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 .
Information Disclosure Statement
The information disclosure statement filed 04/17/24 (30 pages) fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. No copy has been provided for Foreign Patent Document Cite No 10 (WO 2017/132557). It has been placed in the application file, but the information referred to therein has not been considered.
Claim Objections
Claim 3 is objected to because there is a lack of antecedent basis for “the plurality of injection pens” in line 3. Appropriate correction is required.
Claim 5 is objected to because there is a typo regarding “wherein the wherein the clicker portion…” in line 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-11 and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the limitation “the clicker mechanism is configured to removably couple any of the plurality of injection pens by mechanically adapting the clamping mechanism and the clicker mechanism to a given injection pen having a given geometry” in lines 3-5 renders the claim indefinite. As currently presented, it appears that the clicker mechanism is configured to couple any of the plurality of injection pens to a given injection pen. It is unclear how the clicker mechanism can couple one injection pen to another injection pen. According to the disclosure as originally filed, the clicker mechanism is configured to removably couple the pen cap to a given injection pen having a given geometry (see at least [0247-0248]). For examination purposes, this limitation has been interpreted as “the clicker mechanism is configured to removably couple the pen cap by mechanically adapting the clamping mechanism and the clicker mechanism to a given injection pen having a given geometry”.
Claim 4 recites the limitation "the clamp link" in line 6. There is insufficient antecedent basis for this limitation in the claim, and therefore the limitation “a clamping link attaching the clamp link to the spring well” is unclear. It is unclear what structure a clamping link attaches to the spring well. According to the disclosure as originally filed, the clamping link is coupled to the pen clamp and the spring well (see at least [0249-0251] and Figures 39). For examination purposes, the limitation “the clamp link” is being considered a typo that should be interpreted as “a clamping link attaching the pen clamp to the spring well”.
Claims 5-11 and 13-15 are rejected for being dependent upon claims 3 and 4.
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 1-4, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dumet et al. (FR 3025433, with citations from provided English translation).
Regarding claim 1, Dumet discloses a pen cap (withdrawal device 10) for use with injection pens (injection syringe 1), the pen cap comprising: one or more adaptable elements (first part 12 and second part 14) configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens (“the withdrawal device can accommodate different types of caps as well as different types of receiving devices.” [Page 2, 1st paragraph]; noted that the “plurality of different injection pens” are not positively claimed or recited).
Regarding claim 2, Dumet discloses the pen cap of claim 1, wherein the plurality of different injection pens comprises at least two different injection pens with different geometries (“the withdrawal device can accommodate different types of caps as well as different types of receiving devices.” [Page 2, 1st paragraph], noted that the “plurality of different injection pens” are not positively claimed or recited).
Regarding claim 3, Dumet discloses the pen cap of claim 1, wherein the one or more adaptable elements includes a clamping mechanism (first part 12 and clamping jaws 32, 34) and a clicker mechanism (pair of levers 36, 38), wherein the clicker mechanism is configured to removably couple any of the plurality of injection pens by mechanically adapting the clamping mechanism and the clicker mechanism to a given injection pen having a given geometry (Figures 5-8).
Regarding claim 4, Dumet discloses the pen cap of claim 3, wherein the clamping mechanism includes a clamp spring (spring 66), a spring well (between lateral sides 20, 22) accommodating the clamp spring oriented along a longitudinal axis of the pen cap (Figures 1 and 5-8), a pen datum (rods 56, 58) configured to move along the longitudinal axis of the pen cap within a portion of the spring well and the clamp spring (Figures 5-8), a pen clamp (clamping jaws 32, 34) movably attached to the spring well via a hinge connection so as to swing radially inward toward the longitudinal axis of the pen cap (Figures 5-8; “The user then exerts a force directed substantially along the arrow 72 in order to bring the levers 36, 38 closer together…the third and fourth rods 60, 62 respectively traverse the guide slots 28, 30. In the cutting plane, the guide lights 28, 30 each has a guiding contour 74 converging towards the guide grooves 26 and in the direction of removal of the protective cap C…The displacement of the third and fourth rods 60, 62 along the guide slots 28, 30 imposes a bringing together of the clamping jaws 32, 34 with respect to each other and a movement in the direction of the withdrawal F of the protective cap C of the first and second rods 56, 58, which has the effect of bringing the clamping surfaces 70 around the protective cap C.” [Page 4, 6th paragraph]), and a clamping link (third and fourth rods 60, 62) attaching the clamp link (pen clamp, see rejection under 35 USC 112 above) to the spring well (Figure 5, via guiding slots 28, 30), wherein the pen clamp is configured to compress the clamp spring, via the clamping link and the spring well, as the injection pen is inserted into the pen cap (Figures 5-8; “The user then exerts a force directed substantially along the arrow 72 in order to bring the levers 36, 38 closer together. The first and / or second rods 56, 58 being guided in the guide grooves 26, the third and fourth rods 60, 62 respectively traverse the guide slots 28, 30…It will be noted that the displacement of the first and second rods 56, 58 has the effect of putting the spring 66 in compression.” [Page 4, 6th paragraph].
Regarding claim 9, Dumet discloses the pen cap of claim 4, wherein the pen clamp includes a ball protrusion (rods 60, 62) that is configured to movably attach to the spring well via a ball and socket method (“the third and fourth rods 60, 62 respectively traverse the guide slots 28, 30.” [Page 4, 6th paragraph]; Figure 2).
Regarding claim 11, Dumet discloses the pen cap of claim 4, wherein the pen clamp includes two frictional shoes (clamping jaws 32, 34 having clamping surface 70) configured to apply a radial force to the given injection pen being inserted into the pen cap (Figures 5-8; “The displacement of the third and fourth rods 60, 62 along the guide slots 28, 30 imposes a bringing together of the clamping jaws 32, 34 with respect to each other and a movement in the direction of the withdrawal F of the protective cap C of the first and second rods 56, 58, which has the effect of bringing the clamping surfaces 70 around the protective cap C.” [Page 4, 6th paragraph]).
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fincham et al. (US 20160250421).
Regarding claim 1, Fincham discloses a pen cap (cap 20, Figure 4) for use with injection pens (“The lower portion 22 may carry the required snap fit connection means or other means for connecting the cap to the housing of an injector device.” [0052]), the pen cap comprising: one or more adaptable elements (upper portion 21 and lower portion 22) configured to removably couple the pen cap to a plurality of different geometries of a plurality of different injection pens (“a single cap may be extendible in order to accommodate a needle if it is not desired to remove a needle for any reason. This allows the convenience of being able to choose a short cap length when it is not necessary to accommodate a needle within the cap and a long cap length when it is desired to accommodate a needle. This solution has the further advantage of a single cap preventing the possibility of mislaying a cap that is not in use.” [0050]; noted that the “plurality of different injection pens” are not positively claimed or recited).
Regarding claim 2, Fincham discloses the pen cap of claim 1, wherein the plurality of different injection pens comprises at least two different injection pens with different geometries (“a single cap may be extendible in order to accommodate a needle if it is not desired to remove a needle for any reason. This allows the convenience of being able to choose a short cap length when it is not necessary to accommodate a needle within the cap and a long cap length when it is desired to accommodate a needle. This solution has the further advantage of a single cap preventing the possibility of mislaying a cap that is not in use.” [0050]; noted that the “plurality of different injection pens” are not positively claimed or recited).
Regarding claim 3, Fincham discloses the pen cap of claim 1, wherein the one or more adaptable elements includes a clamping mechanism (upper portion 21) and a clicker mechanism (lower portion 22), wherein the clicker mechanism is configured to removably couple any of the plurality of injection pens by mechanically adapting the clamping mechanism and the clicker mechanism to a given injection pen having a given geometry (“The cap 20 includes two portions, upper portion 21 and lower portion 22 connected by a screw thread 23 on a connecting portion 24 of the upper portion 21. The screw thread 23 may be a shallow screw thread as shown co-operating with corresponding grooves (not shown) on the internal surface of lower portion 22.” [0052]).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Dumet et al. (FR 3025433, with citations from provided English translation) in view of McLusky et al. (US 20210213209).
Regarding claim 10, Dumet discloses the pen cap of claim 4.
Dumet fails to explicitly disclose the pen clamp includes a rigid body and an elastic member attached to a bottom surface of the rigid body, wherein the rigid body includes undercuts for the elastic member to fit within to increase a contact surface area between the rigid body and the elastic member.
McLusky teaches a pen cap (housing cap 500) for use with injection pens (Figure 6A), the pen cap comprising a pen clamp (sidewalls 512, 514) includes a rigid body (outer walls of housing cap 500) and an elastic member (engagement portion 520) attached to a bottom surface of the rigid body (Figure 6A), wherein the rigid body includes undercuts (Figure 6A) for the elastic member to fit within to increase a contact surface area between the rigid body and the elastic member (Figure 6A; “the engagement portion may be formed separately from but assembled with the housing cap… the engagement portion may be made from a different material than the housing cap. Where the material of the engagement portion is different than that of the housing cap, it will be understood that a resilient material such as rubber or an elastomer may be chosen such that the friction of engagement is increased” [0067]).
Before the effective filing date of the claimed invention, it would have been obvious to ne having ordinary skill in the art to modify the pen clamp of Dumet to include a rigid body and an elastic member attached to a bottom surface of the rigid body, wherein the rigid body includes undercuts for the elastic member to fit within to increase a contact surface area between the rigid body and the elastic member based on the teachings of McLusky to increase the frictional engagement between the pen clamp and the given injection pen (McLusky [0067]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fincham et al. (US 20160250421) in view of Nielsen et al. (USPN 9734302).
Regarding claim 12, Fincham discloses the pen cap of claim 1, further comprising an ingress wall (distal wall of upper portion 21).
Fincham fails to explicitly disclose the ingress wall protecting electronic components of the pen cap from foreign substances.
Nielsen teaches a pen cap (pen cap 200) for use with injection pens (pen body 110; “a pen cap 200 adapted to be used with a pen body having a general design as the pen body 110” [Col 15, lines 8-9]), the pen cap comprising an ingress wall (inner partition wall 211 and skirt portion 221) protecting electronic components (electronic means 230 within distal cavity 216) of the pen cap from foreign substances (“The skirt portion and/or the cylindrical portion are adapted to provide a seal between the two cavities, this preventing e.g. fluid from entering the distal cavity.” [Col 15, lines 25-28]).
Before the effective filing date of the claimed invention, it would have been obvious to ne having ordinary skill in the art to modify the pen cap of Fincham to include electronic components based on the teachings of Nielsen to provide an electronic system for tracking the use of the injection pen (Nielson [Col 3, lines 18-32]) and to modify the ingress wall of Fincham to protect the electronic components based on the teachings of Nielsen to prevent fluid from damaging the electronic components (Nielson [Col 15, lines 25-28]).
Allowable Subject Matter
Claims 5-8 and 13-15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to anticipate or render obvious a clicker mechanism as recited in dependent claim 5, including a bias member oriented along a longitudinal axis of the pen cap and the clicker potion forms a guide path that wraps around the clicker portion, in combination with the other limitations of the claims from which claim 5 depends.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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