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
This office action is responsive to the amendment filed on 5/15/2026. As directed by the amendment: claim(s) 1, 21, and 83 have been amended, claim(s) 3, 5-10, 16, 18-20, 23, 25, 29, 30, 32, 33, 37-80, 82, and 84 have been cancelled. Claims 21-22, 24, 26-28, 31, 34-36, and 84 stand withdrawn in light of applicant’s election without traverse dated 7/17/2025. Thus, claims 1-2, 4, 11-15, 17, 81, and 83 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 5/15/2026 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the preceding drawing objection on page 11-12:
Applicant's present amendment resolves the preceding office actions stated drawing objection.
Regarding applicant’s argument regarding the independent claims on page 8-10:
Applicant argues that the prior art relied upon in the preceding office action does not teach the following limitations of the presently amended claims:
"the support disposed in a cavity within the housing such that the support laterally displaces within the cavity defined by a circumferential gap between an outer sidewall of the support and a sidewall of the cavity responsive to displacement of the housing relative to the injection site without displacing the needle assembly relative to the injection site"
Applicant particularly argues in this regard that because Anderson is silent regarding the lateral displaceability of certain elements, it is rendered incapable of performing the claimed function of the support being laterally displaceable within the claimed cavity in response to a displacement of the housing relative to the injection site without displacing the needle assembly relative to the injection site. Applicant also cites Anderson’s paragraph 58-59 as supporting this incapability since the prior art of Anderson’s carrier 550 and plate 570 relative displacement is governed by a profiled head in a keyway.
Examiner notes that applicant’s arguments do not accurately reflect the interpretation of the prior art provided in the preceding and present office action, as the plurality of springs which enable the claimed function of displacement within the claimed cavity by claimed support, are drive springs 532. Applicant appears correct that the prior art’s spring 577 could possibly be prohibited from lateral movement, however because of the disposal of the noted profiled head and keyway between carrier 550 and plate 570, carrier 550 and plate 570 -which therein include the claimed support of Anderson- can be laterally displaced within the claimed cavity of Anderson in the claimed manner as enabled by the space around the claimed cavity and the flexibility and freedom of displacement of drive springs 532.
Further examiner notes that as the prior art of Anderson recites the structure of the claims which contribute to this function, and is demonstrated as not prohibiting this function, and for the reasons detailed in examiner's rejection as necessitated by the amendment, below, the prior art of Anderson anticipates/teaches the subject matter of the presently amended independent claim, see MPEP 2114 &217.05(G)
Without acquiescing to applicant’s arguments, and only for the sake of compact prosecution if applicant disagrees with examiner’s interpretation that the prior art of Anderson is capable of performing the claimed functions, an additional optional modification of the prior art of Anderson is provided which demonstrates that such a supposed modification of the prior art of record would be obvious.
Regarding applicant’s argument regarding dependent claims on page 10:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable.
See examiner's rejection as necessitated by the amendment, below, detailing the prior art which discloses/teaches the limitations of the dependent claims.
Drawings
The drawings were received on 5/15/2026. These drawings are acceptable.
Claim Rejections - 35 USC § 103
Claims 1-2, 4, 11-15, 17, 81, and 83 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160354553 A1, henceforth written as Anderson, and optionally in view of US 3884230 A, henceforth written as Wulff.
Regarding Claim 1,
Anderson discloses:
An injection device comprising:
(invention of fig 5-6)
a housing configured to receive a medicament container;
(See examiner's annotation of Anderson's fig 5 below)
a parenteral interface comprising
(the claimed parenteral interface comprises the claimed support, noted below, and needle 520; fig 5+6 and examiner's annotation of Anderson's fig 5 below)
a support and
(plate 570 and plate 575, inclusive of plate 575's spikes 576, are together considered the claimed support; fig 5-6
a needle assembly mounted to the support,
(paragraph 2+59; needle 520 can be considered mounted to the claimed support in the manner by which is directly carried by carrier 550 which is directly mounted on the claimed support; fig 5-6)
the parenteral interface being configured to deliver a dose of medicament to an injection site,
(paragraph 2+59; needle 520 is configured to dispense medicament)
the support disposed in a cavity within the housing such that the support laterally displaces within the cavity defined by a circumferential gap between an outer sidewall of the support and a sidewall of the cavity responsive to displacement of the housing relative to the injection site without displacing the needle assembly relative to the injection site;
(fig 5-6, and examiner's annotation of Anderson's fig 5 below, demonstrate that there is a gap of space circumscribing the outer sidewall (not enumerated) of plates 570 575 and within the inner sidewall (not enumerated) of the housing (not enumerated); claim language of "being disposed… such that…" and “responsive to” implies a functional language and the prior art must at least be capable of performing the recited function allowing/permitting/being configured to enable lateral movement of the claimed support within the cavity; examiner notes that the claimed support can be considered functionally capable of lateral movement within the cavity in the manner by which the support is indirectly coupled to the housing, which defines the cavity, via the resilient drive springs 532 and a circumscribing gap of space is disposed around the support and between the support and the housing, such that when the invention is in the configuration illustrated by Anderson's fig 5c-e where it's needle has penetrated and become temporarily fixed in a patient, the resilient/pliant nature of the springs 532 permits some amount of lateral bending of the springs 532 when a certain amount of lateral force acts on the housing and consequently the housing may displace relative to the claimed support and needle an amount which does not disconnect the needle from/break the needle within a patient, and thus the claimed support may be considered functionally capable of moving laterally within the cavity without displacing the needle assembly relative to the injection site)
a plurality of springs
(drive springs 532; fig 5-)
coupled to a spring base provided in the housing,
(carrier 550 may be considered the claimed spring base in the manner by which the disclosed springs 532 577 are coupled thereto; fig 5-6)
the support being mounted on the plurality of springs,
(the claimed support is considered mounted to drive springs 532 in the manner by which they are indirectly connected together via plate 570's direct connection to carrier 550 and carrier 550's direct coupling to drive springs 532; fig 5-6)
each spring having a longitudinal axis, and the longitudinal axes being non-coincident; and
(fig 5 demonstrate springs 532 are not coincident along a needle injection axis, considered the claimed longitudinal axis direction)
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The device of Anderson discloses the elements of the present claim, as described above. Yet, its present embodiment remains silent on:
a flexible conduit configured to deliver medicament from the medicament container to the needle assembly,
However, a further embodiment of Anderson teaches:
a flexible conduit configured to deliver medicament from the medicament container to the needle assembly,
(paragraph 60; flexible conduit 724 between needle 720 and cartridge 710 to enable relative movement therebetween; fig 7; paragraph 38 of Anderson notes that embodiments of the invention are able to be used together)
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Anderson’s further teachings of connecting a flexible conduit joining a medicament container and needle assembly to the modified device of Anderson, such that Anderson’s cartridge of fig 5-6 is provided at a base of plate 575 and a flexible conduit 724 joins to Anderson’s needle 520 which remains with carrier 550, resembling Anderson’s fig 7, in order to advantageously arrive at an invention which enables relative movement between a medicament cartridge and needle, see paragraph 60 of Anderson, which consequently reduces the mass its compression spring 577 act upon and therein reduces the wear on those components over the course of subsequent injections and improves the reliability of those aspects of the invention because of the reduced wear.
The device of Anderson discloses the elements of the present claim, as described above. Yet, if applicant disagrees with examiner’ interpretation of the prior art such that applicant considers Anderson silent regarding:
“the support disposed in a cavity within the housing such that the support laterally displaces within the cavity defined by a circumferential gap between an outer sidewall of the support and a sidewall of the cavity responsive to displacement of the housing relative to the injection site without displacing the needle assembly relative to the injection site;”
It is notable that the prior art of Wulff teaches a parenteral needle interface for injecting therapeutic media comprising a spring 59 supporting a needle interface such that if a patient is startled by the injection and moves slightly – thus a displacement force applied to the housing relative to an injection site and the needle disposed therein- then the spring is permitted to bias laterally to compensate for this displacement force in order to maintain the needle in the patient, see fig 3-4, col 1 line 41-54, and col 4 line 9-37.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate Wulff’s laterally biasing spring in a needle interface teachings to the plurality of springs of Anderson, such that Anderson’s drive springs 532 are capable of lateral displacement, in order to advantageously arrive at an invention which can compensate for a patient’s movement relative to an injection device’s housing by improving the device’s ability to maintain its needle position within a patient, see col 4 line 9-37 of Wulff, and consequently improve delivery of life saving therapeutics.
Regarding claim 2, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the needle assembly comprises a hollow injection needle or a microneedle array.
Anderson: (paragraph 59; needle 520 conveying medicament from the cartridge (not enumerated) ; fig 5-6)
Regarding claim 4, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the plurality of springs comprises at least one helical spring.
Anderson: (fig 5-6 demonstrate drive springs 532 as helical springs)
Regarding claim 11, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the plurality of springs are configured to bias the support into a position in which the needle assembly extends beyond a skin contacting surface of the housing.
Anderson: (see examiner's annotation of Anderson's figure 5 above which details Anderson's housing's skin contacting surface, lower plane 544, which the needle assembly extends beyond as a result of the plurality of springs biasing the claimed support)
Regarding claim 12, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the injection device further comprises an insertion mechanism configured to move the spring base between: a first position relative to the housing in which the needle assembly does not extend from the housing, and a second position relative to the housing, in which the needle assembly extends from the housing for insertion into the injection site.
Anderson: (fig 5-6 demonstrate the manner by which springs 532 are released to bias carrier 550 from a first position, where needle 520 is not exposed, to a second position, where needle 520 is exposed, which constitutes the claimed insertion mechanism)
Regarding claim 13, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, further comprising a releasable locking mechanism configured to: maintain the support or the spring base in a first position relative to housing, in which the needle assembly does not extend from the housing, when the locking mechanism is in an active state; and allow movement of the support or the spring base to a second position, in which the needle assembly extends from the housing, when the locking mechanism is in an inactive state.
Anderson: (paragraph 2+44+57-59; embodiment of fig 5-6 operates in a similar manner to that of fig 3-4 with regard to the manner by which drive springs 532 are compressed and secured with the carrier 550 in a first position shielding the needle 520 and disposed in a position relative to plate 570, see fig 5a+6a, and a second position where springs 532 have been released by a user initiated action pressing a button or trigger, needle 520 is exposed from the housing (not enumerated), and carrier 550 is disposed in a more proximate position relative to plate 570, see fig 5e+6e)
Regarding claim 14, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 13 wherein the releasable locking mechanism configured to: maintain the support in the first position relative to the spring base in which the plurality of springs are compressed when the locking mechanism is in the active state; and allow movement of the support relative to the spring base under influence of the plurality of springs to the second position when the locking mechanism is in the inactive state.
Anderson: (paragraph 2+44+57-59; a user activating a button/trigger permits decompression of springs 532, which results in the compression of compression spring 577 and consequently carrier 550 moves relative to plate 575 and plate 570)
Regarding claim 15, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1 further comprising a deployment mechanism coupled to the support, wherein the deployment mechanism is configured to move the support between a first position in which the needle assembly does not extend from the housing and a second position in which the needle assembly extends from the housing.
Anderson: (paragraph 2+44+57-59; embodiment of fig 5-6 operates in a similar manner to that of fig 3-4 with regard to the manner by which drive springs 532 are compressed and secured with the carrier 550, and thus indirectly coupled to the claimed support, in a first position shielding the needle 520, see fig 5a+6a, and a second position where springs 532 have been released by a user initiated action pressing a button or trigger where needle 520 is exposed from the housing, see fig 5e+6e)
Regarding claim 17, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the housing includes a skin contacting surface, the skin contacting surface comprising an adhesive portion configured to attach the injection device to the skin of a user.
Anderson: (paragraph 36; the invention of fig 5-6 is configured to be worn by a patient such that its the lower surface (not enumerated) includes an adhesive dressing (not enumerated/illustrated) for securing to a patient's skin)
Regarding claim 81, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the support is configured to contact skin at the injection site.
Anderson: (paragraph 58; blunt spikes 576 contact a patient's skin to cause stimuli; fig 5-6)
Regarding claim 83, the modified invention of Anderson and optionally the modified invention of Anderson in view of Wulff discloses:
The injection device of claim 1, wherein the lateral movement of the support within the cavity is angled relative to the longitudinal axes of the plurality of springs.
Examiner noted in the rejection of claim 1 above, the manner by which the support is considered functionally capable of moving laterally within the claimed gap, which includes an angle of movement perpendicular to the longitudinal axes of the claimed springs, is due to the pliant nature of the drive springs 532 which indirectly couple the claimed support to the claimed housing such that a force applied to housing may permit a relative lateral movement between the claimed support and claimed housing, and thus a movement at angle relative to the longitudinal axes of the springs.
Examiner noted in the optional rejection of claim 1 in view of Anderson and Wulff above, the manner that the modified invention is rendered capable of performing the claimed function in that Anderson’s drive springs 532 are enabled to be laterally displaceable to maintain the needle interface in a patient during injection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
