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 .
Response to Amendment
This office action is responsive to the amendment filed on 10/14/2025 . As directed by the amendment: claim(s) 15 has been cancelled, claim(s) 11 and 16 have been amended, and claim(s) 21-31 have been added. Thus, claims 11-14 and 16-31 are presently pending in this application.
Applicant also has amended paragraph 42 of the written description. This amendment to the written description is accepted.
Response to Arguments
Applicant's arguments filed 10/14/2025 have been fully considered but they are not persuasive.
Regarding applicant’s argument regarding the drawings on page 9:
Applicant's present amendment resolves the preceding office actions stated objections to the drawings.
Regarding applicant’s argument regarding the independent claims on page 9-13:
Applicant particularly argues that it is improper for examiner to consider that the claimed housing of the prior art to be Sarkinen's housing 112 and guard 140, while simultaneously considering the claimed needle guard of the prior art to be Sarkinen's guard 140. Applicant argues that examiner is relying upon the same structure to teach two separate claim limitations.
Examiner notes that the office is not relying upon the same exact structure to teach two separate claim limitations, instead the office considers the claimed housing to comprise both Sarkinen's housing 112 and guard 140, however the claimed needle guard is considered Sarkinen's guard 140. The broadest reasonable interpretation of either claim term is not so narrow as to exclude the interpretation of the prior art presented in the preceding and present office action. Sarkinen's housing 112 and guard 140 may together be considered the claimed housing in the manner by which they collectively house/enclose/encompass internal aspects of the invention such as ram 128, see fig 12 of Sarkinen. Sarkinen's guard 140 alone, without housing 112, is considered the claimed needle guard in the manner by which it exposes/covers injection conduit 122. Thus the same the prior art structure is not relied upon for both limitations, and the rejection is proper.
Amendments to the claim which may better distinguish the prior art in this manner could consist of such language as "wherein the entirety of the housing does not move relative to the [spring holder or another appropriate disclosed element] while the [needle guard is moving from an extended state to a retracted state with the needle exposed or another appropriate circumstance where the housing in its entirety does not move relative to an element, while the needle guard moves relative to that element]" or other language which better defines the entire scope of each claim element such that the Sarkinen's housing 112 and guard 140 together cannot be considered the claimed housing.
Regarding applicant’s argument regarding claim 16 and 19 on page yyy:
Applicant argues that their preceding arguments render the independent claims allowable, and consequently likewise the dependent claims are allowable as examiner had allegedly not yet applied prior art disclosing/teaching the independent claim.
As examiner's arguments present above, and examiner's rejection as necessitated by the amendment below, the rejection of the dependent claims in view of the prior art of record stands.
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.
Regarding claim 11, 30, and 31,
The claims recite a “locking unit” which recites a generic placeholder of “unit” which performs functions of “being disposed inside the spring holder”, “being adapted to keep the spring holder in a locked state”, and “being pushed by the needle guard into the spring holder”, however lacks recited structure for performing this function. Applicant’s written disclosure similarly does not recite specific structure of the locking unit for performing this function, but applicant’s figures 2-3 do illustrate the locking unit. Thus for examination purposes the claimed locking unit is to be interpreted as the disclosed structures for performing this function, illustrated by figures 2-3, and the structural equivalents thereof for performing the claimed functions.
Claim Rejections - 35 USC § 112
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 25 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.
Regarding claim 25,
The claim recites “wherein the housing is monolithic”, and examiner notes per applicant’s disclosure the housing 102 is demonstrated as including a proximal portion 108 and distal portion 110 which are two separable elements which may enjoined together to form the housing 102, see fig 1-4 of applicant’s disclosure, via some mechanical connectors disposed at the proximal end of distal portion 110 and the distal end of proximal portion 108. Examiner notes that the claim term “monolithic” as it is typically understood to person of ordinary skill in the art means the claim element is “unitarily formed body with integral parts”, which is distinct from the disclosed housing comprising a non-unitarily formed body with integral parts. Accordingly, applicant’s claim reciting that the claimed housing is monolithic consists of new matter as a unitarily formed integral housing was not disclosed at the time of filing, instead a housing comprising two separable elements is disclosed.
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.
Claims 11-14 and 16-29 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.
Regarding claim 11
The claim recites “the syringe holder” however a syringe holder had not been previously recited in the claim, thus the lack of antecedent basis renders the claim unclear whether the claim is reciting a new distinct syringe holder, or is instead referring to another syringe element, such as the aforementioned syringe assembly. For examination purposes the claim is to be interpreted as having “a syringe holder” distinct from other elements like the syringe assembly, in view of applicant’s disclosure page 9.
Regarding claim 13
The claim recites “a syringe holder” however a syringe holder had already been previously recited in independent claim 11, thus the lack of antecedent basis renders the claim unclear whether the claim is reciting a new distinct syringe holder, or is instead referring to the previously recited syringe holder. For examination purposes the claim is to be interpreted as referring to the same syringe holder, in view of applicant’s disclosure page 9.
Regarding claim 21
The claim recites that “the locking unit is adapted to be snap-locked with the locking unit”, however it is unclear how an element can be snap locked to itself, particularly without referencing to the structure which contributes to the snap locking of the element to itself, which renders the claim indefinite as it is not apparent how an element may be considered snap locked to itself, for instance does one sub-structure of the locking unit snap lock to another sub-structure of the locking unit or does an element of the locking unit snap lack to another distinct element such that the locking unit has been snap locked into place by the action of one of its elements. For examination purposes the claim language is to be interpreted as an element of the locking unit snap locking such that locking unit is considered snap locked, in view of page 8 of applicant’s disclosure detailing that the spring holder 218 may be snap locked with the locking unit 220.
Regarding claim 25
The claim recites “wherein the housing is monolithic”, however as detailed above, the disclosed housing is comprised of two separable proximal and distal portions. The claim term “monolithic” to a person of ordinary skill in the art is understood a “unitarily formed body with integral parts”. Accordingly, the claim can be considered indefinite as it is not clear whether the term monolithic should be interpreted under the meaning of the term in the art, or as it may be understood in view of applicant’s disclosure as encompassing an element being comprised of non-unitary separable structures which may be integrated together. For examination purposes the meaning of the term “monolithic” is to be interpreted throughout the claims as coinciding with the broadest reasonable interpretation of the term consistent with applicant’s disclosure. Examiner notes that broadest reasonable interpretation of the claim term "monolithic" consistent with the disclosure, may be best provided by Merriam-Webster's dictionary: "resembling a monolith, [a monolith being a massive structure or organized whole which as a single unified element]".
Regarding claim 26
The claim recites “the needle shield” however a needle shield had not already been previously recited in the present claim nor independent claim 11, thus the lack of antecedent basis renders the claim unclear whether the claim is reciting a new distinct needle shield, or is instead referring to the previously recited needle guard. For examination purposes the claim is to be interpreted as referring to a distinct needle shield, in view of applicant’s disclosure page 10.
Regarding claim 12-14 and 16-29
The dependent claims are at least rejected for being dependent upon the rejected independent claim 1.
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) 11-14, 16-18, and 20-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20180001025 A1, henceforth written as Sarkinen.
Regarding claim 11, Sarkinen discloses:
An auto-injector assembly comprising:
(injection device 110; fig 1-18)
a housing having a proximal end and a distal end;
(the claimed housing comprises housing 112 and guard 140; fig 1-18; see examiner's annotation of Sarkinen's figure 12 below demonstrating the proximal end and distal end of the claimed housing)
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a syringe assembly disposed adjacent to the proximal end of the housing and adapted to store a predetermined volume of a drug to be administered through a needle;
(paragraph 90; reservoir 118 dispense medicament through conduit 122; fig 1-18)
a needle guard disposed to surround the syringe assembly such that a portion of the needle guard is adapted to extend out of the housing in an initial state and to retract into the housing when the portion is pressed on to an injection site;
(fig 8-16 illustrate guard 140 extending from the claimed housing by the nature of extending the cumulative axial length of the claimed housing, and illustrate guard 140 retracting into the housing when the device is applied to an patient for injection)
a spring holder disposed adjacent to the distal end of the housing and adapted to hold a dose delivery spring in a compressed state:
(paragraph 94-98; the claimed spring holder comprises latch 132, nut 130, and dose setting mechanism 116 which cooperate to maintain biasing member 126 in a compressed state; fig 1-18)
a locking unit disposed inside the spring holder and adapted to keep the spring holder in a locked state with the housing; and
(the claimed locking unit comprises slant surface 140d of guard 140, illustrated in fig 6-10 as radially within, therein inside the claimed spring holder, and latch arms 132c; paragraph 96+120-121 which demonstrate the conditions that surface 140d and latch arms 132c maintains the claimed spring holder in a state inhibiting travel of nut 130 and piston 120)
a plunger engaged with the spring holder and adapted to move towards the syringe assembly when the spring holder is unlocked,
(ram 128; fig 1-18)
wherein a position of engagement of the plunger with the spring holder is adapted to change for controlling a travelling distance of the plunger within the housing based on the predetermined volume of the drug in the syringe assembly,
(paragraph 92-102 demonstrates the manner by which mechanism 116 is rotated and its engagement with ram 128, and ram 128's consequent engagement with nut 130, and nut 130's consequent engagement with latch 132 contribute to changing the axial position by which ram 128 begins its travel within the claimed housing for delivering a set dose of media from reservoir 118; fig 6-7)
wherein the locking unit is movable relative to the syringe holder and the needle guard such that
(the claimed locking unit can be considered movable relative to the claimed syringe holder, sleeve 134, and claimed needle guard in the manner by which arms 132c can be deflected radially outward relative to guard 140 )
the needle guard, when being retracted, is adapted to push the locking unit further into the spring holder, unlocking the spring holder from the housing such that the plunger is moved towards the syringe assembly for administering the drug into the injection site.
(fig 13-16 illustrate the manner in which guard 140 retracting into the claimed housing, particularly telescoping within element 112, moves surface 140d proximally and further into the claimed syringe holder by the nature of surface 140d being advanced further in between latch 132's surface 132b and nut 130)
Regarding claim 12, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein the needle guard is adapted to be pressed against the injection site to extend the needle of the syringe assembly for being inserted into the injection site and to return to an original position when the drug is administered.
(fig 13-16 illustrate guard 140 retracting when pressed against a patient to permit conduit 122 to penetrate a patient for administering drug in reservoir 118)
Regarding claim 13, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, comprising a syringe holder adapted to support the syringe assembly within the housing; and
(paragraph 105; sleeve 134; fig 2)
a needle guard spring adapted to be disposed between an inner surface of the housing and an outer surface of the needle guard,
(biasing member 138 is disposed axially between a distal-most inner surface (not enumerated) of housing 112, of the claimed housing, and a proximal-most outer surface (not enumerated) of guard 140; fig 8-16)
wherein the needle guard spring is adapted to support the movement of the needle guard within the housing for administering the drug.
(paragraph 104-105 details the manner by which biasing member 138 biases guard 140 in a distal direction relative to the claimed housing to support the injection procedure; fig 8-16)
Regarding claim 14, Sarkinen discloses:
The auto-injector as claimed in claim 11, comprising: the housing having a pair of stoppers formed on an inner surface; and
(paragraph 97+123-124; the claimed stoppers of the claimed housing are considered the pair of radial stop 140e formed on guard 140, an element of the claimed housing, in that they retain slanted surface 132b and thus retain latch 132; fig 2+13-16)
the spring holder comprising a pair of arms adapted to engage with the pair of stoppers for locking the spring holder with the housing, restricting the movement of the plunger.
(paragraph 97; slant surfaces 132b of latch 132, a component of the claimed spring holder and illustrated in fig 14c as a protruding element from latch 132 and thus can be considered a pair of arms, interact with the claimed pair of stoppers to restrict movement of the claimed plunger, in that the claimed plunger cannot move axially relative to the claimed housing until slanted surface 132b has disengaged from stop 140e)
Regarding claim 16, Sarkinen discloses:
The auto-injector as claimed in claim 11, comprising: wherein: the spring holder comprises a shaft adapted to engage with the plunger, and
(paragraph 94-97; nut 130 may be considered a shaft, and has threads for engaging threads 128b on ram 128; fig 4)
wherein the plunger is rotated into the shaft for controlling the travelling distance of the plunger within the housing to administer the drug into the injection site based on the predetermined volume of the drug in the syringe assembly.
(paragraph 94-97; position of engagement between nut 130 and ram 128 corresponds to one of a plurality of volume of medicament to be expelled)
Regarding claim 17, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein the spring holder is adapted to unlock, releasing the dose delivery spring from the compressed state and pushing the plunger towards the syringe assembly based on a compressive force of the dose delivery spring.
( paragraph 92-93+96-98; the locking unit is engaged, by surface 140d deflecting arms 132c, to unlock the claimed spring holder such that the compressive force of biasing member 126 acts to deliver medication from reservoir 118)
Regarding claim 18, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, comprising: a needle shield adapted to encapsulate the needle; and
(needle cap 124; fig 6-7)
a cap fixed with the needle shield and adapted to close the proximal end of the housing when not in use,
(safety cap 114; fig 6-7)
wherein the cap and the needle shield are adapted to be removed before pressing the needle guard against the injection site for administering the drug.
(Paragraph 91; removal of cap 114 removes cap 124 to permit pressing of guard 140 for initiating drug administration)
Regarding claim 20, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, comprising a viewing slot formed on the housing to view the movement of the plunger from outside.
(paragraph 89; window 112b permits movement of components displacing inside reservoir 118, such as ram 128 and piston 120 ; fig 1; paragraph 102; window 112a gives indicia 116e corresponding to the position of ram 128 during injection, therein also permitting viewing of the plunger's movement from outside the claimed housing)
Regarding claim 21, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein the locking unit is adapted to be snap-locked with the locking unit.
(the claimed locking unit, pivots arms 132c and slant surface 140d can be considered to be snap-locked to itself in the manner by which arms 132c deflect outwardly/inwardly, therein snapping, to govern the retracted position of guard 140 and consequent releasing of ram 128; paragraph 97+124)
Regarding claim 22, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein the locking unit comprises a body and bifurcated arms extending from the body.
(the body of the locking unit may be considered the slant surfaces 140d, and fig 10b+13-15 demonstrate the manner by which the bifurcated arms, arms 132c, may be considered to axially extend from surfaces 140d in an initial state, or radially extend from surfaces 140d in an injection state)
Regarding claim 23, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein the spring holder is monolithic.
(note examiner's interpretation of the claim term "monolithic", above; the claimed spring holder comprising comprises latch 132, nut 130, and dose setting mechanism 116 may be considered monolithic in the manner by which the elements are coupled together such that in their unified/assembled form they form a structure which is unified in its function to retain the dose delivery spring in a compressed state, and stand out as massive relative to a patient's injection site)
Regarding claim 24, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, further comprising the dose delivery spring, the dose delivery spring being positioned outside of the plunger.
(fig 6-16 illustrate biasing member 126 radially around, thus positioned outside, ram 128)
Regarding claim 25, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein the housing is monolithic.
(note examiner's interpretation of the claim term "monolithic", above; the claimed housing comprising comprises housing 112 and guard 140 may be considered monolithic in the manner by which the elements are coupled together such that in their unified/assembled form they form a structure which is unified in its function of enclosing/surround the inner workings of the invention in an initial state, and stand out as massive relative to a patient's injection site)
Regarding claim 26, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, further comprising a cap that is fixed with the needle shield and adapted to close a proximal end of the housing when not in use.
(needle cap 124 is fixed with safety cap 114, such that cap 124 covers a proximal end of the claimed housing prior to use; fig 6-7)
Regarding claim 27, Sarkinen discloses:
The auto-injector assembly as claimed in claim 26, wherein the cap is removably coupled to the housing.
(fig 6-8; cap 124 is removable from the claimed housing)
Regarding claim 28, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein a portion of the locking unit extends circumferentially about the plunger.
(fig 6-16 demonstrate that arms 132c and surfaces 140d extended circumferentially around ram 128)
Regarding claim 29, Sarkinen discloses:
The auto-injector assembly as claimed in claim 11, wherein an end of the plunger is positioned within the locking unit.
(fig 6-16 demonstrate that an intermediate end of ram 128 is positioned radially within arms 132c and surfaces 140d)
Regarding claim 30, Sarkinen discloses:
An auto-injector assembly comprising:
(injection device 110; fig 1-18)
a housing having a proximal end and a distal end;
(the claimed housing comprises housing 112 and guard 140; fig 1-18; see examiner's annotation of Sarkinen's figure 12 above demonstrating the proximal end and distal end of the claimed housing)
a syringe assembly disposed adjacent to the proximal end of the housing and adapted to store a predetermined volume of a drug to be administered through a needle;
(paragraph 90; reservoir 118 dispense medicament through conduit 122; fig 1-18)
a needle guard disposed to surround the syringe assembly such that a portion of the needle guard is adapted to extend out of the housing in an initial state and to retract into the housing when the portion is pressed on to an injection site;
(fig 8-16 illustrate guard 140 extending from the claimed housing by the nature of extending the cumulative axial length of the claimed housing, and illustrate guard 140 retracting into the housing when the device is applied to an patient for injection)
a spring holder disposed adjacent to the distal end of the housing and adapted to hold a dose delivery spring in a compressed state;
(paragraph 94-98; the claimed spring holder comprises latch 132, nut 130, and dose setting mechanism 116 which cooperate to maintain biasing member 126 in a compressed state; fig 1-18)
a locking unit disposed inside the spring holder such that a portion of the locking unit extends circumferentially about the plunger, the locking unit being adapted to keep the spring holder in a locked state with the housing; and
(the claimed locking unit comprises slant surface 140d of guard 140, illustrated in fig 6-10 as radially within, therein inside the claimed spring holder, and latch arms 132c; paragraph 96+120-121 which demonstrate the conditions that surface 140d and latch arms 132c maintains the claimed spring holder in a state inhibiting travel of nut 130 and piston 120; fig 6-16 demonstrate that arms 132c and surfaces 140d extended circumferentially around ram 128)
a plunger engaged with the spring holder and adapted to move towards the syringe assembly when the spring holder is unlocked,
(ram 128; fig 1-18)
wherein a position of engagement of the plunger with the spring holder is adapted to change for controlling a travelling distance of the plunger within the housing based on the predetermined volume of the drug in the syringe assembly,
(paragraph 92-102 demonstrates the manner by which mechanism 116 is rotated and its engagement with ram 128, and ram 128's consequent engagement with nut 130, and nut 130's consequent engagement with latch 132 contribute to changing the axial position by which ram 128 begins its travel within the claimed housing for delivering a set dose of media from reservoir 118; fig 6-7)
wherein the needle guard, when being retracted, is adapted to push the locking unit further into the spring holder, unlocking the spring holder from the housing such that the plunger is moved towards the syringe assembly for administering the drug into the injection site.
(fig 13-16 illustrate the manner in which guard 140 retracting into the claimed housing, particularly telescoping within element 112, moves surface 140d proximally and further into the claimed syringe holder by the nature of surface 140d being advanced further in between latch 132's arm 132c and nut 130)
Regarding claim 31, Sarkinen discloses:
An auto-injector assembly comprising:
(injection device 110; fig 1-18)
a housing having a proximal end and a distal end;
(the claimed housing comprises housing 112 and guard 140; fig 1-18; see examiner's annotation of Sarkinen's figure 12 above demonstrating the proximal end and distal end of the claimed housing)
a syringe assembly disposed adjacent to the proximal end of the housing and adapted to store a predetermined volume of a drug to be administered through a needle;
(paragraph 90; reservoir 118 dispense medicament through conduit 122; fig 1-18)
a needle guard disposed to surround the syringe assembly such that a portion of the needle guard is adapted to extend out of the housing in an initial state and to retract into the housing when the portion is pressed on to an injection site;
(fig 8-16 illustrate guard 140 extending from the claimed housing by the nature of extending the cumulative axial length of the claimed housing, and illustrate guard 140 retracting into the housing when the device is applied to an patient for injection)
a spring holder disposed adjacent to the distal end of the housing and adapted to hold a dose delivery spring in a compressed state;
(paragraph 94-98; the claimed spring holder comprises latch 132, nut 130, and dose setting mechanism 116 which cooperate to maintain biasing member 126 in a compressed state; fig 1-18)
a locking unit disposed inside the spring holder and adapted to keep the spring holder in a locked state with the housing; and
(the claimed locking unit comprises slant surface 140d of guard 140, illustrated in fig 6-10 as radially within, therein inside the claimed spring holder, and latch arms 132c; paragraph 96+120-121 which demonstrate the conditions that surface 140d and latch arms 132c maintains the claimed spring holder in a state inhibiting travel of nut 130 and piston 120)
a plunger engaged with the spring holder and adapted to move towards the syringe assembly when the spring holder is unlocked,
(ram 128; fig 1-18)
wherein a position of engagement of the plunger with the spring holder is adapted to change for controlling a travelling distance of the plunger within the housing based on the predetermined volume of the drug in the syringe assembly,
(paragraph 92-102 demonstrates the manner by which mechanism 116 is rotated and its engagement with ram 128, and ram 128's consequent engagement with nut 130, and nut 130's consequent engagement with latch 132 contribute to changing the axial position by which ram 128 begins its travel within the claimed housing for delivering a set dose of media from reservoir 118; fig 6-7)
wherein an end of the plunger is positioned within the locking unit such that
(fig 6-16 demonstrate that ram 128, thus an intermediate end of it, is positioned radially within arms 132c and surfaces 140d)
the needle guard, when being retracted, is adapted to push the locking unit further into the spring holder, unlocking the spring holder from the housing such that the plunger is moved towards the syringe assembly for administering the drug into the injection site.
(fig 13-16 illustrate the manner in which guard 140 retracting into the claimed housing, particularly telescoping within element 112, moves surface 140d proximally and further into the claimed syringe holder by the nature of surface 140d being advanced further in between latch 132's arm 132c and nut 130)
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Sarkinen, as applied to claim 13 above, and further in view of Sarkinen.
Regarding Claim 19,
Sarkinen discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The auto-injector assembly as claimed in claim 13, comprising: the syringe holder having a lock portion formed on an outer surface;
(paragraph 104-105; tabs 134a radially extend outward from sleeve 134; fig 2)
and the needle guard comprising: a longitudinal groove adapted to receive the lock portion of the syringe holder, wherein the lock portion is adapted to travel along the longitudinal groove for accommodating relative movement of the needle guard with respect to the syringe holder when the needle guard retracts into the housing; and
(paragraph 105; axially extending slots 140c on guard 140 receive tabs 134a and the relationship between slots 140c and tabs 134a define the axial range of motion of guard 140; fig 2)
However, Sarkinen is silent regarding:
a longitudinal slot formed adjacent to the longitudinal groove and adapted to accommodate return travel of the lock portion when the needle guard is moving back to the original position after administering of the drug,
wherein the longitudinal slot comprising a stopper slot that is adapted to hold the lock portion at the end of return travel, restricting further movement of the needle guard once the drug is administered.
Notably, in paragraph 104 and 123 Sarkinen does disclose that after delivering medication and removing the needle from the patient, the guard 140 is axially locked relative to the housing 112 by a retaining member, however Sarkinen does not detail the specific structure/relationship of the retaining member which contributes to locking the guard 140 axially after injection.
However, Sarkinen teaches an alternative embodiment of post injection needle guard lock out mechanism in paragraph 162-168:
the syringe holder having a lock portion formed on an outer surface;
(paragraph 166+168; radial projections 334a extend outward from sleeve 334; fig 41)
and the needle guard comprising: a longitudinal groove adapted to receive the lock portion of the syringe holder, wherein the lock portion is adapted to travel along the longitudinal groove for accommodating relative movement of the needle guard with respect to the syringe holder when the needle guard retracts into the housing; and
(paragraph 166+168; slot 340c of guard 340 receives projections 334a, the portion of slot 340c distal to arms 340a is considered to be the longitudinal groove as that is the portion which projections 334a travels when guard 340 is retracted into claimed housing)
a longitudinal slot formed adjacent to the longitudinal groove and adapted to accommodate return travel of the lock portion when the needle guard is moving back to the original position after administering of the drug,
(paragraph 166+168; the portion of slot 340c proximal of arms 340a, therein adjacent to the claimed longitudinal groove, receives projections 334a such that arms 340a engage with grooves 334b on projections 334a when guard 340c returns to the original position after injection; fig 38-39)
wherein the longitudinal slot comprising a stopper slot that is adapted to hold the lock portion at the end of return travel, restricting further movement of the needle guard once the drug is administered.
(paragraph 168; the slots formed by arms 340a on guard 340, therein the stopper slot as fig 39 illustrates it as a continuous cut-out from slot 340c, can be considered adapted to hold the claimed lock portion at the end guard 340's travel and restrict guard 340's further movement after injection by the nature by which they permit arms 340a to flex away from one another until they engage grooves 334b, therein restricting guard 340's movement; fig 39+41
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate the specific structure of a post-injection needle guard lock out mechanism taught by Sarkinen to the general lock out mechanism disclosed by Sarkinen by substituting the tabs 134a and slot 140c and their associated interaction disclosed by Sarkinen for the structure involved with and interaction of tabs 334a & grooves 334b mating with slot 340c & arms 340a, in order to advantageously arrive at an invention which prevents accidental exposure to or use of a needle after injection, see paragraph 168 of Sarkinen.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/FORREST B DIPERT/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783