DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
This action is Non-Final.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on 12/19/2025 is acknowledged. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant’s request for rejoinder is acknowledged, but is premature as no claims are in condition for allowance; applicant should amend the withdrawn claims consistent with the elected group during prosecution for rejoinder consideration at such time as the elected claims are in a condition for allowance.
Drawings
The drawings are objected to because there are references to drawing numbers which are not present in the drawings as filed (see specification objections below). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: paragraph 40 makes reference to Figures 5-13, there is no Figures 11-13 in the application as filed; paragraph 44 makes reference to Fig. 11, there is no Figure 11 in the application as filed; paragraph 48 makes reference to Figures 8-11, there are is no Figure 11 in the application as filed; there is no mention of Figure 10B in the detailed description.
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not make reference to the features of original claim 7 “wherein the previous expiratory times include expiratory times from at least four previous cycles” but refers to 10, 15, 20 in [0074]).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the limitations “compare the plethysmograph and the at least one of the flow waveform and the pressure waveform; determine if an asynchronous event occurred based on comparing the plethysmograph and the at least one of the flow waveform and the pressure waveform;” are rejected for lack of adequate written description for the scope claimed. While the written description as filed repeats the claimed scope, it is not clear that the waveforms claimed are directly compared themselves to identify the asynchronous event which is scope apprised by the form claimed. It appears that at most, based on the original disclosure as filed, that points/information/data gleaned from plethysmograph waveform may be used together with points/information/data gleaned from flow or pressure data to identify asynchronous event. Applicant is invited to explain support for the scope set forth that the waveforms themselves compared as claimed provide the basis for the asynchronous event determination as claimed or amend the claims to more closely align with the support as filed.
Regarding claim 10, the limitations “wherein the instructions cause the processor to determine if the respiratory cycle is valid by determining that no artifact affected the respiratory cycle” is rejected for lack of adequate written description for the functions being claimed. The disclosure as filed supports that an invalid cycle is set when an artifact is detected, but not that the artifact has affected the respiratory cycle as claimed.
[0047] “After identifying missing trigger events, the process of evaluating respiratory cycles 500 may search for artifacts in act 504. As used herein, an “artifact” is an event that will cause (e.g., result in, effectuate) inaccurate readings, such as a sensor disconnection, a change in parameters (e.g., pressure, PEEP, flow, etc.), purge, aspiration, etc. If an artifact is detected, the associated breathing cycle is labeled as an invalid cycle. This may substantially prevent the controller from mis-identifying an asynchrony during an artifact event. The detection of artifacts is described in further detail below with reference to FIG. 7.” and [0060]-[0066] and Figure 7.
Applicant is invited to explain support with citation to the as filed description, but as provided previously, it does not appear such has basis. As such, one of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
The dependent claims are rejected for depending on a rejected claim.
Federal Register Notice of January 7, 2019:
At issue in Vasudevan was whether the patent specification provided sufficient written description support for a limitation of the asserted claims. Vasudevan, 782 F.3d at 681–83. The Federal Circuit explained that ‘‘[t]he test for the sufficiency of the written description ‘is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date.’ ’’ Id. at 682 (quoting Ariad, 598 F.3d at 1351). The Federal Circuit emphasized that ‘‘[t]he written description requirement is not met if the specification merely describes a ‘desired result.’ ’’ Vasudevan, 782 F.3d at 682 (quoting Ariad, 598 F.3d at 1349). Thus, in applying this standard to the computer-implemented functional claim at issue, the Federal Circuit stated that ‘‘[t]he more telling question is whether the specification shows possession by the inventor of how [the claimed function] is achieved.’’ Vasudevan, 782 F.3d at 683. In order to satisfy the written description requirement set forth in 35 U.S.C. 112(a), the specification must describe the claimed invention in sufficient detail such that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. For instance, the specification must provide a sufficient description of an invention, not an indication of a result that one might achieve. The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Information that is well known in the art need not be described in detail in the specification. However, sufficient information must be provided to show that the inventor had possession of the invention as claimed. See MPEP § 2163, subsection II(A)(2). The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant hasdemonstrated possession of the claimed invention. Id.; see also Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000) (‘‘The purpose of [the written description requirement] is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification’’); LizardTech Inc. v. Earth Resource Mapping Inc., 424 F.3d 1336, 1345 (Fed. Cir. 2005) (‘‘Whether the flaw in the specification is regarded as a failure to demonstrate that the applicant possessed the full scope of the invention recited in [the claim] or a failure to enable the full breadth of that claim, the specification provides inadequate support for the claim under [§ 112(a)]’’); cf. id. (‘‘A claim will not be invalidated on [§ ] 112 grounds simply because the embodiments of the specification do not contain examples explicitly covering the full scope of the claim language.’’). While ‘‘[t]here is no special rule for supporting a genus by the disclosure of a species,’’ the Federal Circuit has stated that ‘‘[w]hether the genus is supported vel non depends upon the state of the art and the nature and breadth of the genus.’’ Hynix Semiconductor Inc. v. Rambus Inc., 645 F.3d 1336, 1352 (Fed. Cir. 2011); id. (further explaining that ‘‘so long as disclosure of the species is sufficient to convey to one skilled in the art that the inventor possessed the subject matter of the genus, the genus will be supported by an adequate written description.’’). See also Rivera v. Int’l Trade Comm’n, 857 F.3d 1315, 1319–21 (Fed. Cir. 2017) (affirming the Commission’s findings that ‘‘the specification did not provide the necessary written description support for the full breadth of the asserted claims,’’ where the claims were broadly drawn to a ‘‘container . . . adapted to hold brewing material’’ while the specification disclosed only a ‘‘pod adapter assembly’’ or ‘‘receptacle’’designed to hold a ‘‘pod’’). Computer-implemented inventions are at times disclosed and claimed in terms of their functionality. For computer-implemented functional claims, the determination of the sufficiency of the disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software (i.e., ‘‘how [the claimed function] is achieved,’’ Vasudevan, 782 F.3d at 683), due to the interrelationship and interdependence of computer hardware and software. When examining computer implemented, software-related claims, examiners should determine whether the specification discloses the computer and the algorithm(s) that achieve the claimed function in sufficient detail that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as ‘‘a finite sequence of steps for solving a logical or mathematical problem or performing a task.’’ Microsoft Computer Dictionary (5th ed., 2002). Applicant may ‘‘express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure.’’ Finisar, 523 F.3d at 1340 (internal citation omitted). It is not enough that one skilled in the art could theoretically write a program to achieve the claimed function, rather the specification itself must explain how the claimed function is achieved to demonstrate that the applicant had possession of it. See, e.g., Vasudevan, 782 F.3d at 682–83. If the specification does not provide a disclosure of the computer and algorithm(s) in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention that achieves the claimed result, a rejection under 35 U.S.C. 112(a) for lack of written description must be made. See MPEP § 2161.01, subsection I.
MPEP 2161.01:
I. DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION
The 35 U.S.C. 112(a) or first paragraph of pre-AIA 35 U.S.C. 112 contains a written description requirement that is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1344-45, 76 USPQ2d 1724, 1731-32 (Fed. Cir. 2005); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-64, 19 USPQ2d 1111, 1115-16 (Fed. Cir. 1991). Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.;Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. The function of the written description requirement is to ensure that the inventor had possession of the specific subject matter later claimed as of the filing date of the application relied on; how the specification accomplishes this is not material. In re Herschler, 591 F.2d 693, 700-01, 200 USPQ 711, 717 (CCPA 1979), further reiterated in In re Kaslow, 707 F.2d 1366, 217 USPQ 1089 (Fed. Cir. 1983); see also MPEP §§ 2163 - 2163.04.
The written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, applies to all claims including original claims that are part of the disclosure as filed. Ariad, 598 F.3d at 1349, 94 USPQ2d at 1170. As stated by the Federal Circuit, “[a]lthough many original claims will satisfy the written description requirement, certain claims may not.” Id. at 1349, 94 USPQ2d at 1170-71; see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-46, 76 USPQ2d 1724, 1730-33 (Fed. Cir. 2005); Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1405-06 (Fed. Cir. 1997)(“The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention.”). Problems satisfying the written description requirement for original claims often occur when claim language is generic or functional, or both. Ariad, 593 F.3d at 1349, 94 USPQ2d at 1171 ("The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.").
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 (“[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.”) (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that “only similar language in the specification or original claims is necessary to satisfy the written description requirement”).
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 “merely by clearly describing one embodiment of the thing claimed.” LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. “[T]he description of one method for creating a seamless DWT does not entitle the inventor . . . to claim any and all means for achieving that objective.” LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Vasudenvan Sofware, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) in the context of determining possession of a claimed means of accessing disparate databases).
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding “whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved”). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2162- § 2163.07(b). If the specification does not provide a disclosure of sufficient corresponding structure, materials, or acts that perform the entire claimed function of a means- (or step-) plus- function limitation in a claim under 35 U.S.C. 112(f) or the sixth paragraph of pre-AIA 35 U.S.C. 112, "the applicant has in effect failed to particularly point out and distinctly claim the invention" as required by the 35 U.S.C. 112(b) [or the second paragraph of pre-AIA 35 U.S.C. 112]. In re Donaldson Co., 16 F.3d 1189, 1195, 29 USPQ2d 1845, 1850 (Fed. Cir. 1994) (en banc). A rejection under 35 U.S.C. 112(b) or the second paragraph of pre-AIA 35 U.S.C. 112 must be made in addition to the written description rejection.
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 1-11 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 1, the limitations “compare the plethysmograph and the at least one of the flow waveform and the pressure waveform; determine if an asynchronous event occurred based on comparing the plethysmograph and the at least one of the flow waveform and the pressure waveform” render the claim indefinite. The claims are not clear in meaning as it is not clear what is meant in the claims. For example, what is compared and what is such compared to? The disclosure as filed contains verbatim this passage, but also contains a passage that states in [0048] “Asynchronies may be identified by comparing lung volume data from the EIT system to the gas pressure wave forms and gas flow waveforms from the gas monitoring sensors.”. Based on review of the specification, lung volume data is synonymous with the plethysmograph. It appears that the first data is compared to at least one of the second data. Because this aspect is not clear, the metes and bounds of the claims are not clear and the claim is rendered indefinite. For examination purposes, the features read as “compare the plethysmograph to[[and]] the at least one of the flow waveform and the pressure waveform; determine if an asynchronous event occurred based on comparing the plethysmograph to[[and]] the at least one of the flow waveform and the pressure waveform”.
Further regarding claim 1, the limitations “classify the asynchronous event; and provide a classification of the asynchronous event” are not clear in meaning. Are classify and classification referring to the same feature or unrelated aspects? For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite. Likely these are one in the same and such is how the claim is interpreted to read “classify the asynchronous event; and provide the classified
Regarding claim 3, the limitations “The system of claim 2, wherein the instructions cause the processor to determine if the asynchronous event occurred if the trapped volume is greater than a threshold volume” renders the claim indefinite. It is not clear what is meant by this limitation in view of the requirements of claim 1 which state “determine if an asynchronous event occurred based on comparing the plethysmograph and the at least one of the flow waveform and the pressure waveform”. These two limitations do not appear to be related as one compares plethysmograph to flow or pressure waveforms, and the other looks at trapped volume to a threshold. Is claim 3 attempting to replace, build, or be additional programing of a different event than that referenced in claim 1? For these reasons, the metes and bounds of the claim are unclear which renders the claim indefinite. As there is a great deal of uncertainty and high degree of speculation, it would be improper to reject the claim in view of prior art, In re Steele, MPEP 2173.06:
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
As such, claim 3 and the claims which depend from claim 3 (which have further issues as discussed below) are not rejected in view of prior art due to the considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims, this includes claims 4-5.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “volume” in claim 4 is used by the claim to mean “specific volume (mL/kg),” while the accepted meaning is “mL.” The term is indefinite because the specification does not clearly redefine the term. This is an issue in view of claim 3, which refers to trapped volume comparing to a threshold, and the trapped volume is a volume in the common meaning. As such, claims 3-5 are indefinite as a volume is being compared to a specific volume threshold which are not the same units (including stacked volume). This makes the metes and bounds of the claim unclear which renders the claims indefinite.
Regarding claim 5, the limitations “The system of claim 3, wherein the instructions cause the processor to determine the asynchronous event occurred if: a stacked volume during a cycle is greater than the threshold volume; the expiratory time between the two cycles is below the threshold time; and the expiratory time between the two cycles is less than the previous expiratory times” renders the claim indefinite. Similar to claim 3, it is not clear what is meant by this limitation in view of the requirements of claim 1, which state “determine if an asynchronous event occurred based on comparing the plethysmograph and the at least one of the flow waveform and the pressure waveform”, and in addition to the requirements of claim 3. These different limitations do not appear to be related as one compares plethysmograph to flow or pressure waveforms, one looks at trapped volume to a threshold, and one looks at stacked volume to the same threshold as trapped volume. Is claim 5 attempting to replace, build, or be additional programing of a different event than that referenced in claims 1 and 3? For these reasons, the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 8, the limitations “The system of claim 1, wherein the instructions cause the processor to communicate a recommended adjustment to a user” renders the claim indefinite. It is not clear how the processor achieves the claimed function because the system of claim 1 only includes a receiver, processor, memory and medium with instructions. What structures provide for the communication? It appears that an electric display is the structure disclosed for such functions. For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 10, the limitations “wherein the instructions cause the processor to determine if the respiratory cycle is valid by determining that no artifact affected the respiratory cycle” is rejected for being inconsistent with the disclosure as filed, MPEP 2173.03. In review of the specification, validity is discussed in paragraphs [0047] “After identifying missing trigger events, the process of evaluating respiratory cycles 500 may search for artifacts in act 504. As used herein, an “artifact” is an event that will cause (e.g., result in, effectuate) inaccurate readings, such as a sensor disconnection, a change in parameters (e.g., pressure, PEEP, flow, etc.), purge, aspiration, etc. If an artifact is detected, the associated breathing cycle is labeled as an invalid cycle. This may substantially prevent the controller from mis-identifying an asynchrony during an artifact event. The detection of artifacts is described in further detail below with reference to FIG. 7.” and [0060]-[0066] and Figure 7. However, identifying artifacts itself is the determination, not that any affect of the respiration cycle is dependent on such. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
The dependent claims are rejected for depending on a rejected claim.
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 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1:
compare the plethysmograph and the at least one of the flow waveform and the pressure waveform (mental process, mathematical concepts)
determine if an asynchronous event occurred based on comparing the plethysmograph and the at least one of the flow waveform and the pressure waveform (mental process, mathematical concepts)
classify the asynchronous event (mental process, mathematical concepts)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1:
a receiver configured to receive ventilation data from at least one of a mechanical ventilator, an airway flow sensor, or an airway pressure sensors and impedance data from an electrical impedance tomography device (limitations related to data gathering, insignificant pre solution activities)
a processor (computer structures used as a tool for implementation)
a memory device configured to store the ventilation data and the impedance data (computer structures used as a tool for implementation)
a non-transitory computer readable medium storing instructions thereon that, when executed by the processor, cause the processor to perform steps (computer structures used as a tool for implementation)
retrieve a plethysmograph from the impedance data (limitations related to data gathering, insignificant pre solution activities)
retrieve at least one of a flow waveform and a pressure waveform from the ventilation data (limitations related to data gathering, insignificant pre solution activities)
provide a classification of the asynchronous event (limitations related to insignificant post solution activities)
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
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 - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2A. Such limitations related to the receiver and retrieving are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm, and thus, do not add a meaningful limitation to the system as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm. In addition, the sensor structures are claimed in inference intended to be used with the required computer related structures gathering data and processing data. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further limitations related to extra solution activities including to the inference intended to be used structures, and to further details of the data algorithm (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamura, (WO 2021/074747 A1; cited by applicant on the IDS filed 1/29/2024).
Regarding claim 1, Nakamura teaches a system configured to detect asynchronous respiratory events (see at least abstract, Figures 3-4); the system comprising:
a receiver configured to receive ventilation data from at least one of a mechanical ventilator, an airway flow sensor, or an airway pressure sensors and impedance data from an electrical impedance tomography device (interpreted as data input structures, see at least Figures 3-4, page 2 lines 24- 27, p. 11 lines 12-21);
a processor (see at least figure 3-4, p. 12 lines 3-22);
a memory device configured to store the ventilation data and the impedance data (see at least figure 3-4, p. 12 lines 3-22); and
a non-transitory computer readable medium storing instructions thereon that, when executed by the processor, cause the processor to perform steps (see at least page 6 lines 14-17, p. 12 lines 3-22) comprising:
retrieve a plethysmograph from the impedance data (see at least p14 line 26-p. 15 line 30, Figure 5);
retrieve at least one of a flow waveform and a pressure waveform from the ventilation data (see at least page 14 line 26-p.15 line 9, Figure 5);
compare the plethysmograph and the at least one of the flow waveform and the pressure waveform (see at least Figure 5 510, p. 16 line 14-page 17 line 9);
determine if an asynchronous event occurred based on comparing the plethysmograph and the at least one of the flow waveform and the pressure waveform (see at least Figure 5, p. 16 line 14- page 17 line 9);
classify the asynchronous event (step for such as detection of ineffective effort or reverse trigger, see at least page 7 line 24-13) ; and
provide a classification of the asynchronous event (computer processing, storing, or using such data of the classified event, see at least page 7 line 24-13, p. 12 lines 22-page 13 lines 15).
Regarding claim 8, Nakamura teaches wherein the instructions cause the processor to communicate a recommended adjustment to a user (see at least page 8 lines 9-11 corrective action).
Regarding claim 9, Nakamura teaches wherein the instructions cause the processor to send a signal providing an adjustment to the mechanical ventilator (see at least page 8 lines 9-11 corrective action, mechanical ventilator is outside the claimed structures and is claimed in inference).
Regarding claim 10, Nakamura teaches wherein the instructions cause the processor to determine if the respiratory cycle is valid by determining that no artifact affected the respiratory cycle (result of detection/control of change in PEEP, see at least page 11 line 27-29, page 12 lines 22-29, page 15 lines 10-14m page 17 lines 13-18).
Regarding claim 11, Nakamura teaches wherein the artifact includes one of a sensor disconnection, a change in PEEP, a purge, and a leak (result of detection/control of change in PEEP, see at least page 11 line 27-29, page 12 lines 22-29, page 15 lines 10-14, page 17 lines 13-18).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura, (WO 2021/074747 A1; cited by applicant on the IDS filed 1/29/2024) as applied to claim 1 above, and further in view of Gholami et al. (Gholami, US 2020/0261674) and Mulqueeny et al. (Mulqueeny, US 20120037159).
Regarding claim 2, the limitations are met by Nakamura, except the limitations of wherein the instructions cause the processor to: determine a trapped volume during a cycle; determine if an expiratory time between two cycles is below a threshold time; and compare the expiratory time between the two cycles to previous expiratory times are not directly taught.
Gholami teaches a related system for monitoring patient asynchrony (see at least title and abstract), and teaches processor to: determine a trapped volume during a cycle (see at least [0036], [0046], [0066], [0089]); determine if an expiratory time between two cycles is below a threshold time (see at least [0041]). Mulqueeny teaches a related system for detecting asynchrony (see title and abstract), and teaches that double triggering feature detection is known to include comparing a ration of expiratory times to average time over a duration such as two minutes which reasonably teaches compare the expiratory time between the two cycles to previous expiratory times (see at least [0229]-[00244] “This feature may be considered the ratio of the current expiration time to the mean expiratory time calculated over the preceding two minutes.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using different known rules to combine in identifying known patterns of asynchronous ventilation in a patient in order to improve ventilation control.
Regarding claim 6, the limitations are met by Nakamura in view of Gholami and Mulqueeny, where Gholami teaches wherein the threshold time is within a range of from about 0.5 second to about 2 seconds (see at least [0041], [0088]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using different known rules to combine in identifying known patterns of asynchronous ventilation in a patient in order to improve ventilation control.
Regarding claim 7, the limitations are met by Nakamura in view of Gholami and Mulqueeny, where Mulqueeny teaches wherein the previous expiratory times include expiratory times from at least four previous cycles (see at least [0244] where two minutes implicitly/inherently, or in the alternative, obviously contains at least 4 cycles for a ventilated patient. Such is routine optimization and that average breath rates are greater than 2 per minute). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using different known rules to combine in identifying known patterns of asynchronous ventilation in a patient in order to improve ventilation control.
Conclusion
No prior art rejections have been applied to claims 3-5 as discussed above, In re Steele, MPEP 2173.06:
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.”
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791