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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 19, 2025 has been entered.
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 mating unit must be shown or the feature(s) canceled from the claim(s). There is no reference number present indicating a mating unit. 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.
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: a mating unit in claim 15.
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 15-19, 22-33, and 35-37 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. The claim limitations “mating unit” invokes 35 U.S.C. 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for performing the function and to clearly link the structure, material, or acts to the function. The structure of the mating unit is not disclosed or indicated in the drawings. As would be recognized by those of ordinary skill in the art, there are many different ways to effect mating. The specification does not provide sufficient details such that one of ordinary skill in the art would understand which structures perform the claimed function.
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.
Claim(s) 15-19, 22-27, 29-33, and 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (US 5,509,905), Michel (US 5,383,865), Jorgensen et al. (US 2011/0270214 A1), Chen et al. (US 2014/0276583 A1), and Packman et al. (US 6,585,698).
With regard to claims 15, 16, and 19, Michel teaches the supplemental device for attachment to an injection device, the supplemental device comprising: an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 outer housing); and a protrusion configured to protrude from the main body such that the protrusion contacts a surface of the injection device (Fig. 1 protrusions 10 and 11 contacts 3 via at least 7), wherein the open state or the closed state of the electromechanical switch arrangement is configured to change when a dose dialled into the attached injection device is decreased from one unit to zero units (Col. 3 lines 3-17, Col. 3 line 58-Col. 4 line 55); and a processor arrangement configured to: detect one or more changes in the open state or the closed state of the electromechanical switch arrangement (Col. 3 lines 45-49); determine from the one or more changes in the open state or the closed state that the dose dialled into the injection device has decreased from one unit to zero units (Col. 3 lines 24-35). Michel does not disclose the supplemental device is configured to be removably attached with a housing comprising a mating unit and configured to at least partially surround an exterior of an injection device. However, Michel ‘865 discloses a delivery device in which the LCD display and associated switches may be removable or permanently attached. (Figs. 2, 11, 17, housing 106 mating unit includes at least 98 and 102, exemplary switch 124 contacts 132, Col. 5 line 44-55). It would have been obvious to a person having ordinary skill in the art at the time the invention was made before the effective filing date of the claimed invention to have the LCD portion and switches of Michel be part of a removably attachable housing as Michel ’85 teach such to be an art effective equivalent which would yield the same operation. Michel does not disclose placing the device into a power saving mode. However, Jorgensen et al. teach using a power saving mode when the end of dose is signaled ([0130]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device enter a power saving mode after the dose is delivered in Michel as in Jorgensen et al. as this is beneficial to avoid using power when the device is not in use. Michel does not disclose in response to determining zero units the processor is configured to trigger communication of data stored in the supplemental device to an external apparatus. However, Chen et al. teach that when the sensor detects a zero-dose position this triggers the controller to transmit dose data ([0006], [0019], [0033]). This allows accurate information to be transmitted and recorded for proper monitoring and dose calculations ([0003]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit information after determining the dose has been delivered in Michel as Chen et al. teach this is beneficial for recording accurate information. As such the user input of triggering the dose to be delivered ultimately causes connection to the external apparatus. Michel does not disclose a processor to determine a type of medicament based on visual recognition of a visible code. However, Packman et al. teach a supplemental device which has a photodetector which senses a color code on a cartridge to determine the medicament preparation to ensure the correct substance is administered and prevent error (Col. 1 lines 40-46, Col. 2 lines 30-39, Col. 7 lines 1-45, Fig. 7, photodetector 190, color code 49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a photometer and color recognition in Michel as Packman et al. teach this is beneficial to determine the medicament preparation to ensure the correct substance is administered and prevent error. The colored code is visible to the user prior to insertion into the overall injection device and it is visible to the photodetector/processor.
With regard to claims 17, switch protrusion 12 is alternatively considered and is taken to not contact the surface as it does not enter channel 19 until the end of the injection (Col. 3 lines 24-35).
With regard to claim 18, as combined above there would necessarily be an amount of time between when the end of dose is detected and when the power save mode begins.
With regard to claim 22, see protrusion 12 (Fig. 1, Col. 3 lines 24-35).
With regard to claim 23, see Col. 3 lines 45-65, Col. 4 lines 50-55.
With regard to claim 24, Col. 3 line 50-Col. 4 line 55.
With regard to claim 25, member 7 biases the protrusions 10 and 11 up and down.
With regard to claim 26, member 12 goes into channel 19 which is taken as separate from the surface of the injection device.
With regard to claim 27, turns are counted by means of 17 (Col. 4 lines 4-7).
With regard to claim 35, alternatively member 7 is considered as part of the injection device.
With regard to claim 36, the inward portions of 10 and 11 contact 7 which is alternatively considered as part of the injection device.
With regard to claim 37, 7 is taken as a surface of the injection device and comprises ramped cam surfaces (Fig. 2 exemplary 18, Col. 3 lines 3-14).
With regard to claim 29, Michel teaches a system comprising: an injection device (Fig. 1 member 3); and a supplemental device for attachment to the injection device, the supplemental device comprising: an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Figs. 1 and 2 housing of switch part 9); a protrusion configured to protrude from the main body such that the protrusion contacts a surface of the injection device (Fig. 1 protrusions 10 and 11 contacts 3 via at least 7), wherein the open state or the closed state of the electromechanical switch arrangement is configured to change when a dose dialled into the attached injection device is decreased from one unit to zero units (Col. 3 lines 3-17, Col. 3 line 58-Col. 4 line 55); and a processor arrangement configured to: detect one or more changes in the open state or the closed state of the electromechanical switch arrangement (Col. 3 lines 45-49); determine from the one or more changes in the open state or the closed state that the dose dialled into the injection device has decreased from one unit to zero units (Col. 3 lines 24-35). Michel does not disclose the supplemental device is configured to be removably attached with a housing comprising a mating unit and configured to at least partially surround an exterior of an injection device. However, Michel ‘865 discloses a delivery device in which the LCD display and associated switches may be removable or permanently attached. (Figs. 2, 11, 17, housing 106 mating unit includes at least 98 and 102, exemplary switch 124 contacts 132, Col. 5 line 44-55). It would have been obvious to a person having ordinary skill in the art at the time the invention was made before the effective filing date of the claimed invention to have the LCD portion and switches of Michel be part of a removably attachable housing as Michel ’85 teach such to be an art effective equivalent which would yield the same operation. Michel does not disclose placing the device into a power saving mode. However, Jorgensen et al. teach using a power saving mode when the end of dose is signaled ([0130]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device enter a power saving mode after the dose is delivered in Michel as in Jorgensen et al. as this is beneficial to avoid using power when the device is not in use. Michel does not disclose in response to determining zero units the processor is configured to trigger communication of data stored in the supplemental device to an external apparatus. However, Chen et al. teach that when the sensor detects a zero-dose position this triggers the controller to transmit dose data ([0006], [0019], [0033]). This allows accurate information to be transmitted and recorded for proper monitoring and dose calculations ([0003]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit information after determining the dose has been delivered in Michel as Chen et al. teach this is beneficial for recording accurate information. As such the user input of triggering the dose to be delivered ultimately causes connection to the external apparatus. Michel does not disclose a processor to determine a type of medicament based on visual recognition of a visible code. However, Packman et al. teach a supplemental device which has a photodetector which senses a color code on a cartridge to determine the medicament preparation to ensure the correct substance is administered and prevent error (Col. 1 lines 40-46, Col. 2 lines 30-39, Col. 7 lines 1-45, Fig. 7, photodetector 190, color code 49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a photometer and color recognition in Michel as Packman et al. teach this is beneficial to determine the medicament preparation to ensure the correct substance is administered and prevent error. The colored code is visible to the user prior to insertion into the overall injection device and it is visible to the photodetector/processor.
With regard to claims 30 and 31, the housing is taken as the outer housing, the corrugated sleeve is taken as 7 with corrugations 16 and 17, dose knob 2 (Figs. 1 and 2).
With regard to claim 32, the claim does not recite where the diameter is measured, the diameter of a corrugation is smaller than an outer diameter of member 2 which has a flange at the proximal surface (Figs. 1 and 2).
With regard to claim 33, Michel teaches a supplemental device for attachment to an injection device, the supplemental device comprising: an electromechanical switch arrangement having an open state and a closed state, the electromechanical switch arrangement comprising: a main body (Fig. 1 outer housing); and a first protrusion configured to protrude from the main body such that the first protrusion contacts a surface of the injection device when any number of dose units are dialled into the injection device (Fig. 1 protrusions 10 and 11 contact 3 via at least 7), wherein the open state or the closed state of the electromechanical switch arrangement is configured to change when a dose dialled into the injection device is decreased from one unit to zero units (Col. 3 lines 3-17, Col. 3 line 58-Col. 4 line 55); a switching member having an open state and a closed state, the switching member comprising a second protrusion configured to contact an additional surface of the injection device only when a dose of zero units is dialled into the injection device (protrusion 12 Fig. 1, Col. 3 lines 24-35); and a processor arrangement configured to: detect one or more changes in the open state or the closed state of the switching member (Col. 3 lines 45-49); determine from the one or more changes in the open state or the closed state that the dose dialled into the injection device has decreased from one unit to zero units (Col. 3 lines 24-35). Michel does not disclose the supplemental device is configured to be removably attached with a housing comprising a mating unit and configured to at least partially surround an exterior of an injection device. However, Michel ‘865 discloses a delivery device in which the LCD display and associated switches may be removable or permanently attached. (Figs. 2, 11, 17, housing 106 mating unit includes at least 98 and 102, exemplary switch 124 contacts 132, Col. 5 line 44-55). It would have been obvious to a person having ordinary skill in the art at the time the invention was made before the effective filing date of the claimed invention to have the LCD portion and switches of Michel be part of a removably attachable housing as Michel ’85 teach such to be an art effective equivalent which would yield the same operation. Michel does not disclose placing the device into a power saving mode. However, Jorgensen et al. teach using a power saving mode when the end of dose is signaled ([0130]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the device enter a power saving mode after the dose is delivered in Michel as in Jorgensen et al. as this is beneficial to avoid using power when the device is not in use. Michel does not disclose in response to determining zero units the processor is configured to trigger communication of data stored in the supplemental device to an external apparatus. However, Chen et al. teach that when the sensor detects a zero-dose position this triggers the controller to transmit dose data ([0006], [0019], [0033]). This allows accurate information to be transmitted and recorded for proper monitoring and dose calculations ([0003]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to transmit information after determining the dose has been delivered in Michel as Chen et al. teach this is beneficial for recording accurate information. Michel does not disclose a photometer or camera, or a processor to determine a type of medicament based on recognition of a color or code of a visible external surface. However, Packman et al. teach a supplemental device which has a photodetector which senses a color code on a cartridge to determine the medicament preparation to ensure the correct substance is administered and prevent error (Col. 1 lines 40-46, Col. 2 lines 30-39, Col. 7 lines 1-45, Fig. 7, photodetector 190, color code 49). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a photometer and color recognition in Michel as Packman et al. teach this is beneficial to determine the medicament preparation to ensure the correct substance is administered and prevent error. The colored code is visible to the user prior to insertion into the overall injection device. It is on an external surface of a component of the injection device and it is visible to the photodetector/processor.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Michel (US 5,509,905), Michel (US 5,383,865), Jorgensen et al. (US 2011/0270214 A1), Chen et al. (US 2014/0276583 A1), and Packman et al. (US 6,585,698) as applied to claim 27 above, and further in view of Cirillo et al. (US 2012/0065588 A1).
With regard to claim 28, Michel teaches a device substantially as claimed. Michel does not disclose an image capture device and an optical recognition system. However, Cirillo et al. teach a supplemental device (Fig. 1 member 100) wherein the dose dialed detector comprises an image capture device and an optical character recognition system ([0009]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use image capture and optical character recognition in Michel for the purpose of determining the dose of medicament that has already been dialed into the device which is beneficial for preventing overdose ([0005]) and keeping accurate injection records ([0031]).
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783