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 .
Election/Restrictions
Applicant's election with traverse of Group III, Claims 11 and 12 in the reply filed on 21 NOVEMBER 2025 is acknowledged. The traversal is on the grounds that the groups share the same special technical feature and that a search of all of the claims would not impose a serious burden. This is not found persuasive because specification of the shared special technical feature is not made by the Applicant. Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
MPEP 803 and MPEP 806.03 for proof of burden apply to a requirement for restriction, not a unity of invention under PCT Rule 13.1 and 37 CFR 1.475(a). A requirement for unity of invention for a national stage application does not require that serious burden be proven. The argument is not persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are not of sufficient quality. Fig 1c, 1d, 1e, 2b, 2c, 2d, 2e, 2f, 2g, 2h, 2j, 2k, 4a, 4g, and 4h are very blurry, likely due to scan quality, such that it is difficult to discern the points of interest in these drawings. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“recording unit” to record…an oxygen consumption amount and a core body temperature in Claim 12
The claim limitation is interpreted according to paragraph [0028] as “a recording unit 80 that records a measured outside air temperature and at least one numeric value selected from the group consisting of a body temperature and an oxygen concentration”; [0033] “The recording unit records the oxygen consumption amount (VO2) and the core body temperature (TB) recorded under at least two different ambient environment temperature (TA) conditions. [0059] “In order to continuously record the TB (intraperitoneal temperature), a telemetry temperature sensor (TA1TA-F10, DSI) was implanted…”, “The VO 2 and carbon dioxide discharge rate (VCO2) of the animal were continuously recorded using a respiratory gas analyzer (ARCO-2000 mass spectrometer, ARCO System).” There appear to be up to two separate pieces of hardware that make up a collective “recording unit”. The “recording unit” is shown as generic box element “recording unit 80” in Fig. 8.
“calculation unit” to estimate and determine in Claim 12
The claim limitation is interpreted according to paragraph [0058] “Thermograms of DREADD and optogenetic experiments were collected at 0.5 Hz and 1 Hz, respectively, and analyzed using the InfReC Analyzer NS9500 Professional software (Nippon Avionics),”; [0061] “analog signal output from the sensor was converted to a digital signal by an AD converter (NI-9205, National Instruments) at 250 Hz, and stored in a computer using data logging software developed by Biotex Inc.”; [0049] “..estimating a correlation between the oxygen consumption amount and the core body temperature…”; and [0072] “Statistical analysis… Bayesian statistics were applied to evaluate the hypothesis of the inventors and the experimental results.” It is unclear which particular hardware structure is actually used as the hardware structure to “estimate the correlation.” It appears that it is possibly Bayesian statistics is the “unit” for doing statistical analysis. The “calculation unit” is not shown in a figure.
“determination unit” to determine in Claim 12
The claim limitation is interpreted according to paragraph [0031] “ determination unit 92 that determines, based on the theoretical set-point temperature (TR) of the body temperature and the feedback gain (H) of heat production, whether a hibernation-like state has been induced in the subject. “. There is insufficient disclosure present of the particular corresponding structure that performs the claimed function “determining”. The “determination unit” is shown as generic box element “determination unit 92” in Fig. 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 11 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 11 (lines 5 - 6) and Claim 12 (line 2), the phrase "such as" in the term “in a mammal such as a human” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purposes of examination, the term “in a mammal such as a human” is interpreted to claim “in a mammal”.
Claim 11 (line 6) recites the term “to which a test compound has been administered”. It is unclear if this is intended to be the same or different than the previously-recited test compound. For the purposes of examination, the term “to which a test compound has been administered” is deemed to claim “to which the test compound has been administered”.
Claim 11 (line 10) and Claim 12 (line 6 – 7 and lines 9 - 10) each recite the term “before administration and after administration of the test compound”. It is unclear if this is intended to be the same or different than the previously-recited administration of a test compound. For the purposes of examination, the term “before administration and after administration of the test compound” is deemed to claim “before the administration and after the administration of the test compound”.
Claim 11 (lines 14 – 15 and line 16) and Claim 12 (line 12 – 13 and lines 14 - 15) each recite the term “is reduced after administration in comparison to before administration”. It is unclear if this is intended to be the same or different than the previously-recited administration of a test compound. For the purposes of examination, the term “is reduced after administration in comparison to before administration” is deemed to claim “is reduced after the administration in comparison to before the administration of the test compound”.
Claim 11 (lines 17 - 18) and Claim 12 (line 17) each recite the term “after administration of the test compound”. It is unclear if this is intended to be the same or different than the previously-recited administration of a test compound. For the purposes of examination, the term “after administration of the test compound” is deemed to claim “after the administration of the test compound”.
Claim 11 (line 19) and Claim 12 (line 18) each recite the term “comparison to before administration”. It is unclear if this is intended to be the same or different than the previously-recited administration of a test compound. For the purposes of examination, the term “comparison to before administration” is deemed to claim “comparison to before the administration of the test compound”.
Claim 11 (lines 21 - 22) and Claim 12 (lines 20 - 21) each recite the term “after administration of the test compound in comparison to before administration”. It is unclear if this is intended to be the same or different than the previously-recited administration of a test compound. For the purposes of examination, the term “after administration of the test compound in comparison to before administration” is deemed to claim “after the administration of the test compound in comparison to before the administration of the test compound.”
Claim 11 (lines 9, 12 – 13, 15, 18, and 20) and Claim 12 (lines 8 -9, 11, 14, 17 – 18, and 19 – 20) each recite the term “the oxygen consumption amount”. The metes and bounds of the claim cannot be ascertained based on the previously-recited limitation. There is a previously-recited limitation (lines 5 – 6 in Claim 11, similarly in lines 4 – 7 in Claim 12), “providing an oxygen consumption amount and a core body temperature that are recorded under at least two different ambient environment conditions for both before administration and after administration”. It is unclear which of the multiple “oxygen consumption amounts” taken under “at least two different ambient conditions” are the singular subsequent “the oxygen consumption amount” in the claims. It appears that there are either
2 oxygen consumption amounts: one before administration and one after administration
4 oxygen consumption amounts: one before administration at ambient environment condition 1, one before administration at ambient environment condition 1, one after administration at ambient environment condition 1, one after administration at ambient environment condition 2
More than 4 oxygen consumption amounts, if there are more than two different ambient environment conditions
Thus, it is unclear which is the single “oxygen consumption amount” that is intended to be analyzed in the limitations of Claim 11, lines 9 – 22 and Claim 12, lines 8 – 21.
Claim 11 (lines 9 - 10, 13, 15, 18 - 19, and 20) and Claim 12 (lines 9, 11 -12, 13, 18, and 19) each recite the term “the core body temperature”. The metes and bounds of the claim cannot be ascertained based on the previously-recited limitation. There is a previously-recited limitation (lines 5 – 6 in Claim 11, similarly in lines 4 - 7 in Claim 12), “providing an oxygen consumption amount and a core body temperature that are recorded under at least two different ambient environment conditions for both before administration and after administration”. It is unclear which of the multiple “core body temperatures” taken under “at least two different ambient conditions” are the singular subsequent “the core body temperature” in the claims. It appears that there are either
2 core body temperatures: one before administration and one after administration
4 core body temperatures: one before administration at ambient environment condition 1, one before administration at ambient environment condition 1, one after administration at ambient environment condition 1, one after administration at ambient environment condition 2
More than 4 core body temperatures, if there are more than two different ambient environment conditions
Thus, it is unclear which is the single “core body temperature” that is intended to be analyzed in the limitations of Claim 11, lines 9 – 22 and Claim 12, lines 8 - 21.
Claim 11 (lines 17 - 21) and Claim 12 (lines 16 - 20) each recite the limitation “the mammal is determined to hibernate if…the oxygen consumption amount is assumed to be 0” (and similarly in Claim 12, “determine that the mammal is hibernating if”). It is unclear why the mammal would be determined to hibernate if the oxygen consumption amount is zero. Based on Lyman, “Oxygen Consumption, Body Temperature and Hearty Rate of Woodchucks Entering Hibernation”, being in hibernation still involves oxygen consumption by the body. For the woodchucks in hibernation, [Page 87, Right Column, Paragraph 2] “As the animals entered into deep hibernation, the oxygen consumption and heart rate reached their minimal values…The minimal oxygen consumption varied between 12.5 and 50 cc/K/hr among the three animals but remained very steady for each individual during one period of hibernation.” An actual oxygen consumption of zero would seem to indicate that the subject is deceased, unless this is intended to be referring to inhalation and exhalation, or some other respiratory term.
It is unclear if the recited “oxygen consumption amount is zero” is intended to be an assumption based on a measurement of one of the oxygen consumption amounts, or if this is an unrelated assumption to the measurements. Further, the metes and bounds of the claim are unclear, as it is unclear what is “assuming” that the oxygen consumption amount is assumed to be zero. If the “assumption” is an observation and judgment thought by the researcher regarding the subject’s appearance, or if it is an “assumption” input to an equation.
Claim 11 (lines 14 – 16) and Claim 12 (lines 13 - 15) each recite the limitation “determining whether an estimated value of the core temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration in comparison to before administration”. Based on the discussion above regarding “when the oxygen consumption amount is assumed to be zero”, the metes and bounds of “when the oxygen consumption amount is assumed to be zero” are unclear. As such, it is also unclear when that assumption is active, so the metes and bounds of when to determine if the estimated value of the core body temperature is reduced are also unclear. It is unclear if this is a comparison that is made when the subject is assumed to be deceased, or if it is something else.
Claim 11 (lines 17 - 22) and Claim 12 (lines 16 - 21) each recite the limitation “the mammal is determined to hibernate if, after administration of the test compound, the extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced in comparison to before administration, and the estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration of the test compound in comparison to before administration.“ Based on the discussion above, the metes and bounds of the limitations of “the extent of decrease in the oxygen consumption amount…in comparison to before administration” and “the estimated value of the core body temperature…to before administration” are unclear. Therefore, it is also unclear how to satisfy the condition of “wherein the mammal is determined to hibernate it” the two unclear limitations are satisfied.
Claim 12 (lines 2 – 6) recites the term “a recording unit configured to record…record an oxygen consumption amount and a core body temperature recorded under at least two different ambient environment temperature conditions.” It is unclear if the second recitation of “record” and “recorded under at least two different” are intended to be a single recording by the “recording unit”, or if the recording unit is intended to record something that has already been recorded by some other hardware. For the purposes of examination, the term “a recording unit configured to record…record an oxygen consumption amount and a core body temperature recorded under at least two different ambient environment temperature conditions” is deemed to claim “a recording unit configured to record… an oxygen consumption amount and a core body temperature under at least two different ambient environment temperature conditions”
Claim limitations “calculation unit” and “determination unit” each invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
For “calculation unit”, and as described in the 112f interpretation above, it is unclear which particular hardware structure is actually used as the hardware structure to “estimate the correlation.” It appears that it is possibly Bayesian statistics is the “unit” for doing statistical analysis. The “calculation unit” is not shown in a figure.
For “determination unit”, and as described in the 112f interpretation above, there is insufficient disclosure present of the particular corresponding structure that performs the claimed function “determining”. The “determination unit” is shown as generic box element “determination unit 92” in Fig. 8.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 11 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 11, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Regarding Claim 12, the claim recites an apparatus, which is one of the statutory categories of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of claims 11 – 12 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 11 - 12 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 11 - 12 recites an abstract idea.
Specifically, Claims 11 - 12 recite (underlined are observations, judgments, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim 11.
A method of determining whether a test compound induces hibernation in a mammal, the method comprising:
providing an oxygen consumption amount and a core body temperature that are recorded under at least two different ambient environment temperature conditions for both before administration and after administration of the test compound in the mammal such as a human to which a test compound has been administered in regions including an anteroventral periventricular nucleus (AVPe), a medial preoptic area (MPA), and a periventricular nucleus (Pe)
estimating a correlation between the oxygen consumption amount and the core body temperature for each of before administration and after administration of the test compound; and
determining, based on the estimated correlation, whether an extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced after administration in comparison to before administration, and determining whether an estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration in comparison to before administration;
wherein the mammal is determined to hibernate if, after administration of the test compound, the extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced in comparison to before administration, and the estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration of the test compound in comparison to before administration.
Claim 12.
A device for determining hibernation, the device comprising:
a recording unit configured to record, in a mammal such as a human to which a test compound has been administered in regions including an anteroventral periventricular nucleus (AVPe), a medial preoptic area (MPA), and a periventricular nucleus (Pe), record an oxygen consumption amount and a core body temperature recorded under at least two different ambient environment temperature conditions for both before administration and after administration of the test compound;
a calculation unit configured to estimate a correlation between the oxygen consumption amount and the core body temperature for each of before administration and after administration of the test compound, to determine, based on the estimated correlation, whether an extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced after administration in comparison to before administration, and to determine whether an estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration in comparison to before administration;
and a determination unit configured to determine that the mammal is hibernating if, after administration of the test compound, the extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced in comparison to before administration, and the estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration of the test compound in comparison to before administration.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, 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 human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or 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 mathematical calculations and/or mental process steps. For example, in Independent Claims 11 and 12, these limitations include:
Observation and Judgment of a correlation between the oxygen consumption amount and the core body temperature for each of before administration and after administration of the test compound;
Observation and Judgment, based on the Observation and Judgment of a correlation, whether an extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced after administration in comparison to before administration
Observation and Judgment whether an estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration in comparison to before administration;
wherein the mammal is Observed and Judged to hibernate if, after administration of the test compound, the extent of decrease in the oxygen consumption amount when the core body temperature has decreased is reduced in comparison to before administration, and the estimated value of the core body temperature when the oxygen consumption amount is assumed to be 0 is reduced after administration of the test compound in comparison to before administration.
all of which are grouped as mental processes under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claims 11 - 12 are not integrated into a practical application under 2019 PEG because the additional elements (identified above in Independent Claims 1 and 20), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
recording unit
calculation unit
determination unit
test compound
Additional elements recited include a “recording unit”, “calculation unit”, “determination unit”, and “test compound” in the Independent Claims 11 - 12. These components are recited at a high level of generality, , i.e., as a recording unit performing a generic function of recording data(the recording), and a generic test compound for being administered. These generic hardware component limitations for “recording unit” to record, “calculation unit” to estimate, “determination unit”, and “test compound” are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Independent Claims 11 - 12 include pre-solution activity limitations, such as:
providing an oxygen consumption amount and a core body temperature that are recorded under at least two different ambient environment temperature conditions for both before administration and after administration of the test compound in the mammal such as a human to which a test compound has been administered in regions including an anteroventral periventricular nucleus (AVPe), a medial preoptic area (MPA), and a periventricular nucleus (Pe)
a recording unit configured to record, in a mammal such as a human to which a test compound has been administered in regions including an anteroventral periventricular nucleus (AVPe), a medial preoptic area (MPA), and a periventricular nucleus (Pe), record an oxygen consumption amount and a core body temperature recorded under at least two different ambient environment temperature conditions for both before administration and after administration of the test compound;
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “recording unit”, “calculation unit”, “determination unit”, and “test compound” as recited in Independent Claims 11 - 12 and their dependent claims are generically recited computer and hardware elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract ideas identified above in Independent Claims 11 - 12 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in Independent Claims 11 - 12 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claims 11 - 12 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 11 - 12 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “recording unit”, “calculation unit”, “determination unit”, and “test compound” as recited in Independent Claims 1 and 20 and their dependent claims.
The additional elements of the “recording unit”, “calculation unit”, “determination unit”, and “test compound” in Claims 11 - 12, as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification and the 112f interpretation above, the “recording unit” is described generically in paragraph [0028] as “a recording unit 80 that records a measured outside air temperature and at least one numeric value selected from the group consisting of a body temperature and an oxygen concentration”; [0033] “The recording unit records the oxygen consumption amount (VO2) and the core body temperature (TB) recorded under at least two different ambient environment temperature (TA) conditions. [0059] “In order to continuously record the TB (intraperitoneal temperature), a telemetry temperature sensor (TA1TA-F10, DSI) was implanted…”, “The VO2 and carbon dioxide discharge rate (VCO2) of the animal were continuously recorded using a respiratory gas analyzer (ARCO-2000 mass spectrometer, ARCO System).” There appear to be up to two separate pieces of hardware that make up a collective “recording unit”. The “recording unit is shown as generic box element “recording unit 80” in Fig. 8.
Per Applicant’s specification and the 112f interpretation above, the “calculation unit” is described generically in paragraph [0058] “Thermograms of DREADD and optogenetic experiments were collected at 0.5 Hz and 1 Hz, respectively, and analyzed using the InfReC Analyzer NS9500 Professional software (Nippon Avionics),”; [0061] “analog signal output from the sensor was converted to a digital signal by an AD converter (NI-9205, National Instruments) at 250 Hz, and stored in a computer using data logging software developed by Biotex Inc.”; [0049] “..estimating a correlation between the oxygen consumption amount and the core body temperature…”; and [0072] “Statistical analysis… Bayesian statistics were applied to evaluate the hypothesis of the inventors and the experimental results.” It is unclear which particular hardware structure is used as the hardware structure to “estimate the correlation.” It appears that it is possibly Bayesian statistics is the “unit” for doing statistical analysis. The “calculation unit” is not shown in a figure.
Per Applicant’s specification and the 112f interpretation above, the “determination unit” is described generically in paragraph [0031] “ determination unit 92 that determines, based on the theoretical set-point temperature (TR) of the body temperature and the feedback gain (H) of heat production, whether a hibernation-like state has been induced in the subject. “. There is insufficient disclosure present of the particular corresponding structure that performs the claimed function “determining”. The “determination unit” is shown as generic box elements “determination unit 90” and “determination unit 92” in Fig. 8.
Per Applicant’s specification, the “test compound” is described in the form of compounds and stimulus in [0037] including “administering a ligand” and that [0005] “method of testing whether a test compound induces hibernation”. The “test compound” is not particularly labeled in a figure.
Accordingly, in light of Applicant’s specification, the claimed terms “recording unit”, “calculation unit”, “determination unit”, and “test compound” are reasonably construed as a generic computing and hardware devices. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “recording unit”, “calculation unit”, “determination unit”, and “test compound”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 11 - 12 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the apparatus and method of Claims 11 - 12 are directed to applying an abstract idea as identified above on a general-purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. Neither of Claims 11 - 12 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements for Step 2A Prong 2 in Independent Claims 11 - 12 do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 11 - 12 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 11 - 12 amounts to significantly more than the abstract idea itself. Accordingly, Claims 11 - 12 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
In light of the current 112(b) rejections, no prior art rejection is currently able to be applied to Claims 11 and 12.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791