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 25 and 26 are objected to because of the following informalities:
Claim 25: The phrase "compared to first resilient portion" contains a minor
grammatical error and lacks the definite article. It should be amended to "compared to
the first resilient portion" to ensure clarity.
Claim 26: The phrase "the resilient portion is multiple resilient portions" introduces a
grammatical inconsistency in number (singular subject with a plural predicate),
rendering the claim indefinite. It is suggested to amend this to "the resilient portion
comprises multiple resilient portions" or "the delivery member cover comprises
multiple resilient portions."
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 27 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.
Claim 27 recites "the first resilient portion and/or the second resilient portion" and "the multiple resilient portions." However, claim 27 depends directly on claim 24, which does not recite these elements. These elements are introduced in claims 25 and 26. Therefore, claim 27 lacks proper antecedent basis. Claim 27 should be amended to depend from claim 25 or 26, or the elements must be properly introduced.
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 16-20, 22-27, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2015/0119809A1) in view of Crawford et al. (US 2005/0096596; hereinafter “Crawford”).
Independent claim 16 recites a delivery member cover of a medicament delivery device, the medicament delivery device comprising a medicament container structure having a delivery member for expelling a medicament, the delivery member cover being configured to cover at least the delivery member, the delivery member cover comprising: a housing structure having a proximal end, a distal end, and a receiving recess arranged between the proximal end and the distal end, the receiving recess being configured to receive at least a portion of the medicament container structure; and a resilient portion arranged inside the receiving recess, the resilient portion being configured to flex radially outwards to radially support said portion of the medicament container structure upon insertion of the medicament container structure into the receiving recess.
In relation to independent claim 16, Loof discloses a medicament container retaining mechanism of a medicament delivery device (medicament delivery device 10, ¶ [0020]), the medicament delivery device comprising a medicament container structure (medicament container 22, ¶ [0021]) having a delivery member for expelling a medicament (injection needle 26, ¶ [0021]), the retaining mechanism comprising:
a housing structure (proximal housing part 12, ¶ [0020]) having a proximal end
(proximal end surface 30, ¶ [0022]), a distal end, and a receiving recess arranged
between the proximal end and the distal end (the interior of the proximal housing part
12, FIG. 2), the receiving recess being configured to receive at least a portion of the
medicament container structure ("The housing part is configured or designed to receive
a generally tubular medicament container therein," ¶ [0008]; "proximal housing part 12
is designed to accommodate a medicament container 22," ¶ [0021]); and
a resilient portion (flexible retaining member 34, ¶ [0024]) arranged inside the receiving
recess ("The tongues are designed to protrude radially inwards a distance d more than
the inner surface of the proximal housing part," ¶ [0025]), the resilient portion being
configured to flex radially outwards (flex laterally in a direction substantially
perpendicular to the longitudinal axis, ¶ [0027]) to radially support said portion of the
medicament container structure ("provide lateral clamping forces on the outer surface
medicament container 22," ¶ [0027]) upon insertion of the medicament container
structure into the receiving recess ("medicament container 22 entered into the proximal
housing part from a distal direction," ¶ [0023]).
Loof does not explicitly disclose that the housing structure is a "delivery member cover"
that is "configured to cover at least the delivery member." Crawford discloses a medicament delivery device comprising a delivery member cover (shield body 22) that receives a medicament container structure (syringe barrel 24) and is configured to cover at least the delivery member (needle cannula 26) ("the forward tip 126 of the needle cannula 26 is contained within the shield body 22," ¶ [0034]; "shield body 22 which surrounds a portion of the syringe 20," ¶ [0032]).
Based on the above teachings, it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the housing structure of Loof to function as a delivery member cover configured to cover at least the delivery member, as taught by Crawford. The motivation to combine would be to provide the dual benefits of securely retaining the medicament container and preventing rattling during handling (as taught by Loof at ¶ [0001]-[0003]) while automatically shielding the delivery member to protect the user from unintentional needle sticks (as taught by Crawford at ¶ [0005]).
In relation to claim 17, this claim recites the delivery member cover according to claim 16, wherein the resilient portion is radially movable within the receiving recess between a first position in which the resilient portion defines a first cross section area of the receiving recess, and a second position in which the resilient portion defines a second cross section area of the receiving recess, wherein the second cross section area is larger than the first cross section area.
Loof discloses the resilient portion is radially movable within the receiving recess between a first position defining a first cross section area ("The tongues are designed to protrude radially inwards a distance d more than the inner surface of the proximal housing part," ¶ [0025]), and a second position defining a larger second cross section area ("the retaining members 34 are able to flex laterally in a direction substantially perpendicular to the longitudinal axis 36... to provide lateral clamping forces," ¶ [0027]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 18, this claim recites the delivery member cover according to claim 17, wherein the first cross section area in the first position of the resilient portion is smaller than a cross-section area of said portion of the medicament container structure.
Loof discloses the first cross section area in the first position of the resilient portion is smaller than a cross-section area of said portion of the medicament container structure, as the tongues protrude radially inwards a distance d (¶ [0025]), which necessitates that they flex laterally outward to accommodate the outer surface of the medicament container and provide clamping forces (¶ [0027]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 19, this claim recites the delivery member cover according to claim 17, wherein the resilient portion is configured to be displaced from the first position to the second position upon insertion of the medicament container structure into the receiving recess.
Loof discloses the resilient portion is configured to be displaced from the first position to the second position upon insertion of the medicament container structure into the receiving recess ("the retaining members 34 are able to flex laterally... to provide lateral clamping forces on the outer surface medicament container 22 received therein," ¶ [0027]; "securement of a medicament container 22 entered into the proximal housing part from a distal direction," ¶ [0023]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 20, this claim recites the delivery member cover according to claim 16, wherein the resilient portion is configured to bear against said portion of the medicament container structure upon insertion of the medicament container structure into the receiving recess.
Loof discloses the resilient portion is configured to bear against said portion of the medicament container structure upon insertion ("provide lateral clamping forces on the outer surface medicament container 22 received therein," ¶ [0027]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 22, this claim recites the delivery member cover according to claim 16, wherein the resilient portion is arranged between the proximal end and the distal end of the housing structure.
Loof discloses the resilient portion is arranged between the proximal end and the distal end of the housing structure ("the medicament container retaining mechanism 32 is provided on at least a distal portion of the proximal housing part 12," ¶ [0024], which is between the proximal end surface 30 and the distal end). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 23, this claim recites the delivery member cover according to claim 16, wherein the resilient portion forms a part of the housing structure.
Loof discloses the resilient portion forms a part of the housing structure ("The retaining members 34 are in the embodiment shown formed integral with the material of the proximal housing part 12," ¶ [0025]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 24, this claim recites the delivery member cover according to claim 16, wherein the resilient portion extends from an outer surface of the housing structure into the receiving recess.
Loof discloses the resilient portion extends from an outer surface of the housing structure into the receiving recess ("each retaining member is formed by a generally U-shaped cutout 38... whereby a tongue is formed... The tongues are designed to protrude radially inwards a distance d more than the inner surface of the proximal housing part," ¶ [0025]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 25, this claim recites the delivery member cover according to claim 24, wherein the resilient portion is a first resilient portion and the delivery member cover further comprises a second resilient portion arranged on an opposite side of the housing structure compared to first resilient portion, wherein the housing structure is configured to receive said portion of the medicament container structure between the first and second resilient portions.
Loof discloses a first resilient portion and a second resilient portion arranged on an opposite side of the housing structure ("the proximal housing part 12 comprises at least one flexible retaining member 34, FIG. 3, preferably two positioned on opposite sides as seen along a longitudinal axis 36," ¶ [0024]), wherein the housing structure is configured to receive the medicament container between them. Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 26, this claim recites the delivery member cover according to claim 24, wherein the resilient portion is multiple resilient portions configured to receive said portion of the medicament container structure between the multiple resilient portions.
Loof discloses multiple resilient portions configured to receive said portion of the medicament container structure between them ("preferably two positioned on opposite sides," ¶ [0024]). Based on the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the apparatus.
In relation to claim 27, this claim recites the delivery member cover according to claim 24, wherein the first resilient portion and/or the second resilient portion is a tab and/or the multiple resilient portions are tabs.
Loof in view of Crawford discloses the first resilient portion and/or the second resilient portion is a tab ("each retaining member is formed by a generally U-shaped cut-out 38... whereby a tongue is formed," Loof ¶ [0025], where a "tongue" is structurally and functionally equivalent to a "tab").
Based on the above comments, it would have been obvious to a person of ordinary skill in the art at the time of the invention to form the resilient portions as tabs (tongues) as taught by Loof, because such a structure allows the resilient portion to be easily formed integrally with the housing via simple cut-outs, thereby simplifying manufacturing and reducing assembly costs (Loof at ¶ [0013]-[0014]).
In relation to claim 28, this claim recites a medicament delivery device comprising a medicament container structure having a delivery member for expelling a medicament, and the delivery member cover according to claim 16.
As discussed above, Loof in view of Crawford discloses a medicament delivery device comprising a medicament container structure having a delivery member, and the delivery member cover, as discussed above for claim 16.
In relation to claim 29, this claim recites the medicament delivery device according to claim 28, wherein the delivery member cover is configured to move axially relative to the delivery member from a delivery position in which the delivery member is uncovered for expelling the medicament, into a storage position in which the delivery member is covered by the delivery member cover.
Loof does not explicitly disclose the delivery member cover is configured to move axially relative to the delivery member from a delivery position to a storage position. Crawford discloses a delivery member cover (shield body 22) configured to move axially relative to the delivery member (needle cannula 26) from a delivery position in which the delivery member is uncovered for expelling the medicament (first position), into a storage position in which the delivery member is covered by the delivery member cover (second position) ("syringe barrel being selectively movable within said shield body between a first position in which said forward tip of said needle cannula is exposed, and a second position in which said forward tip of said needle cannula is contained within said shield body," Claim 1).
Based on the above teachings, it would have been obvious to a person of ordinary skill in the art at the time of the invention to configure the delivery member cover of Loof to move axially relative to the delivery member between a delivery position and a storage position, as taught by Crawford. The motivation to combine would be to allow the delivery member to be exposed for medicament delivery while ensuring it is safely covered during storage to prevent accidental needle stick injuries (Crawford at ¶ [0005]).
In relation to claim 30, this claim recites the medicament delivery device according to claim 29, wherein the resilient portion of the delivery member cover is configured to radially support the medicament container structure while allowing axial movement of the medicament container structure within the delivery member cover.
Loof discloses the resilient portion is configured to radially support the medicament container structure ("provide lateral clamping forces," ¶ [0027]). Crawford discloses allowing axial movement of the medicament container structure within the delivery member cover ("the barrel 24 is axially movable within the shield body 22 with interference between the barrel 24 and first cylindrical portion 36," ¶ [0035]).
Based on the above comments, it would have been obvious to a person of ordinary skill in the art to configure the resilient portion of Loof to radially support the medicament container structure while allowing axial movement of the medicament container structure within the delivery member cover, as taught by Crawford. The motivation to combine would be to maintain radial stability and prevent rattling of the container while simultaneously permitting the necessary axial movement required for the safety shield deployment mechanism (Crawford at ¶ [0035]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Loof (US 2015/0119809A1) in view of Crawford et al. (US 2005/0096596; hereinafter “Crawford”), as discussed above, and in further view of Olson (US 7,771,397).
In relation to claim 21, this claim recites The delivery member cover according to claim 16, wherein the resilient portion comprises a contact surface configured to be in contact with said portion of the medicament container structure upon insertion of the medicament container structure into the receiving recess, wherein the contact surface comprises a thermoplastic
elastomer.
Loof in view of Crawford discloses the resilient portion comprises a contact surface configured to be in contact with said portion of the medicament container structure upon insertion ("The free ends of the tongues are arranged with a contacting surface 40... shaped to protrude inwardly toward the outer surface of the medicament container 22," Loff ¶ [0026]).
Loof does not explicitly disclose that the contact surface comprises a thermoplastic elastomer. However, Olson discloses a needle cover assembly having a resilient portion comprising a contact surface that comprises a thermoplastic elastomer (rubber) configured to be in contact with a medicament container structure ("a rigid needle shield (RNS) 38 provided with an internally arranged resilient cap 40," Col. 3, lines 43-44; "The resilient cap 40 made of a rubber material is designed to house and protect an injection needle 42 and intended to be attached to or made integral with a medicament container 44," Col. 4, lines 26-28; "The inner cap is preferably of a resilient material, normally rubber that ensures a tight grip and a good seal between the cap and the syringe," Col. 1, lines 23-26).
Based on the above comments, it would have been obvious to a person of ordinary skill in the art at the time of the invention to modify the contact surface of the resilient portion of Loof to comprise a thermoplastic elastomer, such as rubber, as taught by Olson. The motivation to combine would be to enhance the frictional grip and securement of the medicament container, as elastomeric materials like rubber are well-known in the art for ensuring a tight grip and preventing undesirable slippage between a cover and a syringe.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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