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 Objections
Claims 1, 17, and 24 are objected to because of the following grammatical informalities:
Claim 1, line 4, recites “from a distal end to a proximal end” should read, “from a distal end to a proximal end of the housing and primary package”.
Claim 1, lines 10-11, recites “to the proximal end of the medicament container” should read, “to a proximal end of the medicament container”.
Claim 1, lines 21 and 22, recites “the force”, should read, “a force”.
Claim 17, line 2, recites “at the distal end of the medicament container”, should read, “at a distal end of the medicament container”.
Claim 17, line 7, recites “towards the distal end relative to the medicament”, should read, “towards a distal end relative to the medicament”.
Claim 24, line 2, recites “the proximal end than at the distal end”, should read, “a proximal end than at a distal end”.
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.
Claim 19 is 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 19, it recites the limitation “the protrusion” in lines 1-2. This limitation renders the claim indefinite because It is unclear which protrusion is being disclosed, the primary package protrusion or the housing protrusion as disclosed in claim 18, which claim 19 depends upon. For examining purposes, the examiner will be interpreting “the protrusion”, as the protrusion of the primary package.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-20, 27, 29, and 30 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Schmidt et al. (DE 2056688 B1, herein, Schmidt). For ease of discussion, examiner will be referencing the foreign document translation of Schmidt that the examiner provided.
Regarding claim 16, Schmidt discloses a medicament delivery device assembly kit comprising a primary package (2 – Fig.1) and a housing (60 – Fig.2),
wherein the housing and the primary package each extend along an axis in an axial direction from a distal end to a proximal end (Fig.1),
wherein the housing defines a cavity, the cavity extending in the axial direction from the proximal end of the housing, the cavity being configured to receive the distal end of the primary package (See annotated Fig.2 below),
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the primary package comprising:
a medicament container (Shown at 2 – Fig.1) containing a medicament (“when mixing the ampoule contents with powdered medications” – Para [0010]), and
a medicament delivery member container (48, 51 – Fig.1) attached to the proximal end of the medicament container (Fig.1), the medicament delivery member container containing a medicament delivery member (42 – Fig.3, Fig.2),
wherein the medicament delivery member is spaced apart in the axial direction from the medicament (Fig.1),
wherein the medicament delivery member container is moveable in the axial direction relative to the medicament container (See Figs. 2-3, “the same time the ampoule head is pushed over the stop lugs” – Para [0028]),
wherein the medicament container comprises an attachment portion (56, 58 – Fig.1) and the housing comprises a corresponding attachment mechanism (57 – Fig.2) configured to attach to the attachment portion of the medicament container so as to hold the primary package in place in the cavity of the housing (Para [0022]), and
wherein the force required to attach the attachment portion of the medicament container to the attachment mechanism of the housing is larger than the force required for the medicament delivery member container to move towards the distal end relative to the medicament so that the medicament delivery member moves into contact with the medicament (“The syringe is then made ready for use by pressing the head into the syringe housing so far that the locking bars engage with the locking tabs, while at the same time the ampoule head is pushed over the stop lugs so that the inner needle end enters the ampoule” – Para [0028], Since the art discloses all of the claimed structural features associated with the attachment portion, attachment mechanism and the moveable medicament delivery member container, the disclosed device is inherently capable of satisfying the force limitation).
Regarding claim 17, Schmidt discloses the medicament delivery device set forth above, wherein the attachment portion of the medicament container is a protrusion at the distal end (56, 58 – Fig.1) of the medicament container and wherein the protrusion extends in the axial direction (Fig.1),
wherein the attachment mechanism of the housing is one or more flexible (“flexible stops” – Para [0001]) fingers (57 – Fig.3), and
wherein the force required for the protrusion of the primary package to flex the flexible fingers so that the protrusion extends between the flexible fingers is higher than the force required for the medicament delivery member container to move towards the distal end relative to the medicament so that the medicament delivery member moves into contact with the medicament (“The syringe is then made ready for use by pressing the head into the syringe housing so far that the locking bars engage with the locking tabs, while at the same time the ampoule head is pushed over the stop lugs so that the inner needle end enters the ampoule” – Para [0028], Since the art discloses all of the claimed structural features associated with the protrusion of the primary package, flexible fingers, and the moveable medicament delivery member container, the disclosed device is inherently capable of satisfying the force limitation).
Regarding claim 18, Schmidt discloses the medicament delivery device set forth above, wherein the attachment portion of the primary package is a protrusion at the distal end of the medicament container extending in the axial direction (56, 58 – Fig.1), and
wherein the attachment mechanism of the housing is a protrusion extending perpendicular to the axis (57 – Fig.2).
Regarding claim 19, Schmidt discloses the medicament delivery device set forth above, wherein the protrusion comprises a pointed end that points towards the axis (Fig.2).
Regarding claim 20, Schmidt discloses the medicament delivery device set forth above, wherein the attachment portion of the primary package and the attachment mechanism of the housing are the two halves of a snap-fit connection (“Snap-fit connections can be provided by sawtooth-like projections on the inside of the part of the syringe housing that encloses the ampoule and on the outside of the housing head” – Para [0007]), and the force required to connect the two halves of the snap- fit connection together is higher than the force required for the medicament delivery member container to move towards the distal end relative to the medicament so that the medicament delivery member moves into contact with the medicament (“The syringe is then made ready for use by pressing the head into the syringe housing so far that the locking bars engage with the locking tabs, while at the same time the ampoule head is pushed over the stop lugs so that the inner needle end enters the ampoule” – Para [0028], Since the art discloses all of the claimed structural features associated with the two halves of the snap-fit connection and the moveable medicament delivery member container, the disclosed device is inherently capable of satisfying the force limitation).
Regarding claim 27, Schmidt discloses the medicament delivery device set forth above, wherein the medicament delivery member container is a needle cover (48 – Fig.2, “needle cover” - Para [0032]) and the medicament delivery member is a needle (42 – Fig.3, “injection needle” – Para [0019]).
Regarding claim 29, Schmidt discloses the medicament delivery device set forth above, comprising the primary package (2 – Fig.1) and the housing (60 – Fig.2) of claim 16.
Regarding claim 30, Schmidt discloses the medicament delivery device set forth above, comprising the steps of:
providing a medicament delivery device assembly kit according to claim 16; and
whilst gripping the primary package by the medicament delivery member container and gripping the housing, pushing the primary package into the housing so that the primary package is attached to the housing (“the part of the syringe housing enclosing the ampoule is provided at the handle end with a stop for the inserted ampoule, so that it is completely secured against removal.” – Para [0010]) and so that the medicament delivery member container is pushed in the distal direction relative to the rest of the primary package, resulting in the medicament delivery member coming into contact with the medicament (“The syringe is then made ready for use by pressing the head into the syringe housing so far that the locking bars engage with the locking tabs, while at the same time the ampoule head is pushed over the stop lugs so that the inner needle end enters the ampoule” – Para [0028]).
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.
The factual inquiries 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.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Schmidt.
Regarding claim 28, discloses the medicament delivery device set forth above, but Schmidt does not expressly disclose wherein the primary package is a blow-fill-seal primary package.
However, the recitation that the primary package is a blow-fill-seal primary package, is considered to be a product by process limitation. In product-by- process claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference." MPEP 2113. MPEP 2113 clearly states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes." In this instance, the product taught by Schmidt is the same as or makes the product claimed obvious, meeting the limitation of the claims. This rejection under 35 U.S.C. 102/103 is proper because the "patentability of a product does not depend on its method of production." In re Thorpe, 227 USPQ 964,966 (Fed. Cir.1985).
Allowable Subject Matter
Claims 21-26 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 claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Basile (US Pub No. 20170007766 A1): discloses a medicament delivery device assembly kit comprising a flexible primary package, housing, a medicament container, a delivery member container and attachment portions/ mechanisms.
Genosar (US Pub No. 20110270220 A1): discloses a medicament delivery device assembly kit comprising a flexible primary package, housing, a medicament container, and a delivery member container.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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