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 September 25, 2025 were received and fully considered. Claims 51, 65, and 71 were amended. Please see corresponding rejection headings and response to arguments section below for more detail.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 25, 2025 has been entered.
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 (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 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 appears to argue that Dombrowski, the maintained secondary reference, does not teach and/or suggest the pre-deployment position of the flow activator is different than the post-retraction position of the flow activator. Examiner respectfully disagrees. As clearly depicted in Figs. 1-2, Dombrowski teaches a flow activator (lancet 29) that can be arranged in multiple different positions/locations (retracting/pre-deploying and unretracting/post-retracting) via slot portions 60, 62, 64, 66, 72 and springs 42/44. While the instant claims recite “pre-deployment position” and “post-retracted position”, Examiner argues that these terms provide no structural distinction over Dombrowski’s assembly when taking into consideration broadest reasonable interpretation1.
For purposes of compact prosecution, Examiner also cites additional reference(s), not relied upon, that set forth the concept of a pre-deployment position/distance and a post-retraction position/distance between the opening and the flow activator. See prior art of record section immediately below.
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 Applying BRI, Examiner interprets that Dombrowski’s teaching of retracting the flow activator 29 to a position equates to a pre-deployment position; and unretracting the flow activator 29 to a different position equates to post-retraction position.