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 .
Acknowledgments
In the reply, filed on April 19, 2024, Applicant amended claims 1, 5-7, 9-10, 12-13, and 15-17.
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, “a piston” (claim 1, line 3), “a screw” (claim 1, line 3), “a groove” (claim 5, line 3), “a junction” (claim 10, line 3), and “an insulating sealing material” (claim 10, line 4) must be shown or the feature(s) canceled from the claim(s). 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 abstract of the disclosure is objected to because:
In line 2, “the drug” should be changed to “a drug”
In line 2, “provided” should be changed to “the drug reservoir provided”
In line 3, “driving the screw” should be changed to “the driving wheel driving the screw”
Lines 4-5 recite “a power supply, used to supply power to the infusion device” which means that the power supply is not part of the infusion device. However, lines 1-4 previously recite “A highly integrated drug infusion device, includes… a power supply” which means that the power supply is part of the infusion device. It is unclear how the power supply can be both part of and not part of the infusion device.
In line 6, “for accommodating” should be changed to “the lower case for accommodating”
In line 6, “the drive wheel” should be changed to “the driving wheel”
Lines 8-9 recite “the power supply to supply power to the infusion device” which means that the power supply is not part of the infusion device. However, lines 1-4 previously recite “A highly integrated drug infusion device, includes… a power supply” which means that the power supply is part of the infusion device. It is unclear how the power supply can be both part of and not part of the infusion device.
In line 9, “power” should be changed to “the power”
In line 10, “the internal space” should be changed to “an internal space”
In line 11, “the internal arrangement” should be changed to “an internal arrangement”
In lines 11-12, “the volume” should be changed to “a volume”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 6, 12, 14-15, and 17 are objected to because of the following informalities:
In regards to claim 1, line 2, “provided” should be changed to “the drug reservoir provided”.
In regards to claim 1, line 4, “driving the screw” should be changed to “the driving wheel driving the screw”.
In regards to claim 1, line 8, “for accommodating” should be changed to “the lower case for accommodating”.
In regards to claim 1, line 9, “the drive wheel” should be changed to “the driving wheel”.
In regards to claim 6, line 3, “electrolyte” should be changed to “an electrolyte”.
In regards to claim 6, line 6, “lower case” should be changed to “the lower case”.
In regards to claim 12, line 4, “the drive wheel” should be changed to “the driving wheel”.
In regards to claim 14, line 3, “discarded” should be changed to “the infusion mechanism module and the control mechanism module discarded”.
In regards to claim 15, line 4, “connected” should be changed to “the detection mechanism module connected”.
In regards to claim 17, line 2, “infusion mechanism module” should be changed to “the infusion mechanism module”.
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 1-17 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.
In regards to claim 1, line 6 recites “a power supply, used to supply power to the highly integrated drug infusion device” which means that the power supply is not part of the highly integrated drug infusion device. However, claim 1, lines 1-6 previously recite “A highly integrated drug infusion device, comprising… a power supply” which means that the power supply is part of the highly integrated drug infusion device. It is unclear how the power supply can be both part of and not part of the highly integrated drug infusion device. Claims 2-17 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 9-10 recite: wherein a three dimensional circuit is provided “on” the case. It is unclear how the three dimensional circuit is provided “on” the case. Figure 2a instead shows the three dimensional circuit 116 provided “in” the lower case 111b. Claims 2-17 are rejected by virtue of being dependent upon claim 1.
In regards to claim 1, lines 10-11 recite “the power supply to supply the power to the highly integrated drug infusion device” which means that the power supply is not part of the highly integrated drug infusion device. However, claim 1, lines 1-6 previously recite “A highly integrated drug infusion device, comprising… a power supply” which means that the power supply is part of the highly integrated drug infusion device. It is unclear how the power supply can be both part of and not part of the highly integrated drug infusion device. Claims 2-17 are rejected by virtue of being dependent upon claim 1.
In regards to claim 2, line 2 recites: wherein the three dimensional circuit is coated “on” the upper case and/or the lower case. It is unclear how the three dimensional circuit is coated “on” the upper case and/or the lower case. Figure 2a instead shows the three dimensional circuit 116 provided “in” the lower case 111b.
In regards to claim 12, lines 4-5 recite: wherein the drug reservoir, the drive wheel, and the power supply are provided “on” the infusion mechanism module. It is unclear how the drug reservoir, the drive wheel, and the power supply are provided “on” the infusion mechanism module. Figure 2a instead shows the drug reservoir 112, the drive wheel 114, and the power supply 113 provided “in” the infusion mechanism module 110. Claims 13-17 are rejected by virtue of being dependent upon claim 12.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 3-5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 3, line 2 recites: wherein the three dimensional circuit is embedded “in” the upper case and/or the lower case. Claim 3 depends upon claim 2, which depends upon claim 1. Claim 1, lines 9-10 recite: wherein a three dimensional circuit is provided “on” the case, and claim 2, line 2 recites: wherein the three dimensional circuit is coated “on” the upper case and/or the lower case. Thus, claim 3, reciting wherein the three dimensional circuit is embedded “in” the upper case and/or the lower case, is of improper dependent form for failing to include all the limitations of claims 1-2, reciting wherein a three dimensional circuit is provided “on” the case, and wherein the three dimensional circuit is coated “on” the upper case and/or the lower case, upon which it depends. Claims 4-5 are rejected by virtue of being dependent upon claim 3.
In regards to claim 4, lines 3-4 recite: the three dimensional circuit is embedded “in” the upper case and/or the lower case. Claim 4 depends upon claim 3, which depends upon claim 2, which depends upon claim 1. Claim 1, lines 9-10 recite: wherein a three dimensional circuit is provided “on” the case, and claim 2, line 2 recites: wherein the three dimensional circuit is coated “on” the upper case and/or the lower case. Thus, claim 4, reciting the three dimensional circuit is embedded “in” the upper case and/or the lower case, is of improper dependent form for failing to include all the limitations of claims 1-2, reciting wherein a three dimensional circuit is provided “on” the case, and wherein the three dimensional circuit is coated “on” the upper case and/or the lower case, upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-9, 12, and 15-16 of copending Application No. 18/703,719 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the applications at least claim A highly integrated drug infusion device (A drug infusion device with integrated power supply), a drug reservoir, a piston, a screw, a driving wheel (at least one driving wheel), a power supply, a case, an upper case, a lower case, and a three dimensional circuit (a three-dimensional circuit).
The table below shows the examined application claims 1-3 and 6 corresponding to claims 1, 8-9, 12, and 15-16 of copending Application No. 18/703,719:
Application claims
Application No. 18/703,719 claims
1
1, 8, 9
2
15
3
16
6
1, 8, 9, 12
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 1-6 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Causey et al (US 2007/0100283).
In regards to claim 1, Causey et al teaches a highly integrated drug infusion device (Figures 3, 5, 8), comprising:
a drug reservoir (12), used for accommodating a drug to be infused, provided with a piston (58) and a screw (54)
a driving wheel (52), connected with the screw, driving the screw to push the piston forward by rotation
a power supply (44), used to supply power to the highly integrated drug infusion device
a case (84/22), including an upper case (84) and a lower case (22), for accommodating the drug reservoir, the drive wheel, and the power supply, wherein a three dimensional circuit (30/85) is provided on the case, and the three dimensional circuit is electrically connected to the power supply to supply the power to the highly integrated drug infusion device (Figure 8)
In regards to claim 2, Causey et al teaches wherein the three dimensional circuit is coated on the upper case and/or the lower case (Figure 8).
In regards to claim 3, Causey et al teaches wherein the three dimensional circuit is embedded in the upper case and/or the lower case (Figure 8).
In regards to claim 4, Causey et al teaches wherein the three dimensional circuit and the upper case and/or the lower case are integrated (Figure 8).
In regards to claim 5, Causey et al teaches wherein the upper case and/or the lower case are provided with a groove (82/83), and the three dimensional circuit is embedded in the upper case and/or the lower case through the groove (Figure 8).
In regards to claim 6, Causey et al teaches wherein the power supply includes a power supply shell (22), a battery cell (44), electrolyte (inherent component of battery 44) and a cover plate (84), and the highly integrated drug infusion device further comprises a frame (64), the power supply shell is integrated with the frame and/or the cover plate is integrated with the upper case or lower case (Figures 5, 8).
In regards to claim 12, Causey et al teaches an infusion mechanism module (Figure 5) and a control mechanism module (42), wherein the drug reservoir, the drive wheel, and the power supply are provided on the infusion mechanism module (Figure 5).
In regards to claim 13, Causey et al teaches wherein the infusion mechanism module and the control mechanism module are detachable to each other (the infusion mechanism module (Figure 5) and the control mechanism module (42) are separate pieces and capable of being detached from each other), and the control mechanism module is reusable (the control mechanism module (42) is capable of being reused).
In regards to claim 14, Causey et al teaches wherein the infusion mechanism module and the control mechanism module are disposed of in one housing (22), discarded together after a single-use (the infusion mechanism module (Figure 5) and the control mechanism module (42) are capable of being discarded together after a single-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 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Causey et al, as applied to claim 6 above, and further in view of Yuan (CN 209859978).
In regards to claim 7, Causey et al is silent about wherein an electrolyte isolation layer is arranged on an inside of the power supply shell and the cover plate. Yuan teaches a device (Figures 1-2) wherein an electrolyte isolation layer (3) is arranged on an inside of a power supply shell (1) and a cover plate (4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device, of Causey et al, with an electrolyte isolation layer, as taught by Yuan, as such will provide the action of anti-static, vacuumizing, light, oxygen, water-proof, moisture-proof, anti-volatilization (Specific implementation methods).
In regards to claim 8, in the modified device of Causey et al and Yuan, Causey et al is silent about wherein the electrolyte isolation layer is a coated TPE or PET layer. Yuan teaches wherein the electrolyte isolation layer is a coated PET layer (3). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrolyte isolation layer, of the modified device of Causey et al and Yuan, to be a coated PET layer, as taught by Yuan, as such will provide the action of anti-static, vacuumizing, light, oxygen, water-proof, moisture-proof, anti-volatilization (Specific implementation methods).
In regards to claim 9, in the modified device of Causey et al and Yuan, Causey et al is silent about wherein the electrolyte isolation layer is a TPE or PET layer which is an independent layer disposed at the inside of the power supply shell. Yuan teaches wherein the electrolyte isolation layer is a PET layer (3) which is an independent layer disposed at the inside of the power supply shell (1). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrolyte isolation layer, of the modified device of Causey et al and Yuan, to be a PET layer, as taught by Yuan, as such will provide the action of anti-static, vacuumizing, light, oxygen, water-proof, moisture-proof, anti-volatilization (Specific implementation methods).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Causey et al, as applied to claim 6 above, and further in view of Xu et al (CN205303540).
In regards to claim 10, Causey et al is silent about wherein a junction between the power supply shell and the cover plate is coated with an insulating sealing material. Xu et al teaches a device (Figure 4) wherein a junction between a power supply shell (bottom piece of 7) and a cover plate (top piece of 7) is coated with an insulating sealing material (8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify a junction between the power supply shell and the cover plate, of the device of Causey et al, to be coated with an insulating sealing material, as taught by Xu et al, as such will provide waterproof and stronger mechanical strength, and can effectively prevent water (Preferred Embodiment).
In regards to claim 11, in the modified device of Causey et al and Xu et al, Causey et al is silent about wherein the insulating sealing material is hot melt glue or silica gel. Xu et al teaches wherein the insulating sealing material is silica gel (8). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the insulating sealing material, of the modified device of Causey et al and Xu et al, to be silica gel, as taught by Xu et al, as such will provide waterproof and stronger mechanical strength, and can effectively prevent water (Preferred Embodiment).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Causey et al, as applied to claim 12 above, and further in view of Yodfat et al (US 8,337,486).
In regards to claim 15, Causey et al an artificial pancreas (Figures 3, 5, 8), comprising:
the highly integrated drug infusion device of claim 12 (Figures 3, 5, 8)
Causey et al is silent about a detection mechanism module, configured to detect blood glucose continuously, connected or integrated with the control mechanism module and the infusion mechanism module of the highly integrated drug infusion device. Yodfat et al teaches an artificial pancreas (Figure 4) comprising a detection mechanism module (120), configured to detect blood glucose continuously, connected or integrated with a control mechanism module (15) and an infusion mechanism module (202) of a highly integrated drug infusion device (10). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the artificial pancreas, of Causey et al, with a detection mechanism module, as taught by Yodfat et al, as such will monitor a body analyte (e.g., glucose) and fluid delivery can be adjusted based on the monitored body analyte to thus implement a semi, or fully, closed-loop system (column 10, lines 48-52).
In regards to claim 16, in the modified artificial pancreas of Causey et al and Yodfat et al, Causey et al is silent about wherein any two of the control mechanism module, the infusion mechanism module and the detection mechanism module are connected or integrated with each other configured to form a single part whose attached position on a skin is different from a rest one of the control mechanism module, the infusion mechanism module and the detection mechanism module. Yodfat et al teaches wherein the control mechanism module and the detection mechanism module are connected or integrated with each other configured to form a single part (100) whose attached position on a skin is different from the infusion mechanism module (Figure 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the control mechanism module and the detection mechanism module, of the modified artificial pancreas of Causey et al and Yodfat et al, to be connected or integrated with each other configured to form a single part whose attached position on a skin is different from the infusion mechanism module, as taught by Yodfat et al, as such will provide for the relatively expensive components of the fluid delivery device to be deployed within a reusable part of the device while the relatively less expensive components, including, for example, a power source, may be accommodated within a disposable part (column 9, lines 28-33).
In regards to claim 17, in the modified artificial pancreas of Causey et al and Yodfat et al, Causey et al is silent about wherein the control mechanism module, infusion mechanism module and the detection mechanism module are connected or integrated with each other configured to form a single part, which is adapted to be attached on only one position on a skin. Yodfat et al teaches wherein the control mechanism module, infusion mechanism module and the detection mechanism module are connected or integrated with each other configured to form a single part (10), which is adapted to be attached on only one position on a skin (Figure 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the control mechanism module, infusion mechanism module and the detection mechanism module, of the modified artificial pancreas of Causey et al and Yodfat et al, to be connected or integrated with each other configured to form a single part, which is adapted to be attached on only one position on a skin, as taught by Yodfat et al, as such will as such will allow for monitoring a body analyte (e.g., glucose) and fluid delivery can be adjusted based on the monitored body analyte to thus implement a semi, or fully, closed-loop system (column 10, lines 48-52).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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