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 .
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
Claim 2 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 2 recites a different preamble stating “The electrode device of claim 1” and further recites structures of “a first protruding part and contact surface of the electrode device”. None of these components are found in claim 1 and further they are not supported or described in the Specification in any way. Additionally dependent claim 2 which depends on claim 1 cannot recite a different preamble from claim 1. Claim 1 is directed to a subassembly for a drug delivery device claim 2 is an electrode device. Thus there is no support in either the claims or specification to support the limitations of claim 2. It appears claim 2 may have been added in error. If claim 2 remains in the claim set moving forward, this would bring up further 112(a) enablement, 112(b) issues as well as Specification Objections and Drawing Objections. It is suggested that claim 2 be deleted as no other claims depend on claim 2. For purposes of examination claim 2 will not be examined under prior art because there is not enough support to understand how this claim could be used in combination with the limitations of claim 1.
Claim Rejections - 35 USC § 112(b)
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.
Claim 4, 5, 8, 13 and all dependents thereof 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.
Claim 4 recites the limitation "the tab" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 and 13 recites the limitation "the extension member" in line 2. There is insufficient antecedent basis for this limitation in the claim. It appears that claim 13 should depend on claim 10 where the extension member is introduced.
Claim 8 recites the limitation "the tab" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 3-5, 7-13, 15-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexandersson (EP 3,320,932 A1).
With regard to claim 1, Alexandersson discloses a subassembly (Fig. 2, elements 1-7, 9) for a drug delivery device comprising: a housing (2); a displaceable needle cover (3, see it assembled with housing in Fig. 15) comprising a distal end comprising a flange (Fig. 4, element 33), the needle cover (3) received within the housing (portion 37 is within housing 2, as shown in in Fig. 4 and 15) and configured to have a pre-use position in which the needle cover (as shown in Fig. 15) extends from the housing and a use position in which the needle cover ([0023]) is at least partially displaced into the housing, wherein displacement of the needle cover into the housing actuates the drug delivery device through interaction with a drive mechanism ([0023]); and a cap assembly (5, 7, 9, 4) comprising: a cap remover (7) configured to be grasped by a user; a retainer (9) received within the cap remover (fig. 12b) and configured to engage the flange (Fig. 12b, flange 33 engaged with retainer 9 via 912 and 916) of the needle cover (3) of the drug delivery device; and a push back element (5) operatively received within the retainer (best seen in Fig. 10, showing push back element 5 located within retainer 9, can be seen at connection point 514 and 98),wherein the push back element (5) is configured to push the retainer in a proximal direction (see between Fig. 10, where pushback element 5 and retainer are at its most distal position, and Fig. 13, showing the pushback element which has moved proximally by length W and in turn via its connection with the retainer moves the retainer proximally. [0036]. Further this limitation is functional due to the use of the “configured to” language, therefore the pushback member must only be capable of moving the retainer element proximally which is described in [0036]).
With regard to claim 3, Alexandersson discloses wherein the push back element (5) is removably held in the retainer (5, can be seen as a separate component in Fig. 2 and is thus considered removable relative to the retainer if desired).
With regard to claim 4 and 8, Alexandersson discloses wherein the push back element (5) comprises a tab (bottom disk portion of 5 is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 5 is show in Fig. 8a).
With regard to claim 5, Alexandersson discloses wherein the push back element (5) comprises the extension member (511/512/514) configured to be received in the retainer (9, see Fig. 8a and Fig. 9/10), wherein at least a portion of the retainer (9) defines an opening with a cross-sectional shape that corresponds to a cross-sectional shape of the extension member (see Fig. 10 showing the extension member fitting into corresponding members of the retaining such as 98, the extension members fit into the opening formed in the distal end of retainer 9 into corresponding latch opening such as 98).
With regard to claim 7, Alexandersson discloses wherein a proximal surface (52) of the push back element is configured to push the retainer in the proximal direction.
With regard to claim 9, Alexandersson discloses a drug delivery device (fig. 2) comprising: a housing (2); a syringe (8) comprising a needle (81) and received at least partially within the housing; a needle cover (3, see it assembled with housing in Fig. 15) comprising a distal end comprising a flange (Fig. 4, element 33), the needle cover (3) received within the housing (portion 37 is within housing 2, as shown in in Fig. 4 and 15) and configured to have a pre-use position in which the needle cover (as shown in Fig. 15) extends from the housing and a use position in which the needle cover ([0023]) is at least partially displaced into the housing, wherein displacement of the needle cover into the housing actuates the drug delivery device through interaction with a drive mechanism ([0023]); and a cap assembly (5, 7, 9, 4) comprising: a cap remover (7) configured to be grasped by a user; a retainer (9) received within the cap remover (fig. 12b) and configured to engage the flange (Fig. 12b, flange 33 engaged with retainer 9 via 912 and 916) of the needle cover (3) of the drug delivery device; and a push back element (5) operatively received within the retainer (best seen in Fig. 10, showing push back element 5 located within retainer 9, can be seen at connection point 514 and 98),wherein the push back element (5) is configured to push the retainer in a proximal direction (see between Fig. 10, where pushback element 5 and retainer are at its most distal position, and Fig. 13, showing the pushback element which has moved proximally by length W and in turn via its connection with the retainer moves the retainer proximally. [0036]. Further this limitation is functional due to the use of the “configured to” language, therefore the pushback member must only be capable of moving the retainer element proximally which is described in [0036]).
With regard to claim 10, Alexandersson discloses wherein the push back element (5) comprises a tab (bottom disk portion of 5 is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 5 is show in Fig. 8a) and an extension member (511/513/514) that extends from the tab.
With regard to claim 11, Alexandersson discloses wherein the push back element (5) is removably held in the retainer (5, can be seen as a separate component in Fig. 2 and is thus considered removable relative to the retainer if desired).
With regard to claim 12, Alexandersson discloses wherein the push back element (5) comprises a tab (bottom disk portion of 5 is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 5 is show in Fig. 8a).
With regard to claim 13, Alexandersson discloses wherein the push back element (5) comprises the extension member (511/512/514) configured to be received in the retainer (9, see Fig. 8a and Fig. 9/10), wherein at least a portion of the retainer (9) defines an opening with a cross-sectional shape that corresponds to a cross-sectional shape of the extension member (see Fig. 10 showing the extension member fitting into corresponding members of the retaining such as 98, the extension members fit into the opening formed in the distal end of retainer 9 into corresponding latch opening such as 98).
With regard to claim 15, Alexandersson discloses a cap assembly (Fig. 2, elements 5, 7, 9, 4) for a drug delivery device, the cap assembly (5, 7, 9, 4) comprising: a cap remover (7) configured to be grasped by a user; a retainer (9) received within the cap remover (fig. 12b) and configured to engage the flange (Fig. 12b, flange 33 engaged with retainer 9 via 912 and 916) of the needle cover (3) of the drug delivery device; and a push back element (5) operatively received within the retainer (best seen in Fig. 10, showing push back element 5 located within retainer 9, can be seen at connection point 514 and 98),wherein the push back element (5) is configured to push the retainer in a proximal direction (see between Fig. 10, where pushback element 5 and retainer are at its most distal position, and Fig. 13, showing the pushback element which has moved proximally by length W and in turn via its connection with the retainer moves the retainer proximally. [0036]. Further this limitation is functional due to the use of the “configured to” language, therefore the pushback member must only be capable of moving the retainer element proximally which is described in [0036]).
With regard to claim 16, Alexandersson discloses wherein the push back element (5) comprises a tab (bottom disk portion of 5 is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 5 is show in Fig. 8a) and an extension member (511/513/514) that extends from the tab.
With regard to claim 17, Alexandersson discloses wherein the push back element (5) is removably held in the retainer (5, can be seen as a separate component in Fig. 2 and is thus considered removable relative to the retainer if desired).
With regard to claim 18, Alexandersson discloses wherein the push back element (5) comprises a tab (bottom disk portion of 5 is considered the tab portion because it covers over the opening of the needle cap remover 7, this is generally where label 5 is show in Fig. 8a).
With regard to claim 19, Alexandersson discloses wherein the push back element (5) comprises the extension member (511/512/514) configured to be received in the retainer (9, see Fig. 8a and Fig. 9/10), wherein at least a portion of the retainer (9) defines an opening with a cross-sectional shape that corresponds to a cross-sectional shape of the extension member (see Fig. 10 showing the extension member fitting into corresponding members of the retaining such as 98, the extension members fit into the opening formed in the distal end of retainer 9 into corresponding latch opening such as 98).
Claim(s) 6, 14, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alexandersson (EP 3,320,932 A1) in view of Cucarouge (WO 2020/173997 A1).
With regard to claim 6, 14, 20, Alexandersson discloses the claimed invention except for the material of the push back element.
Ducarouge teaches a similar overall cap assembly (fig. 3, element 100) that includes a needle remover (150), a retainer (110 within the needle remover) and a pushback member (120). All the elements can be made with medical-grade plastic ([0040]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the material of the push back member of Alexandersson with the medical-grade plastic as taught by Ducarouge because the substitution of one well-known material with another is well-known in the art and does not alter the overall function of the device ([0040]), and further provides a rigid material for a user to firmly grip the cap remover ([0040]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783