DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
The amendment filed 07/28/2025 has been entered. Claims 78-99 are pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/28/2025 was filed after the mailing date of the non-final rejection on 01/29/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
With regard applicant’s argument, see pages 6-7, with respect 35 USC 102 rejections have been considered and are at least partially persuasive, but are moot in light of new rejection/interpretation.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 78-80, 84-90, 92 and 94-99 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lum et al (US 6132449 A) in view of Fujiwara et al (EP 2064993 A1).
Regarding claim 78, Lum teaches a device for receiving bodily fluid from a subject, the device comprising:
a fluid transporter (figure 10, chamber 172) comprising at least one sidewall (figure 10, side walls 173a defining chamber) defining a recess, an opening (figure 10, opening of chamber 172 adjacent skin 24) configured to receive bodily fluid on skin of a subject into the recess (col 11 lines 1-5), and a flow activator (figure 10 and col 5 lines 27-29, tact 166 comprising a plurality of lancets having 220 um in diameter) comprising a plurality of microneedles;
a channel (figure 10, channel 170 and 174) configured to fluidly connect the recess to a storage chamber (figure 10, col 9 lines 65-67 and col 10 lines 52-67, the channel 170 and 174 are configured to fluidly connect the chamber 172 to any reservoir for blood sample analysis); and
a vacuum source (figure 10, collapsible bubble 176).
Lum and/or Fujiwara does not teach the device comprising a first wall and a second wall protruding into the recess, the first and second walls configured to guide bodily fluid from the opening toward the channel, the first and second walls flanking a longitudinal axis of the channel.
However, in the same field of endeavor, namely a blood sensor and blood examining instrument, Fujiwara teaches a blood storing part (figures 10a-c, 24) comprising a first wall (figure 10a, cover 23) and a second wall (figure 10a, substrate 21) protruding into the recess (figure 10a, plates 21-23 of the blood storing part 24 defines a recess and 23a and 21a projected into the recess), the first and second walls configured to guide bodily fluid from the opening toward the channel (figures 10b-c and [0073]-[0074], blood drop 15a abuts tips of projecting part 23c and 21a being spread and guide the blood into supply channel 25 by capillary force produced in groove 26a), the first and second walls flanking a longitudinal axis of the channel (the plates 21 and 23 flanking along a longitudinal axis of supply channel 25).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lum to incorporate the teachings of Fujiwara and provide the first and second walls as claimed, for the purpose of leading sufficient amount of blood to a supply channel in a reliable manner, which reduce the amount of blood that is required to sample as taught by Fujiwara ([0014]-[0015]).
Regarding claim 79, Lum, as modified by Fujiwara, teaches the device of claim 78.
Lum further teaches an interface (figure 10, the portion of the rim of the opening contacting the skin, or alternatively the surface of (134)) configured to draw skin towards the fluid transporter when vacuum from the vacuum source is applied to the skin.
Regarding claim 80, Lum, as modified by Fujiwara, teaches the device of claim 70.
Lum further teaches that interface comprises a suction cup ((134) is interpreted to form a suction cup as it is cup shaped (i.e. surrounds an opening of a chamber, and forms a seal against the skin).
Regarding claims 84 and 85, Lum, as modified by Fujiwara, teaches the device of claim 78
Lum further teaches wherein vacuum is created from the vacuum source manually, and wherein the vacuum source comprises a bulb (collapsible bubble (176); Col. 11, ll. 5-9 or alternatively bubble (182)).
Regarding claim 86, Lum, as modified by Fujiwara, teaches the device of claim 78,
Lum further teaches comprising a support structure (annotated figure below and col 10 lines 50-67, at least the underside of the upper portion of tack (166) which attaches to the lancets, and the support structure is configured to move from unpressed position to pressed position that bring the flow activator to the skin) that is moveable mechanically from a first position to a second position, the plurality of microneedles being immobilized relative to the support structure, wherein the support structure is configured to bring the flow activator to the skin (See annotated figure below).
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Regarding claim 87, Lum, as modified by Fujiwara, teaches the device of claim 86.
Lum further teaches comprising a button (annotated figure above, upper surface of the support structure), wherein pushing the button causes the support structure to move from the first position to the second position, alternatively (180) and/or (196).
Regarding claim 88, Lum, as modified by Fujiwara, teaches the device of claim 78.
Lum further teaches comprising a retraction mechanism comprising a spring (127) configured to move the plurality of microneedles away from the skin (Fig. 2a-2b).
Regarding claim 89, Lum, as modified by Fujiwara, teaches the device of claim 86.
Lum further teaches comprising a retraction mechanism comprising a spring (127) configured to move the plurality of microneedles away from the skin, wherein the retraction mechanism is separate from the support structure (Fig. 2a-2b).
Regarding claim 90, Lum teaches a method of receiving bodily fluid from a subject, comprising:
placing a device (figure 10 and col 10 lines 50-67 10, placing device 164 on a skin) for receiving bodily fluid from a subject on skin of the subject, the device including a fluid transporter (figure 10, chamber 172) comprising at least one sidewall (figure 10, side wall 173a defining a chamber) defining a recess, an opening (figure 10, opening of chamber 172 adjacent skin 24), and a flow activator (figure 10 and col 5 lines 27-29, tact 166 comprising a plurality of lancets having 220 um in diameter) comprising a plurality of microneedles;
actuating the plurality of microneedles to pierce the skin and cause release of bodily fluid from the subject (col 10 lines 50-67, pressing tact pierce the skin causes blood emitted from the skin); and
creating a vacuum (figure 10 and col 10 lines 50-67, bulb 176 creates vacuum to draw blood from chamber into channel 174) from a vacuum (figure 10, bulb 176) source to draw the bodily fluid from the subject through the opening into the recess and into a storage chamber (figure 10, channel 174) via a channel fluidly connecting the storage chamber and the recess (col 10 lines 50-67, the channel 172 fluidly connect chamber 172 and channel 174),
Lum and/or Fujiwara does not teach wherein a first wall and a second wall protruding into the recess guide the bodily fluid from the opening toward the storage chamber,
wherein the first wall and second wall flank a longitudinal axis of the channel.
However, in the same field of endeavor, namely a blood sensor and blood examining instrument, Fujiwara teaches a blood storing part (figures 10a-c, 24) comprising a first wall (figure 10a, cover 23) and a second wall (figure 10a, substrate 21) protruding into the recess (figure 10a, plates 21-23 of the blood storing part 24 defines a recess and 23a and 21a projected into the recess), the first and second walls configured to guide bodily fluid from the opening toward the channel (figures 10b-c and [0073]-[0074], blood drop 15a abuts tips of projecting part 23c and 21a being spread and guide the blood into supply channel 25 by capillary force produced in groove 26a),
the first and second walls flanking a longitudinal axis of the channel (the plates 21 and 23 flanking along a longitudinal axis of supply channel 25).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lum to incorporate the teachings of Fujiwara and provide the first and second walls as claimed for the purpose of leading sufficient amount of blood to a supply channel in a reliable manner, which reduce the amount of blood that is required to sample as taught by Fujiwara ([0014]-[0015]).
Regarding claim 92, Lum, as modified by Fujiwara, teaches the method of claim 90.
Lum further teaches wherein the device further includes an interface (portion of the rim of the opening contacting the skin, or alternatively the surface of (134)) configured to draw skin towards the fluid transporter when vacuum from the vacuum source is applied to the skin.
Regarding claim 94, Lum, as modified by Fujiwara, teaches the method of claim 90,
Lum further teaches wherein the plurality of microneedles are actuated by pushing a button (figure 10, tact 166, col 10 lines 50-67 “By pressing the tack 166 to drive the lancets 104 through the chamber 172 the skin 24 can be lanced”).
Regarding claim 95, Lum, as modified by Fujiwara, teaches the method of claim 90,
Lum further teaches comprising retracting the plurality of microneedles away from the skin after the release of the bodily fluid from the subject (figure 14 and col 11 lines 1-3, lancets will be retracted after withdrawing blood).
Regarding claims 96 and 97, Lum, as modified by Fujiwara, teaches the method of claim 90. Lum further teaches wherein the step of creating the vacuum from the vacuum source comprises creating the vacuum manually (col 10 lines 57-67, manually activating pump 168 creates vacuum), and wherein the vacuum source comprises a bulb (figure 10, collapsible bubble 176)
Regarding Claim 98, Lum teaches the device of claim 78.
Lum further teaches wherein the channel is upstream of the storage chamber (figure 10, the channel 172 is upstream of channel 174).
Regarding claim 99, Lum, as modified by Fujiwara, teaches the method of claim 90.
Lum further teaches wherein the channel is upstream of the storage chamber (figure 10, the channel 172 is upstream of channel 174).
Claims 81-82 and 91 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lum et al (US 6132449 A) in view of Fujiwara et al (EP 2064993 A1), and in further view of Leong (US Patent No. 6,712,792).
Regarding claim 81, Lum, as modified by Fujiwara, teaches the device of claim 78.
Lum further teaches comprising the storage chamber (figure 10, channel 174)
Lum and/or Fujiwara does not teach wherein the storage chamber is removable from the device.
However, it would have been obvious to a person having ordinary skill in the art at the time of the invention to make the elements of a device separable in order to allow the sample within the storage chamber to be removed for analysis, transport, or storage. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would have been obvious to make the cap removable for that purpose.").
Furthermore or alternatively, Leong teaches a device and method for the collection of a body fluid through the skin of a patient, wherein the device comprises a fluid transporter (10) and a storage chamber (70), wherein the device is modular as claimed, and wherein the chamber is removed for subsequent analysis.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the device of Lum, as modified by Fujiwara, with the teachings of Leong and to make the storage chamber removeable, and one of skill in the art motivated to do so, in order to allow for later analysis in a machine designed for a standard sample holder, to transport the sample, to store it, or to simplify the manufacture of the device.
Regarding claim 82, Lum, as modified by Fujiwara, teaches the device of claim 78.
Lum further teaches comprising the storage chamber (figure 10. Channel 174).
Lum and/or Fujiwara does not teach wherein the transport is part of a first module and the storage chamber is part of a second module, wherein the first module is removable from the second module.
However, it would have been obvious to a person having ordinary skill in the art at the time of the invention to make the elements of a device separable that providing the transport is part of a first module and the storage chamber is part of a second module, wherein the first module is removable from the second module for analysis, transport, or storage. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would have been obvious to make the cap removable for that purpose.").
Furthermore or alternatively, Leong teaches a device and method for the collection of a body fluid through the skin of a patient, wherein the device comprises a fluid transporter (10) and a storage chamber (70), wherein the device is modular as claimed, and wherein the chamber is removed for subsequent analysis.
Therefor it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the device of Lum, as modified by Fujiwara, with the teachings of Leong and to make transport is part of a first module and the storage chamber is part of a second module, wherein the first module is removable from the second module, and one of skill in the art motivated to do so, in order to allow for later analysis in a machine designed for a standard sample holder, to transport the sample, to store it, or to simplify the manufacture of the device.
Regarding Claim 91, Lum, as modified by Fujiwara, teaches the method of claim 90.
Lum and/or Fujiwara does not teach further comprising removing the storage chamber from the device after bodily fluid has been entered the storage chamber.
However, it would have been obvious to a person having ordinary skill in the art at the time of the invention to make the storage chamber removed from the device after bodily fluid has entered the storage chamber in order to allow the sample within the storage chamber to be removed for analysis, transport, or storage. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would have been obvious to make the cap removable for that purpose.").
Furthermore or alternatively, Leong teaches a device and method for the collection of a body fluid through the skin of a patient, wherein the device comprises a fluid transporter (10) and a storage chamber (70), wherein the device is modular as claimed, and wherein the chamber is removed for subsequent analysis.
Therefore it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the device of Lum, as modified by Fujiwara, with the teachings of Leong and to remove the storage chamber from the device after bodily fluid has been entered the storage chamber, and one of skill in the art motivated to do so, in order to allow for later analysis in a machine designed for a standard sample holder, to transport the sample, to store it, or to simplify the manufacture of the device.
Claims 83 and 93 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lum et al (US 6132449 A) in view of Fujiwara et al (EP 2064993 A1), and in further view of Staehlin (US Patent No. 5,636,640).
Regarding claim 83, Lum, as modified by Fujiwara, teaches the device of claim 78
Lum and/or Fujiwara does not teach an adhesive positioned on a surface of the device that is applied to the skin of the subject, or the corresponding step of adhering the device to the skin via an adhesive positioned on a surface of the device.
However, in the same field of endeavor, namely a device for sampling a body fluid from the skin of a patient, Staehlin teaches a device for sampling a body fluid from the skin of a patient (See Abstract), wherein the device comprises an adhesive sealing ring (6) positioned on the surface of the device which is adhered to the skin, and the corresponding step of adhering the device to the skin via an adhesive positioned on a surface of the device (See col. 4, ll. 60-67; Fig. 5).
Therefore it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the device of Lum, as modified by Fujiwara, to include an adhesive ring as taught by Staehlin, and one of skill in the art motivated to do so, in order to ensure the device remain in place while taking a sample.
Regarding claim 93, Lum, as modified by Fujiwara, teaches the method of claim 90
Lum and/or Fujiwara does not teach an adhesive positioned on a surface of the device that is applied to the skin of the subject, or the corresponding step of adhering the device to the skin via an adhesive positioned on a surface of the device.
However, in the same field of endeavor, namely a device for sampling a body fluid from the skin of a patient, Staehlin teaches a device for sampling a body fluid from the skin of a patient (See Abstract), wherein the device comprises an adhesive sealing ring (6) positioned on the surface of the device which is adhered to the skin, and the corresponding step of adhering the device to the skin via an adhesive positioned on a surface of the device (See col. 4, ll. 60-67; Fig. 5).
Therefore it would have been obvious to a person having ordinary skill in the art at the time of the invention to modify the method of Lum, as modified by Fujiwara, to include an adhesive ring as taught by Staehlin, and one of skill in the art motivated to do so, in order to ensure the device remain in place while taking a sample.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nicholas J Weiss can be reached at (571)270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.H./Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781