DETAILED ACTION
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 § 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 1-4, 7-21 and 93-97 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. In accordance with MPEP 2106.04, each of Claims 1-21 and 93-97 have been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claim 1 is directed to “a drug-delivery system” (i.e. a machine), claim 15 is directed to “a method” (i.e. a process), and claim 21 is directed to “a non-transitory computer-readable media” (i.e. a machine), hence the claims are directed to one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter). In other words, Step 1 of the subject-matter eligibility analysis is “Yes.”
Step 2A, Prong 1 per MPEP 2106.04(a)
Each of claims 1-4, 7-21 and 93-97 recites at least one step or instruction for “determine when the one or more skin contact sensors detect contact with skin tissue; determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly initiates the dispensing event, measure a first time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event, compare the first time duration against a first pre-programmed threshold time duration, and generate a first user indication signal when the first time duration is greater than the first threshold time duration”, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) or a certain method of organizing human activity in MPEP 2106.04(a)(2)(II) or mathematical concept in MPEP 2106.04(a)(2)(I). For example, determining when the one or more skin sensor detect contact with skin tissue can be performed by the human mind through observation (mental processes – see MPEP 2106.04(a)(2)(III)), additionally the other determining step, measuring step, comparing step and generating step consist of mental steps (i.e., can all be performed in the human mind and/or carried out using pen and paper).
Accordingly, each of Claims 1-4, 7-21 and 93-97 recite an abstract idea.
Specifically, Claim 1 recites
A drug-delivery system comprising:
a device housing defining an interior volume and an opening in communication with the interior volume;
a syringe assembly at least partially disposed within the interior volume, the syringe assembly including a barrel configured to hold a medication and an injection needle extending from the barrel;
a drive mechanism configured to initiate a dispensing event in which the syringe assembly ejects the medication from the injection needle when the injection needle extends at least partially out of the opening;
one or more skin contact sensors disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue;
one or more syringe assembly sensors disposed within the housing configured to output a syringe assembly sensor signal based on at least one of a position of at least part of the syringe assembly and movement of at least part of the syringe assembly;
and one or more processing circuits configured to:
determine when the one or more skin contact sensors detect contact with skin tissue; determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly initiates the dispensing event, measure a first time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event, compare the first time duration against a first pre-programmed threshold time duration, and generate a first user indication signal when the first time duration is greater than the first threshold time duration (abstract idea – and considered observation, judgment or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III) as well as involves managing interactions between people, namely, humans following rules, which is grouped as a certain method of organizing human activity in MPEP 2106.04(a)(2)(II)(C) and/or a judgement or evaluation, which is grouped as a mental process in MPEP 2106.04(a)(2)(III));
Further, dependent claims 2-4, 7-21 and 93-97 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the claimed functions/steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea as in MPEP 2106.04(a).
Step 2A, Prong 2 per MPEP 2106.04(d)
The above-identified abstract idea in each of independent Claims 1, 15, and 21 (and their respective dependent Claims 2-4, 7-14, 16-20, and 93-97) is not integrated into a practical application under MPEP 2106.04(d) because the additional elements of a device housing, an interior volume an opening in communication with the interior volume, a syringe assembly, a barrel, a medication, an injection needle, a drive mechanism, one or more skin contact sensors, one or more syringe assembly sensors, and one or more processing circuits as recited in independent claims 1, a piston for claim 2, a mobile device for claim 8, displaying or playing instructions for claim 16, 19, 93, and 96 transmitting over a network for claim 17, 20, 94, and 97, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use according to MPEP 2106.05(h) or represent insignificant extra-solution activity according to MPEP 2106.05(g). The additional elements (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field according to MPEP 2106.04(d)(1) and 2106.05(a). Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine according to MPEP 2106.05(b), effect a transformation according to MPEP 2106.05(c), provide a particular treatment or prophylaxis according to MPEP 2106.04(d)(2) or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception according to MPEP 2106.04(d)(2) and 2106.05(e). Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer in accordance with MPEP 2106.05(f). For at least these reasons, the abstract idea identified above in independent Claims 1, 15, and 21 (and their respective dependent claims) is not integrated into a practical application in accordance with MPEP 2106.04(d).
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer (e.g., processing circuit as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 1, 15, and 21 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Accordingly, independent Claims 1, 15, and 21 (and their respective dependent claims) are each directed to an abstract idea according to MPEP 2106.04(d).
Step 2, prong 2B per MPEP 2106.05
None of Claims 1-4, 7-21 and 93-97 include additional elements that are sufficient to amount to significantly more than the abstract idea in accordance with MPEP 2106.05 for at least the following reasons.
These claims require the additional elements of: a device housing, an interior volume an opening in communication with the interior volume, a syringe assembly, a barrel, a medication, an injection needle, a drive mechanism, one or more skin contact sensors, one or more syringe assembly sensors, and one or more processing circuits as recited in independent claims 1, a piston for claim 2, a mobile device for claim 8, displaying or playing instructions for claim 16, 19, 93, and 96 transmitting over a network for claim 17, 20, 94, and 97.
For claim 1, the sensors and processing circuits, claim 8 a mobile device are additional elements that are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification, paragraph 0084, the processing circuit can be MCU or SOC or ASIC which includes a plurality of sensors and paragraph 0058 for mobile device. These structures are generically described without any specifics and with a high level of generality and thus the specification/disclosure supports the computer components are well understood, routine, and conventional.
Accordingly, in light of Applicant’s specification, the claimed term processing circuit, mobile device, sensors are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processing circuit. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Claim 1 further recites additional elements of: a device housing, an interior volume an opening in communication with the interior volume, a syringe assembly, sensors, a barrel, a medication, an injection needle, a drive mechanism, and a piston for claim 2 which are all well understood, routine and conventional structures of an autoinjector. US Patent Pub. 2014/0207058 provides evidence that injectors with a housing, syringe, drive mechanism, controller and sensor are well-known (routine and conventional in the art) in paragraphs 0002-0004. The US Patent Publication provides teachings that a device housing, an interior volume an opening in communication with the interior volume, a syringe assembly, a barrel, a medication, an injection needle, a drive mechanism, sensor, controller and a piston for claim 2 which are all well understood, routine and conventional structures of an injector (drug delivery device). Therefore, adding these elements will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Moreover, the recitation of the above-identified additional limitations of displaying or playing instructions for claim 16, 19, 93, and 96 transmitting over a network for claim 17, 20, 94, and 97 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See MPEP 2106.05(f) along with Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. See MPEP 2106.05(a) along with McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, per MPEP 2106.05(a), the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the drug delivery system of claim 1-4, 7-14, the method of claims 15-20 and the non-transitory computer readable media of claims 21, 93-97 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself or providing a technical solution to a problem in a technical field according to MPEP 2106.05(a), or (ii) providing meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e).
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 1, 15, and 21 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment according to MPEP 2106.05(h). When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment according to MPEP 2106.05(h). When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself according to MPEP 2106.04(d)(2) and 2106.05(e). Moreover, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity according to MPEP 2106.05(g). As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application as required by MPEP 2106.05.
Therefore, for at least the above reasons, none of the Claims 1-4, 7-21 and 93-97 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-4, 7-21 and 93-97 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: drive mechanism in the claims.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim 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, 14-17, 21, 93 and 94 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being clearly anticipated by Adams et al. (WO 2020/072299 A1 – In IDS).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
With regards to claim 1, 15, 21, a drug-delivery system and a method of generating indications regarding delivery device and a computer readable media storing instructions for, a device housing defining an interior volume and an opening in communication with the interior volume; a syringe assembly at least partially disposed within the interior volume, the syringe assembly (22) including a barrel configured to hold a medication and an injection needle extending from the barrel; a drive mechanism (24) configured to initiate a dispensing event in which the syringe assembly ejects the medication from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors (122, 123, 124) disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue; one or more syringe assembly sensors (112/118, 116 or accelerometer 2012) disposed within the housing configured to output a syringe assembly sensor signal based on at least one of a position of at least part of the syringe assembly and movement of at least part of the syringe assembly; and one or more processing circuits configured to: determine when the one or more skin contact sensors detect contact with skin tissue (Para 00159-00166, 00218 and fig. 31-34); determine, based at least in part on the syringe assembly sensor signal (Para 00159-00166, 00218 and fig. 31-34), when the syringe assembly initiates the dispensing event (Para 00159-00166, 00218 and fig. 31-34), measure a first time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event (Para 00159-00166, 00218 and fig. 31-34), compare the first time duration against a first pre-programmed threshold time duration (Para 00159-00166, 00218 and fig. 31-34), and generate a first user indication signal when the first time duration is greater than the first threshold time duration (Para 00159-00166, 00212-00218 and fig. 31-34).
With regards to claim 2, the drug-delivery system of claim 1, wherein: the syringe assembly further comprises a piston (32) configured to slide along a longitudinal axis within the barrel to force the medication out of the injection needle; the syringe assembly sensor signal is based on a position of the piston; and the one or more processing circuits are configured to determine when the syringe assembly has initiated the dispensing event based on the position of the piston (Para 00159-00166, 00218 and fig. 31-34). With regards to claim 3, the drug-delivery system of claim 1, wherein the drive mechanism is configured to move the syringe assembly from a storage position to an injection position in which the injection needle extends at least partially out of the opening (see fig. 3). With regards to claim 4, the drug-delivery system of claim 3, wherein the one or more processing circuits are configured to determine when the syringe assembly has initiated the dispensing event by determining when the syringe assembly has moved from the storage position to the injection position (Para 00159-00166, 00218 and fig. 31-34). With regards to claim 5, the drug-delivery system of claim 4, wherein the one or more syringe assembly sensors comprise a syringe position detector switch (Ref. 1710). With regards to claim 6, the drug-delivery system of claim 4, wherein the one or more syringe assembly sensors comprise an accelerometer configured to output the syringe assembly sensor signal based on a sensed acceleration caused by movement of the syringe assembly; and the one or more processing circuits are configured to determine when the syringe assembly has initiated the dispensing event based at least in part on the sensed acceleration (Para 00159-00166, 00218 and fig. 31-34). With regards to claim 7, wherein at least one of the one or more processing circuits is disposed within the device housing (see fig. 8). With regards to claim 8, 17, 94, wherein at least one of the one or more processing circuits is disposed within a mobile device separate from the device housing and in wireless communication with a wireless transmitter disposed within the device housing (see Para 004, 00102, 00110, 00159-00166, 00218, 00230 and fig. 31-34). With regards to claim 9, 16, 93, wherein the one or more processing circuits are further configured to display or play instructions on how to use the drug-delivery system in response to the first user indication signal (see Para 00159-00166, 00218 and fig. 31-34). With regards to claim 10, wherein the one or more processing circuits are configured to transmit the first user indication signal over a network to a remote device (para. 00102 and 00230). With regards to claim 14, wherein the barrel holds the medication (22, para 0068).
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.
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 1-21, 93-97 are rejected under 35 U.S.C. 103 as being unpatentable over McLoughlin et al. (US Pat Pub. 2015/0273151) and further in view of Song et al. (US Pat Pub. 2021/0151160).
With regards to claims 1, 14, 15, 21, McLoughlin et al. discloses a drug delivery system (see fig. 20-24I) comprising a device housing defining an interior volume and an opening in communication with the interior volume (see fig. 24H); a syringe assembly (10) at least partially disposed within the interior volume, the syringe assembly including a barrel configured to hold a medication and an injection needle extending from the barrel (see fig. 20-24I); a drive mechanism (drive unit – 70 with respective elements for driving the plunger/piston, such as the motors, lead screw, gears) configured to initiate a dispensing event in which the syringe assembly ejects the medication from the injection needle when the injection needle extends at least partially out of the opening; one or more skin contact sensors (3110 – para 0454) disposed on the housing adjacent to the opening, each skin contact sensor configured to detect contact with skin tissue (the skin contact sensors can be arranged with both embodiments, see para. 0451); and one or more processing circuits (ECU with the skin sensors, para. 0072-0106) configured to: determine when the one or more skin contact sensors detect contact with skin tissue; determine (see para. 0042, 0072-0106), measure a first-time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event (see para. 0039, 0042, 0097, 0098, 0239-0242, 439), compare the first-time duration against a first pre-programmed threshold time duration (see para. 0039, 0042, 0097, 0098, 0239-0242, 439) and generate a first user indication signal when the first-time duration is greater than the first threshold time duration (see para. 0089, 0095, 0440-0445 and 0465-0468).
However, McLoughlin et al. fails to teach “one or more syringe assembly sensors disposed within the housing configured to output a syringe assembly sensor signal based on at least one of a position of at least part of the syringe assembly and movement of at least part of the syringe assembly” and the processors configured to “determine based at least in part on the syringe assembly sensor signal, when the syringe assembly initiates the dispensing event” and “measure a first time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event”.
Song et al. discloses an adapter that can be used with an autoinjector (AI) that captures and confirms autoinjector use as well as injection information and transmit the information wirelessly to a smart phone or other receiving system. Song et al. teaches multiple sensors within the housing of the device to determine when an injection has started (a magnetic proximity sensor array, 20/ 54, fig. 5, and sound/vibration systems, see para. 0096, an accelerometer – fig. 9 and 10). The magnetic sensors sense usage information (see para 0091 and fig. 10) and orientation (see para 0106). The processing circuits compare the information sensed by the magnetic proximity sensor array with the vibrations and noise with a pre-programmed threshold time (see para 118, see fig. 16-31) and generates signals (see para 118-135, see fig. 16-31) and displays the information on a mobile device (see fig. 19-31).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device housing and processing circuits of McLoughlin et al. with the teachings and disclosure of Song et al. to arrive at the claimed invention. One of ordinary skill in the art would have found it obvious to add the one or more syringe assembly sensors (magnetic, accelerometer, and microphone/other sensors) located within the housing of the injector device of Song et al. because it would provide the benefit of determining movement of the syringe, when a proper injection occurs, and displaying the information of the injector to a user which helps to improve patient compliance (see Song, para 0004-0005).
Once the additionally one or more syringe assembly sensors are added to the device of McLoughlin et al., it would also have been obvious to modify the processing circuits and software so the combined device of McLoughlin would determine when the one or more skin contact sensors detect contact with skin tissue; determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly initiates the dispensing event, measure a first time duration between when the one or more skin contact sensors detect contact with skin tissue and when the syringe assembly initiates the dispensing event, compare the first time duration against a first pre-programmed threshold time duration, and generate a first user indication signal when the first time duration is greater than the first threshold time duration because Song et al. teaches the benefit of tracking time after the start of the injection in order to determine if an injection failed (see, Song et al., para. 0004, 0012-0045, 0118-0135). Furthermore, McLoughlin et al. suggestions comparing the data from the skin contact sensors with a timer once the injection starts in order to stop the injection data from the skin contact sensors (see McLoughlin et al., para. 0042, 0089, 0095, 0440, 0468), thus providing additional support that the modifications to the circuits and software would have been obvious modifications to one of ordinary skill in the injector art. With regards to claim 15 and 21, once the modification is made, the combined device teaches the methods steps and software/instructions executed by the processing circuit (see combination above).
With regards to claim 2, McLoughlin et al. teaches a piston/plunger (18/81) and Song et al. teaches the sensor arrangement that includes accelerometers and microphones are used to measure the movement of the piston and determine the start and stop of the injection, (Song, para. 0093). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include an accelerometer and microphone as part of the sensor assembly in the modified combined device of McLoughlin et al. and Song et al. of claim 1, so that the piston movement can be accurately determined. Furthermore, it would have been obvious to modify the processing circuits in order to determine the injection start and stop time based on the position of the piston because Song et al. provides a teaching and benefit of tracking the movement of the piston in order to determine the start of the injection in order to increase patient compliance.
With regards to claim 3-6, the combined device of McLoughlin et al. and Song et al. of claim 1, teach a drive mechanism being configured to move the syringe from a storage position to an injection position (see McLoughlin et al., figs 23E-23G, para. 0440-0442). The combination has been modified above (see combination of claim 1) to include the one or more syringe assembly sensors (including a syringe position detector switch for claim 5 - the magnetic sensors and an accelerometer for claim 6), thus making it obvious to one of ordinary skill in the art to include a syringe position detector switch (magnets) and an accelerometer to determine the movement of the syringe assembly because Song et al. taught using those specific sensors to collect data on the injection process which is used to improve patient compliance. Furthermore, one of ordinary skill in the art would have found the modifications routine and well-known in the art based on the teachings of Song et al. Additionally, it would have been obvious to modify the processing circuits to use the magnets and accelerometer to determine an injection has been initiated based on the movement of the syringe assembly since this was taught by Song et al. and the data collected by the magnets (syringe position detector switch) and the acceleration was used to determine when the syringe assembly has initiated the dispensing event (the movement of the syringe assembly from the storage position to the injection position for claim 4 and based on the sensed acceleration of the syringe assembly) (Song et al., see para. 0096, 0106, 118-135 fig. 9, 10, 16-31). Therefore, it would have been obvious to modified the device of McLoughlin et al. and Song et al. to have processing circuits determine when the syringe assembly has initiated the dispensing event by determining when the syringe assembly has moved from the storage position to the injection position and determine when the syringe assembly has initiated the dispensing event based at least in part on the sensed acceleration because determining the injection start time helps with determining if an injection failure has occurred which improves patient compliance (as taught by Song et al.).
With regards to claim 7, McLoughlin teaches the processing circuits within the housing, see fig. 17-20 and 31.
With regards to claims 8-10, 16-17, and 93-94, McLoughlin teaches sending information wireless to a mobile device separate from the device housing and/or over a network and displaying relevant information, see McLoughlin para. 0292-0300. McLoughlin fails to explicitly state the one or more processing circuits is within a mobile device separate from the device housing and the processing circuits displaying the instructions in response to the first user indication. However, Song et al. discloses in figures 18-33 (para 0132-0140), a mobile device providing instructions and displaying instructions on how to use the drug delivery system. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the combined device of McLoughlin et al. and Song et al. of claim 1 (method of claim 15 for claims 16-17 and CRM of claim 21 for claims 93-94) to include the processing circuit and software on a mobile device separate from the device housing in order to make user interface easier to use. The GUI and app in Song et al. provides a benefit by making it easier to use, thus making it an obvious modification to add at least one of one or more processing circuits within a mobile device separate from the device housing and in wireless communication with a wireless transmitter disposed within the device housing and having the circuits displaying instructions on how to use the system in response to the first user indication signal (for example injection complete, remove the injection from your skin – see Song et al., fig. 27). With regards to claim 16-17 and 93-94, once the modification is made as explained above, the combined device teaches the methods steps and software/instructions executed by the processing circuit (see combination above).
With regards to claim 11, 18 and 95, McLoughlin et al. and Song et al. fail to explicitly state measure a second time duration between when the syringe assembly completes the dispensing event and when the one or more skin contact sensors stop detecting contact with skin tissue; compare the second time duration against a second pre-programmed threshold time duration; and generate a second user indication signal when the second time duration is greater than the second threshold time duration. However, it would have been obvious to modify the combined device of McLoughlin et al. and Song et al. to have the one or more processing circuits determine, based at least in part on the syringe assembly sensor signal, when the syringe assembly completes the dispensing event; determine when the one or more skin contact sensors stop detecting contact with skin tissue; measure a second time duration between when the syringe assembly completes the dispensing event and when the one or more skin contact sensors stop detecting contact with skin tissue; compare the second time duration against a second pre-programmed threshold time duration; and generate a second user indication signal when the second time duration is greater than the second threshold time duration because McLoughlin et al. and Song et al. as modified in claim 1 (method of claim 15 and CRM of claim 21) already determine when a syringe assembly completes the dispensing event (Song et al., para 0004, 0012-0045, 0118-0140), determine when the one or more skin contact sensors stop detecting contact with skin tissue (McLoughlin et al., 0042, 0089, 0095, 0439-0440, 0468) and both McLoughlin et al. and Song et al. are continually monitoring the injection event, thus making it obvious to measure and compare and “second” time duration during the injection event in order to ensure proper delivery of the injection dose within the predetermined time frame as well as generate and display a second user indication signal when the second time duration is greater than the second threshold time duration (See Song et al. para 0118-0121, 0123-0124). For example, McLoughlin et al. provides continued monitoring, measuring, and comparing with the skin sensors and skin contact during the injection (see para. 0468, fig. 36) and Song et al. also provides continuous monitoring during the injection event (see para 0118-0121, 0123-0124) and generating a second user indication signal when the second time duration is greater than the second threshold time duration which is ultimately displayed and provides instructs for the user (see Song et al., fig. 26-31). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the combined device of McLoughlin et al. and Song et al. of claim 1 (as explained above) [and the method of claim 15 and CRM of claim 21] with the additional teachings of McLoughlin et al. and Song et al. (as explained above) to arrive at the claimed invention, such that the combination of McLoughlin et al. and Song et al. teach measuring a second time duration between when the syringe assembly completes the dispensing event and when the one or more skin contact sensors stop detecting contact with skin tissue; comparing the second time duration against a second pre-programmed threshold time duration; and generating a second user indication signal when the second time duration is greater than the second threshold time duration because comparing when the syringe assembly completes the dispensing event and when the skin sensors stop detecting contact with the skin tissue to a pre-programmed threshold time duration helps to determine if the injection event was a failure or success and helps to improper patient compliance. Additionally, generating a second indication signal and displaying the information for a user helps with making the injection device a more user-friendly device. With regards to claims 18 and 95, once the modification is made as explained above, the combined device teaches the methods steps and software/instructions executed by the processing circuit (see combination above).
With regards to claims 12, 13, 19-20, and 96-97, it would have been obvious to modify the combined device of claim 11, to have the processing circuits display instructions on how to determine when the syringe assembly has completed the dispensing event in response to the second user indication signal and transmit the second user indication signal over a network to a remote device (mobile device) because Song et al. discloses in figures 18-33 (para 0132-0140), a mobile device providing instructions and displaying instructions on how to use the drug delivery system. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the combined device of McLoughlin et al. and Song et al. of claim 11 (and the method of claim 18 and CRM of claim 95) to include the processing circuit and software that displays instructions on how to determine when the syringe assembly has completed the dispensing event in response to the second user indication signal in order to provide an easier to use device and provide the information for the user to determine the next step in the injection event. Transmitting the second user indication signal over a network to a remote device provides a benefit so that multiple parties can receive the indication signal and make sure the user is following the proper medical regimen. Furthermore, Song et al., teaches it is well known and routine to display the information and providing next steps in figures 26-31 as well as transmitting the signal over a network to the remote device (mobile device), thus further supporting the obvious modification. With regards to claims 19-20 and 96-97, once the modification is made as explained above, the combined device teaches the methods steps and software/instructions executed by the processing circuit (see combination above).
Conclusion
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Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, TC 3700