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
Claims 1, 6-7, 9, and 14-15 are objected to because of the following informalities:
-Claim 1, line 4: please correct “screw, driving” to “screw, for driving”
-Claim 1, line 7: please correct “electrolyte” to “an electrolyte”
-Claim 1, line 8: please correct “drive” to “driving”
-Claim 1, line 11: please correct “power” to “the power”
-Claim 1, line 13: please correct “drive” to “driving”
-Claim 6, line 6: please correct “terminal” to “terminals”
-Claim 6, line 7: please correct “includes” to “include”
-Claim 7, line 3: please correct “the conductors” to “the plurality of conductors”
-Claim 9, line 3: please correct “the small holes located” to “the two holes are located”
-Claim 14, line 3: please correct “the elastic conductor” to “the elastic conductors”
-Claim 15, line 4: please correct “the drug reservoir” to “and wherein the drug reservoir”
-Claim 15, line 4: please correct “drive” to “driving”
-Claim 15, line 4: please correct “the frame” to “and the frame”
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 1-20 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 recites the limitation “a frame, used to carry the drug reservoir, the drive wheel, the power supply and electrical connection terminals of components, wherein the power supply is electrically connected to the electrical connection terminals of the components to supply power to the drug infusion device” in lines 8-11. It is unclear what is meant by “components”. Does “components” include any of the elements which have previously been recited in the claim? Or does components only include additional elements of the drug infusion device which have not previously been recited? For examination purposes, the Examiner interprets that both recitations of “components” in claim 1 are intended to mean additional elements of the drug infusion device which have not been previously recited.
Claims 2-20 are rejected by virtue of their dependency on rejected claim 1.
Claim 6 recites the limitation “the electrical connection terminal of the components includes a plurality of conductors” in lines 6-7. As described in the 112(b) rejection of claim 1 above, it is unclear what is meant by “components”. Does “components” include any of the elements which have previously been recited in the claims? Or does components only include additional elements of the drug infusion device which have not previously been recited? For examination purposes, the Examiner interprets that all recitations of “components” in claims 1 and 6 are intended to mean additional elements of the drug infusion device which have not been previously recited.
Claims 7-14 and 19-20 are rejected by virtue of their dependency on rejected claim 6.
The term “small” in line 3 and line 5 of claim 8 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how to apply prior art to the term “small holes”. For examination purposes, the Examiner interprets “two small holes” as “two holes”.
Claims 9 and 12-13 are rejected by virtue of their dependency on rejected claim 8.
The term “small” in line 3 of claim 9 is a relative term which renders the claim indefinite. The term “small” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how to apply prior art to the term “small holes”. For examination purposes, the Examiner interprets “small holes” as “holes”.
Claim 13 is rejected by virtue of their dependency on rejected claim 8.
Claim 18 recites the limitation “the infusion mechanism module and the control mechanism module are disposed in one housing”. However, claim 1 previously recites “a case, including an upper case and a lower case”, and case appears to be synonymous with housing in the application. It is unclear whether the Applicant intends for “housing” in claim 18 to be an additional structure to the case/upper case/lower case of claim 1. Further, it is unclear what “one housing” would be since the case has at least two parts- the upper case and the lower case. For examination purposes, the Examiner interprets “one housing” in claim 18 as “the case”.
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, 15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burren et al. (US 2020/0405951 A1).
Regarding claim 1, Burren discloses a drug infusion device with embedded power supply (see Figs. 1-7, par. [0104], [0107]), comprising:
a drug reservoir (cartridge unit 12), used for accommodating a drug to be infused (see Fig. 2, par. [0105] and [0107]), provided with a piston (piston rod 31) and a screw (threaded rod 25) (see par. [0107]);
a driving wheel (ratchet wheel 26), connected with the screw (threaded rod 25), driving the screw (threaded rod 25) to push the piston (piston rod 31) forward by rotation (see par. [0107]-[0108]);
a power supply (battery 30, holder 58, and drive cover 23), used to supply power to the drug infusion device, including a power supply shell (holder 58), a battery cell (body of battery 30), electrolyte (electrolyte within battery 30) and a cover plate (drive cover 23) (see Figs. 4, 5a, 5h, par. [0107], [0110]);
a frame (drive carrier 24), used to carry the drug reservoir (cartridge unit 12) (see par. [0113], the drive unit 10 and the needle unit 11 are fixed together such that the drive unit carries the cartridge unit 12), the drive wheel (ratchet wheel 26) (see Figs. 5k, 6), the power supply (battery 30, holder 58, and drive cover 23) and electrical connection terminals of components (see Figs. 3d, 4, 5h, par. [0106]-[0107], [0110]), wherein the power supply (battery 30, holder 58, and drive cover 23) is electrically connected to the electrical connection terminals of the components to supply power to the drug infusion device (see par. [0106]-[0107], [0110]); and
a case (housing unit 2), including an upper case (housing cover 168) and a lower case (housing base 171), for accommodating the drug reservoir (cartridge unit 12), the drive wheel (ratchet wheel 26), the power supply (battery 30, holder 58, and drive cover 23 ) (see Fig. 2, the power supply is held within drive unit 10 which is held within housing unit 2) and the frame (drive carrier 24) (see Fig. 26, par. [0138]), wherein the power supply shell (holder 58) is integrated with the frame (drive carrier 24) (see Fig. 5h, par. [0110]) and/or the cover plate (drive cover 23) is integrated with the lower case (housing base 171) (see Figs. 1-2, 4, 26, par. [0138]).
Regarding claim 15, Burren discloses the drug infusion device with embedded power supply of claim 1, wherein the drug infusion device includes an infusion mechanism module (drive unit 10) and a control mechanism module (printed circuit board unit 9), the drug reservoir (cartridge unit 12), the drive wheel (ratchet wheel 26), the power supply (battery 30, holder 58, and drive cover 23), and the frame (drive carrier 24) are arranged on the infusion mechanism module (drive unit 10) (see Figs. 2-4, 5h, par. [0105]-[0106]).
Regarding claim 18, Burren discloses the drug infusion device with embedded power supply of claim 15, wherein the infusion mechanism module (drive unit 10) and the control mechanism module (printed circuit board unit 9) are disposed in one housing, discarded together after a single-use (see par. [0106], PCB 9 and drive unit 10 are fixed to each other such that they are capable of being disposed of as a single piece after one use).
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 2, 6-12, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2020/0405951 A1), as applied to claim 1 above, in view of Pyszczek (US 2011/0151310 A1).
Regarding claim 2, Burren discloses the drug infusion device with embedded power supply of claim 1. However, Burren is silent as to wherein an electrolyte isolation layer is arranged on an inside of the power supply shell and the cover plate.
Pyszczek teaches a drug infusion device with embedded power supply (see par. [0094]), wherein an electrolyte isolation layer is arranged on an inside of the power supply shell and the cover plate (see par. [0008], [0036], [0211]-[0212], the battery is placed within a case of the device which is lined with an insulative material).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of Burren to include wherein an electrolyte isolation layer is arranged on an inside of the power supply shell and the cover plate, as taught by Pyszczek, in order to insulate the battery from the remainder of the medical device (see Pyszczek par. [0008], [0036], [0211]-[0212]).
Regarding claim 6, Burren discloses the drug infusion device with embedded power supply of claim 1, wherein the electrical connection terminals of the components include a plurality of conductors (see par. [0106]-[0107]).
However, Burren is silent as to wherein the battery cell includes a positive electrode sheet, a negative electrode sheet, a separator, a positive electrode tab and a negative electrode tab, the positive electrode tab is fixedly connected to the positive electrode sheet, the negative electrode tab is fixedly connected to the negative electrode sheet.
Pyszczek teaches a drug infusion device with embedded power supply (see par. [0094]), wherein the battery cell includes a positive electrode sheet (cathode layer, see par. [0123]), a negative electrode sheet (anode layer, see par. [0118]), a separator (insulative separator layer, see par. [0122]), a positive electrode tab (cathode lead, see par. [0124]) and a negative electrode tab (anode lead, see par. [0119]), the positive electrode tab (cathode lead, see par. [0124]) is fixedly connected to the positive electrode sheet (cathode layer, see par. [0123]-[0126]), the negative electrode tab (anode lead, see par. [0119]) is fixedly connected to the negative electrode sheet (anode layer, see par. [0118]-[0121]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of Burren to include wherein the battery cell includes a positive electrode sheet, a negative electrode sheet, a separator, a positive electrode tab and a negative electrode tab, the positive electrode tab is fixedly connected to the positive electrode sheet, the negative electrode tab is fixedly connected to the negative electrode sheet, as taught by Pyszczek, in order to provide the structure for the battery cell to function to conduct electricity (see Pyszczek par. [0109]-[0130]).
Regarding claim 7, modified Burren teaches the drug infusion device with embedded power supply of claim 6 substantially as claimed. Burren further teaches wherein the conductors are elastic conductors (see par. [0107], [0110], at least contact springs 29 are elastic conductors).
Regarding claim 8, modified Burren teaches the drug infusion device with embedded power supply of claim 7 substantially as claimed. Modified Burren further teaches wherein two small holes (Burren, apertures 56) are provided on the power supply shell (Burren, holder 58), and the positive electrode tab and the negative electrode tab (Pyszczek, cathode lead and anode lead, see previous modifications in rejection of claim 6 above) are electrically connected to the elastic conductors (Burren, see par. [0107], [0110], at least contact springs 29 are elastic conductors), respectively, through the two small holes (apertures 56) (see Burren Fig. 5h, par. [0107], [0110]).
Regarding claim 9, modified Burren teaches the drug infusion device with embedded power supply of claim 8 substantially as claimed. However, modified Burren is silent as to wherein portions of the power supply shell where the two small holes are located are coated with an insulating sealing material.
Pyszczek teaches a drug infusion device with embedded power supply (see par. [0094]), wherein portions of the power supply shell where the small hole is located is coated with an insulating sealing material (glass-to-metal seal 40), (see Fig. 9, par. [0204]-[0207], at least the cathode lead 22 extends through a hole of the casing 10 that coated with an insulating glass-to-metal seal 40).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of Burren to include wherein portions of the power supply shell where the two small holes are located are coated with an insulating sealing material, as suggested by Pyszczek, in order to further insulate the battery from the remainder of the medical device (see Pyszczek par. [0008], [0036], [0211]-[0212).
Regarding claim 10, modified Burren teaches the drug infusion device with embedded power supply of claim 7 substantially as claimed. Modified Burren further teaches wherein when the cover plate (Burren, drive cover 23) covers the power supply shell (Burren, holder 58), a part of the positive electrode tab (Pyszczek, cathode lead, see par. [0124]) and a part of the negative electrode tab (Pyszczek, anode lead, see par. [0119]) are reserved out of the power supply shell (Burren, holder 58) to be electrically connected to the elastic conductors (Burren, see par. [0107], [0110], at least contact springs 29 are elastic conductors), respectively (see previous modifications in rejection of claim 6 above, see Burren Fig. 5h, par. [0107], [0110], a part of the electrode tabs must extend through apertures 56 to communicate with contact springs 29).
Regarding claim 11, modified Burren teaches the drug infusion device with embedded power supply of claim 10 substantially as claimed. However, modified Burren is silent as to whether a junction between the power supply shell and the cover plate is coated with an insulating sealing material.
Pyszczek teaches a drug infusion device with embedded power supply (see par. [0094]) wherein a junction between the power supply shell (one half of the clamshell case) and the cover plate (other half of the clamshell case) is coated with an insulating sealing material (see par. [0212], the insulating bag forms a coating on both halves of the clamshell case when the clamshell case is loaded and closed).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of modified Burren to include wherein a junction between the power supply shell and the cover plate is coated with an insulating sealing material, as taught by Pyszczek, in order to insulate the battery from the remainder of the medical device (see Pyszczek par. [0008], [0036], [0211]-[0212]).
Regarding claim 12, modified Burren teaches the drug infusion device with embedded power supply of claim 8 substantially as claimed. Modified Burren further teaches wherein the positive electrode tab (Pyszczek, cathode lead, see par. [0124]) and the negative electrode tab (Pyszczek, anode lead, see par. [0119]) are integrated with the elastic conductors (Burren, see par. [0107], [0110], at least contact springs 29 are elastic conductors), respectively (see previous modifications in rejection of claim 6 above, see Burren Fig. 5h, par. [0107], [0110], a part of the electrode tabs must communicate with contact springs 29).
Regarding claim 14, modified Burren teaches the drug infusion device with embedded power supply of claim 7 substantially as claimed. Modified Burren further teaches wherein a protrusion (see Fig. 4, par. [0107], contact springs 29 are spiral springs which are shown to have a thicker portion which protrudes from a thinner portion) is provided on the elastic conductors (Burren, see par. [0107], [0110], at least contact springs 29 are elastic conductors).
Regarding claim 19, modified Burren teaches the drug infusion device with embedded power supply of claim 10 substantially as claimed. Modified Burren further teaches wherein the positive electrode tab (Pyszczek, cathode lead, see par. [0124]) and the negative electrode tab (Pyszczek, anode lead, see par. [0119]) are integrated with the elastic conductors (Burren, see par. [0107], [0110], at least contact springs 29 are elastic conductors), respectively (see previous modifications in rejection of claim 6 above, see Burren Fig. 5h, par. [0107], [0110], a part of the electrode tabs must communicate with contact springs 29).
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2020/0405951 A1) in view of Pyszczek (US 2011/0151310 A1), as applied to claim 2 above, further in view of Jones et al. (US 2019/0282791 A1).
Regarding claim 3, modified Burren teaches the drug infusion device with embedded power supply of claim 2 substantially as claimed. However, modified Burren fails to expressly state wherein the electrolyte isolation layer is a coated TPE or PET layer.
Jones teaches a drug infusion device (see Figs. 1-4, par. [0047]-[0048]) wherein the electrolyte isolation layer is a coated PET layer (see par. [0059]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of modified Burren such that the electrolyte isolation layer is a coated PET layer, as taught by Jones, because Jones teaches that PET is a material suitable for isolating electrolytes (see Jones par. [0059]).
Regarding claim 4, modified Burren teaches the drug infusion device with embedded power supply of claim 3 substantially as claimed. However, modified Burren fails to expressly state wherein a thickness of the electrolyte insulation layer is 300 µm-500 µm.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of modified Burren such that a thickness of the electrolyte isolation layer is 300 µm-500 µm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the drug infusion device of modified Burren would not operate differently with the claimed thickness and since the electrolyte isolation layer must be thin enough to allow the battery to be received within the power supply shell, the drug infusion device would function appropriately having the claimed thickness. Further, it appears that Applicant places no criticality on the range claimed, indicating simply that the thickness is within the claimed range (see Specification page 11).
Regarding claim 5, modified Burren teaches the drug infusion device with embedded power supply of claim 2 substantially as claimed. However, modified Burren fails to expressly state wherein the electrolyte isolation layer is a separated TPE or PET layer.
Jones teaches a drug infusion device (see Figs. 1-4, par. [0047]-[0048]) wherein the electrolyte isolation layer is a separated PET layer (see par. [0059]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of modified Burren such that the electrolyte isolation layer is a separated PET layer, as taught by Jones, because Jones teaches that PET is a material suitable for isolating electrolytes (see Jones par. [0059]).
Claims 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2020/0405951 A1) in view of Pyszczek (US 2011/0151310 A1), as applied to claims 9 and 11 above, further in view of Liu et al. (US 2019/0223503 A1).
Regarding claim 13, modified Burren teaches the drug infusion device with embedded power supply of claim 9 substantially as claimed. However, modified Burren fails to expressly state wherein the insulating sealing material is hot melt glue or silica gel.
Liu teaches a device (see Figs. 9-10) wherein the insulating sealing material (silica gel sleeve 82) is silica gel (see par. [0021], [0040], [0082], [0100]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of modified Burren such that the insulating sealing material is silica gel, as taught by Liu, because Liu teaches that silica gel is a material which is capable of sealing the device, insulating, and has enough elasticity to buffer vibrations during use of the device (see Liu par. [0021]).
Regarding claim 20, modified Burren teaches the drug infusion device with embedded power supply of claim 11 substantially as claimed. However, modified Burren fails to expressly state wherein the insulating sealing material is hot melt glue or silica gel.
Liu teaches a device (see Figs. 9-10) wherein the insulating sealing material (silica gel sleeve 82) is silica gel (see par. [0021], [0040], [0082], [0100]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of modified Burren such that the insulating sealing material is silica gel, as taught by Liu, because Liu teaches that silica gel is a material which is capable of sealing the device, insulating, and has enough elasticity to buffer vibrations during use of the device (see Liu par. [0021]).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Burren et al. (US 2020/0405951 A1), as applied to claim 15 above, in view of Yang (US 2016/0158436 A1).
Regarding claim 16, Burren discloses the drug infusion device with embedded power supply of claim 15. However, Burren fails to expressly state wherein the infusion mechanism module and the control mechanism module are detachable to each other, and the control mechanism module is reusable.
Yang teaches a drug infusion device (see Fig. 1) wherein the infusion mechanism module (pump base 12) and the control mechanism module (controller 11) are detachable to each other (see Fig. 1, abstract, par. [0013], [0017], [0106]), and the control mechanism module (controller 11) is reusable (see par. [0017], [0106]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug infusion device of Burren such that the infusion mechanism module and the control mechanism module are detachable to each other, and the control mechanism module is reusable, as taught by Yang, in order to reduce costs associated with the drug infusion device (see Yang par. [0017], [0106]).
Regarding claim 17, modified Burren teaches the drug infusion device with embedded power supply of claim 16 substantially as claimed. Burren further teaches wherein the infusion mechanism module (drive unit 10) and the control mechanism module (printed circuit board unit 9) are electrically connected by an electrical contact (see par. [0105]-[0108]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783