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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 4/23/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
Claim Rejections - 35 USC § 112(b)
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 7 and 12 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.
The term “substantially smaller” in claim 7 is a relative term which renders the claim indefinite. The term “substantially smaller” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claimed invention is indeterminate with respect to the infinite possibilities of required degree of size differential required or excluded to be considered “substantially smaller” when considering the relative sizes of the diameter and width of the microchannel of the blade.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 12 recites the broad recitation “a tip radius smaller than 20 µm”, and the claim also recites “preferably smaller than 5 µm, more preferably smaller than 1 µm” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-8, 10, 12-14, 17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freemen et al. (US 5,938,679, hereinafter Freeman).
For claim 1, Freeman discloses a microneedle configured for extracting a blood sample from skin of a mammal subject (Figs 6A-6F) (Cols 4-7), comprising inter alia:
at least one flat oriented blade (blade element 164) (Figs 6A-6F) (Cols 4-7) comprising at least one cutting edge (edges of blade element 164), wherein the at least one cutting edge is configured to incise the skin of the mammal subject (Figs 6A-6F) (Cols 4-7);
at least one microchannel (three capillary tubes 156/162) (Figs 6A-6F) (Cols 4-7) comprising an opening (distal fluid receiving openings of each of three capillary tubes 156/162) (Figs 6A-6F) (Cols 4-7) and a passage (fluid lumens of each of three capillary tubes 156/162) (Figs 6A-6F) (Cols 4-7), wherein the at least one microchannel is independent of the at least one flat oriented blade and configured to be inserted into the skin of the mammal subject together with the at least one flat oriented blade (Figs 6A-6F) (Cols 4-7, especially Col 7), and wherein the passage is configured to transport the blood sample away from the opening via capillary action (Figs 6A-6F) (Cols 4-7, especially Col 7).
For claim 3, Freeman discloses the microneedle according to claim 1, wherein the at least one flat oriented blade is independently movable in relation to the at least one microchannel (Figs 6A-6F, particularly 6D-6E) (Cols 4-7, especially Col 7).
For claim 4, Freeman discloses the microneedle according to claim 3, wherein the at least one flat oriented blade is configured to be removed from the skin of the mammal subject independently from the at least one microchannel while the at least one microchannel is aspirating blood (Figs 6A-6F, particularly 6D-6E) (Cols 4-7, especially Col 7).
For claim 5, Freeman discloses the microneedle according to claim 1, wherein the at least one microchannel further comprises an exit (proximal exit opening of each of three capillary tubes 156/162) (Figs 6A-6F) (Cols 4-7) arranged at an end portion of the passage opposing the opening (Figs 6A-6F) (Cols 4-7), and wherein the exit comprises a cut (proximal exit opening cut of each of the three capillary tubes 162) (Figs 6A-6F) (Cols 4-7) extending along an axial direction of the passage (Figs 6A-6F) (Cols 4-7).
For claim 6, Freeman discloses the microneedle according to claim 5, wherein the cut creates at least one contact point allowing the blood sample in the at least one microchannel to come into contact with a material (sample storage chamber 158) (Figs 6A-6F) (Cols 4-8, particularly Col 8) outside of the at least one microchannel (Figs 6A-6F) (Cols 4-8, particularly Col 8).
For claim 7, Freeman discloses the microneedle according to claim 1, wherein a diameter of the at least one microchannel is substantially smaller than a width of the at least one flat oriented blade (Figs 6A-6F) (Cols 4-7).
For claim 8, Freeman discloses the microneedle according to claim 1, wherein the at least one flat oriented blade is formed by two sub blades (two of the three blades 164) (Figs 6A-6F) (Cols 4-7), each comprising a cutting edge (two of the three cutting edges of blades 164) (Figs 6A-6F) (Cols 4-7), wherein the two sub blades are joined into a tip (Figs 6A-6F) (Cols 4-7).
For claim 10, Freeman discloses the microneedle according to claim 8, wherein the at least one microchannel is arranged in-between the two sub blades (Figs 6A-6F) (Cols 4-7) so that each sub blade extends at least partially along a length direction of the at least one microchannel and so that the opening is aligned with the tip (Figs 6A-6F) (Cols 4-7).
For claim 12, Freeman discloses the microneedle according to claim 1, wherein the at least one cutting edge comprises an apex (114) with a tip radius smaller than 20 µm (Figs 6A-6F) (Cols 4-7, particularly Col 5).
For claim 13, Freeman discloses the microneedle according to claim 1, wherein the at least one microchannel has an inner diameter larger than 30 µm and smaller than 500 µm (Figs 6A-6F) (Cols 4-7, particularly Col 7).
For claim 14, Freeman discloses the microneedle according to claim 1, wherein the at least one flat oriented blade has a thickness smaller than 1 mm and larger than 10 µm (Figs 6A-6F) (Cols 1-7, particularly Cols 1, 2, 5).
For claim 17, Freeman discloses the microneedle according to claim 1, wherein the at least one microchannel is a circumferentially closed microchannel (Figs 6A-6F) (Cols 4-7).
For claim 19, Freeman discloses the microneedle according to claim 1, further comprising a capillary force in connection to the at least one microchannel (capillary tip 168) (Figs 6A-6F) (Cols 4-7, Col 7).
Response to Arguments
Applicant's arguments filed 4/23/26 have been fully considered but they are not persuasive, specifically arguing the following:
“Applicant submits that Freeman fails to disclose the feature of claim 1 reciting "at least one flat oriented blade." Applicant further submits that Freeman employs angled blades to address blade flex. In contrast, claim 1 recites a "flat oriented blade," which provides the geometry necessary to achieve a distinct purpose-namely, the seamless integration of a cutting element and an automatic, capillary-action collection channel in a simple, one-step device. The flat configuration is not merely an alternative design; rather, it is a critical feature that enables core functionality. It also reduces invasiveness (e.g., a smaller, easier-to-heal wound), improves penetration (e.g., easier to penetrate skin well when blades get smaller/shallower), and improves ease of assembly-none of which are disclosed or suggested by Freeman.”
In response the Examiner respectfully notes the following:
As broadly as structurally and/or functionally claimed Freeman anticipates the claimed invention as set forth and reiterated above. Although Freeman shows three flat blades with flat sides coming to an angled point, this does not preclude each of the blades from being fairly and reasonably considered at least a “flat oriented blade”, even if they may not be square and/or rectangular which is not claimed. As evidenced by Figure 6F and corresponding description thereof, Freeman evidentiarily demonstrates at least three flat oriented blades 164 is particularly concerned with the creation of an incision therewith and associated capillary resultant sampling activities.
The claims do not positively recite only a single blade or the blade being only of any specific flatness. It remains that an angled blade with a polygonal shape may also be “flat oriented” when considering thickness, especially on at least one flat side even if a tapering thickness may be utilized.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “geometry necessary to achieve a distinct purpose”, “seamless integration of a cutting element and an automatic, capillary-action collection channel in a simple, one-step device”, “flat configuration”, and/or “reduces invasiveness (e.g., a smaller, easier-to-heal wound), improves penetration (e.g., easier to penetrate skin well when blades get smaller/shallower), and improves ease of assembly”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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