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 .
Response to Amendment
The amendment filed on 4/6/2026 has been entered. Claims 1-4, 6-9, 11-12, 14, 21-26, 28-29, and 31 remain pending in the present application. Applicant’s amendments to the claims have overcome the 35 U.S.C. 101 rejection set forth previously.
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: 1-4, 6-9, 11-12, 14, 21-26, 28-29, and 31
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.
Claims 1-4, 6-9, 11-12, 14, 21-26, 28-29, and 31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fitzgibbon et al. (US PGPUB 20190050375).
Regarding Claims 1 and 21; Fitzgibbon teaches; Fitzgibbon teaches; A method of reducing combination device variability, the method comprising: (Fitzgibbon; at least paragraphs [0005] and [0008]; disclose providing a combination of device parameters to a prediction model in order to determine a failure rate and from the prediction, select the lowest probability of failure, thus reducing variability)
identifying, by one or more processors, a plurality of potential combinations of at least first components and second components, wherein each combination of the potential combinations can form one or more units of a combination device; (Fitzgibbon; at least paragraphs [0006]-[0007]; disclose wherein the system and method includes receiving a plurality of combinations including syringe, liquid drugs, and drug injection devices)
for each combination of the potential combinations, predicting, by the one or more processors, a property or result of the units of the combination device when formed from at least the first and second components of the combination, at least by applying (i) values of one or more characteristics of the first component of the combination, and (ii) values of one or more characteristics of the second component of the combination, as inputs to a predictive model; (Fitzgibbon; at least paragraphs [0006]-[0008]; disclose receiving a plurality of parameters from said devices which are used to determine a predicted peak pressure experienced the combination device)
selecting, by the one or more processors and based on the predicted properties or results for the potential combinations, a subset of combinations from among the potential combinations; and providing, by the one or more processors, an indication of the selected subset of combinations, wherein a plurality of units of the combination device are assembled in accordance with the selected subset of combinations. (Fitzgibbon; at least paragraphs [0007]-[0008]; disclose wherein a plurality of predicted property results (i.e. failure prediction based on peak pressure of the particular combination) is compared to a threshold, wherein this process is repeated iteratively until a group of predicted properties/results is below a threshold, wherein the system then selects this subset of candidate parameters if it meets the threshold criteria and further, the system included manufacturing the injection device using the determined/selected parameters).
Regarding Claims 2 and 22; Fitzgibbon teaches; The method of claim 1, wherein: each combination of the potential combinations is a different pair consisting of (i) a batch of the first components and (ii) a batch of the second components; and for each combination of the potential combinations, the respective values of the one or more characteristics of the first component are statistically representative of the respective batch of the first components, and the respective values of the one or more characteristics of the second component are statistically representative of the respective batch of the second components. (Fitzgibbon; at least paragraphs [0007]-[0008] and [0037]).
Regarding Claim 3; Fitzgibbon teaches; The method of claim 2, wherein identifying the plurality of potential combinations includes: receiving a first set of identifiers of different batches of the first component; receiving a second set of identifiers of different batches of the second component and identifying the plurality of potential combinations by forming different pairs each consisting of an identifier of the first set and an identifier of the second set. (Fitzgibbon; at least paragraphs [0007]-[0008] and [0038]).
Regarding Claims 4 and 23; Fitzgibbon teaches; The method of claim 1, wherein identifying the plurality of potential combinations includes at least one of omitting infeasible combinations, or receiving an indication of each of the plurality of potential combinations. (Fitzgibbon; at least paragraphs [0038] and [0093]).
Regarding Claims 6 and 24; Fitzgibbon teaches; The method of claim 1, wherein selecting the subset of combinations includes solving an objective function using the predicted properties or results for the potential combinations as inputs to the objective function. (Fitzgibbon; at least paragraphs [0007]-[0008]).
Regarding Claim 7; Fitzgibbon teaches; The method of claim 6, wherein: the method further comprises, for each combination of the potential combinations, predicting one or more additional properties or results of the units of the combination device when formed from the first and second components of the combination, using one or more additional predictive models; and the objective function includes a plurality of function terms each corresponding to a different property or result of the combination device. (Fitzgibbon; at least paragraphs [0007]-[0008] and [0037]-[0038]).
Regarding Claims 8 and 25; Fitzgibbon teaches; The method of claim 1, wherein: the combination device is a filled syringe; the first component is a syringe; and the second component is a fluid drug product. (Fitzgibbon; at least paragraphs [0005]-[0006]).
Regarding Claims 9 and 26; Fitzgibbon teaches; The method of claim 8, wherein the one or more characteristics of the first component include one or more of glide force, shield removal force, barrel diameter, crush test results, plunger diameter, or plunger weight, and wherein the one or more characteristics of the second component include one or more of viscosity, density, or protein concentration. (Fitzgibbon; at least paragraph [0094]).
Regarding Claims 11 and 28; Fitzgibbon teaches; The method of claim 1, wherein: the combination device is an autoinjector; the first component is a pre-filled syringe; and the second component is an autoinjector subassembly. (Fitzgibbon; at least paragraphs [0006] and [0093]).
Regarding Claims 12 and 29; Fitzgibbon teaches; The method of claim 11, wherein the one or more characteristics of the first component include one or more of extrusion force, breakloose force, protein concentration, or particle characterization, and wherein the one or more characteristics of the second component include one or more of specification number, saline release testing results, injection time, activation force, or spring force. (Fitzgibbon; at least paragraphs [0063], [0115]-[0117], and [0131]).
Regarding Claims 14 and 31; Fitzgibbon teaches; The method of claim 1, wherein predicting the property or result of the units of the combination device includes at least one of: (a) predicting a value indicative of variability in injection time or activation force across the units of the combination device, (b) predicting a probability distribution of a characteristic of the combination device across the units of the combination device, or (c) predicting a presence, amount, frequency, or likelihood of user complaints associated with the units of the combination device. (Fitzgibbon; at least paragraph [0109]).
Response to Arguments
Applicant’s arguments, see pages 8-13, filed 4/6/2026, with respect to the 35 U.S.C. 101 rejection have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of 1-4, 6-9, 11-12, 14, 21-26, 28-29, and 31 has been withdrawn.
Applicant's arguments filed 4/6/2026 with respect to the 35 U.S.C. 102(a)(1) argument have been fully considered but they are not persuasive.
The applicant argues that the reference of Fitzgibbon fails to explicitly teach or disclose, “…identifying potential combinations of first components and second components, where each combination form one or more units of a combination device.”, and that Fitzgibbon merely describes receiving a set of parameters from a syringe, a liquid drug, and a drug injection device, not a plurality of combinations. However, the office respectfully disagrees.
With respect to the applicant’s arguments, the claim requires identification of a plurality of potential combinations or at least first and second components, wherein the combination forms a combination device. Fitzgibbon describes the first component as a syringe (see paragraph [0006]) and describes the second component as a liquid drug (see paragraph [0006]) and wherein the combination forms a drug injection device (see paragraph [0006]). Next, the claim requires a plurality of potential combinations of the first and second components, which is explicitly disclosed in paragraphs [0007]-[0008], wherein the system iteratively applies various parameters to a kinematic model to determine a probability of failure to the syringe, if the failure rate is above a threshold, another set of parameters is generated and tested, thus forming a plurality of potential combination candidates as the process is iterated for the components.
This logic is applied to the rest of the limitations for instance, when a property result is predicted as a result of the parameters being iterated (i.e. peak pressure is predicted for each simulation; see paragraph [0007]) when applied to the prediction model and further, a selection is made of a subset of parameters that result in the probability of failure being above a threshold is selected to be manufactured (paragraph [0007]).
Therefore, the reference of Fitzgibbon reasonably reads on the claim language as currently written. The office understands that the intent of the application is to present a plurality of unique first components and second plurality of unique second components, and then combine them to form groups of different combinations to create different devices. The office recommends including further limitations to distinguish these different device combinations, such as incorporating and expanding upon claim 3, which includes providing identifiers to differentiate the different device combinations as a way to disclose the differences between the present application and the closest prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boyd et al. (US PGPUB 20160129191): disclose an injection design system and method for creating needle-free injectors which account for a plurality of components and optimal design parameters to ensure manufacturing of an optimal injection system.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER W CARTER whose telephone number is (469)295-9262. The examiner can normally be reached 9-6:30.
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/CHRISTOPHER W CARTER/Examiner, Art Unit 2117
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