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 .
This communication is in response to the amendment received on 05/27/2026. Claims 1-19 remain pending in this application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-19 are drawn to a system which is within the four statutory categories (i.e. machine).
Step 2A, Prong 1:
Claim 1 recites “(1) receive pre-treatment data about a treatment area associated with the person's skin; (2) based on the pre-treatment data about the treatment area, identify one or more target medicament injection sites relative to the treatment area; and (3) output pre-injection targeting data for the one or more target medicament injection sites relative to the treatment area…”, which corresponds to an abstract idea of “certain methods of organizing human activity”. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic computing device does not take the claim out of the methods of organizing human interactions grouping.
Dependent claims also recite limitations that are directed to an abstract idea of “certain methods of organizing human activity”, such as claim 2 recites “identifying the one or more target medicament injection sites relative to the treatment area comprises identifying at least one muscle animation associated with the person's skin”, claim 3 has been amended to recite “…identify the one or more target medicament injection sites relative to the treatment area based on the at least one captured image of the treatment area” claim 6 recites “based on a spatial relationship between the at least one rhytid and an animation of at least one muscle associated with the at least one rhytid, identify the one or more target medicament injection sites relative to the treatment area”, claim 12 recites “identify one or more target medicament dosages for the one or more target medicament injection sites”, claim 14 recites “based on the post-treatment data, output a recommendation for a retreatment”, claim 18 recites “based on the data about earlier treatments and based on the follow-up data, output a recommendation for a follow-up treatment”. These limitations correspond to an abstract idea of certain methods of organizing human activity, such as user following rules and instructions using generic computing components.
The current specification recites, for instance, “As illustrated in FIG. 14, 15 and 17, in some embodiments, the treatment management subsystem 180 may include at least one personal electronic device 214. The personal electronic device 214 may include at least one smartphone or tablet computer, for example and without limitation. In some embodiments, the treatment management subsystem 180 may include at least one smart stand 200, which will be hereinafter described. The smart stand 200 may be configured to be used alone or in conjunction with the personal electronic device 214. As illustrated in FIG. 16, in some embodiments, the treatment management subsystem 180 may include at least one smart mirror 224. In various other embodiments, the treatment management subsystem 180 may include at least one desktop computer, laptop computer, and/or any other device, subsystem, web-based system or platform, or combination of devices or subsystems which, with supporting software, is configured and programmed to carry out the functions of the treatment management subsystem 180 described herein. In embodiments in which the treatment management subsystem 180 includes the personal electronic device 214, the software program for the various functions of the treatment management subsystem 180 may include an app which can be downloaded onto the device and installed. The app or other software may be configured to maintain statistics on injection procedures, treatment sessions, and other actions provided by the application after analyzing the obtained data. In some embodiments, the app may be configured to provide the capability for online purchase and shipping of medicament cartridges 132.” in [0147], where the personal electronic device corresponds to a generic computing device.
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 2-19 are ultimately dependent from claim 1 and include all the limitations of claim 1. Therefore, claims 2-19 recite the same abstract idea. Claims 2-19 describe a further limitation regarding the basis for identifying medicament injection sites. These are all just further describing the abstract idea recited in claim 1, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims 1-19 recite the additional elements of “a medicament injection component comprising an injector and a replaceable medicament cartridge, wherein actuation of the injector injects a set medicament dosage unit into or beneath a person's skin; a computing device comprising: (i) a processor device; and (ii) a non-transitory computer-readable medium having instructions stored thereon that are executable by the processor device”, using processor to perform: “receiving pre-treatment data…, identifying one or more target medicament injection sites relative to the treatment area; and output pre-injection targeting data…”, “wherein the output targeting data comprises at least one of: (i) a targeting beam projected onto the one or more target medicament injection sites for guiding a targeted medicament injection using the medicament injection component, (ii) an image of the person's skin with an injection site pattern overlaid on the person's face for guiding a targeted medicament injection using the medicament injection component; (iii) audible feedback confirming proper alignment of the medicament injection component relative to the one or more target medicament injection sites; or (iv) haptic feedback confirming proper alignment of the medicament injection component relative to the one or more target medicament injection sites”, using the computing device that has a processor to perform the “identify one or more target medicament injection sites”, “captured image data that is a static image or a video image”, “computing device component further comprises a camera that captures the at least one image”, “the system further comprises a display”, “the display outputs the targeting data”, “the display outputs the targeting data overlaid on an image comprising the treatment area”, “the computing device component comprises the display”, which are hardware and software elements, these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment, and mere instructions to apply/implement/automate an abstract idea in a particular technological environment and merely limiting the use of an abstract idea to a particular field or technological environment do not provide practical application for an abstract idea (MPEP 2106.05(f) & (h)).
Claims also recite other additional limitations beyond abstract idea, including functions such as receiving/retaining (storing) data from/to a database, displaying/outputting data are insignificant extra-solution activities (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the identifying and outputting steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 1 has been amended to recite “output pre-injection targeting data for the one or more target medicament injection sites relative to the treatment area; wherein the output targeting data comprises at least one of: (i) a targeting beam projected onto the one or more target medicament injection sites for guiding a targeted medicament injection using the medicament injection component, (ii) an image of the person's skin with an injection site pattern overlaid on the person's face for guiding a targeted medicament injection using the medicament injection component; (iii) audible feedback confirming proper alignment of the medicament injection component relative to the one or more target medicament injection sites; or (iv) haptic feedback confirming proper alignment of the medicament injection component relative to the one or more target medicament injection sites”, and this feature is found to be a well-understood, routine and conventional activity in the field, as evidenced by Boyden (US9550029B2).
In particular, Boyden discloses “the computer processor can include one or more instructions for recognizing an injector or accessory thereof in a captured image and assessing the injector's proximity to an illuminated injection site in the same captured image and issuing an alert if the injector is not properly located. In one embodiment, a real-time video stream may be used to monitor injector location. An injection event at the illuminated injection site can be recorded by the computer processor as, for example, an image. In one embodiment, the injector can be registered relative to the illuminated injection site based on interaction of some component of the injector with the illuminated injection site. For example, the injector may include an injector-tracking device including one or more photo-sensors that are activated when a specific portion of the injector, e.g., the injection needle, crosses the beam of light illuminating an injection site. In one embodiment, the injector-tracking device can directly issue an audible, visible, or haptic alert or alarm. In one embodiment, the injector-tracking device can send a signal, e.g., a radio-frequency signal, to another device, e.g., the computer processor, a headset, a phone, or other device, which then issues an alarm.” in col. 55, lines 15-36. The well-understood, routine and conventional activities are not sufficient to amount to significantly more than the judicial exception.
The claims are not patent eligible.
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (hereinafter Rios) (US 12,217,626 B2) in view of Boyden et al. (hereinafter Boyden) (US 9,550,029 B2).
Claim 1 has been amended to recite a custom medicament injection system comprising:
(a) a medicament injection component comprising an injector and a replaceable medicament cartridge, wherein actuation of the injector injects a set medicament dosage unit into or beneath a person's skin (Rios discloses “…an injection apparatus and training system…cosmetic injection” in col. 2, lines 52-55);
(b) a computing device comprising:
(i) a processor device (Rios; col. 15, lines 38-58); and
(ii) a non-transitory computer-readable medium having instructions stored thereon that are executable by the processor device (Rios; col. 36, lines 20-36) to cause the computing device to:
(1) receive pre-treatment data about a treatment area associated with the person's skin (Rios discloses “…the injection apparatus can be configured to mimic certain muscle contraction conditions common with a particular type of injection. For example, this can include contractions of facial features, such as furrowing of an eyebrow, squinting of the eyes, or pursing of the lips. The removable skin can also include blemishes, such as scars or wrinkles.” in col. 5, lines 39-45);
(2) based on the pre-treatment data about the treatment area, identify one or more target medicament injection sites relative to the treatment area (Rios discloses “…the injection apparatus can be configured to mimic certain muscle contraction conditions common with a particular type of injection. For example, this can include contractions of facial features, such as furrowing of an eyebrow, squinting of the eyes, or pursing of the lips. The removable skin can also include blemishes, such as scars or wrinkles.” in col. 5, lines 39-45 and “…The base layer 400 may be mapped with a grid of target zones…” in col. 18, lines 43-60).
Rios fails to expressly teach the “output pre-injection targeting data for the one or more target medicament injection sites relative to the treatment area; wherein the output targeting data comprises at least one of: (i) a targeting beam projected onto the one or more target medicament injection sites for guiding a targeted medicament injection using the medicament injection component, (ii) an image of the person's skin with an injection site pattern overlaid on the person's face for guiding a targeted medicament injection using the medicament injection component; (iii) audible feedback confirming proper alignment of the medicament injection component relative to the one or more target medicament injection sites; or (iv) haptic feedback confirming proper alignment of the medicament injection component relative to the one or more target medicament injection sites”. However, this feature is well known in the art, as evidenced by Boyden.
In particular, Boyden discloses “the computer processor can include one or more instructions for recognizing an injector or accessory thereof in a captured image and assessing the injector's proximity to an illuminated injection site in the same captured image and issuing an alert if the injector is not properly located. In one embodiment, a real-time video stream may be used to monitor injector location. An injection event at the illuminated injection site can be recorded by the computer processor as, for example, an image. In one embodiment, the injector can be registered relative to the illuminated injection site based on interaction of some component of the injector with the illuminated injection site. For example, the injector may include an injector-tracking device including one or more photo-sensors that are activated when a specific portion of the injector, e.g., the injection needle, crosses the beam of light illuminating an injection site. In one embodiment, the injector-tracking device can directly issue an audible, visible, or haptic alert or alarm. In one embodiment, the injector-tracking device can send a signal, e.g., a radio-frequency signal, to another device, e.g., the computer processor, a headset, a phone, or other device, which then issues an alarm.” in col. 55, lines 15-36.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Boyden with the motivation of providing guiding for injection (Boyden; col. 21, lines 19-43).
Claim 2 recites the custom medicament injection system of claim 1 wherein identifying the one or more target medicament injection sites relative to the treatment area comprises identifying at least one muscle animation associated with the person's skin (Rios; col. 5, lines 39-45).
Claim 3 has been amended to recite the custom medicament injection system of claim 1 wherein the pre-treatment data is at least one captured image of the treatment area including at least one indicia associated with at least one muscle animation; and wherein the instructions are executable by the processor device to cause the computing device to identify the one or more target medicament injection sites relative to the treatment area based on the at least one captured image of the treatment area (Rios; col. 5, lines 39-45, col. 23, line 65 to col. 24, line 14).
Claim 4 recites the custom medicament injection system of claim 3 wherein the at least one captured image is a static image or a video image (Rios; col. 21, lines 47-60).
Claim 5 recites the custom medicament injection system of claim 3 wherein the at least one indicia is at least one rhytid in the treatment area (Rios; col. 18, lines 16-23).
Claim 6 recites the custom medicament injection system of claim 5 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to, based on a spatial relationship between the at least one rhytid and an animation of at least one muscle associated with the at least one rhytid, identify the one or more target medicament injection sites relative to the treatment area (Rios; col. 17, line 60 to col. 18, line 23).
Claim 7 recites the custom medicament injection system of claim 3 wherein the computing device component further comprises a camera that captures the at least one image (Rios; col. 17, line 60 to col. 18, line 23).
Claim 8 recites the custom medicament injection system of claim 1 wherein the system further comprises a display (Rios; col. 18, lines 43-59).
Claim 9 has been amended to recite the custom medicament injection system of claim 7 wherein the display outputs the pre-injection targeting data (Rios; col. 18, lines 43-59).
Claim 10 has been amended to recite the custom medicament injection system of claim 8 wherein the display outputs the pre-injection targeting data overlaid on an image comprising the treatment area; the image comprising a captured image of the person.
Rios fails to expressly teach the “the display outputs the pre-injection targeting data overlaid on an image comprising the treatment area; the image comprising a captured image of the person”. However, this feature is well known in the art, as evidenced by Boyden.
In particular, Boyden discloses “the computer processor can include one or more instructions for recognizing an injector or accessory thereof in a captured image and assessing the injector's proximity to an illuminated injection site in the same captured image and issuing an alert if the injector is not properly located. In one embodiment, a real-time video stream may be used to monitor injector location. An injection event at the illuminated injection site can be recorded by the computer processor as, for example, an image. In one embodiment, the injector can be registered relative to the illuminated injection site based on interaction of some component of the injector with the illuminated injection site. For example, the injector may include an injector-tracking device including one or more photo-sensors that are activated when a specific portion of the injector, e.g., the injection needle, crosses the beam of light illuminating an injection site. In one embodiment, the injector-tracking device can directly issue an audible, visible, or haptic alert or alarm. In one embodiment, the injector-tracking device can send a signal, e.g., a radio-frequency signal, to another device, e.g., the computer processor, a headset, a phone, or other device, which then issues an alarm.” in col. 55, lines 15-36.
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include the aforementioned limitation as disclosed by Boyden with the motivation of providing guiding for injection (Boyden; col. 21, lines 19-43).
Claim 11 recites the custom medicament injection system of claim 9 wherein the computing device component comprises the display (Rios; col. 18, lines 43-59).
Claim 12 recites the custom medicament injection system of claim 1 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to identify one or more target medicament dosages for the one or more target medicament injection sites (Rios; col. 18, lines 43-59).
Claim 13 recites the custom medicament injection system of claim 1 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to receive post-treatment data about the treatment area associated with the person's skin (Rios; col. 18, lines 24-29).
Claim 14 recites the custom medicament injection system of claim 13 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to, based on the post-treatment data, output a recommendation for a retreatment (Rios; col. 18, lines 24-29).
Claim 15 recites the custom medicament injection system of claim 14 wherein the retreatment includes at least one modified target medicament injection site or at least one modified injection dosage (Rios; col. 23, lines 44-64).
Claim 16 recites the custom medicament injection system of claim 13 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to receive follow-up data about the treatment area associated with the person's skin (Rios; col. 23, lines 44-64).
Claim 17 recites the custom medicament injection system of claim 16 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to retain data about earlier treatments (Rios; col. 21, lines 47-60).
Claim 18 recites the custom medicament injection system of claim 17 wherein the non-transitory computer-readable medium has instructions stored thereon that are executable by the processor device to cause the computing device to, based on the data about earlier treatments and based on the follow-up data, output a recommendation for a follow-up treatment (Rios; col. 23, lines 44-64).
Claim 19 recites the custom medicament injection system of claim 18 wherein the follow-up treatment includes at least one modified target medicament injection site or at least one modified injection dosage (Rios; col. 23, lines 44-64).
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered. Applicant’s arguments will be addressed below in the order in which they appear.
Arguments about 35 USC 101 rejection:
Step 2A, prong one: Applicant argues that claim 1 recites “a medicament injection component in which actuation of the injector injects a set medicament dosage unit into or beneath a person’s skin” and “output of a projected beam, haptic feedback, audible feedback, or a specifically overlaid graphical interface to align a medicament injection component” which are technological processes that cannot be performed in the human mind nor directed to following rules and instructions.
In response, Examiner submits that these features are not a part of the abstract idea rejection (Step 2A, prong one), but rather they are part of the additional elements that are directed to hardware and software elements and these limitations are not enough to qualify as “practical application” being recited in the claims along with the abstract idea since these elements are merely invoked as a tool to apply instructions of the abstract idea in a particular technological environment. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Step 2A, prong two: Applicant argues that claimed system provides a specific technological improvement in the administration of the medicaments, by outputting the pre-injection targeting data to provide feedback to the user to confirm proper alignment of the medicament injection component.
In response, Examiner submits that outputting the pre-injection targeting data using feedback (audible or haptic) based on the identified target injection sites corresponds to be a well-understood, routine and conventional activity in the field, as evidenced by Boyden (US9550029B2).
In particular, Boyden discloses “the computer processor can include one or more instructions for recognizing an injector or accessory thereof in a captured image and assessing the injector's proximity to an illuminated injection site in the same captured image and issuing an alert if the injector is not properly located. In one embodiment, a real-time video stream may be used to monitor injector location. An injection event at the illuminated injection site can be recorded by the computer processor as, for example, an image. In one embodiment, the injector can be registered relative to the illuminated injection site based on interaction of some component of the injector with the illuminated injection site. For example, the injector may include an injector-tracking device including one or more photo-sensors that are activated when a specific portion of the injector, e.g., the injection needle, crosses the beam of light illuminating an injection site. In one embodiment, the injector-tracking device can directly issue an audible, visible, or haptic alert or alarm. In one embodiment, the injector-tracking device can send a signal, e.g., a radio-frequency signal, to another device, e.g., the computer processor, a headset, a phone, or other device, which then issues an alarm.” in col. 55, lines 15-36. The well-understood, routine and conventional activities are not sufficient to amount to significantly more than the judicial exception.
Therefore, the arguments are not persuasive and claims 1-19 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Arguments about 35 USC 102 rejection:
Applicant’s arguments with respect to claims 1-19 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DILEK B COBANOGLU whose telephone number is (571)272-8295. The examiner can normally be reached 8:30-5:00 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, Obeid Mamon can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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