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 .
Election/Restrictions
During a telephone conversation with Barnabas Fekete on 04/02/2026 a provisional election was made without traverse to prosecute the invention of a biomedical connector, drawn to claims 1-23, 29-35. Affirmation of this election must be made by applicant in replying to this Office action. Claims 24-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The following is the complete first examination of the elected claims 1-23 and 29-35.
Information Disclosure Statement
The information disclosure statements (IDS) submitted are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19-20, 22-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shusterman (US Patent No 20180020931).
Regarding claim 19, Shusterman teaches a biomedical connector (sensor connector 100, [0189]) comprising: a housing defining an interior space (housing member 101, [0189]) and an opening dimensioned to receive an electrode at least partially into the interior space (see from fig 1B in which there is a slot 102S configured to receive the circuitry 102 which may take form as a PCB or electrode, [0189]); an electrical contact member disposed in the interior space of the housing (see electrical-coupling wire element 103, which acts as an electrical contact member, [0200]); and a foam dampener disposed in the interior space of the housing and configured to engage the electrode when the electrode is received in the opening in the housing (the housing 101 may contain foam padding 104 on the interior to help receive and act as a dampener to the electrode, [0200]), the foam dampener being configured to limit movement of the biomedical connector relative to the electrode to reduce motion artifact in a biomedical signal received by the biomedical connector (the padding element 104 is used to secure the electrode component 102 which may contain accelerometers and other sensors, and the padding element functions for limiting the motion artifact, [0200]).
Regarding claim 20, Shusterman teaches the connector of claim 19, wherein the electrical contact member comprises metal (the wire element 103 is electrically conducting and comprising a metal pin connector, [0204]).
Regarding claim 22, Shusterman teaches the connector of claim 19, wherein the foam dampener comprises a viscoelastic foam (the padding material 104 can be comprised of a urethane foam, which is known in the art to be viscoelastic, [0200]).
Regarding claim 23, Shusterman teaches the connector of claim 19, wherein the foam dampener has a thickness extending between top and bottom surfaces of the foam dampener and a width extending laterally across the foam dampener (see in which the width and thickness of the foam dampener is as thick as the distance between the circuitry surface 102 to that of the surface of the housing 101M1, [0200]), a maximum width of the foam dampener being less than about ½ inch when the foam dampener is in an undeformed state (see in which the thickness of the housing 101M1 is approximately 50 microns, [0193], therefore the foam thickness is less than that and thereby less than 0.5 inch).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-4, 7-15, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US Patent No 20180020931) in view of Simpson (US Patent No 20140275927).
Regarding claim 1, Shusterman teaches a biomedical connector (sensor connector 100, [0189]) comprising: a housing defining an interior space (housing member 101, [0189]) and an opening dimensioned to receive an electrode at least partially into the interior space (see from fig 1B in which there is a slot 102S configured to receive the circuitry 102 which may take form as a PCB or electrode, [0189]); and a dampener disposed in the interior space of the housing and configured to engage the electrode when the electrode is received in the opening in the housing (the housing 101 may contain padding 104 on the interior to help receive and act as a dampener to the electrode, [0200]), the dampener being configured to limit movement of the biomedical connector relative to the electrode to reduce motion artifact in a biomedical signal received by the biomedical connector (the padding element 104 is used to secure the electrode component 102 which may contain accelerometers and other sensors, and the padding element functions for limiting the motion artifact, [0200]).
Shusterman does not teach a lever movably attached to the housing and biased toward an engagement position for contacting the electrode when the electrode is received in the opening in the housing to retain the biomedical connector to the electrode.
However, the analogous electrode connector device taught by Simpson does teach a lever movably attached to the housing (see the lever element 336 moveably attached to the housing via spring member 338, fig 8, see also [0041]) and biased toward an engagement position for contacting the electrode when the electrode is received in the opening in the housing to retain the biomedical connector to the electrode (see [0041] in which the biasing or spring member uses the force of the lever element 336 to movably press into the stud member 124 thus inhibiting the removal of the biomedical electrode from the connector element 320).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the sensor connector taught by Shusterman with that of the moveable lever element for attaching the electrode and housing taught by Simpson, as it is another known method in the art to attach and inhibit the removal of the electrode from the connector housing, and allows for more secure fastening of the electrode element, as taught by Simpson, [0041].
Regarding claim 2, Shusterman teaches the connector of claim 1, wherein the dampener comprises foam (the housing may contain a foam padding material 104, [0200]).
Regarding claim 3, Shusterman teaches the connector of claim 2, wherein dampener comprise a viscoelastic foam (the padding material 104 can be comprised of a urethane foam, which is known in the art to be viscoelastic, [0200]).
Regarding claim 4, Shusterman teaches the connector of claim 2, wherein the dampener has a thickness extending between top and bottom surfaces of the dampener and a width extending laterally across the dampener (see in which the width and thickness of the foam dampener is as thick as the distance between the circuitry surface 102 to that of the surface of the housing 101M1, [0200]), a maximum width of the dampener being less than about ½ inch when the dampener is in an undeformed state (see in which the thickness of the housing 101M1 is approximately 50 microns, [0193], therefore the foam thickness is less than that and thereby less than 0.5 inch).
Regarding claim 7, the combination teaches the connector of claim 1, wherein at least a portion of the lever and dampener are disposed at opposite sides of the opening in the housing such that the lever and dampener are configured to engage the electrode on diametrically opposite sides of the electrode (see from Shusterman fig 1A in which the padding foam 104 is found on the side opposite to the housing opening 102S which contains the locking mechanism in which the locking lever would be found, [0200], and therefore engage the electrode on different sides of the housing).
Regarding claim 8, Shusterman teaches the connector of claim 1, wherein the dampener is configured to deform upon engagement by the electrode to at least partially surround lateral sides of the electrode (see from fig 1A in which the padding element 104 is at least partially surrounding the electrode element 102, furthermore the foam may be deformed upon engagement to hold the element 102 in the housing slot 102S, [0200]).
Regarding claim 9, Shusterman teaches the connector of claim 8, wherein the dampener is configured to surround at least half of an outer circumference of the electrode (see from the fig 1A, in which over half of the outer side of the electrode is covered with the foam element 104 when the electrode element 102 is fully in the housing 101).
Regarding claim 10, Shusterman teaches the connector of claim 1, wherein the dampener extends partially across the opening in the housing prior to receiving the electrode in the opening (see in which the foam element 104 creates an envelope type enclosure for receiving the electrode 102 which partially covers the opening 102S from which the electrode 102 is inserted, [0200]).
Regarding claim 11, Shusterman teaches the connector of claim 1, wherein the connector comprises reprocessed components (the housing 101 may be single use or be designed to be reusable components, [0200]).
Regarding claim 12, the combination teaches the connector of claim 1, further comprising an electrical contact member disposed in the housing (see from Simpson, in which the housing 322 contains a contact plate member 332, [0040]).
Regarding claim 13, the combination teaches the connector of claim 12, further comprising a lead wire disposed in the housing, wherein an end of the lead wire is electrically coupled to the electrical contact member (see from Simpson, [0040] in which the contact member 332 is connected to lead wire 304 via the lead wire terminal 330).
Regarding claim 14, the combination teaches the connector of claim 13, wherein the electrical contact member defines an opening (from Simpson, the contact plate 332 defines the keyhole slot 334, [0040], part of the opening), the lever being biased to the engagement position by a biasing member, the lever including an actuating end and an engaging region (from Simpson, see in which the lever element 336 has a cam finger 336a which acts as the engaging region, and the lever 336 is the actuating end, [0041], see also fig 8), the lever extending across a portion of the contact opening when the lever is in the engagement position (from Simpson, see from fig 8, in which the lever covers a portion of the contact plate 332 when engaged).
Regarding claim 15, the combination teaches the connector of claim 14, wherein the lever is actuatable against the bias of the biasing member to a receiving position wherein the engaging region does not obstruct or extend across the portion of the contact opening permitting the electrode to be received in the opening in the housing (from Simpson, see from the fig 8, in which when the lever 336 is engaged with the cam finger element 336a, the key hold opening 334 is still open to permit the connection of the electrode element).
Regarding claim 18, Shusterman teaches the connector of claim 1, wherein the dampener is electrically conductive (see in which the foam material is made with the electronic-coupling conductive element 103, [0200]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US Patent No 20180020931) in view of Simpson (US Patent No 20140275927) further in view of Batzer (US Patent No 20220287644).
Regarding claim 5, the combination of Shusterman and Simpson teaches the connector of claim 4.
The combination does not teach wherein the maximum width of the dampener is between about 0.3 inches and about 0.4 inches when the dampener is in the undeformed state.
However, the analogous movement compensation dampener system taught by Batzer does disclose the maximum width of the dampener is between about 0.3 inches and about 0.4 inches when the dampener is in the undeformed state (see from [0128], in which the visceoelastic foam material or dampener has a thickness ranging between .5 to 1.5cm, thereby falling within the claimed width of 0.3 to 0.4 inches).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the dampener system taught by Shusterman and Simpson to contain the foam dampener thickness taught by Batzer, as it is a known thickness in the art to use for a foam dampener and it allows the electrode connector device to maintain a low profile when in use, as taught by Batzer, [0128].
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US Patent No 20180020931) in view of Simpson (US Patent No 20140275927) further in view of Meng (US Patent No 20210061941).
Regarding claim 6, Shusterman teaches the connector of claim 2.
Shusterman does not teach wherein the foam dampener has a density of between about 80 kg/m3 and about 300 kg/m3.
However, the analogous flexible dampening foam structure which is taught by Meng does teach the foam dampener has a density of between about 80 kg/m3 and about 300 kg/m3 (the flexible foam is characterized by having a density of 24 to 150 kg/m^3, [0086], thereby teaching in the claimed limitation range).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode connector containing a foam dampener of Shusterman, to have the specific dampening foam and foam density taught by Meng, as it is another known density in the art to be used in a foam dampener, and also allows for ideal deformation and resiliency in the dampening foam as taught by Meng, [0087].
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US Patent No 20180020931) in view of Simpson (US Patent No 20140275927) further in view of Rogers (US Patent No 20200397326).
Regarding claim 16, the combination of Shusterman and Simpson teaches the connector of claim 1.
The combination does not teach wherein a motion artifact value of the connector is less than 0.6 mV.
However, the analogous wireless tissue mounted connection device of Rogers does teach a motion artifact value of the connector is less than 0.6 mV (from Rogers, in which the system is optimized to provide a signal noise value of 100 to 300 microvolts, [0111], resulting in 0.1 to 0.3mv which falls less than 0.6mv).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the connector device of Shusterman and Simpson to have a motion artifact value taught by Rogers, as it is a known motion artifact value in the art to help alleviate the noise interference, and allows for an optimized connection which depletes excess motion artifact as taught by Rogers, [0111].
Regarding claim 17, the combination teaches the connector of claim 1, wherein a motion artifact value of the connector is maintained between about 0.3 mV and about 0.5 mV during use of the connector over 14 days (from Rogers, in which the system is optimized to provide a signal noise value of 100 to 300 microvolts, [0111], resulting in 0.1 to 0.3mv which overlaps the claimed range).
Claim(s) 21, 29-33, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US Patent No 20180020931) in view of Meng (US Patent No 20210061941).
Regarding claim 21, Shusterman teaches the connector of claim 19.
Shusterman does not teach wherein the foam dampener has a density of between about 80 kg/m3 and about 300 kg/m3.
However, the analogous flexible dampening foam structure which is taught by Meng does teach the foam dampener has a density of between about 80 kg/m3 and about 300 kg/m3 (the flexible foam is characterized by having a density of 24 to 150 kg/m^3, [0086], thereby teaching in the claimed limitation range).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode connector containing a foam dampener of Shusterman, to have the specific dampening foam and foam density taught by Meng, as it is another known density in the art to be used in a foam dampener, and also allows for ideal deformation and resiliency in the dampening foam as taught by Meng, [0087].
Regarding claim 29, Shusterman teaches a biomedical connector (sensor connector 100, [0189]) comprising: a housing defining an interior space (housing member 101, [0189]) and an opening dimensioned to receive an electrode at least partially into the interior space (see from fig 1B in which there is a slot 102S configured to receive the circuitry 102 which may take form as a PCB or electrode, [0189]); an electrical contact member disposed in the housing and configured for electrically connecting to the electrode when the electrode is received in the opening in the housing (see electrical-coupling wire element 103, which acts as an electrical contact member for connecting the electrode element 102, [0200]); and foam disposed in the interior space of the housing (the housing 101 may contain foam padding 104 on the interior to help receive and act as a dampener to the electrode, [0200]).
Shusterman does not teach the foam having a rate of recovery of about 10 seconds to about 35 seconds for 100% recovery after deformation.
However, the analogous flexible dampening foam structure which is taught by Meng does teach the foam having a rate of recovery of about 10 seconds to about 35 seconds for 100% recovery after deformation (see in which the foam from Meng contains a recovery time ranging from at least 0.5 seconds to up to 20 seconds for full deformation recovery, [0090], thereby teaching within the claimed recovery limitation).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the electrode connector containing a foam dampener of Shusterman, to have the specific dampening foam and foam density taught by Meng, as it is another known foam density recovery rate in the art to be used in a foam dampener, and also allows for ideal deformation and resiliency in the dampening foam as taught by Meng, [0087].
Regarding claim 30, the combination teaches the connector of claim 29, wherein the rate of recovery is about 10 seconds to about 15 seconds for 100% recovery after deformation (see in which the foam from Meng contains a recovery time ranging from at least 0.5 seconds to up to 20 seconds for full deformation recovery, [0090], thereby teaching within the claimed recovery limitation).
Regarding claim 31, the combination teaches the connector of claim 29, wherein the foam has a density of between about 80 kg/m3 and about 300 kg/m3. (from Meng, the flexible foam is characterized by having a density of 24 to 150 kg/m^3, [0086], thereby teaching in the claimed limitation range).
Regarding claim 32, Shusterman teaches the connector of claim 29, wherein the foam comprises a viscoelastic foam (the padding material 104 can be comprised of a urethane foam, which is known in the art to be viscoelastic, [0200]).
Regarding claim 33, Shusterman teaches the connector of claim 29, wherein the foam has a thickness extending between top and bottom surfaces of the foam and a width extending laterally across the foam (see in which the width and thickness of the foam dampener is as thick as the distance between the circuitry surface 102 to that of the surface of the housing 101M1, [0200]), a maximum width of the foam being less than about ½ inch when the foam is in an undeformed state (see in which the thickness of the housing 101M1 is approximately 50 microns, [0193], therefore the foam thickness is less than that and thereby less than 0.5 inch).
Regarding claim 35, Shusterman teaches the connector of claim 29, wherein the foam is configured to engage the electrode when the electrode is received in the opening in the housing (see from fig 1A in which the foam element 104 is at least partially surrounding and engaging the electrode element 102, [0200]).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shusterman (US Patent No 20180020931) in view of Meng (US Patent No 20210061941) further in view of Batzer (US Patent No 20220287644).
Regarding claim 34, the combination of Shusterman and Meng teaches the connector of claim 33.
The combination does not teach wherein the maximum width of the dampener is between about 0.3 inches and about 0.4 inches when the dampener is in the undeformed state.
However, the analogous movement compensation dampener system taught by Batzer does disclose the maximum width of the dampener is between about 0.3 inches and about 0.4 inches when the dampener is in the undeformed state (see from [0128], in which the visceoelastic foam material or dampener has a thickness ranging between .5 to 1.5cm, thereby falling within the claimed width of 0.3 to 0.4 inches).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the dampener system taught by Shusterman and Meng to contain the foam dampener thickness taught by Batzer, as it is a known thickness in the art to use for a foam dampener and it allows the electrode connector device to maintain a low profile when in use, as taught by Batzer, [0128].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794