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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 4-5, 11-12, 25 is/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.
Claim 4 recites the limitation "the first indicia" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "the first indicia" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11, the phrase "the mutable indicia can comprise a second indicia" renders the claim indefinite because it is unclear whether the limitation “a second indicia” is positively required in claim 11 since claim 11 uses the language “can”.
Claim 11 recites the limitation "the first indicia" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the first indicia" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the body " in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(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.
Claim(s) 1-10, 24-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopper et al. (US 2019/0341136).
Regarding claim 1, Hopper discloses
A medical delivery system (100, figs. 1A-2C) comprising:
a drug delivery device (100, figs. 1A-1B) selected from the group comprising a syringe, an autoinjector pen, and a wearable autoinjector (see par. 0022), the drug delivery device (100) comprising a mutable indicia (112) that is altered after a designated operation of the drug selected from the group consisting of removal of a pen cap or needle cap, movement of a plunger or other drive mechanism to dispense a fluid from the drug delivery device, mechanical motion of a component of the drug delivery device, and movement of a drug delivery device component after the fluid is dispensed (see pars. 0006, 0027, and 0040); and
a set of computer-readable instructions (see par. 0029) that analyze an image of the mutable indicia and assign a first state of the drug delivery device (the unused state of 100) when analysis of the image detects that the mutable indicia is unaltered, and assign a second state of the drug delivery device (the used state of 100) when analysis of the image detects that the mutable indicia has been altered by the designated operation of the drug delivery device (see figs. 2A-2C and pars. 0027-0031), and stores the assigned states in a memory device (see pars. 0032-0033).
Regarding claim 2, Hopper discloses
The medical delivery system of claim 1, wherein the set of computer-readable instructions associates and stores in the memory device respective time stamps corresponding to the assigned states (see figs. 2A-2C and pars. 0002, 0030, 0032-0033).
Regarding claim 3, Hopper discloses
The medical delivery system of claim 1, wherein the set of computer-readable instructions is in a software application stored in a memory of a digital device (120), and the image is generated by a camera associated with the digital device (see figs. 2A-2C and par. 0029).
Regarding claim 4, Hopper discloses
The medical delivery system of claim 1, wherein the first indicia (112) comprises one or more characteristics selected from the group consisting of a machine-readable code, a barcode, printed indicia, etched indicia, alphanumeric indicia, color-coded indicia, optical indicia, indicia representing a measurement scale, indicia comprising one or more stripes, and indicia comprising one or more shapes (see pars. 0006, 0031).
Regarding claim 5, Hopper discloses
The medical delivery system of claim 1, wherein the first indicia (112) is altered by an operation selected from extending the first indicia, shortening the first indicia, changing an optical property of the first indicia, and changing a physical property of the first indicia (see pars. 0006, 0027, 0031).
Regarding claim 6, Hopper discloses
The medical delivery system of claim1, wherein the set of computer-readable instructions are configured to communicate the determined first state or second state to another device (see par. 0032).
Regarding claim 7, Hopper discloses
The medical delivery system of claim 1, wherein the drug delivery device (100) is a syringe (see figs. 6A-6B) and the mutable indicia (see figs. 6A-6B) comprises at least a first indicia provided on the syringe (see figs. 6A-6B and par. 0037), the syringe (500) comprising a barrel having a cavity for holding a fluid (see figs. 6A-6B), an opening at a proximal end thereof for receiving a plunger (see figs. 6A-6B), an opening at a distal end thereof in fluid connection with a needle (see figs. 6A-6B), and a plunger (544) movable within the cavity of the barrel and comprising a stopper on a distal end thereof (see figs. 6A-6B and par. 0037); and wherein the set of computer-readable instructions analyzes an image of the first indicia and assigns the first state to the syringe when analysis of the image detects that the first indicia is unaltered, and assigns the second state to the syringe when analysis of the image detects that the first indicia has been altered by the movement of the plunger (see figs. 6A-6B and par. 0037).
Regarding claim 8, Hopper discloses
The medical delivery system of claim 7, wherein the set of computer-readable instructions are configured to communicate the determined state of the syringe to another device (see par. 0032).
Regarding claim 9, Hopper discloses
The medical delivery system of claim 7, wherein the first state of the syringe is a pre-delivery state (fig. 6A), and the second state of the syringe (fig. 6B) is selected from the group consisting of delivery commenced by movement of plunger, and delivery completed by movement of plunger to an end position (see figs. 6A-6B and par. 0037).
Regarding claim 10, Hopper discloses
The medical delivery system of claim 9, wherein the set of computer-readable instructions is configured to determine a state of the syringe selected from the group consisting of a movement distance of the plunger, an amount of fluid remaining in the syringe, and an amount of fluid delivered from the syringe by movement of the plunger (see figs. 6A-6B and par. 0037).
Regarding claim 24, Hopper discloses
The medical delivery system of claim 1, wherein the drug delivery device is an autoinjector pen (see figs. 1A-6B) and the mutable indicia is provided on at least one of a pen cap removably affixed to the autoinjector pen, a needle removably affixed to the autoinj ector pen, a dose window through which a fluid for delivery and a drive mechanism configured to expel the fluid from the autoinjector pen are visable (see the plunger rod in figs. 3A-4B), and a fluid cartridge if the autoinjector pen is reusable (see figs. 1A-6B and pars. 0022-0041).
Regarding claim 25, Hopper discloses
The medical delivery system of claim 24, wherein the mutable indicia is provided on the dose window or on the body of the autoinjector pen (see figs. 1A-6B for the indicator on the body of the device) and adjacent to the dose window (see figs. 1A-6B), and the drive mechanism (plunger rod of Hopper) has a rubber seal at its distal end (distal end of plunger rod of Hopper) that is translated to dispense the fluid (see figs. 1A-6B and pars. 0022-0041), and the set of computer-readable instructions analyzes one or more images of the mutable indicia, and assigns the first state to the drug delivery device when analysis of the one or more images detects that the mutable indicia is unaltered (see figs. 3A-4B for the pre-used state of the plunger rod), and assigns the second state to the drug delivery device when analysis of the one or more images detects a condition selected from the group consisting of the mutable indicia being at least partially obscured by the rubber seal, a change in the location of an obscured part of the mutable indicia by the rubber seal, and a change in the mutable indicia relative to a measurement scale provided on the dose window or on the body adjacent resulting from at least one of fluid dispensing or rubber seal movement (see figs. 3A-3B for the change in the indicator on the body resulting from the movement of the plunger rod/rubber seal, see figs. 4A-4B for the change in the location of the obscured part of the indicator by the movement of the plunger rod/rubber seal) .
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.
Claim(s) 12-13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hopper et al. (US 2019/0341136) in view of Appy et al. (US 2021/0196900).
Regarding claim 12, Hopper discloses
The medical delivery system of claim 1, wherein the syringe comprises a needle shield (108, figs. 1A-1B) removably affixed to the syringe (100), the needle shield being configured to cover the needle before the needle shield is removed and to expose the needle after the needle shield is removed (see par. 0023).
Hopper discloses different embodiments that comprise indicators to identify the states of the device wherein the different embodiments include the housing of the device, the plunger rod of the device, the barrel/plunger rod (see figs. 1A-6B).
Hopper is silent about the first indicia being provided on the needle shield and configured to be altered by removal of the needle shield from the syringe, the first state of the syringe being the needle shield affixed to the syringe and the second state of the syringe being the needle shield removed from the syringe.
However, Appy teaches an indicator (1102) provided on the needle shield (1104) and configured to be altered by removal of the needle shield from the syringe (par. 0467), the first state of the syringe being the needle shield affixed to the syringe and the second state of the syringe being the needle shield removed from the syringe (see par. 0467).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify the needle shield of Hopper by adding an indicator, as taught by Appy, for the purpose of providing a clear visibility to the user so the user can easily recognize the states of the needle shield (par. 0467 of Appy).
Regarding claim 13, Hopper in view of Abby discloses the medical delivery system of claim 12,
Hopper further discloses wherein the set of computer-readable instructions are configured to communicate, to another device, the determined first state or the determined second state (see par. 0032).
Abby further teaches the indicator to determine the different states of the needle shield (par. 0467).
Regarding claim 15, Hopper in view of Abby discloses the medical delivery system of claim 12,
Hopper further discloses wherein the first indicia being obscured in the first state and the first indicia not being obscured in the second state (par. 0028)
Abby further teaches the indicator to determine the different states of the needle shield (par. 0467).
Allowable Subject Matter
Claim(s) 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 16-23 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783