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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, elements such as the claimed tab, temperature sensor, mechanical actuation system, sample detection sensor, pressure sensor, and adjustable knob must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are further objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: at least the “fluid reservoir 65” is not shown in any of the provided drawings Paragraph [0061] of the published specification discusses a fluid reservoir 65 being located proximate lip 66, “as shown in FIG. 3”. Figure 3 does not show a fluid reservoir 65. None of Figures 1-11 show fluid reservoir 65. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 6 and 9 are objected to because of the following informalities:
the term “having” in line 1 of claim 6 should be amended to read “has”;
the term “a” should be added before “pressure sensor” in line 6 of claim 9.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “puncture element”, “heating element”, and “vacuum source” in claim 1; “mechanical actuation system” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
According to the specification, the puncture element is one or more needles or lancets, the heating element is a printed circuit board, and the vacuum source is a vacuum pump. The specification provides no details of the structure of mechanical actuation system.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 9, 10, 13, 17, and 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.
Regarding claim 9, the phrase “the reusable actuation device further comprising a controller, the controller configured to” renders the claim indefinite (emphasis added). Claim 1 already recites that the reusable actuation device comprises a controller. In claim 9, does the reusable actuation device comprise two controllers? If so, to which of the two controllers does the phrase “the controller” in lines 2 and 8 refer? For this examination, claim 9 is being interpreted such that the reusable actuation device comprises one controller, the one controller configured to control the elements recited in claim 9.
Regarding claim 10, it is unclear if the phrase “the controller” is referring to the controller of claim 1 or to the controller of claim 9. As noted above with respect to claim 9, the claimed invention is being interpreted such that one controller is present in the reusable actuation device.
Regarding claim 17, the term “acceptable” is a relative term that does not adequately define the metes and bounds of the claimed invention. What is to be considered “acceptable testing” and what is to be considered “unacceptable testing”? For this examination, any liquid reagent that interacts with bodily fluid will be considered an acceptable reagent.
Regarding claim 20, claim 1 recites that the disposable collection cartridge comprises the fluid container. If the fluid container is part of the disposable collection cartridge, how would it be coupled to the collection cartridge? For this examination, the claim is being interpreted such that the fluid container is connected to any other element of the disposable collection cartridge (i.e., the housing or the puncture element) by a threaded coupling.
Further regarding claim 9, limitation “mechanical actuation system” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For this examination, any system/element capable of actuating the puncture element will be considered a mechanical actuation system.
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, 11-13, 15-19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Escutia et al.’131 (US Pub No. 2007/0083131) in view of Qin et al.’267 (US Pub No. 2021/0353267).
Regarding claim 1, Figure 4 of Escutia et al.’131 discloses a blood drawing device for collecting a blood sample from a patient, the blood drawing device comprising: a disposable collection cartridge 22 (section [0048]: “The arrangement 10 can comprise a plurality of skin penetration members 22. According to certain embodiments, the plurality of skin penetration members 22 can be provided in the form of a replaceable cartridge.”), the disposable collection cartridge comprising: a housing 24, a puncture element 22 (sections [0047], [0051-0052]), and a fluid container 24 (sections [0051-0052]); and a reusable actuation device (Figure 2, actuation catalyst device 14) releasably coupled to the disposable collection cartridge, the reusable actuation device comprising: a vacuum source in fluid communication with the disposable collection cartridge (sections [0043], [0052]: “The blood or body fluid 32 is drawn though the inner lumen by any suitable mechanism, such as capillary action, vacuum, or a combination of both.”).
Escutia et al.’131 discloses all of the elements of the current invention, as discussed above, except for the reusable actuation device comprising a controller in electronic communication with the disposable collection cartridge and a power source in electronic communication with the disposable collection cartridge. It is noted that section [0050] discloses that the device of Escutia et al.’131 may operate in a fully automatic mode. This would require the puncture element of the disposable collection cartridge to be driven towards the patient’s skin automatically. Section [0048] discloses that the disposable collection cartridge is driven into the patient’s skin using an actuation element 26, wherein the actuation element may comprise an electrical element. One of ordinary skill in the art would have realized that in order to automatically drive the puncture element of the disposable collection cartridge into the skin of the patient using an electrical actuation element, a controller would need to control/be in electrical communication with the actuation element. That controller would be in communication with the disposable collection cartridge as the actuation element is in electrical communication with the disposable collection cartridge.
Furthermore, Qin et al.’267 teaches that electronic actuators can be used to control the movement of a needle assembly and or a vacuum device in a blood drawing device (section [0066]). Qin et al.’267 specifically teaches that a spring used to actuate a puncture element may be replaced by an electronic actuator. It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have substituted an electronic actuator in communication with the disposable collection cartridge for the spring in communication with the disposable collection cartridge (Escutia et al.’131 also teaches using a spring as actuation element 26 in section [0048]), as it would merely be the simple substitution of one known puncture element activation means for another to obtain predictable results.
Regarding the limitation that the reusable actuation device comprises a power source in electronic communication with the disposable collection cartridge, Official notice is being taken that a power source would need to be in electronic communication with the controller in order to provide power to the controller (section [0005] of Nishida et al.’777 – US Pub No. 2010/0150777 – teaches that conventional blood testing devices comprise a power source that supplies power to the circuits/electronic components of the blood testing devices).
Regarding claim 11, Escutia et al.’131 discloses that the vacuum source is a vacuum pump configured to provide vacuum proximate a target area while the puncture element is in a retracted position and during movement of the puncture element into an extended position (sections [0039], [0043], [0045], [0056]).
Regarding claims 12 and 13, while Escutia et al.’131 is silent with regard to the pressure profile(s) provided by the vacuum pump, it would have been obvious to try using either a fixed predetermined profile of pressure or one or more variable vacuum profiles as this would be choosing from a finite number of identified, predictable solutions (either a fixed profile or a variable profile), with a reasonable expectation of success.
Regarding claim 15, it is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed shape of the fluid container. The configuration of the fluid container including a lip extending axially from an end portion thereof is considered a matter of obvious design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed fluid container was significant (MPEP 2144.04 IV. B.).
Regarding claim 16, Escutia et al.’131 discloses that the blood drawing device further comprises a fluid reservoir, the fluid reservoir comprising a liquid reagent, wherein the liquid reagent treats the blood during collection of the blood sample (sections [0048], [0051]).
Regarding claim 17, the liquid reagent comprises an acceptable testing or anticoagulant reagent (sections [0048], [0051]).
Regarding claim 18, Escutia et al.’131 discloses that the puncture element includes one or more lancets (section [0047]).
Regarding claim 19, by virtue of the vacuum pump of Escutia et al.’131 providing a negative pressure within the disposable collection cartridge before, during, and/or after lancing (sections [0039], [0043]), air is continuously being pumped out of the disposable collection cartridge before and during collection of the blood sample.
Regarding claim 21, it is noted that Applicant has failed to provide details of criticality or unexpected results in the specification with regard to the particularly claimed orientation/shape of the fluid container with respect to the puncture element. The configuration of the fluid container being positioned at an oblique angle relative to the puncture element is considered a matter of obvious design choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed fluid container and puncture element was significant (MPEP 2144.04 IV. B.).
Claims 8 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Escutia et al.’131 in view of Qin et al.’267, as applied to claim 1, further in view of Diebold et al.’318 (US Pub No. 2019/0142318).
Regarding claim 8, Escutia et al.’131 in view of Qin et al.’267 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the disposable collection cartridge including an adhesive tape, and wherein an aperture of the disposable collection cartridge includes an anticoagulation film. Qin et al.’267 teaches a disposable collection cartridge including an adhesive tape, the adhesive tape being used to adhere an absorbent pad to a puncture element (section [0089]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the absorbent pad of Escutia et al.’131 (absorbent pad 34 of sections [0048], [0051]) to include an adhesive tape that adheres the pad to the puncture element, as it would merely be combining prior art elements according to known methods to yield predictable results.
Diebold et al.’318 teaches providing an anticoagulant film within an aperture of a puncture element to prevent a patient’s blood from coagulating (section [0046]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the disposable collection cartridge of Escutia et al.’131 in view of Qin et al.’267 such that an aperture of the disposable collection cartridge (the hollow space within the puncture element) includes an anticoagulation film, as this would prevent the patient’s blood from coagulating.
Regarding claim 14, Escutia et al.’131 discloses that the fluid container includes a capillary channel in fluid communication with an open end of the fluid container (section [0052]). As modified by Diebold et al.’318, the same capillary channel would also include an anticoagulation agent to prevent the patient’s blood from coagulating.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Escutia et al.’131 in view of Qin et al.’267, as applied to claim 1, further in view of Braig et al.’828 (US Pub No. 2018/0317828) further in view of Inaba et al.’865 (USPN 5,035,865).
Escutia et al.’131 in view of Qin et al.’267 discloses all of the elements of the current invention, as discussed in paragraph 9 above, and also discloses a controller configured to control the vacuum pump (one of ordinary skill in the art would have found it obvious that the automatic vacuum pump is controlled by a controller); a mechanical actuation system configured to actuate the puncture element (as discussed with regard to claim 1); and a sample detection sensor disposed within the fluid container (reagent pad 34 or detector 36 of Escutia et al.’131).
Escutia et al.’131 in view of Qin et al.’267 discloses all of the elements of the current invention, as discussed above, except for a temperature sensor coupled to a heating element. It is noted that Escutia et al.’131 teaches use of a heating element to help with blood sampling (sections [0039], [0042]). Braig et al.’828 teaches using a temperature sensor in communication with a heating element in order to provide temperature feedback to the heating element based on a temperature detected by the temperature sensor and a desired temperature, thus ensuring a desired temperature is maintained (sections [0078], [0112-0113]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood drawing device of Escutia et al.’131 in view of Qin et al.’267 to include a temperature sensor coupled to a heating element, as taught by Braig et al.’828, as it would allow feedback control of the heating element. The modification to Escutia et al.’131 in view of Qin et al.’267 would help ensure that a proper amount of heat is provided by the heating element to the skin of the patient. It is noted that the temperature sensor would inherently be coupled to a controller, the controller configured to adjust the temperature of the heating element based on the temperature detected by the temperature sensor and the desired temperature.
Escutia et al.’131 in view of Qin et al.’267 further in view of Braig et al.’828 discloses all of the elements of the current invention, as discussed above, except for a pressure sensor disposed within the disposable collection cartridge. Inaba et al.’865 teaches providing a pressure sensor within a blood sampling chamber in order to ensure that a proper pressure is being provided within the blood sampling chamber by a vacuum pump (col. 2, lines 22-37). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood drawing device of Escutia et al.’131 in view of Qin et al.’267 further in view of Braig et al.’828 to include a pressure sensor disposed within the disposable collection cartridge, as this would help ensure that a proper pressure is being provided within the fluid container by the vacuum source.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Escutia et al.’131 in view of Qin et al.’267 further in view of Braig et al.’828 further in view of Inaba et al.’865, as applied to claim 9, further in view of Fehlau et al.’153 (USPN 4,210,153).
Escutia et al.’131 in view of Qin et al.’267 further in view of Braig et al.’828 further in view of Inaba et al.’865 discloses all of the elements of the current invention, as discussed in paragraph 11 above, except for the reusable actuating device comprising an adjustable knob coupled to the controller and configured to control the desired temperature of the heating element. Fehlau et al.’153 teaches using a knob coupled to a controller to allow a user to input a desired temperature of a system (col. 5, lines 21-30). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood drawing device of Escutia et al.’131 in view of Qin et al.’267 further in view of Braig et al.’828 further in view of Inaba et al.’865 to include an adjustable knob coupled to the controller of the reusable actuation device and configured to control the desired temperature of the heating element, as it would merely be combining prior art elements according to known methods to yield predictable results. The modification to Escutia et al.’131 in view of Qin et al.’267 further in view of Braig et al.’828 further in view of Inaba et al.’865 would allow a user to set a desired heating element temperature.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Escutia et al.’131 in view of Qin et al.’267, as applied to claim 1, further in view of Samsoondar’259 (US Pub No. 2006/0228259).
Regarding claim 20, Escutia et al.’131 in view of Qin et al.’267 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the fluid container being coupled to the disposable collection cartridge by a threaded coupling. Samsoondar’259 teaches that a fluid container may be coupled to a disposable collection cartridge by a threaded coupling (sections [0157-0158]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the blood drawing device of Escutia et al.’131 in view of Qin et al.’267 such that its fluid container is coupled to the disposable collection cartridge by a threaded coupling, as it would merely be combining prior art elements according to known methods to yield predictable results.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections:
Regarding claims 2-4, none of the prior art discloses or suggests, either alone or in combination, a blood drawing device wherein a disposable collection cartridge of the blood drawing device comprises a heating element coupled to a surface of a housing of the disposable collection cartridge extending from a reusable actuation device, in combination with the other claimed elements.
Regarding claims 5-7, none of the prior art discloses or suggests, either alone or in combination, a blood drawing device comprising a heating element, wherein the heating element includes a flexible printed circuit board that includes an aperture, and further wherein a puncture element of the blood drawing device extends through the aperture when the puncture element is in an extended position, in combination with the other claimed elements.
Regarding claim 22, none of the prior art discloses or suggests, either alone or in combination, a blood drawing device comprising a heating element, wherein the heating element includes a flexible printed circuit board that includes an aperture, and further wherein a puncture element of the blood drawing device extends through the aperture when the puncture element is in an extended position, in combination with the other claimed elements.
Claims 2-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 22 is allowed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hsiung et al.’954 (US Pub No. 2017/0332954) provides motivation to modify Escutia in view of Qin such that its fluid container includes a capillary channel in fluid communication with an open end of the fluid container (capillary channel 14 of Figures 1, 3, and 4).
Breteau et al.’335 (US Pub No. 2017/0035335) teaches a heating element that includes a flexible printed circuit board and a compliant layer (section [0081]).
Prausnitz et al.’180 (US Pub No. 2015/0209180) provides motivation to modify Escutia in view of Qin such that its fluid container is coupled to the disposable collection cartridge by a threaded coupling (section [0082]).
Harman et al.’956 (US Pub No. 2007/0232956) teaches that movement of a puncture element may be performed and controlled by manual operation, spring force, pneumatic force, hydraulic force, electrical force motorized operation under automatic control or a combination of the above (section [0105]).
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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