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 12/30/2025 . As directed by the amendment: claim(s) 1-2, 4, 11-15, 17, 21-22, 24, 26-28, 31, and 34-36 have been amended, claim(s) 5-6, 10, 30 has/have been cancelled, and claim(s) 81-84 has/have been added. Claims 21-22, 24, 26-28, 31, 34-36, and 84 stand withdrawn in light of applicant’s election without traverse dated 7/17/2025. Applicant’s amendment specification does not introduce new matter. Thus, claims 1-2, 4, 11-15, 17, and 81-83 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the preceding drawing objection and 112 rejection on page 11-12:
Applicant's present amendment resolves the preceding office actions stated drawing objection and 112 rejection of the claim(s).
Regarding applicant’s argument regarding the independent claims on page 12-13:
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 being arranged in a cavity within the housing such that a circumferential gap between an outer sidewall of the support and a sidewall of the cavity allows lateral movement of the support within the cavity"
In this regard applicant particularly argues that the prior art of Anderson's carrier, considered the claimed carrier in the preceding office action, cannot be considered capable of moving laterally relative to plate 570 and only travels up and down relative to plate 570 as it follows a keyway 574 up and down.
Examiner's rejection as necessitated by the amendment, below, details the manner by which this functional language a support is permitted a gap between the support and housing to move laterally within the housing's inner cavity relies on a distinct interpretation of the prior art of Anderson where the support is considered the plates 570 575, and not the carrier 550. Accordingly, for this reason and the reasons detailed in examiner's rejection as necessitated by the amendment, the present claims are rejected in view of the prior art of record.
Applicant also provides arguments detailing why their invention allegedly overcomes deficiencies in the art of fixedly mounted needles, which applicant alleges includes the prior art of Anderson.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Regarding applicant’s argument regarding dependent claims on page 13: 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
In view of applicant’s remarks filed 12/30/2025, particularly page 13 which details how the invention distinguishes itself from the art, discussing the subject matter of page 9 line 21 to page 11 line 12 of applicant’s disclosure, it is determined that Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
Claims 1-2, 4, 11-15, 17, and 81-83 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160354553 A1, henceforth written as Anderson.
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 being arranged in a cavity within the housing such that a circumferential gap between an outer sidewall of the support and a sidewall of the cavity allows lateral movement of the support within the cavity;
(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 arranged… such that…" and “allows” 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 a patient, the resilient/pliant nature of the springs 532 permits a lateral bending of the springs 532 when a lateral force acts on the housing and consequently the housing may displace relative to the claimed support and needle and thus the claimed support may be considered functionally capable of moving laterally within the cavity)
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.
Regarding claim 2, the modified invention of Anderson discloses:
The injection device of claim 1, wherein the needle assembly comprises a hollow injection needle or a microneedle array.
(paragraph 59; needle 520 conveying medicament from the cartridge (not enumerated) ; fig 5-6)
Regarding claim 4, the modified invention of Anderson discloses:
The injection device of claim 1, wherein the plurality of springs comprises at least one helical spring.
(fig 5-6 demonstrate drive springs 532 as helical springs)
Regarding claim 11, the modified invention of Anderson 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.
(see examiner's annotation of Anderson's figure 5 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 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.
(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 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.
(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 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.
(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 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.
(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 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.
(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 discloses:
The injection device of claim 1, wherein the support is configured to contact skin at the injection site.
(paragraph 58; blunt spikes 576 contact a patient's skin to cause stimuli; fig 5-6)
Regarding claim 82, the modified invention of Anderson discloses:
The injection device of claim 1, wherein the circumferential gap allows lateral movement of the support within the cavity- during the delivery of the medicament.
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 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 during medicament delivery.
Regarding claim 83, the modified invention of Anderson 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.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure, particularly the inventions recitation of suspension systems which permit an angular or lateral motion of one axially extensible element relative to a structure the axially extensible element is contained within:
US 20120037785 A1
US 20090189360 A1
US 20130118098 A1
US 6988718 B1
US 5467971 A
US 20080281276 A1
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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