DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
‘central hardware unit’ and its associated limitations in claim(s) 1-2,16, and 18; and
the recited ‘modules’ and their associated limitations in claim(s) 1-2,16, and 18 (accelerometer-gyroscope, bioimpedance).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eTerminal-disclaimer
Claim(s) 1-8 and 16-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2 and 4-6 of U.S. Patent No. 11672288. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim(s) substantially anticipate(s) the identified claim(s) of this application.
While this application is a divisional of the application of the anticipating ‘288 patent, the basis of restriction set forth in the application for the ‘288 patent (application no. 17003906) would not apply to this application’s instant claim(s) 1-8 and 16-20 rejected under nonstatutory double patenting. Claim(s) 1-8 and 16-20 of this instant application are ‘not consonant’ in scope with any of the non-elected inventions (i.e., groupings of claim(s)) of the 2/10/21 restriction set forth in the ‘906 application (the application of the ‘288 patent). See MPEP § 804.01 which sets forth
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply: …
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
Claim(s) 1-8 and 16-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-6 of U.S. Patent No. 12063993. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim(s) substantially anticipate(s) the identified claim(s) of this application.
While this application is a divisional of the application of the anticipating ‘288 patent, the basis of restriction set forth in the application no. 17003906 would not apply to this application’s instant claim(s) 1-8 and 16-20 rejected under nonstatutory double patenting. Claim(s) 1-8 and 16-20 of this application are ‘not consonant’ in scope with any of the non-elected inventions (i.e., groupings of claim(s)) of the 2/10/21 restriction set forth in the ‘906 application (the application of the ‘288 patent). See MPEP § 804.01 which sets forth
The following are situations where the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply: …
(B) The claims of the application under examination and claims of the other application/patent are not consonant with the restriction requirement made by the examiner, since the claims have been changed in material respects from the claims at the time the requirement was made. For example, the divisional application filed includes additional claims not consonant in scope with the original claims subject to restriction in the parent. Symbol Technologies, Inc. v. Opticon, Inc., 935 F.2d 1569, 19 USPQ2d 1241 (Fed. Cir. 1991); Gerber Garment Technology, Inc. v. Lectra Systems, Inc., 916 F.2d 683, 16 USPQ2d 1436 (Fed. Cir. 1990). In order for consonance to exist, the line of demarcation between the independent and distinct inventions identified by the examiner in the requirement for restriction must be maintained. 916 F.2d at 688, 16 USPQ2d at 1440.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claim(s) 7 and 12-20 is/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 pre-AIA the applicant regards as the invention.
For claim(s) 7, the phrase ‘or any skin-contacting garment’ is open-ended in scope and for which this specification does not provide a clear understanding of scope. It is not clear, in the context of the claim(s), what variety and amount of garments are encompassed by such a phrase and thus the claim(s) as a whole is unclear. Examiner suggests amending the claims(s) to remove the phrase.
For claim(s) 12, the body of the claim(s) recites
‘herein the compression garment includes two layers, each layer delivering half the required pressure, wherein the proposed smart compression legging applies pressure identical to that of a waist-high compression stocking’
Which makes the claim(s) unclear in its entirety. It is not clear, in the context of the claim(s), what the term ‘the required pressure’ refers to as no such standard has been defined by the claim(s). It is not clear, in the context of the claim(s), what the term ‘that’ refers to. Such a lack of clarity necessarily affects the applicability of any cited reference — further determination of any applicable prior art will be made upon resolution of the identified issues.
Claim(s) 13-15 is/are rejected due to its/their dependence on claim(s) 12.
There are two claims numbered as claim(s) 16 and, as such, it is not clear whether there were intended to be 21 claim(s) total or one of the two claim(s) 16 should not have been included. The scope of claim(s) 16 is unclear.
Claim(s) 17-20 are rejected due to their dependence on claim(s) 16.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-4, 8-13, and 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Houmanfar (US 20150272482 A1).
For claim(s) 1 and 16, Houmanfar teaches A system for detection of a human disease, [entire disclosure – see at least abstract1]
wherein the system comprises:
a compression garment, [102] the compression garment comprising a wearable sensor network [104 106 108 110] and an application; [firmware/software of 108-110]
the wearable sensor network comprising a plurality of electrodes, [106]
wherein four electrodes of the plurality of electrodes are configured to be alternately activated in at least two different body portions of a user, [switching operation of ¶¶137-142; more broadly, use of multiplexer as detailed throughout ¶¶130-200 (more specific citations) below constitute(s), under BRI, a form of ‘alternate’ activation via sequential acquisition of signals]
wherein the four electrodes are configured to be activated in a configuration sequence consisting of two current-injecting electrodes and two voltage-sensing electrodes a first current injecting electrode, a first voltage sensing electrode, a second voltage sensing electrode, and a second current injecting electrode, respectively; [¶84 ¶175]
and the wearable sensor network comprising a multiplexor configured to sequentially alternate which two electrodes of the four electrodes are activated as the voltage-sensing electrodes, enabling a data collection and a data analysis from a plurality of different locations of the at least two different body portions of the user, [see esp. ¶¶175-180 et seq.; see also bioimpedance and skin impedance analysis via multiplexors including for various tetrapolar electrode configurations of electrodes 106a-n (a form of sequentially alternating of pairs of current and voltage electrodes) per at least ¶¶136-146 (some later detail in ¶¶150-157 as well) — including for leg analysis per ¶¶110-111 and Fig. 2B]
the collected data comprising bio-impedance measurements of each location of the plurality of different locations of the at least two different body portions of the user, [bioimpedance as detailed throughout ¶¶136-146, ¶¶175-180]
and each location of the plurality of different locations of the at least two different body portions of the user positioned between the two voltage-sensing electrodes, [most explicitly ¶198; see also alignment per ¶¶99-103 constitutes location data collection; see also ¶¶156-157]
wherein the wearable sensor network further comprises a central hardware unit, [modules 104 in Fig. 1; modules 302, 304, 308, and 330 in Fig. 3; “central feature” most specifically discussed in ¶130]
wherein at least one accelerometer-gyroscope module [IMU 322 in Fig. 3 per ¶131] and at least one bio-impedance module [314/414 verbatim; more broadly, relevant impedance processing portions of processor/controller and memory depicted in Figs. 1, 3-4, and 7] are connected to the central hardware unit by wiring, textile electronic traces, or conductive connections; [see esp. ¶128 and ¶213, see also ¶71, ¶97, ¶104];
the at least one bio-impedance module configured to collect the bio-impedance measurements from each location of the plurality of different locations of the at least two different body portions of the user positioned between the two voltage-sensing electrodes, [see most summarily ¶¶83-86; more detail in in ¶¶136-146 and ¶¶175-180 per above],
and the at least one accelerometer-gyroscope module [322] configured to collect an additional data set from the user; [IMU data with impedance data per ¶¶156-157]
and the additional data set comprising acceleration and gyroscopic data from the at least two different body portions of the user. [IMU data with impedance data per ¶¶156-157]
For claim(s) 2 and 18, Houmanfar teaches
wherein the central hardware unit is configured to supply power to the at least one accelerometer-gyroscope module and to the at least one bio-impedance module; [battery power per ¶105, ¶114; more general power unit per ¶¶72-75];
to temporarily store the bio-impedance measurements from the bio-impedance module and the additional data set from the at least one accelerometer-gyroscope module; [see ¶73, ¶168 detailing phone alone or with servers/cloud/network for performing storage, transmission, and analysis (at least in ¶74 et seq.); memory detailed in ¶90, ¶126, and ¶165]
and to transmit the bio-impedance measurements and the additional data set to a mobile application, [see ¶73, ¶168 detailing phone alone or with servers/cloud/network for performing storage, transmission, and analysis (at least in ¶74 et seq.); memory detailed in ¶90, ¶126, and ¶165]
wherein the mobile application is configured to receive a third data set from additional modules and to further transmit the bio-impedance measurements, the additional data set, and the third data set to an online server; [per at least ¶66, ¶¶73-78]
wherein the bio-impedance module is configured to collect the bio-impedance measurements by delivering a plurality of current signals to each location positioned between the two voltage-sensing electrodes of the at least two different body portions of the user; [e.g,. see 50 kHz signal at 1 mA per ¶¶176-177 including injection to pairs in ¶177 thus a plurality of currents]
and wherein the bio-impedance module is further configured to analyze the plurality of delivered current signals after the plurality of delivered current signals have passed through a section of tissue at each location positioned between the two voltage-sensing electrodes of the at least two different body portions of the user. [¶¶178-181]
For claim(s) 3 and 16-17, Houmanfar teaches
wherein the electrode configuration includes a circular current injecting band electrode on each end of the compression garment at the distal and proximal end of the garment. [configuration of Fig. 2B shows bands including proximal and distal bands]
For claim 4, Houmanfar teaches The system of claim 3,
wherein the voltage-sensing electrodes lie on the compression garment adjacent to each leg of the user between each pair of current-injecting band electrodes. [Fig(s). 2B]
For claim 8, Houmanfar teaches The system of claim 1,
wherein the wearable sensor network includes an artificial neural network to distinguish between several classes of clinically-relevant human activity selected from the group consisting of sitting, standing, sleeping, and elevating a limb. [¶260 ¶289]
For claim 9, Houmanfar teaches The system of claim 8,
wherein the artificial neural network includes a recurrent neural network configured to detect a context of the human activity, [¶235 ¶260 ¶289]
wherein the recurrent neural network uses 30 individual signals as input, and wherein the 30 individual signals comprise 6 samplings from each of 5 sensors, [Fig(s). 16A throughout ¶¶234-289]
wherein the recurrent neural network classifies across 5 second time point samples from each of the 5 sensors. [Fig(s). 16A throughout ¶¶234-289]
For claim 10, Houmanfar teaches The system of claim 9,
wherein the recurrent neural network is trained and evaluated using open source datasets, wherein the open source datasets include the USC-HAD dataset. [this is a product-by-process claim(s) see MPEP § 2113] [consider at least ¶¶233-235]
For claim(s) 11, Houmanfar fails to teach the neural network configured to detect multiple architectures.
Hefner teaches a system of sensor signal analysis including a neural network that detects multiple architectures including LSTM-RNNs which are trained and evaluated. [¶¶56-60 esp. ¶60]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the neural network of Houmanfar to incorporate the LSTM-RNN of Hefner in order to improve model usefulness and accuracy. As motivated by Hefner ¶53 ¶¶60-63.
For claim 12, Houmanfar teaches The system of claim 1,
wherein the compression garment includes two layers, each layer delivering half the required pressure, wherein the proposed smart compression legging applies pressure identical to that of a waist-high compression stocking. [see § 112b rejection — consider at least Houmanfar Fig(s). 2 and ¶¶110-111]
For claim 13, Houmanfar teaches The system of claim 12,
wherein an interior layer comprises the textile electrodes, [Fig(s). 2A]
wherein the textile electrodes are seamlessly knitted into the compression garment with a circular knitting machine. [this is a product-by-process limitation see MPEP § 2113]
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 5 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houmanfar in view of Leschinsky (US 20180028106 A1).
For claim(s) 5 and 19, Houmanfar fails to teach the electrodes applied to the skin at 15-40 mmHg.
Leschinsky teaches a wearable electrode-based analysis device [abstract] comprising electrodes applied to the skin at a pressure of 15-40 mmHg. [¶47]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the electrodes of Houmanfar to be applied at 15-40 mmHg as taught by Leschinsky in order to ensure proper electrode contact. As motivated by Leschinsky ¶47.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houmanfar in view of Hefner (US 20210298648 A1).
For claim(s) 11, Houmanfar fails to teach the neural network configured to detect multiple architectures.
Hefner teaches a system of sensor signal analysis including a neural network that detects multiple architectures including LSTM-RNNs which are trained and evaluated. [¶¶56-60 esp. ¶60]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the neural network of Houmanfar to incorporate the LSTM-RNN of Hefner in order to improve model usefulness and accuracy. As motivated by Hefner ¶53 ¶¶60-63.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Houmanfar.
For claim(s) 14, Houmanfar fails to teach a zipper on the garment. Examiner takes official notice that zippers are well-known and widely available for fastening garments and as such it would be obvious to incorporate one onto the compression garment of Houmanfar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791