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 .
Claim Rejections - 35 USC § 112
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 1-13 is 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.
Claims 1 (lines 11 and 16) and claim 11 (line 2) recites the limitation "the inclined surface". There is insufficient antecedent basis for this limitation in the claim. The Examiner believes that this is a typographical mistake and that the Applicant meant to recite “the inclined planar surface”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 11 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Renlund et al. (US 2018/0161563 A1).
Regarding claim 1, Renlund et al. discloses a microneedle structure formed from a single crystal of silicon (the Examiner notes that the limitation “formed from a single crystal of silicon” is being treated as a product-by-process limitation and since it has been held that a product-by-process limitation is not construed as being limited to the product formed by the specific process recited, therefore, even though Renlund et al. is silent as to the process used to make the microneedle structure, it appears that Renlund et al.’s product would be the same or similar as that claimed, especially since both applicant’s product and the prior art product is made of silicon material (see paragraphs 2 and 79). MPEP 2113.), the microneedle structure comprising:
(a) a substrate (substrate 102) having a major surface (surface of substrate 102 that the microneedles 101 protrudes from; see Figs. 4-5);
(b) at least one microneedle (microneedle 101) integrally formed with said substrate (substrate 102) so as to project from said major surface (see Figs. 4-5), said at least one microneedle (microneedle 101) comprising:
(i) a penetrating tip (tip at distal end 504) formed at an intersection between at least one upright surface (upright surface, see Examiner’s annotated Fig. 5 below) perpendicular to said major surface of said substrate (substrate 102) and an inclined planar surface (surface of bevel 505) corresponding to a (1 1 1) crystallographic plane (paragraphs 35-36),
(ii) an expanding portion (expanding portion, see Examiner’s annotated Figs 4-5 below) bounded by a continuation of said at least one upright surface and said inclined surface (see Figs. 4-5), and
(iii) a constant cross-section portion (constant cross-section portion, see Examiner’s annotated Figs. 4-5 below) bounded by a continuation of said at least one upright surface and a slicing plane (slicing plane, see Examiner’s Annotated Fig. 5 below) extending from an edge of said inclined surface towards, and perpendicular to, said major surface of said substrate (substrate 102) (see Figs. 4-5 and 8),
wherein a width of said inclined surface (surface of bevel 505) increases monotonically from said penetrating tip to said edge (see Figs. 4 and 8), and wherein the slicing plane extends to, and meets, a cut edge (opposite of 506 in figure 5) of said substrate 102.
The embodiment of Figs. 4-5 of Renlund et al. does not expressly state that the microneedle structure is made of silicon.
However, paragraph 79 teaches that the substrate 102 is made of silicon and paragraph 7 states that the microneedles are integrally formed with the substrate.
As such, the Examiner is of the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention that the microneedle structure is formed of silicon, since paragraphs 79 and 7 of Renlund et al. suggest this, and since it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. MPEP 2144.07.
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Regarding claim 2, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, but Renlund et al. does not expressly state that said constant cross- section portion extends for at least a fifth of a height of said penetrating tip from said major surface of said substrate.
However, the Examiner is of the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to modify the height of the constant cross-section portion relative to the height of the penetrating tip from the major surface of the substrate, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(A).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to modify the height of the constant cross-section portion relative to the height of the penetrating tip from the major surface of the substrate to be at least a fifth of a height of said penetrating tip from said major surface of said substrate since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding claim 3, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches a height of said penetrating tip from said major surface of said substrate is at least 200-1000 microns (paragraph 42), and wherein a maximum dimension of said microneedle parallel, and adjacent, to said major surface is 127-255 microns (paragraph 42 discloses the outer circumference of the microneedles as between 400-800 microns, which converts to a range of 127-255 microns in diameter).
As to claim 3, Renlund et al. does not expressly state that a ratio of a height of said penetrating tip from said major surface of said substrate to a maximum dimension of said microneedle adjacent to said major surface is at least 1.6, as recited in claim 3.
However, Renlund et al. teaches a height of said penetrating tip from said major surface of said substrate is at least 200-1000 microns (paragraph 42), and wherein a maximum dimension of said microneedle parallel, and adjacent, to said major surface is 127-255 microns (paragraph 42 discloses the outer circumference of the microneedles as between 400-800 microns, which converts to a range of 127-255 microns in diameter).
The Examiner is of the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention that there is some disclosed combination of measurements of height and outer circumference of the microneedles of Renlund et al. that results in a ratio of a height of said penetrating tip from said major surface of said substrate to a maximum dimension of said microneedle adjacent to said major surface is at least 1.6, as recited in claim 3. For instance, a height of 250 microns, and a diameter of 127 microns, results in a ratio of approximately 1.97, which is at least 1.6 as recited in claim 3.
Regarding claim 4, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches a height of said penetrating tip from said major surface of said substrate is at least 200-1000 microns (paragraph 42), and wherein a maximum dimension of said microneedle parallel, and adjacent, to said major surface is 127-255 microns (paragraph 42 discloses the outer circumference of the microneedles as between 400-800 microns, which converts to a range of 127-255 microns in diameter).
As to claim 4, Renlund et al. does not expressly state that a ratio of a height of said penetrating tip from said major surface of said substrate to a maximum dimension of said microneedle adjacent to said major surface is at least 1.7, as recited in claim 4.
However, Renlund et al. teaches a height of said penetrating tip from said major surface of said substrate is at least 200-1000 microns (paragraph 42), and wherein a maximum dimension of said microneedle parallel, and adjacent, to said major surface is 127-255 microns (paragraph 42 discloses the outer circumference of the microneedles as between 400-800 microns, which converts to a range of 127-255 microns in diameter).
The Examiner is of the position that it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention that there is some disclosed combination of measurements of height and outer circumference of the microneedles of Renlund et al. that results in a ratio of a height of said penetrating tip from said major surface of said substrate to a maximum dimension of said microneedle adjacent to said major surface is at least 1.7, as recited in claim 4. For instance, a height of 250 microns, and a diameter of 127 microns, results in a ratio of approximately 1.97, which is at least 1.7 as recited in claim 4.
Regarding claim 5, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches a height of said penetrating tip from said major surface of said substrate is at least 750 microns(paragraph 42 teaches a height range of 200-1000 microns), and wherein a maximum dimension of said microneedle parallel, and adjacent, to said major surface is 127-255 microns (paragraph 42 discloses the outer circumference of the microneedles as between 400-800 microns, which converts to a range of 127-255 microns in diameter), which is not more than 500 microns, as recited in claim 5.
Regarding claim 6, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches a height of said penetrating tip from said major surface of said substrate is at least 800 microns(paragraph 42 teaches a height range of 200-1000 microns), and wherein a maximum dimension of said microneedle parallel, and adjacent, to said major surface is 127-255 microns (paragraph 42 discloses the outer circumference of the microneedles as between 400-800 microns, which converts to a range of 127-255 microns in diameter), which is not more than 450 microns, as recited in claim 6.
Regarding claim 7, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches a cross-section taken through said constant cross-section portion of said microneedle (microneedle 101) parallel to said major surface of said substrate has a length perpendicular to said slicing plane (length of constant cross-section portion; see Examiner’s annotated Fig. 4 and 5 below) and a width parallel to said slicing plane (width of constant cross section portion, see Examiner’s annotated Figs. 4-5 below).
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Renlund et al. does not expressly state that the length is at least 50% greater than the width.
The Examiner is of the position that it would have been an obvious matter of design choice before the effective filing date of the present invention to the length so that it is at least 50% greater than the width, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04(IV)(A).
Regarding claim 11, Renlund et al. teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches a bore (bore 507) extending from said inclined surface (bevel surface 505) through said expanding portion, through said constant cross-section portion and through said substrate (substrate 102) to a rear surface of said substrate (see Figs. 4-5).
Regarding claim 12, Renlund teaches the slicing plane is also an edge between 503,506 of said substrate 102.
Regarding claim 13, Renlund teaches the claimed invention as discussed above concerning claim 1, and Renlund et al. further teaches that at least one microneedle (microneedle 101) is implemented as a plurality of microneedles integrally formed (abstract, paragraph 69) with said substrate (substrate 102), said plurality of microneedles having co-planar slicing planes (see Figs. 1-2 and 4).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Renlund et al (US 20180161563 A1) in view of Adamati et al (CN 213048990 U).
Regarding claims 8, Renlund fails to disclose (claim 8) said at least one upright surface adjacent to said penetrating tip comprises a first planar surface and a second planar surface smoothly linked by an arcuate surface, said first and second planar surfaces being symmetrically deployed on opposite sides of a center plane passing through said microneedle and forming between them an angle of between 45 degrees and 75 degrees; (claim 9) said arcuate surface has a radius of curvature between 10 microns and 40 microns; and (claim 10) said at least one upright surface further comprises a third planar surface and a fourth planar surface arranged symmetrically on opposite sides of said center plane, said third and fourth planar surfaces forming between them of between 5 degrees and 25 degrees.
Adamati teaches (figures 3C-3F) (page 8 of translation, starting second paragraph), said at least one upright surface adjacent to said penetrating tip comprises a first planar surface and a second planar surface ( both sides of 20, fig 3C) smoothly linked by an arcuate surface 26 (fig 3E), said first and second planar surfaces being symmetrically deployed on opposite sides of a center plane passing through said microneedle and forming between them an angle of between 45 degrees and 75 degrees (see abstract; page 3). About claim 9, said arcuate surface 26 has a radius of curvature between 10 microns and 40 microns (page 3, 20-50 microns). About claim 10, said at least one upright surface further comprises a third planar surface and a fourth planar surface (fig 3A) arranged symmetrically on opposite sides of said center plane, said third and fourth planar surfaces forming between them of between 5 degrees and 25 degrees (page 3 last three paragraphs; page 8, fourth paragraph).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Renlund microneedle with Adamanti’s planar surfaces and arcuate since such modification would have enhanced the tissue penetration with minimum fluid leakage.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783