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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the limitations of claim 18 (“a pair of inclined surfaces that connect opposite edges of the first planar surface and the second planar surface”) must be shown or the feature(s) canceled from the claim(s). It is possible that these features are present in Figure 2A, however the description of Figure 2A does not match the claim language, and therefore this is not clear. If this is the case, then the specification should also be amended to provide basis for the language that appears in claim 18. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The use of the term nitinol, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
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.
Claim 20 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.
Claim 20 contains the trademark/trade name nitinol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an alloy of nickel and titanium and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-2, 5-6, 8, 10, 15 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allen et al (US 2009/0131905 A1).
Allen discloses a method comprising:
applying an etch mask 96 (Fig. 3B, [0090]) to a plate 95 (a silicon substate, which broadly interpreted, is a plate); and
etching first portions of the plate that are unmasked by the etch mask with an etching process to completely remove the first portions of the plate (as depicted in Fig. 3C, portions of the plate are etched and removed that are not covered by the mask 96, [0090]),
wherein the plate includes second portions that are masked by the etch mask during the etching process (also as depicted in Fig. 3C), the second portions include a plurality of microblades (e.g., Fig 1B shows a plurality of microblades) each having a shaft and a tip adjacent to a first end of the shaft, and the tip includes a plurality of surfaces at least two of which taper toward the end of the shaft (as depicted in Figure 3C, 3F, [0038]).
As to claim 2, Allen discloses removing the etch mask (Fig. 3C, [0090]); and applying a dielectric coating 97 on a portion of the shaft of each of the plurality of microblades (as depicted in Fig. 3F, [00090]), wherein the tip is uncoated by the dielectric coating (see Fig. 3F).
As to claim 5, Allen discloses that the plate has a side edge following the etching process, the shaft of each microblade has a second end connected to the side edge of the plate, and the portion of the shaft is arranged between the tip and the side edge (all as depicted in Fig. 3F).
As to claim 6, Allen discloses that the dielectric coating is further applied to a portion of the plate (see Fig. 3F).
As to claims 8 and 10, Allen discloses that the dielectric coating comprises silicon dioxide, which is an electrical insulator (by oxidation of silicon, [0090]).
As to claim 15, Allen discloses planar surfaces following the etching process (as depicted in Fig. 3F).
As to claim 19, Allen discloses that the plurality of microblades and the plate have an integral construction (all from silicon, Fig. 3F).
Claims 1, 5, 16 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zuck (US 6,050,988).
Zuck discloses a method comprising:
applying an etch mask (col.7, lines 39-51) to a plate 6 (metal such as stainless steel or titanium, col.7, lines 41-42; col.8, lines 14-33); and
etching first portions of the plate that are unmasked by the etch mask with an etching process to completely remove the first portions of the plate (as depicted in Fig. 8, portions of the plate are etched and removed that are not covered by the mask, col.7, lines 51-52),
wherein the plate includes second portions that are masked by the etch mask during the etching process (also as depicted in Fig. 8), the second portions include a plurality of microblades (e.g., Fig 8 shows a plurality of microblades) each having a shaft and a tip adjacent to a first end of the shaft, and the tip includes a plurality of surfaces at least two of which taper toward the end of the shaft (as depicted in Figure 8).
As to claim 5, Zuck discloses that the plate has a side edge 5 following the etching process, the shaft of each microblade has a second end connected to the side edge of the plate, and the portion of the shaft is arranged between the tip and the side edge (all as depicted in Fig. 8).
As to claim 16, Zuck discloses forming at least one alignment opening in the plate 102, 103 (Fig. 15, col.5, lines 50-54).
As to claim 19, Zuck discloses that the plurality of microblades and the plate have an integral construction (all from metal, Fig. 8).
As to claim 20, Zuck discloses that the plurality of microblades and the plate comprise stainless steel or copper (col.6, line 20).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Zuck (US 6,050,988).
The discussion of Zuck from above is repeated here.
As to claim 17, Zuck discloses a first alignment opening 102 and a second alignment opening 103 in the plate 106, wherein the second alignment opening is spaced from the first alignment opening (as depicted in Fig. 15), the first alignment opening has a circular shape (see Fig. 15). Zuck fails to disclose that the second opening has an oval shape. Rather, the second opening has a circular shape (Fig. 15). However the shape of an opening is an obvious design choice. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide an oval opening as cited in the method of Zuck in order to optimize the openings for alignment and ease of assembly, and because the shape is an obvious matter of design choice since such a modification would have involved a mere change in the size of a component. A change of size is generally recognized as being within the ordinary level of skill in the art. In re Dailey, 357 F.2nd 669, 149 USPQ 1966.
Claims 1-7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang et al (US 2020/0360072 A1) in view of Zuck (US 6,050,988).
Kuang discloses a method of manufacturing microblades (Fig. 3A-3E) by etching and deposition processing [0096]. Kuang fails to explicitly disclose applying an etch mask to a plate, and etching portions unmasked by the etch mask. The discussion of Zuck from above is repeated here. A person of ordinary skill in the art upon reading the disclosure of Kuang and Zuck would arrive at the claimed invention in order to achieve the desired structures of, e.g. Fig. 3A or Fig. 3C, by the etching and deposition techniques Kuang also teaches to use. Kuang also discloses that the plurality of microblades [0091] may have a conductive tip and an insulated shaft and base [0094], [0108]. The microblades each have a shaft and a tip adjacent to a first end of the shaft, and the tip includes a plurality of surfaces at least two of which taper toward the end of the shaft (as depicted in Fig. 3C). Accordingly, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to mask and etch as cited in the method of Kuang because Zuck teaches they are useful configurations to achieve microblades and because it is within the scope of one skilled in the art to use the etching and coating techniques to arrive at the microblade structures desired by Kuang.
As to claim 2, Kuang discloses to form an insulating structure except for the tip (see rejection of claim 1). It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to remove an etch mask and apply a dielectric coating as cited because it is useful to remove masks that are not part of the final product, and because Kuang already discloses to use a deposition technique, and such is expected to give the predictable result of a dielectric coating applied in portions other than the tip.
As to claims 3-4, Kuang discloses that the dielectric coating is applied by vapor-phase coating [0096]. Physical vapor deposition or sputter deposition are well known semiconductor processes, which are already described by Kuang as available to form the microblades. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to use physical vapor deposition or sputter deposition in the modified method of Kuang because they are useful deposition techniques that are expected to give the predictable result of depositing an insulating film.
As to claim 5, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide a side edge as cited because Zuck teaches that such is a useful structure for forming microblades, and such is expected to give the predictable result of a plurality of microblade structures.
As to claim 6, Kuang discloses to apply a dielectric coating to a portion of the microblade, and not the tip. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide the dielectric coating to a portion of the plate as a part of the deposition process that does not provide the dielectric coating to the tip, but does apply it elsewhere, including the plate.
As to claim 7, Kuang discloses to establish an electrical connection (in order to heat the tips, [0110]-[0111]) that is configured to establish electrical connections with the plurality of microblades. Kuang fails to disclose the structure of “a plurality of tabs.” However, broadly interpreted, an electrical supply configured to connect microneedles would need some structure such as tabs. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to provide tabs as cited in the modified method of Kuang in order to supply the desired electrical connection to the microblades.
As to claim 18, Kuang discloses that the plurality of surfaces of the tip include a first planar surface, a second planar surface separated from the first planar surface by a thickness of the shaft, and a pair of inclined surfaces that connect opposite edges of the first planar surface and the second planar surface (as depicted in Fig. 3C).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kuang et al (US 2020/0360072 A1) and Zuck (US 6,050,988), as applied to claim 2, and further in view of Ahn et al (US 2021/0353933 A1).
As to claim 9, Kuang fails to disclose parylene. Ahn teaches that in microblade structures, that parylene is a useful material to cover an outer surface of the needle body [0052]. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to include parylene as cited in the modified method of Kuang because Ahn teaches that it is a useful material to include in microneedle structures to cover an outer surface of the microneedle.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kuang et al (US 2020/0360072 A1) and Zuck (US 6,050,988), as applied to claim 2, and further in view of Reihs (US 2003/0124360 A1).
As to claim 11, Kuang fails to disclose applying the dielectric coating by dipping, Reihs teaches dipping/immersion is a common semiconductor deposition technique [0190]. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to use dipping as cited because Reihs teaches it is a useful semiconductor deposition process and such is expected to give the predictable result of an applied dielectric coating.
As to claim 12, Kuang fails to disclose to apply a mechanical mask. Reihs teaches that mechanical masks are a common technique to structure coatings [0211]. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to apply a mechanical mask to provide the insulating material in areas that do not include the tip in the modified method of Kuang because Reihs teaches that it is a useful technique for applying structure coatings.
As to claim 13, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to apply the mechanical mask before applying the dielectric coating to the tip of each of the plurality of microblades in the modified method of Kuang because Reihs teaches that such is a useful technique in order to form structured coatings.
As to claim 14, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to remove the mechanical mask after applying the dielectric coating to the tip of each of the plurality of microblades in the modified method of Reihs because it is useful to remove coatings that are not desired as part of the final product.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art shows methods and structures of microblades or tips.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANITA K ALANKO whose telephone number is (571)270-0297. The examiner can normally be reached Monday-Friday, 9 am-5pm.
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, Joshua Allen can be reached at 571-270-3176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANITA K ALANKO/Primary Examiner, Art Unit 1713
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