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 Objections
Claim 48 is objected to because of the following informalities: the word, “bioimplantable” should be amended to “bio-implantable”. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: the word, “bioimplantable” should be amended to “bio-implantable”. Appropriate correction is required.
Claim 51 is objected to because of the following informalities: the phrase, “5 mm or less,,” includes an extra comma. 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.
Claims 33-52 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 33 recites the limitations: "the environment", “the inner wall”, “the skull”, “the brain surface”, and “the body” in lines 4-6. There is insufficient antecedent basis for these limitations in the claim. Claims 34-50 are also rejected because they are dependent on claim 33.
Claim 36 recites the limitation "environment " in line 3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this environment is different from the environment already cited in claim 33, or if they are the same environment. For examination purposes, Examiner will treat both environments as being the same.
Claim 36 recites the limitation “the group” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 37 recites the limitation “the polymer” in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 38 is also rejectedbecause it is dependent on claim 37.
Claim 38 recites the limitation "DNA conjugated to the polymer" in line 3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this conjugated DNA is different from the conjugated DNA cited in previously dependent claim 37, or if they are the same conjugated DNA. For examination purposes, Examiner will treat both conjugated DNAs as being the same.
Claim 41 recites the limitations “the terminal end” and “the target” in line 5. There is insufficient antecedent basis for these limitations in the claim.
Claim 42 recites the limitation “the connection portion” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 43 recites the limitation “the terminal and intermediate points” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 44-47 are also rejected because they are dependent on claim 43.
Claim 47 recites the limitation “the central support” in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner will treat the central support of claim 47 to be same as the central support portion of independent claim 33.
Claim 49 recites the limitation “the outside” in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 50 is also rejectedbecause it is dependent on claim 49.
Claim 49 recites the limitation “the central support” in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner will treat the central support of claim 49 to be same as the central support portion of independent claim 33.
Claim 50 recites the limitation “the standing structure” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 50 recites the limitation “the central support” in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner will treat the central support of claim 50 to be same as the central support portion of independent claim 33.
Claim 51 recites the limitations “the body” in lines 4, “the z-axis direction” in line 5, and “the x-y axis direction” in line 7. There is insufficient antecedent basis for these limitations in the claim. Claim 52 is also rejected because it is dependent on claim 51.
Claim 51 recites the limitation "the central support portion" in line 8. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this central support portion is different from the central support previously cited in the claim, or if they are the same structure. For examination purposes, Examiner will treat both the central support portion and the central support as being the same structure on the electronic device.
Claim 52 recites the limitation “the electronic umbrella device” in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner will interpret the bio-implantable electronic device of claim 51 as being the same as the electronic umbrella device.
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.
Claims 33-36, 39-40, 42-47, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over a first embodiment of Kang (K.R. Application No. 20210113957 A), and further in view of a second embodiment of the Kang reference.
Regarding independent claim 33, the first embodiment of Kang discloses a bio-implantable electronic device (170) (page 4, lines 1-2 & Fig. 9) comprising:
a central support portion (811) (page 6, lines 28-29); and
a branch portion (812) extending from the central support portion (page 6, lines 28-29);
wherein, when entering the environment between the inner wall of the skull and the brain surface having a height of 5 mm or less, the branch portion unfolds, contacts the brain surface, operates (page 4, lines 26-27; page 7, lines 16-21), and then biodegrades to be discharged outside the body (page 3, lines 1-2, bottom-up),
wherein the electronic device is characterized as an electronic umbrella device for minimally invasive procedures (page 3, lines 17-19 & Fig. 9).
It is noted by Examiner that the claim recitation of, “when entering the environment between the inner wall of the skull and the brain surface having a height of 5 mm or less” is regarded as a functional recitation of the intended use of the electronic device. It has been held that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the electronic device of Kang readily provides for such functionality given that it is able to be inserted and implanted into a body of a patient, including the 5 mm or less space between the inner wall of the skull and the brain surface. Therefore, the prior art meets the claim limitation.
However, the first embodiment of Kang does not disclose the central support portion including an internal space, wherein the central support portion forms a pillar-shaped shaft structure having a height in a z-axis direction.
The second embodiment of Kang, in the same field of endeavor, teaches another type of electronic device (140) comprising a different shape and arrangement (page 5, lines 20-21 & Fig. 7), wherein a central support portion (450) includes an internal space (created between buffer 452 and deformable part 200) (page 6, line 1), wherein the central support portion forms a pillar-shaped shaft structure having a height in a z-axis direction (page 6, lines 11-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the central support portion of the first embodiment of Kang to include the deformable buffer, as taught by the second embodiment of Kang, for the purpose of maintaining a stable adhesion state between the remaining sections of the contact portion and the rest of the electronic device (page 6, lines 11-17).
Regarding claim 34, the combination of Kang embodiments discloses wherein the branch portion comprises an electrode (700) (first embodiment, page 6, lines 28-29); and a cover layer covering the electrode from above and below (first embodiment, page 4, lines 10-13);
wherein the cover layer has an open structure that includes a partially exposed area of the electrode.
Examiner is interpreting that the cover layer has a partially exposed area given that the cover layer is described as temporarily blocking the biodegradation of the electronic device. In other words, the cover layer provides the electronic device with a predetermined amount of time to perform its desired functionality inside the body before disintegrating; therefore, if the electronic device is able to perform such functionalities, then the cover layer must have some partially exposed areas to allow the electrode to function as intended before disintegration.
Regarding claim 35, the combination of Kang embodiments discloses wherein the branch portion includes a shape-memory polymer that restores its shape when conditions of the surrounding environment are met (first embodiment, page 6, lines 33-34).
Regarding claim 36, the combination of Kang embodiments discloses wherein the conditions of the surrounding environment include one or more conditions selected from the group consisting of temperature, humidity, pH concentration, light intensity, ultrasound, and electromagnetic field (first embodiment, page 7, lines 16-21; page 7, lines 7-9, bottom-up).
Regarding claim 39, the combination of Kang embodiments discloses wherein the branch portion forms a network structure (combination of the connecting member 812, an internal support member 813, and a support member 814) (first embodiment, page 6, lines 28-29).
Regarding claim 40, the combination of Kang embodiments discloses wherein the network structure comprises:
a plurality of chassis portions (i.e., a physical frame or skeleton that makes up the network structure) radially spreading from the central support portion (see Fig. 9); and
chassis support portions (combination of the internal support member 813 and the support member 814) formed to connect between the chassis portions (see Fig. 9).
Regarding claim 42, as best understood, the combination of Kang embodiments discloses wherein at least a part of the connection portion between the chassis portion and the chassis support portion is formed with a device portion (see Fig. 9).
Regarding claim 43, as best understood, the combination of Kang embodiments discloses wherein at least some of the terminal and intermediate points of the chassis portion are formed with respective device portions (see Fig. 9).
Regarding claim 44, the combination of Kang embodiments discloses wherein the device portion includes one or more selected from a sensor unit, electrode unit, electrical stimulation unit, drug injection unit, ultrasonic transmission unit, battery unit, and optical transmission unit (first embodiment, page 4, lines 1-2; page 6, lines 28-29).
Regarding claim 45, the combination of Kang embodiments discloses wherein the device portion is configured such that a single device portion performs multiple functions (first embodiment, page 4, lines 1-2).
Regarding claim 46, the combination of Kang embodiments discloses wherein at least two of the device portions perform different functions (first embodiment, page 4, lines 1-2).
Regarding claim 47, the combination of Kang embodiments discloses wherein each of the chassis portions having device portions performing different functions is assembled to be connected to the central support (see Fig. 9).
Regarding independent claim 51, the first embodiment of Kang discloses a bio-implantable electronic device (170) (page 4, lines 1-2 & Fig. 9) comprising:
a central support portion (811) (page 6, lines 28-29); and
a branch part (812) including a plurality of chassis portions (i.e., a physical frame or skeleton that makes up the network structure) extending from the central support (page 6, lines 28-29);
wherein the device, when outside the body, is maintained in a bundled three-dimensional structure in the z-axis direction, and is configured to be injected into an in vivo environment having a height of 5 mm or less, and after being injected into the in vivo environment, unfolds into a 2D structure in the x-y axis direction (page 4, lines 26-27; page 7, lines 16-21),
enabling minimally invasive procedures (page 3, lines 17-19 & Fig. 9).
It is noted by Examiner that the claim recitation of, “the device.. configured to be injected into an in vivo environment having a height of 5 mm or less” is regarded as a functional recitation of the intended use of the electronic device. It has been held that a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the electronic device of Kang readily provides for such functionality given that it is able to be inserted and implanted into a body of a patient, including an in vivo environment having a height of 5 mm or less. Therefore, the prior art meets the claim limitation.
However, the first embodiment of Kang does not disclose the central support including an internal space, wherein the central support portion forms a pillar-shaped shaft structure having a height in a z-axis direction.
The second embodiment of Kang, in the same field of endeavor, teaches another type of electronic device (140) comprising a different shape and arrangement (page 5, lines 20-21 & Fig. 7), wherein a central support portion (450) includes an internal space (created between buffer 452 and deformable part 200) (page 6, line 1), wherein the central support portion forms a pillar-shaped shaft structure having a height in a z-axis direction (page 6, lines 11-17).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the central support of the first embodiment of Kang to include the deformable buffer, as taught by the second embodiment of Kang, for the purpose of maintaining a stable adhesion state between the remaining sections of the contact portion and the rest of the electronic device (page 6, lines 11-17).
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Kang as applied to claim 33 above, and further in view of Ueberle (U.S. Application No. 20030147812 A1).
Regarding claim 37, the combination of Kang embodiments discloses the invention substantially as claimed in claim 33 discussed above.
However, Kang does not disclose wherein the branch portion further includes DNA conjugated to the polymer, and the DNA includes a hairpin structure or double-stranded DNA.
Ueberle, in the same field of endeavor, teaches an implantable drug delivery device (pa. 0034) that includes genetic material that is combined with proteins or other polymers (pa. 0126) in order to direct the desired drug or biological agent to a specified organ (pa. 0030). The genetic material refers generally to nucleotides and polynucleotides, including deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), wherein the DNA and RNA are single or double stranded (pa. 0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the branch portion of the bio-implantable electronic device of Kang to include the DNA conjugated to the polymer, as taught by Ueberle, for the purpose of directing the desired drug or biological agent to a specific organ (Ueberle, pa. 0030).
Regarding claim 38, the combination of Kang embodiments discloses the invention substantially as claimed in claims 33 and 37 and discussed above.
However, Kang does not disclose wherein the branch portion is formed of a material that includes DNA conjugated to the polymer only in a partial region.
Ueberle, in the same field of endeavor, teaches an implantable drug delivery device (pa. 0034) that includes genetic material that is combined with proteins or other polymers (pa. 0126) in order to direct the desired drug or biological agent to a specified organ (pa. 0030). The genetic material refers generally to nucleotides and polynucleotides, including deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) (pa. 0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the branch portion of the bio-implantable electronic device of Kang to include the DNA conjugated to the polymer, as taught by Ueberle, only a partial region, for the purpose of directing the desired drug or biological agent to a specific organ (Ueberle, pa. 0030).
Claims 41 and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Kang as applied to claim 33 above, and further in view of Kuzniecky (U.S. Application No. 20180117331 A1).
Regarding claim 41, the combination of Kang embodiments discloses wherein when the biological implantable electronic device is in a bundled state and the branch portion is inserted in a direction to first contact the brain surface (first embodiment, page 4, lines 5-6).
However, Kang does not disclose the contact angle between the terminal end of the chassis portion and the target is 70 degrees or less.
Kuzniecky, in the same field of endeavor, teaches an implantable device that may be implanted perpendicular or parallel to a head axis of the patient. In further embodiments, the device may be implanted at an angle between 0 to 90° to the head axis of the patient (pa. 0047).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the angle of insertion of the biological implantable electronic device of Kang to be at an angle of 70 degrees or less, as taught by Kuzniecky, in order to implant the electronic device in the desired brain location of the patient.
Regarding claim 49, the combination of Kang embodiments discloses the invention substantially as claimed in claim 33 discussed above.
However, Kang does not disclose wherein the central support includes means for enabling wireless communication with the outside or a conductive line that allows wired communication to pass through.
Kuzniecky, in the same field of endeavor, teaches an implantable device comprising a wireless transceiver controlled by a processor to wirelessly transmit signal data to and from a remote computer (pa. 0003, 0033).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the wireless transceiver and processor taught by Kuzniecky to the central support of the electronic device of Kang in order to wirelessly transmit signal data to and from a remote computer (Kuzniecky, pa. 0003, 0033).
Regarding claim 50, as best understood, the combination of Kang embodiments discloses wherein the central support includes an auxiliary support (610) that supports the standing structure of the central support (first embodiment, page 6, lines 33-34).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Kang as applied to claim 33 above, and further in view of Tachibana (U.S. Patent No. 6176842 B1).
Regarding claim 48, the first embodiment of Kang embodiments discloses the electronic device can be made of a material that can restore shape by stimulation of light in addition to heat, and if it is desired to artificially induce deformation at a desired time and location, the operator can directly irradiates light to the electronic device (page 7, lines 7-9, bottom-up).
However, Kang does not disclose wherein the bioimplantable electronic device includes a position detection marker.
Tachibana, in the same field of endeavor, teaches a catheter device that is positioned within a tumor of a patient using radiopaque markers (Col. 52, lines 35-37).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the radiopaque markers taught by Tachibana, to the electronic device of Kang for the purpose of tracking the location of the device so that the user may artificially induce deformation at a desired time and location.
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Kang as applied to claim 51 above, and further in view of Richter (U.S. Application No. 20180363115 A1).
Regarding claim 52, the combination of Kang embodiments discloses the invention substantially as claimed in claim 51 discussed above.
However, Kang does not disclose wherein the electronic umbrella device has a filling ratio of 0.6 or less.
Richter, in the same field of endeavor, teaches an implantable device comprising a plurality of composite wire/rods with a filling ratio of 25 percent (pa. 0057, 0177).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electronic device of Kang to have a filling ratio of 0.6 or less, as taught by Richter, in order to ensure the device can bend, twist, or compress without damaging any internal circuit components.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Williams (US 20100130844 A1) teaches a thin-film microelectrode array tailored for long-term, minimally invasive cortical recording or stimulation.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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