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, claims 1-8, in the reply filed on August 5, 2026 is acknowledged.
Claims 9-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5, 2026.
Applicant's election with traverse of the species corresponding to figure 7 in the reply filed on August 5, 2026 is acknowledged. The traversal is on the ground(s) that examination of the elected species would not materially reduce the search or examination burden, and that the disclosed species primarily differ in the resulting electrode configuration and associated structural arrangements, rather than the claimed manufacturing process, and underlying technical principles, and thus the same consideration of substantially the same claimed manufacturing steps, technical features and patentability issues applicable to the other disclosed species occur. This is not found persuasive because, while applicant argues that same consideration of substantially the same claimed manufacturing steps, technical features and patentability issues applicable to the other disclosed species occur, it is not argued that the species are obvious variants or patentably indistinct such that finding of one species would teach or suggest the other species. Therefore, there is a burden on the Examiner of considering what is covered and what would be patentable based on the species examined.
The requirement is still deemed proper and is therefore made FINAL.
After the election of August 5, 2026, claims 9-16 are withdrawn and claims 1-8 are pending for examination, as filed April 14, 2023.
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 1-8 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.
Claim 1 is confusing as to whether “the sensor substrate” is inclusive of the microneedle array as to deposition of materials, where claim 1 has forming electrodes “on the sensor substrate” and also each cover a part of the microneedle array, and where dependent claim 1 indicates specifically forming the coating on the hollow needle array on the sensor substrate. For the purpose of examination, either option is understood to meet the claim requirements, but applicant should clarify what is intended, without adding new matter. This confusion also applies to claim 3 and claim 4 and claim 6 as to their use of forming layers on the substrate or microneedle. The other dependent claims are also rejected as not curing the defects of the claims from which they depend.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 1-3, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/119546 (hereinafter ‘546) in view of Nejad et al (US 2020/0238066) and EITHER CN 113977829 (hereinafter ‘829) OR Ueno et al (US 2020/0306517).
Claims 1, 2, 8: ‘546 teaches a method of making a microneedle biosensor (note figure 7, 0002, 0005-0006, 0016, 0023). The method includes providing a substrate, that can be a polymer (note figure 7, 0034, 0036), with a hollow microneedle array provided on the sensor substrate, where the microneedles can also be made of polymer (note figure 7, 0016, 0034 and have a pyramidal structure or a conical structure). Each microneedle is provided with a hole on the needle opening to the hollow inside of the microneedle (note figure 7, 0034). A working electrode and a counter electrode are formed on the sensor substrate, where both the working electrode and the counter electrode each cover a part of the hollow microneedle array (note figure 7, 0005, 0006, 0036, 0039-0040).
(A) ‘546 does not provide that the microneedle array pattern is formed by a molding step where a mold is provided, with a microneedle array pattern is formed on the mold (where for claim 8, the mold is polydimethylsiloxane, PDMS), casting a liquid polymer material on the mold, and drying and then demolding to form a sensor substrate, where a hollow microneedle array is provided on the sensor substrate, and the liquid polymer material is a biodegradable material or a biocompatible material (such as, for claim 2, chitosan),
However, Nejad teaches an efficient, clean room free method of forming microneedle arrays that can be used in contact with a person/subject (note 0007, 0003-0004, 0100), where the microneedle arrays are formed by a molding step where a patterned mold is provided, with a microneedle array pattern formed on the mold (note the mold part 302 of PDMS, the material desired by present claim 8) (note figures 3A-3B, 0088-0090), casting a liquid polymer material on the mold, and then drying and then demolding to form a hollow microneedle array provided on a substrate area (note for example, where arrow for 312 pointing) (note figures 3C-3D, 0091-0100). The liquid polymer material can be a biocompatible material (note, for example, chitosan, the material desired by present claim 2) (note 0092-0093).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘546 to provide that the hollow microneedle array pattern is formed by a molding step where a mold is provided, with a microneedle array pattern is formed on the mold (where for example, the mold is polydimethylsiloxane, PDMS), casting a liquid polymer material on the mold, and drying and then demolding to form a sensor substrate, where a hollow microneedle array is provided on the sensor substrate, and the liquid polymer material is a biodegradable material or a biocompatible material (such as chitosan) as suggested by Nejad with an expectation of providing an efficient method for forming the microneedle array and substrate, since ‘546 indicts the desire to have a polymeric hollow microneedle array and substrate, and Nejad teaches that an efficient method for forming polymeric array and substrate would be forming by a molding step where a mold is provided, with a microneedle array pattern is formed on the mold (where for example, the mold is polydimethylsiloxane, PDMS), casting a liquid polymer material on the mold, and drying and then demolding to form a sensor substrate, where a hollow microneedle array is provided on the sensor substrate, and the liquid polymer material is a biodegradable material or a biocompatible material (such as chitosan)
(B) Further as to the penetrating through a tip of each microneedle in the hollow microneedle array, ‘546 indicates providing a hole in each microneedle, but does not give the steps, and the process of Nejad provides the hollow polymer microneedles but without the hole. However,
(B1) When using ‘829: ‘829 indicates how it is desirable to provide hollow polymeric microneedles in an array for forming a biosensor (note page 2, translation). It is indicated that after an array of polymeric microneedles have been formed by molding, the needles can be hollowed and also a hole at the tip provided by punching the microneedles with a laser (note the figures, and pages 2-3, translation), where further coating of sensing materials can be insider the hollow microneedle (note pages 2-3, translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘546 in view of Nejad to provide penetrating through the formed tip of each of the molded microneedles in the array to form a hole in each microneedle as suggested by ‘829, with an expectation of providing a desirable hole formation for a biosensor, since ‘546 indicates the desire to have holes in microneedles of the array, so by providing an hole in each a desired structure is formed, and ‘829 teaches that when providing hollow polymer microneedle arrays for use for a biosensor, a hole in the needle can be desirably provided at the tip and by a laser punch through (where while ‘546 in view of Nejad would indicate that the molded polymer microneedle array can be hollow, it would still be expected that the laser punch through can also open a hole at the tip, since the laser punches through polymer in microneedle arrays).
(B)(2) When using Ueno, Ueno further describes how holes can be provided in the tip 3h of microneedles 3 in a microneedle array using a metal projection/needle (since shaped as the microneedles) 110 array, by penetrating the tips of the microneedles with the metal needles using a metal needle array in a one to one correspondence with the microneedles being formed (note figure 4, 5. 0050-0056, 061-0062). Note as shown the needle can initially punch through a polymer surface with a small amount of deformation (note figure 5(b)) and also provide needle shaping deformation and hole formation (figures 5(c)-(d), figures 1, 3) (0050-0056). The microneedles can be used to pierce skin (note 0002).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘546 in view of Nejad to provide penetrating through the formed tip of each of the molded microneedles in the array to form a hole in each microneedle as suggested by Ueno with an expectation of providing a desirable hole formation for a biosensor, since ‘546 indicates the desire to have holes in microneedles of the array, so by providing an hole in each a desired structure is formed, and Ueno teaches that when providing hollow polymer microneedle arrays for use for a biosensor, a hole in the needle can be desirably provided at the tip by a punch through with a metal needle array and as well, the needle array punches through polymer (where while ‘546 in view of Nejad would indicate that the molded polymer microneedle array can already be hollow with a back opening (note figure 3dD), it would still be expected that the metal needle punch through can also open a hole at the tip of this structure, since the metal needle punches through polymer for microneedles). As well, Ueno would indicate using a metal needle array for the punching where the metal needles would be in a 1 to 1 correspondence to where the holes are to be punched.
Claim 3: As: to forming the working electrode and counter electrode on a recessed side of the hollow microneedle array, for example, ‘546 indicates that the electrode material for each can be put in the hollow area/interior of the microneedle which would be on the recessed side (note figure 3D of Nejad) (note 0034, 0039, 0040, figure 7), thus suggesting providing forming on the recessed side.
Claim 5: As to providing a partition area between the working and counter electrode, this would be suggested by ‘546. Note figure 1 placement, such that there would be an unoccupied/partition area between the working and counter electrode.
Claim 4 and optionally claim 5 are rejected under 35 U.S.C. 103 as being unpatentable over ‘546 in view of Nejad and EITHER ’829 OR Ueno as applied to claims 1-3, 5 and 8 above, and further in view of Liu, et al “Continuous monitoring of diabetes with an integrated microneedle biosensing device through 3D printing” (hereinafter Liu article) and Feng, et al “A long-term stable and flexible glucose sensor coated with poly(ethylene glycol)-modified polyurethane” (hereinafter Feng article).
Claim 4: As to the sequence of layers formed on the working electrode over the microneedle array, ‘546 indicates that the electrode (a working electrode) can be functionalized with an enzyme, glucose oxidase, for glucose detection (note 0072, figure 6).
Liu article describes how a microneedle array can be used for glucose detection, where working electrodes and counter electrodes provided on the array (page 2). For example, to provide a working electrode, Au was sputtered on a microneedle to provide an Au layer (so electrode layer on substrate of microneedle array), and thereafter a Prussian blue layer applied over the top of the Au layer (so on a side of the electrode layer far away from the sensor substrate), the enzyme layer of glucose oxidase is provided over the Prussian blue layer, so far away from the electrode layer (note page 10, page 4, figure 2).
Feng article further provides providing a glucose sensor with a layer of Au on a substrate, with glucose oxidase over that (note section 2.2). Furthermore, over the glucose oxidase layer, a polyurethane-PEG layer is provided as a protective membrane (note the abstract, section 2.2). It is indicated that such device would be used for wearable devices, and would be indicated to improve biocompatibility (note the abstract, and section 4. Conclusions).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘546 in view of Nejad and EITHER ’829 OR Ueno to further provide that the working electrode is provided with a series of layers on the microneedle as part of the sensor substrate where the layers include, in order from the substrate microneedle, an Au sputtered electrode layer, a Prussian blue layer formed on the electrode layer, an enzyme layer formed on the Prussian blue, and a biocompatible polymer (polyurethane-PEG) formed on the enzyme layer as suggested by Liu article and Feng article to provide desirable sensing, since ‘546 indicates providing glucose testing for a microneedle working electrode with glucose oxidase functionalization on the microneedle, and Liu article teaches a layer system for such testing for a microneedle would include and Au sputtered electrode layer, a Prussian blue layer formed on the electrode layer, a glucose oxidase enzyme layer formed on the Prussian blue, and Feng article would further suggest providing a polyurethane-PEG layer over the enzyme layer for further biocompatibility improving.
Claim 5: Optionally, when used as in claim 4, Liu article further suggests that providing a partition area between the working electrode and counter electrode would be conventional when using microneedle arrays (note page 10, “sensing electrode preparation” section).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over ‘546 in view of Nejad and EITHER ’829 OR Ueno as applied to claims 1-3, 5 and 8 above, and further in view of Baek et al (US 2018/0185625).
Claim 6: as to forming a water proof layer on the sensor substrate, Baek teaches providing a microneedle array by molding, with the array made of a polymer and that can include biocompatible material such as chitosan (note 0010-0015). It is further taught that the array can be coated with active ingredients (note 0020). It is further taught that the array can also be coated with waterproofing material (note 0031-0032), where the waterproofing coating can occur after the active coating (note figure 1). This would coat the needles as part of the substrate, and also the substrate can also be acceptably coated as coating such as dipping or electrospinning can be provided with no masking limitations (note 0031).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify ‘546 in view of Nejad and EITHER ’829 OR Ueno to further provide a waterproof layer on the substrate before the electrodes formed (by applying electrode layers) as suggested by Baek to provide desirable protection, since ‘546 indicates providing testing, where various coatings can be provided, and Baek indicates that it can be desirable to provide waterproofing coating/layer for a microneedle array, and while it does not specifically provide applying the coating before the electrode features, as discussed in MPEP 2144.04(C), “See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results)”, and here the same waterproofing effects expected, and by providing to the substrate, it would be protected from water.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over ‘546 in view of Nejad and Ueno as applied to claims 1-3, 5 and 8 above.
For claim 7, when the reference to Ueno used, as discussed for that option for claim 1, this would further provide all the features of claim 7.
Zhu et al (US 2010/0062142) also notes removing the tip from a microneedle (note abstract, figure 1). Wang et al (US 2022/0361776)also notes making biosensor arrays of microneedles (note the abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE A BAREFORD whose telephone number is (571)272-1413. The examiner can normally be reached M-Th 6:00 am -3:30 pm, 2nd F 6:00 am -2:30 pm.
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/KATHERINE A BAREFORD/Primary Examiner, Art Unit 1718
