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 .
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.
Restriction Requirement
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claim 1-18, drawn to a body, classified in many different classes as the claim merely recites a device-encasing body. For the purposes of the restriction and based upon what appears to applicants intent A61M 5/14248.
II. Claim 19 and 20, drawn to cannula injector, classified in A61M2005/1585.
The inventions are independent or distinct, each from the other because:
Inventions I. and II. are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed in invention I is a device for injecting a drug, Invention II is a device for inserting a cannula encased in a tube. The devices are operated separately and have different functions. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
A search on each of the above-identified inventions would require diverging search strategies (i.e. different keyword searches and classification searches) in order to locate prior art which is pertinent to each (See MPEP 808.02 (C)).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Rashmika Reddy-Mazzitello, on 27 October 2025 a provisional election was made without traverse to prosecute the invention of the device encasing-body, claims 1-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 19-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: secondary port in paragraph 16 is not shown in the drawings. 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. 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.
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 hinged gates with expansionary hinge springs of claim 7 and a connection band, center motor panel, and a PCB attached push band of claim 18 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
Since the Applicant is a pro se. Examiner has provided claim objections in the form of claim suggested changes that are consistent with typical patent practice. These suggestions can be incorporated into any other amendments that the Applicant wishes to make.
Claim 2, “the prescribed drug” should be “a prescribed drug.”
Claim 3, “the liquid drug” should be “a liquid drug.”
Claim 4 should be written as “The body of claim 3, wherein the drug cartridge further comprises a drug cartridge injection and refill point that includes a push-door mechanism to allow drug refillment to the device.
Claim 5 should be written as “The body of claim 3, wherein the drug cartridge further comprises a micro-ultrasonic drug cartridge content-level sensing transmitter with an encased and wired PCB connection scheme that detects when the devices’ drug levels are running low and in need of refillment.”
Claim 6 should be written as “The body of claim 3, wherein the drug cartridge further comprises cartridge support bevels that provide support and structural anchoring of the drug cartridge to the walls of the device.
Claim 7 should be written as “The body of claim 3, wherein the drug cartridge further comprises a secondary port for drug insertion that consists of a hinged gate with expansionary hinge springs to prevent inward release of the gates and leakage of the drug into the drug cartridge.
Claim 8 should be written as “The body of claim 3, further comprising a set of cartridge gate expansion crossbars, corresponding to top and bottom cartridge gates that widen and close the cartridge gates when needed.”
Claim 9 should be written as “The body of claim 3, wherein the drug cartridge further comprises cartridge expander gates located on a top and bottom of the drug cartridge that work to open and close to grant cannula replacement.
Claim 10 should be written as ” The body of claim 1, further comprising body support beams structured to support upper and lower sections of the device.”
Claim 11 should be written as “The body of claim 1, wherein a pH skin color configuring adhesive connection of which colors the adhesive of the device in accordance to the patient's skin-PH and securely connects the pod to the patient’s skin.”
Claim 12 should be written as “The body of claim 1, further comprising a battery replacement and containment point for accessible battery configuration and holding exists.”
Claim 13 should be written as “The body of claim 1, further comprising a printed circuit board electronically connects the devices' body operations together.
Claim 14 should be written as “The body of claim 13, wherein the PCB further comprises a center data chip that operates bluetooth, inter-device connection, and control functions of the device.
Claim 15 should be written as “The body of claim 1, further comprising a 38 mm replaceable cannula to transfer a drug intradermally.”
Claim 16 should be written as “The body of claim 1, further comprising a right motor with panels connected to the printed circuit board to contract the right crossbars inwards and relax them outwards mechanizes for cartridge gate operation; via connection to a Bluetooth mobile app.”
Claim 17 should be written as ”The body of claim 1, further comprising a cannula replacement port including a push-door mechanism that accepts and releases replacement cannulas.”
Claim 18 should be written as “The body of claim 1, further comprising a left motor with a connection band, center motor panel, and a PCB attached push band that pushes the left crossbars inwards.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8, 9, 15, 16 and 18 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 8, 9, 16 and 18, the claims recite in claim 8, a set of cartridge gate expansion crossbars, corresponding to the top and bottom cartridge gates, widens and closes the cartridge gates when needed, in claim 9, cartridge expander gates located on the top and bottom of the drug cartridge work to open and close to grant cannula replacement, in claim 16, a right motor with panels connected to the printed circuit board to contract the right crossbars inwards and relax them outwards mechanizes for cartridge gate operation; via connection to a Bluetooth mobile app and in claim 18, a left motor with a connection band, center motor panel, and PCB attached push band push the left crossbars inwards.
It is not clear how the top and bottom cartridge gates are part of the cartridge or if they are even coupled to the cartridge. It is not clear if the gates open and close ports in the cartridge that allow access to an internal volume of the cartridge or there is a hole with walls through the cartridge and the gates allow access through the hole in the cartridge. It is not clear how the cartridge gate expansion crossbars are attached and interact with the cartridge gates to open and close them. For the gates on the top of the cartridge, it is not clear how the expansion crossbars go around or through the cartridge to reach the top gates. It is not clear how the motors are attached and interact with the crossbars. Is the motion of the motors linear or rotary and then how does this motion, applied to the crossbars, result into opening and closing of the expander gates. For these reasons, claim 8, 9, 16, and 18 fails to comply with the written description requirement.
Regarding claim 15, a 38 mm replaceable cannula exists to transfer the drug intradermally is recited. It is not clear how the cannula interacts with the fluid in the drug cartridge. It is not clear if the cannula is extending into an interior volume of the drug cartridge or there is hole through cartridge and there is a fluid coupling in some other manner. It is not clear how fluid is forced into the cannula and injected intradermally. Typically, a pump or some other device is required to force the fluid into the cannula and then into the body of the person receiving the injection. A pump or some other mechanism that enables the drug to be delivered intradermally is not described. For these reasons, claim 15 fails to comply with the written description requirement.
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.
Claim 2 is 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.
Regarding claim 2, wherein a drug injection syringe administered and provided by a separate provider may administer the prescribed drug is recited in claim 2. It appears the drug injection syringe is separate from the claimed device. It is not clear how a device, in this case, the drug injection syringe, separate from the claimed device, used to administer a prescribed drug further limits the body of claim 1.
Claim Rejections - 35 USC § 102
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.
Claim 1, 2, 10, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prudden (US 2019/0015583).
Regarding claim 1, Prudden teaches a device-encasing body (2, Fig. 2).
Regarding claim 2, Prudden teaches the device as discussed above and further teaches a drug injection syringe administered and provided by a separate provider may administer the prescribed drug (¶44, ¶45, refill syringe 45 can be used to administer the prescribed drug).
Regarding claim 10, Prudden teaches the device as discussed above and further teaches body support beams are structured to support the upper and lower sections of the device (Fig. 7 shows a number of beams extending upwards from the base that are used to support upper and lower sections of the device).
Regarding claim 12, Prudden teaches the device as discussed above and further teaches a battery replacement and containment point for accessible battery configuration and holding exists (In Fig. 2, batteries 5 are shown. The base 9 is removable via 91 to allow the batteries to be accessed and replaced.).
Regarding claim 13, Prudden teaches the device as discussed above and further teaches a printed circuit board electronically connects the devices' body operations together (Fig. 4, 121 in Fig. 7 is a PCB, ¶56).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3, 4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Prudden (US 2019/0015583).
Regarding claim 3, Prudden teaches the invention of claim 1 and Prudden further teaches a drug cartridge contains the liquid drug (4A, Fig. 3, ¶12, the cartridge can be filled with insulin)
Prudden doesn’t teach a volume of the cartridge i.e., a 10.1 mL/1010 IU.
It would have been an obvious matter of design choice to have the volume of the drug cartridge to be 10.1 ml since applicant has not disclosed the volume solves any stated problem or is for any particular purpose and it appears the invention would perform equally well with a volume of 10.1 ml. 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 Prudden to have a drug cartridge of 10.1 ml because such a modification would have been considered an obvious matter of design choice within the level of one of ordinary skill in the art which fails to patentably distinguish over the prior art. Ex parte Clapp, 227 USPQ 972 (Bd. Pat. App. & Inter. 1985). MPEP 2144 I.
Regarding claim 4, Prudden teaches the invention as discussed above and Prudden further teaches a drug cartridge injection and refill point utilizes a push-door mechanism to allow drug refillment to the device (Fig. 3, 43 is the refill point for drug refillment, ¶44, ¶45. The scored cover with triangular flaps is a push door mechanism.).
Regarding claim 6, Prudden teaches the invention as discussed above and Prudden further teaches cartridge support bevels provide support and structural anchoring of the drug cartridge to the walls of the device (In. Fig. 3, the ledges extending from the cartridge 4A on 3 sides are support bevels that provide support and structural anchoring of the drug cartridge to the walls of the device.).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Prudden (US 2019/0015583) in view of Uber (US 20160279324).
As discussed above, Prudden teaches the invention of claim 3 and Prudden further teaches a volume sensor (48, Fig. 4) coupled to a PCB for monitoring a fluid level in the cartridge 4A (¶45).
Prudden doesn’t teach what type of volume sensor is used and in particular a micro-ultrasonic drug cartridge content-level sensing transmitter with an encased and wired PCB connection scheme may detect when the devices’ drug levels are running low and in need of refillment.
Uber teaches a drug delivery device with a reservoir for delivering drugs to a patient (Abstract, Fig. 5). The fluid reservoir is monitored by sensors 222. An ultrasonic sensor is given as an example of a sensor that can be used to measuring fluid levels in the device ¶57. The sensors are in electrical communication with a control (¶57).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the volume sensor of Prudden be a micro-ultrasonic sensor, as taught by Uber, in order to allow fluid levels in the cartridge to be determined.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Prudden (US 2019/0015583) in view of Hein (1,557,836).
As discussed above, Prudden teaches the invention of claim 3 and Prudden further teaches a secondary port (Fig. 3, 43, which is a scored diaphragm) that allows refilling of the cartridge and prevents leakage of the drug in the drug cartridge.
Prudden doesn’t teach a secondary port to drug insertion, consists of a hinged gate with expansionary hinge springs to prevent inward release of the gates.
Hein teaches a one way check valve (16, Fig. 1) that is associated with injecting a fluid into a reservoir (Col. 2:68-77). The check valve 16 prevents leakage of the drug out of the reservoir. The flap of the check valve is a hinged gate. The attachment is of the flap acts as expansionary springs as it resists bending.
It would have been obvious to one of ordinary skill of the art before the effective filing date of the claimed invention to make the secondary port of Prudden have a hinged gate with expansionary hinge springs, as taught by Hein, in order to apply a known technique, in this case designing a one-way port into a cartridge, to a known device ready for improvement, in this case a cartridge, to yield a predictable result of a cartridge with port that prevents leakage. KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007), MPEP 2141, III.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Prudden (US 2019/0015583) in view of Shoats (US 2023/0255878).
As discussed above, Prudden teaches the invention of claim 1 and Prudden further teaches an adhesive connection that connects the pod to the patient’s skin (¶11).
Prudden doesn’t teach a pH skin color configuring adhesive connection of which colors the adhesive of the device in accordance to the patient's skin-PH.
Shoats teaches a color changing adhesives (Abstract). The adhesives have a dye that change color in response to PH changes (¶38, ¶46). The color of the adhesive provides a measure of its tackiness and ability to stick as a function of PH(¶20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the adhesive connection of Prudden be a pH skin color configuring adhesive connection of which colors the adhesive of the device in accordance to the patient's skin-PH, as taught by Shoats, in order to indicate the skin PH of the patient is not interfering with the attachment of the device in Prudden.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Prudden (US 2019/0015583) in view of Amarasekera (US 2022/0105263).
As discussed above, Prudden teaches the invention of claim 1 and Prudden further teaches a center data chip operates wireless, inter-device connection, and control functions of the device (Fig. 4, microcontroller 8A, Fig. 7, shows a center data chip, ¶12, teaches wireless communications).
Prudden doesn’t teach Bluetooth communication.
Amarasekera teaches an injection device that is adhesively attached to a user’s body that uses Bluetooth communications (Fig. 9, ¶89). The wireless communications are used to communicate with a smartphone (¶53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the device of Prudden communicate wirelessly via a bluetooth connection, as taught by Amarasekera, in order to allow the device of Prudden to communicate with a smart phone.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Prudden (US 2019/0015583) in view of Moh (US 2006/0079839).
As discussed above, Prudden teaches the invention of claim 1 and Prudden further teaches a replaceable cannula to transfer drugs intradermally (106, Figs. 5 and 6, ¶46, the cannula is replaceable as the device can be taken apart and a new one installed.).
Prudden doesn’t teach the cannula is 38 mm.
Moh teaches an injection device with a cannula 71 for injecting drugs (Fig. 6). The cannula can be 23 mm to 38 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cannula of Prudden be 38 mm, as taught by Amarasekera, in order to allow the drugs to be properly injected into the patient’s skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID OLYNICK whose telephone number is (571)272-2355. The examiner can normally be reached M-F: 7:30 am-5 pm (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID P. OLYNICK/ Primary Examiner, Art Unit 3741