DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on April 14, 2026 were received and fully considered. Claims 51and 65 were amended. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 51-59 and 61-71 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Garcia et al. (US Patent No. 4637403) (hereinafter “Garcia”) in view of Dombrowski (US Patent No. 4653513).
Garcia and Dombrowski were applied in the previous office action.
With respect to claim 51, Garcia teaches a device for receiving fluid from a subject, comprising: a housing having an opening through which fluid is received from the subject (Fig. 4 shows a device for collecting a blood sample; housing 12 and opening at bottom contacts patient’s finger); a flow activator (needle 90) being arranged to cause fluid to be released from the subject (column 7, lines 36-46, further note that the limitation flow activator arranged to cause fluid to be released from the subject invokes 112(f), page 12 of the specification indicates the flow activator 90 includes one or more needles, as needle 90 of Garcia is disclosed as puncturing the finger to draw blood from capillaries needle 90 of Garcia reads on the flow activator of the claim); a vacuum source (column 7, lines 40-46 with regard release of diaphragm 49 creating a vacuum which draws blood through needle 90); a deployment actuator configured to move the flow activator in a deployment direction from a pre-deployment position to a deployed position (col.7, lines 24-40 which discloses that spring 44 is in a compressed state and once released drives core 34, housing core 46, probe 12 and needle 90 downwardly to puncture the finger); and a retraction actuator configured to move the flow activator in a retraction direction from the deployed position to a post-retraction position (needle is moved upwards and away from finger prior to pricking the patient’s finger; see Figs. 8-10).
However, Garcia does not explicitly teach the pre-deployment position of the flow activator is different than the post-retraction position of the flow activator.
Dombrowski teaches a blood sampler (title) and a flow activator (lancet 29) that can be arranged in various positions including a pre-deployment position of the flow activator that is different than a post-retraction position of the flow activator (Figs. 1-2 show lancet 29 can be arranged in multiple different positions via slots 60, 62, 64, 66, 72 and springs 42/44 for the purpose of retracting/pre-deploying and unretracting/post-retracting the lancet 29 with respect to the patient’s skin; see also col. 4, lines 16+ “unretracted position… to the retracted position”, which expressly disclose that these positions are different).
Therefore, it would have been obvious to person having ordinary skill in the art (“PHOSITA”) at the time of invention to modify Garcia to utilize internal slots and springs in the housing to allow the flow activator placed in different positions/distances as desired by the operator, as evidence by Dombrowksi (see Figs. 1-2). Additionally, PHOSITA would have had predictable success combining Garcia and Dombrowski as both teachings relate to the same narrow field of endeavor, i.e., blood collection devices with disposable lancets.
With respect to claims 52 and 66, Garcia teaches the deployment actuator comprises a spring (spring 44, as set forth above).
With respect to claims 53 and 67, Garcia teaches the retraction actuator comprises a spring (spring 42, as set forth above).
With respect to claim 54, Garcia teaches vacuum is generated from the vacuum source during actuation of the device (column 7, lines 40-46).
With respect to claims 55 and 68, Garcia teaches vacuum from the vacuum source is created manually (column 7, lines 40-46).
With respect to claims 56 and 69, Garcia teaches the flow activator comprises at least one needle (needle 90, as set forth above).
With respect to claims 57, 70, and 71, Garcia teaches the at least one needle comprises a plurality of needles/microneedles (col. 2, lines 62-63).
With respect to claim 58, Garcia teaches a device interface that provides a seal against skin (Fig. 4).
With respect to claim 59, Garcia teaches the device interface comprises an adhesive (col.14, lines 7+).
With respect to claim 60, Garcia teaches movement of the device actuator in the deployment direction causes the release to move in the deployment direction (col.7, lines 29-40).
With respect to claim 61, Garcia teaches the actuation of the device actuator comprises pushing down on the device actuator (col.3, lines 55-57).
With respect to claim 62, Garcia teaches a user pressing down on the device actuator causes the retraction actuator to be compressed (col.3, lines 55-57; col.7, lines 24+).
With respect to claim 63, Garcia teaches the retraction actuator is configured to move the deployment actuator in the retraction direction (col.7, lines 46-48).
With respect to claim 64, Garcia teaches the deployment actuator moves the flow activator a first distance, and the retraction actuator moves the flow activator a second distance, the first distance between shorter than the second distance (col.7, lines 24+).
With respect to claim 65, Garcia teaches a device for receiving fluid from a subject, comprising: a housing having an opening through which fluid is received from the subject (Fig. 4 shows a device for collecting a blood sample; housing 12 and opening at bottom contacts patient’s finger); a device actuator (96; column 7 lines 29-37); a flow activator (needle 90) being arranged to cause fluid to be released from the subject (column 7, lines 36-46, further note that the limitation flow activator arranged to cause fluid to be released from the subject invokes 112(f), page 12 of the specification indicates the flow activator 90 includes one or more needles, as needle 90 of Garcia is disclosed as puncturing the finger to draw blood from capillaries needle 90 of Garcia reads on the flow activator of the claim); a vacuum source (column 7, lines 40-46 with regard release of diaphragm 49 creating a vacuum which draws blood through needle 90); a deployment actuator configured to move the flow activator in a deployment direction from a pre-deployment position (col.7, lines 24-40 which discloses that spring 44 is in a compressed state and once released drives core 34, housing core 46, probe 12 and needle 90 downwardly to puncture the finger); and a retraction actuator configured to move the flow activator in a retraction direction to a post-retraction position (needle is moved upwards and away from finger prior to pricking the patient’s finger; see Figs. 8-10).
However, Garcia does not explicitly teach a distance between the opening and the flow activator when the flow activator is in the pre-deployment position is different than a distance between the opening and the flow activator when the flow activator is in the post-retraction position.
Dombrowski teaches a blood sampler (title) and a flow activator (lancet 29) that can be arranged in various positions including a distance between the opening and the flow activator when the flow activator is in the pre-deployment position is different than a distance between the opening and the flow activator when the flow activator is in the post-retraction position (see Figs. 1-2, which shows slot portions 60, 62, 64, 66, 72 and springs 42/44 that allow the flow activator to be oriented at various different positions/distances for the purpose of retracting/pre-deploying and unretracting/post-retracting the lancet 29 with respect to the patient’s skin; see also col. 4, lines 16+ “unretracted position… to the retracted position”, which expressly disclose that these positions/distances are different).
Therefore, it would have been obvious to person having ordinary skill in the art (“PHOSITA”) at the time of invention to modify Garcia to utilize internal slots and springs in the housing to allow the flow activator placed in different positions/distances as desired by the operator, as evidence by Dombrowksi (see Figs. 1-2). Additionally, PHOSITA would have had predictable success combining Garcia and Dombrowski as both teachings relate to the same narrow field of endeavor, i.e., blood collection devices with disposable lancets.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been considered, but they were not persuasive. Applicant argues that Garcia and Dombrowski do not teach and/or suggest a deployment actuator configured to move the flow activator in a deployment direction from a pre-deployment position to a deployed position; and a retraction actuator configured to move the flow activator in a retraction direction from the deployed position to a post-retraction position, as amended. More specifically, applicant takes issue with Dombrowski, the maintained secondary reference, and argues that Dombrowski’s slots 60, 62, 64, 66, 72 do not inherently or expressly disclose that the pre-deployment position of the flow activator is different than the post-retraction position of the flow activator. Examiner respectfully disagrees. Examiner maintains that Dombrowski’s actuators (springs 42/44) allow for flow activator (needle 29) to move along multiple different positions (slots 60, 62, 64, 66, 72), as desired by the user. These multiple different positions allow the flow activator to be deployed, retracted, loaded, etc., which, when taking into consideration broadest reasonable interpretation, equates to the claimed pre-deployment position, deployed position, and post-retraction position. Examiner further argues that nothing prevents the user from operating Dombrowski’s device from a pre-deployment position to a deployed position and/or from the deployed position to a post-retraction position, as amended. Furthermore, and as originally cited in the previous office action, it is known to deploy or retract a flow activator to one of several desired positions. See prior art of record section immediately below for additional example teaching(s). For at least these reasons, the 35 USC 103 rejections are maintained. Please see prior art section above for more detail.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Previously cited:
US PG Pub. No. 2003/0195502 A1, see par.0022 “manually manipulated to deploy or retract the needles and to a desired position”
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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