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 .
Status of the Claims
Claims 1, 10, and 14 have been amended. Claims 4-9 and 15 are cancelled. Claims 1-3, 10-14, and 16 are currently pending. Claims 1-3, 10-14, and 16 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 11/10/2025, with respect to the rejection(s) of claim(s) 1 and 14 under 35 U.S.C. 103 have been fully considered and are persuasive, since as previously discussed, the amended independent claims place both the connecting member and the connection tube as part of the cartridge module. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation of Togawa, Gagnebin, and Johnson.
The amendments to claims 1 and 14 obviate the previous drawing objection and related 112b rejections, which as such are not extended to the application as currently amended. However, the 112(b) rejection of claim 2 regarding lack of clarity between the terms “driving module” and “driving unit” was not addressed by the amendments and is repeated below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “driving unit” (claim 2, note 112b rejection below) 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
“connection tube” in claims 1 and 14 lacks antecedent basis in the specification, though pg. 9 para. 2 provides support for a “connection pipe” which seems to perform the function associated with the “connection tube” in the claims.
“driving unit” in claim 2. Although the specification mentions a “driving unit”, there is no support for having both a “driving module” and a “driving unit” as claimed in claim 2. Note related 112b rejection of claim 2.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“rotation unit” in claim 1. For the purposes of examination, a “rotation unit” is being interpreted, in light of specification pg. 19 para. 4, to be a device which transfers a driving force form a driving module to rotate a pressing portion.
“driving module” in amended claims 1 and 14. For the purposes of examination, a “driving module” is interpreted, in light of instant specification pg. 17 para. 4 to be any one of “all kinds of devices with drug suction power and drug discharge power by electricity” such as the provided examples of “a diaphragm displacement pump, a fluid displacement pump, a rotary pump… an electro hydrodynamic pump (EHD), an electro osmotic pump, a magneto hydrodynamic pump, an electro wetting pump” and equivalents.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2-3 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 2 recites the limitation “a driving unit for driving the drug discharge assembly” on lines 1 and 3-4. Claim 2 is dependent on claim 1, which recites the limitation “a driving module…configured to drive the drug discharge assembly”. It is unclear, in claim 2, if “a driving unit” is supposed to be the same as “a driving module” as introduced in claim 1, since both are stated to perform the same function, or whether the driving unit and driving module are terms meant to refer to different structures. Please alter the claim language of claims 1 and/or 2 as appropriate to clarify the relationship between the “driving module”, “driving unit”, and “drug discharge assembly”. For purposes of examination, either interpreting the driving unit as a separate part from the driving module, or interpreting the driving unit to be the same structure as the driving module introduced in claim 1 has been interpreted to meet the claim limitation.
Claim 3 is rejected for depending from claim 2, since dependent claims inherit the deficiencies of those claims from which they depend.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 11-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Togawa (US-20100318032-A1; hereafter Togawa) in view of Gagnebin (US-5083908-A; hereafter Gagnebin) and Johnson et al (US-20180193557-A1; hereafter Johnson).
Regarding claim 1, Togawa discloses a drug injection device comprising: a base body (base portion 25, fig. 2); a needle module (cannula 1b, fig. 2) comprising a needle configured to be injected into a user's body for discharging a drug and mounted on the base body ([0021] tip of cannula enters body, medicinal solution is deployed through cannula, fig. 1 and fig. 3 shows needle module/cannula 1b mounted on base body/portion 25);
a cartridge module (medicinal-solution reservoir 10, fig. 2) comprising a reservoir (pipe within reservoir 10; see [0022] reservoir 10 includes pipe) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for storing the drug ([0022] The medicinal-solution reservoir 10 is formed with a pipe and the medicinal solution is accommodated in the pipe.) to be discharged to the needle and having a structure attachable to and detachable from the base body ([0023] the medicinal-solution reservoir 10 is detachably attached to the drive body unit 30; base body 25 integrally assembled with driving unit 20 which is part of drive body unit 30 as shown in fig. 2);
a drug discharge assembly (drive-liquid unit 11, fig. 2 shows that the drug liquid unit 11 is located between the needle and the reservoir of medicinal-solution reservoir 10) disposed between the needle and the reservoir and configured for dispensing the drug to the needle in a preset amount ([0029] information input unit 33 allows for medicinal-solution administration information such as a dose amount to be programmed into the device); and
a driving module (see 112f interpretation above; driving unit 20, fig. 2, [0022] The driving unit 20 includes a pump 27 … for example, an electro-osmotic pump) mounted on the base body (base portion 25) (see fig. 2 which shows the driving module 20 mounted on the base body 25) and configured to drive the drug discharge assembly (11) ([0024] driving unit 20 has a pump 27 which drives fluid through the drug discharge assembly 11),
wherein the cartridge module (10, fig. 2) further comprises:
a connecting member (drive-liquid connection portion 31, fig. 2), fluidly connecting the reservoir ([0022] pipe within reservoir 10) and the drug discharge assembly (11) ([0028] cartridge module/medicinal-solution reservoir 10 and the drug discharge assembly/drive-liquid unit 11 connected by a drive-liquid connection portion 31 and a medicinal-solution connection portion 32 that combine an inlet and an outlet of the medicinal-solution reservoir 10; fig. 3 shows assembled state; fig. 4 and 11 show prior to assembled state) to allow the drug in the reservoir to flow to the drug discharge assembly ([0024] drug/medicinal solution flows from cartridge module/medicinal-solution reservoir 10 through the drug discharge assembly/drive-liquid unit 11 to the needle assembly/cannula 1b when connected via the flow channel F12).
Togawa is silent to the details of the drug discharge assembly.
Gagnebin, in the related field of infusion pumps (col. 1 ln. 4-7 peristaltic pump is adapted to be carried on the human body for continuous injection of aqueous medicament), teaches wherein the drug discharge assembly (pump module 2, Abstract, fig. 1) comprises: a tube (pipe 19, fig. 2, col. 3 ln. 49-53) installed between the reservoir (reservoir 67, fig. 5) and the needle (hypodermic needle 64, fig. 5) (col. 5 ln. 65-68 the output 14 of the pump is coupled to the needle 64 and the input 13 of the pump is coupled to the reservoir 67, thus the tube/pipe 19 is disposed between the input 13 and output 14 as shown in fig. 2), and having a curved portion (see fig. 2 which shows curved portion of pipe 19),
a rotation unit (rotor 80 and shaft 14, fig. 3; see 112f interpretation above; col. 3 ln. 34-37 rotor 80 is borne on shaft 14) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to rotate in one direction (col. 1 ln. 32-37 rotation speed of rotor modifies pump discharge), and
a pressing unit (second set of rollers 18, col. 3 ln. 36-41) with a plurality of pressing portions (each of the three rollers 18, fig. 2) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be spaced apart (see fig. 2 which shows rollers 15 spaced apart, col. 3 ln. 42-45 notes that rollers 18 are analogous to rollers 15), and upon rotation of the rotation unit, at least one of the pressing portions (18) compresses the curved portion of the tube (see fig. 2 which shows compression of curved portion of tube/pipe 16; col. 3 ln. 42-45 rollers 18 revolve along tube/pipe 19 and locally compress the pipe 19; col. 3 ln. 42-45 notes that the second set of rollers is analogous to the first), thereby deforming an internal cross-sectional area of the tube (fig. 2 shows deformation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Togawa, which is meant for targeted delivery over a relatively long period (Togawa [0003]) to include the peristaltic pump with tubing disposed between the reservoir and needle because the peristaltic pump of Gagnebin, which is meant for slow and continuous injection (Gagnebin col. 1 ln. 4-7). One would have been motivated to make the modification because the purpose for which Gagnebin is designed for, namely portable, continuous injection, is well suited for the purposes of Togawa, namely targeted delivery over time. Additionally, Gagnebin notes that it is known in the art that peristaltic pumps permit precise dosage (Gagnebin col. 1 ln. 21-24).
Togawa modified by Gagnebin as applied above is silent to the connecting member comprising a pierceable barrier rib configured to be pierced by an insertion portion.
Johnson, in the field of drug delivery devices, teaches wherein the tube (needle 330, fig. 3A/B, [0067]) has an insertion portion (fluid coupling end 330a of needle 330, fig. 3A/B, [0067]) at one end, the insertion portion being configured to be inserted into the cartridge module (cartridge 222, fig. 2, [0066]),
wherein the cartridge module further comprises:
a connecting member (fill port 116, fig. 2, [0066]) comprising a pierceable barrier rib (solid, filled-in tip of pierceable septum 218, fig. 2 and 3A/B; see annotated fig. 2 of Johnson below) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be pierced by the insertion portion (fluid coupling end 330a of needle 330, see fig. 3B which shows insertion portion 330a interfacing with pierceable septum 218 which seals fluid reservoir 220), the insertion portion (end 330a of needle 330, fig. 3B) being configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to pierce the pierceable barrier rib (solid tip of septum 218, fig. 2) when the cartridge module (222) is mounted on the base body (housing 112 and adhesive bottom surface 114, fig. 3A, [0066]), thereby fluidly connecting the reservoir (fluid reservoir 220, fig. 2, [0067]) to allow the drug in the reservoir (220) to flow ([0067] a translation of button 332 toward the patient causes a fluid coupling end 330a to be fluidly coupled to fluid reservoir 220 and a delivery end 330b to extend from bottom surface 114.),
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wherein the connecting member (fill port 116) is disposed apart from the reservoir (reservoir 220), and a connection tube (narrowed opening formed by septum 218, see annotated fig. 2 of Johnson above) fluidly connecting the connecting member to the reservoir (see fig. 2 which shows the hollow portion of septum 218 forming a connection tube between connecting member/fill port 116 and reservoir 220).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the connecting member of Togawa and Gagnebin to have the barrier rib punctured by an insertion portion as taught by Johnson, since Johnson also deals with a cartridge and needle system for delivering fluid. One would have been motivated to make the modification because the inclusion of the barrier rib/septum and the insertion portion/fluid coupling end ensures the cartridge does not spill during installation, thus preventing drug waste, contamination of the medication, and liquid interference with the electronic portions of the drug delivery device.
Regarding claim 2, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 1, as described above. Togawa discloses further comprising a driving unit (driving unit 20, fig. 2) (note 112b interpretation above, “driving unit” is interpreted to be the same as the “driving module” in claim 1) for driving the drug discharge assembly ([0026] pump 27 of driving unit 20 pushes out the drive liquid), wherein the cartridge module (10, fig. 2) further comprises a battery (battery 13) supplying power to the driving unit (battery 13, [0025] battery 13 is supplied to pump driving unit 26 via electrode 24; [0039] possible to mount the battery 13 on the medicinal-solution reservoir 10, as shown in fig. 11).
Regarding claim 11, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 1, as described above, including further details of the drug discharge assembly noted below with reference to Gagnebin.
Togawa is silent to a guide portion fixed to the base body.
Gagnebin teaches wherein the drug discharge assembly further comprises a guide portion (second backing 20, fig. 2 and 3) fixed to the base body (pump body 8 and cover 9, fig. 2 shows second backing 20 pressed against the base body/pump body 8) and configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to align a position of the tube (col. 3 ln. 42-46 second backing 20 surrounds the second pipe 19 along a first predetermined arc length DE; Examiner notes that second backing does serve to align a position of the tube since it prevents the tube from flexing past the second backing when compressed.).
Examiner notes that the combination of the peristaltic pump of Gagnebin with the device of Togawa has already been motivated above with reference to claim 1, and thus no further motivation would be needed to add additional elements of the peristaltic pump of Gagnebin to the device. Additionally, it would further have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include a guide portion/second backing as taught by Gagnebin with the invention of Togawa modified by Gagnebin and Johnson as applied to claim 1. One would have been motivated to make the modification to provide a hard surface against which the tubing can be compressed to better ensure that all fluid is removed from the tube and the tube is fully compressed.
Regarding claim 12, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 1, as described above, including further details of the drug discharge assembly noted below with reference to Gagnebin.
Togawa is silent to a cover surrounding the tube.
Gagnebin further teaches wherein the drug discharge assembly further comprises a cover (second backing 20, fig. 2 and 3) installed to surround (col. 3 ln. 42-46 second backing 20 surrounds the second pipe 19 along a first predetermined arc length DE) the tube (19, fig. 2) that is pressed by the at least one of the pressing portions (18, fig. 2) (col. 3 ln. 42-45 pressing portions/rollers 18 compress tube/pipe 19).
Examiner notes that the combination of the peristaltic pump of Gagnebin with the device of Togawa has already been motivated above with reference to claim 1, and thus no further motivation would be needed to add additional elements of the peristaltic pump of Gagnebin to the device. Additionally, it would further have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include a cover/second backing as taught by Gagnebin with the invention of Togawa modified by Gagnebin and Johnson as applied to claim 1. One would have been motivated to make the modification to provide a hard surface against which the tubing can be compressed to better ensure that all fluid is removed from the tube and the tube is fully compressed.
Regarding claim 14, Togawa discloses a drug injection device comprising: a base body (base portion 25, fig. 2); a needle module (cannula 1b, fig. 2) comprising a needle configured to be injected into a user's body for discharging a drug and mounted on the base body ([0021] tip of cannula enters body, medicinal solution is deployed through cannula, fig. 1 and fig. 3 shows needle module/cannula 1b mounted on base body/portion 25);
a drug discharge assembly (drive-liquid unit 11, fig. 2) configured to dispense the drug to the needle in a preset amount ([0029] information input unit 33 allows for medicinal-solution administration information such as a dose amount to be programmed into the device) and mounted on the base body (25) (fig. 2 shows the drive-liquid unit 11/drug discharge assembly mounted on base body 25);
a driving module (driving unit 20, fig. 2) mounted on the base body (base portion 25) (see fig. 2 which shows the driving module 20 mounted on the base body 25) and configured to drive the drug discharge assembly (11) ([0024] driving unit 20 has a pump 27 which drives fluid through the drug discharge assembly 11),
a cartridge module (medicinal-solution reservoir 10, fig. 2) detachably coupled to the base body (25) ([0023] the medicinal-solution reservoir 10 is detachably attached to the drive body unit 30; base body 25 integrally assembled with driving unit 20 which is part of drive body unit 30 as shown in fig. 2),
wherein the cartridge module comprises:
a reservoir (pipe within reservoir 10; see [0022] reservoir 10 includes pipe) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to store the drug ([0022] The medicinal-solution reservoir 10 is formed with a pipe and the medicinal solution is accommodated in the pipe.) to be discharged to the needle,
a battery (battery 13, fig. 3) configured to supply power for driving the drug discharge assembly ([0025] battery 13 is supplied to pump driving unit 26 via electrode 24; [0026] pump pushes fluid through drug discharge assembly), and
wherein the driving module comprises:
a body (pump driving unit 26 and pump 27, fig. 3, [0025]) connected to the battery (battery 13, [0025] battery 13 is supplied to pump driving unit 26 via electrode 24) and configured to receive a driving force ([0026] pump 27 pushes out the drive liquid).
wherein the cartridge module (10, fig. 2) further comprises:
the connecting member (drive-liquid connection portion 31, fig. 2) fluidly connecting the reservoir ([0022] pipe within reservoir 10) and the drug discharge assembly (11) ([0028] cartridge module/medicinal-solution reservoir 10 and the drug discharge assembly/drive-liquid unit 11 connected by a drive-liquid connection portion 31 and a medicinal-solution connection portion 32 that combine an inlet and an outlet of the medicinal-solution reservoir 10; fig. 3 shows assembled state; fig. 4 and 11 show prior to assembled state) to allow the drug in the reservoir to flow to the drug discharge assembly ([0024] drug/medicinal solution flows from cartridge module/medicinal-solution reservoir 10 through the drug discharge assembly/drive-liquid unit 11 to the needle assembly/cannula 1b when connected via the flow channel F12).
Togawa is silent to the details of the drug discharge assembly.
Gagnebin, in the related field of infusion pumps (col. 1 ln. 4-7 peristaltic pump is adapted to be carried on the human body for continuous injection of aqueous medicament), teaches wherein the drug discharge assembly (pump module 2, Abstract, fig. 1) comprises:
a tube (pipe 19, fig. 2, col. 3 ln. 49-53) having an inlet end (input 13, fig. 2, col. 5 ln. 65-68) fluidly connected to the reservoir and an outlet end (output 14, fig. 2, col. 5 ln. 65-68) connected to the needle (see fig. 2, col. 5 ln. 65-68 the output 14 of the pump is coupled to the needle 64), the tube (19) including a curved portion (see fig. 2 which shows curved portion of pipe 19) disposed between the inlet end (input 13, fig. 2) and the outlet end (output 14, fig. 2),
a rotation unit (rotor 80 and shaft 14, fig. 3; see 112f interpretation above; col. 3 ln. 34-37 rotor 80 is borne on shaft 14) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to rotate in one direction (col. 1 ln. 32-37 rotation speed of rotor modifies pump discharge), and
a pressing unit (second set of rollers 18, col. 3 ln. 36-41) comprising a plurality of pressing portions (each of the three rollers 18, fig. 2) spaced apart from one another (see fig. 2 which shows rollers 15 spaced apart, col. 3 ln. 42-45 notes that rollers 18 are analogous to rollers 15), wherein upon rotation of the rotation unit, the pressing portions (18) compress the curved portion of the tube (see fig. 2 which shows compression of curved portion of tube/pipe 16; col. 3 ln. 42-45 rollers 18 revolve along tube/pipe 19 and locally compress the pipe 19; col. 3 ln. 42-45 notes that the second set of rollers is analogous to the first), thereby deforming an internal cross-sectional area of the tube (fig. 2 shows deformation).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Togawa, which is meant for targeted delivery over a relatively long period (Togawa [0003]) to include the peristaltic pump with tubing disposed between the reservoir and needle because the peristaltic pump of Gagnebin, which is meant for slow and continuous injection (Gagnebin col. 1 ln. 4-7). One would have been motivated to make the modification because the purpose for which Gagnebin is designed for, namely portable, continuous injection, is well suited for the purposes of Togawa, namely targeted delivery over time. Additionally, Gagnebin notes that it is known in the art that peristaltic pumps permit precise dosage (Gagnebin col. 1 ln. 21-24).
Togawa modified by Gagnebin is silent to the connecting member comprising a pierceable barrier rib configured to be pierced by an insertion portion.
Johnson, in the field of drug delivery devices, teaches wherein the drug discharge assembly comprises an insertion portion (fluid coupling end 330a of needle 330, fig. 3A/B, [0067]) inserted into the connecting member (fill port 116, fig. 2, [0066], see fig. 3B which shows insertion portion 330a interfacing with pierceable septum 218 which seals fluid reservoir 220).
wherein the cartridge module further comprises:
a connecting member (fill port 116, fig. 2, [0066]) comprising a pierceable barrier rib (solid, filled-in tip of pierceable septum 218, fig. 2 and 3A/B; see annotated fig. 2 of Johnson above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be pierced by the insertion portion (fluid coupling end 330a of needle 330, see fig. 3B which shows insertion portion 330a interfacing with pierceable septum 218 which seals fluid reservoir 220), the insertion portion (end 330a of needle 330, fig. 3B) being configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to pierce the pierceable barrier rib (solid tip of septum 218, fig. 2) when the cartridge module (222) is mounted on the base body (housing 112 and adhesive bottom surface 114, fig. 3A, [0066]), thereby fluidly connecting the reservoir (fluid reservoir 220, fig. 2, [0067]) to allow the drug in the reservoir (220) to flow ([0067] a translation of button 332 toward the patient causes a fluid coupling end 330a to be fluidly coupled to fluid reservoir 220 and a delivery end 330b to extend from bottom surface 114.),
wherein the connecting member (fill port 116) is disposed apart from the reservoir (reservoir 220), and a connection tube (narrowed opening formed by septum 218, see annotated fig. 2 of Johnson above) fluidly connecting the connecting member to the reservoir (see fig. 2 which shows the hollow portion of septum 218 forming a connection tube between connecting member/fill port 116 and reservoir 220).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the connecting member of Togawa and Gagnebin to have the barrier rib punctured by an insertion portion as taught by Johnson, since Johnson also deals with a cartridge and needle system for delivering fluid. One would have been motivated to make the modification because the inclusion of the barrier rib/septum and the insertion portion/fluid coupling end ensures the cartridge does not spill during installation, thus preventing drug waste, contamination of the medication, and liquid interference with the electronic portions of the drug delivery device.
Claim(s) 3, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Togawa modified by Gagnebin and Johnson and further in view of Yodfat et al (US-20110160652-A1; hereafter Yodfat).
Regarding claim 3, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 2, as described above.
Togawa modified by Gagnebin and Johnson as applied above is silent to a case accommodating the reservoir and the battery.
Yodfat teaches wherein the cartridge module further comprises a case (housing 202) accommodating the reservoir (reservoir 220, fig 14a; [0231] housing 202 may include the reservoir) and the battery (power source 240, fig. 14a; [0230] power source 240 may be included in disposable part 200) as one body (see fig. 14a).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the case/housing of Yodfat to the cartridge module of Togawa to arrive at the claimed invention, since both references deal with fluid delivery systems having reservoirs and batteries. One would have been motivated to make this modification because as noted in Yodfat [0231] the housing serves to protect the chassis which holds the battery and the reservoir. As the drug delivery device may be worn on the body, it would be obviously beneficial to protect the cartridge module and better prevent accidental disruption or disconnection of fluid flow, reservoir damage and following leaks, or power loss due to accidental battery disturbances.
Regarding claim 10, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 1, as described above.
Togawa and Gagnebin are silent to wherein the insertion portion extends vertically from a bottom surface of an attachment portion of the base body to engage the cartridge module.
Johnson further teaches the insertion portion (fluid coupling end 330a, fig. 3A/3B, [0067]) extending vertically to engage the cartridge module (see fig. 3B), and a bottom surface (see surface of attachment surface/adhesive bottom surface 114 in fig. 3A/B) of an attachment surface (bottom surface 114, fig. 3A, [0066]) of the base body (housing 112 and adhesive bottom surface 114, fig. 3A).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the adhesive bottom surface of Johnson with the device of claim 1. One would have been motivated to make the modification because the adhesive bottom surface would facilitate attachment of the device to the patient’s skin.
Togawa modified by Gagnebin and Johnson teaches the claimed invention except the insertion portion extending vertically from a bottom surface of an attachment portion of the base body to engage the cartridge module. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the insertion portion such that it extended vertically from a bottom surface of the attachment portion of the base body since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of supplying fluid from the reservoir through the insertion portion to the peristaltic pumping region just as well with the described arrangement.
Regarding claim 16, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 14, as described above.
Togawa modified by Gagnebin and Johnson as applied above is silent to a case accommodating the reservoir and the battery.
Yodfat teaches wherein the cartridge module further comprises a case (housing 202) configured to integrally accommodate the reservoir (reservoir 220, fig 14a; [0231] housing 202 may include the reservoir) and the battery (power source 240, fig. 14a; [0230] power source 240 may be included in disposable part 200) as one body (see fig. 14a).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to add the case/housing of Yodfat to the cartridge module of Togawa to arrive at the claimed invention, since both references deal with fluid delivery systems having reservoirs and batteries. One would have been motivated to make this modification because as noted in Yodfat [0231] the housing serves to protect the chassis which holds the battery and the reservoir. As the drug delivery device may be worn on the body, it would be obviously beneficial to protect the cartridge module and better prevent accidental disruption or disconnection of fluid flow, reservoir damage and following leaks, or power loss due to accidental battery disturbances.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Togawa modified by Gagnebin and Johnson, and further in view of Troutner (EP-0239255-A1; hereafter Troutner). Text references are made to the pdf version of Troutner included in the previous Office Action.
Regarding claim 13, Togawa modified by Gagnebin and Johnson discloses the drug injection device of claim 1, as described above.
Togawa modified by Gagnebin and Johnson are silent to how the number of pressing portions relates to the length of the curved portion.
Troutner, in the art of pumps, teaches wherein a number of the pressing portions (rollers 640, pg. 8 ln. 48-49) is determined according to a length of the curved portion (arcuate track 212, pg. 9 ln. 1-4) (pg. 9 ln. 1-4 roller spaced 120 degrees apart and the arcuate track covers more than 120 degrees, so one roller is always contacting the arcuate track; pg. 9 ln. 8-10 having three rollers allows for a pumping track to curve for less than 180 degrees).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to determine the number of pressing portions by the length of the curved portion as taught by Troutner, since Troutner also deals with fluid delivery. One would have been motivated to make the modification so that at least one roller is always contacting the arcuate track, as taught by Troutner, because this contact ensures that the fluid is being pushed in the correct direction and prevents backflow of fluid.
Conclusion
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.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 01/30/2026