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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/20/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 05/20/2026 (“Amendment”). Claims 1-5, 7, 8, 10-13, 16-19, and 77 are currently under consideration. The Office acknowledges the amendments to claim 1 as well as the addition of new claim 77. Claims 6, 9, 14, 15, and 20 remain withdrawn.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: the recitation of “actuation,, wherein” should instead read --actuation, wherein--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5, 7, 8, 10-13, 16-19, and 77 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, there is no support for the interface defining an opening in fluid communication with the internal volume of the device prior to device actuation. There is nothing disclosing or suggesting that the channel openings 183 of the elected Fig. 79B exist prior to device actuation.
Regarding claim 77, there is no support for the thickness of the interface tapering towards the opening. The elected Fig. 79B does not show tapering, and there is nothing to suggest that the rounding of e.g. Fig. 10B or the tapering as described in ¶ 0153 of the specification as published can be applied to Fig. 79B.
Claims 2-5, 7, 8, 10-13, 16-19, and 77 are rejected because they depend on rejected claims.
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.
Claims 1-5, 7, 8, 11-13, 16, 17, 19, and 77 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2019/0142318 (“Diebold”) in view of US Patent Application Publication 2002/0169411 (“Sherman”) and US Patent Application Publication 2006/0184189 (“Olson”).
Regarding claim 1, Diebold teaches [a] device (Figs. 8a and 8b, extraction device 800) for receiving fluid from a subject (Abstract), comprising: an internal volume (Fig. 8a, the volume defined by snap dome tripper 808, support structure 806, etc.); one or more flow activators (Fig. 8a, ¶ 0091, a plurality of hollow needles 802 integrated to a needle carrier 804) configured to cause fluid to be released from the subject (¶ 0092) in response to device actuation (via the snap dome tripper 808 of Fig. 8a, and as shown in Fig. 8b), the one or more flow activators being disposed in the internal volume of the device prior to device actuation (Fig. 8a, as shown); … a support having a sidewall (Fig. 8a, support structure 806); and an interface (Fig. 8b, the interface may include the application layer 810, protective layer 814, and/or adhesive layer 816) configured to contact the subject's skin (¶ 0092), the interface defining an opening in fluid communication with the internal volume of the device (where the protective layer 814 has been pierced by the needles) …, wherein at least a portion of the interface (the application layer 810 and/or protective layer 814) is moveable (¶¶s 0091, 0092, etc., the movement between the Figure 8a state and the Figure 8b state) relative to the sidewall of the support (compare the position of application layer 810 and protective layer 814 relative to the wall of support structure 806 in Figures 8a and 8b).
Diebold does not appear to explicitly teach the device comprising a vacuum source (although it may be considered that the snap dome, when the snap dome tripper 808 returns to its original state (i.e. the first stable state), creates a vacuum; ¶ 0092).
Sherman teaches extracting interstation fluid by cocking a pushbutton actuator such that when the actuator is released from a lowered position, it will cause a vacuum to occur and thereby withdrawn the fluid (¶ 0120 – also see ¶¶s 0132-0135).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the snap dome of Diebold create a vacuum as it moved from the second position to the first position, as in Sherman, for the purpose of aiding in extraction of the fluid (Sherman: ¶¶s 0120, 0135), including with a simple mechanism that does not require advanced control circuitry (Diebold: ¶ 0092; Sherman: ¶ 0120), and as the simple substitution of one known extraction means (Diebold: ¶ 0084, capillary action, wicking, etc.) for another (Sherman: ¶ 0120, vacuum), with predictable results (Sherman: Abstract – fluid extraction).
Diebold-Sherman does not appear to explicitly teach the interface defining an opening in fluid communication with the internal volume of the device prior to device actuation,, wherein at least a portion of the interface is moveable relative to the sidewall of the support
Olson teaches an interface arrangement that has an opening for receiving skin/fluid, the interface moveable with respect to a sidewall (cap body 104 as shown in Figs. 6A, 6C, 9A, 9B, etc.) and in fluid communication with an internal volume (as shown in Figs. 9A, 9B, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an interface like the one of Olson in the combination as the simple substitution of one interface arrangement for another with predictable results (interfacing a needle arrangement with skin to draw blood – Olson: Abstract), and for the purpose of enabling more efficient lancing (Olson: ¶ 0071).
Regarding claim 2, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface is made of a first material and the sidewall of the support is made of a second material, the first material having a lower Young's modulus than a Young's modulus of the second material (Diebold: Figs. 8a and 8b, the support structure 806 is rigid (meant to support the other elements) and the interface is flexible/deflectable).
Regarding claim 3, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface includes a main body and a first section, the first section being connected to the main body[, permitting] the first section to move relative to the main body, and wherein the first section is moveable relative to the sidewall of the support (Diebold: Figs. 8a and 8b show e.g. the central portions of elements 810 and 814 as connected to and moveable with respect to the peripheral portions and the sidewall), the first section being connected to the main body by a region having reduced cross-sectional area as compared to the main body (Olson: Figs. 6A, 6C, 9A, 9B, etc., show a weakness 128 in cap body 104 – also see ¶¶s 0071, 0073, etc.). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a region of reduced cross-sectional area into the interface of the combination, as in Olson, for the purpose of allowing deformation that creates a bulge to enable more efficient lancing (Olson: ¶ 0071).
Regarding claim 4, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein a diameter of the opening is smaller than a largest diameter of the sidewall of the support (Olson: reduced diameter as shown in Figs. 6A, 6B, 9A, 9B, etc.).
Regarding claim 5, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the sidewall forms a cylindrical shape (Diebold: Fig. 13 shows a circular profile from the top, and Figs. 8a and 8b suggest the same profile based on the configuration of the device. They also show the depth direction, which creates the cylindrical shape; Sherman: Figs. 22-24 show the device as being cylindrical. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a cylindrical shape in Diebold (as already suggested), since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art when the choice of shape has no significant impact on the operation of the invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Regarding claim 7, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface includes a distal surface configured to contact the subject's skin, and the sidewall includes a distal end, wherein a surface area of the distal surface of the interface is larger than a surface area of the distal end of the sidewall (Diebold: Figs. 8a and 8b, the distal end of the sidewall has a relatively narrow profile).
Regarding claim 8, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface is attached to the sidewall (Diebold: as shown in Figs. 8a and 8b).
Regarding claim 11, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface has a horizontal portion and a vertical portion, where the horizontal portion is moveable relative to the support (Diebold: Fig. 8b, application layer 810 and protective layer 814 have a vertical portion at the ends and a horizontal portion in the center. The horizontal portion moves up and down as shown in Figs. 8a and 8b).
Regarding claim 12, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface has a horizontal portion and a C-shaped portion that transitions the interface from the support to the horizontal portion of the interface (Diebold: Fig. 8b, application layer 810 and protective layer 814 have a C-shaped portion at the ends and a horizontal portion in the center).
Regarding claim 13, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the interface comprises a horizontal shape (Diebold: Figs. 8a and 8b) with a rounded corner at the opening (Olson : Figs. 6A, 6C, 9A, 9B, etc., show a rounded corner at inner edge 126). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the opening and rounded corner of Olson into the combination, for the purpose of facilitating creation of a bulge that allows for efficient lancing (Olson: ¶¶s 0070, 0071, etc.), and since such a modification would have involved a mere change in the shape of a component. A change in shape is generally recognized as being within the level of ordinary skill in the art when the choice of shape has no significant impact on the operation of the invention. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)).
Regarding claim 16, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the vacuum source comprises a vacuum bulb that generates a vacuum when the bulb expands from a smaller volume to a larger volume (the snap dome of Diebold as modified above).
Regarding claim 17, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches a storage chamber configured to store fluid received into the device (Diebold: Figs. 8a and 8b, collection unit 818).
Regarding claim 19, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the flow activators comprise needles (Diebold: Figs. 8a and 8b, hollow needles 802).
Regarding claim 77, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson further teaches wherein the one or more flow activators are configured to move in a deployment direction (Diebold: as shown in Figs. 8a and 8b), wherein the interface comprises a thickness in a direction approximately parallel to the deployment direction, and wherein the thickness tapers towards the opening (Olson: Figs. 6C, 9B, etc., showing the thickness tapering due to tissue engaging features 114, or tapering to a point at the opening. It should be noted that Figs. 6A, 9A, etc., also show a tapering towards the opening).
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Diebold-Sherman-Olson in view of US Patent Application Publication 2017/0172481 (“Berthier”).
Regarding claim 10, Diebold-Sherman-Olson teaches all the features with respect to claim 1, as outlined above. Diebold-Sherman-Olson does not appear to explicitly teach wherein the interface is made of thermoplastic elastomer.
Berthier teaches making a membrane from a flexible/deformable material such as thermoplastic elastomer (¶¶s 0096, 0115 – also see Figs. 10A-10C, membrane 80).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the interface of the combination of a thermoplastic elastomer, as in Berthier, since it is known for being flexible/deformable, and it has been held to be within the ordinary skill of one in the art to select, as a matter of obvious design choice, a known material on the basis of its suitability for the intended use. See In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960). It also would have been obvious to do so for the purpose of facilitating a hermetic and/or fluidic seal between the subject’s skin and the device (Berthier: ¶ 0074).
Regarding claim 18, Diebold-Sherman-Olson teaches all the features with respect to claim 17, as outlined above. Diebold-Sherman-Olson does not appear to explicitly teach wherein the storage chamber is removable from the device.
Berthier teaches using a removable reservoir 34 in a similar type of body fluid collection device (¶ 0063, Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a removable storage chamber into the combination, as in Berthier, for the purpose of enabling it to easily and simply be used with existing testing or lab equipment (Berthier: ¶ 0063).
Response to Arguments
Applicant’s arguments filed 05/20/2026 have been fully considered, but they are not persuasive. The rejection describes a simple substitution of interface arrangements. Thus, the interface of Diebold is substituted with the interface of Olson. Applicant argues that this would render the device of Diebold unsatisfactory for its intended purpose. The Office disagrees. Although the Fig. 8 embodiment of Diebold uses a protective layer 814, ¶¶s 0012, 0013, and 0085 clearly state that only “some embodiments” use a sealed chamber for sterility. Figs. 1-3 and 14 show that no sealed chamber or protective membrane is required. ¶ 0036 explains that sterility can be achieved via a detachable sealing layer. ¶ 0096 suggests that not every case requires sterility. Regarding a negative pressure, ¶ 0085 explains that only “some embodiments” facilitate extraction with a pressure gradient. ¶ 0031 explains that there are other alternatives, such as via capillary action. Thus, it is evident that the device of Diebold would not be rendered unsuitable for its intended purpose. It would still be able to draw blood, and with the additional benefit of more efficient lancing (Olson: ¶ 0071). Applicant also argues about rendering the protective layer 814 unsatisfactory for its intended purpose, but this is not the same as rendering the prior art unsatisfactory for its intended purpose. There is no requirement that all parts of a device be kept during obvious modifications in view of the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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