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 1-17 are pending.
This action is Non-Final.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 15204392, filed on 7/7/2016.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17242906, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The method steps in the independent claim are first seen in the filing of the instant application. As this application is a CIP, the claims are entitled to an effective filing date of 1/22/2024.
Drawings
The drawings are objected to because Figures 3 and 9 drawing elements do not comply with Rules 1.84 as underlining is improper as used, and lead lines need to be present for each element in place (or in addition for elements S110m S120, and S210). 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: S210. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 use of the terms Bluetooth, and WiFi, which are each a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities: drawing and specification elements are not in agreement, see drawing objection above.
Appropriate correction is required.
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 1-17 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 claimed are rejected for lack of adequate written description for the scope being claimed for two different aspects of the claimed process. The first aspect is to the data analyzed. The disclosure as filed only contains a single type of signal analyzed and not all electrical physiological signals including EEG, ECG, EMG, etc. The only type of signal mentioned is from a PPG sensor, however, the preferred measurement while acceptable is not required to overcome the rejection, but an amendment of replacing all broadly claimed electrophysiological signals with electrophysiological pulse signals would be sufficient in overcoming the first aspect. The second aspect of the rejection is that the pre-trained model is broadly claimed, but applicant only has a single way discussed for generating a model and not all models that could potentially fall under the scope claimed which could include basic regression. The only model generated is based on deep learning, which is adequate to refer to specific algorithms commonly used in such deep learning. As such, the establishing step amended to recite a pre-trained deep learning model would be sufficient in overcoming the second aspect of the rejection. The rationale for the rejection is similarly based on LizardTech rationale. See MPEP 2161.01, 2163, and Federal Register Notice of January 7, 2019. Although such step may be possible, this is not the test for compliance with the written description requirement. Rather, “the test for [written description] sufficiency 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.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In this case, Applicant merely establish that the inventor(s) could have had possession of the claimed subject matter as of the filing date, not that they did have possession at that time. 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.
MPEP 2163:
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 inventor 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. Id.; see also Tronzo v. Biomet, 156 F.3d at 1159, 47 USPQ2d at 1833 (Fed. Cir. 1998)(holding that the disclosure of a species in a parent application did not provide adequate written description support for claims to a genus in a child application where the specification taught against other species).
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. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345, 54 USPQ2d 1915, 1917 (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, 76 USPQ2d 1724, 1732 (Fed. Cir. 2005) (“Whether the flaw in the specification is regarded as a failure to demonstrate that the patentee [inventor] 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, 98 USPQ2d 1711, 1724 (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, 123 USPQ2d 1059, 1061-62 (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”).
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 [inventor] has made a generic invention that achieves the claimed result and do so by showing that the applicant [inventor] 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 the inventor 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. Vasudevan Software, 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. 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 Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008) (internal citation omitted). 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. See also MPEP § 2181, subsection II.B.2(a).
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 8, 12, 14-15 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.
Claim 8 recites the limitation "the subject basic information". There is insufficient antecedent basis for this limitation in the claim.
Claim 12 “the first second segment in sequence” is unclear which renders the claim indefinite. The claimed feature should be either the first or second, a term for both does not exist in the claims.
Claim 14 recites the limitation "the basic personal information from the person in the first group". There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the basic personal information from the person in the second group". There is insufficient antecedent basis for this limitation in the 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 1-17 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:
creating a plurality of first characteristic signals, wherein each first characteristic signal of the plurality of first characteristic signals consists of a first feature segment extracting from the first sample electrophysiological signal, a first derivative of the first feature segment, and a second derivative of the first feature segment in sequence (mathematical concepts, mental processes including pen and paper)
establishing a pre-trained model based on the plurality of first characteristic signals and the plurality of first measured blood pressures (mathematical concepts, mental processes including pen and paper)
establishing a fine-tuned model by retraining the pre-trained model based on the plurality of second sample electrophysiological signals (mathematical concepts, mental processes including pen and paper)
obtaining the blood pressure by inputting a personal electrophysiological signal and a basic personal information from the subject into the fine-tuned model (mathematical concepts, mental processes including pen and paper)
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
providing a plurality of first sample electrophysiological signals and a plurality of first measured blood pressures, respectively, wherein each first sample electrophysiological signal of the plurality of first sample electrophysiological signals corresponds to a person in a first group (data gathering, insignificant pre-solution activities)
providing a plurality of second sample electrophysiological signals and a plurality of second measured blood pressures, respectively, wherein each second sample electrophysiological signal of the plurality of second sample electrophysiological signals corresponds to a person in a second group, wherein, the person in the second group are more similar to the subject in physiological characteristics than the person in the first group (data gathering, insignificant pre-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 regards to step 2A of the analysis. Such limitations related to providing data are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental process, and thus, do not add a meaningful limitation to the method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental process. The method does not contain any computing structure, such that the steps can all be analog/mental processing of the equation from the data gathered which further supports that the claims are directed to a judicial exception without significantly more. The additional limitations recited in the dependent claims are directed to further details of data gathering (further extra solution details), further data/mathematical (A more specific abstraction is still an abstraction), and intended use of the data generated. 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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5-7, 9, 11-12, 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rundo et al. (Rundo, US 2019/0159735) in view of Moloney et al. (Moloney, US 2023/0240380).
Regarding claim 1, Rundo teaches a method of predicting a blood pressure of a subject, comprising:
providing a plurality of first sample electrophysiological signals and a plurality of first measured blood pressures, respectively, wherein each first sample electrophysiological signal of the plurality of first sample electrophysiological signals corresponds to a person in a first group (see at least [0125]);
creating a plurality of first characteristic signals, wherein each first characteristic signal of the plurality of first characteristic signals consists of a first feature segment extracting from the first sample electrophysiological signal, a first derivative of the first feature segment, and a second derivative of the first feature segment in sequence (see at least [0108]);
establishing a pre-trained model based on the plurality of first characteristic signals and the plurality of first measured blood pressures (see at least [0124]);
providing a plurality of second sample electrophysiological signals and a plurality of second measured blood pressures, respectively, wherein each second sample electrophysiological signal of the plurality of second sample electrophysiological signals corresponds to a person in a second group (see at least [0142] retrain, such would include more data as in [0125]);
establishing a fine-tuned model by retraining the pre-trained model based on the plurality of second sample electrophysiological signals (see at least [0142] result of retraining); and
obtaining the blood pressure by inputting a personal electrophysiological signal (see at least [0088]-[0089]);
wherein, the person in the second group are more similar to the subject in physiological characteristics than the person in the first group (result of the retraining, see at least [0142]).
However, the limitation that the obtained blood pressure is related to inputting personal information is not directly taught.
Maloney teaches a related system using different modeling processes including training multiple models based on patient demographics, where the demographics are known to have affects on blood pressure, as well as other personal information to be obtained, where machine learning models can be tailored for different user groups including based on demographics that the subject user falls into, and allow for refined personalization of the model based on such factors (see at least [0107], [0108], [0126]-[0127], [0288] “Similarly, separate rules, algorithms, and/or heuristics, look up tables, or machine learning systems may be generated for different user groups, for example based on demographics and/or patterns of response to feedback actions, so that the proposed feedback actions are better tailored to a particular user falling within one of these groups, even if measured or reported assessments of feedback efficacy are not available from the particular user, or are too sparse to effectively refine the training of a machine learning system or alter the parameters of an algorithm etc., to personalize its response to them.”). 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 obtaining user information in order to retrain original datasets with demographically linked datasets in order to better related user data to a similar dataset of individuals to generate a more accurate result of machine learning data generated such as blood pressure.
Regarding claim 5, the limitations are met by Rundo in view of Moloney, where Rundo teaches wherein the plurality of first sample electrophysiological signals, the plurality of second sample electrophysiological signals, and the personal electrophysiological signals are Photoplethysmography (PPG) signals (see at least title, abstract, [0088]-[0089], [0124]-[0125], [0142]).
Regarding claim 6, the limitations are met by Rundo in view of Moloney, where Rundo teaches further comprising eliminating noise of the plurality of first sample electrophysiological signals before creating the plurality of first characteristic signals (see at least [0125], [0015], [0101], [0140] [0147], [0237]).
Regarding claim 7, the limitations are met by Rundo in view of Moloney, where the combination teaches further comprising retraining the fine-tuned model based on a subject information received from the subject before obtaining the blood pressure (see Rundo [0142], see Moloney at least [0107], [0108], [0126]-[0127], [0288]). 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 obtaining user information in order to retrain original datasets with demographically linked datasets in order to better related user data to a similar dataset of individuals to generate a more accurate result of machine learning data generated such as blood pressure.
Regarding claim 9, the limitations are met by Rundo in view of Moloney, where Rundo teaches wherein a first measured blood pressure of the plurality of first measure blood pressure comprises a systolic blood pressure value and a diastolic blood pressure value (see at least [0125]).
Regarding claim 11, the limitations are met by Rundo in view of Moloney, where Rundo teaches further comprising using the blood pressure to identify gestational hypertension or preeclampsia (intended use, the determination of blood pressures allows for such use by standard determinations in medicine for such diagnosis, see [0088]-[0089]).
Regarding claim 12, the limitations are met by Rundo in view of Moloney, where wherein the fine-tuned model is established based on a plurality of second characteristic signals, wherein each second characteristic signal of the plurality of second characteristic signals consists of a second feature segment extracting from the second sample electrophysiological signal, a first derivative of the second feature segment, and a second derivative of the first second segment in sequence (see at least [0142] retrain, such would include more data as in [0125]).
Regarding claim 14, the limitations are met by Rundo in view of Moloney, where the combination teaches wherein the pre-trained model is established based on the basic personal information from the person in the first group (basic information can be any information, see Rundo [0125], Moloney [0288]). 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 forming demographically linked datasets in order to better related user data to a similar dataset of individuals to generate a more accurate result of machine learning data generated such as blood pressure.
Regarding claim 15, the limitations are met by Rundo in view of Moloney, where the combination teaches wherein the fine-tuned model is established based on the basic personal information from the person in the second group (basic information can be any information, see Rundo [0125], [0142], Moloney [0288]). 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 forming demographically linked datasets in order to better related user data to a similar dataset of individuals to generate a more accurate result of machine learning data generated such as blood pressure.
Regarding claim 16, the limitations are met by Rundo in view of Moloney, where Rundo teaches wherein the first feature segment is two complete continuous waveforms in the first sample electrophysiological signal (see at least [0077], Figures 2-3, segments can include at least two cycles, [0136]).
Regarding claim 17, the limitations are met by Rundo in view of Moloney, where Rundo teaches wherein the personal electrophysiological signal is transferred to a subject characteristic signal before inputting into the fine-tuned model, and the subject characteristic signal consists of a subject feature segment extracting from the personal electrophysiological signal, a first derivative of the subject feature segment, and a second derivative of the subject feature segment in sequence (see at least [0142] retrain, such would include more data as in [0125]).
Claims 2-4, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Rundo et al. (Rundo, US 2019/0159735) in view of Moloney et al. (Moloney, US 2023/0240380) as applied to claim 1 above, and further in view of Au et al. (Au, US 2022/0378377) and Guo (US 2023/0060613).
Regarding claims 2-4, the limitations are met by Rundo in view of Moloney, except the limitations related to the provided data sample sizes provided and obtained are not directly taught in the features:
wherein the plurality of first sample electrophysiological signals is greater than the plurality of second sample electrophysiological signals in quantity.
routine;
wherein the plurality of first sample electrophysiological signals is greater than the plurality of second sample electrophysiological signals in sampling rate; or
wherein the plurality of second sample electrophysiological signals and the personal electrophysiological signal have the same sampling rate.
Au and Guo teach related systems for machine learning related to physiological data (see title, abstract of both and Guo [0141]), and teach that generating models, refining, and running raw data can be completed on the same or similar or different datasets of the raw data which is interpreted as reading that the size of the data can be the same or similar which reasonably teaches the differences in claims 2-4 among the data used to train or operate the machine learning algorithm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select dataset input sizes as desired to allow for the model to perform as desired. In addition, such features amount to routine optimization in model creating and running in terms of determining how the data training an operating can generate the most accurate result.
Regarding claim 13, the limitations are met by Rundo in view of Moloney, where Moloney teaches refining models based on demographic information (see at least [0288]), but does not directly teach wherein the basic personal information comprises gender, age, height, and weight.
Au and Guo teach related systems for machine learning related to physiological data (see title, abstract of both and Guo [0141]), and teach that generating models, refining, and running raw data can be completed on the same or similar or different datasets of the raw data, and that specific patient data can include comprises gender, age, height, and weight (see at least Guo [0005], [0068], [0126], see Au [0204], [0263]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to obtain known demographic information from patient and training patients in order to refine machine learning datasets to more accurately determine patterns between physiological signals and parameter of interest such as blood pressure.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Rundo et al. (Rundo, US 2019/0159735) in view of Moloney et al. (Moloney, US 2023/0240380) as applied to claim 1 above, and further in view of Mulligan et al. (Mulligan, US 2015/0065826).
Regarding claim 8, the limitations are met by Rundo in view of Moloney, the combination teaches the subject basic information (see rejection of claim 1), except the limitation of wherein the subject information comprises a measured blood pressure also is not directly taught.
Mulligan teaches a related system for estimating blood pressure (see title and abstract), and teaches that model refinement can include using the subjects blood pressure measured and fed into the model for refinement (see at least [0092] “In some cases, the estimate of a patient's blood pressure will be based on the analysis of a plurality of measured (or derived) values of a particular physiological parameter (or plurality of parameters). Hence, in some cases, the analysis of the data might be performed on a continuous waveform, either during or after measurement of the waveform with a sensor (or both), and the estimated blood pressure can be updated as measurements continue. Further, the patient's blood pressure can be measured directly (using conventional techniques), and these direct measurements (at block 235) can be fed back into the model to update the model and thereby improve performance of the algorithms in the model (e.g., by refining the weights given to different parameters in terms of estimative or predictive value).”). 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 feeding measured blood pressure back into a model in order to refine weights and allow for more accurate blood pressure estimates to be made by a model.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rundo et al. (Rundo, US 2019/0159735) in view of Moloney et al. (Moloney, US 2023/0240380) as applied to claim 1 above, and further in view of Frank et al. (US 2024/0407735).
Regarding claim 10, the limitations are met by Rundo in view of Moloney, where the combination teaches retraining and demographic samples (see rejection of claim 1), but is silent to wherein the subject is a pregnant woman, and the person in the first group excludes any pregnant woman.
Frank teaches a related system which includes blood pressure level and trend sensing (see [0160]), and teaches that machine learning can be trained or retrained to specifically target data related to pregnant patients (see [0315]), where exclusivity of demographic separation can include binary details and memberships of yes or no and thus such exclusions would be routine expedient in the art to allow for further differences in patterns to be identified. 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 forming demographically linked datasets in order to better relate user data to a similar dataset of individuals including pregnancy to generate a more accurate result of machine learning data generated such as blood pressure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/ Primary Examiner, Art Unit 3791