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 .
Preliminary Acknowledgement
Applicant has defined a distal end as the direction pointing away from the dose delivery site during use of the medicament delivery device and a proximal end as the direction pointing towards the dose delivery site during use of the medicament delivery device (see page 4, line 23 - page 5, line 3 of Applicant disclosure). Therefore, the proximal and distal end interpretations of the prior art will be applied in accordance with Applicant definition.
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 is: “pre-stressed resilient member” in claims 17 and 25.
The corresponding structure disclosed in the specification for performing the claimed function of moving the carrier from the proximal position to the distal position (upon offset of the stop surfaces) is a compression spring. See page 7, lines 8-9 of the specification (“preferably, according to another embodiment, the pre-stressed resilient member is a compression spring”) and the associated description and drawings showing the spring arranged between the stop surfaces.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 § 103
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 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 16, 18-19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Elmen (WO Publication No.2014/056874), hereinafter, Elmen, in view of Durvasula (WO Publication No. 2016/190980), hereinafter, Durvasula.
Regarding claim 16, Elmen discloses A sub-assembly of a medicament delivery device (injection delivery device comprising a housing formed by a distal housing part 10 and a proximal housing part 12, and wherein the distal housing part comprises a first distal housing part 10a and a second distal housing part 10b in figs. 1-4), the sub-assembly comprising:
a tubular housing (distal housing part 10 which includes distal housing part 10a and a second distal housing part 10b in figs. 1-4; proximal and distal housing parts are generally tubular and arranged such that one housing part may move inside the other housing part; page 7, lines 8-22);
a carrier (proximal housing part 12 which accommodates a multi-compartment medicament container 34 in figs. 1-4; page 7, lines 8-22);
a carrier retracting assembly (mixing force member 30 operably arranged between housing parts, such that manual activation of auto mixing mechanism allows mixing force member 30 to cause the two housing parts to move from the first position to the second position in figs. 3 and 10; page 7, lines 24-29),
wherein the tubular housing extends along a longitudinal axis between a distal end and a proximal end (distal housing part 10 which includes distal housing part 10a and a second distal housing part 10b extend along central longitudinal axis L in fig. 1; page 3, lines 31-35),
wherein the carrier is configured to receive a medicament container (proximal housing part 12 which accommodates a multi-compartment medicament container 34 in figs. 1-4; page 7, lines 8-22) of the medicament delivery device, and
wherein the carrier retracting assembly is configured to move the carrier relative to the tubular housing in the direction of the longitudinal axis from a proximal position where the carrier is at least partially arranged within the tubular housing to a distal position where the carrier is further into the tubular housing (mixing force member 30 operably arranged between housing parts, such that manual activation of auto mixing mechanism allows mixing force member 30 to cause the two housing parts to move from the first position to the second position in fig. 3; page 7, lines 24-29).
Elmen does not, however, disclose a cap or that the cap is removably attached to the tubular housing and at least partially enclosing the carrier.
Durvasula teaches a cap (Durvasula: cap 200 in figs. 1A-1C and 3-6; para [0040-0049]); and that the cap is removably attached to the tubular housing and at least partially enclosing the carrier (Durvasula: cap 200 is removably attached to housing 100 that partially encloses injection assembly 300 in figs. 1A-1C and 3-6; para [40-41]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medicament delivery device of Elmen to include a removable actuating cap that is rotatably and removably attached to the tubular housing and at least partially encloses the carrier, as taught by Durvasula, in order to provide a single, intuitive user action that both protects the device prior to use and initiates the mixing sequence upon removal of the cap.
Regarding claim 18, modified Elmen discloses the sub-assembly according to claim 16, wherein the tubular housing (distal housing part 10 which includes distal housing part 10a and a second distal housing part 10b in figs. 1-4) comprises a fastener (Durvasula: lip 102 in figs. 5C-5D), wherein the cap (Durvasula: cap 200 in figs. 1A-1C and 3-6; para [40-49]) comprises a counter fastener (Durvasula: protrusions 202 in figs. 1C and 4) releasably attached to the fastener, and wherein the cap is movable relative to the tubular housing between an attached position where the fastener is fixed to the counter fastener and a detached position where the fastener is not fixed to the counter fastener (Durvasula: cap 200 can further include one or more protrusions 202, and wherein the housing 100 can further comprises a corresponding lip 102 about a distal or injection end, wherein the one or more protrusions 202 of the cap 200 can be configured to engage the corresponding lip 102 in a stowed and intermediate state, as shown in figs. 1A an 1B respectively, and wherein the protrusions 202 disengage from the corresponding lip 102 at a mixed state, as shown in fig. 1C; para [42]).
Regarding claim 19, modified Elmen discloses the sub-assembly according to claim 18, wherein the fastener and the counter fastener form a bayonet engagement or a screw engagement (Durvasula: cap 200 is removably attached to housing 100 via bayonet-style rotation that disengages protrusions 202 on housing 100 from lip 102 on cap 200 in figs. 1A-1C and 3-6; para [40-41]; in an alternative embodiment, cap 200 is provided with a plurality of threads 102D that correspond to a plurality of corresponding threads 102D in figs. 18A-18C; para [48]).
Regarding claim 23, modified Elmen discloses the sub-assembly according to claim 16, wherein the carrier is rotationally fixed to the tubular housing by a rotational engagement (proximal housing part 12 is fixed to distal housing part 10 by a rotational engagement in which protrusions 22 are seated in seat 20 of ledge 16 in figs. 3-4; page 8, lines 5-14).
Allowable Subject Matter
Claims 17, 20-22, 24-28 are 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 claims and any intervening claims.
Claims 29 and 30 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
As interpreted under 35 U.S.C. § 112(f), claim 17 requires a pre-stressed resilient member limited to a compression spring (and structural equivalents thereof) that is arranged between a distally directed stop surface on the carrier and a proximally directed stop surface, wherein the stop surfaces are adjacent when the cap is attached and are offset during removal of the cap, thereby allowing the spring to move the carrier further into the tubular housing.
The prior art of record, including Elmen and Durvasula, fails to teach or suggest this specific arrangement in which removal of the cap itself offsets the stop surfaces to release a pre-stressed compression spring that drives the carrier further into the housing for mixing.
Claims 20-22 and 24-26 depend from claim 17 and are allowable for at least the same reasons.
Claim 27 requires a rod that is fixed relative to the tubular housing in the direction of the longitudinal axis during the removal of the cap.
The prior art of record, including Elmen and Durvasula, does not teach or suggest a rod that becomes fixed relative to the housing as a result of (or during) the cap-removal step that also triggers the carrier retraction.
Claim 28 depends from claim 27 and is allowable for at least the same reasons.
Claim 29 is an independent method claim that requires the affirmative step of removing the cap, thereby triggering the carrier retracting assembly.
The prior art of record, including Elmen and Durvasula, does not teach or suggest the underlying structure and therefore does not teach the method of operational sequence that is triggered by cap removal.
Claim 30 depends from claim 29 and is allowable for at least the same reasons.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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