DETAILED ACTION
This office action is responsive to the supplemental amendment filed 3/26/2026. Claims 17, 19-23, 28, and 30-33 remain pending and under prosecution.
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 .
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim elements are interpreted under 112(f).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 17, 19, 28, 30, 31 is/are rejected under 35 U.S.C. 103 as being obvious over Kelly et al (US Pub No. 20160287155) in view of Tamir (US Pub No. 20100261988).
In regard to Claim 17, Kelly et al (‘2016) disclose an integrated test unit comprising a blood collection unit 28 (0035 -- capillary) adapted to receive a sample of blood;
a test component 60 (0036);
a reservoir containing test fluid 40 located directly below actuator mechanism 26
(0033), best seen in Figure 3;
an actuator (defined by both depressible section 26 and arm 25); and
wherein: the blood collection unit is adapted to move and thereby deliver the sample of blood directly to the test component via a channel having an outlet 20, best seen in Figure 4C – “After the collecting device is filled, the arm 25 may then be rotated… into a delivery position. The collection device is then in contact, via opening 20, with test material 60, and the sample is discharged onto test material 60” (0036);
the reservoir is adapted to release the test fluid directly to the test component by exerting a force upon the reservoir – “The user may then depress section 26, which applies pressure to sachet 40 so that the test fluid 41 is released” (0037) – so that the test fluid is discharged onto the test component via a discharge opening 51, the discharge opening being separate from the outlet 20 of the channel – “When the fluid discharges from the sachet 40, it is collected in vessel 50, via discharge conduit 52. Vessel 50 has an opening 51 in its bottom wall, which discharges directly onto area 61 of the test material 60,” best seen in Figure 5 (0041),
the arrangement is such that the sample of blood and the test fluid have independent fluid paths to the test component because outlet 20 and opening 51 are distinct and separate.
However, Kelly et al do not expressly disclose the mechanisms of movement of the blood collection unit to deliver the sample of blood to the test component and discharging the test fluid from the discharge opening onto the test component are performed by a single depression of a single actuator, since it has been defined above by two separate components above.
Tamir teach that it is well-known in the art to provide an analogous integrated test unit comprising a single actuator that after activation, simultaneously moves the blood collection unit to deliver the sample of blood to the test component – “Simultaneously, the blood holding element is moved from its position in FIG. 3A to the position in FIG. 38 (aligned vertically below the reagent holding element and above the test strip)” (0109), and
discharges the test fluid onto the test strip – “There may be a reagent measuring element 272 (not shown), which limits the transfer of the reagent to the strip to be of a maximal volumetric quantity. [0117] 8. The certain volumetric quantity of blood then falls onto the test strip. [0118] 9. If a reagent is required for the particular test, the maximal volumetric quantity of the reagent falls onto the strip. It should be understood that steps 8 and 9 may occur simultaneously… [0119] 10. Within a number of seconds the strip, blood and optional reagent interact automatically thereby performing the test” (0109).
This occurs after actuation of the lancing of the finger – “the lancet housing element 230 is pressed upwards or activated by a spring element (not shown), depending on the particular design thereof. [0113] 4. The fleshy pouch is pierced by the lancet. [0114] 5. Blood accumulates within the device, typically within blood holding element 280. [0115] 6. Blood holding element 280 is in fluid contact with a calibration window 284, which shows the user when sufficient blood has accumulated for the purpose of the test. [0116] 7. The user then retracts the lancet and releases his finger by opening the clasp and withdrawing the finger from the finger straightening element 202. In so doing, this brings forward the test strip conveying element 210 from the position in FIG. 2A, to a position as seen in FIG. 38. Simultaneously, the blood holding element is moved from its position in FIG. 3A to the position in FIG. 38 (aligned vertically below the reagent holding element and above the test strip). Additionally, there may be a blood sampling element 282, which limits the transfer of blood to the test strip to a certain volumetric quantity (two drops, for example)” (0109).
Tami thus teach that simultaneous actuation of the blood sample onto the test strip along with the reagent onto the test strip advantageously reduces inaccuracy from user mistake – “ simultaneous operations of sampling and testing inherently might reduce the accuracy of the measurement resulting from inaccuracies caused by user mistakes and variations resulting from fear induced by a blood drawing scenario” (0154).
The simultaneous execution of both the actuation of the blood sample onto the test strip along with the reagent onto the test strip constitutes “a single depression of the single actuator” as broadly as has been recited.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al (‘2016) such that there is a single actuator by a single depression during operation causes both movement of the blood collection unit to deliver the sample of blood to the test component and exerts a force upon the reservoir so that the test fluid is discharged from the discharge opening onto the test component as taught by Tamir as broadly as has been claimed and when combined with Kelly et al, which positions the reservoir containing test fluid directly below the actuator of Kelly et al already, to advantageously combine both functions of movement of the blood collection unit to deliver the sample of blood to the test component and discharging the test fluid from the discharge opening onto the test component so that they are performed by a single actuator with a single depression to prevent user mistakes, and especially since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Also, Howard v. Detroit Stove Works, 150 U.S. 164 (1893). See MPEP 2144.04.
19. Kelly et al (‘2016) disclose an integrated test unit according to claim 17, wherein in response to activation of the single actuator 25 as modified above, the blood collection unit tilts into a delivery position so as to deliver the blood to the test component, best seen in Figure 4b-c (0036).
28. Kelly et al (‘2016) disclose an integrated test unit, including a blood collection recess 28 (capillary 0035), the recess being adapted to directly receive the blood from a user (0133, 0136), the recess including a channel in the capillary which operatively progressively fills with blood, such that when the channel is full it provides a visual indication to the user that sufficient blood has been received to conduct a test, i.e. user can observe the blood in the capillary.
30. Kelly et al (‘2016) disclose an integrated test unit according to claim 28, wherein the blood collection unit is adapted to tilt downward to place an end of the channel (capillary) adjacent to the test component, so that the blood flows from the channel to the test component, best seen in Figure 4b-c (0036, 0045).
31. Kelly et al (‘2016) disclose an integrated blood test unit according to claim 30, wherein the integrated blood test unit is arranged so that in operation the blood is delivered to the test component at an area, and the test fluid is delivered to the test component at a second area, so that the test fluid is delivered behind the blood so that the test fluid can drive the movement of the blood for use in the test component, wherein the position of “behind” is relative and Kelly et al necessarily provides for the blood flowing toward the test fluid as would be expected for test reaction, and thus the test fluid is delivered behind the blood as claimed.
Claim 20 is/are rejected under 35 U.S.C. 103 as being obvious over Kelly et al (‘2016) in view of Tamir as applied to claim 17, further in view of Brenneman et al (US Pub No. 20090326355).
Kelly et al (‘2016) in combination with Tamir disclose the invention above but do not expressly disclose the test unit further includes an electronic component, and the electronic component is made operative by activation of the actuator.
Brenneman et al teach that it is well-known in the art to provide an analogous sampling device comprising a test unit with an electronic component 222, and the electronic component is made operative by activation of the actuator to sequentially activate use of the sensor and the electronics after actuation as necessary in the process (0054, 0093).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al (‘2016) as modified by Tamir such that the test unit further includes an electronic component, and the electronic component is made operative by activation of the actuator as taught by Brenneman et al to sequentially activate the electronic component after activation of the activator for sensor analysis.
Claims 21-22 and 32 is/are rejected under 35 U.S.C. 103 as being obvious over Kelly et al (‘2016) in view of Tamir as applied to claim 18, further in view of Garcia (US Pat No. 4627445).
In regard to Claim 21 and 32, Kelly et al (‘2016) in combination with Tamir disclose the invention above but do not expressly disclose the actuator is locked into an actuated position once operated.
Garcia teach an analogous integrated test unit comprising a latch that prevents a component, i.e. actuator 310 from moving by locking the actuator into place after it is activated until the next desired step, i.e. activating the button 314 releases the latch for puncture of the user, best seen in Figure 9 (Col.10: 62-Col.11: 24).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al (‘2016) as modified by Tamir such that the actuator is locked into an actuated position once activated using a latch, as taught by Garcia, to effectively lock the device until the next desired step, such that in combination, Kelly et al as modified teaches in a sample collection position the blood collection unit is biased towards the test component (Figure 4a-c) but prevented from delivering the blood to the test component by a latch as taught by Garcia, and wherein operatively, activation of the actuator releases the latch and allows the blood collection unit to move to a sample delivery position, so that blood is delivered to the test component, wherein it would be obvious to provide a latch for the locking of other steps such as the movement of the blood collection unit as well.
22. Kelly et al (‘2016) disclose the locked actuator exerts a continuing force so as to compress the reservoir in order to dispense the test fluid onto the test component (0037).
Claim 23 is/are rejected under 35 U.S.C. 103 as being obvious over Kelly et al (‘2016) in view of Tamir, further in view of Kelly et al (US Pub No. 20140236044).
Kelly et al (‘2016) in combination with Tamir disclose the invention above including lancet 30 and an interlock such that the test fluid cannot be released until the blood collection unit is moved to a delivery position (0043-0045) but do not expressly disclose the blood collection unit cannot move to a delivery position until after the lancet has been discharged.
Kelly et al (‘2014) teach that it is well-known in the art to provide an analogous sampling device wherein the blood collection unit cannot be moved to a delivery position until after the lancet has been discharged to maintain the sequential nature of the process (0145).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al (‘2016) as modified by Tamir such that the blood collection unit cannot be moved to a delivery position until after the lancet has been discharged as taught by Kelly et al (‘2014) and therefore in combination, the test fluid cannot be released until after the lancet has been discharged to maintain the sequential nature of the process.
Claim 33 is/are rejected under 35 U.S.C. 103 as being obvious over Kelly et al (‘2016) in view of Tamir, further in view of Perez et al (US Pub No. 20020188223).
Kelly et al (‘2016) in combination with Tamir disclose the invention above but do not expressly disclose the test unit further includes a transparent window located so that each visual indication by the test component is visible.
Perez et al teach that it is well-known in the art to provide an analogous integrated test unit that includes a transparent window 325 to allow the test strip and its reaction to be observed by the user (0115). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Kelly et al (‘2016) as modified by Tamir such that there is included a transparent window located as taught by Perez et al so that each visual indication by the test component is visible to the user.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive. Applicant contends that Tamir does not disclose a single depression of a single actuator to cause both the two actions cited because retraction of the finger does not cause said actions and retraction of the finger does not cause a depression of an actuator in Tamir, and that retraction of the finger teaches away from depression of an actuator (Remarks pg. 7-8).
However, it appears that applicant is not addressing the art as cited. Tamir clearly discloses that the device is actuated, necessarily by an actuator even if not shown, to lance the finger and collect blood – “the lancet housing element 230 is pressed upwards or activated by a spring element (not shown), depending on the particular design thereof. [0113] 4. The fleshy pouch is pierced by the lancet” (0109). In other words, the actuator structure is inherent in Tamir.
The retraction of the finger afterwards does not detract or add an extra step outside of “a single depression of a single actuator” as broadly as has been claimed because the movement of the finger does not constitute said depression of the single actuator of Tamir. Tamir is thus set forth to show that an actuator of sorts can “simultaneously” with “a single depression” – since it occurs simultaneously in one actuation – deliver the sample of blood to the test component and allow the test fluid to be discharged from the discharge opening onto the test component. It is also noted that where Tamir recites Figure 38, it is believed that the reference means to recite Figure 3B, since Figure 3A is already referenced.
It is noted that the claims do not structurally define any specifics regarding the actuator and how it must be connected to the reservoir and test component to perform the two actions with a single depression of the single actuator. Accordingly, no such details are required in Tamir. Additionally, the “comprising” nature of the claims do not preclude the addition of other details in the art, including retraction of the finger. It is further noted that retraction of the finger necessarily occurs in every lancing procedure, so it is not unique. As such, disclosure of Tamir to point out said finger retraction is not the mechanism behind which the sample of blood is delivered to the test component and allows the test fluid to be discharged from the discharge opening onto the test component.
Applicant contends that the actuation mechanism of Tamir “does not result in discharge of the test fluid, which is recited in Claim 17” (Remarks pg.8). However, it is unclear why applicant states this as Tamir explicitly states the actuation of the device above results in the discharge of the test fluid – “If a reagent is required for the particular test, the maximal volumetric quantity of the reagent falls onto the strip. It should be understood that steps 8 and 9 may occur simultaneously… [0119] 10. Within a number of seconds the strip, blood and optional reagent interact automatically thereby performing the test” (0109).
Lastly, since Kelly et al already disclose all of the structure of the device as claimed including the two functions, the broad recitation of a single depression of a single actuator to perform both said steps is made obvious in light of Tamir, as well as the case law cited. Thus, Tamir does not need to disclose the structure of the reservoir or the fluid paths as claimed or any specifics to structurally modify Kelly et al (Remarks pg. 8), especially as the claims do not recite any structural details required to specifically enable the actuator to have the sample of blood is delivered to the test component and the test fluid to be discharged from the discharge opening onto the test component. It is noted that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, the rejection is maintained.
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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