DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/18/2024 and 05/07/2024 are being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of U.S. Patent No. 10,617,355. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 under examination is anticipated by claims 19 of the reference patent. Every limitation in claim 1 is recited in the conflicting reference patent claims, and the differences between the claims are highlighted below by bolding all limitations that differ, underlining additional limitations, and italicizing limitations that will be addressed below.
Instant application
U.S. Patent No. 10,617,355
Claim 1: A garment, wherein the garment is a self-adjusting garment that is configured to be worn by a pregnant human subject during a course of pregnancy and to self-adjust positioning of at least one sensor integrated into the garment during the course of pregnancy; wherein the garment comprises: a securing portion operable to removably secure the garment about an abdomen of a wearer; at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one sensor mount configured to receive and retain a sensor therein; and at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion; wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured around the back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion across (a) an upper portion of the wearer’s abdomen or (b) a lower portion of the wearer’s abdomen, and wherein each of the at least one flexible sensor mount is configured so as to orient a sensor received therein so as to be continuously flush with skin of the wearer when the garment is worn by the wearer and self-adjusts during the course of pregnancy.
Claim 1: A garment,
wherein the garment is a self-adjusting garment that is configured to be worn by a pregnant human subject during a course of pregnancy and to self-adjust positioning of at least one sensor integrated into the garment during the course of pregnancy;
wherein the garment comprises:
a securing portion operable to removably secure the garment about an abdomen of a wearer;
first and second sensor attachment portions pivotably attached to the securing portion, each of the sensor attachment portions including at least one flexible sensor mount configured to receive and retain a sensor therein;
at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of one of the sensor attachment portions;
a first hinge connecting a first end of the securing portion to (a) a first end of the first one of the sensor attachment portions and (b) a first end of the second one of the sensor attachment portions; and
a second hinge connecting a second end of the securing portion to (a) a second end of the first one of the sensor attachment portions and (b) a second end of the second one of the sensor attachment portions;
wherein the securing portion and the first and second sensor attachment portions are configured such that, when the securing portion is secured around a back of a wearer, the first and second sensor attachment portions pivot with respect to the securing portion so as to self-position the at least one sensor attachment portion across (a) an upper portion of the wearer's abdomen or (b) a lower portion of the wearer's abdomen, and
wherein each of the at least one flexible sensor mount of the first and second sensor attachment portions is configured so as to orient a sensor received therein so as to be continuously flush with skin of the wearer when the garment is worn by the wearer and self-adjusts during the course of pregnancy.
Claim 16: A method for positioning at least one sensor so as to be flush with skin on an abdomen of a wearer, the method comprising: providing a garment including: a securing portion operable to removably secure the garment about an abdomen of a wearer; at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one flexible sensor mount configured to receive and retain a sensor therein; at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion; wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured about the back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to extend around (a) an upper portion of the wearer’s abdomen or (b) a lower portion of the wearer’s abdomen, and wherein each of the at least one sensor mount is configured so as to orient a sensor received therein so as to be flush with skin of the wearer when the garment is worn by the wearer; positioning the garment so as to encircle a midsection of the wearer such that the securing portion extends around a back of the wearer and the at least one sensor attachment portion extends around an abdomen of the wearer; securing the securing portion so as to retain the garment encircling the midsection of the wearer, whereby the at least one sensor attachment portion is positioned around one of an upper portion of an abdomen of the wearer and a lower portion of an abdomen of the wearer, and whereby the at least one flexible sensor mount flexes so as to allow the one of the at least one sensor received therein to be positioned flush with skin of the wearer.
Claim 12: A method for positioning at least one sensor so as to be flush with skin on an abdomen of a wearer, the method comprising: providing a garment including: a securing portion operable to removably secure the garment about an abdomen of a wearer;
first and second sensor attachment portions pivotably attached to the securing portion, each of the sensor attachment portions including at least one flexible sensor mount configured to receive and retain a sensor therein;
at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of one of the sensor attachment portions;
a first hinge connecting a first end of the securing portion to (a) a first end of the first one of the sensor attachment portions and (b) a first end of the second one of the sensor attachment portions; and
a second hinge connecting a second end of the securing portion to (a) a second end of the first one of the sensor attachment portions and (b) a second end of the second one of the sensor attachment portions;
wherein the securing portion and the first and second sensor attachment portions are configured such that, when the securing portion is secured around a back of a wearer, the first and second sensor attachment portions pivot with respect to the securing portion so as to self-position the at least one sensor attachment portion across (a) an upper portion of the wearer's abdomen or (b) a lower portion of the wearer's abdomen, and wherein each of the at least one flexible sensor mount of the first and second sensor attachment portions is configured so as to orient a sensor received therein so as to be flush with skin of the wearer when the garment is worn by the wearer; positioning the garment so as to encircle a midsection of the wearer such that the securing portion extends around a back of the wearer and the first and second sensor attachment portions extend around an abdomen of the wearer;
securing the securing portion so as to retain the garment encircling the midsection of the wearer,
whereby the first sensor attachment portion is positioned around an upper portion of an abdomen of the wearer and the second sensor attachment portion is positioned around a lower portion of an abdomen of the wearer, and
whereby the at least one flexible sensor mount flexes so as to allow the one of the at least one sensor received therein to be positioned flush with skin of the wearer.
As shown in the mapping above, claims 1 and 12 of the reference patent includes all the limitations of claims 1 and 16 of the instant application. As can be seen by the bolded text, the examined application claim is either anticipated by, or would have been obvious over, the reference patent claims. The reference patents claims are further narrowing than the instant application and therefore, the reference patent’s claims cover all claimed matter in claim 1 and 16 of the instant application.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,492,707. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-20 under examination are anticipated by claims 1-20 of the reference patent. All of the limitations in claims 1-20 are recited in the conflicting reference patent claims, and the differences between the claims are highlighted below by bolding all limitations that differ, underlining additional limitations, and italicizing limitations that will be addressed below.
Instant application
U.S. Patent No. 10,492,707
Claim 1: A garment, wherein the garment is a self-adjusting garment that is configured to be worn by a pregnant human subject during a course of pregnancy and to self-adjust positioning of at least one sensor integrated into the garment during the course of pregnancy; wherein the garment comprises: a securing portion operable to removably secure the garment about an abdomen of a wearer; at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one sensor mount configured to receive and retain a sensor therein; and at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion; wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured around the back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion across (a) an upper portion of the wearer’s abdomen or (b) a lower portion of the wearer’s abdomen, and wherein each of the at least one flexible sensor mount is configured so as to orient a sensor received therein so as to be continuously flush with skin of the wearer when the garment is worn by the wearer and self-adjusts during the course of pregnancy.
Claim1: A garment, wherein the garment is a self-adjusting garment that is configured to be worn by a pregnant human subject during a course of pregnancy and to self-adjust positioning of at least one sensor integrated into the garment during the course of pregnancy;
wherein the garment comprises: a securing portion operable to removably secure the garment about an abdomen of a wearer; at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one flexible sensor mount configured to receive and retain a sensor therein, wherein the at least one flexible sensor mount comprises: a flexible portion including an elastomeric material and having an opening formed therein, wherein the opening in the elastomeric material is configured to maintain a sensor in a desired location when the garment is worn by the pregnant human subject, and
a rigid portion positioned within the opening of the flexible portion, wherein the rigid portion is configured to receive a sensor; and
at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion; wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured around a back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion across (a) an upper portion of the wearer's abdomen or (b) a lower portion of the wearer's abdomen, and wherein each of the at least one flexible sensor mount is configured so as to orient a sensor received therein so as to be continuously flush with skin of the wearer when the garment is worn by the wearer and self-adjusts during the course of pregnancy.
Claim 16: A method for positioning at least one sensor so as to be flush with skin on an abdomen of a wearer, the method comprising: providing a garment including: a securing portion operable to removably secure the garment about an abdomen of a wearer; at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one flexible sensor mount configured to receive and retain a sensor therein; at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion; wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured about the back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to extend around (a) an upper portion of the wearer’s abdomen or (b) a lower portion of the wearer’s abdomen, and wherein each of the at least one sensor mount is configured so as to orient a sensor received therein so as to be flush with skin of the wearer when the garment is worn by the wearer; positioning the garment so as to encircle a midsection of the wearer such that the securing portion extends around a back of the wearer and the at least one sensor attachment portion extends around an abdomen of the wearer; securing the securing portion so as to retain the garment encircling the midsection of the wearer, whereby the at least one sensor attachment portion is positioned around one of an upper portion of an abdomen of the wearer and a lower portion of an abdomen of the wearer, and whereby the at least one flexible sensor mount flexes so as to allow the one of the at least one sensor received therein to be positioned flush with skin of the wearer.
Claim 14: A method for positioning at least one sensor so as to be flush with skin on an abdomen of a wearer, the method comprising: providing a garment including: a securing portion operable to removably secure the garment about an abdomen of a wearer; at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one flexible sensor mount configured to receive and retain a sensor therein, wherein the at least one flexible sensor mount comprises: a flexible portion including an elastomeric material and having an opening formed therein, wherein the opening in the elastomeric material is configured to maintain a sensor in a desired location when the garment is worn by the pregnant human subject, and
a rigid portion positioned within the opening of the flexible portion, wherein the rigid portion is configured to receive a sensor; at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion;
wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured about a back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to extend around (a) an upper portion of the wearer's abdomen or (b) a lower portion of the wearer's abdomen, and
wherein each of the at least one sensor mount is configured so as to orient a sensor received therein so as to be flush with skin of the wearer when the garment is worn by the wearer;
positioning the garment so as to encircle a midsection of the wearer such that the securing portion extends around the back of the wearer and the at least one sensor attachment portion extends around an abdomen of the wearer;
securing the securing portion so as to retain the garment encircling the midsection of the wearer,
whereby the at least one sensor attachment portion is positioned around one of an upper portion of an abdomen of the wearer and a lower portion of an abdomen of the wearer, and
whereby the at least one flexible sensor mount flexes so as to allow the one of the at least one sensor received therein to be positioned flush with skin of the wearer.
As shown in the mapping above, claims 1 and 14 of the reference patent include all the limitations of claims 1 and 16 of the instant application. As can be seen by the bolded text, the examined application claim is either anticipated by, or would have been obvious over, the reference patent claims. The reference patent claims are narrower in scope than the instant application and therefore, the reference patent’s claims cover all claimed matter in claims 1 and 16 of the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “one sensor mount” in line 9 and “the at least one flexible sensor mount” in line 12. The language lacks consistency and should be amended to either include that both mounts are flexible or to remove the word flexible altogether. As the claim is written it is indefinite because it is unclear if these are the same components. Claims 2-15 are rejected by virtue of dependency on claim 1.
Claims 1 and 16 recite “the back of a wearer’ in lines 15 and 13 respectively, this language lacks antecedent basis and the word “the” should be replaced with “a”. Claims 2-15 are rejected by virtue of dependency on claim 1 and claims 17-20 are rejected by virtue of dependency on claim 16.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-7 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Rood et al. (US 9,579,055 B1) herein referred to as “Rood” in view of Armstrong et al. (US 2017/0262077 A1) herein referred to as “Armstrong”.
Regarding claim 1, Rood discloses a garment (apparatus for measuring biopotential signals comprises a plurality of electrodes embedded or affixed to a wearable worn about the torso of a pregnant subject, Abstract, the wearable 12 may be a belt, strap, shirt bra, gown, undergarment, high-waisted pant, or other garment or garment-like device, Col. 11, lines 3-30, Figure 1),
wherein the garment is a self-adjusting garment that is configured to be worn by a pregnant human subject during a course of pregnancy and to self-adjust positioning of at least one sensor integrated into the garment during the course of pregnancy (the wearable is a tube or stretchable garment that is continuous and seamless and may be donned by sliding over the head or by stepping through, in other embodiments the wearable is a strap or belt that may be adjustably resized and secured by mechanical or electrical closures including but not limited to hook and loop closures, buttons, snaps, buckles, latches, clasps, zippers, twists, hooks, magnets, electromagnets, or any other mechanical closure means known in the art, the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52);
wherein the garment comprises: a securing portion operable to removably secure the garment about an abdomen of a wearer (the wearable 12 is a strap or belt that may be adjustably resized and secured by mechanical or electrical closures including but not limited to hook and loop closures, buttons, snaps, buckles, latches, clasps, zippers, twists, hooks, magnets, electromagnets, or any other mechanical closure means known in the art, Col. 7, lines 40-52);
at least one sensor attachment portion, including at least one sensor mount configured to receive and retain a sensor therein (garment and a plurality of sensors affixed to or embedded in the wearable, Col. 6, line 45 - Col. 7, line 2, sensors are placed in an arrangement around the circumference of the subject’s torso, Col. 7, lines 11-39, Connector ring 35 includes keys 36 , when the electrode is placed inside of the wearable, proximal to the skin surface of the patient, with raised area of the electrode protruding distally through a hole in the wearable, the hole being of diameter larger than the diameter of raised area 37 but smaller than diameter of connector ring 35, then the connector ring 35 is fitted to the electrode on the outside of the wearable to the distal side of the electrode, such that the keys 36 of the connector ring 35 fit to keyholes 34 of the electrode, Col. 11, line 47- Col. 12, line 21);
and at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion (the electrodes or sensors embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 - Col. 8, line 15);
wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured around the back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion across (a) an upper portion of the wearer’s abdomen or (b) a lower portion of the wearer’s abdomen (secured by mechanical or electrical closures including but not limited to hook and loop closures, buttons, snaps, buckles, latches, clasps, zippers, twists, hooks, magnets, electromagnets, or any other mechanical closure means known in the art, Col. 7, lines 40-52, Figure 1, with multiple attachments for electrodes 13 some placed at the upper portion and some at the lower portion of the abdomen, the wearable 12 further comprises electrical pathways 16 which carry the biopotential signals from the electrodes 13 to the transceiver 14, Col. 11, lines 3-30),
and wherein each of the at least one flexible sensor mount is configured so as to orient a sensor received therein so as to be continuously flush with skin of the wearer when the garment is worn by the wearer and self-adjusts during the course of pregnancy (the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52; the electrodes or sensors embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 Col. 8, line 15; Each of these effects may have negative consequences on the proper positioning of the electrode 47 and the gentle compression of the electrode 47 onto the surface of the skin as exerted by the material of the wearable 48, by contrast, in Figure 4a, the forces 44 and 45 that stretch the material of the wearable 43 do not pull apart the wearable at the site of the electrode 42 thanks to the augmentation of the material of the wearable by the stiffening ring 42, Col. 12, lines 22-50).
However Rood does not specifically disclose at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one sensor mount configured to receive and retain a sensor therein; the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion.
Armstrong discloses a garment (watch embodiment, Figure 58) comprising: at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one sensor mount configured to receive and retain a sensor therein (three mutually perpendicular encoders (sensors) 124, 126, 128 mounted on the upper surface of lower member 20 for sensing rotation, Paragraph [0117]; Figure 6 depicts a rocker style sensor assembly 158 includes a T-shaped member and having a vertical center arm 160 engaged within a groove in the underside of collet 16, and the T-shaped member being pivotally supported at a lower center so that the two oppositely disposed lateral arms 162 may be pivotally moved up and down dependent upon the direction of rotation of the collet to interact with a direction indicating negative sensor 164 and a direction indicating positive sensor 166 shown mounted on lower member 20, Paragraph [0122]); the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion (Figure 6 depicts a rocker style sensor assembly 158 includes a T-shaped member and having a vertical center arm 160 engaged within a groove in the underside of collet 16, and the T-shaped member being pivotally supported at a lower center so that the two oppositely disposed lateral arms 162 may be pivotally moved up and down dependent upon the direction of rotation of the collet to interact with a direction indicating negative sensor 164 and a direction indicating positive sensor 166 shown mounted on lower member 20, Paragraph [0122]; Figure 23 shows T-bone actuator 345 mounted to plate 322 by mounting structure 352 and pivoting (shown actuating sensor in dashed lines) about fulcrum 334 shown as a living hinge, Paragraph [0166]).
Thus, it would have been obvious to a person having ordinary skill in the art to mount the sensor in a pivoting fashion as taught by Armstrong in the garment of Rood to allow for rotation with six degrees of freedom (Armstrong, Paragraphs [0148]-[0154]) to allow in a manner suitable for a human hand (Armstrong, Paragraph [0029]) which could be applied to a belt of Rood to improve alignment with the torso.
Regarding claim 2, Rood in view of Armstrong discloses the garment of claim 1.
Rood further discloses wherein the at least one sensor comprises at least one electrode (the electrodes or sensor embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 – Col. 8, line 15).
Regarding claim 3, Rood in view of Armstrong discloses the garment of claim 1.
Rood further discloses wherein the at least one sensor comprises at least one acoustic sensor (sensors may include, but are not limited to, gel-based electrodes, acoustic sensors, thermistors, accelerometers, pulse oximetry sensors, skin conductivity sensors, and sensors for signals corresponding to temperature, pulse rate, blood pressure, blood oxygenation or composition characteristics or blood flow, Col. 9, line 62 to Col. 10 line 18).
Regarding claim 4, Rood in view of Armstrong discloses the garment of claim 1.
Rood further discloses wherein the at least one sensor attachment portion includes two sensor attachment portions (Figure 1, with multiple attachments for electrodes 13, the wearable 12 further comprises electrical pathways 16, which carry the biopotential signals from the electrodes 13 to the transceiver 14, Col. 11, lines 3-30).
Regarding claim 5, Rood in view of Armstrong discloses the garment of claim 4.
Rood further discloses wherein a first one of the sensor attachment portions is configured to extend around an upper portion of the abdomen of the wearer and a second one of the sensor attachment portions is configured to extend around a lower portion of the abdomen of the wearer (Figure 1, with multiple attachments for electrodes 13 some placed at the upper portion and some at the lower portion of the abdomen, the wearable 12 further comprises electrical pathways 16 which carry the biopotential signals from the electrodes 13 to the transceiver 14, Col. 11, lines 3-30).
Regarding claim 6, Rood in view of Armstrong discloses the garment of claim 1.
Rood further discloses wherein each of the sensor attachment portions includes a plurality of the flexible sensor mounts, wherein the at least one sensor includes a plurality of sensors, and wherein each of the plurality of sensors is received within a corresponding one of the plurality of flexible sensor mounts (Connector ring 35 includes keys 36, when the electrode is placed inside of the wearable, proximal to the skin surface of the patient, with raised area of the electrode protruding distally through a hole in the wearable, the hole being of diameter larger than the diameter of raised area 37 but smaller than diameter of connector ring 35, then the connector ring 35 is fitted to the electrode on the outside of the wearable to the distal side of the electrode, such that the keys 36 of the connector ring 35 fit to key holes 34 of the electrode, the connector ring 35 may be twisted to secure it to the electrode either permanently or semi-permanently, Other embodiments of a permanently or semi-permanently attachable electrode, not illustrated, follow similar design but may use screw threading or tapered clips in lieu of keys 36 and keyholes 34, Col.11, line 47- Col.12, line 21).
Regarding claim 7, Rood in view of Armstrong discloses the garment of claim 6.
Rood further discloses wherein each of the sensor attachment portions includes five sensor mounts (Figures 1 and 2, multiple sensors around the garment 12).
Regarding claim 12, Rood in view of Armstrong discloses the garment of claim 1.
Rood further discloses wherein at least one of the at least one flexible sensor mount includes a flexible portion including an elastomeric material (the base material of the wearable may be either elastic (stretchy) or non-elastic, Col. 7, lines 40-52).
Regarding claim 13, Rood in view of Armstrong discloses the garment of claim 12 but does not specifically disclose wherein the elastomeric material has a spring coefficient of between 1 N/mm and 20 N/mm. However, it would have been obvious to a person having ordinary skill in the art to determine the optimal elasticity coefficient for the wearable garment to stretch and conform to a growing abdomen via routine experimentation without undue burden.
Regarding claim 14, Rood in view of Armstrong discloses the garment of claim 12.
Rood further discloses wherein the at least one of the at least one sensor mount includes a rigid portion positioned within an opening in the flexible portion, the rigid portion configured to receive one of the at least one sensor therein (see Figure 4a-4b, wearable material 43 is flexible, stiffening ring 41 is flexible, and the sensor electrode 42 is secured to the ring 41, FIG. 4a and FIG.4b illustrate the usefulness of a stiffening ring in some embodiments of the present invention, FIG.4a shows a schematic view of a dry electrode with a stiffening ring, In embodiments that use a stiffening ring, stiffening ring 41, made from an electrically insulating material such as plastic, is either placed in between electrode 42 and wearable 43, proximal to the subject within the wearable but on the distal side of the electrode, or is impregnated within the material of the wearable, or is adhered or otherwise attached to one or both sides of the wearable, Col.12, lines 22-50).
Regarding claim 15, Rood in view of Armstrong discloses the garment of claim 1.
Rood further discloses wherein each of the at least one sensor mount is configured to orient a sensor received therein so as to be flush with the skin of the wearer (the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52, the electrodes or sensors embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 - Col.8, line 15).
Regarding claim 16, Rood discloses a method for positioning at least one sensor so as to be flush with skin on an abdomen of a wearer (the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52, the electrodes or sensors embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 - Col.8, line 15),
the method comprising: providing a garment (the wearable 12 may be a belt, strap, shirt bra, gown, undergarment, high-waisted pant, or other garment or garment-like device, Col. 11, lines 3-30, Figure 1) including: a securing portion operable to removably secure the garment about an abdomen of a wearer b(the wearable is a tube or stretchable garment that is continuous and seamless and may be donned by sliding over the head or by stepping through, in other embodiments the wearable is a strap or belt that may be adjustably resized and secured by mechanical or electrical closures including but not limited to hook and loop closures, buttons, snaps, buckles, latches, clasps, zippers, twists, hooks, magnets, electromagnets, or any other mechanical closure means known in the art, the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52);
at least one sensor attachment portion attached to the securing portion, each of the at least one sensor attachment portion including at least one flexible sensor mount configured to receive and retain a sensor therein (garment and a plurality of sensors affixed to or embedded in the wearable, Col. 6, line 45 - Col. 7, line 2, sensors are placed in an arrangement around the circumference of the subject’s torso, Col. 7, lines 11-39, Connector ring 35 includes keys 36 , when the electrode is placed inside of the wearable, proximal to the skin surface of the patient, with raised area of the electrode protruding distally through a hole in the wearable, the hole being of diameter larger than the diameter of raised area 37 but smaller than diameter of connector ring 35, then the connector ring 35 is fitted to the electrode on the outside of the wearable to the distal side of the electrode, such that the keys 36 of the connector ring 35 fit to keyholes 34 of the electrode," Col. 11, line 47- Col. 12, Line 21);
at least one sensor, each of the at least one sensor being received in a corresponding one of the at least one flexible sensor mount of the at least one sensor attachment portion(garment and a plurality of sensors affixed to or embedded in the wearable, Col. 6, line 45 - Col. 7, line 2, sensors are placed in an arrangement around the circumference of the subject’s torso, Col. 7, lines 11-39, Connector ring 35 includes keys 36 , when the electrode is placed inside of the wearable, proximal to the skin surface of the patient, with raised area of the electrode protruding distally through a hole in the wearable, the hole being of diameter larger than the diameter of raised area 37 but smaller than diameter of connector ring 35, then the connector ring 35 is fitted to the electrode on the outside of the wearable to the distal side of the electrode, such that the keys 36 of the connector ring 35 fit to keyholes 34 of the electrode, Col. 11, Line 47- Col. 12, Line 21);
wherein the securing portion and the at least one sensor attachment portion are configured such that, when the securing portion is secured about the back of a wearer, the at least one sensor attachment portion pivots with respect to the securing portion so as to extend around (a) an upper portion of the wearer’s abdomen or (b) a lower portion of the wearer’s abdomen (in other embodiments the wearable is a strap or belt that may be adjustably resized and secured by mechanical or electrical closures including but not limited to hook and loop closures, buttons, snaps, buckles, latches, clasps, zippers, twists, hooks, magnets, electromagnets, or any other mechanical closure means known in the art, the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52, Figure 1, with multiple attachments for electrodes 13 some placed at the upper portion and some at the lower portion of the abdomen, the wearable 12 further comprises electrical pathways 16 which carry the biopotential signals from the electrodes 13 to the transceiver 14, Col. 11, lines 3-30),
and wherein each of the at least one sensor mount is configured so as to orient a sensor received therein so as to be flush with skin of the wearer when the garment is worn by the wearer (Each of these effects may have negative consequences on the proper positioning of the electrode 47 and the gentle compression of the electrode 47 onto the surface of the skin as exerted by the material of the wearable 48. By contrast, in FIG.4a, the forces 44 and 45 that stretch the material of the wearable 43 do not pull apart the wearable at the site of the electrode 42 thanks to the augmentation of the material of the wearable by the stiffening ring 42, Col.12, Lines 22-50);
positioning the garment so as to encircle a midsection of the wearer such that the securing portion extends around a back of the wearer and the at least one sensor attachment portion extends around an abdomen of the wearer (the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52, the electrodes or sensors embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 - Col.8, line 15);
securing the securing portion so as to retain the garment encircling the midsection of the wearer (wearable 12 in belt, Figure 1), whereby the at least one sensor attachment portion is positioned around one of an upper portion of an abdomen of the wearer and a lower portion of an abdomen of the wearer, and whereby the at least one flexible sensor mount flexes so as to allow the one of the at least one sensor received therein to be positioned flush with skin of the wearer (see wearable 12 in belt form in FIG.1; the wearable is sizable to a range of body types and a range of gestational ages, Col. 7, lines 40-52; the electrodes or sensors embedded in or affixed to the wearable are connected via electrode leads or wires that are singly and individually attached to each electrode or sensor, Col. 7, line 53 - Col. 8, line 15).
However Rood does not specifically disclose at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one sensor mount configured to receive and retain a sensor therein; the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion.
Armstrong discloses a garment (watch embodiment, Figure 58) comprising: at least one sensor attachment portion pivotably attached to the securing portion, each of the at least one sensor attachment portion including at least one sensor mount configured to receive and retain a sensor therein (three mutually perpendicular encoders (sensors) 124, 126, 128 mounted on the upper surface of lower member 20 for sensing rotation, Paragraph [0117]; Figure 6 depicts a rocker style sensor assembly 158 includes a T-shaped member and having a vertical center arm 160 engaged within a groove in the underside of collet 16, and the T-shaped member being pivotally supported at a lower center so that the two oppositely disposed lateral arms 162 may be pivotally moved up and down dependent upon the direction of rotation of the collet to interact with a direction indicating negative sensor 164 and a direction indicating positive sensor 166 shown mounted on lower member 20, Paragraph [0122]); the at least one sensor attachment portion pivots with respect to the securing portion so as to self-position the at least one sensor attachment portion (Figure 6 depicts a rocker style sensor assembly 158 includes a T-shaped member and having a vertical center arm 160 engaged within a groove in the underside of collet 16, and the T-shaped member being pivotally supported at a lower center so that the two oppositely disposed lateral arms 162 may be pivotally moved up and down dependent upon the direction of rotation of the collet to interact with a direction indicating negative sensor 164 and a direction indicating positive sensor 166 shown mounted on lower member 20, Paragraph [0122]; Figure 23 shows T-bone actuator 345 mounted to plate 322 by mounting structure 352 and pivoting (shown actuating sensor in dashed lines) about fulcrum 334 shown as a living hinge, Paragraph [0166]).
Thus, it would have been obvious to a person having ordinary skill in the art to mount the sensor in a pivoting fashion as taught by Armstrong in the garment of Rood to allow for rotation with six degrees of freedom (Armstrong, Paragraphs [0148]-[0154]) to allow in a manner suitable for a human hand (Armstrong, Paragraph [0029]) which could be applied to a belt of Rood to improve alignment with the torso.
Regarding claim 17, Rood in view of Armstrong discloses the method of claim 16.
Rood further discloses wherein the at least one sensor attachment portion includes two sensor attachment portions, and wherein, when the securing portion is secured, a first one of the sensor attachment portions is positioned around an upper portion of the abdomen of the wearer and a second one of the sensor attachment portions is positioned around a lower portion of an abdomen of the wearer (see FIG.1, with multiple attachments for electrodes 13, some placed at the upper portion and some at the lower portion of the abdomen; the wearable 12 further comprises electrical pathways 16, which carry the biopotential signals from the electrodes 13 to the transceiver 14, Col. 11, lines 3-30).
Regarding claim 18, Rood in view of Armstrong discloses the method of claim 16.
Rood further discloses wherein the wearer is a pregnant human (placing the wearable around a torso of a pregnant subject, Col. 11, lines 3-30).
Regarding claim 19, Rood in view of Armstrong discloses the method of claim 16.
Rood Further discloses wherein the at least one sensor includes ten sensors (Figures 1 and 2 include multiple sensor mounts around the garment 12).
Regarding claim 20, Rood in view of Armstrong discloses the method of claim 16.
Rood further discloses wherein the at least one sensor includes at least one electrode and at least one acoustic sensor (sensors may include, but are not limited to, gel-based electrodes, acoustic sensors, thermistors, accelerometers, pulse oximetry sensors, skin conductivity sensors, and sensors for signals corresponding to temperature, pulse rate, blood pressure, blood oxygenation or composition characteristics or blood flow, Col. 9, line 62 to Col. 10 line 18).
Claim(s) 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rood in view of Armstrong further in view of Proud et al. (US 2014/0247151 A1) herein referred to as “Proud”.
Regarding claim 8, Rood in view of Armstrong discloses the garment of claim 1.
However Rood in view of Armstrong does not explicitly disclose wherein the garment further comprises at least one hinge, each of the at least one hinge connecting an end of the securing portion to an end of the at least one sensor attachment portion.
Proud discloses a garment (the present invention provides a user monitoring device 10, including but not limited to, a wearable device, where one size fits all, Para