DETAILED ACTION
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 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 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(s) is/are: “an injection drive mechanism” in claims 8, 15, and 22, and “a needle hiding element” in claims 8-27.
Specifically, the limitation “an injection drive mechanism” in claims 8, 15, and 22 invokes 35 U.S.C. 112(f) since,
the term “mechanism” is a non-structural generic placeholder, having no specific structural meaning, which would not be recognized by one of ordinary skill in the art as being sufficiently definite structure for performing the claimed function,
this term is modified by the functional language “injection drive”, which expresses the intended use of the “mechanism”, thereby setting forth the “mechanism” in terms of the function it performs (driving the a piston for injection) rather than the specific structure, material, or acts that perform the function, and
this term is not modified by sufficient structure, material, or acts for achieving the specified function within the claims.
Further, the limitation “a needle hiding element” in claims 8-27 invokes 35 U.S.C. 112(f) since,
the term “element” is a non-structural generic placeholder, having no specific structural meaning, which would not be recognized by one of ordinary skill in the art as being sufficiently definite structure for performing the claimed function,
this term is modified by the functional language “needle hiding”, which expresses the intended use of the “element”, thereby setting forth the “element” in terms of the function it performs (hiding the needle) rather than the specific structure, material, or acts that perform the function, and
this term is not modified by sufficient structure, material, or acts for achieving the specified function within the claims.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are 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.
Specifically, the limitation “an injection drive mechanism” in claims 8, 15, and 22 is interpreted to include a computer controlled motor, which is described in the specification as performing the claimed function (see specification, pg. 5, ln 1-2), and equivalents thereof (including commonly used mechanical (e.g., a spring-driven piston/plunger rod) and manual (e.g., a manually driven piston/plunger rod) drive configurations, acknowledged by the applicant as equivalents – see specification, pg. 5, ln 1-2).
Specifically, the limitation “a needle hiding element” in claims 8-27 is interpreted to include an integrally formed element with a substantially cylindrical form/base comprising an opening formed through the base designed to at least partially enclose a needle to hide and prevent access to the tip of the needle, which is described in the specification as performing the claimed function (see specification, pg. 7, ln 28-38), and equivalents thereof (sleeves, covers, caps, and guards of similar form).
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.
(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.
Claim(s) 8-11, 15-18, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Roervig (U.S. Pat. Pub. No. 2015/0174335 A1).
Regarding claim 8, Roervig discloses an injector (1) comprising: a housing (outer housing 3) arranged along a longitudinal axis and configured to receive a medicament cartridge (105) (see Fig. 1-18, [0040], and [0095-0099]); an injection drive mechanism (threaded piston rod 40, driven by torsion spring A upon activation of the dose release process) for driving a piston (plunger 107), said piston forming a part of said medicament cartridge (see Fig. 8-11, [0100-0102], [0108], and [0130-0137]), said injection drive mechanism injecting a medicament when said piston is forwardly displaced (see Fig. 8-11, [0098], and [0100]); and a needle hiding element (shield 20), which is slidably attached to said housing and positionable in at least one of an extended orientation and a retracted orientation (see Fig. 3-7 and 12-15, [0081-0086], and [0103]), wherein in said extended orientation said needle hiding element protrudes forwardly from said housing (see Fig. 4, 7.2-7.3, and 13-15, [0084], and [0089]) and in said retracted orientation, said needle hiding element is locked relative to said housing (see Fig. 12, [0081-0082], [0086], and [0103]).
Regarding claim 9, Roervig further discloses that in said extended orientation said needle hiding element is slidable relative to said housing (see Fig. 7.2-7.5 and 13-15, [0085], and [0103]) and in said retracted orientation the needle hiding element does not protrude forwardly from said housing or protrudes to a lesser extent than in said extended orientation (see Fig. 7 and 12).
Regarding claim 10, Roervig further discloses that said needle hiding element is also positionable in a partially retracted orientation (see Fig. 7.4), in which said needle hiding element protrudes forwardly from said housing to a greater extent than in said retracted orientation and is slidably moveable relative to said housing (see Fig. 7.4, wherein, upon release of the shield 20 from its locked retracted orientation, the shield 20 is slidably movable relative to the housing 3 over a broad range of intermediate positions between the fully retracted Fig. 7.1 position and fully extended Fig. 7.2 position, thus the shield 20 may be positioned in any of these intermediate positions by pressing the shield against a surface, such as a patient’s skin, to thereby arrest the extension of the shield 20 prior to its fully extended position).
Regarding claim 11, Roervig further discloses that said needle hiding element is biased to be displaced forwardly under an urge of at least one biasing element (helical spring B), which is supported between said housing and said needle hiding element (see Fig. 8-16 and [0112]).
Regarding claim 15, Roervig discloses an injector (1) comprising: a housing (outer housing 3) arranged along a longitudinal axis and configured to receive a medicament cartridge (105) (see Fig. 1-18, [0040], and [0095-0099]); an injection drive mechanism (threaded piston rod 40, driven by torsion spring A upon activation of the dose release process) for driving a piston (plunger 107), said injection drive mechanism injecting a medicament when said piston is forwardly displaced (see Fig. 8-11, [0098], [0100-0102], [0108], and [0130-0137]); and a needle hiding element (shield 20), which is slidably attached to said housing and positionable in at least one of an extended orientation and a retracted orientation (see Fig. 3-7 and 12-15, [0081-0086], and [0103]), wherein in said extended orientation said needle hiding element protrudes forwardly from said housing (see Fig. 4, 7.2-7.3, and 13-15, [0084], and [0089]) and in said retracted orientation, said needle hiding element is locked relative to said housing (see Fig. 12, [0081-0082], [0086], and [0103]).
Regarding claim 16, Roervig further discloses that in said extended orientation said needle hiding element is slidable relative to said housing (see Fig. 7.2-7.5 and 13-15, [0085], and [0103]) and in said retracted orientation the needle hiding element does not protrude forwardly from said housing or protrudes to a lesser extent than in said extended orientation (see Fig. 7 and 12).
Regarding claim 17, Roervig further discloses that said needle hiding element is also positionable in a partially retracted orientation (see Fig. 7.4), in which said needle hiding element protrudes forwardly from said housing to a greater extent than in said retracted orientation and is slidably moveable relative to said housing (see Fig. 7.4, wherein, upon release of the shield 20 from its locked retracted orientation, the shield 20 is slidably movable relative to the housing 3 over a broad range of intermediate positions between the fully retracted Fig. 7.1 position and fully extended Fig. 7.2 position, thus the shield 20 may be positioned in any of these intermediate positions by pressing the shield against a surface, such as a patient’s skin, to thereby arrest the extension of the shield 20 prior to its fully extended position).
Regarding claim 18, Roervig further discloses that said needle hiding element is biased to be displaced forwardly under an urge of at least one biasing element (helical spring B), which is supported between said housing and said needle hiding element (see Fig. 8-16 and [0112]).
Regarding claim 22, Roervig discloses a method of using a medicament injector, the method comprising: inserting a medicament cartridge into a housing of an injector, the housing being arranged along a longitudinal axis (see Fig. 1-18, [0040], and [0095-0099]); retracting a needle hiding element of said injector and locking said needle hiding element relative to said housing in a retracted orientation (see Fig. 2 and 12, [0081-0086], and [0103], wherein the shield 20 is initially retracted and locked in a retracted orientation in order to allow the user to install a needle 100 onto the connecting means 31 of the needle holder 30); attaching a needle (100) to said medicament cartridge (see Fig. 3, 5, and 7.5, [0103] and [0124-0129], wherein the needle 100 is first attached to the needle holder 30 prior to injection, at which point the needle holder is extended forward of the cartridge, however upon activation of injection, the needle holder 30 is pushed backward into contact with the cartridge 105, whereupon the rear end 104 of the needle cannula penetrates septum 106, thereby attaching the needle 100 to the cartridge 105); releasing said needle hiding element such that said needle hiding element is returned to an extended orientation protruding forwardly from said housing (see Fig. 4, 7.2-7.3, and 13, [0082-0084], and [0103]); pressing said injector against an injection site (see Fig. 7.4 and [0085]); and driving, by an injection drive mechanism of said injector, a piston that forms a part of said medicament cartridge, said injection drive mechanism injecting a medicament via said needle when said piston is forwardly displaced (see Fig. 7.5 and 8-11, [0085], [0098], [0100], and [0130-0137]).
Regarding claim 23, Roervig further discloses that in said extended orientation said needle hiding element is slidable relative to said housing (see Fig. 7.2-7.5 and 13-15, [0085], and [0103]) and in said retracted orientation the needle hiding element does not protrude forwardly from said housing or protrudes to a lesser extent than in said extended orientation (see Fig. 7 and 12).
Regarding claim 24, Roervig further discloses positioning said needle hiding element in a partially retracted orientation (see Fig. 7.4), in which said needle hiding element protrudes forwardly from said housing to a greater extent than in said retracted orientation and is slidably moveable relative to said housing (see Fig. 7.4, wherein, upon release of the shield 20 from its locked retracted orientation, the shield 20 is slidably movable relative to the housing 3 over a broad range of intermediate positions between the fully retracted Fig. 7.1 position and fully extended Fig. 7.2 position, and when the injector is positioned against a patient’s skin in preparation for injection, the shield 20 is pressed against the surface of the patient’s skin, thereby the shield 20 is slid into a partially retracted intermediate position, as depicted in Fig. 7.4).
Regarding claim 25, Roervig further discloses that said needle hiding element is biased to be displaced forwardly under an urge of a biasing element (helical spring B), which is supported between said housing and said needle hiding element (see Fig. 8-16 and [0112]).
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(s) 12-14, 19-21, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Roervig in view of Martin (U.S. Pat. No. 5,201,708).
Regarding claim 12, Roervig discloses the injector according to claim 8, wherein the injector comprises a locking configuration (flexible arms 32 of the needle holder 30, which engages grooves 21 provided on the shield 20 to retain the shield within its retracted orientation) for retaining the needle hiding element in a retracted orientation during needle installation (see Fig. 12 and [0103]). Roervig, however, fails to teach that the needle hiding element includes at least a flexible arm, extending axially and comprising a snap-fit locking feature that can be engaged in a corresponding feature provided on the housing and a radially protruding button that can be handled by a user for deflecting the arm and axially moving the needle hiding element, whereby the user can position the needle hiding element in one of said extended and retracted orientations.
Martin exhibits an injector (10) for injecting medicament in a similar manner as that of Roervig, the injector of Martin comprising a housing (barrel casing 14) arranged along a longitudinal axis and configured to receive a medicament cartridge (syringe barrel 16); an injection drive mechanism (plunger 18); a needle (92); and a needle hiding element (needle guard 12), which is slidably attached to said housing and positionable in at least one of an extended orientation and a retracted orientation (see Fig. 1-12, Col. 1, ln 49-68, Col. 3, ln 34-44, and Col. 5, ln 3-38). Martin teaches a locking configuration for securing the needle hiding element in position (in the case of Martin, in an extended position) relative to the housing, wherein the needle hiding element comprises a pair of opposing flexible arms (tab supports 60/62 – see Fig. 1-3 and 6, and Col. 3, ln 29-33), each extending axially and comprising a snap-fit locking feature (the radially inner portions of locking tabs 52/54, which directly contact the housing within openings 64 and 66) that can be engaged in a corresponding feature (openings 64/66) provided on the housing (see Fig. 1-3 and 6, and Col. 3, ln 29-44) and each comprising a radially protruding button (the radially outer portions of locking tabs 52/54 which protrude radially outward from the locking features and extend beyond the housing outer surface) that can be handled (pressed) by a user for deflecting the arm, thereby disengaging the snap-fit locking feature from the corresponding feature of the housing (see Fig. Fig. 1-4 and 6-7, and Col. 3, ln 34-44). When the user presses on both buttons simultaneously, both flexible arms are deflected and both snap-fit locking features are disengaged from the housing, thereby the user unlocks the needle hiding element, freeing it to be slidably positioned in one of said extended and retracted orientations (see Fig. 4 and 7, and, Col. 1, ln 49-68, and Col. 5, ln 39 – Col. 6, ln 15).
Based on the teachings of Martin, 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 housing and the needle hiding element of Roervig such that the needle hiding element may include a pair of opposing flexible arms, each extending axially and comprising a snap-fit locking feature that can be engaged in a corresponding feature provided on the housing and each comprising a radially protruding button that can be handled by a user for deflecting the arm and axially moving the needle hiding element, in the manner taught by Martin, in place of the locking configuration of Roervig as a matter of simple substitution of one known locking configuration (the snap-fit locking configuration of Martin) for another (that of Roervig) in order to obtain predictable results, both configurations providing a releasable means of securing the needle hiding element in a retracted orientation during processes such as needle replacement. See MPEP 2143(I)(B). In doing so, it would be clear to one of ordinary skill in the art that the locking configuration of Martin may be for the same purpose as the original locking configuration of Roervig – to secure the needle hiding element in a retracted orientation during processes such as needle replacement – despite the fact that Martin’s use of the locking configuration is to secure a needle hiding element in an extended orientation. Implementation of the locking configuration of Martin to operate in this manner would be straightforward to one of ordinary skill in the art based upon the example of Martin, the configuration of Roervig, and common understanding within the field. Upon such a modification, Roervig would exhibit that the needle hiding element includes at least a flexible arm, extending axially and comprising a snap-fit locking feature that can be engaged in a corresponding feature provided on the housing and a radially protruding button that can be handled by a user for deflecting the arm and axially moving the needle hiding element, whereby the user can position the needle hiding element in extended and retracted orientations (including the partially retracted orientation of Fig. 7.4).
Regarding claim 13, Roervig as modified by Martin according to claim 12 further exhibits that the snap-fit locking feature of the flexible arm and the corresponding feature of the housing are designed to provide the locked retracted orientation of the needle hiding element, that can be unlocked by the user by pressing on the button whereby the locking feature of the arm is disengaged from the corresponding feature of the housing (see in re claim 12, wherein the locking configuration of Martin is incorporated as a replacement for the locking configuration of Roervig, but achieving the same purpose - to secure the needle hiding element in a retracted orientation during processes such as needle replacement).
Regarding claim 14, Roervig as modified by Martin according to claim 13 further exhibits that the needle hiding element includes a pair of opposing flexible arms, each provided with a snap-fit locking feature and a button, whereby the locked retracted orientation of the needle hiding element can be unlocked by the user by simultaneously pressing on the buttons for simultaneous deflection of the arms (see above modification in re claim 12, wherein Martin teaches that the pair of opposing flexible arms may be operated in this manner to unlock the needle hiding element from engagement with the housing).
Regarding claim 19, Roervig as modified by Martin exhibits that the needle hiding element includes at least a flexible arm, extending axially and comprising a snap-fit locking feature that can be engaged in a corresponding feature provided on the housing and a radially protruding button that can be handled by a user for deflecting the arm and axially moving the needle hiding element, whereby the user can position the needle hiding element in one of said extended and retracted orientations (see above modification in re claim 12).
Regarding claim 20, Roervig as modified by Martin exhibits the snap-fit locking feature of the flexible arm and the corresponding feature of the housing are designed to provide the locked retracted orientation of the needle hiding element, that can be unlocked by the user by pressing on the button whereby the locking feature of the arm is disengaged from the corresponding feature of the housing (see in re claim 12, wherein the locking configuration of Martin is incorporated as a replacement for the locking configuration of Roervig, but achieving the same purpose - to secure the needle hiding element in a retracted orientation during processes such as needle replacement).
Regarding claim 21, Roervig as modified by Martin exhibits that the needle hiding element includes a pair of opposing flexible arms, each provided with a snap-fit locking feature and a button, whereby the locked retracted orientation of the needle hiding element can be unlocked by the user by simultaneously pressing on the buttons for simultaneous deflection of the arms (see above modification in re claim 12, wherein Martin teaches that the pair of opposing flexible arms may be operated in this manner to unlock the needle hiding element from engagement with the housing).
Regarding claim 26, Roervig as modified by Martin exhibits that the needle hiding element includes at least a flexible arm, extending axially and comprising a snap-fit locking feature that can be engaged in a corresponding feature provided on the housing and a radially protruding button that can be handled by a user for deflecting the arm and axially moving the needle hiding element (see above modification in re claim 12).
Regarding claim 27, Roervig as modified by Martin exhibits that the snap-fit locking feature of the flexible arm and the corresponding feature of the housing are designed to provide the locked retracted orientation of the needle hiding element (see in re claim 12, wherein the locking configuration of Martin is incorporated as a replacement for the locking configuration of Roervig, but achieving the same purpose - to secure the needle hiding element in a retracted orientation during processes such as needle replacement). Prior to the modification of Roervig, the method step of installing a needle 100 onto the needle holder 30 would have disengaged the shield 20 from the needle holder flexible arms 32, thereby unlocking the shield 20 for automatic extension (see [0103]), however upon the above modification, this locking configuration for securing the shield 20 in a retracted orientation is replaced with the locking configuration of Martin, which requires the user to unlock the snap-fit locking feature of the shield 20 by pressing on the button to disengage the locking feature of the arm from the corresponding feature of the housing (see in re claim 12, concerning Martin). It thus follows that, as result of the above modification (see in re claim 12) and in place of the automatic unlocking of the shield 20, it would have been obvious to one of ordinary skill in the art to perform this additional method step of pressing on the button to disengage the locking feature of the arm from the corresponding feature of the housing in order to operate the locking configuration of Martin to effect the unlocking of shield 20 from its retracted orientation, thereby allowing the shield 20 to automatically extend in the manner described by Roervig.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Leap (U.S. Pat. No. 5,106,379), which describes an injector comprising a needle hiding sleeve that is locked in a retracted orientation, and is unlockable by the user manipulating a lever which disengages a snap-fit locking feature of the sleeve from engagement with a corresponding feature of the injector housing.
Roberts (U.S. Pat. Pub. No. 2013/0289480 A1), which describes an injector comprising a needle hiding sleeve that is slidably connected to a housing of the injector via snap-fit locking features that can be engaged in a corresponding feature provided on the housing.
Hoste (U.S. Pat. Pub. No. 2004/0236284 A1), which describes an injector comprising a needle hiding sleeve that is slidably connected to a housing of the injector and which may be locked in a retracted position by the attachment of a cap.
Morgan (U.S. Pat. No. 4,923,447), which describes an injector comprising a needle hiding sleeve that may be locked in a retracted orientation and optionally in an extended orientation with respect to the injector housing, the needle hiding sleeve being unlockable by way of the user manipulating a peg connected to the needle hiding sleeve which travels within a guide slot formed in the housing of the injector in order to disengage the sleeve, allow for sleeve extension/contraction, and re-engage the sleeve in a locked configuration with respect to the housing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
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/ERIC A LANGE/Examiner, Art Unit 3745
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783