DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
As set forth previously, for purposes of prior art, the claim(s) are examined with an earliest priority date of 5/13/10.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 149-155, 157, 159, 160, 162, 164, 165, 167, and 169-175 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Frederickson (US 20100222743 A1) in view of Cunningham (US 20020169393 A1).
For claim(s) 149, 159, 160, and 175 Frederickson teaches A device for withdrawing blood from the skin and/or from beneath the skin of a subject [entire disclosure – see at least abstract], the device comprising:
an opening [132] configured to receive blood from the skin of a subject into the device;
a flexible concave member / reversibly deformable structure [122, 166],
wherein the flexible concave member / reversibly deformable structure is moveable between a first configuration and a second configuration upon actuation of the device; [Figs. 6c-e]
a volume of space enclosed beneath the reversibly deformable structure, [space between 132 and 174]
wherein the volume of space is configured to decrease as the reversibly deformable structure moves from the first configuration to the second configuration; [Fig(s). 6c-e]
at least one cutter [174], wherein the at least one cutter is in a first position before actuation of the device and in a second position after actuation of the device, [Figs. 6c-e]
wherein, upon actuation of the device, the at least one cutter moves from the first position to the second position at a speed of at least 1 cm/s [¶56]
wherein the flexible concave member is configured to be in the second configuration when the at least one cutter is inserted into the skin, [Fig(s). 6C]
and wherein at least a portion of the flexible concave member is concave up away from the opening in the second configuration [Fig(s). 6C with 122 concave in a ‘second configuration’]
wherein in the first position, the at least one cutter extends in a direction perpendicular to the opening [shown in Fig(s). 6C where 174 is ‘extending in a direction’ (e.g., positioned along an axis) perpendicular to the horizontal face having opening 132]
Frederickson fails to teach the retraction mechanism configured to move the at least one cutter away from the skin.
Cunningham teaches a device for withdrawing blood from a subject [abstract] including a retraction mechanism [68] configured to move a cutter away from a subject’s skin.
It would have been obvious to one of ordinary skill at the time the invention was made to modify the device of Frederickson to incorporate the retraction mechanism of Cunningham in order to increase the comfort and reliability of blood sampling. As motivated by Cunningham ¶¶10-13, Frederickson ¶33.
For claim(s) 150 and 161, Frederickson teaches The device of claim 149,
wherein actuation of the device causes the at least one cutter from the first position to the second position at a speed of at least 10 cm/s. [¶56]
For claim(s) 151 and 159, Frederickson teaches The device of claim 149,
wherein actuation of the device causes the at least one cutter to move from the first position to the second position at a speed of an acceleration of at least 100,000 meters/second2. [the structure of Frederickson is capable of such an acceleration]
For claim(s) 152 and 162, Frederickson teaches The device of claim 149, wherein the first position and the second position of the at least one cutter are separated by a distance of no more than 5 mm. [there are at least two positions of 166 and 174 between the positions of Figs. 6c-e that are 5 mm apart]
For claim(s) 153 and 163, Frederickson teaches The device of claim 149, wherein the actuator is able to move the at least one cutter from the first position to the second position in a period of time of less than 0.002 seconds. [the structure of Frederickson is capable of such a movement interval]
For claim(s) 154 and 164, Frederickson teaches The device of claim 149, wherein the actuator is able to move the at least one cutter from the first position to the second position with a force sufficient to insert the at least one cutter into the skin to a depth of at least 60% of the length of the at least one cutter. [full insertion shown in Fig. 6f]
For claim(s) 155 and 165, Frederickson teaches The device of claim 149, wherein the at least one cutter is a microcutter. [¶50]
For claim(s) 156 and 166, Frederickson teaches The device of claim 149, wherein the device is configured such that movement of the flexible concave member from the first configuration to the second configuration inserts the at least one cutter into the subject's skin. [Figs. 6c-f]
For claim(s) 157 and 167, Frederickson teaches The device of claim 149, wherein the device is configured such that movement of the flexible concave member from the first configuration to the second configuration and moves the at least one cutter from the first position to the second position. [Figs. 6c-e]
For claim(s) 170 and 173, Frederickson teaches
wherein the flexible concave member is configured to be pushed using a hand or a finger contacting the flexible concave member directly. [¶49]
For claim(s) 171 and 174, Frederickson teaches
wherein in the first configuration, the flexible concave member has a dome shape. [137 in Fig(s). 6B]
For claim(s) 169 and 172, the motivated combination of Frederickson and Cunningham teaches
wherein the flexible concave member is configured to spontaneously return from the second configuration back to the first configuration after force to the flexible concave member is removed. [via spring 68 of Cunningham in the structure of Frederickson] As motivated in claim(s) 149 and 159.
Response to Arguments
Applicant's arguments filed 4/6/26 have been fully considered but they are not persuasive.
Applicant argues in remarks p. 7 that Frederickson fails to teach a flexible member concave away from the opening in the second configuration. Examiner respectfully disagrees. Housing 122 of Frederickson can be considered to constitute(s), under BRI, a part of the flexible member which then remains concave (122 shown as concave in Fig(s). 6e with 174 deployed).
Applicant argues in remarks p. 8 that Frederickson fails to teach the cutter extending in a direction perpendicular to the opening in the first position. Examiner respectfully disagrees. An annotated Frederickson Fig(s). 6c shows that there is at least some axis along which cutter 174 is arranged that would make it perpendicular to at least some plane of opening 132 in a first position.
PNG
media_image1.png
360
724
media_image1.png
Greyscale
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).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
Prosecution Insights