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 .
Response to Amendment
The amendment filed on 12/17/2025 has been entered. Claims 15-17, 19-27, and 29-31 are pending in the application. Claims 1-14, 18, and 28 are cancelled. The amendments to the claims and specification overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 9/17/2025.
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: “an injection mechanism” in claim 15 (interpreted to include an injection button, a dosage dial, a dosage window, and a container region, or its equivalents; see Specification page 7 lines 6-8).
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 Objections
Claim 15 is objected to because of the following informalities:
-Claim 15, line 9: please correct “a memory” to “the memory”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 24-27 and 29-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schabbach et al. (WO 2018/108855 A1).
Regarding claim 24, Schabbach discloses a user device (data collection apparatus 2/20) (see Figs. 1-3 and 5-10, page 6 lines 17-30, page 7 line 33 - page 8 line 2) comprising a processor (processing arrangement 22), a memory (memory units 23/24), a display (display 29), and a camera (camera 21) (see Figs. 1 and 3, page 7 line 33 - page 8 line 29), wherein the memory (memory units 23/24) of the user device (data collection apparatus 2/20) stores instructions which, when executed by the processor (processing arrangement 22), cause the user device (data collection apparatus 2/20) to perform operations comprising:
capturing, using the camera (camera 21) of the user device (data collection apparatus 2/20), at least one image and/or video of a drug delivery device (medicament delivery device 1) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32);
if the drug delivery device (medicament delivery device 1) has at least one distinctive feature (visual attributes 18a-c) that matches at least one distinctive feature of at least one predefined set of distinctive features (reference visual attributes) stored in a memory (memory units 23/24) of the user device (data collection apparatus 2/20):
identifying, in the at least one image and/or video of the drug delivery device (medicament delivery device 1), the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25- 32);
comparing the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified based on the at least one image and/or video to the at least one predefined set of distinctive features (reference visual attributes) (see page 7 lines 21-31, page 8 lines 25- 29, page 9 lines 9-30, page 10 lines 25-32);
identifying the drug delivery device (medicament delivery device 1) based on a match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) in the at least one image and/or video with at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes) (see page 7 lines 21-31, page 8 lines 25- 29, page 9 lines 9-30, page 10 lines 25-32); and
if the drug delivery device (medicament delivery device 1) does not have the at least one distinctive feature (visual attributes 18a-c):
identifying an absence of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 10 lines 8-23); and
indicating, using the display (display 29) of the user device (data collection apparatus 2/20), based on the absence of the at least one distinctive feature (visual attributes 18a-c), that the drug delivery device (medicament delivery device 1) is likely damaged (see page 10 lines 8-23).
Regarding claim 25, Schabbach discloses the user device of claim 24, wherein the operations further comprise:
in case of no match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified based on the at least one image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes):
capturing at least one second image and/or video (see Fig. 5, page 3 lines 18-30);
identifying, in the at least one second image and/or video, the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 3 lines 18-30, page 9 lines 20-27); and
identifying the drug delivery device (medicament delivery device 1) based on a match of the at least one distinctive feature (visual attributes 18a-с) of the drug delivery device (medicament delivery device 1) in the at least one second image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes) (see page 3 lines 18-30, page 9 lines 20-30).
Regarding claim 26, Schabbach discloses a method of identification of a drug delivery device (medicament delivery device 1) (see Figs. 1-3 and 5-10, page 6 lines 17-30, page 7 line 33 - page 8 line 2), the method comprising:
capturing, using a camera (camera 21), at least one image and/or video of the drug delivery device (medicament delivery device 1) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32);
if the drug delivery device (medicament delivery device 1) has at least one distinctive feature (visual attributes 18a-c) that matches at least one distinctive feature of at least one predefined set of distinctive features (reference visual attributes) stored in a memory (memory units 23/24) of a user device (data collection apparatus 2/20):
identifying, in the at least one image and/or video of the drug delivery device (medicament delivery device 1), the at least one distinctive feature (visual attributes 18a-с) of the drug delivery device (medicament delivery device 1) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32);
comparing the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) in the at least one image and/or video to the at least one predefined set of distinctive features (reference visual attributes) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9- 30, page 10 lines 25-32); and
identifying the drug delivery device (medicament delivery device 1) based on a match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified in the at least one image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes (see page 7 lines 21-31, page 8 lines 25- 29, page 9 lines 9-30, page 10 lines 25-32); and
if the drug delivery device (medicament delivery device 1) does not have the at least one distinctive feature (visual attributes 18a-c):
identifying an absence of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 10 lines 8-23); and
indicating, using a display (display 29) of the user device (data collection apparatus 2/20), based on the absence of the at least one distinctive feature (visual attributes 18a-c), that the drug delivery device (medicament delivery device 1) is likely damaged (see page 10 lines 8-23).
Regarding claim 27, Schabbach discloses the method of claim 26, further comprising:
in case of no match of the at least one distinctive feature (visual attributes 18а-с) of the drug delivery device (medicament delivery device 1) identified based on the at least one image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes):
capturing at least one second image and/or video (see Fig. 5, page 3 lines 18-30);
identifying, in the at least one second image and/or video, the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 3 lines 18-30, page 9 lines 20-27); and
identifying the drug delivery device (medicament delivery device 1) based on a match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) in the at least one second image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes) (see page 3 lines 18-30, page 9 lines 20-30).
Regarding claim 29, Schabbach discloses the method of claim 26, wherein the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) comprises at least three dots or pixels having a color different form a color of a body (housing 10) of the drug delivery device (medicament delivery device 1) (see Fig. 1, page 7 lines 21-31).
Regarding claim 30, Schabbach discloses the method of claim 29, further comprising:
detecting the at least three dots or pixels (see Fig. 1, page 7 lines 21-31, page 9 lines 9-27);
determining, based on the detection of the at least three dots or pixels, a distance between the drug delivery device (medicament delivery device 1) and the camera (camera 21) and/or an orientation of the drug delivery device (medicament delivery device 1) with respect to the camera (camera 21) (see page 12 lines 16-32, page 13 lines 6-16).
Regarding claim 31, Schabbach discloses the method of claim 26, wherein the at least one predefined set of distinctive features (reference visual attributes) comprises one or more of the following:
an outer shape of a body (housing 10) of the drug delivery device (medicament delivery device 1) (see Fig. 1, page 7 lines 21-31); and
a color of the body (housing 10) of the drug delivery device (medicament delivery device 1) (see Fig. 1, page 7 lines 21-31).
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 15-17 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Schabbach et al. (WO 2018/108855 A1) in view of Riedel et al. (US 2018/0353694 A1).
Regarding claim 15, Schabbach discloses a system (see Figs. 1-3 and 5-10) comprising a user device (data collection apparatus 2/20) and a drug delivery device (medicament delivery device 1) (see Figs. 1-3 and 5-10, page 6 lines 17-30, page 7 line 33 – page 8 line 2),
the user device (data collection apparatus 2/20) comprising a processor (processing arrangement 22), a memory (memory units 23/24), a display (display 29) and a camera (camera 21) (see Figs. 1 and 3, page 7 line 33 – page 8 line 29);
the drug delivery device (medicament delivery device 1) comprising a body (housing 10), an injection mechanism (button 11, dosage knob 12, dosage window 13, and container 14);
wherein the memory (memory units 23/24) of the user device (data collection apparatus 2/20) stores instructions which, when executed by the processor (processing arrangement 22), cause the user device (data collection apparatus 2/20) to:
capture, using the camera (camera 21) of the user device (data collection apparatus 2/20), at least one image and/or video of the drug delivery device (medicament delivery device 1) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32);
if the drug delivery device (medicament delivery device 1) has at least one distinctive feature (visual attributes 18a-c) that matches at least one distinctive feature of at least one predefined set of distinctive features (reference visual attributes) stored in a memory (memory units 23/24) of the user device (data collection apparatus 2/20):
identify, in the at least one image and/or video of the drug delivery device (medicament delivery device 1), the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32);
compare the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified based on the at least one image and/or video to the at least one predefined set of distinctive features (reference visual attributes) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32);
identify the drug delivery device (medicament delivery device 1) based on a match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified in the at least one image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes) (see page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32); and
output, on the display (display 29), a result of the identification of the drug delivery device (medicament delivery device 1) (see Fig. 5, page 7 lines 21-31, page 8 lines 25-29, page 9 lines 9-30, page 10 lines 25-32); and
if the drug delivery device (medicament delivery device 1) does not have the at least one distinctive feature (visual attributes 18a-c):
identify an absence of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 10 lines 8-23); and
indicate, using the display (display 29) of the user device (data collection apparatus 2/20), based on the absence of the at least one distinctive feature (visual attributes 18a-c), that the drug delivery device (medicament delivery device 1) is likely damaged (see page 10 lines 8-23).
However, Schabbach fails to expressly state that the drug delivery device comprises a cap.
Riedel teaches a system (see Fig. 1a) comprising a drug delivery device (injection device 1) comprising a cap (outer needle cap 17) (see Fig. 1a, par. [0044]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Schabbach to include that the drug delivery device comprises a cap, as taught by Riedel, in order to protect the needle of the drug delivery device (see Riedel par. [0044]).
Regarding claim 16, modified Schabbach teaches the system of claim 15 substantially as claimed. Schabbach further teaches wherein the injection mechanism (button 11, dosage knob 12, dosage window 13, and container 14) comprises at least a dosage dial (dosage knob 12) for selecting a dose, a dosage window (dosage window 13) for showing the selected dose (see Fig. 1, page 7 lines 1-6), and a needle (needle 16).
Regarding claim 17, modified Schabbach teaches the system of claim 15 substantially as claimed. Schabbach further teaches wherein, in case of no match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified in the at least one image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes), the memory (memory units 23/24) of the user device (data collection apparatus 2/20) stores instructions which, when executed by the processor (processing arrangement 22), cause the user device (data collection apparatus 2/20) to:
capture at least one second image and/or video (see Fig. 5, page 3 lines 18-30);
identify, in the at least one second image and/or video, the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) (see page 3 lines 18-30, page 9 lines 20-27); and
identify the drug delivery device (medicament delivery device 1) based on a match of the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) identified in the at least one second image and/or video with the at least one distinctive feature of the at least one predefined set of distinctive features (reference visual attributes) (see page 3 lines 18- 30, page 9 lines 20-30).
Regarding claim 19, modified Schabbach teaches the system of claim 16 substantially as claimed. Schabbach further teaches wherein the at least one predefined set of distinctive features (reference visual attributes) comprises one or more of the following:
an outer shape of the body (housing 10) of the drug delivery device (medicament delivery device 1) (see Fig. 1, page 7 lines 21-31); and
a color of the body (housing 10) of the drug delivery device (medicament delivery device 1) (see Fig. 1, page 7 lines 21-31).
Regarding claim 20, modified Schabbach teaches the system of claim 16 substantially as claimed. Schabbach further teaches wherein the at least one distinctive feature (visual attributes 18a-c) of the drug delivery device (medicament delivery device 1) comprises at least three dots or pixels having a color different form a color of the body (housing 10) of the drug delivery device (medicament delivery device 1) (see Fig. 1, page 7 lines 21-31).
Regarding claim 21, modified Schabbach teaches the system of claim 20 substantially as claimed. Schabbach further teaches wherein the memory (memory units 23/24) of the user device (data collection apparatus 2/20) stores instructions which, when executed by the processor (processing arrangement 22), further cause the user device (data collection apparatus 2/20) to:
detect the at least three dots or pixels (see Fig. 1, page 7 lines 21-31, page 9 lines 9-27);
determine, based on the detection of the at least three dots or pixels, a distance between the drug delivery device (medicament delivery device 1) and the user device (data collection apparatus 2/20) and/or an orientation of the drug delivery device (medicament delivery device 1) with respect to the user device (data collection apparatus 2/20) (see page 12 lines 16-32, page 13 lines 6-16).
Regarding claim 22, modified Schabbach teaches the system of claim 16 substantially as claimed. Schabbach further teaches wherein the injection mechanism comprises the dosage dial (dosage knob 12), the dosage dial (dosage knob 12) comprises a collar (see Fig. 1, dosage knob 12 is collar-shaped), the body (housing 10) of the drug delivery device (medicament delivery device 1) comprises a collar (see Fig. 1, housing 10 is collar-shaped), and the collar (dosage knob 12 is collar-shaped) of the dosage dial (dosage knob 12) and the collar (housing 10 is collar-shaped) of the drug delivery device (medicament delivery device 1) are positioned facing each other (see Fig. 1).
Regarding claim 23, modified Schabbach teaches the system of claim 22 substantially as claimed. Schabbach further teaches wherein an outermost diameter of the collar (see Fig. 1, dosage knob 12 is collar-shaped) of the dosage dial (dosage knob 12) and the collar (housing 10 is collar-shaped) of the drug delivery device (medicament delivery device 1) is larger than an outermost diameter of elsewhere on the body (housing 10) of the drug delivery device (medicament delivery device 1), so that the collar (housing 10 is collar-shaped) of the body (housing 10) of the drug delivery device (medicament delivery device 1) and the collar (dosage knob 12 is collar-shaped) of the dosage dial (dosage knob 12) protrude from the body (housing 10) and the dosage dial (dosage knob 12), respectively, forming ring-like structures (see Fig. 1, housing 10 and dosage knob 12 have larger diameters than and protrude from chamber 14).
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive.
In regards to independent claims 15, 24, and 26, Applicant argues that Schabbach fails to teach that if the drug delivery device does not have the at least one distinctive feature, the user device is caused to identify an absence of the at least one distinctive feature of the drug delivery device; and indicate, using the display of the user device, based on the absence of the at least one distinctive feature, that the device is likely damaged. However, the Examiner respectfully disagrees. The example warning conditions described in lines 8-23 of page 10 of Schabbach include determining/warning the user that an expiration date of the medication has passed. The Examiner interprets that this can be considered a damaged condition of the device. The claim is not limited to a particular type of damage required to be identified by the device.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783 /Lauren P Farrar/Primary Examiner, Art Unit 3783
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