e. "if..., then..."
7
the results of questionnaires...
Requires but lacks clear antecedent basis. There is no preceding recitation of "questionnaires..."
7
the results of a group consisting of:
Requires but lacks clear antecedent basis
12
selecting a final dose from the set of final doses most compatible with the parameters of the target user
It is unclear which preceding element is modified by the recited "most compatible..." Possibly: "selecting a final dose most compatible with the parameters of the target user, selecting from the set of final doses" or an equivalent
25
A SYSTEM..., comprising:
a processor...,
wherein the processor is configured to perform the steps
Claim 25 is to a 101 machine or manufacture, i.e. a "SYSTEM" in this instance, limited according to its claimed physical structure, but it is not clear what is the structure associated with the recited "processor is configured to..." The recited "SYSTEM" and "processor" are not interpreted as requiring structure clearly linking the recited "SYSTEM" to the recited "configured to" in a structural sense appropriate to a claim to a machine or manufacture. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "SYSTEM" or "processor" and instructions stored therein, the instructions "configured" as recited.
25
at least one final dose based on feedback information
The relationship is unclear between this instance of "feedback information" and the instance recited in the preceding step.
27
feedback information from the at least one initial user and the at least one target user
The relationship is unclear between this instance and the similar claim 25 instances. Possibly this claim 27 instance should begin with "the..."
Claim interpretations
The following claim interpretations apply to all instances of the following terms throughout all claims:
Claim
Recitation
Comment
14
distribution platform
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "platform") and function and/or result (here "distribution") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at p. 10, lines 7-25. MPEP 2181.III-IV pertain.
14, 26-27
communication network
Recites means (or an equivalent, nonce term, here "network") and function and/or result (here "communication"), but the recitation does not invoke 112/f because it is interpreted as well-known. MPEP 2181.I.A,3rd para. pertains with analogy to structures having "sufficiently definite meaning," such as "filters" and "brakes."
26-27
energy dose application device
Definite under 112/b after properly invoking 112/f. Recites means (or an equivalent, nonce term, here "device") and function and/or result (here "energy dose application") without reciting steps or structure to prevent invoking. However, clearly linked portion of the specification do disclose sufficient structure, material, or acts and not just desired results, as exemplified at p. 4, lines 1-7; p. 10, lines 26-28; . MPEP 2181.III-IV pertain.
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 1, 5-14 and 25-27 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a method (claims 1 and 5-14), and a system (claims 25-27), each of which falls within one of the categories of statutory subject matter. [Step 1: claims 1, 5-14 and 25-27 Yes].
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Mathematical concepts recited in instant claims 1, 5, 10, and 25 include the terms “calculating”, “adjusting” a dose value, “determining the solution from the matrix”; “summing each variation of biological marker”, “simulating/re-simulating” a variation in concentration of at least one biological marker”; which are mathematical concepts. Regarding the simulating step, claims 1 and 25 recite “wherein the simulating variation in the concentration of the at least one biological marker n comprises calculating a stimulus”; which shows evidence that the recited “simulating” constitutes a mathematical process. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one having ordinary skill in the art. Thus, the recited terms corresponds to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include “determining a power per unit of area from at least one initial dose” (claims 1 and 25); and “selecting a final dose from the set of final doses most compatible with the parameters of the target user " (claim 12). Under the BRI, the recited limitations are mental processes because a human mind is sufficiently capable of determine a value for a parameter and select a final energy dose.
Dependent claim 8 recites further details about the “biological markers from which the variation in concentration is simulated”; dependent claims 10 13-14 and 26 recite further details about “value adjustments”; not reciting any additional non-abstract elements; all reciting further aspects of the information being analyzed, the manner in which that analysis is performed. Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The instant claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: claims 1, 5-14 and 25-27 Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 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).
Instant claims 1, 6, 9, 11, 25 and 27 recite additional elements that are not abstract ideas: “computer” (claim 1); “processor” (claims 1 and 25); “simulating the at least one effect of the initial dose from power per unit of area E on at least one biological tissue m of the standard human organism for a predetermined exposure time” (claims 1 and 25); receiving … parameters” (claims 1 and 25); and “receiving feedback information” (claims 1 and 25 ). The recited limitations in these claims are interpreted to require multiple computer parts (processor/ memory), not requiring specialized hardware other than a generic computer, which does not integrate the abstract idea into a practical application. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions or instructions to implement on a generic computer.
Dependent claim 6 recites further details about the “feedback information received”; dependent claim 9 recites further details about the “parameters received”; dependent claim 11 recites further details about “the user” from which information is received from; and dependent claim 27 recites further details about the receiving step. The recited claims read on data gathering activities or the type of data being gathered; not amounting to a practical application. The type of data doesn’t change that it is mere data gathering or conventional computer receiving means.
Claims reciting “receiving … parameters” and “receiving feedback information” read on receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321; which constitutes just necessary data gathering and outputting and therefore correspond to insignificant extra-solution activity.
Claims reciting “simulating the at least one effect of the initial dose from power per unit of area E on at least one biological tissue m of the standard human organism for a predetermined exposure time” read on apply it steps. There are no additional limitations to indicate that the claimed computer, processor, or computer readable medium require anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)). None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed, the manner in which that analysis is performed, or the mathematical operations performed on the information.
In Step 2A, Prong One 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, Prong Two, 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, Prong Two 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: p. 1, line 23 through p. 2, line 15).
[Step 2A Prong Two: claims 1, 5-14 and 25-27 No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of the 35 USC § 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claims 1, 6, 9, 11, 25 and 27 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Claims directed to “receiving” data read on performing a standard computer task, which the courts have identified as a conventional computer function in Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362; OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015); and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014).
The step of “simulating the at least one effect of the initial dose from power per unit of area E on at least one biological tissue of the standard human organism for a predetermined exposure time” is well-understood, routine and conventional (Pearce et. al. "Mathematical models of laser-induced tissue thermal damage." International Journal of Hyperthermia 27(8):741-750 (2011) – pg. 742 para. 1).
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h). [Step 2B: claims 1, 5-14 and 25-27 No]
Conclusion: Instant claims are directed to non-statutory subject matter
For these reasons, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the abstract idea, so instant claims 1, 5-14 and 25-27 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
No prior art has been applied to the following claims
No prior art is applied to claims 1, 5-14 and 25-27.
The following art is listed on the attached form 892 and made of record but not relied upon:
Lavinsky et. al. "Subvisible retinal laser therapy: titration algorithm and tissue response." Retina 34(1):87-97 (2014) – teaches a computational model–based titration algorithm for predictable laser dosimetry (i.e. a computer implemented method for calculating energy doses) (pg. 1 para. 1); wherein a graphic user interface allows control over laser parameters (i.e. reading on parameter adjustments on any dose, by a processor, based on feedback information from the user), including the spot size, power, and pulse duration (i.e. reading on receiving, by a processor, a plurality of parameters from a user) (pg. 2 col. 2 para. 4); wherein the algorithm adjusts both power and pulse duration to vary the expected level of thermal damage (i.e. reading on adjusting parameters regarding the effect of the at least one adjusted initial dose) at different percentages of a reference titration energy dose (i.e. reading on adjustment of an initial energy dose to obtain a final energy dose) (pg. 1 para. 2); wherein the threshold energy levels for the laser settings required to produce an specific effect were calculated (i.e. (pg. 4 col. 1 para. 3); wherein two laser modalities - 577 nm/10 ms pulse, and near-infrared micropulse - resulted the same observable effects (i.e. reading on electromagnetic energy with a wavelength between 400 to 1000 nm) (pg. 10 col. 1 para. 2); wherein the system provided 10 ms to 100 ms pulses with up to 2 W power and an spot size ranging from 100 mm to 400 mm (pg. 2 col. 2 para. 4) with the incident laser spot depicted as a circumference area (pg. 9 Fig. 9A) (i.e. reading on determining a power per unit of area E from the at least one initial dose); wherein tissue damage is measured by the decrease in critical molecular component and the criterion for cell viability is then determined as a maximum tolerable decrease in concentration of the critical component (i.e. variation in concentration of at least one biological marker after exposure of the at least one biological tissue) (pg. 3 col. 1 para. 3); wherein percentages adjustments in retinal treatment indicate the energy setting of each retinal lesion (pg. 4 Fig. 1);wherein tissue damage can be described with first-order reaction kinetics (Arrhenius law) parameterized by an activation energy, corresponding to the denaturation of a single critical molecular component (i.e. stimulus received from the at least one biological tissue m during the predetermined exposure time) (pg. 3 col. 2 para. 2) (pg. 3 col. 1 para. 3); wherein computational analysis of clinical laser settings indicated that nondestructive thermal therapy corresponds to Arrhenius integral (Ω) values approximately from 0.1 to 1 (i.e. calculating a stimulus received from the at least one biological tissue m during the predetermined exposure time) (pg. 3 col. 1 para. 4); wherein the algorithm maps a range of calculated Arrhenius integral values to linear steps in pulse energy normalized to a titration dose specified at a particular duration(pg. 3 col. 2 para. 1); wherein the Arrhenius cellular damage model is used to estimate retinal damage (pg. 3 col. 1 para. 2) (i.e. reading on a stimulus comprising an energy parameter integrated over time for a biological tissue); wherein the Arrhenius integral is a function of the pulse duration and laser power via the temperature time course and the mapping of a particular value of integral value to a fractional pulse energy uniquely defining a pulse duration and power (pg. 3 col. 2 para. 1);
Fuentes et. al. "Computational modeling and real-time control of patient-specific laser treatment of cancer." Annals of biomedical engineering 37(4):763-782 (2009) – teaches a computational model that describes the bioheat transfer as the conservation of energy applied to a motionless nondeforming mass of human tissue for the evaluation of temperature in the biological domain due to energy supplied by the laser (i.e. simulating the at least one effect of the initial dose from power per unit of area E on at least one biological tissue m of the standard human organism) (pg. 768 col. 1 para. 3); wherein initial parameters such as laser power as a function of time (i.e. energy dose) are identified from bioheat transfer data (i.e. retrieving (1020) from a database (110), by the processor) (pg. 765 col. 2 para. 1); wherein the initial parameters are ultimately corrected during the calibration phase of the process using thermal image data stored in a data server (pg. 765 col. 2 para. 1); wherein the model detects the full set of thermal images for a time instance (i.e. images collected by an user – user feedback) and predicts the power to be used for the next time interval (i.e. simulation of at least one effect of the initial dose on a standard human organism to generate at least one adjusted initial dose; and… adjusting the at least one initial dose based on the simulated variation in concentration of the at least one biological marker n and at least one of the parameters of the at least one initial user) (pg. 768 col. 1 para. 1).
Pinheiro et. al. “Assessment of thermal damage in precooled CO2 laser wounds using biological markers." British Journal of Oral and Maxillofacial Surgery 31(4):239-243 (1993) – teaches the assessment of cooled biological tissue thermal damage caused by laser by studying changes in the activity of lactate dehydrogenase and succinate dehydrogenase enzymes (i.e. reading on the variation in the concentration of the at least one biological marker) (pg. 239 para. 1); wherein correlation studies showed that thermal damage to the biological tissue cause smaller enzyme activity (i.e. susceptibility of the at least one biological tissue m to modulate the production of the at least one biological marker) (pg. 242 col. 1 para. 3); wherein Table 1 depicts the summation of thermally damaged enzyme amounts per exposure time of laser (i.e. summing each variation of biological marker by a tissue to determine the total variation of each biological marker) (pg. 242 Table 1)
However the above-described prior art does not teach the instant combination of particular steps/elements regarding “wherein the stimulus Vm comprises the volumetric energy density integrated over the predetermined period of time for the at least one biological tissue m, that is,
PNG
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59
178
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Greyscale
determining the solution of the matrix equation C=M • V,
PNG
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101
135
media_image2.png
Greyscale
wherein Cn is the variation in the concentration of the at least one biological marker n
PNG
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111
253
media_image3.png
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wherein Mnm is the susceptibility of the at least one biological tissue m to modulate the production of the at least one biological marker n; wherein the susceptibility can be any number between -1 and 1, wherein if it is -1, there is complete inhibition of production of the biological marker n; if it is 0, there is no influence, and if it is 1, there is maximum stimulation of production of the biological marker n” claims 1 and 25; and it is not clear that any combination of art would have rendered the claims obvious. Therefore, the claims are interpreted as free of the prior art.'
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCINI A FONSECA LOPEZ whose telephone number is (571)270-0899. The examiner can normally be reached Monday - Friday 8AM - 5PM ET.
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/F.F.L./Examiner, Art Unit 1685
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686