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 .
Election/Restrictions
Applicant’s election without traverse of Invention I, drawn to a microneedle apparatus, Species A1, embodiment drawn to Figure 1, and Species A2, embodiment drawn to Figure 8, in the reply filed on 10/22/25 is acknowledged.
Claims 20-26 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/22/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 positively recites “a capillary means”. Although the limitation finds support as originally filed and in the past paragraph on page 6 of the instant Specification, no corresponding structure(s) are disclosed and/or linked to the recited “a capillary means”. In light of the instant Specification, one of ordinary skill would not recognize and be guessing as to what structure(s) may or may not correspond to the “a capillary means”, rendering a lack of written description of the claim limitation. Thus, given the lack of written description one of ordinary skill would not recognize a demonstrated possession of the claimed invention in light of the Specification.
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 1, 3-8, 10, 12-14, 17, and 19 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 flat” in claim 1 is a relative term which renders the claim indefinite. The term “substantially flat” 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 required degree of flatness required or excluded to be considered “substantially flat”. Depending claims 3-8, 10, 12-14, 17, and 19 inherit and do not remedy the indefiniteness.
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 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. Depending claims 3-8, 10, 12-14, 17, and 19 inherit and do not remedy the indefiniteness.
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 19 positively recites “a capillary means” and is indefinite. Although the limitation finds support as originally filed and in the past paragraph on page 6 of the instant Specification, no corresponding structure(s) are disclosed and/or linked to the recited “a capillary means”. In light of the instant Specification, one of ordinary skill would not be apprised of the metes and bounds of the claimed invention recognize as they would be guessing as to what structure(s) may or may not correspond to the “a capillary means”. The scope of the claim is unclear as it is indeterminate what explicitly, implicitly, inherently, and/or inferentially must necessarily be required and/or excluded by the recitation “a capillary means”. Thus, given the lack of corresponding disclosed structure(s) the claim is indefinite in light of the Specification.
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 blade (blade element 164) (Figs 6A-6F) (Cols 4-7)being substantially flat (Figs 1A-1C) and comprising at least one cutting edge (edges of blade 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 blade and configured to be inserted into the skin of the mammal subject together with the at least one 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 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 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 aspiring 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 blade (Figs 6A-6F) (Cols 4-7).
For claim 8, Freeman discloses the microneedle according to claim 1, wherein the at least one 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 1A-1C, 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 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 means (capillary tip 168) in connection to the at least one microchannel (Figs 6A-6F) (Cols 4-7, Col 7).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring microneedles for blood sampling via capillary 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.
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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