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 .
Acknowledgments
In the reply, filed on January 21, 2026, Applicant amended claims 1, 5-6, 12, 14, and 18-20.
Applicant cancelled claim 13.
In the non-final rejection of November 5, 2025, Examiner objected to the Drawings under 37 CFR 1.83(a). Applicant amended claims 1, 12, and 18; however, Applicant did not address all of the objections. Objection is maintained.
Examiner objected to the Abstract. Applicant amended the Abstract. however, Applicant did not address all of the objections. Objection is maintained.
Examiner objected to claims 5-6, 12-14, and 18-20. Applicant amended claims 5-6, 12, 14, and 18-20, and cancelled claim 13. Objection is withdrawn.
Examiner rejected claims 1-21 under 35 U.S.C. 112(b). Applicant amended claims 1, 12, and 18. Rejection is withdrawn.
Currently, claims 1-12 and 14-21 are under examination.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “an injection needle at the distal end of the housing” (claim 12, line 11; claim 18, line 11) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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.
Specification
The abstract of the disclosure is objected to because:
In line 3, “and a cartridge” should be changed to “a cartridge”
In lines 5-6, “a biasing component” should be changed to “and a biasing component”
In line 6, “the proximal end portion” should be changed to “a proximal end portion”
In line 7, “where” should be changed to “wherein”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6-8, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Walters et al (US 6,096,010).
In regards to claim 1, Walters et al teaches a medical injection device (Figures 15-18, medication delivery pen 500) comprising:
a housing (540) having a distal end and a proximal end
a brake tower (701) within the housing, the brake tower having a proximal end portion, a distal end portion, and a sidewall therebetween defining a longitudinal axis
a cartridge (530) received within the housing distally of the brake tower and holding a composition therein, wherein a proximal end portion of the cartridge is configured to extend at least partially within the distal end of the housing along the longitudinal axis
a piston rod (600) coaxially positioned within the brake tower and capable of axial travel within the brake tower and the cartridge along the longitudinal axis (Figure 18)
a biasing component (610) positioned between the proximal end portion of the cartridge and the distal end portion of the brake tower, wherein the biasing component surrounds a portion of the piston rod (Figures 15-18)
In regards to claim 2, Walters et al teaches wherein the biasing component is configured to engage an outer surface of the piston rod (Figures 15-17).
In regards to claim 3, Walters et al teaches wherein the biasing component comprises a plurality of inwardly-projecting protrusions (Figures 15-18)(column 10, lines 8-10: star wash 610 near its distal end 542 which perform the same function as an earlier embodiments)(column 7, lines 56-57: star washer 348, also shown in FIG. 14)(Figure 14 shows a plurality of inwardly-projecting protrusions of 348).
In regards to claim 4, Walters et al teaches wherein the plurality of inwardly-projecting protrusions of the biasing component are configured to engage an outer surface of the piston rod (Figure 14).
In regards to claim 6, Walters et al teaches wherein each of the plurality of inwardly- projecting protrusions includes a prong configured to engage the piston rod (Figure 14).
In regards to claim 7, Walters et al teaches wherein the plurality of inwardly-projecting protrusions comprises four protrusions (Figure 14).
In regards to claim 8, Walters et al teaches wherein the biasing component comprises a plurality of notches formed therein (Figures 15-18)(column 10, lines 8-10: star wash 610 near its distal end 542 which perform the same function as an earlier embodiments)(column 7, lines 56-57: star washer 348, also shown in FIG. 14)(Figure 14 shows a plurality of notches of 348), wherein the plurality of notches are configured to allow for flexing of engagement surfaces of the biasing component (Figure 14)(as star washers are known to be flexible, it would be expected that the plurality of notches of 348 would allow for flexing of engagement surfaces between the plurality of notches of 348).
In regards to claim 18, Walters et al teaches a medical injection device (Figures 15-18, medication delivery pen 500) comprising:
a housing (540) having a distal end and a proximal end
a brake tower (701) having a proximal end portion, a distal end portion, and a sidewall therebetween defining a longitudinal axis
a cartridge (530) received within the housing distally of the brake tower and holding a composition therein, wherein a proximal end portion of the cartridge is configured to extend at least partially within the distal end of the housing along the longitudinal axis
a cartridge housing (535) received within the housing distally of the brake tower and configured to hold the cartridge therein
an injection needle at the distal end of the housing and in fluid communication with the cartridge (column 9, lines 21-24: All of these figures, of course, do not show the cap and pen-needle assembly which has been sufficiently described above with respect to the earlier embodiments)(column 3, lines 64-65: Pen-needle assembly 20 includes a double-ended needle cannula 21)
an actuation member (551) at the proximal end of the housing, the actuation member configured to actuate the medical injection device to deliver the composition through the injection needle (Figure 18)
a piston rod (600) coaxially positioned within the brake tower and capable of axial travel within the brake tower and the cartridge along the longitudinal axis (Figure 18), the piston rod non-rotatably coupled to the brake tower (in Figures 15-18, there is no rotatable coupling shown between piston rod 600 and brake tower 701)
a biasing component (610) positioned between the proximal end portion of the cartridge and the distal end portion of the brake tower, wherein the biasing component comprises a partial or full ring member configured to allow for flexing of engagement surfaces of the biasing component (Figures 15-18)(column 10, lines 8-10: star wash 610 near its distal end 542 which perform the same function as an earlier embodiments)(column 7, lines 56-57: star washer 348, also shown in FIG. 14)(Figure 14 shows a full ring member 348; and as star washers are known to be flexible, flexing of engagement surfaces of 348 would be expected)
In regards to claim 19, Walters et al teaches wherein the partial or full ring member comprises a plurality of notches which are configured to allow for the flexing of the engagement surfaces of the biasing component (Figure 14 shows a plurality of notches of 348; as star washers are known to be flexible, it would be expected that the plurality of notches of 348 would allow for flexing of engagement surfaces between the plurality of notches of 348).
In regards to claim 20, Walters et al teaches wherein the biasing component is configured as a star washer (610/348).
In regards to claim 21, Walters et al teaches wherein the biasing component is configured to engage an outer surface of the piston rod (Figures 15-17)(Figure 14).
Claim Rejections - 35 USC § 103
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.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Walters et al, as applied to claims 1 and 8 above, and further in view of Burren et al (US 2007/0021718).
In regards to claim 9, Walters et al does not teach wherein the biasing component is configured as a leaf spring, as Walters et al instead teaches wherein the biasing component is configured as a star washer (column 10, line 8: star wash 610). Burren et al teaches a medical injection device (Figures 1-3) wherein a biasing component (10) is configured as a leaf spring (paragraph [0016]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the biasing component, of the device of Walters et al, to be configured as a leaf spring, as taught by Burren et al, as such may serve as a driving spring of a mechanism for conveying a product which can be administered, for example insulin, may also serve as a return spring for a needle guard of an injection pen, for example, or as a return spring for another component of the device, for example a return spring for a trigger button, and it may be used as a supporting or compensating spring to serve as a means of compensating longitudinal tolerances for supporting a medicament container in an injection device, such as an injection pen (paragraph [0017]).
In regards to claim 11, Walters et al is silent about wherein the biasing component is formed from polymer. Burren et al teaches a medical injection device (Figures 1-3) wherein a biasing component (10) is formed from polymer (Abstract: spring is molded from plastic)(paragraph [0012]: polyoxymethylene). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the biasing component, of the device of Walters et al, to be formed from polymer, as taught by Burren et al, as such will allow the biasing component to be produced by the same manufacturers of the device and will reduce cost as inexpensive plastic materials can be used (paragraph [0010]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Walters et al, as applied to claim 1 above, and further in view of Harms et al (US 2011/0306939).
In regards to claim 10, Walters et al is silent about wherein the biasing component is formed from metal. Harms et al teaches a medical injection device (Figures 1-6) wherein a biasing component (50) is formed from metal (paragraph [0055]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the biasing component, of the device of Walters et al, to be formed from metal, as taught by Harms et al, as such will exert a force on the cartridge in the distal direction and secure the cartridge against movement with respect to the cartridge retaining member and against movement with respect to the housing (paragraph [0044]).
Response to Arguments
Applicant's arguments filed January 21, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: Amended independent claim 1 recites, in part, "a brake tower within the housing, the brake tower having a proximal end portion, a distal end portion, and a sidewall therebetween defining a longitudinal axis". None of the cited references disclose or teach such claimed features. The Office Action at pages 7-8 likens the housing 540, and inner sleeve 701 and outer sleeve 702 of Walters to the claimed housing and brake tower, respectively. However, the inner sleeve 701 and outer sleeve 702 are part of the priming control mechanism 700, which is external to the housing 540. "Medication delivery pen 500 also includes a priming control mechanism like that described in the earlier embodiment which is rotatably mounted on housing 540 to allow a user to prime medication delivery pen 500 prior to arming the medication delivery pen 500." (Walters at Col. 10, Lines 47-51). (emphasis added). Further, one skilled in the art would not alter the outer sleeve 702 of Walters to be internal to the housing 540, as the outer sleeve 702 aides the user in rotating the priming control 700. "Priming control mechanism 700 includes an inner sleeve 701 and an outer sleeve 702 having a textured surface to aide the user in rotating priming control 700." (Walters at Col. 10, Lines 51-54). Therefore, Walters does not disclose or teach all of the features of amended independent claim 1, and there is no basis by which one of ordinary skill in the art would modify Walters to include the claimed features, as doing so would be contrary to the purpose of the Walters device. For the foregoing reasons, Applicant submits that independent claim 1 is allowable (Remarks, pages 9-10). Examiner disagrees. Walters et al teaches a brake tower (701) within the housing (540), the brake tower having a proximal end portion, a distal end portion, and a sidewall therebetween defining a longitudinal axis (Figures 15-18).
In regards to claim 18, Applicant argued: Amended independent claim 18 recites, in part, "a piston rod coaxially positioned within the brake tower and capable of axial travel within the brake tower and the cartridge along the longitudinal axis, the piston rod non-rotatably coupled to the brake tower". None of the cited references disclose or teach such claimed features. The Office Action at pages 7-8 likens the plunger 600, inner sleeve 701 and outer sleeve 702 of Walters to the claimed piston rod and brake tower, respectively. However, the inner sleeve 701 and outer sleeve 702 rotates in relation to the plunger 600. "Medication delivery pen 500 also includes a priming control mechanism like that described in the earlier embodiment which is rotatably mounted on housing 540 to allow a user to prime medication delivery pen 500 prior to arming the medication delivery pen 500." (Walters at Col. 10, Lines 47-51). (emphasis added). Further, one skilled in the art would not alter the outer sleeve 702 of Walters to be fixed to the housing 540 to prevent rotation, as the rotational mount allows a user to prime the pen. "Inner sleeve 701 include priming control ratchet 703 at a proximal end 704 that meets with distal end ratchet 508 on plunger nut 506 so that rotation of priming control mechanism 700 causes rotation of plunger nut 506 that then causes movement of plunger 600 in a distal direction to dispense medication from medication delivery pen 500 during a priming operation. Priming control mechanism 700 and its priming control ratchet 703 are designed so that they only provide rotational forces to plunger nut 506 in one direction." (Walters at Col. 10, Lines 54-63). Therefore, Walters does not disclose or teach all of the features of amended independent claim 18, and there is no basis by which one of ordinary skill in the art would modify Walters to include the claimed features, as doing so would be contrary to the purpose of the Walters device. For the foregoing reasons, Applicant submits that independent claim 18 is allowable (Remarks, page 10). Examiner disagrees. Walters et al teaches a piston rod (600) coaxially positioned within the brake tower (701) and capable of axial travel within the brake tower and the cartridge (530) along the longitudinal axis (Figure 18), the piston rod non-rotatably coupled to the brake tower (in Figures 15-18, there is no rotatable coupling shown between piston rod 600 and brake tower 701).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to dependent claim 5, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a medical injection device, as claimed, specifically including wherein the plurality of inwardly-projecting protrusions are configured to engage the outer surface of the piston rod when the biasing component is in a substantially uncompressed configuration, and further wherein the plurality of inwardly-projecting protrusions are configured to disengage from the outer surface of the piston rod when the biasing component is in a substantially compressed configuration.
Walters et al teaches wherein the plurality of inwardly-projecting protrusions (of 348) are configured to engage the outer surface of the piston rod (300) (Figure 14).
However, Walters et al is silent about wherein the plurality of inwardly-projecting protrusions are configured to engage the outer surface of the piston rod “when the biasing component is in a substantially uncompressed configuration”. And Walters et al is silent about “wherein the plurality of inwardly-projecting protrusions are configured to disengage from the outer surface of the piston rod when the biasing component is in a substantially compressed configuration”.
Thus, dependent claim 5 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim 1 and intervening claims 3-4.
Claims 12 and 14-17 are allowed.
In regards to independent claim 12, the prior art of record does not disclose or render obvious before the effective filing date of the claimed invention the combination of a medical injection device, as claimed, specifically including wherein the plurality of inwardly-projecting protrusions are configured to engage the outer surface of the piston rod when the biasing component is in a substantially uncompressed configuration, and further wherein the plurality of inwardly-projecting protrusions are configured to disengage from the outer surface of the piston rod when the biasing component is in a substantially compressed configuration.
Walters et al teaches a medical injection device (Figures 15-18, medication delivery pen 500) comprising: a piston rod (600), and a biasing component (610) comprising a plurality of inwardly-projecting protrusions configured to engage an outer surface of the piston rod (Figures 15-18)(column 10, lines 8-10: star wash 610 near its distal end 542 which perform the same function as an earlier embodiments)(column 7, lines 56-57: star washer 348, also shown in FIG. 14)(Figure 14 shows a plurality of inwardly-projecting protrusions of 348 engaging an outer surface of 300).
However, Walters et al is silent about wherein the plurality of inwardly-projecting protrusions are configured to engage the outer surface of the piston rod “when the biasing component is in a substantially uncompressed configuration”. And Walters et al is silent about “wherein the plurality of inwardly-projecting protrusions are configured to disengage from the outer surface of the piston rod when the biasing component is in a substantially compressed configuration”.
Thus, independent claim 12 is allowed. Dependent claims 14-17 are allowed by virtue of being dependent upon independent claim 12.
Conclusion
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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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