Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
2. This office action is in response to the filing of the application on 06/12/2023. Since the initial
filing, no claims have been amended, added, or canceled. Thus, claims 1-15 are pending in the
application.
Priority
3. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/351,553, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim(s) 6-7, 9-15 are not supported by the above listed provisional or the references incorporated-by-reference therein.
The non-supported limitations in these claims are listed below:
“at least one user accessible electronic device is one of a mobile device, a smartphone, a personal digital assistant (PDA), a tablet, a wearable smart device, a phone, a cellular device, a cellphone, a mobile phone, a mobile terminal, an electronic tablet, and any other device configured to communicate using a wireless communication” in claim 6 lines 2-5;
“user accessible electronic device communicates by one of long term evolution (LTE), global system for mobile communication (GSM), universal mobile telecommunications system (UMTS), enhanced data rates for GSM evolution (EDGE), code division multiple access (CDMA), and CDMA2000” in claim 7 lines 2-5;
“a plurality of projections extending outwardly from a surface of the glove adapted to be pressed against a subject for enhancing the stimulation of the subject during vibration of the glove.” In claim 9 lines 1-3;
“a current generating device configured to generate an electrical output Trans Epithelial Nerve Stimulating (TENS) current; and an array of electrodes electrically coupled to the current generating device and configured to be placed around an injection location on the skin of a patient” in claim 10 lines 1-4;
“a pressure sensor coupled to the housing to detect contact between the injection glove and the subject's skin.” In claim 11 lines 1-3;
“an activation switch within the glove housing, that activates when pressed against a subject causes the injection glove to vibrate against the subject's skin during an injection to distract the patient from pain caused by the injection” in claim 12 lines 2-4;
“a cooling mechanism coupled to the housing, that when activated, causes cooling of the injection glove before an injection to distract the subject from pain caused by the injection” in claim 13 lines 1-3;
“a pressure sensor coupled to the housing to detect contact between the injection glove and the subject’s skin” in claim 14 lines 1-2;
“a temperature sensor coupled to the housing to detect a temperature of the injection glove” in claim 15 lines 1-2.
Therefore, the above listed claims 6-7 and 9-15 are given the effective filing date of the date when the corresponding subject matter and claims were filed with the office: 06/12/2023.
Accordingly, claim(s) 6-7 and 9-15 are not entitled to the benefit of the prior application 63/351553.
Drawings
4. 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 limitations listed below:
“a plurality of projections extending outwardly from a surface of the glove” in claim 9 lines 1-2;
the “pressure sensor” in claim 11 line 1 and claim 14 line 1;
the “temperature sensor” in claim 15;
the “current generating device configured to generate an electrical output Trans Epithelial Nerve Stimulating (TENS) current” in claim 10 lines 1-2;
an “array of electrodes electrically coupled to the current generating device and configured to be placed around an injection location on the skin of a patient” in claim 10 lines 3-4;
an “activation switch within the glove housing” claim 12 line 2;
The limitations must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
5. Claim 4 objected to because of the following informalities:
Claim limitation “vibration can be varied per user to use variations selected from the group consisting of different fingers” claim 4 lines 1-2 potentially be interpreted to positively claim a human body part (i.e. human fingers) in violation of 35 USC 101. It is suggested to include functional language such as –selecting different vibrators contained in different fingers of the glove--.
Appropriate correction is required.
Claim Interpretation
6. Claim limitation “embedded with a communication module” in claim 1 line 2 is being interpreted to mean a communication module that is attached to or implanted in an injection glove system.
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:
“vibratory elements” in claim 2 line 1 and claim 3 line 1;
“a current generating device” in claim 10 line 1;
“a vibration mechanism” in claim 12 lines 1-2;
“a cooling mechanism” in claim 13 line 1.
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.
A review of the specification appears to show a lack of corresponding structure for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation(s):
“vibratory elements”: “The injection glove can include multiple vibratory elements placed within multiple glove digits” ([para. 0015] [para. 0023] [para. 0029] [para. 0030]);
“a current generating device”: “a current generating device configured to generate an electrical output Trans Epithelial Nerve Stimulating (TENS) current” ([para. 0037]);
“a vibration mechanism”: “a vibration mechanism coupled to an activation switch within the glove housing” ([para. 39]);
“a cooling mechanism”: “a cooling mechanism coupled to the housing” ([para. 40]).
Claim Rejections - 35 USC § 112
7. 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 1-15 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.
8. Claim limitations “vibratory elements” (claim 2 line 1 and claim 3 line 1), “current generating device” (claim 10 line 1), “vibration mechanism” (claim 12 lines 1-2) and “cooling mechanism” in claim 13 line 1 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Therefore, the claim(s) are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
9. Claim 1 is rejected due to not clearly claiming a statutory category the claim limitation “An injection glove produces a variable vibration pattern that can be used to do injections with less pain” is unclear whether this language is claiming a device or method. Claims can only be directed to one statutory category See: MPEP 2106.03(II).
The lack of a transitional phrase further creates an indefinite scope. The transitional phrase defines the scope of the claim. “The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim….” See MPEP section 2111.03.
For purposes of this examination, claim 1 is being interpreted to mean a glove device configured to lower pain for injections which includes “a communication module to connect to at least one user accessible electronic device with human interface functionality that allows variation of the strength of the impulses, the digits of vibration, as well as various patterns of potential vibration” in claim 1 lines 2-5.
Claim 1 is further rejected due to indefinite wording, as the claim limitation “the digits of vibration” in claim 1 line 4 it is unclear what is being claimed by “digits” of vibration. For purposes of examination, this limitation is being interpreted to mean separate fingers of the glove having vibrating elements.
Claim 2 recites the limitation " the digits " in claim 2 lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if the term “digits” is referring to fingers of the glove or fingers of the user. For purposes of this examination, “digits” is being interpreted to mean fingers of the glove.
Regarding claim 4, the term "the vibration" (claim 4 line 1) lacks an antecedent basis.
Regarding claim 13, the term "the housing" (claim 13 line 2) lacks an antecedent basis because it is dependent upon claim 3, not claim 11.
Regarding claim 14, the term "the housing" (claim 14 lines 1-2) lacks an antecedent basis because it is dependent upon claim 3, not claim 11.
Regarding claim 15, the term "the housing" (claim 15 lines 1-2) lacks an antecedent basis because it is dependent upon claim 3, not claim 11.
Use of the term "can be" (claims 1 line 1 and claim 4 line 1) is unclear whether the limitations following "can be" are required or optional.
The remaining claims are rejected as being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
8. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
9. Claim(s) 1-4, 6-8, and 10 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gulesserian(US 20200238022 A1).
Regarding claim 1, Gulesserian discloses an injection glove produces a variable vibration pattern that can be used to do injections with less pain (para. 28, unique and novel apparatus and method for reducing pain during injection, Fig. 4A, glove tissue system 400); wherein the glove is embedded with a communication module to connect to at least one user accessible electronic device with human interface functionality (para. 54, wearable computing device 650 interfacing and communicating with the two or more gum vibrating and stimulating devices or assemblies, para. 56, communicates with a mobile computer device 750 which can be a smartphone, a mounted communication module is being interpreted to count as being "embedded" with the glove in the same manner as the applicant’s device) that allows variation of the strength of the impulses (para. 44, change in vibration amplitude of a gum vibration), the digits of vibration (para. 37, the fingers and/or vibration assemblies 420 421, para. 33, each vibration device is coupled to and/or controlled by a medical professional's finger and thus can be operated independently of other vibration and stimulation assemblies), as well as various patterns of potential vibration (para. 67, All device implementations can be executable and/or interpretable on a programmable device. A programmable device allows for using programmable vibration to make patterns of vibration. It is noted that claim 1 currently states that the at least one user accessible electronic device “allows” various patterns of potential vibration without actually stating that the electronic device is programmed with various patterns of potential vibration).
Regarding claim 2, Gulesserian discloses the injection glove of claim 1, further comprising multiple vibratory elements in the digits (para. 33, the two or more vibration devices 335 may be placed inside of two or more finger gripping/insertion housings 330, Fig. 3, Finger holding assemblies 330).
Regarding claim 3, Gulesserian discloses the injection glove of claim 2, wherein the multiple vibratory elements are controlled with and connected with the at least one user accessible electronic device (para. 54, wearable computing device 650 interfacing and communicating with the two or more gum vibrating and stimulating devices or assemblies, para. 56, communicates with a mobile computer device 750 which can be a smartphone).
Regarding claim 4, Gulesserian discloses the injection glove of claim 2, wherein the vibration can be varied per user to use variations selected from the group consisting of different fingers (para. 37, the fingers and/or vibration assemblies 420 421, para. 33, each vibration device is coupled to and/or controlled by a medical professional's finger and thus can be operated independently of other vibration and stimulation assemblies), pulses (para. 39, frequency of pulses may determine the rotational speed of the motor), patterns (para. 67, All implementations can be executable and/or interpretable on a programmable device), and intensities (para. 44, change in vibration amplitude of a gum vibration).
Regarding claim 6, Gulesserian discloses the injection glove of claim 3, wherein the at least one user accessible electronic device is one of a mobile device, a smartphone, a personal digital assistant (PDA), a tablet, a wearable smart device, a phone, a cellular device, a cellphone, a mobile phone, a mobile terminal, an electronic tablet, and any other device configured to communicate using a wireless communication (para. 54, wearable computing device 650 interfacing and communicating with the two or more gum vibrating and stimulating devices or assemblies, para. 56, communicates with a mobile computer device 750 which can be a smartphone, Fig. 7, Mobile computing device 750).
Regarding claim 7, Gulesserian discloses the injection glove of claim 3, wherein the at least one user accessible electronic device communicates by one of long term evolution (LTE), global system for mobile communication (GSM), universal mobile telecommunications system (UMTS), enhanced data rates for GSM evolution (EDGE), code division multiple access (CDMA), and CDMA2000 (para. 66, Computing device 750 may communicate wirelessly through wireless communication transceivers 768, which may include digital signal processing circuitry where necessary. In some embodiments, wireless communication interface 768 may provide for communications under various modes or protocols, such as GSM voice calls, SMS, EMS, or MMS messaging, CDMA, TDMA, PDC, WCDMA, CDMA2000, or GPRS, among others).
Regarding claim 8, Gulesserian discloses the injection glove of claim 3, wherein the glove is configured for reducing or eliminating the pain from injections or minor surgical procedures by the local application of vibrations about the injection or surgical site to block afferent pain fiber transmission (Abs., two or more gum stimulation assemblies to stimulate a patient's gum before a needle is inserted into the patient's gum).
Regarding claim 10, Gulesserian discloses the injection glove of claim 3, further comprising a current generating device configured to generate an electrical output Trans Epithelial Nerve Stimulating (TENS) current (para. 49, a TENS unit or device may be utilized to stimulate and/or merge nerve endings in a patient's gums); and an array of electrodes electrically coupled to the current generating device and configured to be placed around an injection location on the skin of a patient (para. 49, one or more electrodes 573 may not be included in the housing 570 and may stick out or protrude from the housing 570).
Claim Rejections - 35 USC § 103
10. 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.
11. Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulesserian (US 20200238022 A1) in view of Valero (WO 2011133797 A1).
Regarding claim 5, Gulesserian discloses the injection glove of claim 3, which includes the ability to program/control vibration (para. 67, all vibrating device implementations can be executable and/or interpretable on a programmable device), but is silent on the at least one user accessible electronic device comprises programs pre-sets allowing for usage patterns per patient or per practitioner.
However, Valero teaches a device for masking pain due to sharp objects penetrating skin (Abs.) which includes at least one user accessible electronic device comprises programs pre-sets allowing for usage patterns per patient or per practitioner (Valero, para. 64, the user can press one button for low, medium or high intensity prior to application of the unit in order to deliver appropriate amounts of vibration to various age groups with differing sensitivity levels).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the programmable treatment device disclosed in Gulesserian with the programming presets taught in Valero to improve device ease of use by saving the medical practitioner time during operations, quickly selecting a vibration intensity appropriate for the age of their patient.
12. Claim(s) 11, 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulesserian(US 20200238022 A1) in view of Gulesserian et al.(US 20220105281 A1), hereafter referred to as Gulesserian 2.
Regarding claim 11, Gulesserian discloses the injection glove of claim 3, further comprising: a glove housing (para. 44, five-fingered glove 401, Fig. 4e, five-fingered glove 401), but is silent on a pressure sensor coupled to the housing to detect contact between the injection glove and the subject's skin.
However, Gulesserian 2 teaches a device for numbing gums before injection through vibration (para. 13, the tissue numbing device is positioned on a medical professional's fingers, the medical professional can localize numbing for injection) which includes a pressure sensor coupled to the housing to detect contact between the injection glove and the subject's skin (para. 32, a pressure sensor and/or a piezo-electric sensor may be installed on the wireless gum or tissue numbing device may be activated in response to pressure on the sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the injection glove of Gulesserian with the pressure sensor of Gulesserian 2 to improve device energy efficiency allowing for longer device usage time between charges and/or battery switches.
Regarding claim 12, Gulesserian discloses the injection glove of claim 3, further comprising: a glove housing (Gulesserian, para. 44, five-fingered glove 401, Fig. 4e, five-fingered glove 401), but is silent on a vibration mechanism coupled to an activation switch within the glove housing, that activates when pressed against a subject causes the injection glove to vibrate against the subject's skin during an injection to distract the patient from pain caused by the injection
However, Gulesserian 2 teaches a vibration mechanism coupled to an activation switch within the glove housing, that activates when pressed against a subject causes the injection glove to vibrate against the subject's skin during an injection to distract the patient from pain caused by the injection. (Gulesserian 2, para. 32, a pressure sensor and/or a piezo-electric sensor may be installed on the wireless gum or tissue numbing device may be activated in response to pressure on the sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the injection glove of Gulesserian with the pressure sensor/activation switch of Gulesserian 2 to improve device energy efficiency allowing for longer device usage time between charges and/or battery switches.
Regarding claim 14, Gulesserian discloses the injection glove of claim 3, but is silent on a pressure sensor coupled to the housing to detect contact between the injection glove and the subject’s skin (Gulesserian 2, para. 32, a pressure sensor and/or a piezo-electric sensor may be installed on the wireless gum or tissue numbing device may be activated in response to pressure on the sensor).
However, Gulesserian 2 teaches a pressure sensor coupled to the housing to detect contact between the injection glove and the subject’s skin(Gulesserian 2, para. 32, a pressure sensor and/or a piezo-electric sensor may be installed on the wireless gum or tissue numbing device may be activated in response to pressure on the sensor).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the injection glove of Gulesserian with the pressure sensor of Gulesserian 2 to improve device energy efficiency allowing for longer device usage time between charges and/or battery switches.
13. Claim(s) 13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gulesserian (US 20200238022 A1) in view of Shachar (WO 2011159317 A1).
Regarding claim 13, Gulesserian discloses the injection glove of claim 3, but is silent on a cooling mechanism coupled to the housing, that when activated, causes cooling of the injection glove before an injection to distract the subject from pain caused by the injection.
However, Shachar teaches a pain abatement device to diminish injection site pain (abs.) which includes a cooling mechanism (para 74, Peltier thermoelectric pad which allows cooling of the surface adjacent to the patient's skin).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the injection glove setup of Gulesserian with the cooling pad of Shachar to create a system which numbs the area around the injection site through a variety of different treatment means allowing more variety to patients who might respond better to the various numbing treatment options.
Regarding claim 15, Gulesserian discloses the injection glove of claim 3, but is silent on a temperature sensor coupled to the housing to detect a temperature of the injection glove.
However, Shachar teaches a pain abatement device to diminish injection site pain (abs.) that includes a temperature sensor coupled to the housing (para. 78, a temperature sensor senses the temperature at the point of contact of that particular vibration head).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the injection glove setup of Gulesserian with the temperature sensor of Shachar to create a system which actively monitors the temperature of the device at point of contact while treating the patient, that way, if secondary and/or direct heating/cooling is being applied as a numbing measure, the medical practitioner can ensure at treatment site that skin/surface temperature is within desired ranges to create a numbing effect before injection.
14. Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Gulesserian (US 20200238022 A1) in view of Huttner (US 20020013602 A1).
Regarding claim 9, Gulesserian discloses the injection glove of claim 3, but is silent on a plurality of projections extending outwardly from a surface of the glove adapted to be pressed against a subject for enhancing the stimulation of the subject during vibration of the glove.
However, Huttner teaches an apparatus for applying pressure at the site of an injection to reduce pain (abs.) which includes a plurality of projections extending outwardly from a surface of a device for assisting in numbing at an injection point (para. 32, skin engaging surface 24 with a plurality of projections 26 to reduce pain from injections, Fig. 3, projections 26).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the surface of the injection glove setup of Gulesserian with the projections taught by Huttner to create a system which better promotes numbing at injection site due to (para. 12, a plurality of projections better blocking pain signals from the small diameter nerve fibers around the injection site), as taught by Huttner.
Conclusion
15. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Burkett (WO 2021055878 A1) and Haluska (US 20210338413 A1). These references are a system for numbing injection sites and a glove device for applying vibration treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEC ROBERT WAHL whose telephone number is (571)272-9880. The examiner can normally be reached Monday - Friday 8:30 a.m. to 6:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571) 272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.R.W./Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785