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 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:
Claim 1
“detector configured to detect when the piston rod has reached the final position;
a conveying mechanism configured to move the piston rod along the thrust axis;
a control unit configured to control”
Claims 8-11, 16,
“control unit”
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 § 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.
Claim(s) 1-7, 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kohlbrenner et al (Pub. No.: US 2009/0247960) in view of Shaked et al (Pub. No.: US 2021/0128823)
Regarding claim 1, Kohlbrenner et al disclose a conveying device for a medicament delivery device, comprising:
a piston rod movable along a thrust axis from an initial position to a final position defining a thrust range [see 0022, 0068] by disclosing thrust sleeve 90 therefore acts as a piston rod for the piston [see 0068]
a detector (dose limiting arrangement behaves as a detector, emphasis added) configured to detect when the piston rod has reached the final position (by reaching its maximum range)) [see 0022, 0069, 0103];
a conveying mechanism configured to move the piston rod along the thrust axis [see 0014-0015, 0068];
Kohlbrenner et al don’t disclose a control unit configured to control a speed of movement of the piston rod at a target speed,
wherein the thrust range is divided in at least two zones:
a final zone in which the control unit is adapted to decrease the target speed to zero upon the detector determining a stall or stop of the piston rod when the piston rod has reached the final position, a priming zone in which the control unit is adapted to decrease the target speed to a reduced speed upon the detector determining a stall or stop of the piston rod in the priming zone.
Nonetheless, Shaked et al disclose control a speed of movement of the piston rod at a target speed [see 0218]
wherein the thrust range is divided in at least two zones:
a final zone in which the control unit is adapted to decrease the target speed to zero upon the detector determining a stall (by detecting partial rotation, emphasis added) or stop (by preventing rotation, emphasis added, 0222) of the piston rod when the piston rod has reached the final position (due to the infusion being ended, emphasis added) [see 0218-0219, 0222];
a priming zone in which the control unit is adapted to decrease the target speed to a reduced speed upon the detector determining a stall or stop (by preventing rotation, emphasis added) of the piston rod in the priming zone [see 0222] and disclose the worm gear serves to reduce rotational speed and/or transmit higher torque [see 0145].
Therefore, it would have been motivated to combine Kohlbrenner et al Shaked et al by controlling a speed of movement of the piston rod at a target speed and a final zone in which the control unit is adapted to decrease the target speed to zero upon the detector determining a stall or stop of the piston rod when the piston rod has reached the final position, a priming zone in which the control unit is adapted to decrease the target speed to a reduced speed upon the detector determining a stall or stop of the piston rod in the priming zone; to prevent overspeed.
Regarding claim 2, Kohlbrenner et al disclose wherein the priming zone (initial position) is defined by the piston rod reaching less (the piston is controllable and can reach it maximum thrust range; therefore the priming zone can be set to be 30 %, emphasis added) than 30% of the thrust range, and wherein the final zone starts upon the piston rod reaching above 80% (the piston is controllable and can reach it maximum thrust range; therefore the priming zone can be set to be above 80% emphasis added) of the thrust range (maximum thrust range) [see 0022].
Regarding claims 3-5, Kohlbrenner et al don’t disclose wherein the target speed is stepwise or
continuously decreased to zero or to the reduced speed and wherein the reduced speed is below 60% of
the target speed and reduce the target speed to zero before setting the target speed at the
reduced speed.
Nonetheless, Shaked et al disclose wherein the target speed is stepwise or continuously decreased to zero or to the reduced speed and wherein the reduced speed is below 60% (via speed control) of the target speed and reduce the target speed to zero (via speed control) before setting the target speed at the reduced speed [see 0217-0218].
Therefore, it would have been motivated to combine Kohlbrenner et al Shaked et al by having the target speed is stepwise or continuously decreased to zero or to the reduced speed and wherein the reduced speed is below 60% of the target speed and reduce the target speed to zero before setting the target speed at the reduced speed; to prevent overspeed.
Regarding claim 6, Kohlbrenner et al don’t disclose wherein the piston rod is adapted to be
moved using an electric drive comprising an electric motor, and wherein the detector is activated by detecting non-rotation or limited rotation of the electric motor.
Nonetheless, Shaked et al disclose the piston rod is adapted to be moved using an electric drive comprising an electric motor [see 0221]
wherein the detector is activated by detecting non-rotation or limited rotation (partial rotation) of the electric motor [see 0217-0219].
Therefore, it would have been motivated to combine Kohlbrenner et al Shaked et al by using an electric drive comprising an electric motor, and wherein the detector is activated by detecting non-rotation or limited rotation of the electric motor; to prevent overspeed.
Regarding claim 7, Kohlbrenner et al don’t disclose wherein the detector is adapted to determine the non-rotation or limited rotation of the electric motor by at least one of:
measuring steps of the electric motor,
measuring a Back-EMF signal, using an encoder,
or
measuring a current of the electric motor.
Nonetheless, Shaked et al disclose measuring a Back-EMF signal, using an encoder [see 0218]
Therefore, it would have been motivated to combine Kohlbrenner et al Shaked et al by measuring a Back-EMF signal; to control piston speed and infusion rate and to indicate when the infusion has ended.
Regarding claim 13, Kohlbrenner et al disclose a reservoir containing a medicament and
a plunger (thrust flange 100) moveable within the reservoir by the piston rod [see 0068-0069].
Regarding claim 14, Kohlbrenner et al disclose wherein the initial position of the
piston rod is defined by a plunger position for a full reservoir, and wherein the final position is defined by a plunger position for the plunger engaging a neck region of the reservoir preventing further plunger movement [see 0068-0069].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kohlbrenner et al (Pub. No.: US 2009/0247960) in view of Shaked et al (Pub. No.: US 2021/0128823) as applied to claim 1 above and further in view of Kuhni et al (Pub. No.: US 2020/0261654)
Regarding claim 15, Kohlbrenner et al don’t disclose a wearable bolus injector.
Nonetheless, Kuhni et al disclose a wearable bolus injector [see 0004].
Therefore, it would have been motivated to combine Kohlbrenner et al, Shaked et al and Kuhni et al by using a wearable bolus injector; so it can be attached to desired position.
Allowable Subject Matter
Claims 8-12, 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: No prior arts of record alone or in combination discloses the following:
Claim 8,
“wherein the control unit is adapted to activate the electric motor for moving the piston rod at the target speed by rotation of the electric motor at a target rotational speed, and wherein the control unit is adapted to decrease the target rotational speed to zero when the detector detects the final position in the final zone or is adapted to decrease the target rotational speed to a reduced rotational
speed for moving the piston rod at the reduced speed when the detector is activated in the priming zone”
Claim 16,
“wherein the control unit is adapted to activate the electric motor for moving the
piston rod at the target speed by rotation of the electric motor at a target rotational speed,
wherein the control unit is adapted to decrease the target rotational speed to zero
when the detector detects the final position in the final zone, or is adapted to decrease the
target rotational speed to a reduced rotational speed for moving the piston rod at the
reduced speed when the detector is activated in the priming zone”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Kozak can be reached at 571-270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
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