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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/04/2026 has been entered.
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 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.
In making the below rejections, the examiner has considered and addressed each of the applicants arguments. Claims 14 and 16 have been canceled and Claims 1-13, 15, and 17-22 are currently pending and being examined.
Claim Rejections - 35 USC § 112-1st
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-22 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter, which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 17 recite: “has a non-annular profile in a view taken perpendicular to the longitudinal axis with the window visible”.
There is no mention of the newly amended limitation in the original Specification. Thus, the limitations include subject matter that was not described in the original Specification.
If the examiner has overlooked the portion of the original Specification that describes this feature of the present invention, then Applicant should point it out (by page number and line number) in the response to this Office Action.
Applicant may obviate this rejection by canceling the claim.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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Claims 1-12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Andre (USPAP 2020/0289753) in view of Durvasula (USPAP 2016/0220764) further in view of Bostrom (USPAP2014/0257193).
In reference to independent claim 1, Andre discloses a drug delivery device (fig 1-22) comprising:
a housing (10 to include 54, hereafter 10, fig 2) defining a longitudinal axis (runs down the center of the injector) and a camming feature (18; [0028]), the housing having an opening (60, fig 4b) and an outer surface (outer surface of 10); a drug storage container (86) including a delivery member (90) having an insertion end configured to extend at least partially through the opening (60) during a delivery state (needle passes thru 60 when the bottom of 54 is pressed against the skin); and a removable cap (14) defining a cap camming feature (16; [0028]) and configured to be removably coupled with the housing (10) such that the removable cap (14) has a storage position where the removable cap is coupled with the housing (shown in fig 3A) and at least partially covering the opening (60) and a removed position where the removable cap is not coupled with the housing (shown in fig 2); wherein the cap (14) camming feature (16) and the housing camming (18) feature are configured to translate rotational motion into axial motion such that, upon rotational movement of the removable cap (14), the cap camming feature (16) and/or the housing camming feature urge the removable cap along the longitudinal axis (para 0028 discloses “A distal end surface 16 of the protective cap 14 and the proximally directed surface 18 between the reduced area 12 and the rest of the housing 10 are provided with cam-shapes so as to facilitate removal of the protective cap 14 when turning it in relation to the housing 10 such that the cam-shaped surfaces 16, 18 provide a motion in the proximal direction of the protective cap 14”); and wherein the housing camming feature (18) and the cap camming feature (16) are each visible to a user of the drug delivery device to signal the camming function of the housing camming feature and/or the cap camming feature (both are visible in fig 2), however
Andre does not teach a window configured to permit a user of the drug delivery device to view inside the housing, and
the housing camming feature comprises at least one protrusion extending away from the outer surface of the housing,
the at least one protrusion has a non-annular profile in a view taken perpendicular to the longitudinal axis with the window visible.
Durvasula, a similar medicine delivery system, teaches the housing camming feature comprises at least one protrusion (top 102D, fig 18A-C, https://www.merriam-webster.com/dictionary/cam defines a cam as “ a rotating or sliding piece (such as an eccentric wheel or a cylinder with an irregular shape) in a mechanical linkage used especially in transforming rotary motion into linear motion or vice versa” 102D interacts with the protrusion 202D and causes the linear motion in response to a rotary motion of the cap para 0007 discloses “to allow travel between the cap and the housing in response to rotation”, meeting the claim language) extending away from the outer surface of the housing (100) and
the at least one protrusion (102d) has a non-annular profile in a view taken perpendicular to the longitudinal axis with the window visible (fig 18 shows that the protrusion 102D has a non-annular profile from no direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the camming feature of Andre extend from the surface of the housing as taught in Durvasula to give more surface area for the camming feature on the cam to rotate against, increasing the reliability of the camming feature. To be clear the modification is done by extending out the cam feature from the housing for a short distance, like the feature 102d.
Durvasula does not teach a window configured to permit a user of the drug delivery device to view inside the housing.
Bostrom, a similar medicine delivery system, teaches a window (6 fig 2) configured to permit a user of the drug delivery device to view inside the housing (para 0066 discloses “a window allows the user to view the state of the injection, i.e. whether the injection device 1 is still in its initial position with the medicament not yet being injected, or whether the medicament container is already emptied. Through”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the window shown in Bostrum to the device of Andre in view of 21. Durvasula to “allow[[s]] the user to view the state of the injection, i.e. whether the injection device 1 is still in its initial position with the medicament not yet being injected, or whether the medicament container is already emptied” para 0066.
In reference to independent claim 17, Andre discloses a drug delivery device (fig 1-22) comprising: a housing (10 to include 54, hereafter 10, fig 2) defining a longitudinal axis (runs down the center of the injector) and a camming feature (18), the housing (10) having an opening (60, fig 4b) and an outer surface (outer surface of 10); a drug storage container (86) including a delivery member (90) having an insertion end (bottom of 90 fig 3b) configured to extend at least partially through the opening during a delivery state (needle passes thru 60 when the bottom of 54 is pressed against the skin); and a removable cap (14) defining a cap camming feature (16) and configured to be removably coupled with the housing such that the removable cap (14) has a storage position where the removable cap is coupled with the housing and at least partially covering the opening (shown in fig 3a) and a removed position where the removable cap is not coupled with the housing (shown in fig 2); wherein the cap (14) camming feature (16) and the housing camming feature are configured to translate rotational motion into axial motion such that, upon rotational movement of the removable cap (14), the cap camming feature (16) and/or the housing camming feature urge the removable cap along the longitudinal axis (para 0028 discloses “A distal end surface 16 of the protective cap 14 and the proximally directed surface 18 between the reduced area 12 and the rest of the housing 10 are provided with cam-shapes so as to facilitate removal of the protective cap 14 when turning it in relation to the housing 10 such that the cam-shaped surfaces 16, 18 provide a motion in the proximal direction of the protective cap 14”); and wherein the housing camming feature (18) and the cap camming feature (16) are each defined by or positioned on an outer surface of the drug delivery device to signal the camming function of the housing camming feature and/or the cap camming feature (fig 2 shows that the camming features are on the outside of the surface of 10 and 14), however
Andre does not teach a window configured to permit a user of the drug delivery device to view inside the housing, and
the housing camming feature comprises at least one protrusion extending away from the outer surface of the housing,
the at least one protrusion has a non-annular profile in a view taken perpendicular to the longitudinal axis with the window visible.
Durvasula, a similar medicine delivery system, teaches the housing camming feature comprises at least one protrusion (top 102D, fig 18A-C, https://www.merriam-webster.com/dictionary/cam defines a cam as “ a rotating or sliding piece (such as an eccentric wheel or a cylinder with an irregular shape) in a mechanical linkage used especially in transforming rotary motion into linear motion or vice versa” 102D interacts with the protrusion 202D and causes the linear motion in response to a rotary motion of the cap para 0007 discloses “to allow travel between the cap and the housing in response to rotation”, meeting the claim language) extending away from the outer surface of the housing (100) and
the at least one protrusion (102d) has a non-annular profile in a view taken perpendicular to the longitudinal axis with the window visible (fig 18 shows that the protrusion 102D has a non-annular profile from no direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the camming feature of Andre extend from the surface of the housing as taught in Durvasula to give more surface area for the camming feature on the cam to rotate against, increasing the reliability of the camming feature. To be clear the modification is done by extending out the cam feature from the housing for a short distance, like the feature 102d.
Durvasula does not teach a window configured to permit a user of the drug delivery device to view inside the housing.
Bostrom, a similar medicine delivery system, teaches a window (6 fig 2) configured to permit a user of the drug delivery device to view inside the housing (para 0066 discloses “a window allows the user to view the state of the injection, i.e. whether the injection device 1 is still in its initial position with the medicament not yet being injected, or whether the medicament container is already emptied. Through”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the window shown in Bostrum to the device of Andre in view of Durvasula to “allow[[s]] the user to view the state of the injection, i.e. whether the injection device 1 is still in its initial position with the medicament not yet being injected, or whether the medicament container is already emptied” para 0066.
In reference to dependent claim 2, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 1, Andre further discloses a device wherein the cap camming feature (16) defines a wave shape (fig 2 shows that 16 is generally in the shape of a wave).
In reference to dependent claim 3, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 2, Andre further discloses a device wherein the wave shape is a generally sinusoidal shape (fig 2 shows that 16 is generally in the shape of a sinusoidal wave).
In reference to dependent claim 4, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 3, Andre further discloses a device wherein the removable cap (14) includes a generally cylindrical body portion defining an annular leading rim (in the area of 16) and an end wall (16) generally perpendicular to the body portion and wherein the annular leading rim defines the wave shape (fig 2 shows that 16 is generally in the shape of a wave).
In reference to dependent claim 5, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 2, Andre further discloses a device wherein the outer surface is a generally cylindrical outer surface (10 is generally cylindrical).
In reference to dependent claim 6, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 5, Andre further discloses the at least one protrusion (see annotated fig 2 above, Andre is silent to a protrusion, after modification a protrusion extends from the housing in the disclosed position) is aligned with the wave shape of the cap camming feature when the removable cap (14) is in the storage position (the cap and the aligned ).
In reference to dependent claim 7, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 6, Andre further discloses the at least one protrusion (see annotated fig 2 above) abuts the wave shape of the cap camming feature when the removable cap is in the storage position (fig 2 shows that the bottom of the protrusion and the matching cap both have the general shape of a wave).
In reference to dependent claim 8, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 7, Andre further discloses the at least one protrusion (see annotated fig 2 above) defines a wave surface corresponding to the wave shape of the cap camming feature (fig 2 shows that the bottom of the protrusion and the matching cap both have the general shape of a wave).
In reference to dependent claim 9, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 6, Andre further discloses the housing includes two protrusions each extending away from the generally cylindrical outer surface (fig 2 shows a protrusion on either side that matches the cap, after modification by Durvasula both sides have protrusions, furthermore fig 18 show 102D on one side an the tail end of another 102D on the far side of the injector).
In reference to dependent claim 10, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 1, Andre further discloses a device wherein the housing defines a securing feature (22) configured to engage the removable cap (14) and retain the removable cap in the storage position (para 0028 discloses “the protective cap 14 is arranged with inwardly directed protrusions 20 that are designed to interact with recesses 22” 22 are on the outer surface of 10).
In reference to dependent claim 11, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 10, Andre further discloses a device wherein the securing feature (22) is configured to retain the removable cap (14) in the storage position regardless of whether the drug storage container is coupled with the housing (para 0028 discloses “the protective cap 14 is arranged with inwardly directed protrusions 20 that are designed to interact with recesses 22” 22 are on the outer surface of 10).
In reference to dependent claim 12, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 1, Andre further discloses a device wherein the housing camming feature (18) and the cap camming feature (16) are each defined by or positioned on an outer surface of the drug delivery device (the features are both positioned on the outer surface of the housing and cap).
In reference to dependent claim 18, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 17, Andre further discloses a device wherein the cap camming feature (16) defines a wave shape (fig 2 shows that 16 is generally in the shape of a sinusoidal wave); and wherein the removable cap includes a generally cylindrical body portion defining an annular leading rim (in the area of 16) and an end wall (16) generally perpendicular to the body portion and wherein the annular leading rim defines the wave shape (fig 2 shows that 16 is generally in the shape of a wave).
In reference to dependent claim 19, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 18, Andre further discloses a device wherein the outer surface is a generally cylindrical outer surface (10 is generally cylindrical).
In reference to dependent claim 20, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 19, Durvasula further discloses the at least one protrusion (see annotated fig 2 above) is aligned with the wave shape of the cap camming feature when the removable cap is in the storage position (fig 2 shows that the bottom of the protrusion and the matching cap both have the general shape of a wave).
Claims 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Andre (USPAP 2020/0289753) in view of Durvasula (USPAP 2016/0220764) further in view of Bostrom (USPAP2014/0257193) further in view of Hannaman (USPAP 2019/0030329).
In reference to dependent claim 13, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 1, however
Andre, Durvasula, and Bostrum do not teach at least one of the housing camming feature and/or the cap camming feature includes an aspect to improve the visibility thereof, wherein optionally, the aspect to improve the visibility includes a bright color.
Hannaman, a similar injector device (100), teaches the cap camming feature includes an aspect to improve the visibility thereof, wherein optionally, the aspect to improve the visibility includes a bright color (para 0159 discloses “While protection of the distal end of the cartridge assembly 100 serves the purpose of protecting the needle and electrodes from the environment, a commonly-encountered problem is that users often forget to remove such caps. One solution is to make the cap a bright color that is different from the color(s) of the other components in cartridge 100, so as to notify the user of its presence and thus remind the user to remove it.” By making the entire cap a bright color the cap camming feature’s visibility is improved).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cap of Andre in view of Durvasula and Bostrum a bright color as taught in Hannaman “to notify the user of its presence and thus remind the user to remove it” para 0159; Hannaman.
In reference to dependent claim 21, Andre in view of Durvasula and Bostrum disclose the drug delivery device of claim 17, however
Andre, Durvasula, and Bostrum do not teach wherein at least one of the housing camming feature and/or the cap camming feature includes an aspect to improve the visibility thereof.
Hannaman, a similar injector device (100), teaches the cap camming feature includes an aspect to improve the visibility thereof (para 0159 discloses “While protection of the distal end of the cartridge assembly 100 serves the purpose of protecting the needle and electrodes from the environment, a commonly-encountered problem is that users often forget to remove such caps. One solution is to make the cap a bright color that is different from the color(s) of the other components in cartridge 100, so as to notify the user of its presence and thus remind the user to remove it.” By making the entire cap a bright color the cap camming feature’s visibility is improved).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the cap of Andre in view of Durvasula and Bostrum a bright color as taught in Hannaman “to notify the user of its presence and thus remind the user to remove it” para 0159; Hannaman.
Claims 15 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Andre (USPAP 2020/0289753) in view of Durvasula (USPAP 2016/0220764) further in view of Bostrom (USPAP2014/0257193) further in view of Swanson (USPAP 2016/0015897).
In reference to dependent claim 15, Andre in view of Durvasula and Bostrum discloses the drug delivery device of claim 1, however
Andre, Durvasula, and Bostrum do not disclose wherein the cap includes at least one rotation-assistance feature.
Swanson, a similar injecting device, teaches a cap (136, fig 1) includes at least one rotation-assistance feature (136b; para 0061 discloses “safety cap 136 includes a set of ribs 136B configured to increase friction between a user's fingers and outer peripheral surface of safety cap 130 to facilitate removal of safety cap 136 by the user”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use assistance feature taught in Swanson in the device of Andre in view of Durvasula and Bostrum “to increase friction between a user's fingers and outer peripheral surface of safety cap 130 to facilitate removal of safety cap 136 by the user” para 0061; Swanson.
In reference to dependent claim 22, Andre in view of Durvasula and Bostrum discloses the drug delivery device of claim 17, however
Andre, Durvasula and Bostrum do not disclose wherein the cap includes at least one rotation-assistance feature.
Swanson, a similar injecting device, teaches a cap (136, fig 1) includes at least one rotation-assistance feature(136b; para 0061 discloses “safety cap 136 includes a set of ribs 136B configured to increase friction between a user's fingers and outer peripheral surface of safety cap 130 to facilitate removal of safety cap 136 by the user”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use assistance feature taught in Swanson in the device of Andre in view of Durvasula and Bostrum “to increase friction between a user's fingers and outer peripheral surface of safety cap 130 to facilitate removal of safety cap 136 by the user” para 0061; Swanson.
Response to Arguments
Applicant's arguments filed on 02/04/2026 have been considered but, unless otherwise addressed below, are moot in view of the new ground(s) of rejection.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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 at (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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/CHARLES W NICHOLS/Examiner, Art Unit 3783