DETAILED ACTION
Contents
I. Notice of Pre-AIA or AIA Status 5
II. Priority 5
III. Pertinent Prosecution History 6
IV. Reissue Requirements 6
V. Election/Restrictions 7
VI. Claim Status 12
VII. Information Disclosure Statement 13
VIII. Oath/Declaration 13
IX. Specification Objections 15
X. Claim Objections 15
XI. Drawing Objections 16
XII. Claim Interpretation 17
A. Lexicographic Definitions 18
B. 35 U.S.C. § 112 6th Paragraph 18
XIII. Claim Rejections – 35 U.S.C. § 112 19
A. 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph 19
(1) New Matter/Written Description 19
B. 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph 23
XIV. Broadening of Examined Claims 30
A. Broadening of Examined Claims’ Limitations 30
(1) Method Claim 24 30
(2) Apparatus Claim 28 31
XV. Claim Rejections - 35 USC § 251 33
A. Oath/Declaration 33
B. New Matter 33
C. Broadening/Recapture 33
D. Original Patent Requirement 40
XVI. Claim Rejections – 35 U.S.C. § 103 43
A. Claims 1 and 12 are rejected under 35 U.S.C. 103 as obvious over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”)… 43
B. Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Kim et al. (U.S. Publication No. 2008/0009685)(“Kim”). 49
C. Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Stivoric et al. (U.S. Publication No. 2005/0245839)(“Stivoric”). 52
D. Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Ungless et al. (U.S. Publication No. 2006/0235316)(“Ungless”). 53
E. Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Kortelainen (U.S. Publication No. 2010/0249628)(“ Kortelainen”). 55
F. Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Brauers et al. (U.S. Publication No. 2008/0208063)(“Brauers”). 57
G. Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Vu et al. (U.S. Publication No. 2010/0041973)(“Vu”). 59
H. Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Meftah et al. (U.S. Publication No. 2010/0262026)(“Meftah”). 60
I. Claim 13, 16 and 19 are rejected under 35 U.S.C. 103 as obvious over Stivoric et al. (U.S. Publication No. 2005/0245839)(“Stivoric”) in view of Mazzarolo (U.S. Publication No. 2006/0155182) (“Mazzarolo”). 61
J. Claims 14, 17, 18, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Stivoric et al. (U.S. Publication No. 2005/0245839)(“Stivoric”) in view of Mazzarolo (U.S. Publication No. 2006/0155182) (“Mazzarolo”) as applied to claims 13, 16 and 19 above, and in further view of Brauers et al. (U.S. Publication No. 2008/0208063)(“Brauers”). 65
K. Claim 24 is rejected under 35 U.S.C. 103 as obvious over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Kim et al. (U.S. Publication No. 2008/0009685)(“Kim”)… 69
L. Claim 28 is rejected under 35 U.S.C. 103 as obvious over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”). 73
XVII. Prior Art 76
XVIII. Conclusion 77
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Applicant filed the instant reissue application 18/220,018 (“‘018 Reissue Application”) on 10 July 2023 for U.S. Application No. 13/401,711 (“‘711 Application”), filed 21 February 2012, now U.S. Patent No. 11,331,197 (“‘197 Patent”), issued 26 April 2022, which is a continuation-in part of PCT Application No. PCT/CN2010/001252 (“‘252 PCT Application”), filed 18 August 2010, and PCT Application No. PCT/CN2009/000947 (“‘947 PCT Application”), filed 18 August 2009. However, in examination of the entirety of both the ‘252 PCT and ‘947 PCT Applications, the Examiner finds insufficient disclosure to any parameters of judgement criteria being stored in a database of body positions.
Thus, the Examiner concludes that for examination purposes: (1) claims 1-12, 24 and 28 of the instant ‘018 Reissue Application have an effective filing data of 21 February 2012, which is the filing date of the ‘711 Application; and (2) claims 13-19, 29 and 30 of the instant ‘018 Reissue Application have an effective filing data of 18 August 2009, which is the filing date of the ‘947 PCT Application.
Pertinent Prosecution History
As set forth supra, Applicant filed the application for the instant ‘018 Reissue Application on 10 July 2023. The Examiner finds that the instant ‘018 Reissue Application included a preliminary amendment (“July 2023 Preliminary Amendment”) to the claims (“July 2023 Claim Amendment”).
Reissue Requirements
For reissue applications filed before September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the law and rules in effect on September 15, 2012. Where specifically designated, these are “pre-AIA ” provisions.
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions.
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which the ‘197 Patent is or was involved. These proceedings would include interferences, reissues, reexaminations, post-grant proceedings and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
The Examiner notes that Amendment practice for Reissue Applications is NOT the same as for non-provisional applications. See MPEP §§ 1413 and 1453. Reissue application amendments must comply with 37 CFR 1.173, while non-provisional application amendments must comply with 37 CFR 1.121. Particularly,
Manner of making amendments under 37 CFR 1.173:
All markings (underlining and bracketing) are made relative to the original patent text, 37 CFR 1.173(g) (and not relative to the prior amendment).
For amendments to the abstract, specification and claims, the deleted matter must be enclosed in brackets, and the added matter must be underlined. See 37 CFR 1.173(d).
For amendments to the drawings, any changes to a patent drawing must be submitted as a replacement sheet of drawings which shall be an attachment to the amendment document. Any replacement sheet of drawings must be in compliance with § 1.84 and shall include all of the figures appearing on the original version of the sheet, even if only one figure is amended. Amended figures must be identified as "Amended," and any added figure must be identified as "New." In the event that a figure is canceled, the figure must be surrounded by brackets and identified as "Canceled." All changes to the drawing(s) shall be explained, in detail, beginning on a separate sheet accompanying the papers including the amendment to the drawings. See 37 CFR 1.173(d)(3).
The Examiner further notes that all amendments to the instant ‘018 Reissue Application must comply with 37 CFR 1.173(b)-(g).
Election/Restrictions
Applicable rules and regulations:
CFR 1.176 states (in pertinent parts):
(b) Restriction between subject matter of the original patent claims and previously unclaimed subject matter may be required (restriction involving only subject matter of the original patent claims will not be required). If restriction is required, the subject matter of the original patent claims will be held to be constructively elected unless a disclaimer of all the patent claims is filed in the reissue application, which disclaimer cannot be withdrawn by applicant.
[42 FR 5595, Jan. 28, 1977; revised, 65 FR 54604, Sept. 8, 2000, effective Nov. 7, 2000].
MPEP § 1450 states (in pertinent parts):
37 CFR 1.176(b) permits the examiner to require restriction in a reissue application between claims newly added in a reissue application and the original patent claims, where the added claims are directed to an invention which is separate and distinct from the invention(s) defined by the original patent claims. The criteria for making a restriction requirement in a reissue application between the newly added claims and the original claims are the same as that applied in a non-reissue application. See MPEP §§ 806 through 806.05(i). The authority to make a "restriction" requirement under 37 CFR 1.176(b) extends to and includes the authority to make an election of species.
Where a restriction requirement is made by the examiner, the original patent claims will be held to be constructively elected (except for the limited situation where a disclaimer is filed as discussed in the next paragraph). Thus, the examiner will issue an Office action in the reissue application (1) providing notification of the restriction requirement, (2) holding the added claims to be constructively non-elected and withdrawn from consideration, (3) treating the original patent claims on the merits, and (4) informing applicant that if the original claims are found allowable, and a divisional application has been filed for the non-elected claims, further action in the application will be suspended, pending resolution of the divisional application.
If a disclaimer of all the original patent claims is filed in the reissue application containing newly added claims that are separate and distinct from the original patent claims, only the newly added claims will be present for examination. In this situation, the examiner's Office action will treat the newly added claims in the reissue application on the merits. The disclaimer of all the original patent claims must be filed in the reissue application before the issuance of the examiner's Office action containing the restriction requirement, in order for the newly added claims to be treated on the merits. Once the examiner has issued the Office action providing notification of the restriction requirement and treating the patent claims on the merits, it is too late to obtain an examination on the added claims in the reissue application by filing a disclaimer of all the original patent claims, If reissue applicant wishes to have the newly added claims be treated on the merits, a divisional reissue application must be filed to obtain examination of the added claims. Reissue applicants should carefully note that once a disclaimer of the patent claims is filed, it cannot be withdrawn. It does not matter whether the reissue application is still pending, or whether the reissue application has been abandoned or issued as a reissue patent. For all these situations 37 CFR 1.176(b) states that the disclaimer cannot be withdrawn; the disclaimer will be given effect. Note that cancellation of all the original patent claims in the reissue application will not be effective as an alternative to disclaiming all the original patent claims, and 37 CFR 1.176(b) will not be waived to permit the same. This is because the patent owner can subsequently file a reissue continuation presenting the original patent claims.
Restriction between multiple inventions recited in the newly added claims will be permitted provided the added claims are drawn to several separate and distinct inventions. In such a situation, the original patent claims would be examined in the first reissue application, and applicant is permitted to file a divisional reissue application for each of the several separate and distinct inventions identified in the examiner's restriction requirement.
A situation will sometimes arise where the examiner makes an election of species requirement between the species claimed in the original patent claims and a species of claims added in the reissue application. (The filing of a reissue application to only add species claims that require all the limitations of an issued generic claim would not meet the requirements of 35 U.S.C. 251 - see MPEP § 1402; however, this situation can occur where there is another change to the patent being made, which does correct a 35 U.S.C. 251 "error." ) In such a situation, if (1) the non-elected claims to the added species depend from (or otherwise include all limitations of) a generic claim which embraces all species claims, and (2) the generic claim is found allowable, then the non- elected claims of the added species must be rejoined with the elected claims of the original patent. See MPEP § 821.04(a).
MPEP 1450.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12 and 24, drawn to a method for detecting a non-posture physiological function and or posture status of a user.
II. Claims 13, 14, 16-19, 29 and 30, drawn to an object for detecting a non-posture physiological function and or posture status of a user.
III. Claims 21-23, 26 and 27, drawn to an object for detecting a sensor function and a posture status.
IV. Claim 25, drawn to a method for detecting a non-posture physiological function and or posture status of a user.
V. Claim 28, drawn to an object for detecting a non-posture physiological function and or posture status of a user.
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the method/process as claimed can be: (1) practiced by another materially different apparatus such as either one of the products of Inventions II, III or V.
Inventions I and III are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the method/process as claimed can be practiced by another materially different apparatus such as either one of the products of Inventions II, III or V.
Inventions I and V are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the method/process as claimed can be practiced by another materially different apparatus such as either one of the products of Inventions II, III or IV.
Inventions I and IV are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have a materially different design, mode of operation, function, or effect. Specifically, the Examiner finds that Invention I is actually providing at least two non-posture-posture physiological sensors to determine posture status of a user, whereas Invention IV is simply just providing at least electrodes, with one being a ground electrode, to determine posture status of a user. Furthermore, while the inventions in Group I and IV overlap in some aspects, the Examiner finds them distinct and further do not find any evidence in the record that shows they are obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Since no disclaimer of all the original patent claims 1-20 has been filed before the issuance of this Office action in the instant reissue application, the original patent claims 1-14 and 16-19, and new patent claims 24 and 28-30, will be held to be constructively elected by original presentation for prosecution on the merits, and the newly added claims 21-23 and 25-27 are withdrawn from consideration as being directed to a non-elected inventions. If applicant wishes to have the newly added claims be treated on the merits, a divisional reissue application must be filed to obtain examination of the added claims. Applicant is noted that if a divisional application is subsequently being filed to obtain examination of the non-elected claims, further action in the instant reissue application will be suspended, pending resolution of the divisional application. See CFR 1.176(b) and MPEP § 1450.
Claim Status
The Examiner finds that the claim status in the instant ‘018 Reissue Application is as follows:
Claim(s) 1-14 and 16-19 (Original)
Claim(s) 15 and 20 (Original and Canceled)
Claim(s) 24 and 28-30 (New)
Claim(s) 21-23 and 25-27 (New and Withdrawn)
Thus, the Examiner concludes that claims 1-14, 16-19, 24 and 28-30 are pending in the instant ‘018 Reissue Application. Claims 1-14, 16-19, 24 and 28-30 are examined (“Examined Claims”).
Information Disclosure Statement
The Applicants’ Information Disclosure Statement, filed 10 July 2023 (July 2023 IDS Statement”) has been received and entered into the record. Since the Information Disclosure Statement complies with the provisions of MPEP § 609, the references cited therein have been considered by the Examiner. See attached form PTO-1449.
Oath/Declaration
The Examiner finds that the Declaration filed by Applicant on 10 July 2023 (“July 2023 Oath/Declaration”) is defective because of the following:
The Examiner finds that the July 2023 Oath/Declaration filed by Applicant states,
Patentee believes U.S. Patent No.11,317, 197 to be wholly or partially inoperative or invalid by reasons of the patentee claiming lass than patentee had the right io claim in the patent. Patentee thus needs to broaden the claims by introducing new method claims 24 and 25 and new apparatus claims 21 and 28.
(July 2023 Oath/Declaration; emphasis added). Thus, Applicant asserts that new claims 21-28 are broadening claims. While the July 2023 Oath/Declaration states that the instant ‘018 Reissue Application is a broadening application, the July 2023 Oath/Declaration is defective because the statement does not specify a particular error within the ‘197 Patent as a basis for the instant ‘018 Reissue Application.
First, the July 2023 Oath/Declaration filed with this application is defective because the error which is relied upon to support the reissue application is not an error upon which a reissue can be based. See 37 CFR 1.175and MPEP § 1414.
The Examiner finds that the error upon which the instant reissue is based is addressed partially by the non-elected Groups: (1) III, claims 21-23, 26 and 27; and (2) IV, claim 25, not Groups: (1) I, claims 1-12 and 24; (2) II, claims 3, 14, 16-19, 29 and 30; and (3) V, claims 28, which is constructively elected by original presentation. Thus, the Aug 2022 Oath/Declaration is incorrect because it does not correctly state an error upon which this instant ‘018 Reissue Application is based. The Examiner notes that if there is no correction made in this instant ‘018 Reissue Application and if Applicant files non-elected claims as a divisional application to correct the above note error, then this oath/declaration may be proper. (See MPEP 1451.I)
In addition, a proper error statement must identify a single word, phrase, or expression in the specification or in an original claim in the underlying patent, i.e., the ‘197 Patent, and how it renders the original patent wholly or partly inoperative or invalid. (See MPEP §1414(II)). In addition, the reissue oath or declaration must also identify a claim that the application seeks to broaden in the identification of the error that is relied upon to support the reissue application. (Id.)
Furthermore, the Examiner finds that the July 2023 Oath/Declaration is defective because it indicates that the ‘711Application of the ‘197 Patent was filed under 37 CFR 1.46. The Examiner finds that this is incorrect because the original ‘711 Application was filed 21 February 2012, which is not after 16 September 2012, and there was no mechanism to file the original ‘711 Application under 37 CFR 1.46 at that time.
Thus, Applicant is required to provide a new declaration with: (1) a statement of error with respect to ‘197 Patent, directed to a correction with respect to the elected claims above; (2) identifying “a single word, phrase, or expression” from the ‘197 Patent that was not included therein that rendered the ‘197 Patent invalid or inoperative; (3) identify a claim that the application seeks to broaden in the identification of the error; and (4) without the 37 CFR 1.46 box checked. (See 37 CFR 1.175 and MPEP § 1414).
Specification Objections
The disclosure is objected to because of the following informalities:
In c.1, line 40, the ‘197 Patent disclosure of “For example, ECG is a most…” should read – For example, electrocardiogram (ECG) is a most…–.
In c.26, ll.27-30, the ‘197 Patent provides disclosure to “use of some switch connected to the third electrode will enables to detect the position more accurately, that is, a switch or pressure sensor is connected to the third electrode;.” (Emphasis added). The Examiner finds it unclear to what this phrase is trying to state.
Appropriate correction is required.
Claim Objections
The disclosure is objected to because of the following informalities:
Claim 1 is objected to because of the following informalities: in lines 18-19, “… at least two of P, Q, R, S and T…” should read – … at least two points of P, Q, R, S and T… –; line 11, “ … comprise ECG electrodes …” should read – … comprise electrocardiogram (ECG) electrodes …–; and line 19, “ … on ECG .” should read – … on an ECG …– .
Claim 3 is objected to because of the following informalities: in line 3, “… receives RFID signal …” should read – … receives an RFID signal … – .
Claim 8 is objected to because of the following informalities: in lines 2-3, “… wherein the step for sensing the non-posture physiological function further comprises: …” should read – … wherein the step for sensing the non-posture physiological function of the user further comprises: … – ; and in line 4, “ … when signal from the at least one posture sensor …” should read – … when the signal from the at least one posture sensor …–.
Claim 14 is objected to because of the following informalities: in line 2, “… loosely wearable on user body …” should read – … loosely wearable on the user’s body … – ; and in line 4, “… between user body …” should read – … between the user’s body … – .
Claim 24 is objected to because of the following informalities: in lines 16-17, “… at least two of P, Q, R, S and T…” should read – … at least two points of P, Q, R, S and T… – .
Appropriate correction is required.
Drawing Objections
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: 13 and 14 in Figure 3.
Corrected drawing sheets in compliance with 37 CFR 1.173(b)(3), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.173(b)(1) 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 of an amended drawing should be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be surrounded by brackets and identified as "Canceled," 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 1.173(b)(3). 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.
Claim Interpretation
During examination, claims are given the broadest reasonable interpretation consistent with the specification and limitations in the specification are not read into the claims. See MPEP § 2111, MPEP § 2111.01 and In re Yamamoto et al., 222 USPQ 934 (Fed. Cir. 1984). Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01(I). It is further noted it is improper to import claim limitations from the specification, i.e., a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment. See MPEP § 2111.01(II). Therefore, unless one of the exceptions applies below, Examiners will interpret the limitations of the pending and examined claims using the broadest reasonable interpretation.
Lexicographic Definitions
A first exception to the prohibition of reading limitations from the specification into the claims is when the Applicant for patent has provided a lexicographic definition for the term. (See MPEP § 2111.01(IV)). After careful review of the original specification, the prosecution history, and unless expressly noted otherwise by the Examiner, the Examiner finds that he is unable to locate any lexicographic definitions (either express or implied) with reasonable clarity, deliberateness, and precision. Because the Examiner is unable to locate any lexicographic definitions with reasonable clarity, deliberateness, and precision, the Examiner concludes that Applicant is not his/her own lexicographer. (Id.)
35 U.S.C. § 112 6th Paragraph
A second exception to giving words in the claims their ordinary and customary meaning is when a claimed phrase is interpreted in accordance with 35 U.S.C. § 112 6th paragraph. See MPEP § 2181 et seq.
The Examiner finds that because the Examined Claims do not recite “step,” “means” or a claim term used as a substitution for “means” (i.e. a generic placeholder for “means”), the Examined Claims fail Prong (A) as set forth in MPEP §2181. Because the twenty-four (24) Examined Claims fail Prong (A) as set forth in MPEP §2181 I., the Examiner concludes that all Examined Claims do not invoke 35 U.S.C. §112, 6th paragraph. See also Ex parte Miyazaki, 89 USPQ2d 1207, 1215-16 (B.P.A.I. 2008)(precedential).
Claim Rejections – 35 U.S.C. § 112
35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph
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.
New Matter/Written Description
Claims 1-12, 24 and 28 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The Examiner finds that claims 1 and 24 recite,
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, Sand T of the ECG fiction, and amplitudes of the points P, Q, R, S and T
(July 2023 Claim Amendment at claims 1 and 24; emphasis added). The Examiner finds that recitation to the “step for processing… compris[ing]: finding… amplitudes of the points P, Q, R, S and T is not sufficiently described in the ‘197 Patent. To support the Examiner’s position, the Examiner finds that the ‘197 Patent specifically discloses “those skilled in the art can still find out the points as per the characteristics of R, P, Q, S and T, as well as amplitudes of R, S and T (defined as VR, VS, VT). (‘197 Patent at c.16, ll.3-6; also see c.16, ll.9-28 for further discussion w/r to “eight characteristics” including Amplitudes of VR, VS and VT; and Table 2). From this perspective, the Examiner finds that the ‘197 Patent utilizes the amplitudes of three points (i.e., R, S and T (defined as VR, VS, VT)), and not the amplitudes of P or Q.
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Applicant had possession of a “method” or “object” including “the step for processing the non-posture physiological function compris[ing]: finding out a polarity of at least one point of P, Q, R, Sand T of the ECG fiction, and amplitudes of the points P, Q, R, S and T” as recited.
Claims 2-12 are similarly rejected based on their dependency from independent claim 1.
In addition, the Examiner finds that claim 24 recites,
wherein the judgment criteria is difference between amplitudes of at least two of P, Q, R, S and T on ECG electrodes
(July 2023 Claim Amendment at claim 24; emphasis added). The Examiner finds that the recitation to the difference between amplitudes of points being determined on ECG electrodes is not sufficiently described in the ‘197 Patent. To support the Examiner’s position, the Examiner finds that the points P, Q, R, S and T are on an ECG function. (See Figure 5 of the ‘197 Patent). While one of ordinary skill in the art can recognize that ECG electrodes provide information, the Examiner finds that this information is provided to generate a representative ECG function, and it is ECG function that provides amplitudes that can be compared to determine a difference.
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Applicant had possession of a “method” or “object” including “the judgment criteria [being] difference between amplitudes of at least two of P, Q, R, S and T on ECG electrodes” as recited.
Moreover, the Examiner finds that claim 24 recites,
wherein the non-posture physiological function of the user is used to determine the body position or posture of the user and whether there is external force applied to the user or not.
(July 2023 Claim Amendment at claim 24; emphasis added). The Examiner finds that the recitation to the non-posture physiological function (i.e., the ECG function) determining whether there is external force applied to the user or not is not sufficiently described in the ‘197 Patent. To support the Examiner’s position, the Examiner finds that the ECG function is only utilized to determine the body position or posture of the user. (‘197 Patent at Figures 5-8).
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Applicant had possession of a “method” or “object” including “wherein the non-posture physiological function of the user is used to determine the body position or posture of the user and whether there is external force applied to the user or not” as recited.
Moreover, the Examiner finds that claim 24 recites,
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T
(July 2023 Claim Amendment at claim 24; emphasis added). The Examiner finds that the recitation to the step of processing not including “while reverse connecting at least one ECG electrode to produce inverse polarity” is not sufficiently described in the ‘197 Patent. To support the Examiner’s position, the Examiner finds that analyzing of the polarity and amplitude characteristic of the ECG function to better detect posture status is only done when some electrodes of are reverse connected to produces an inverse phase ECG (‘197 Patent at c.4, ll.46-52; c.13, ll.15-31; c.15, l.41 – c.16, l.55; see Table 2). It is readily apparent that the entire point of the ‘197 Patent was to solve a problem of previous posture status determinations that inherently provided ECG measurement data issues that decrease the accuracy of performing posture status determinations on desired users. (Id. at c.13, ll.15-31; c.16, ll.36-55).
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Applicant had possession of a “method” or “object” including the step for processing without “reverse connecting at least one ECG electrode to produce inverse polarity.”
Moreover, the Examiner finds that claim 28 recites,
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions
(July 2023 Claim Amendment at claim 28; emphasis added). The Examiner finds that the recitation to the step of processing not including “finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG” is not sufficiently described in the ‘197 Patent. To support the Examiner’s position, the Examiner finds that analyzing of the polarity and amplitude characteristic of the ECG function to better detect posture status is only done by finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG. (‘197 Patent at c.4, ll.46-52; c.13, ll.15-31; c.15, l.41 – c.16, l.55; see Table 2). It is readily apparent that the entire point of the ‘197 Patent was to solve a problem of previous posture status determinations that inherently provided ECG measurement data issues that decrease the accuracy of performing posture status determinations on desired users. (Id. at c.13, ll.15-31; c.16, ll.36-55).
Thus, as such, the Examiner concludes that there is insufficient indication in the specification that Applicant had possession of a “method” or “object” including the step for processing without “finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG” is not sufficiently described in the ‘197 Patent. To support the Examiner’s position, the Examiner finds that analyzing of the polarity and amplitude characteristic of the ECG function to better detect posture status is only done by finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG.”
35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph
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 2, 4, 8, 11, 12, 19, 24, 28 and 29 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.
With respect to the limitations of claim 2, the Examiner finds that claim 2 recites the limitations,
wherein the deepness of sleep or consciousness status is deduced by the changing of a noise level of the non-pasture physiological function acquired by the at least two non-posture physiological sensors;…
wherein an increase of noise represents an increase of conciseness or light sleep, while a decrease of noise represents a decrease of consciousness or deep sleep;
wherein the noise is caused by separation…
(July 2023 Claim Amendment at claim 2; emphasis added). It is unclear and indefinite to what the exact relationship is between “a noise level,” “noise” and “the noise” recited in the claims. Further clarification is required to either further differentiate or provide proper antecedent basis for the claim requirements.
With respect to the limitations of claim 4, the Examiner finds that claim 4 recites the limitations,
wherein the parameters of judgment criteria are data acquired by a motion sensor when the user is prompted by a guide to take different postures
(July 2023 Claim Amendment at claim 4; emphasis added). It is unclear and indefinite to what a guide is. The Examiner queries Applicant to whether this is a person, a document, or anything. Further clarification is required to provide the required specificity of what a “guide” actually is.
With respect to the limitations of claim 8, the Examiner finds that claim 8 recites the limitations,
stopping the processing non-posture physiological signal to prevent wrong judgment
(July 2023 Claim Amendment at claim 8; emphasis added). The preceding claim recites the limitation “a signal processor processing the non-posture physiological function to determine….” It is unclear and indefinite to how the processing can be stopped with respect to a “non-posture physiological signal” when the “processing” was performed on “the non-posture physiological function.” (Emphasis added). Further clarification is required to either further differentiate or provide proper antecedent basis for the claim requirements.
With respect to the limitations of claim 19, the Examiner finds that claim 19 recites the limitations,
wherein the other one of the at least two non-posture physiological sensors is…
(July 2023 Claim Amendment at claim 19; emphasis added). The preceding claim recites the limitation “wherein at least one of the at least two non-posture physiological sensors is a temperature sensor….” It is unclear and indefinite to how the claim can recite “the other one” when the claim requirement of “at least two” includes two or more. Further clarification is required to either further differentiate or provide proper antecedent basis for the claim requirements.
In addition, the Examiner finds that claim 24 recites,
wherein the judgment criteria is difference between amplitudes of at least two of P, Q, R, S and T on ECG electrodes wherein the other one of the at least two non-posture physiological sensors is
(July 2023 Claim Amendment at claim 24; emphasis added). It is unclear and indefinite to how the difference being various amplitudes can be determined on ECG electrodes. To support the Examiner’s position, the Examiner finds that the points P, Q, R, S and T are on an ECG function. (See Figure 5 of the ‘197 Patent). While one of ordinary skill in the art can recognize that ECG electrodes provide information, the Examiner finds that this information is provided to generate a representative ECG function, and it is ECG function that provides amplitudes that can be compared to determine a difference. Further clarification is required to what is utilized to determine the difference between the amplitudes of points.
Moreover, the Examiner finds that claim 24 recites,
wherein the non-posture physiological function of the user is used to determine the body position or posture of the user and whether there is external force applied to the user or not.
(July 2023 Claim Amendment at claim 24; emphasis added). It is unclear and indefinite to how the non-posture physiological function (i.e., the ECG function) can determine whether there is external force applied to the user or not when the ‘197 Patent measures external forces via different sensors, and not via the EXCG function. To support the Examiner’s position, the Examiner finds that that the ECG function is only utilized to determine the body position or posture of the user. (‘197 Patent at Figures 5-8). Similarly, from this perspective, it is unclear and indefinite to what exactly an “external force” is. Further clarification is required to either further differentiate or provide proper antecedent basis for the claim requirements.
From this perspective, and in order to expedite prosecution, the Examiner construes an “external force” is something that is happening to a user when the non-posture physiological function is generated and used to determine the body position or posture of the user. The claims will be examined as such.
With respect to the limitations of claim 28, the Examiner finds that claim 28 recites the limitations,
An object… comprising:
at least two non-posture physiological sensors…
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body position
(July 2023 Claim Amendment at claim 28; emphasis added). Claim 28 is indefinite because the claimed structure cannot be reasonably determined. In particular, it is unclear to a person of ordinary skill in the art if Applicant intends claim 28 to be drawn to the structure of the subcombination (i.e. “object”) alone, or alternatively, Applicant intends claim 28 to be drawn to the structure of the “object” in combination with the “a database oof body positions.”
Claim 28 begins: “an object ....” From this evidence, a person of ordinary skill in the art could reasonably interpret claim 28 as being drawn to an “object” alone. In addition, the Examiner finds that the “object” further positively recite at least two non-posture physiological sensors and a signal processor.
However claim 28 recites “a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions.” From this evidence, a person of ordinary skill in the art could reasonably interpret claims 28 as being drawn to an “object” in combination with an “a database of body positions.”
Because a potential infringer of claim 28 would not know if direct infringement required creation or importation (i.e. possession) of the subcombination “object” alone, or if direct infringement required possession of the combination “object” and “a database of body positions,” claim 28 is indefinite under 35 U.S.C. §112 2nd paragraph.
To overcome this particular 35 U.S.C. §112, 2nd paragraph rejection and assuming Applicants’ original specification supports such an amendment under 35 U.S.C. § 112 1st paragraph, the Examiner recommends (by way of example only) that if its Applicants desire to claim only the subcombination “object,” the body of claim 28 must be amended to include (or positively recite) only structure from the claimed object. Alternatively, if its Applicants desire to claim the combination “object” in addition to the “a database of body positions” the preambles of claim 28 must be amended to reflect Applicants’ intent (e.g. claim 18 could be amended to recite --A system comprising--).
With respect to the limitations of claim 29, the Examiner finds that claim 29 recites the limitations,
wherein generation of characteristics of the physiological signal features that, capturing the signal from the posture sensor at the same time: when the signal from the posture sensor is stronger than specific critical value, stopping analyzing physiological signal to prevent wrong judgment.
(July 2023 Claim Amendment at claim 28; emphasis added). It is unclear and indefinite to the metes and bounds of the claim requirements. First, the preceding claim recites “generating posture characteristics from the non-posture physiological signals.” From this perspective, it is unclear and indefinite to whether the “wherein generation of characteristics of the physiological signal features” is the same “generating” step or a different one. Moreover, the Examiner finds it unclear and indefinite to whether the “characteristics” are same as “posture characteristics,” and whether the “physiological signal” is the same as the “non-posture physiological signals.” In addition, the Examiner finds that claim language narrative as incomprehensible. Further clarification is required to either further differentiate or provide proper antecedent basis for the claim requirements. The Examiner finds that the claim 29 narrative seems to be similar to claim 8. Thus, the Claim will be examined as such.
Claim 2 recites the limitation “the changing of a noise level” in lines 5-6; claim 11 recites the limitation “the non-posture physiological sensor” in line 2; claim 12 recites the limitation “the ECG sensors” in line 2; claim 29 recites the limitations: “the signal” in line 3; and “the posture sensor” in lines 3-4; and claim 30 recites the limitation “the posture sensor” in line 2. There is insufficient antecedent basis for these limitations in the claims.
Broadening of Examined Claims
Broadening of Examined Claims’ Limitations
Method Claim 24
As set forth infra, the Examiner further finds that claim 24 enlarges the scope of the patent, i.e., a claim which is greater in scope than each and every claim of the original patent.
Specifically, the Examiner finds that new claim 24 (“RI Claim 24”) of the instant ‘018 Reissue Application, in part, recites,
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;…
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T,
wherein the judgment criteria is difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG electrodes;
(“Broad RI Claim 24 Processing Step Implementation”; July 2023 Claim Amendment, RI Claims 24; emphasis added). The Examiner finds that now patented claim of the ‘197 Patent (“Patent Claim 1”), in part, recites,
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;…
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and
wherein the judgment criteria is difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG;
(“Narrow Patent Claim 1 Processing Step Implementation”; ‘197 Patent, claim 1; emphasis added).
The Examiner finds that the Broad RI Claim 24 Processing Step Implementation is broader than the Narrow Patent Claim 1 Processing Step Implementation. The Examiner finds that these limitations are surrendered.
Specifically, the Examiner finds that Broad RI Claim 24 Processing Step Implementation does not have the requirement of further reverse connecting at least one ECG electrode to produce inverse polarity. (“RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production”; emphasis added).
Apparatus Claim 28
As set forth infra, the Examiner further finds that claim 28 enlarges the scope of the patent, i.e., a claim which is greater in scope than each and every claim of the original patent.
Specifically, the Examiner finds that new claim 28 (“RI Claim 28”) of the instant ‘018 Reissue Application, in part, recites,
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;…
(“Broad RI Claim 28 Processing Step Implementation”; July 2023 Claim Amendment, RI Claims 28; emphasis added). The Examiner finds that now patented claim of the ‘197 Patent (“Patent Claim 1”), in part, recites,
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;…
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and
wherein the judgment criteria is difference between amplitudes of at least two of P, Q, R, S and T on ECG electrodes;
(“Narrow Patent Claim 1 Processing Step Implementation”; ‘197 Patent, claim 1; emphasis added).
The Examiner finds that the Broad RI Claim 28 Processing Step Implementation is broader than the Narrow Patent Claim 1 Processing Step Implementation. The Examiner finds that these limitations are surrendered.
First, the Examiner finds that Broad RI Claim 28 Processing Step Implementation does not have the requirement of finding the polarity and amplitudes of points P, Q, R, S and T. (“RI Claim 28 Surrendered Polarity/Amplitude Finding”; emphasis added). Similarly, the Examiner finds that Broad RI Claims28 Processing Step Implementation does not have the requirement of further reverse connecting at least one ECG electrode to produce inverse polarity. (“RI Claim 28 Surrendered Reverse Connecting/Inverse Polarity Production”; emphasis added). Moreover, the Examiner finds that Broad RI Claim 28 Processing Step Implementation does not have the requirement of the judgement criteria being based upon the difference between amplitudes of at least two points of P, Q, R, S and T on an ECG (“RI Claim 28 Surrendered Judgement Criteria Requirement”).
Claim Rejections - 35 USC § 251
Oath/Declaration
Claims 1-14, 16-19, 24 and 28-30 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the declaration is set forth in the discussion above in this Office action. (See § VIII supra).
New Matter
Claims 24 and 28 is rejected under 35 U.S.C. 251 as being based upon new matter added to the patent for which reissue is sought. The added material which is not supported by the prior patent is as follows:
The Examiner finds that there is insufficient indication in the specification that Applicant had possession of at least a method that: (1) finds the amplitudes of the points P, Q, R, S and T; (2) the judgment criteria being difference between amplitudes of at least two of P, Q, R, S and T on ECG electrodes; and (3) the non-posture physiological function of the user being used to determine the body position or posture of the user and whether there is external force applied to the user or not. (See § XIII.A.(1), supra).
Broadening/Recapture
Claims 24 and 28 are rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based. See Greenliant Systems, Inc. et al v. Xicor LLC, 692 F.3d 1261, 103 USPQ2d 1951 (Fed. Cir. 2012); In re Shahram Mostafazadeh and Joseph O. Smith, 643 F.3d 1353, 98 USPQ2d 1639 (Fed. Cir. 2011); North American Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 75 USPQ2d 1545 (Fed. Cir. 2005); Pannu v. Storz Instruments Inc., 258 F.3d 1366, 59 USPQ2d 1597 (Fed. Cir. 2001); Hester Industries, Inc. v. Stein, Inc., 142 F.3d 1472, 46 USPQ2d 1641 (Fed. Cir. 1998); In re Clement, 131 F.3d 1464, 45 USPQ2d 1161 (Fed. Cir. 1997); Ball Corp. v. United States, 729 F.2d 1429, 1436, 221 USPQ 289, 295 (Fed. Cir. 1984). A broadening aspect is present in the reissue which was not present in the application for patent. The record of the application for the patent shows that the broadening aspect (in the reissue) relates to claimed subject matter that applicant previously surrendered during the prosecution of the application. Accordingly, the narrow scope of the claims in the patent was not an error within the meaning of 35 U.S.C. 251, and the broader scope of claim subject matter surrendered in the application for the patent cannot be recaptured by the filing of the present reissue application.
It is noted that the following is the three step test for determining recapture in reissue applications (see: MPEP 1412.02(I)):
"(1) first, we determine whether, and in what respect, the reissue claims are broader in scope than the original patent claims;
(2) next, we determine whether the broader aspects of the reissue claims relate to subject matter surrendered in the original prosecution; and
(3) finally, we determine whether the reissue claims were materially narrowed in other respects, so that the claims may not have been enlarged, and hence avoid the recapture rule."
(Step 1: MPEP 1412.02(A)) In the instant ‘811 Reissue Application, and by way of the July 2023 Claim Amendment, Applicant seeks to broaden RI Claims 24 and 28.
RI Claim 24:
Thus, as set forth above, the Examiner finds that RI Claim 24 is broadened at least by deleting/omitting the patent claim language requiring the Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production. (See § XIV.A.(1), supra).
RI Claim 28:
Thus, as set forth above, the Examiner finds that RI Claim 28 is broadened at least by deleting/omitting the patent claim language requiring the: (1) RI Claim 28 Surrendered Polarity/Amplitude Finding; (2) RI Claim 28 Surrendered Reverse Connecting/Inverse Polarity Production; and (3) RI Claim 28 Surrendered Judgement Criteria Requirement. (See § XIV.A.(2), supra).
(Step 2: MPEP 1412.02(B)) In the instant ‘811 Reissue Application, the broader aspects of RI Claims 24 and 28 (i.e., Broad RI Claim 24 Processing Step Implementation and Broad RI Claim 28 Processing Step Implementation) relate to subject matter surrendered in the ‘711 Application prosecution.
In the ‘711 Application, in a response filed by Applicant on 25 February 2020 (“‘711 Application Feb 2020 Response”), Applicant provided an amendment (“‘771 Application Feb 2020 Claim Amendment”) providing new dependent claim 53. Dependent new claim 53 recited:
wherein the step for generating the non-posture physiological function comprises: finding out position and direction of at least one point of P, Q, R, S and T on electrocardiogram, as well as amplitudes of the points R, S and T, while reverse connecting at least one electrocardiogram electrode at front, back, right and left directions to produce inverse polarity electrocardiogram. (Emphasis added).
The Office provided a Final Office action to Applicant on 03 April 2020 (“‘711 Application April 2020 Final Action”) rejecting independent claims 33 and 37 and objecting to new dependent claim 53 indicating that “reverse connecting the electrodes at front, back, right and left directions to produce inverse polarity ECG” as allowable subject matter. (‘711 Application April 2020 NF Action at 10).
In a response filed by Applicant on 20 Aug 2020 (“‘711 Application Aug 2020 Response”), Applicant provided an amendment (“‘771 Application Aug 2020 Claim Amendment”) amending independent claim 37 to now recite:
wherein the step for processing the non-posture physiological function comprises: finding out position and direction of at least one point of P, Q, R, S and T on electrocardiogram, as well as amplitudes of the points P, Q, R, S and T, while reverse connecting at least one electrocardiogram electrode at front, back, right and left directions to produce inverse polarity electrocardiogram. (Emphasis added).
In this regard, Applicant stated that the entirety of new dependent claim 53 is now recited in independent claim 37 making it allowable. (‘711 Application Aug 2020 Response at 10). Applicant further argued that “claim 37 is also amended to add ‘wherein the judgment criteria are difference between amplitudes of at least two of P, Q, R, S and T on electrocardiogram’” and that the prior art of record1 does not teach this limitation. (Id.)
The Office provided a Non-Final Office action to Applicant on 18 September 2020 (“‘711 Application Sept 2020 NF Action”) stating that “[t]he Applied references alone and in combination do not teach “wherein the step for processing the non-posture physiological function comprises finding out position and direction of at least one point of P, Q, R, S, and R on electrocardiogram, as well as amplitudes of the points P, Q, R, S, and T, while reverse connecting at least one electrocardiogram electrode at front, back, right and left directions to produce inverse polarity electrocardiogram.” (‘711 Application Sept 2020 NF Action at 10).
Various Responses and Office actions were exchanged by Applicant and the Office.
The Office provided a Non-Final Office action to Applicant on 18 August 2021 (“‘711 Application Aug 2021 NF Action”) providing a claim amendment to the above allowable subject matter reciting:
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity;
(‘711 Application Aug 2021 NF Action at 4).
The Office provided a subsequent Notice of Allowance to Applicant on 14 December 2021 (“‘711 Application Dec 2021 NoA Action”), including an Interview Summary (“‘711 Application Dec 2021 Interview Summary”), stating “[t]he Examiner emphasized the claim amendment to claim 37 that was proposed in the Non-final office action dated 08/18/2021. The Applicant's representative accepted the Examiner's proposal in order to put the application in condition for allowance.”
RI Claim 24:
Accordingly, the Examiner concludes that the specific limitation (i.e., RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production) added to claim 37 and argued by Applicant, in response to the ‘711 Application April 2020 Final Action, is thus surrendered subject matter.
RI Claim 28:
Similarly, the Examiner concludes that the specific limitations (i.e., RI Claim 28 Surrendered Polarity/Amplitude Finding, RI Claim 28 Surrendered Reverse Connecting/Inverse Polarity Production, RI Claim 28 Surrendered Judgement Criteria Requirement) added to claim 37 and argued by Applicant, in response to the ‘711 Application April 2020 Final Action, are thus surrendered subject matter.
Step 3: MPEP 1412.02(C)),
RI Claim 24: With respect to the RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production, it is noted that the surrendered subject matter of the RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production has been entirely eliminated from RI Claim 24. If surrendered subject matter has been entirely eliminated from a claim present in the reissue application, then a recapture rejection under 35 U.S.C. 251 is proper and must be made for that claim. (MPEP § 1412.02(C)).
Thus, improper recapture of broadened claimed subject matter surrendered in the application is clearly present in the instant ‘018 Reissue Application. Accordingly, Claim 24 is rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based
To the degree a reviewing body finds that the RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production has not been entirely eliminated from RI Claim 24, the following alternative is provide below.
With respect to the RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production, the Examiner finds that the surrendered subject matter of the RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production has not been entirely eliminated from RI Claim 24 in the instant ‘811 Reissue Application, but rather it has been made less restrictive in the reissue application claims. If the surrendered subject matter limitation is modified but not eliminated, the claims must be materially narrowed relative to the surrendered subject matter such that the surrendered subject matter is not entirely or substantially recaptured. The Examiner finds that this is not the case. The Examiner finds that the RI Claim 24 Surrendered Reverse Connecting/Inverse Polarity Production has not been materially narrowed relative to the surrendered subject matter. However, on the other hand, if the retained portion of the modified limitation is “well known in the prior art,” impermissible recapture has not been avoided. (See MPEP § 1412.02 (I)(C)). In the instant ‘018 Reissue Application, the Examiner finds that the Broad RI Claim 24 Processing Step Implementation are new limitations that have been retained. The Examiner finds that the Broad RI Claims 24 Processing Step Implementation limitation is well known in the prior art.2
Thus, improper recapture of broadened claimed subject matter surrendered in the application is clearly present in the instant ‘018 Reissue Application. Accordingly, Claim 24 is rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based
RI Claim 28: With respect to the RI Claim 28 Surrendered Polarity/Amplitude Finding, RI Claim 28 Surrendered Reverse Connecting/Inverse Polarity Production and RI Claim 28 Surrendered Judgement Criteria Requirement, it is noted that the surrendered subject matter of the RI Claim 28 Surrendered Polarity/Amplitude Finding, RI Claim 28 Surrendered Reverse Connecting/Inverse Polarity Production, RI Claim 28 Surrendered Judgement Criteria Requirement have been entirely eliminated from RI Claim 28. If surrendered subject matter has been entirely eliminated from a claim present in the reissue application, then a recapture rejection under 35 U.S.C. 251 is proper and must be made for that claim. (MPEP § 1412.02(C)).
Thus, improper recapture of broadened claimed subject matter surrendered in the application is clearly present in the instant ‘018 Reissue Application. Accordingly, Claim 28 is rejected under 35 U.S.C. 251 as being an improper recapture of broadened claimed subject matter surrendered in the application for the patent upon which the present reissue is based
Original Patent Requirement
Claims 24 and 28 are rejected under 35 U.S.C. 251 as being in violation of the original patent requirement.
Section 251 requires that reissue is for “the invention disclosed in the original patent.” In order to satisfy the original patent requirement, “[i]t must appear from the face of the instrument that what is covered by the reissue was intended to have been covered and secured by the original.” U.S. Indus. Chems., Inc. v. Carbide & Carbon Chems. Corp., 315 U.S. 668, 676 (1942). Furthermore, “it is not enough that an invention might have been claimed in the original patent because it was suggested or indicated in the specification.” Id. In other words, the original patent “must clearly and unequivocally disclose the newly claimed invention as a separate invention.” Antares Pharma, Inc. v. Medac Pharma Inc., 771 F.3d 1354, 1362 (Fed. Cir. 2014).
In the present case, and with respect to claims 24 and 28, it does not appear from the face of the original patent that Applicant intended to cover a method for detecting a non-posture physiological function and a posture status of a user, and correlating object (i.e., apparatus), without the step for processing the non-posture physiological function including finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG. The Technical Problem first makes clear that the invention is drawn to a method for detecting a non-posture physiological function and a posture status of a user utilizing ECG data to produce an ECG function and utilize the polarity and amplitude characteristic of the ECG function to better detect posture status. (‘197 Patent at c.1, ll.13-23; c.2, l.59 – c.3, l.9). The Examiner finds that the problem is solved by a method, and system, in which some electrodes of are reverse connected to produces an inverse phase ECG in order to properly analyze the polarity and amplitude characteristic of the ECG function to better detect posture status. (Id. at c.4, ll.46-52; c.13, ll.15-31; c.15, l.41 – c.16, l.55; see Table 2). It is readily apparent that the entire point of the ‘197 Patent was to solve a problem of previous posture status determinations that inherently provided ECG measurement data issues that decrease the accuracy of performing posture status determinations on desired users. (Id. at c.13, ll.15-31; c.16, ll.36-55). The claims as amended during prosecution were always drawn to a method for detecting a non-posture physiological function and a posture status of a user, and correlating object (i.e., apparatus), with the step for processing the non-posture physiological function including finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG. (Id. at c.4, ll.46-52; c.13, ll.15-31; c.15, l.41 – c.16, l.55; see Table 2; see the ‘771 Application Aug 2020 Claim Amendment in the ‘711 Application Aug 2020 Response).
This situation is also somewhat analogous to the recent Federal Circuit decision in Forum US, Inc. v. Flow Valve, LLC, 926 F.3d 1346 (Fed. Cir. 2019). In Forum US, the original patent claims were drawn to a workpiece having a body member and a plurality of arbors (arbors circled):
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Forum US, 926 F.3d at 1348-49. In reissue, patentee broadened the claims to remove the requirement as to arbors. Id. at 1349. The Federal Circuit determined that the new claims did not comply with the original patent requirement of section 251 because the face of the patent did not disclose any arbor-less embodiment, and the abstract, summary of invention, and all disclosed embodiments including arbors. Id. at 1352. The Court concluded that the specification did not clearly and unequivocally disclose an embodiment without arbors, thus the original patent requirement was violated by broadening the claims to no longer require arbors. Id. Similarly, the patent here does not clearly and unequivocally disclose any embodiment that includes a method for detecting a non-posture physiological function and a posture status of a user, and correlating object (i.e., apparatus), without the step for processing the non-posture physiological function including finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and the judgment criteria being difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG. (See § XV.C, supra). Thus, to broaden the claims to permit such embodiments runs afoul of the original patent requirement.
Claim Rejections – 35 U.S.C. § 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 1 and 12 are rejected under 35 U.S.C. 103 as obvious over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”).
With respect to the limitations of claim 1, and
[1] [a] method for detecting a non-posture physiological function and a posture status of a user, the method comprising:
In this regard, the Examiner finds that Akselrod discloses a computerized method and system (i.e., object) for determining a sleeping person’s body position (i.e., posture status) using electrical activity such as ECG signals (i.e., a non-posture physiological signal). (Akselrod at ¶¶ 0255, 0340; see Figures 6, 13).
providing at least two non-posture physiological sensors on an object configured to be in contact with the body of the user directly or indirectly;
the at least two non-posture physiological sensors sensing the non-posture physiological function of the user, and;
In this regard, the Examiner finds that Akselrod discloses the system comprising various ECG leads/electrodes being attached to the body of a user at various positions to detect ECG data. (Id. at ¶¶ 0278; 0357, 0510-0532).
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;
where the at least two non-posture physiological sensors comprise ECG electrodes and wherein the non-posture physiological function is an ECG function sensed by the ECG electrodes
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, while reverse connecting at least one ECG electrode to produce inverse polarity; and
wherein the judgment criteria is difference between amplitudes of at least two [points] of P, Q, R, S and T on [an] ECG
In this regard, the Examiner finds that Akselrod discloses “the steps of the method, apparatus and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.” (Id. at ¶ 0202). In addition, the Examiner finds that Akselrod discloses determining a body position by extracting RRI (R to R peak intervals) and consideration of RWD (R wave duration) and using this information to classify the user's body position. (Id. at ¶¶ 0340-0350; also see ¶ 0527 and Figure 7.) In the consideration of the RWD, Akselrod discloses first looking for the amplitude of the R component as shown in Figure 7, where the amplitude is represented by the middle dotted line drawn from the x-axis to the peak marked by ‘x.”
While Akselrod discloses looking for amplitude relative to the determination of body position, Akselrod is silent to specifically: (1) generating an ECG function from the ECG electrode data; (2) finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T; and (3) determining the posture status of the user by comparing amplitudes and polarity of the ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions.
However, determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics is known in the art. The Examiner finds that Shusterman, for example, teaches a sleep monitoring method that simultaneously records ECG data to create a PBF (i.e., PBFs being a generated ECG function having the ECG points P, Q, R, S and T with polarity and amplitude characteristics; see Shusterman at ¶¶ 0010-0017; also see Figures 4, 5), associated with body movements, that provides a direct correlation between ECG waveform amplitude and body posture. Specifically, Shusterman teaches that “changes in the body position can cause changes in the heart orientation relative to the ECG recording electrodes on the body surface, resulting in varying amplitudes of the ECG S, and T waves, and the segments between P and Q waves, T and P waves, S and T waves” (Id. at ¶ 0075). Thus, constructing and storing templates of body position specific amplitude measurements would allow for later identification of the source of ECG changes (i.e., comparing the newly acquired data with such body-position specific, fine-tuned PBFs allows one to track various dynamics, including body position). (Id. at ¶ 0076). The stored templates of body position specific amplitude is taken to reject the ‘database of body positions’ as claimed. (Id.)
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics as described in Shusterman, in the method and object of Akselrod.
A person of ordinary skill in the art would be motivated to incorporate determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics, since it provides a mechanism to provide accurate classification of body position using acquired data. (Id. at ¶ 0075).
Akselrod and Shusterman discloses the limitations, as set forth above, except for specifically calling for reverse connecting at least one ECG electrode to produce inverse polarity when generating the ECG function from the ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics.
However, reverse connecting at least one ECG electrode to produce inverse polarity when generating the ECG function from the ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics is known in the art. The Examiner finds that Yeo, for example, teaches a system and methods using a multi-electrode module to sense various ECG functions based upon a selection of electrode pairs. (Yeo at Abstract; ¶¶ 0003, 0127-0129; see Figures 7A-7F, 10A-10F13A-13D, 19). Specifically, Yeo teaches an operation unit 1911 providing control signals to a switch unit 1912 in order to select the type of biological signal to be measured. (Id. at ¶¶ 0127-0129). Since, the operation unit 1911 can be used to select a type of biological signal to be measure, the Examiner finds that the control signals from the operation unit 1911 can include electrode selection and polarity of the selected electrodes.
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate reverse connecting at least one ECG electrode to produce inverse polarity when generating the ECG function from the ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics as described in Yeo, in the method and object of Akselrod and Shusterman.
From this perspective, this combination of references satisfies at least rationale E identified by the Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007): “ ‘Obvious to try’ – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.” The elements of the Graham factual inquiry for supporting a finding of obviousness based on this rationale are provided below:
(1) A finding that at the time of the invention, there had been a recognized problem or need of dynamically selecting ECG electrodes, as described in Yeo, in order to generate a specific type of ECG biological signal to be measured
(2) A finding that Yeo provides a finite number of identified, predictable potential solutions of dynamically selecting ECG electrodes by either 1) normal connection of electrodes to generate a normal polarity ECG function; or 2) reverse connection of electrodes to generate an inverse polarity ECG function.
(3) A finding that one of ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success. Here, since Yeo explicitly teaches dynamically selecting ECG electrodes in order to generate a specific type of ECG biological signal to be measured, Yeo teaches that one of ordinary skill in the art could have pursued the known potential solutions (i.e., reverse connection of electrodes to generate an inverse polarity ECG function) with a reasonable expectation of success (i.e., Obvious to try).
From this perspective, the Examiner asserts choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious to one of ordinary skill in the art. That is, as set forth above, one of ordinary skill in the art could have pursued the known potential solutions (i.e., reverse connection of electrodes to generate an inverse polarity ECG function) with a reasonable expectation of success (i.e., Obvious to try).
Thus, the rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
With respect to the limitations of claim 12, and
[12] wherein the ECG sensors are either only two electrodes or only three electrodes
In this regard, the Examiner finds that Akselrod discloses the system comprising various ECG leads/electrodes being attached to the body of a user at various positions to detect ECG data. (Id. at ¶¶ 0278; 0357, 0510-0532). With respect to the electrode leads, Akselrod discloses tables distinguishing three (3) different leads (i.e., Lead I-III). (Id. at ¶¶ 0514, 0517; see Tables 6, 7). In further examination of Figure 14 of Yeo, one of ordinary skill in the art would recognize that three (3) leads would require three (3) electrodes. Thus, in light of Yeo, the Examiner finds that Akselrod discloses the ECG sensors being only three electrodes.
Claims 2 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Kim et al. (U.S. Publication No. 2008/0009685)(“Kim”).
With respect to the limitations of claim 2, and
[2] determining a deepness of sleep or consciousness status from the non-posture physiological function,
wherein the deepness of sleep or consciousness status is deduced by the changing of a noise level of the non-pasture physiological function acquired by the at least two non-posture physiological sensors:
wherein an increase of noise represents an increase of consciousness or light sleep, while a decrease of noise represents a decrease of consciousness or deep sleep;
wherein the noise is caused by separation between one of the at least two non-posture physiological sensors and skin: and
wherein a contact between the body and one of the at least two non-posture physiological sensors is changing constantly in light sleep.
In this regard, the Examiner finds Akselrod discloses identifying signal noise in the ECG signal, and recognizing that the signal noise is due to motion contamination correlated with electrical activity in the EMG signal. (Akselrod at ¶ 0297). With respect to correlating motion noise with deepness of consciousness, Akselrod discloses that the EMG amplitude decreases (i.e., decrease motion) as a person falls asleep; that is decrease in motion noise is directly correlated with decrease in consciousness/deep sleep, and on the contrary, increase in motion noise is directly correlated with increase in consciousness/light sleep or wakefulness. (Id. at ¶¶ 0008-0012). Moreover, the Examiner finds that Akselrod further discloses identifying REM sleep (i.e. deep sleep) by extracting the noise portions of the ECG data. (Id. at ¶ 0297).
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for the noise being caused by separation between one of the at least two non-posture physiological sensors and skin; and wherein a contact between the body and one of the at least two non-posture physiological sensors is changing constantly in light sleep.
However, an ECG physiological signal comprising noise being caused by separation between one of the at least two non-posture physiological sensors and skin: and wherein a contact between the body and one of the at least two non-posture physiological sensors is changing constantly in light sleep is known in the art. The Examiner finds that Kim, for example, teaches a method and system for sensing the sleeping condition of a user in which the noise in an ECG is utilized to track a motion artifact that is attributed to a user tossing and turning in sleep. (Kim at ¶¶ 0031, 0046-0049, 0068-0069). The Examiner finds that Kim further teaches the noise component being based upon the impedance between the skin and electrode and varies based upon the separation between the skin and electrode. (Id. at ¶ 0047).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate the noise being caused by separation between one of the at least two non-posture physiological sensors and skin; and wherein a contact between the body and one of the at least two non-posture physiological sensors is changing constantly in light sleep, as described in Kim, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate the noise being caused by separation between one of the at least two non-posture physiological sensors and skin; and wherein a contact between the body and one of the at least two non-posture physiological sensors is changing constantly in light sleep, since it provides a mechanism to more easily determine the quality of sleep without additional measurement instruments. (Id. at ¶ 0014).
With respect to the limitations of claim 9, and
[9] further comprising: using a wireless communication device for transmitting the posture status or the non-posture physiological function processed by the signal processor to a personal information device, or the personal information device sending the posture status or the non-posture physiological function to an organization at remote end.
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling using a wireless communication device for transmitting the posture status or the non-posture physiological function processed by the signal processor to a personal information device, or the personal information device sending the posture status or the non-posture physiological function to an organization at remote end.
However, using a wireless communication device for transmitting the posture status or the non-posture physiological function processed by the signal processor to a personal information device, or the personal information device sending the posture status or the non-posture physiological function to an organization at remote end is known in the art. As set forth above, Kim teaches a method and system for sensing the sleeping condition of a user in which the noise in an ECG is utilized to track a motion artifact that is attributed to a user tossing and turning in sleep. (Kim at ¶¶ 0031, 0046-0049, 0068-0069). In addition, Kim teaches utilizing a wireless communication device (i.e., Wireless LAN (WLAN); id. at ¶ 0042; and communication interface module 240 using wireless communication network 260; id. at ¶ 0077 also see Figure 2) for transmitting the posture status or the non-posture physiological function processed by the signal processor to a personal information device (i.e., cellular phone 271, or PC 272.)
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate using a wireless communication device for transmitting the posture status or the non-posture physiological function processed by the signal processor to a personal information device, as described in Kim, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate using a wireless communication device for transmitting the posture status or the non-posture physiological function processed by the signal processor to a personal information device, since it provides a mechanism to more easily communicate an urgent quality of sleep determination to interested third parties. (Id. at ¶ 0014).
Claims 3 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Stivoric et al. (U.S. Publication No. 2005/0245839)(“Stivoric”).
With respect to the limitations of claim 3, and
[3] wherein one of the at least two non-posture physiological sensors starts sensing when the signal processor receives RFID signal or tag signal.
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for one of the at least two non-posture physiological sensors starting sensing when the signal processor receives RFID signal or tag signal.
However, one of the at least two non-posture physiological sensors starting sensing when the signal processor receives RFID signal or tag signal is known in the art. The Examiner finds that Stivoric, for example, teaches a monitoring device that utilizes physiological sensors to determine posture conditions of a user in which the processor is powered on to activate the device by RFID. (Stivoric at ¶ 0172).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate one of the at least two non-posture physiological sensors starting sensing when the signal processor receives RFID signal or tag signal, as described in Stivoric, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate one of the at least two non-posture physiological sensors starting sensing when the signal processor receives RFID signal or tag signal, since it provides a mechanism to easily automatically power on the device. (Id.)
Claims 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Ungless et al. (U.S. Publication No. 2006/0235316)(“Ungless”).
With respect to the limitations of claims 4 and 6, and
[4] wherein the database comprises posture characteristics and parameters of judgment criteria,
wherein the parameters of judgment criteria are data acquired by a motion sensor when the user is prompted by a guide to take different postures, and
wherein the motion sensor is one selected from a group consisting: an accelerometer, a gyroscope, a tilt sensor, a fabric capacitance sensor and a video camera.
[6] forming an actigraph using the determined posture status.
In this regard, the Examiner finds Akselrod discloses the parameters of judgement criteria being data acquired from motion sensors (i.e., EMG data; Akselrod at ¶¶ 0099, 0103) when a user is prompted by a guide to take different postures (i.e., first and second body defined positions; id. at ¶¶ 0071, 0374, 0356). In addition, the Examiner finds that Akselrod discloses displaying graphs of changes in body positions as indicated in Figures 35, 36A-C with the data being generated by EMG electrodes. (Id. at ¶ 0523). In addition, the Examiner finds that Akselrod and Shusterman would teach and/or render obvious a memory for storing templates of the parameters of judgement criteria as correlated to different body parts.3
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for the motion sensor to be one selected from a group consisting: an accelerometer, a gyroscope, a tilt sensor, a fabric capacitance sensor and a video camera; and forming/generating an actigraph.
However, a motion sensor being one selected from a group consisting: an accelerometer, a gyroscope, a tilt sensor, a fabric capacitance sensor and a video camera; and forming/generating an actigraph is known in the art. The Examiner finds that Ungless, for example, teaches a monitoring device that utilizes physiological ECG sensors, in conjunction with an accelerometer, to provide cardiac data that may be stored in memory. (Ungless at Abstract; ¶¶ 0008-0011, 0027-0029). In addition, the Examiner finds that Ungless further teaches providing the accelerometer for forming/generating an actigraph measurement. (Id. at ¶¶ 0008, 0029).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate the motion sensor to be one selected from a group consisting: an accelerometer, a gyroscope, a tilt sensor, a fabric capacitance sensor and a video camera; and forming/generating an actigraph, as described in Ungless, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate the motion sensor to be one selected from a group consisting: an accelerometer, a gyroscope, a tilt sensor, a fabric capacitance sensor and a video camera; and forming/generating an actigraph, since it provides a mechanism to allow for the filtering of noise components from the ECG data. (Id. at ¶¶ 0027-0028).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Kortelainen (U.S. Publication No. 2010/0249628)(“ Kortelainen”).
With respect to the limitations of claims 5 and 7, and
[5] further comprising connecting the at least two non-posture physiological sensors in series or parallel; and
[7] wherein the object for arranging the at least two non-posture physiological sensor comprises: clothes, underclothes, coat, bedspread, pillow, stockings, shoes, scarf, kerchief, gloves, apron, belt, carpet, floor map or chair.
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for connecting the at least two non-posture physiological sensors in series or parallel; and the object for arranging the at least two non-posture physiological sensor comprising: clothes, underclothes, coat, bedspread, pillow, stockings, shoes, scarf, kerchief, gloves, apron, belt, carpet, floor map or chair.
However, connecting the at least two non-posture physiological sensors in series or parallel; and the object for arranging the at least two non-posture physiological sensor comprising: clothes, underclothes, coat, bedspread, pillow, stockings, shoes, scarf, kerchief, gloves, apron, belt, carpet, floor map or chair is known in the art. The Examiner finds that Kortelainen, for example, teaches a monitoring device that utilizes physiological sensors to determine posture conditions of a user in which the ECG sensors are connected in series. (Kortelainen at ¶ 0045; see Figure 1). In addition, the Examiner finds that the object in which the sensors can be arranged in can be a seat or wearable application or the like. (Id. at ¶¶ 0014-0016).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate connecting the at least two non-posture physiological sensors in series or parallel; and the object for arranging the at least two non-posture physiological sensor comprising: clothes, underclothes, coat, bedspread, pillow, stockings, shoes, scarf, kerchief, gloves, apron, belt, carpet, floor map or chair, as described in Kortelainen, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate connecting the at least two non-posture physiological sensors in series or parallel; and the object for arranging the at least two non-posture physiological sensor comprising a chair or a wear application, since it provides a mechanism to make ECG monitoring less restrictive, more comfortable and portable. (Id. ¶ 0006).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Brauers et al. (U.S. Publication No. 2008/0208063)(“Brauers”).
With respect to the limitations of claim 8, and
[8] wherein the step for sensing the non-posture physiological function further comprises: capturing a signal from at least one posture sensor at the same time as the at least two non-posture physiological sensors; when signal from the at least one posture sensor is stronger than a specific critical value, stopping the processing non-posture physiological signal to prevent wrong judgment, wherein the at least one posture sensor is an accelerometer, a gyroscope, a fabric capacitance sensor or a video camera.
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for the step for sensing the non-posture physiological function further comprising: capturing a signal from at least one posture sensor at the same time as the at least two non-posture physiological sensors; when signal from the at least one posture sensor is stronger than a specific critical value, stopping the processing non-posture physiological signal to prevent wrong judgment, wherein the at least one posture sensor is an accelerometer, a gyroscope, a fabric capacitance sensor or a video camera.
However, the step for sensing the non-posture physiological function further comprising: capturing a signal from at least one posture sensor at the same time as the at least two non-posture physiological sensors; when signal from the at least one posture sensor is stronger than a specific critical value, stopping the processing non-posture physiological signal to prevent wrong judgment, wherein the at least one posture sensor is an accelerometer, a gyroscope, a fabric capacitance sensor or a video camera is known in the art. The Examiner finds that Brauers, for example, teaches a patient monitoring device that utilizes physiological sensors to determine ECG, EMG, etc. measurements if a force applied and sensed by the sensor system is sufficiently present. (Brauers at Abstract; ¶¶ 0001, 0005-0018, 0026-0036). The Examiner finds that Brauers teaches that if capacitance increases, the body of a patient is present and the system provides an ECG measurement at that location. (Id.) The Examiner finds that “elastance” is the reciprocal/mathematical inverse of “capacitance.” (Compare definitions “capacitance”4 and “elastance”5). From this perspective, the Examiner finds that, as a user ceases to provide a force on the system of Brauers, the elastance would be stronger than a value indicating the force of a user is present, and therefore stop/cease the step of processing of ECG signals in order to prevent wrong a wrong judgement from the electrode ECG sensor. Moreover, the Examiner finds that Brauers teaches the posture sensor being a fabric capacitance sensor. (Id.)
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate the step for sensing the non-posture physiological function to further comprise: capturing a signal from a fabric capacitance sensor at the same time as the at least two non-posture physiological sensors; when signal from the a fabric capacitance sensor is stronger than a specific critical value, stopping the processing non-posture physiological signal to prevent wrong judgment, as described in Brauers, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate the step for sensing the non-posture physiological function to further comprise: capturing a signal from a fabric capacitance sensor at the same time as the at least two non-posture physiological sensors; when signal from the a fabric capacitance sensor is stronger than a specific critical value, stopping the processing non-posture physiological signal to prevent wrong judgment, since it provides a mechanism to provide a reliable technique for monitoring cardio pulmonary performance or the like which is particular suitable for home use. (Id. at Abstract; 0004, 0007).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Vu et al. (U.S. Publication No. 2010/0041973)(“Vu”).
With respect to the limitations of claim 10, and
[10] wherein a capacitor, resistor or an inductor is selectively connected m series or parallel between the at least two non-posture physiological sensors and the signal processor to consider the characteristics of body impedance and signal frequency.
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for a capacitor, resistor or an inductor being selectively connected in series or parallel between the at least two non-posture physiological sensors and the signal processor to consider the characteristics of body impedance and signal frequency.
However, a capacitor, resistor or an inductor being selectively connected in series or parallel between the at least two non-posture physiological sensors and the signal processor to consider the characteristics of body impedance and signal frequency is known in the art. The Examiner finds that Vu, for example, teaches a monitoring device that utilizes physiological sensors to determine a body condition of a user in which a resistor is selectively connected in series between the at least two non-posture physiological sensors and the signal processor to consider the characteristics of body impedance and signal frequency. (Vu at ¶ 0027).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate a resistor being selectively connected in series between the at least two non-posture physiological sensors and the signal processor to consider the characteristics of body impedance and signal frequency, as described in Vu, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate a resistor being selectively connected in series between the at least two non-posture physiological sensors and the signal processor to consider the characteristics of body impedance and signal frequency, since it provides a mechanism to compensate for tissue impedance and provide isolation for the electrode sensor. (Id.)
Claims 11 is rejected under 35 U.S.C. 103 as being unpatentable over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Yeo et al. (U.S. Publication No. 2006/0009691) (“Yeo”) as applied to claims 1 and 12 above, and in further view of Meftah et al. (U.S. Publication No. 2010/0262026)(“Meftah”).
With respect to the limitations of claim 11, and
[11] wherein signals sensed by the non-posture physiological sensor are negative polarity for one posture and are positive polarity for the other posture.
Akselrod, Shusterman and Yeo discloses the limitations, as set forth above, except for specifically calling for the signals sensed by the non-posture physiological sensor being negative polarity for one posture and positive polarity for the other posture.
However, the signals sensed by the non-posture physiological sensor being negative polarity for one posture and positive polarity for the other posture is known in the art. The Examiner finds that Meftah, for example, teaches a method and system for sensing the sleeping condition of a user in which the signals sensed by the non-posture physiological sensor are negative polarity for one posture and positive polarity for the other posture. (Meftah at ¶¶ Abstract; ¶¶ 0026-0027).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate the signals sensed by the non-posture physiological sensor being negative polarity for one posture and positive polarity for the other posture, as described in Meftah, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate the signals sensed by the non-posture physiological sensor being negative polarity for one posture and positive polarity for the other posture, since it provides a mechanism to integrate a calibration process to create and a user specific position data, correlating body position and ECG signals, this way multiple users can be distinguished when there are more than one users being measured simultaneously. (Id. at ¶¶ 0030-0031).
Claim 13, 16 and 19 are rejected under 35 U.S.C. 103 as obvious over Stivoric et al. (U.S. Publication No. 2005/0245839)(“Stivoric”) in view of Mazzarolo (U.S. Publication No. 2006/0155182) (“Mazzarolo”).
With respect to the limitations of claim 13, and
[13] [a]n object for detecting a non-posture physiological function and a posture status of a user, the object comprising:
In this regard, the Examiner finds that Stivoric discloses an object for determining the sleeping position of a user. (Stivoric at Abstract; ¶¶ 0002, 0038-0041, 0045, 0049-0050, 0099, 0100, 0102-0105, 0110-0111, 0118, 0120,0125, 0129, 0136-0138, 0142-0143, 0145, 0147-0148, 0514, 0157, 0160, 0166, 0172-0173, 0175, 0177, 0180-0181, 0185-0187, 0191-0192, 0200, 0206, 0210-0213, 0218-0219, 0235-0238, 0244).
at least two non-posture physiological sensors adapted to contact with the user’s body directly or indirectly;
wherein the at least two non-posture physiological sensors are adapted to sense a non-posture physiological function of the user to generate non-posture physiological signals; and
In this regard, the Examiner finds that Stivoric discloses the system comprising various different non-posture physiological sensors (i.e.. temperature sensors; ECG, proximity sensors, strain sensors, etc. ¶¶ 0002, 0038, 0138, 0142, 0147, 0175, 0218, 0234-0238). The Examiner finds that Stivoric discloses the various sensors being in direct and/or indirect contact with the user’s body and generating respective signals, accordingly. (Id. at ¶¶ 0104, 0120, 0138, 0142, 0147, 0164, 0175).
a signal processor configured to determine different body position or posture of the user by generating posture characteristics from the non-posture physiological signals and referring to a judgement criteria;
wherein at least one of the at least two non-posture physiological sensors is a temperature sensor,
wherein the temperature sensor is placed in the object comprising materials of varying thickness or varying thermal conductivity, such that the temperature sensor placed in the object is adapted to detect non-posture physiological signals for determining body position or posture of the user based on different resistances or heat conduction speed of said materials having said varying thickness or different varying thermal conductivity.
In this regard, the Examiner finds that Stivoric discloses a system comprising a processor that utilizes sophisticated algorithms to generate posture characteristics from signals from the various non-posture physiological signals in order to determine a body position or posture. (Stivoric at ¶¶ 0038, 0040-0041, 0048-0049, 0104, 0120, 0166; 0171; see Figure 17). The Examiner finds that Stivoric discloses utilizing a database having certain parameters calibrated and stored accordingly that provide the processor, and respective algorithms, the parameters required to determine a body position or posture. (Id.; also see ¶¶ 014, 0154, 0164, 0175, 0177, 0180, 0186-0187, 0191-0192, 0206-0216, 0244).
Stivoric discloses the limitations, as set forth above, except for specifically calling for the temperature sensor being placed in the object comprising materials of varying thickness or varying thermal conductivity, such that the temperature sensor placed in the object is adapted to detect non-posture physiological signals for determining body position or posture of the user based on different resistances or heat conduction speed of said materials having said varying thickness or different varying thermal conductivity.
However, a temperature sensor being placed in the object comprising materials of varying thickness or varying thermal conductivity, such that the temperature sensor placed in the object is adapted to detect non-posture physiological signals for determining body position or posture of the user based on different resistances or heat conduction speed of said materials having said varying thickness or different varying thermal conductivity is known in the art. The Examiner finds that Mazzarolo, for example, teaches a system detecting through a garment information relating to physical and/or biomedical parameter in which the position of the temperature sensor, conditional characteristics of the temperature sensor and type of material the temperature sensor is placed in effect how the temperature sensor functions. (Mazzarolo at ¶¶ 0018, 0020-0021). Specifically, Mazzarolo teaches, based upon the parameters above, the temperature sensors may be incorporated into the structure of the material, may be mounted on the surface of the material in physical contact with the user and/or on the opposite (external) surface of the material. (Id. at ¶ 0021).
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate the temperature sensor being placed in the object comprising materials of varying thickness or varying thermal conductivity, such that the temperature sensor placed in the object is adapted to detect non-posture physiological signals for determining body position or posture of the user based on different resistances or heat conduction speed of said materials having said varying thickness or different varying thermal conductivity, as described in Mazzarolo, in the method and object of Stivoric.
A person of ordinary skill in the art would be motivated to incorporate the temperature sensor being placed in the object comprising materials of varying thickness or varying thermal conductivity, such that the temperature sensor placed in the object is adapted to detect non-posture physiological signals for determining body position or posture of the user based on different resistances or heat conduction speed of said materials having said varying thickness or different varying thermal conductivity, since it provides a mechanism to integrate temperature sensors into multiple different materials, thereby increasing the operational diversity and efficiency of non-posture physiological signal determination. (Id. at ¶¶ 0030-0031).
With respect to the limitations of claims 16 and 19, and
[16] wherein at least one of the at least two non-pasture physiological sensors is a switch sensor, a tension sensor or a pressure sensor (claim 16); and
[19] wherein the other one of the at least two non-posture physiological sensors is at least one of body temperature sensor, sweat wetness sensor, heartbeat sensor, plethysmography sensor, body fat analyzer, oxygen saturation sensor, EEG, respiration sensor, EMG, pulse sensor, speaking sensor, blood pressure sensor, blood glucose sensor, breathing sounds, pressure, biochemical compounds, ultrasound, urine sugar, heart sound, or lung sound sensor.
In this regard, the Examiner finds that Stivoric discloses the system comprising various different non-posture physiological sensors (i.e., temperature sensors; ECG, proximity sensors, strain sensors, etc. ¶¶ 0002, 0038, 0138, 0142, 0147, 0175, 0218, 0234-0238; emphasis added ¶¶ 0234-0238).
Claims 14, 17, 18, 29 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Stivoric et al. (U.S. Publication No. 2005/0245839)(“Stivoric”) in view of Mazzarolo (U.S. Publication No. 2006/0155182) (“Mazzarolo”) as applied to claims 13, 16 and 19 above, and in further view of Brauers et al. (U.S. Publication No. 2008/0208063)(“Brauers”).
With respect to the limitations of claims 14, 16-19, 29 and 30, and
[14] wherein the object is loosely wearable on user body and one of the at least two non-pasture physiological sensors does not generate signal when no touch is present between user body and the at least two non-posture physiological sensors (claim 14);
[17] wherein any of the at least two non-posture physiological sensors is an electrode that also functions as a switch or a pressure sensor to sense ECG signal, sweat, EMG signal or body fat sensor (claim 17);
[18] wherein one of the at least two non-posture physiological sensors is coupled with a switch, a tension sensor, a pressure sensor, or a pressure applicator configured on a different or the same object (claim 18);
[29] wherein generation of characteristics of the physiological signal features that, capturing the signal from the posture sensor at the same time: when the signal from the posture sensor is stronger than specific critical value, stopping analyzing physiological signal to prevent wrong judgment (claim 29); and
[30] wherein the posture sensor is accelerometer, gyroscope, fabric capacitance sensor or video camera (claim 30).
In this regard, the Examiner finds that Stivoric discloses an object, being worn by a user (i.e., clothing, diaper, etc.), for determining the sleeping position of a user. (Stivoric at ¶¶ 0002, 0038-0041, 0099-0100). The Examiner finds that the objects, as set forth above, may be worn by a user loosely.
Stivoric and Mazzarolo discloses the limitations, as set forth above, except for specifically calling for, when the object is worn loosely, one of the at least two non-pasture physiological sensors not generating signal when no touch is present between user body and the at least two non-posture physiological sensors; any of the at least two non-posture physiological sensors being an electrode that also functions as a switch or a pressure sensor to sense ECG signal, sweat, EMG signal or body fat sensor; one of the at least two non-posture physiological sensors being coupled with a switch, a tension sensor, a pressure sensor, or a pressure applicator configured on a different or the same object; wherein generation of characteristics of the physiological signal features that, capturing the signal from the posture sensor at the same time: when the signal from the posture sensor is stronger than specific critical value, stopping analyzing physiological signal to prevent wrong judgment; and the posture sensor being accelerometer, gyroscope, fabric capacitance sensor or video camera.
However, when the object is worn loosely, one of the at least two non-posture physiological sensors not generating signal when no touch is present between user body and the at least two non-posture physiological sensors; any of the at least two non-posture physiological sensors being an electrode that also functions as a switch or a pressure sensor to sense ECG signal, sweat, EMG signal or body fat sensor; one of the at least two non-posture physiological sensors being coupled with a switch, a tension sensor, a pressure sensor, or a pressure applicator configured on a different or the same object; wherein generation of characteristics of the physiological signal features that, capturing the signal from the posture sensor at the same time: when the signal from the posture sensor is stronger than specific critical value, stopping analyzing physiological signal to prevent wrong judgment; and the posture sensor being accelerometer, gyroscope, fabric capacitance sensor or video camera is known in the art. The Examiner finds that Brauers, for example, teaches a patient monitoring device that utilizes physiological sensors to determine ECG, EMG, etc. measurements if a force applied and sensed by the sensor system is sufficiently present. (Brauers at Abstract; ¶¶ 0001, 0005-0018, 0026-0036). The Examiner find that Brauers teaches a posture sensor, detecting the force applied to the object, being a fabric capacitance sensor and coupled to the electrodes for sensing ECG signals. (Id.) The Examiner finds that Brauers teaches that if capacitance increases, the body of a patient is present and the system provides an ECG measurement at that location. (Id.) The Examiner finds that “elastance” is the reciprocal/mathematical inverse of “capacitance.” (Compare definitions “capacitance”6 and “elastance”7). From this perspective, the Examiner finds that, as a user ceases to provide a force on the system of Brauers, the elastance would be stronger than a value indicating the force of a user is present, and therefore stop/cease the step of processing of ECG signals in order to prevent wrong a wrong judgement from the electrode ECG sensor.
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate t when the object is worn loosely, one of the at least two non-pasture physiological sensors not generating signal when no touch is present between user body and the at least two non-posture physiological sensors; any of the at least two non-posture physiological sensors being an electrode that also functions as a pressure sensor to sense ECG signal; one of the at least two non-posture physiological sensors being coupled with a pressure sensor configured on the same object; wherein generation of characteristics of the physiological signal features that, capturing the signal from the posture sensor at the same time: when the signal from the posture sensor is stronger than specific critical value, stopping analyzing physiological signal to prevent wrong judgment; and the posture sensor being a fabric capacitance sensor, as described in Brauers, in the method and object of Akselrod, Shusterman and Yeo.
A person of ordinary skill in the art would be motivated to incorporate, when the object is worn loosely, one of the at least two non-pasture physiological sensors not generating signal when no touch is present between user body and the at least two non-posture physiological sensors; any of the at least two non-posture physiological sensors being an electrode that also functions as a pressure sensor to sense ECG signal; one of the at least two non-posture physiological sensors being coupled with a pressure sensor configured on the same object; wherein generation of characteristics of the physiological signal features that, capturing the signal from the posture sensor at the same time: when the signal from the posture sensor is stronger than specific critical value, stopping analyzing physiological signal to prevent wrong judgment; and the posture sensor being a fabric capacitance sensor, since it provides a mechanism to provide a reliable technique for monitoring cardio pulmonary performance or the like which is particular suitable for home use. (Id. at Abstract; 0004, 0007).
Claim 24 is rejected under 35 U.S.C. 103 as obvious over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”) and Kim et al. (U.S. Publication No. 2008/0009685)(“Kim”).
With respect to the limitations of claim 24, and
[24] [a] method for detecting a non-posture physiological function and a posture status of a user, the method comprising:
In this regard, the Examiner finds that Akselrod discloses a computerized method and system (i.e., object) for determining a sleeping person’s body position (i.e., posture status) using electrical activity such as ECG signals (i.e., a non-posture physiological signal). (Akselrod at ¶¶ 0255, 0340; see Figures 6, 13).
providing at least two non-posture physiological sensors on an object configured to be in contact with the body of the user directly or indirectly;
the at least two non-posture physiological sensors sensing the non-posture physiological function of the user, and;
In this regard, the Examiner finds that Akselrod discloses the system comprising various ECG leads/electrodes being attached to the body of a user at various positions to detect ECG data. (Id. at ¶¶ 0278; 0357, 0510-0532).
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;
where the at least two non-posture physiological sensors comprise ECG electrodes and wherein the non-posture physiological function is an ECG function sensed by the ECG electrodes;
wherein the step for processing the non-posture physiological function comprises: finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T, wherein the judgment criteria is difference between amplitudes of at least two [points] of P, Q, R, S and T on ECG electrodes; and
In this regard, the Examiner finds that Akselrod discloses “the steps of the method, apparatus and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.” (Id. at ¶ 0202). In addition, the Examiner finds that Akselrod discloses determining a body position by extracting RRI (R to R peak intervals) and consideration of RWD (R wave duration) and using this information to classify the user's body position. (Id. at ¶¶ 0340-0350; also see ¶ 0527 and Figure 7.) In the consideration of the RWD, Akselrod discloses first looking for the amplitude of the R component as shown in Figure 7, where the amplitude is represented by the middle dotted line drawn from the x-axis to the peak marked by ‘x.”
While Akselrod discloses looking for amplitude relative to the determination of body position, Akselrod is silent to specifically: (1) generating an ECG function from the ECG electrode data; (2) finding out a polarity of at least one point of P, Q, R, S and T of the ECG function, and amplitudes of the points P, Q, R, S and T; and (3) determining the posture status of the user by comparing amplitudes and polarity of the ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions.
However, determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics is known in the art. The Examiner finds that Shusterman, for example, teaches a sleep monitoring method that simultaneously records ECG data to create a PBF (i.e., PBFs being a generated ECG function having the ECG points P, Q, R, S and T with polarity and amplitude characteristics; see Shusterman at ¶¶ 0010-0017; also see Figures 4, 5) and body moments a direct correlation between ECG waveform amplitude and body posture. Specifically, Shusterman teaches that “changes in the body position can cause changes in the heart orientation relative to the ECG recording electrodes on the body surface, resulting in varying amplitudes of the ECG S, and T waves, and the segments between P and Q waves, T and P waves, S and T waves” (Id. at ¶ 0075). Thus, constructing and storing templates of body position specific amplitude measurements would allow for later identification of the source of ECG changes (i.e., comparing the newly acquired data with such body-position specific, fine-tuned PBFs allows one to track various dynamics, including body position). (Id. at ¶ 0076). The stored templates of body position specific amplitude is taken to reject the ‘database of body positions’ as claimed. (Id.)
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics as described in Shusterman, in the method and object of Akselrod.
A person of ordinary skill in the art would be motivated to incorporate determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics, since it provides a mechanism to provide accurate classification of body position using acquired data. (Id. at ¶ 0075).
wherein the non-posture physiological function of the user is used to determine the body position or posture of the user and whether there is external force applied to the user or not.
As set forth above, the Examiner this claim requirement indefinite. From this perspective, the Examiner construes an “external force” is something that is happening to a user when the non-posture physiological function is generated and used to determine the body position or posture of the user.
Akselrod and Shusterman discloses the limitations, as set forth above, except for specifically calling for the non-posture physiological function of the user being used to determine the body position or posture of the user and whether there is external force applied to the user or not.
However, the non-posture physiological function of the user being used to determine the body position or posture of the user and whether there is external force applied to the user or not is known in the art. The Examiner finds that Kim, from example, a method and system for sensing the sleeping condition of a user in which the noise in an ECG is utilized to track a motion artifact that is attributed to a user tossing and turning in sleep. (Kim at ¶¶ 0031, 0046-0049, 0068-0069). The Examiner finds that the “motion artifact” (i.e., noise) is present in the physiological signal graph and can be sensed by processing the physiological signal to determine whether an “external force” (i.e., frequency of awakening) is happening to the user.
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate the non-posture physiological function of the user being used to determine the body position or posture of the user and whether there is external force applied to the user or not, as described in Kim, in the method and object of Akselrod and Shusterman.
A person of ordinary skill in the art would be motivated to incorporate the non-posture physiological function of the user being used to determine the body position or posture of the user and whether there is external force applied to the user or not, since it provides a mechanism to more easily determine the quality of sleep without additional measurement instruments. (Id. at ¶ 0014).
Claim 28 is rejected under 35 U.S.C. 103 as obvious over Akselrod et al. (U.S. Publication No. 2006/0235315) (“Akselrod”) in view of Shusterman (U.S. Publication No. 2011/0004110) (“Shusterman”).
With respect to the limitations of claim 28, and
[28] [a]n object for detecting a non-posture physiological function and a posture status of a user, the object comprising:
In this regard, the Examiner finds that Akselrod discloses a computerized method and system (i.e., object) for determining a sleeping person’s body position (i.e., posture status) using electrical activity such as ECG signals (i.e., a non-posture physiological signal). (Akselrod at ¶¶ 0255, 0340; see Figures 6, 13).
at least two non-posture physiological sensors sensing the non-posture physiological function of the user, [and];
In this regard, the Examiner finds that Akselrod discloses the system comprising various ECG leads/electrodes being attached to the body of a user at various positions to detect ECG data. (Id. at ¶¶ 0278; 0357, 0510-0532).
a signal processor processing the non-posture physiological function to determine the posture status of the user by comparing amplitudes and polarity of the non-posture physiological function with posture characteristics and parameters of judgment criteria stored in a database of body positions;
where the at least two non-posture physiological sensors comprise two ECG electrodes and wherein the non-posture physiological function is an ECG function sensed by the ECG electrodes.
In this regard, the Examiner finds that Akselrod discloses “the steps of the method, apparatus and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.” (Id. at ¶ 0202). In addition, the Examiner finds that Akselrod discloses determining a body position by extracting RRI (R to R peak intervals) and consideration of RWD (R wave duration) and using this information to classify the user's body position. (Id. at ¶¶ 0340-0350; also see ¶ 0527 and Figure 7.) In the consideration of the RWD, Akselrod discloses first looking for the amplitude of the R component as shown in Figure 7, where the amplitude is represented by the middle dotted line drawn from the x-axis to the peak marked by ‘x.”
While Akselrod discloses looking for amplitude relative to the determination of body position, Akselrod is silent to specifically: (1) generating an ECG function from the ECG electrode data; and (2) determining the posture status of the user by comparing amplitudes and polarity of the ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions.
However, determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics is known in the art. The Examiner finds that Shusterman, for example, teaches a sleep monitoring method that simultaneously records ECG data to create a PBF (i.e., PBFs being a generated ECG function having the ECG points P, Q, R, S and T with polarity and amplitude characteristics; see Shusterman at ¶¶ 0010-0017; also see Figures 4, 5) and body moments a direct correlation between ECG waveform amplitude and body posture. Specifically, Shusterman teaches that “changes in the body position can cause changes in the heart orientation relative to the ECG recording electrodes on the body surface, resulting in varying amplitudes of the ECG S, and T waves, and the segments between P and Q waves, T and P waves, S and T waves” (Id. at ¶ 0075). Thus, constructing and storing templates of body position specific amplitude measurements would allow for later identification of the source of ECG changes (i.e., comparing the newly acquired data with such body-position specific, fine-tuned PBFs allows one to track various dynamics, including body position). (Id. at ¶ 0076). The stored templates of body position specific amplitude is taken to reject the ‘database of body positions’ as claimed. (Id.)
The Examiner finds that it would have been obvious to one of ordinary skill in the art at the time of the invention was made to incorporate determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics as described in Shusterman, in the method and object of Akselrod.
A person of ordinary skill in the art would be motivated to incorporate determining the posture status of the user by comparing amplitudes and polarity of an ECG function with posture characteristics and parameters of judgment criteria stored in a database of body positions with the ECG function being generated from ECG electrode data and having points P, Q, R, S and T with polarity and amplitude characteristics, since it provides a mechanism to provide accurate classification of body position using acquired data. (Id. at ¶ 0075).
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
U.S. Publication No. 2005/0256414 to Kettunen et al. (“Kettunen”) is a teaching of utilizing an ECG signal to determine postural change.
Conclusion
Applicant is respectfully reminded that any suggestions or examples of claim language provided by the Examiner are just that—suggestions or examples—and do not constitute a formal requirement mandated by the Examiner. To be especially clear, any suggestion or example provided in this Office Action (or in any future office action) does not constitute a formal requirement mandated by the Examiner.
Should Applicant decide to amend the claims, Applicant is also reminded that—like always—no new matter is allowed. The Examiner therefore leaves it up to Applicant to choose the precise claim language of the amendment in order to ensure that the amended language complies with 35 U.S.C. § 112 1st paragraph.
Independent of the requirements under 35 U.S.C. § 112 1st paragraph, Applicant is also respectfully reminded that when amending a particular claim, all claim terms must have clear support or antecedent basis in the specification. See 37 C.F.R. § 1.75(d)(1) and MPEP § 608.01(o). Should Applicant amend the claims such that the claim language no longer has clear support or antecedent basis in the specification, an objection to the specification may result. Therefore, in these situations where the amended claim language does not have clear support or antecedent basis in the specification and to prevent a subsequent ‘Objection to the Specification’ in the next office action, Applicant is encouraged to either (1) re-evaluate the amendment and change the claim language so the claims do have clear support or antecedent basis or, (2) amend the specification to ensure that the claim language does have clear support or antecedent basis. See again MPEP § 608.01(o) (¶3). Should Applicant choose to amend the specification, Applicant is reminded that—like always—no new matter in the specification is allowed. See 35 U.S.C. § 132(a). If Applicant has any questions on this matter, Applicant is encouraged to contact the Examiner via the telephone number listed below.
Applicant is reminded of the obligation to apprise the Office of any prior or concurrent proceedings in which the ‘197 Patent is or was involved, such as interferences or trials before the Patent Trial and Appeal Board, other reissues, reexaminations, or litigations and the results of such proceedings.
In accordance with MPEP § 1406, the Examiner has reviewed and considered the prior art cited or ‘of record’ in the original prosecution of the ‘197 Patent. Applicant is reminded that a listing of the information cited or ‘of record’ in the original prosecution of the ‘197 Patent need not be resubmitted in this reissue application unless Applicant desires the information to be printed on a patent issuing from this reissue application.
Applicant is further reminded of the continuing obligation under 37 C.F.R. §1.56 to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN J RALIS whose telephone number is (571)272-6227. The examiner can normally be reached on Monday-Friday 8:30am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hetul Patel can be reached on 571-272-4184. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Stephen J. Ralis/Primary Examiner, Art Unit 3992 Conferees:
/Luke S. Wassum/Primary Examiner, Art Unit 3992 /H.B.P/Hetul PatelSupervisory Patent Examiner, Art Unit 3992
SJR
11/10/2025
1 Akselrod et al. (U.S. Patent No. 7,623,912) (“Akselrod”).
2 See Shusterman (U.S. Publication No. 2011/0004110) at ¶¶ 0075-0076).
3 Se § VI.A.(1).(c)-(f) for prima facia support for obviousness.
4 The Authoritative Dictionary of IEEE Standards Terms, 7th Ed., IEEE, Inc., New York, NY, Dec 2000, p.141, capacitance: “(6) The ratio of a conductor’s electrostatic charge to the potential difference between conductors (required to maintain that charge)”;
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6 The Authoritative Dictionary of IEEE Standards Terms, 7th Ed., IEEE, Inc., New York, NY, Dec 2000, p.141, capacitance: “(6) The ratio of a conductor’s electrostatic charge to the potential difference between conductors (required to maintain that charge)”;
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