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 § 103
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 non-obviousness.
Claim(s) 1, 4, 7, 11, 16 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toy (US 2018/0193623), (hereinafter, Toy).
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RE Claim 1, Toy discloses in FIGS. 1, 3 and 5-9 a drug delivery device includes a base having a first region with a drug delivery assembly associated therewith. The drug delivery device also includes an antenna disposed in the first region to radiate an electromagnetic field, the base defining a plane and the antenna disposed in the plane of the base, and an electromagnetic field generator selectively coupled to the antenna. Since generating an electromagnetic field using the antenna, the electromagnetic field causing migration of cells within the patient relative to the delivery device, and delivering a drug to the patient via the drug delivery assembly, the device is considered an electrically active drug delivery system, hence is considered an electronics device. Toy discloses an electronic device, comprising:
a substrate 152 “base” comprising one or more organic layers and conductive features 166 “EM field generator”/240 “controller”/ 242 “RF receiver, all of such elements must include conductive features. Furthermore, the substrate 152 may be made of made of polymers, copolymers, and combinations, blends or composites thereof or metals, ceramics, or semiconductor materials, hence meeting the claimed limitation; and
a plurality of pins 156 “microneedles” extending out from the substrate 152, wherein the plurality of pins 156 are oriented at a non-orthogonal angle with respect to the substrate 152, referring to FIGS. 3, 8 and 9;
wherein each pin 156 “microneedles” of the plurality of pins has a tip that is substantially flat and has a width narrower than a corresponding base the tip laterally offset from the base along a vertical axis, referring to FIG. 9, and
wherein the plurality of pins 156 are conductive, since it may be made of metals [0053] and are in direct contact with the substrate 152 “base”, referring to FIG. 8 but are distinct in composition from the substrate 152. Since the plurality of pins 156 “microneedles” are may be made of metals, ceramics, semiconductor materials, polymers and composites, while the substrate 152 is made of be made of made of polymers, copolymers, and combinations, blends or composites thereof or metals, ceramics, or semiconductor materials, it seems that the pins 156 “microneedles” the distinct in composition from the substrate 152. However, if applicant have evidence to the contrary, it would have been obvious for one of ordinary skill in the art, at the effective filing date of the instant application to use distinct materials for the pins and substrate in view of Toy discloses an electronic device in order to optimize the functionality of the drug delivery electronic device.
Toy does not explicitly disclose that the tip “second end 210” of the pin 156 “microneedles” is partially vertically overlapping with the base “first end 208” along a vertical axis.
However, Toy discloses that each of pins 156 “microneedles” have an axis 200 having an angle φ, which has values that vary between 0o and 90o with the horizontal plain 164, referring to FIGS. 8 and 9 [0041-0044].
Therefore, it would have been obvious for one of ordinary skill in the art, at the effective filing date of the instant case, to adjust the tilt angle φ of the pins 156 “microneedles” axis 200 such that the tip “second end 210” of the pin 156 “microneedles” is partially vertically overlapping with the base “first end 208” along a vertical axis in order to achieve the maximum pins density per unit area, while maximizing the pins 156 “microneedle” insertion depth, as disclosed by Toy [0041-0044].
RE Claim 4, Toy discloses electronic device, wherein a length of each pin is approximately 250 µm or greater, since Toy discloses the microneedle height is 400-1000 microns, which is greater than 250 µm [0045].
RE Claim 6, Toy discloses electronic device, wherein a width of each pin is non-uniform along a length of the pin 156 “microneedles”, referring to FIG. 9.
RE Claim 7, Toy discloses electronic device, wherein a first width of the pin proximate to the substrate is greater than a second width of the pin 156 “microneedle” distal from the substrate 152, referring to FIG. 9.
RE Claim 11, Toy discloses in FIGS. 1, 3 and 5-9 a drug delivery device includes a base having a first region with a drug delivery assembly associated therewith. The drug delivery device also includes an antenna disposed in the first region to radiate an electromagnetic field, the base defining a plane and the antenna disposed in the plane of the base, and an electromagnetic field generator selectively coupled to the antenna. Since generating an electromagnetic field using the antenna, the electromagnetic field causing migration of cells within the patient relative to the delivery device, and delivering a drug to the patient via the drug delivery assembly, the device is considered an electrically active drug delivery system, hence is considered an electronics device. Furthermore, controller circuitry 240 include programmable logic or microprocessor which is considered a computing device computing device, comprising:
a board 220; and
a component coupled to the board, the component including an integrated circuit structure “microprocessor” [0062], comprising:
a substrate 152 “base” comprising one or more organic layers and conductive features 166 “EM field generator”/240 “controller”/ 242 “RF receiver, all of such elements must include conductive features. Furthermore, the substrate 152 may be made of made of polymers, copolymers, and combinations, blends or composites thereof or metals, ceramics, or semiconductor materials, hence meeting the claimed limitation; and
a plurality of pins 156 “microneedles” extending out from the substrate 152, wherein the plurality of pins 156 are oriented at a non-orthogonal angle with respect to the substrate 152, referring to FIGS. 3, 8 and 9;
wherein each pin 156 “microneedles” of the plurality of pins has a tip that is substantially flat and has a width narrower than a corresponding base the tip laterally offset from the base along a vertical axis, referring to FIG. 9, and
wherein the plurality of pins 156 are conductive, since it may be made of metals [0053] and are in direct contact with the substrate 152 “base”, referring to FIG. 8 but are distinct in composition from the substrate 152. Since the plurality of pins 156 “microneedles” are may be made of metals, ceramics, semiconductor materials, polymers and composites, while the substrate 152 is made of be made of made of polymers, copolymers, and combinations, blends or composites thereof or metals, ceramics, or semiconductor materials, it seems that the pins 156 “microneedles” the distinct in composition from the substrate 152. However, if applicant have evidence to the contrary, it would have been obvious for one of ordinary skill in the art, at the effective filing date of the instant application to use distinct materials for the pins and substrate in view of Toy discloses an electronic device in order to optimize the functionality of the drug delivery electronic device.
Toy does not explicitly disclose that the tip “second end 210” of the pin 156 “microneedles” is partially vertically overlapping with the base “first end 208” along a vertical axis.
However, Toy discloses that each of pins 156 “microneedles” have an axis 200 having an angle φ, which has values that vary between 0o and 90o with the horizontal plain 164, referring to FIGS. 8 and 9 [0041-0044].
Therefore, it would have been obvious for one of ordinary skill in the art, at the effective filing date of the instant case, to adjust the tilt angle φ of the pins 156 “microneedles” axis 200 such that the tip “second end 210” of the pin 156 “microneedles” is partially vertically overlapping with the base “first end 208” along a vertical axis in order to achieve the maximum pins density per unit area, while maximizing the pins 156 “microneedle” insertion depth, as disclosed by Toy [0041-0044].
RE Claim 16, Toy discloses the computing device, further comprising: a battery coupled to the board [0063].
RE Claim 20, Toy discloses the computing device, wherein the component is selected from the group consisting of a processor “microprocessor” [0062], a communications chip, and a digital signal processor.
Claim(s) 2, 3, 8-10, 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toy (US 2018/0193623), (hereinafter, Toy) in view of DADKHAH TEHRANT et al. (US 2018/0264657), (hereinafter, DADKHAH TEHRANI).
RE Claim 2, 3 and 12, Toy discloses electronic device, wherein dimensions L, H and subsequently the width are optimized for permitting the pin 156 “microneedles” transdermal administration, hence the pin 156 “microneedles” dimensions is a result effective variable, referring to FIG.9 [0045].
Toy discloses does not disclose an electronic device, wherein each pin has an aspect ratio of length to width of at least 15:1 or at least 30:1.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the instant application used the claimed pin 156 “microneedles” aspect ratios, absent unexpected results, since the pin 156 “microneedles” dimensions is a result effective variable, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233; In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980); In re Huang, 100 F.3d 135, 40 USPQ2d 1685, 1688 (Fed. Cir. 1996).
RE Claim 8, 9 and 13, Toy discloses an electronic device, wherein the pin 156 “microneedles” is arranged in a different geometric array, referring to FIGS. 5-7 [0037].
Toy does not disclose an electronic device, wherein the plurality of pins comprises over one hundred pins.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the instant application used the claimed pin 156 “microneedles” number, absent unexpected results, since the pin 156 “microneedles” number and arrangement, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233; In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980); In re Huang, 100 F.3d 135, 40 USPQ2d 1685, 1688 (Fed. Cir. 1996).
RE Claim 10, Toy discloses electronic device, wherein the non-orthogonal angle is between 15° and 90°, which overlaps the claimed 0° and 45°.
However, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claim(s) 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toy (US 2018/0193623), (hereinafter, Toy) in view of DADKHAH TEHRANT et al. (US 2018/0264657), (hereinafter, DADKHAH TEHRANI).
RE Claims 14, Toy does not disclose a computing device, further comprising: a memory coupled to the board.
However, in a related art, DADKHAH TEHRANI discloses in FIGS. 1-3 and 5-11 an “engagement sensing systems to be integrated into the microstructures” with an adhesive microstructure including micro pins and computing device, further comprising: a memory coupled to the board [0112].
Therefore, it would have been obvious for one of ordinary skill in the art, at the time the invention was filed to couple a memory to the Toy’s drug delivery system to a memory in order to store information off the system and monitor the drug delivery process.
RE Claims 15, Kazama does not disclose a computing device, further comprising: a communication chip coupled to the board.
However, in a related art, DADKHAH TEHRANI discloses a computing device, further comprising: a communication chip coupled to the board.
Therefore, it would have been obvious for one of ordinary skill in the art, at the time the invention was filed to couple a communication chip to the Toy’s device to in order to communicate information off the system and monitor the drug delivery process.
RE Claims 16-18, Kazama does not disclose a computing device, further comprising: a battery coupled to the board, a camera coupled to the board or display.
However, in a related art, DADKHAH TEHRANI discloses a computing device, further comprising: optical, tactile or auditory system with controller system including computer network, a motherboard and remote communication to tablets or PDA, which are implicitly contain a battery and a camera and a LED display, hence meeting the claimed limitations [0110-0112].
Therefore, it would have been obvious for one of ordinary skill in the art, at the time the invention was filed to a similar PDA arrangement of Toy’s drug delivery system in order to have a monitoring and communication system.
RE Claims 19, Kazama does not disclose a computing device is a packaged integrated circuit die.
However, DADKHAH TEHRANI discloses a computing device, wherein the component is a packaged integrated circuit die, which is implicitly met due to presence of CPU “processor” and memory, hence meeting the limitation of Claim 20 [0112].
Therefore, it would have been obvious for one of ordinary skill in the art, at the time the invention was filed to have the arrangement shown in FIG. 3 of Kazama’s disclosure, and have Toy’s drug delivery system in an integrated package of the well-known system on a chip in order to obtain more complex functions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are not persuasive.
In the instant case, the claimed pin structure does not exclude any other pin or microneedle disclosed in the prior art of record, solid structure or otherwise, hence are not more specific to the instant application. It is understood that the broadest reasonable interpretation of the claims in light of the disclosed invention is requires, however, importing limitations from the disclosed invention is impermissible. Therefore, the claims broadly encompass the disclosed features of the prior art of record. Therefore, the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. In the instant case, Negi et al. (US 2017/0007813) disclose a multi-site electrode array (100) can include a microneedle array and a set of electrically active sites (115). The microneedle array includes a plurality of microneedles (105) supported on a base substrate (110). The set of electrically active sites (115) can be arranged at and/or near the tip of each microneedle (105), and in many cases along a shaft of the microneedles. Further, at least a portion of the active sites (115) can be independently electrically addressable such that a remaining portion of the active sites (115) are optionally electrically shunted together. In some cases all of the active sites (115) are independently electrically addressable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 YASSER ABDELAZIEZ whose telephone number is (571)270-5783. The examiner can normally be reached Monday - Friday 9 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Leonard Chang can be reached at (571)270-3691. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASSER A ABDELAZIEZ, PhD/Primary Examiner, Art Unit 2898