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 4/1/2026 has been entered. Claims 1 and 3-10 are pending in the application. Claim 2 is cancelled. The amendments to the claims and specification overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed on 12/11/2025.
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: “a drive assembly configured to move the container…and configured to move the stopper…” in claims 5-6 (interpreted to include a telescopic plunger arrangement as described in the specification amendment of 4/1/2026).
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.
Claims 1, 3-6, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bar-El et al. (US 2020/0238012 A1).
Regarding claim 1, Bar-El discloses a drug delivery device (injector 10, see Figs. 1-8, par. [0019]) comprising:
a housing (housing 12) (see Fig. 1, par. [0019]);
a needle (injection needle 20) having a retracted position (see Fig. 2) and an extended position (see Fig. 3) (see Figs. 2-3, par. [0020]);
a needle actuator body (needle hub 18) received within the housing (housing 12) (see Fig. 2, par. [0020]) and configured to move from a pre-use position (see Fig. 2) where the needle (injection needle 20) is in the retracted position (see Fig. 2) to a use position (see Fig. 3) where the needle (injection needle 20) is in the extended position (see Fig. 3) (see Figs. 2-3, par. [0020]);
a container (cartridge 28) received within the housing (housing 12) (see Figs. 5-8, par. [0024], [0027]), the container (cartridge 28) comprising a body (body/barrel of cartridge 28), a closure (septum 29), and a stopper (piston 27) moveable within the body (body/barrel of cartridge 28) (see Figs. 5-8, par. [0025]), the container (cartridge 28) having a first position (see Fig. 6) and a second position (see Fig. 8) spaced axially from the first position (Fig. 6) (see Figs. 5-8, par. [0032], [0034], [0037]-[0039]); and
an actuator button (activation button assembly 22) moveable relative to the housing (housing 12) from a first position (see Fig. 2) to a second position (see Fig. 3) to actuate the needle actuator body (needle hub 18) from the pre-use position (see Fig. 2) to the use position (see Fig. 3) (see Figs. 2-3, par. [0020]-[0023]), the actuator button (activation button assembly 22) comprising a container holder (post 42 and tab 44) configured to restrict movement of the container (cartridge 28) from the first position (see Fig. 6) to the second position (see Fig. 8) when the needle actuator body (needle hub 18) is in the pre-use position (see Fig. 2) (see Figs. 2-3 and 5-8, par. [0020]-[0023], [0029], [0032]-[0039]), the container holder (post 42 and tab 44) comprising a projection configured to engage the body (body/barrel of cartridge 28) of the container (cartridge 28) (see Figs. 5-8, par. [0035]-[0040]).
Regarding claim 3, Bar-El discloses the drug delivery device of claim 1, wherein the body (body/barrel of cartridge 28) of the container (cartridge 28) comprises a flange (flange 28d), the container holder (post 42 and tab 44) configured to engage with the flange (flange 28d) of the container (cartridge 28) (see Figs. 5-8, par. [0026], [0032]-[0039]).
Regarding claim 4, Bar-El discloses the drug delivery device of claim 1, further comprising a valve assembly (piercing needle 26 and mount for piercing needle 26, see annotated Fig. 5 below, see par. [0029]) comprising a valve boot (mount for piercing needle 26c, see annotated Fig. 5 below, see par. [0029]) and a valve needle (piercing needle 26c) (see Figs. 5-8, par. [0029]), wherein the container (cartridge 28) is spaced from the valve assembly (piercing needle 26 and mount for piercing needle 26) when the container (cartridge 28) is in the first position (see Fig. 6), and wherein the container (cartridge 28) is engaged with the valve assembly (piercing needle 26 and mount for piercing needle 26) when the container (cartridge 28) is in the second position (see Fig. 8) (see Figs. 5-8, par. [0029], [0032], [0034], [0037]-[0039]).
PNG
media_image1.png
319
586
media_image1.png
Greyscale
Regarding claim 5, Bar-El discloses the drug delivery device of claim 1, further comprising a drive assembly (driving assembly 32 comprising a telescopic plunger arrangement, see par. [0030]) configured to move the container (cartridge 28) from the first position (see Fig. 6) to the second position (see Fig. 8) and configured to move the stopper (piston 27) relative to the body (body/barrel of cartridge 28) of the container (cartridge 28) (see Figs. 5-8, par. [0030]-[0039]).
Regarding claim 6, Bar-El discloses the drug delivery device of claim 5, wherein the actuator button (activation button assembly 22) is configured to actuate the drive assembly (driving assembly 32) (see Figs. 5-8, par. [0030]-[0031], [0038]).
Regarding claim 9, Bar-El discloses the drug delivery device of claim 1, wherein the actuator button (activation button assembly 22) is spaced from the container (cartridge 28) when the container (cartridge 28) is in the second position (see Fig. 8) (see Figs. 5-8).
Regarding claim 10, Bar-El discloses the drug delivery device of claim 1, wherein the container holder (post 42 and tab 44) is formed integrally with the actuator button (activation button assembly 22) (see Figs. 5-8, par. [0035]-[0037]).
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 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bar-El et al. (US 2020/0238012 A1), as applied to claim 1 above, in view of Salter et al. (US 2019/0111207 A1).
Regarding claim 7, Bar-El discloses the drug delivery device of claim 1. However, Bar-El fails to expressly state wherein the needle actuator body comprises a projection configured to restrict movement of the container from the first position to the second position when the needle actuator body is in the pre-use position.
Salter teaches a drug delivery device (drug delivery system 10, see Figs. 1-12, par. [0046]) wherein the needle actuator body (needle actuator assembly 18) comprises a projection (see par. [0056]) configured to restrict movement of the container (container 14) from the first position (see Figs. 2-3) to the second position (see Figs. 5-6) when the needle actuator body (needle actuator assembly 18) is in the pre-use position (see Figs. 2-3) (see Figs. 2-6 and 9A-C, par. [0048], [0050]-[0052], [0056], the needle actuator assembly 18 includes a portion which engages drive surface 40 of the drive assembly 12).
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 modify the drug delivery device of Bar-El to include wherein the needle actuator body comprises a projection configured to restrict movement of the container from the first position to the second position when the needle actuator body is in the pre-use position, as taught by Salter, in order to coordinate and synchronize the needle insertion with the movement of the container when the actuator button is pressed (see Salter par. [0056]).
Regarding claim 8, modified Bar-El teaches the drug delivery device of claim 7 substantially as claimed. Modified Bar-El further teaches wherein the projection (Salter, par. [0056]) of the needle actuator body (Bar-El, needle hub 18) is spaced from the container holder (Bar-El, post 42 and tab 44) of the actuator button (Bar-El, activation button assembly 22) in a direction extending perpendicular to a longitudinal axis of the housing (Bar-El, housing 12) (see Bar-El Figs. 1-8, see Salter Figs. 2-6 and 9A-C, Salter par. [0050]-[0052] and [0056], see previous modifications in rejection of claim 7 above; Salter shows that the drive assembly 12 and the needle actuation assembly 18 are on separate axes such that the portion of needle actuation assembly 18 which engages drive surface 40 must extend perpendicularly across the device to allow such an engagement).
Response to Arguments
Applicant's arguments filed 4/1/2026 have been fully considered but they are not persuasive.
In regards to independent claim 1, Applicant argues that Bar-El fails to teach the limitations “an actuator button… comprising a container holder configured to restrict movement of the container from the first position to the second position when the needle actuator body is in the pre-use position, the container holder comprising a projection configured to engage the body of the container”. These arguments are not found to be persuasive. As described in the rejection of claim 1 above, Bar-El teaches an actuator button (activation button assembly 22) comprising a container holder (post 42 and tab 44) configured to restrict movement of the container (cartridge 28) from the first position (see Fig. 6) to the second position (see Fig. 8) when the needle actuator body (needle hub 18) is in the pre-use position (see Fig. 2) (see Figs. 2-3 and 5-8, par. [0020]-[0023], [0029], [0032]-[0039]), the container holder (post 42 and tab 44) comprising a projection configured to engage the body (body/barrel of cartridge 28) of the container (cartridge 28) (see Figs. 5-8, par. [0035]-[0040]). Post 42 and tab 44 restrict movement of the container prior to the button assembly 22 being actuated (see par. [0036]). Post 42 and tab 44 directly engage with each other, and since post 42 is considered an integral structure of the button assembly 22 (see par. [0035]), tab 44 may also be considered part of the “actuator button”. Tab 44 is shown in Fig. 5 as a projection which engages with the barrel of cartridge 28. Therefore, Bar-El teaches these limitations in the manner recited in the claim.
In regards to dependent claim 7, Applicant appears to argue that the secondary reference Salter additionally fails to teach the aforementioned limitations of claim 1. However, the Examiner interprets that the primary reference Bar-El teaches the aforementioned limitations of claim 1 for the reasons described above. Therefore, the arguments regarding claim 7 and the Salter reference would be rendered moot.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights