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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/24/26 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment and Acknowledgements
The amendment filed 01/29/26 has been entered. Claims 1, 5-7, 9-11, 16, 23, 25 have been amended. Claims 8, 14, 17, 20, 27, and 30-31 are in the original/ previously presented form. Claims 2-4, 12-13, 15, 18-19, 21-22, 24, 26, and 28-29 are cancelled. Thus, claims 1, 5-11, 14, 16-17, 20, 23, 25, 27, and 30-31 remain pending in the application. Applicant’s amendments to the Specification, Drawings, and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 10/29/25.
The current Application appears to recite the “distal” direction as a “rearward” direction toward a location where a user would grip the device (see ‘Modified FIG. 2’ below and at least [0056]: an open distal end 216 of the housing 210).
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Claim Objections
Claims 1, 7, 23, and 25 are objected to because of the following informalities:
Claim 1 in the last line of the claim reads “the opening of the gasket” and should likely read “[[the]] an opening of the gasket” to provide antecedent basis for the gasket opening which has not yet been recited in the claim language
Claim 7 in the first line reads “wherein the the opening of the gasket” and should likely read “wherein the [[the]] opening of the gasket” because a duplicate “the” appears to have been inadvertently kept in the claim language causing grammatical issues
Claim 23 line 7 reads “inserting a distal end of a spacer into opening of the lock cap” and should likely read “inserting a distal end of a spacer into the opening of the lock cap” for grammatical reasons and to provide antecedent basis for opening
Claim 25 line 1 reads “The method of claim 24” and should likely read “The method of claim [[24]] 23” because claim 24 has been cancelled
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 9, & 23, 25, and 27 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 6, line 3 reads “the main face defining the opening” but it is unclear which “opening” (see claim 1 reciting at least a syringe barrel opening, a sleeve opening, a gasket opening, etc.) Applicant refers to. Claim 1 recites the opening achieving the function “configured to coaxially align” being the gasket opening. Therefore, the examiner interprets claim 6 line 3 to read “the main face defining the gasket opening”.
Next regarding claim 6, Claim 6 recites the limitations “the body” and "the opening of the body" in lines 2 and 4, respectively. There is insufficient antecedent basis for this limitation in the claim. Because claim 6 used to depend from claim 5, it appears that the “body” may be referring to the “generally planar body” of the lock cap as recited in claim 5. Therefore for purposes of examination, the examiner interprets that claim 6 still depend from claim 5 in order to provide antecedent basis for “body”. Lastly, “the opening of the body” seems to refer to the opening of the lock cap (see claim 5 reciting the planar body integral with the lock cap annular wall, which forms the opening of the lock cap as recited in claim 1). Therefore, for purposes of examination, the examiner interprets claim 6 line 4 to read “the opening of the [[body]] lock cap”.
Regarding claim 9, Claim 9 recites the limitations “the body” in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. Because a body is recited in claim 5, from which claim 6 is interpreted to depend, the examiner interprets that claim 9 still depend from claim 6 instead of claim 1.
Regarding claim 23, Claim 23 recites the limitation “the opening of the body” in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim. There are multiple openings recited in claim 23 (i.e.: syringe opening and lock cap opening). Therefore, it is unclear to the examiner if the opening of the body refers to one of the previously recited openings or to a new opening of a body. Because the generally planar body forms the lock cap, it seems likely that the opening of the body refers to the same opening of the lock cap because the body forms the lock cap. Therefore, for purposes of examination, the examiner interprets claim 23 line 16 to read “the opening of the [[body]] lock cap”.
Due to claim dependency, claims 25 and 27 are subsequently rejected under 112b.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5-7, 9-10, 14, 16, 20, 23, 25, 27, and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLoughlin et al. (U.S. PGPUB No. 2015/0258278), hereinafter Mcloughlin.
Regarding claim 1, Mcloughlin discloses a cassette for a drug delivery device, the cassette comprising: a cassette (see FIG. 1) for a drug delivery device (see [0008]: cassette unit comprising a syringe), the cassette comprising:
a sleeve (30, see FIG.3 for all subsequently cited numerals unless otherwise specified) having a proximal end and a distal end (see ‘Modified FIG. 3’ below)
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having an opening (see [0017-0018], [0054-0055], [0314]: sleeve receives syringe such as through opening on distal end shown in exploded view of FIG. 3), the sleeve (30) further comprising a lock cap (40) having an annular wall (43) extending around an opening (41, lock cap opening 41, see FIG. 12 and [0323]) thereof;
a syringe (10) disposed in (see [0314]) the sleeve (30), the syringe (10) comprising a barrel (12, see [0309]) having a distal opening (opening of flange 16 where 60 is received as shown in the exploded view of FIG. 3) coaxially aligned (all components as shown in FIG. 3 are coaxially aligned) with the opening (where sleeve 30 receives syringe) of the distal end (see ‘Modified FIG. 3’ above) of the sleeve (30), wherein the lock cap (40) of the sleeve (30) is configured to secure (see FIG. 13 with cap 40 enclosing end of sleeve and thus “configured to secure” syringe in sleeve such that the syringe cannot fall out the distal opening of the sleeve. see [0312]: end cap 40 seats syringe and [0326-0327]: end cap 40 comprising end cap spring secure syringe within device) the syringe (10) in the sleeve (30);
a plunger-stopper (18, see FIG. 13) slidably disposed (see [0309]: 18 has axial movement==slidably disposed) within the barrel (12);
a spacer (60) having a proximal end (67, see FIG. 14A) and a distal end (63, see FIG. 14A), the distal end (63) configured to be inserted into the opening (41) of the lock cap (40) to couple (see FIG. 13 with diameter of distal end 63 being smaller than the diameter of the lock cap opening 41. Therefore, the dimensions of the spacer distal end 43 allow the spacer distal end to be “configured to be inserted into” the opening 41 of the lock cap 40 to couple the spacer to sleeve by way of the syringe as shown in FIG. 13) the spacer (60) to the sleeve (30), the distal end (63) of the spacer (60) adapted to be engaged by a plunger rod of a drive mechanism (see [0320]: 63 has recess for receipt of drive transfer element==a plunger rod) to uncouple (see [0322] and [0325]: spacer 60 uncouples from sleeve via cap 40 when axial force delivered and is therefore “adapted to be engaged by the plunger rod” to uncoupled the spacer from the sleeve) the spacer (60) from the sleeve (30) and slide (see [0321]: spacer 60 slides in barrel) the spacer (60) within the barrel (12) to engage the plunger-stopper (18) with the proximal end (67) thereof (as seen in at least FIG. 13), wherein the spacer (60, see FIG. 12) further comprises a neck portion (69, see FIG. 14A and [0325]: a trough 69) disposed between (as seen best in FIG. 14A), and having a reduced diameter relative to (see FIG. 14A and [0325]), the proximal (67) and distal (62) ends thereof to define a space (see [0325]: 69 described as a ‘trough’ and therefore reasonably defines “a space” in the open annular area surrounding the spacer circumferentially from 69);
the distal end (63) of the spacer (60) configured to engage an interior surface (see [0327]: lock cap annular wall 42/43 engages wall 62 of spacer) of the annular wall (43), wherein the opening (41, see FIG. 13) of the lock cap (43) is defined by a portion (flat surface of cap in which the opening/ through hole is formed) of the lock cap (40) that extends over (see FIG. 13, cap 40 extends circumferentially over syringe barrel 12) the distal opening (opening of flange 16 where 60 is received as shown in the exploded view of FIG. 3 and in FIG. 13) of the barrel (12) such that the spacer (60) is configured to couple to the lock cap (40, see FIG. 13 and [0325]: lock cap 40 and spacer 60 coupled by way of annular wall 43 of lock cap 40 engaging trough 69 of spacer 60. See also [0322-0323]: cap 40 receives drive rod to move spacer and see [0325]: 60 releasable engages cap 40); and
a gasket (45, see [0327]: 45 of a polymeric material and thus reasonably a “gasket”) configured to couple to (see [0327]: 45 seated in cap 40) the lock cap (40), the gasket (45) configured to coaxially align (as seen in FIG. 12 & 13) with the opening (41) of the lock cap (40) to allow the distal end (63) of the spacer (60) to be inserted through (see FIG. 2. Spacer 60 with smaller internal diameter than 45 and therefore is configured to be inserted through coaxially alignment of 48) the opening (48) of the gasket (45).
Regarding claim 5, Mcloughlin discloses the cassette of claim 1, and Mcloughlin further discloses wherein the portion (flat surface of cap in which the opening/ through hole is formed) of the lock cap (40) comprises a generally planar body (see ‘Modified FIG. 12’ below),
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and the annular wall 943) of the lock cap (41) is integral with (see [0325]: an inner facing rim of the end cap 40—thus all components formed as one==an integral lock cap piece 40 as seen in FIG. 12) the generally planar body (see ‘Modified FIG. 12’ above).
Regarding claim 6, Mcloughlin discloses the cassette of claim [[1]]5, and Mcloughlin further discloses wherein the gasket (45, see FIG. 12) includes a main face (46) extending along (see [0327]: 46 is flat profile of 45 and seats against inner end wall of 40) an interior surface (flat internally facing surface of body shown in ‘Modified FIG. 12’ above) of the body (see generally planar body in ‘Modified FIG. 12’ above), the main face (46) defining the gasket opening (48) configured to coaxially align (as seen in FIG. 12 and 13) with the opening (41) of the [[body]] lock cap (40).
Regarding claim 7, Mcloughlin discloses the cassette of claim 1, and Mcloughlin further discloses wherein the the opening (48, see FIG. 13) of the gasket (45) has a diameter sized so that portions (face of 46, see [0327]: 45 sized and shaped to fit about skirt 42 and about circumferential wall 62 of 60 and see FIG. 13 with face 46 of 45 shown extending into the plane of the annular space defined by 69) of the main face (46) extend into (see FIG. 13 with portions of 46 within annular space of trough 69) the space (space formed by 69) between the proximal (67) and distal (63) ends of the spacer (60).
Regarding claim 9, Mcloughlin discloses the cassette of claim [[1]]6, and Mcloughlin further discloses wherein the gasket (45, see FIG. 15A) comprises one or more rims (49) extending away (face of 49 directed radially outward/ “away” distally directed distal face 46) from the main face (46), the rims (49) including lips (see annular surface of 49) configured to engage (see [0327]: 49 enables coupling with 40 by interacting with pegs 44) the body (40) to couple the gasket (45) thereto.
Regarding claim 10, Mcloughlin discloses the cassette of claim 1, and Mcloughlin discloses further comprising a cover (see ‘Modified FIG. 23d’ below)
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configured to couple adjacent to (see Fig. 23c for further visual) the distal end of the sleeve (see ‘Modified FIG. 23d’ above) with the lock cap (40) disposed proximal of the cover (as seen in ‘Modified FIG. 23d’ above), the cover including an opening extending therethrough and an annular wall extending around the opening and extending in a proximal direction (as seen in ‘Modified FIG. 23d’ above), such that the annular wall of the cover extends around the annular wall of the lock cap (where drive rod is inserted as seen in ‘Modified FIG. 23d’ above).
Regarding claim 14, Mcloughlin discloses the cassette of claim 1, and Mcloughlin further discloses wherein the proximal end (67, see FIG. 13) of the spacer (60) has (a) a diameter approximately equal to a diameter (see FIG. 13: both plunger stopper 18 and spacer 60 including proximal end 67 disposed within syringe barrel 12 and thus all components have “approximately” equal diameters because all must be disposed in same barrel) of the plunger-stopper (18) and/or (b) one or more grooves extending along an outer surface thereof (recitation of “or” does not require both limitations).
Regarding claim 16, Mcloughlin discloses the cassette of claim 1, and Mcloughlin further discloses wherein the distal end (63, see FIG. 14A) of the spacer (60) (a) includes a plurality of ribs extending radially outwardly therefrom, the plurality of ribs providing an outer diameter from the distal end to frictionally engage the lock cap (recitation of “or” does not require both limitations), and/or (b) is configured to be coplanar (along plane as shown in ‘Modified FIG. 2i’ below)
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with a distal end surface (distal end surface of arm 31 extending from sleeve 40, see [0337] and FIG. 3 for secondary visual) of the lock cap (40) with the spacer (60) coupled thereto (see [0325]: spacer coupled to sleeve via cap 40).
Regarding claim 20, Mcloughlin discloses the cassette of claim 1, and Mcloughlin discloses further comprising (a) an outer housing (20, see FIG. 3) configured to movably receive (see [0314]) the sleeve (30) and syringe (10) therein, and/or (b) a therapeutic product (see [0309]) in the syringe (10).
Regarding claim 23, Mcloughlin discloses a method for preparing a cassette for an autoinjector, the method comprising:
disposing a plunger-stopper (18, see FIG. 13) within a barrel (12, see FIG. 3 for all subsequent numerals unless otherwise specified) of a syringe (10, see [0309]);
disposing the syringe (10) within a sleeve (30), the sleeve (30) comprising a lock cap (40) comprising an opening (41, see FIG. 12) and an annular wall (43) extending therearound (as shown in FIG. 12), the lock cap (40) configured to secure (see FIG. 13 with cap 40 enclosing end of sleeve and thus “configured to secure” syringe in sleeve such that the syringe cannot fall out the distal opening of the sleeve. see [0312]: end cap 40 seats syringe and [0326-0327]: end cap 40 comprising end cap spring secure syringe within device) the syringe (10) in the sleeve (30);
inserting a distal end (63, see FIG. 13) of a spacer (60) into (see FIG. 13) opening (41) of the lock cap (40) to couple the spacer thereto (see FIG. 13 and [0320-0326]: spacer 60 inserted into syringe and coupled to sleeve and housing via cap and therefore coupled to cap), the opening (41) being aligned with a distal opening (opening of flange 16 where 60 is received as shown in the exploded view of FIG. 3) of the barrel (12) of the syringe (10) to coaxially align (all components as shown in FIG. 3 are coaxially aligned) the spacer (60) with the barrel (12) of the syringe (10), the spacer (60, see FIG. 12) further comprising a proximal end (67) and a neck portion (69, see FIG. 14A and [0325]: a trough 69) disposed between (see FIG. 14A) and having a reduced diameter (see FIG. 14A) relative to the proximal (67) and distal (63) ends to define a space therebetween (see [0325]: 69 described as a ‘trough’ and therefore reasonably defines “a space” in the open annular area surrounding the spacer circumferentially from 69),
wherein the distal end (63) of the spacer (60) is configured to engage an interior surface (see [0325]: inner facing rim of 43 engages rim 61 at distal end 63 of spacer) of the annular wall (43), wherein the spacer (60) is configured to couple to (see FIG. 13 and [0320-0326]: spacer 60 inserted into syringe and coupled to sleeve and housing via cap and therefore coupled to cap) the lock cap (40),
the lock cap (40) comprising a generally planar body (see ‘Modified FIG. 12’ below)
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and a gasket (45) configured to couple thereto (see [0327]: 46 is flat profile of 45 and seats against inner end wall of 40), the gasket (45) configured to coaxially align (as seen in FIG. 12 & 13) with the opening (41) of the [[body]] lock cap (40) to allow the distal end (63) of the spacer (60) to be inserted through (see FIG. 2. Spacer 60 with smaller internal diameter than 45 and therefore is configured to be inserted through coaxially alignment of 48) the opening (48) of the gasket (45).
Regarding claim 25, Mcloughlin discloses the method of claim 24, and Mcloughlin further discloses wherein inserting the distal end (63) of the spacer (60) into an opening (43, see FIG. 12 and [0327]: spacer 60 within opening of cap 40) of the lock cap (40) further comprises inserting the distal end (63) into a cavity (see opening through 43) defined by the annular wall (43) of the lock cap (40), the distal end (63) configured to frictionally engage an interior surface (see [0327]: lock cap annular wall 42/43 engages wall 62 of spacer) of the annular wall (43), wherein inserting the distal end (63) of the spacer (60) into the cavity (opening through 43) defined by the annular wall (43) further optionally comprises inserting the distal end (63) of the spacer (60) through the opening (48, see FIG. 12) of the gasket (45) or (or does not require the following limitations) through an opening of a tubular member coupled to the body of the lock cap such that a portion (see [0327]: 45 sized and shaped to fit about skirt 42 and about circumferential wall 62 of 60 and see FIG. 13 with face 46 of 45 shown extending into the plane of the annular space defined by 69) of the gasket (45) or the tubular member (or does not require the limitation) extends into the space (space of 69, see FIG. 14A and [0325]: a trough 69) between the distal end (63) of the spacer (60) and the proximal end (67) of the spacer (60).
Regarding claim 27, Mcloughlin discloses the method of claim 23, and Mcloughlin discloses further comprising:
(a) selecting the spacer based on a size of the plunger-stopper and a size of a proximal end of the spacer,
(b) selecting the sleeve (see [0017]: selection of a sleeve occurs and thus there must be at least two sleeves to provide selection therefrom. See also [0272]) based on a size of an interior bore defined by one or more interior walls of the sleeve and a diameter of the barrel of the syringe (see [0056-0057], [0270], and [0272]: sleeve selected with interior to match the diameter of the syringe barrel), and/or (recitation of “or” only requires one of the three limitations)
(c) filling the syringe with a therapeutic product.
Regarding claim 30, Mcloughlin discloses a method of assembling a cassette for a drug delivery device, the method comprising:
selecting a syringe having a barrel with an outer diameter (see [0017]: a sleeve is selected to accommodate multiple syringe diameter sizes and therefore a syringe must also be selected. See also [0049], [0272]);
selecting a sleeve from first and second sleeves (see [0017]: selection of a sleeve occurs and thus there must be at least two sleeves to provide selection therefrom. See also [0272]), the first and second sleeves having a common outer configuration (see [0013]: cassette has same geometry and thus sleeve inserted therein must have the same outer configuration to engage each same cassette as in [0017]), common outer dimensions (see [0013] & [0017]), and internal bores defined by one or more walls (see internal bore and wall of sleeve 30 shown in cross-section view of at least FIG. 2) having different diameters (see [0056-0057], [0270], and [0272]: internal cavity of sleeve accepts the syringe of different size and therefore the internal bore MUST have different diameter for accepting syringe), the selection of the sleeve comprising selection of one of the first and second sleeves having an internal bore sized to support the barrel of the syringe (see [0056-0057], [0270], and [0272]);
inserting the syringe (10, see FIG. 3) into the sleeve (30, see FIG. 3 and [0272]: sleeve is interfitted with syringe); and
inserting the syringe (10) and sleeve (30) into a housing (50, see FIG. 3 and [0272]: sleeve and syringe installed into cassette unit), the housing (50) configured to couple to the common outer configuration of the first and second sleeves (see [0272]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Mcloughlin as applied to claim 7 above, and further in view of Runfola (U.S. PGPUB No. 2008/0021389).
Regarding claim 8, Mcloughlin discloses the cassette of claim 7, and Mcloughlin further discloses wherein the gasket (45, see FIG. 12) includes an extension (47) arrayed about (see FIG. 15A for visual clarity) the opening (48) defined in the main face (46), the extension (47) at least partially extending into (see [0327]: 45 sized and shaped to fit about skirt 42 and about circumferential wall 62 of 60. see FIG. 13 with 45 compressed such that extensions 47 extending into the plane of the annular space defined by 69) the space (69, see FIG. 13) between the proximal (67) and distal (63) ends of the spacer (60).
Mcloughlin is silent to wherein the gasket “includes teeth arrayed about and extending radially into the opening defined in the main face, the teeth” at least partially extending into the space between the proximal and distal ends of the spacer.
However, Runfola teaches a safety syringe with a gasket (132, see FIG.7) having an opening and a gasket main face (see ‘Modified FIG. 7’ below)
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wherein the gasket (132) includes teeth (134) arrayed about and extending radially into the opening defined in the main face (see ‘Modified FIG. 7’ above and [0025-0027]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gasket disclosed in Mcloughlin to include teeth arrayed about and extending radially into the opening defined in the main face as taught by Runfola for the purpose of easing or opposing movement of retractable components within the device (see [0025-0027]), which would be advantageous in Mcloughlin that has the spacer and plunger rod moving within the gasket opening, thus achieving wherein the gasket “includes teeth arrayed about and extending radially into the opening defined in the main face, the teeth” at least partially extending into the space between the proximal and distal ends of the spacer.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Mcloughlin as applied to claim 5 above, and further in view of Mcloughlin et al. (U.S. PGPUB No. 2017/0000955), hereinafter Mcloughlin2.
Regarding claim 11, Mcloughlin discloses the cassette of claim 1, but Mcloughlin is silent to “wherein (a) the lock cap comprises a tubular member including the annular wall and further comprises a generally planar body having an annular configuration, the tubular member coupled to the body with the annular wall extending through the body, and the lock cap optionally including a flange extending along the body, the body and tubular member overmolded together with connection posts of the tubular member extending from the annular wall of the lock cap through openings in the body, wherein the tubular member includes one or more projections that extend radially inward from the annular wall of the lock cap, the projections sized to at least partially extend into the space between the proximal and distal ends of the spacer.”
However, Mcloughlin2 teaches a cassette unit (see FIG. 3) comprising a lock cap (45) and a spacer (60), wherein (a) the lock cap (45, seen best in FIG. 12) comprises a tubular member (48) including an annular wall (thickness of 46a, see FIG. 15b) and further comprises a generally planar body (thickness of 46a is generally flat/planar as shown in Cross-sectional view of FIG. 15b) having an annular configuration (ring-like shape shown in cross-section of FIG. 15a), the tubular member (48) coupled to (via posts 44a) the body (flat body thickness of 46a) with the annular wall (thickness of 46a) extending through the body (thickness of annular wall forms body and thus “extends through” the flat portion as shown in FIG. 15b), and the lock cap optionally (optionally does not require the following recitations) including a flange extending along the body, the body and tubular member overmolded together with connection posts of the tubular member extending from the annular wall of the lock cap through openings in the body, wherein the tubular member (48, see FIG. 15a and [0371]) includes one or more projections (47) that extend radially inward (as seen in FIG. 15a) from the annular wall (46, see FIG. 15a and [0371]) of the lock cap (45), the projections (47) sized to at least partially extend into (see FIG. 13 and [0371]) the space (annular space around 69) between (see FIG. 13) the proximal (67) and distal (63) ends of the spacer (60).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the lock cap disclosed in Mcloughlin to include a tubular member including an annular wall and projections extending into the space between the proximal and distal ends of the spacer as taught by Mcloughlin2 for the purpose of maintaining full insertion depth (see [0369]) and providing a dampening effect for the syringe to and should any shock impact occur (see [0370-0371]), thus achieving “wherein (a) the lock cap comprises a tubular member including the annular wall and further comprises a generally planar body having an annular configuration, the tubular member coupled to the body with the annular wall extending through the body, and the lock cap optionally including a flange extending along the body, the body and tubular member overmolded together with connection posts of the tubular member extending from the annular wall of the lock cap through openings in the body, wherein the tubular member includes one or more projections that extend radially inward from the annular wall of the lock cap, the projections sized to at least partially extend into the space between the proximal and distal ends of the spacer.”
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mcloughlin as applied to claim 1 above, and further in view of Flather et al. (U.S. PGPUB No. 2019/0358403), hereinafter Flather.
Regarding claim 17, Mcloughlin discloses the cassette of claim 1, and Mcloughlin further discloses wherein the spacer (60, see FIG. 13) has a cup-shaped configuration (60 is cylindrically shaped and therefore is “cup-shaped”) with a distal end wall (63), wherein the distal end wall optionally (“optionally” does not require the limitation) defines one or more vent openings extending therethrough.
Mclouglin is silent to the spacer has “a cavity having an opening extending through the proximal end”
However, Flather teaches a cassette unit (see FIG. 2) with a spacer (220) comprising a spacer proximal end (232), wherein the spacer (220) includes a cavity (240, see [0042]: spacer cavity bore) having an opening extending through the proximal end (see FIG. 2 and [0041-0042]: spacer has cavity bore==hole through entire component).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spacer disclosed in Mcloughlin to include a cavity having an opening extending through the spacer proximal end as taught by Flather for the purpose of providing the spacer to the plunger rod to adjust to the volume of pharmaceutical agent provided in the syringe (see [0047]), thus achieving “a cavity having an opening extending through the proximal end”.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Mcloughlin as applied to claim 30 above, and further in view of Doyle (U.S. PGPUB No. 2005/0101917).
Regarding claim 31, Mcloughlin discloses the method of claim 30, but Mcloughlin is silent to “wherein the internal bores of the first and second sleeves are defined by an array of radial ribs extending within an interior of the sleeve.”
However, Doyle teaches a sleeve (20, see FIG. 2A) for receiving a syringe (as shown in FIG. 1), wherein an internal bore (bore forms internal surface 30, see FIG. 2A) of the sleeve (20) is defined by an array of radial ribs extending within an interior of the sleeve (20, see FIG. 2A and [0051-0052]: guide rails/ longitudinal ribs provide on inside surface 30 of sleeve).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the internal bores of the first and second sleeves disclosed in Mcloughlin to be defined by an array of radial ribs extending within an interior or the sleeve as taught by Doyle for the purpose of facilitating insertion of the syringe into the sleeve (see [0052]), thus achieving “wherein the internal bores of the first and second sleeves are defined by an array of radial ribs extending within an interior of the sleeve.”
Response to Arguments
Applicant's arguments filed 01/29/26 have been fully considered but they are not persuasive.
On page 11 of Applicant remarks, Applicant submits that Mcloughlin fails to disclose “a gasket that coaxially aligns with the opening of the lock cap to allow the distal end of the spacer to be inserted through the opening of the gasket” and therefore the 35 U.S.C. § 102 claim rejections under Mcloughlin should be withdrawn. Applicant does not appear to elaborate on why Mcloughlin fails to disclose this limitation. Therefore, the examiner disagrees and has maintained the claim rejections. The examiner maintains that the structure 45 identified as Mcloughlin’s gasket is reasonably a ”gasket” because 45 is formed of a polymeric material and would therefore be able to be compressed to form a seal between two components (see definition of gasket according to Collins dictionary). The examiner also maintains the gasket “coaxially aligns with the opening of the lock cap to allow the distal end of the spacer to be inserted through the opening of the gasket” as explained in the rejection of at least claim 1 above. Thus, the examiner has maintained the rejections of the claims including claims 1 and 23.
Next on page 12, Applicant submits that Mcloughlin fails to disclose an internal bore of the sleeve and therefore the 35 U.S.C. § 102 claim rejection of claim 30 under Mcloughlin should be withdrawn. The examiner disagrees and has maintained the claim rejection. The examiner cites FIG. 2 for the internal bore of the sleeve and the examiner maintains that the sleeve has an internal bore because if the sleeve did not have an internal bore, Mcloughlin’s device would not function to retain the syringe therein as shown in at least FIG. 2 (see also FIG. 3 and 13 as cited for other claim rejections such as claims 1 and 23). Therefore, the examiner was not persuaded by this argument.
On pages 12-13, Applicant argues that Mcloughlin fails to disclose inserting the syringe into the internal bore of the sleeve. However, this argument does not align with the breadth of the claims. Claim 30 requires “inserting the syringe into the sleeve”. Therefore, the examiner maintains that a sleeve fitting over the outside of the barrel of the syringe (as argued by Applicant) meets the limitation as claimed because the claim only requires that “inserting the syringe into the sleeve”, not inserting the syringe into the internal bore of the sleeve.
Next, on pages 12-13, Applicant argues that Mcloughlin fails to disclose “sleeves with internal bores of different diameters to accommodate different syringe sizes”. However, this argument does not align with the breadth of the claims. Claim 30 requires “selecting a sleeve from first and second sleeves, the first and second sleeves having…internal bores…” Therefore, the examiner maintains that Mcloughlin discloses selecting a sleeve and meets the limitation as claimed because the claim only requires that “selecting a sleeve” from a first and second sleeve having internal bores. Thus, the selection of a sleeve & sleeve adapter combination as disclosed in Mcloughlin meets the limitation as claimed.
Lastly, on pages 12-13, Applicant argues that Mcloughlin fails to discloses the internal walls/ribs of the sleeve such as in the current Application. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. sleeve ribs) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Because no further arguments were presented, all depending claim rejections were subsequently maintained by the examiner.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE FARRELL whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE FARRELL/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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