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 04/24/2026. As directed by the amendment: claims 22-23, 26, 28, 33, and 39-41 been amended, no claims have been cancelled, and no claims have been added. Thus, claims 22-41 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Rejection mailed on 01/27/2026. The 112(f) interpretations have been maintained.
Response to Arguments
Applicant’s arguments with respect to the 102 rejection of claim 22 in view of Tschirren have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments on p.4-5 of “Remarks”, filed 04/24/2026, with respect to the 102 rejection of claim 22 in view of Imai have been fully considered but they are not persuasive. In response to the applicant’s argument that Imai fails to disclose or teach the needle cover is in the locking position after a delivery operation has been performed, wherein, in the locking position, the needle cover locking feature is configured to abut a blocking feature of the housing” in claim 22, the examiner respectfully disagrees. The applicant argues “See Imai [0084] (“Each elastic piece 64 provided in this manner is further titled inward by the biasing force of the coil spring 70 (see Fig. 6). Then each of the further inclined elastic pieces 64 is engaged with the engaging portion 141, and the movement of the cover member 6 to the puncture position again is restricted (see Fig. 10).)”. This argument is not persuasive because Examiner notes that the cited para. 0084 of Imai (corresponding to para. 075 of the provided translated description) explicitly states that movement to the puncture position is again restricted, indicating an initial restriction i.e. locking position and a subsequent restriction. Further, Imai para. 098 and 099 (in the provided translated description) disclose that after the delivery operation, i.e. “after the dispensing tool 10 is separated from the living body” in para. 098, the cover member 6 returns to the puncture preventing position [locking position] where the elastic pieces 64 [needle cover locking feature] engage with the engaging portion 141 [blocking feature]. Therefore, the 102 rejection of claim 22 in view of Imai is maintained.
Examiner suggests more explicitly defining the subject matter of claim 37 to overcome the 102 rejection of Imai.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a needle cover locking feature” in claims 22, 39, and 41
“a deflection feature” in claim 24,
“a blocking feature” in claim 25,
“a movable member” in claim 32,
“a deflection feature” in claim 34,
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.
Regarding “a needle cover locking feature” in claims 22, 39, and 41, 112(f) is invoked because: (i) it uses a generic placeholder (feature), (ii) it is coupled with functional language (needle cover locking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 6a-6b and P.22, lines 13-16 disclose the needle cover lock feature as a ramp or inwardly or radially protruding structure. Examiner is interpreting the limitation as these structures and equivalents thereof.
Regarding “a deflection feature” in claim 24, 112(f) is invoked because: (i) it uses a generic placeholder (feature), (ii) it is coupled with functional language (deflection), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 6a-6b and p.23, lines 20-24 disclose “the distal surface of the lock features is suitable, e.g. in cooperation with a proximal end wall of the guide slot 602 in the inner portion 600, to deflect the locking arms 163 radially outwardly.” Examiner is interpreting the limitation as a proximal end wall or an equivalent structure that cooperates with the lock features to deflect the locking arms radially outwardly.
Regarding “a blocking feature” in claim 25, 112(f) is invoked because: (i) it uses a generic placeholder (feature), (ii) it is coupled with functional language (blocking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 6a-6b and p.22, lines 30-37 disclose “the distal surface of the wall 601 of the inner portion 600 may be contacted by the needle cover lock features 165 to block proximal movement of the needle cover 105.” Examiner is interpreting the limitation as a distal wall of a wall contacting the needle cover lock features or an equivalent structure that contacts the needle cover lock features to block proximal movement of the needle cover.
Regarding “a movable member” in claim 32, 112(f) is invoked because: (i) it uses a generic placeholder (member), (ii) it is coupled with functional language (movable), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 1e and p.10, lines 22-23 disclose “the needle cover spring 119 may be operatively coupled between the needle cover 105 and the collar 117” wherein collar 117 is illustrated in Fig. 1e as a tubular structure that is movable within the drug delivery device. Examiner is interpreting the limitation as this structure and equivalents thereof.
Regarding “a deflection feature” in claim 34, 112(f) is invoked because: (i) it uses a generic placeholder (feature), (ii) it is coupled with functional language (deflection), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 7a-7b and p.26, lines 10-19 discloses the cap 101 comprises a proximal facing surface of an inner tube section 181 which engages the distally facing surface of the needle cover lock feature 165 and allows the needle cover lock arms 163 and features 165 to deflect. Examiner is interpreting the limitation as a proximal facing surface that can deflect the needle cover lock arms radially outward or equivalent structures thereof that may deflect the needle cover lock arms radially outward.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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.
Claims 25-26 and 36 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 25, the phrase “a blocking feature” in lines 2-3 renders the claim indefinite because it is unclear. It is unclear whether this is a different blocking feature or the aforementioned blocking feature in claim 22. Examiner is interpreting it as the same.
Claim 36 recites the limitation "a portion of the main body of the needle cover" in lines 2-3. There is insufficient antecedent basis for “the main body” in the claim. Examiner suggests the claim is amended to recite “movable towards a portion
Regarding claim 26, this claim is rejected due to its dependency upon a rejected base claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 22-29, 31-33, and 35-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Imai et al. (W.O Patent Pub. No. 2014006754 A1, “Imai”).
Regarding claim 22, Imai discloses (Claim 22) an assembly (see Fig. 1-7) for a drug delivery device (10, see Fig. 1-7 and para. 011), comprising: a housing (11 in Fig. 1) having a proximal end (proximal end of 20) and a distal end (distal end of 20, see Fig. 1 and para. 036), wherein a longitudinal axis extends between the proximal end (proximal end of 20) and the distal end (distal end of 20, see annotated Imai drawing 1 below for axis), wherein the housing (11) is adapted to receive and retain a drug reservoir (reservoir of 1 in Fig. 1) and a needle (50 in Fig. 1,see para. 014 – cylinder 1 defines an internal reservoir for storage of drug Q, see para. 013 for needle); and
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a needle cover (6 in Fig. 1-7 and 9 especially) which is movable between at least two different axial positions relative to the housing (11, see para. 063), the at least two different axial positions comprising a locking position (see Fig. 1 and 10) and a non- locking position (Fig. 6, see para. 063 - examiner notes the non-locking position is being interpreted as any position of the needle cover 6 where the protrusions of pieces 64 do not block proximal movement such as in Fig. 6), wherein the needle cover (6) has a needle cover locking feature (64 in Fig. 9) which is arranged to block a proximal movement of the needle cover (6) relative to the housing (11) in the locking position (see Fig. 10) of the needle cover (6, examiner notes the needle cover locking feature is being interpreted under 112(f) as a ramp, an inwardly or radially protruding structure, or an equivalent structure, see Fig. 9-10 and see para. 073-077 – pieces 64 comprise inwardly extending, ramped protrusions at their distal ends and are thus interpreted as the needle cover locking feature), wherein the needle cover (6) is in the locking position (see Fig. 10) after a delivery operation has been performed (see para. 098-099), wherein, in the locking position (see Fig. 10), the needle cover locking feature (64) is configured to abut a blocking feature (141 in Fig. 10) of the housing (11, examiner notes the blocking feature is interpreted under 112(f) as a distal wall of a wall contacting the needle cover lock features or an equivalent structure that contacts the needle cover lock features to block proximal movement of the needle cover, see Fig. 10 and para. 073 and 075 – groove 141 is an equivalent structure in a wall of the body 14 contacting the protrusions of pieces 64 to block proximal movement of cover 6 after the delivery operation), and
wherein the needle cover (6) has an outer surface (outer surface of 61) delimiting an interior of the needle cover (6, see Fig. 9 and para. 065 and annotated Imai drawing 2 below for interior of needle cover), and wherein the needle cover locking feature (64 in Fig. 9) is disposed in the interior of the needle cover (6, see Fig. 9 – the interior of the needle cover 6 is interpreted as the interior chamber defined by the walls 61 and end plate 621).
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Regarding claim 23, Imai discloses (Claim 23) the assembly of claim 22, wherein the needle cover locking feature (64) is movably connected to the needle cover (6, see para. 075 and 098), wherein the needle cover locking feature (64) is radially movable relative to the needle cover (6, see para. 075 and 098), and/or wherein the locking position (see Fig. 10) is distally offset from the non-locking position (see Fig. 6).
Regarding claim 24, Imai discloses (Claim 24) the assembly of claim 22, wherein, when the needle cover (6) is moved towards the locking position (see Fig. 10), the needle cover (6) is arranged to interact with a deflection feature (outer surface of 14) such that, on its way into the locking position, the needle cover locking feature (64 in Fig. 9) is deflected radially outwardly by mechanical cooperation with the deflection feature (outer surface of 14, examiner is interpreting the deflection feature under 112(f) as a proximal end wall or an equivalent structure that cooperates with the lock features to deflect the locking arms radially outwardly, see para. 075 and 080 – when the injection is completed, the needle cover 6 moves from a non-locking position as seen in Fig. 6 to the locking position in Fig. 10 and during this transition each elastic piece 64 is deflected radially outward by the outer surface of body 14, outer surface of body 14 is interpreted as an equivalent structure to a proximal end wall that cooperates with the pieces 64 to deflect them radially outwardly), wherein the assembly comprises a reservoir holder portion (1 in Fig. 1) of the housing (11, see para. 014 – cylinder 1 which defines the internal reservoir for drug Q is interpreted as the reservoir holder portion as it holds the drug Q), and wherein the deflection feature (outer surface of 14) is a feature of the reservoir holder portion (1, see Fig. 6 and para. 073).
Regarding claim 25, Imai discloses (Claim 25) the assembly of claim 22, wherein when the needle cover (6) is in the locking position (see Fig. 10), the needle cover locking feature (64 in Fig. 9) is arranged to cooperate with a blocking feature (141 in Fig. 10) which is axially secured relative to the housing (11) to block proximal movement of the needle cover (6, examiner notes the blocking feature is interpreted under 112(f) as a distal wall of a wall contacting the needle cover lock features or an equivalent structure that contacts the needle cover lock features to block proximal movement of the needle cover, see Fig. 10 and para. 073 and 075 – groove 141 is an equivalent structure in a wall of the body 14 contacting the protrusions of pieces 64 to block proximal movement of cover 6, groove 141 of body 14 are axially secured relative to the housing 11 when no user force is applied to the top plate 81 of the housing 11).
Regarding claim 26, Imai discloses (Claim 26) the assembly of claim 24, wherein the blocking feature (141) and the deflection feature (outer surface of 14) are integrated into a reservoir holder portion (1) of the housing (11, see Fig. 10 and para. 014, 073, and 075 – groove 141 and outer surface of body 14 are both features of the body 14 of cylinder 1 which defines the internal reservoir for drug Q is interpreted as the reservoir holder portion as it holds the drug Q).
Regarding claim 27, Imai discloses (Claim 27) the assembly of claim 22, wherein the needle cover (6) has a sleeve-like portion (62 in Fig. 9) with which the needle cover locking feature (64) is pivotally connected via a pivot portion (see annotated Imai drawing 3 below for pivot portion and para. 0065 – the inner cylinder portion 62 forms a sleeve-like portion where the elastic pieces 64 are pivotally connected via a pivot portion).
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Regarding claim 28, Imai discloses (Claim 28) the assembly of claim 22, wherein the needle cover (6) comprises a connecting portion (63 in Fig. 9, see para. 065), the connecting portion (63) connects the needle cover locking feature (64) to the outer surface (outer surface of 61 in Fig. 9) of the needle cover (6, see Fig. 9 and para. 065), and provides a bearing surface (distal surface of 63) of the needle cover (6, see Fig. 2), wherein the bearing surface (distal surface of 63) is arranged to contact the body of a user of the drug delivery device (see Fig. 2 and para. 087).
Regarding claim 29, Imai discloses (Claim 29) the assembly of claim 22, wherein, when the needle cover (6) is in the non- locking position, the needle cover (6) is movable in the proximal direction relative to the housing (11) towards an intermediate position during, for preparation of, or for initiating a delivery operation of the assembly (see para. 063 - examiner notes the non-locking position is being interpreted as any position of the needle cover 6 where protrusions of pieces 64 do not block needle cover 6 against proximal movement such as in Fig. Fig. 6 and thus needle cover 6 is movable proximally relative to housing 11 towards intermediate positions to prepare for the delivery operation).
Regarding claim 31, Imai discloses (Claim 31) the assembly of claim 29, further comprising a needle cover spring (60 in Fig. 7) which is arranged to bias the needle cover (6) away from the intermediate position (see para. 070 – spring 60 biases needle cover 6 away from the intermediate positions where the needle cover 6 is not locked as seen in Fig. 10).
Regarding claim 32, Imai discloses (Claim 32) the assembly of claim 31, wherein the needle cover spring (60) is operatively coupled between the needle cover (6) and a movable member (83 in Fig. 1) of the assembly (examiner notes the movable member is being interpreted under 112(f) as a tubular structure that is movable within the drug delivery device or an equivalent structure, see para. 048 and 070 – portions 83 form a tubular structure as seen in Fig. 8 with the spring 60 being operatively coupled between the portions 83 and needle cover 6, wherein portions 83 are movable with top plunger 8 of the assembly as it moves in relation to needle cover 6 during the delivery operation).
Regarding claim 33, Imai discloses (Claim 33) the assembly of claim 22, wherein the needle cover (6) is arranged to cover the needle (2) at least in the locking position (see Fig. 10 and para. 099).
Regarding claim 35, Imai discloses (Claim 35) the assembly of claim 22, wherein the needle cover locking feature (64) is covered by the outer surface (outer surface of 61) of the needle cover (6) in a radial direction (see Fig. 9).
Regarding claim 36, Imai discloses (Claim 36) the assembly of claim 23, wherein the needle cover locking feature (64) is radially outwardly movable towards a portion of the main body (61 in Fig. 9) of the needle cover (6) covering the needle cover locking feature (64) in a radial direction (see Fig. 9 and para. 062 – elastic pieces are movable radially outwardly in the radial direction towards a main body 61 of the needle cover 6).
Regarding claim 37, Imai discloses (Claim 37) the assembly of claim 22, wherein the needle cover locking feature (64) is located closer to a distal end of the needle cover (6) than a proximal end of the needle cover (6, see Fig. 9, the base portion of elastic pieces 64 that connect to inner cylinder 61 is located closer to the distal end than the proximal end).
Regarding claim 38, Imai discloses (Claim 38) a drug delivery device (10 in Fig. 1) comprising the assembly of claim 22 (see rejection of claim 22 above and para. 012 further comprising a drug (Q in Fig. 1, see para. 012).
Regarding claim 39, Imai discloses (Claim 39) an assembly for a drug delivery device (10 see Fig. 1-10 and para. 012), comprising:
a housing (11 in Fig. 1) having a proximal end (proximal end of 20) and a distal end (distal end of 20, see Fig. 1 and para. 036), wherein a longitudinal axis extends between the proximal end (proximal end of 20) and the distal end (distal end of 20, see annotated Imai drawing 1 above for axis), wherein the housing (11) is adapted to receive and retain a drug reservoir (reservoir of 1 in Fig. 1) and a needle (50 in Fig. 1,see para. 014 – cylinder 1 defines an internal reservoir for storage of drug Q, see para. 013 for needle); and
a needle cover (6 in Fig. 1-7 and 9 especially) which is movable between at least two different axial positions relative to the housing (11, see para. 063), the at least two different axial positions comprising a locking position (see Fig. 1 and 10) and a non- locking position (Fig. 6, see para. 063 - examiner notes the non-locking position is being interpreted as any position of the needle cover 6 where the protrusions of pieces 64 do not block proximal movement such as in Fig. 6), wherein the needle cover (6) has a needle cover locking feature (64 in Fig. 9) which is arranged to block a proximal movement of the needle cover (6) relative to the housing (11) in the locking position (see Fig. 10) of the needle cover (6, examiner notes the needle cover locking feature is being interpreted under 112(f) as a ramp, an inwardly or radially protruding structure, or an equivalent structure, see Fig. 9-10 and see para. 073-077 – pieces 64 comprise inwardly extending, ramped protrusions at their distal ends and are thus interpreted as the needle cover locking feature), wherein the needle cover (6) is in the locking position (see Fig. 10) after a delivery operation has been performed (see para. 098-099),
wherein the needle cover (6) has an outer surface (outer surface of 61) delimiting an interior of the needle cover (6, see Fig. 9 and para. 065 and annotated Imai drawing 2 below for interior of needle cover), and wherein the needle cover locking feature (64 in Fig. 9) is disposed in the interior of the needle cover (6, see Fig. 9 – the interior of the needle cover 6 is interpreted as the interior chamber defined by the walls 61 and end plate 621), and wherein the needle cover (6) has a sleeve-like portion (62 in Fig. 9) with which the needle cover locking feature (64) is pivotally connected via a pivot portion (see annotated Imai drawing 3 above for pivot portion and para. 0065 – the inner cylinder portion 62 forms a sleeve-like portion where the elastic pieces 64 are pivotally connected via a pivot portion), wherein an interior surface (inner surface of 62) of the sleeve-like portion (62) is radially inwardly offset relative to an interior surface (inner surface of 61) of a radially adjacent portion (61 in Fig. 9) of the needle cover (6, see Fig. 9).
Regarding claim 40, Imai discloses (Claim 40) the assembly of claim 39, wherein the needle cover (6) has a connecting portion (63 in Fig. 9), the connecting portion (63) connects the needle cover locking feature (64) to the outer surface (outer surface of 61) of the needle cover (6, see Fig. 9), and provides a bearing surface (distal surface of 63) of the needle cover (6, see Fig. 2), wherein the bearing surface (distal surface of 63) is arranged to contact the body of a user of the drug delivery device (10, see Fig. 2 and para 087).
Regarding claim 41, Imai discloses (Claim 41) an assembly for a drug delivery device (10 see Fig. 1-10 and para. 012), comprising:
a housing (11 in Fig. 1) having a proximal end (proximal end of 20) and a distal end (distal end of 20, see Fig. 1 and para. 036), wherein a longitudinal axis extends between the proximal end (proximal end of 20) and the distal end (distal end of 20, see annotated Imai drawing 1 above for axis), wherein the housing (11) is adapted to receive and retain a drug reservoir (reservoir of 1 in Fig. 1) and a needle (50 in Fig. 1,see para. 014 – cylinder 1 defines an internal reservoir for storage of drug Q, see para. 013 for needle); and
a needle cover (6 in Fig. 1-7 and 9 especially) which is movable between at least two different axial positions relative to the housing (11, see para. 063), the at least two different axial positions comprising a locking position (see Fig. 1 and 10) and a non- locking position (Fig. 6, see para. 063 - examiner notes the non-locking position is being interpreted as any position of the needle cover 6 where the protrusions of pieces 64 do not block proximal movement such as in Fig. 6), wherein the needle cover (6) has a needle cover locking feature (64 in Fig. 9) which is arranged to block a proximal movement of the needle cover (6) relative to the housing (11) in the locking position (see Fig. 10) of the needle cover (6, examiner notes the needle cover locking feature is being interpreted under 112(f) as a ramp, an inwardly or radially protruding structure, or an equivalent structure, see Fig. 9-10 and see para. 073-077 – pieces 64 comprise inwardly extending, ramped protrusions at their distal ends and are thus interpreted as the needle cover locking feature), wherein the needle cover (6) is in the locking position (see Fig. 10) after a delivery operation has been performed (see para. 098-099),
wherein the needle cover (6) has an outer surface (outer surface of 61) delimiting an interior of the needle cover (6, see Fig. 9 and para. 065 and annotated Imai drawing 2 below for interior of needle cover), and wherein the needle cover locking feature (64 in Fig. 9) is disposed in the interior of the needle cover (6, see Fig. 9 – the interior of the needle cover 6 is interpreted as the interior chamber defined by the walls 61 and end plate 621), and wherein a connecting portion (63 in Fig. 9) of the needle cover (6) connects the needle cover locking feature (64) to the outer surface (outer surface of 61) of the needle cover (6, see Fig. 9), and provides a bearing surface (distal surface of 63) of the needle cover (6, see Fig. 2, see para. 087),
wherein the bearing surface (distal surface of 63) is arranged to contact the body of a user of the drug delivery device (10, see Fig. 2 and para 087).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Imai in view of Dunn (U.S Patent Pub. No. 20130197475 A1).
Regarding claim 30, Imai discloses the assembly of claim 29, as discussed above.
While Imai discloses a drive mechanism comprising a plunger rod (7 and 8 in Fig. 1, see para. 032), however Imai fails to disclose (Claim 30) a drive spring which drives the plunger rod during the delivery operation of the assembly. Examiner notes Imai discloses that the user manually depresses an actuator (11) to drive the plunger rod (7 and 8, see para. 087-088).
Dunn discloses an injector (1000 in Fig. 44-49) comprising a drug reservoir (1002 in Fig. 46) and a movable needle shield (1550 in Fig. 48), wherein the injector (1000) comprises a drive mechanism including a drive spring (1003 in Fig. 44 and 46) and a plunger rod (1121 in Fig. 44 and 46) which, when released, is driven distally relative to the housing (1001 in Fig. 44 and 46) under the action of the drive spring (1003) during the delivery operation of the assembly (see para. 0139 and 0148).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drive mechanism taught by Imai to be automated such that it comprises a drive spring driving the plunger rod as taught by Dunn according to known methods to yield predictable results. Dunn discloses that auto-injectors are well known in the art for the delivery of liquids, and thus the plunger being depressed by an energy source which is often a compression spring is also a well-known drive mechanism in the art. Thus, one of ordinary skill in the art could have automated the manual drive mechanism of Imai to have the spring-driven drive mechanism taught by Dunn to yield predictable results of an auto-injector.
Allowable Subject Matter
Claim 34 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Tschirren et al. (U.S Patent Pub. No. 20160325044 A1, “Tschirren”) and Imai et al. (W.O Patent Pub. No. 2014006754, “Imai”).
Tschirren discloses an assembly for a drug delivery device (see Fig. 1-4 and para. 0040 – a distal needle assembly is illustrated for an autoinjector), comprising:
a housing (2 in Fig. 1a) having a proximal end and a distal end (see Fig. 1a for distal end and see para. 0040 for proximal end), wherein a longitudinal axis (“L” in Fig. 1b) extends between the proximal end and the distal end (see Fig. 1b and para. 0040), wherein the housing (2) is adapted to receive and retain a drug reservoir (13 in Fig. 1a) and a needle (13a in Fig. 1a, see para. 0042); and
a needle cover (3 in Fig. 3a-3b) which is movable between at least two different axial positions relative to the housing (2, see para. 0044), the at least two different axial positions comprising a locking position (Fig.1a-1b) and a non- locking position (Fig. 4a4b, see para. 0048 for locking position, see para. 0051 for non-locking position – examiner notes the non-locking position is being interpreted as any position of the needle cover 3 where arm 31 is not blocked against proximal movement such as in Fig. 4a-4b), wherein the needle cover (3) has a needle cover locking feature (31 in Fig. 3a) which is arranged to block a proximal movement of the needle cover (3) relative to the housing (2) in the locking position (see Fig. 1a-1b) of the needle cover (3, examiner notes the needle cover locking feature is being interpreted under 112(f) as a ramp, an inwardly or radially protruding structure, or an equivalent structure, see Fig. 1a-1b and para. 0044 – arm 31 comprises a cam 33 which is an inclined, radially protruding structure thus making the arm a locking feature with a contact surface 32 which abuts a stop 21 to block proximal movement of the needle cover 3),
wherein the needle cover (3) has an outer surface delimiting an interior of the needle cover (3, see annotated Tschirren drawing 1 above for outer surface and interior), and wherein the needle cover locking feature (31) is disposed in the interior of the needle cover (3, see annotated Tschirren drawing 1 above for outer surface and interior).
While Tschirren discloses a cap (4 in Fig. 1-2) which does interact with the needle cover locking feature (31), Tschirren fails to disclose that the cap (4) can remain mounted and the needle cover (3) is able to move proximally. Instead, Tschirren discloses that the cap (4) must be removed in order for proximal movement of the needle cover (3) to occur (see para. 048-0050). Tschirren cannot be modified to have a cap that remains mounted for a priming state to be reached where the needle cover is able to move proximally as it would alter the intended use of the device of Tschirren which consists of the cap (4) blocking movement of the needle cover (3) when it is mounted (see Fig. 1a-1b).
Imai discloses an assembly (see Fig. 1-7) for a drug delivery device (10, see Fig. 1-7 and para. 011), comprising:
a housing (11 in Fig. 1) having a proximal end (proximal end of 20) and a distal end (distal end of 20, see Fig. 1 and para. 036), wherein a longitudinal axis extends between the proximal end (proximal end of 20) and the distal end (distal end of 20, see annotated Imai drawing 1 below for axis), wherein the housing (11) is adapted to receive and retain a drug reservoir (reservoir of 1 in Fig. 1) and a needle (50 in Fig. 1,see para. 014 – cylinder 1 defines an internal reservoir for storage of drug Q, see para. 013 for needle); and
a needle cover (6 in Fig. 1-7 and 9 especially) which is movable between at least two different axial positions relative to the housing (11, see para. 063), the at least two different axial positions comprising a locking position (see Fig. 1 and 10) and a non- locking position (Fig. 6, see para. 063 - examiner notes the non-locking position is being interpreted as any position of the needle cover 6 where the protrusions of pieces 64 do not block proximal movement such as in Fig. 6), wherein the needle cover (6) has a needle cover locking feature (64 in Fig. 9) which is arranged to block a proximal movement of the needle cover (6) relative to the housing (11) in the locking position (see Fig. 10) of the needle cover (6, examiner notes the needle cover locking feature is being interpreted under 112(f) as a ramp, an inwardly or radially protruding structure, or an equivalent structure, see Fig. 9-10 and see para. 073-077 – pieces 64 comprise inwardly extending, ramp protrusions at their distal ends and thus are interpreted as the needle cover locking feature),
wherein the needle cover (6) has an outer surface (outer surface of 61) delimiting an interior of the needle cover (6, see Fig. 9 and para. 065 and annotated Imai drawing 2 above for interior of needle cover), and wherein the needle cover locking feature (64 in Fig. 9) is disposed in the interior of the needle cover (6, see annotated Imai drawing 2 below).
However, Imai fails to disclose a cap structure for the drug delivery device.
There is no reference that teaches or discloses the cap and assembly as claimed in claim 34.
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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