DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Heinz et al (US 6,485,474).
Regarding claim 1, Hamilton discloses an arrangement, comprising: a cannula assembly comprising a cannula 27 and a sealing element 30, the cannula comprising an outside channel opening (distal end of cannula), the cannula assembly configured to be connected to a receptacle 10, the sealing element comprising at least one face side which, in a mounted position, faces the receptacle (fig 3) and comprises a passage (passage in sealing element through which needle passes, fig 3) surrounded by an annular region 31 which forms a face-side sealing surface in a plane perpendicular to a center axis of the sealing element (fig 3); and an adapter 18 configured to connect the cannula assembly with the receptacle such that the sealing element contacts the receptacle (fig 3; sealing element 30 contacts end 14 of receptacle).
While Hamilton substantially discloses the invention as claimed, it does not disclose a closure cap comprising a sealing, wherein the channel opening of the cannula protrudes into the sealing of the closure cap thus sealing the channel opening, wherein due to at least one of a radial compression or an axial compression of the sealing element, as well as due to sealing of the channel opening by the closure cap, a chamber of the receptacle is sealed in a fluid-tight manner when connected to the cannula assembly.
Heinz discloses a closure cap 5 comprising a sealing 6, wherein the channel opening of the cannula 4 protrudes into the sealing of the closure cap thus sealing the channel opening (fig 1), wherein due to sealing of the channel opening by the closure cap, a chamber of the receptacle is sealed in a fluid-tight manner when connected to the cannula assembly (Col.1 ll 24-29).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that it includes a closure cap comprising a sealing, wherein the channel opening of the cannula protrudes into the sealing of the closure cap thus sealing the channel opening, wherein due to at least one of a radial compression or an axial compression of the sealing element, as well as due to sealing of the channel opening by the closure cap, a chamber of the receptacle is sealed in a fluid-tight manner when connected to the cannula assembly as taught by Heinz to protect the needle tip and syringe contents.
Regarding claim 2, wherein the adapter is in the form of an elongated hollow body with an axial passage opening (fig 2), a proximal end 19, and a distal end 23, wherein an inside diameter of the passage opening is expanded at the proximal end of the adapter and represents a retainer configured to hold the sealing element (figs 2 and 3).
Regarding claim 15, while Hamilton substantially discloses the invention as claimed, it does not disclose wherein at least one of the cannula protrudes relative to the sealing element approximately 0.1 mm to 3 mm on a side of the face-side sealing surface; or the cannula has a protrusion relative to the sealing element on an opposite side of the sealing element within a range of approximately 0.6 cm to approximately 5 cm.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine an appropriate cannula projection relative to the sealing element to allow injections and various depths, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Claim(s) 3-10, 13, 14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Heinz et al (US 6,485,474) and Iwase (US 10,406,289).
Regarding claim 3, wherein, in the mounted position, the cannula assembly is inserted into the retainer and seals a through-channel of the receptacle when the adapter is connected with the receptacle, and wherein, in the mounted position, the cannula communicates with the chamber (fig 3).
While Hamilton substantially discloses the invention as claimed, it does not disclose the proximal end of the adapter includes an outside thread as part of a Luer-Lock connection which is configured to connect with an inside thread of the receptacle.
Luer-locks are notoriously known in the art as medical connectors to allow connection to a variety of devices.
Iwase demonstrates such a connection via adapter 60 and cannula assembly 90 being connected to a syringe/receptacle 30 (figs 1a and 1b).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that the proximal end of the adapter includes an outside thread as part of a Luer-Lock connection which is configured to connect with an inside thread of the receptacle as taught by Iwase to allow both the adapter and receptacle to connect to other Luer-Lock equipped devices (and to allow the cannula assembly to be swapped off the receptacle if it becomes damaged or contaminated).
Regarding claim 4, further comprising the receptacle comprising a tip connected to the cannula assembly (fig 3), the receptacle comprising a body having a proximal end and a distal end (fig 3), wherein the distal end has an axial through-channel with the tip surrounding the through-channel (fig 3), wherein the sealing element comprises a cylindrically symmetric sealing element with an axial passage (fig 3, 31 is described as generally cylindrical – Col.2 ll 19), wherein the cannula is arranged coaxially relative to the sealing element and at least in sections inside the axial passage of the sealing element (fig 3), wherein one section of an outside surface area of the cannula is connected firmly with the sealing element in at least one of a material seal or a form fitting manner and wherein at least one face side of the sealing element (such as 25) includes a circular region surrounding the passage (Col.2 ll 31-44), wherein the region forms a face-side sealing surface in a plane vertical to a center axis of the sealing element (fig 3).
While Hamilton substantially discloses the invention as claimed, it does not disclose wherein the distal end has an inside thread as part of a Luer-Lock connection.
Luer-locks are notoriously known in the art as medical connectors to allow connection to a variety of devices.
Iwase demonstrates such a connection via adapter 60 and cannula assembly 90 being connected to a syringe/receptacle 30 (figs 1a and 1b).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that the proximal end of the adapter includes an outside thread as part of a Luer-Lock connection which is configured to connect with an inside thread of the receptacle as taught by Iwase to allow both the adapter and receptacle to connect to other Luer-Lock equipped devices (and to allow the cannula assembly to be swapped off the receptacle if it becomes damaged or contaminated).
Regarding claim 5, while Hamilton substantially discloses the invention as claimed, it does not disclose in the mounted position, a contact pressure of the sealing element onto a face side of the tip is at least 0.1 N to 30 N. (which is essentially at least 0.1 N)
As can be see from fig 3 of Hamilton the two structures contact to create a seal (especially as the tip compresses the sealing element).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine an appropriate contact pressure to prevent leakage of fluid, and since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Regarding claim 6, wherein the face-side sealing surface comprises a truncated cone shaped protrusion (see 25 in figs 3-5) which surrounds the passage and which engages at least in sections with the through-channel or protrudes into the through-channel (fig 3, Col.2 ll 26-31).
Regarding claim 7, wherein an angle between the center axis and an outside surface line of the truncated cone shaped protrusion is at least 1º (fig 3).
Regarding claim 8, wherein the adapter comprises an extension 10 at its distal end that is configured to attach and hold the closure cap (see combination in claim 3, Iwase has internal threads on an extension 41 in fig 1A).
Regarding claim 9, while Hamilton substantially discloses the invention as claimed, it does not disclose wherein the receptacle is fabricated from a transparent material.
Heinz discloses the notoriously well-known property that transparent material allows visual inspection of the contents (Col.5 ll 19-20).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that the receptacle is fabricated from a transparent material as suggested by Heinz to allow visual inspection of the receptacle’s contents.
Regarding claim 10, while Hamilton substantially discloses the invention as claimed, it does not disclose wherein the transparent material comprises a thermoplastic synthetic material comprising or consisting of a cyclo-olefin-copolymer (COC), a cyclo-olefin-polymer (COP), acrylonitrile-butadiene-styrene (ABS), polyamide (PA), poly-lactate (PLA), polymethylmethacrylate (PMMA), polycarbonate (PC) or polyethylene-terephthalate (PET).
Iwase discloses the plastics of the device may include polycarbonate (Col.9 ll 45).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that the receptacle since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 227 F.2d 197. 125 USPQ 416 (CCPA 1960).
Regarding claim 13, further comprising at least one of a liquid or a fluid at least partially filling the receptacle (Col.2 ll 38-43).
While Hamilton substantially discloses the invention as claimed, it does not disclose wherein the cannula has a gauge size of greater than 30 G.
Iwase discloses use of a needle with a gauge of preferably 30-33 (Col.6 ll 35-37).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton to determine an appropriate size for the needle for a particular use, especially since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Regarding claim 14, wherein the receptacle is a syringe with a syringe body (fig 1).
Regarding claim 16, while Hamilton substantially discloses the invention as claimed, it does not disclose wherein the cannula has a gauge size of 27 G to 34 G.
Iwase discloses use of a needle with a gauge of preferably 30-33 (Col.6 ll 35-37).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton to determine an appropriate size for the needle for a particular use, especially since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Heinz et al (US 6,485,474), Claussen et al (US 2008/0228161) and Iwase (US 10,406,289).
Regarding claim 11, while Hamilton substantially discloses the invention as claimed, it does not disclose wherein the transparent material comprises a thermosetting synthetic material comprising or consisting of a cellulose-acetate (CA) or a thermosetting resin.
Claussen discloses using cellulose acetate as an indicator layer in a syringe to deliver DMSO to indicate if the syringe is compromised (¶44).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that the transparent material comprises a thermosetting synthetic material comprising or consisting of a cellulose-acetate (CA) as part of designing the syringe to deliver a particular medication.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hamilton (US 3,035,616) in view of Heinz et al (US 6,485,474), Kimura et al (US 2018/0257975) and Iwase (US 10,406,289).
Regarding claim 12, while Hamilton substantially discloses the invention as claimed, it does not disclose wherein the transparent material comprises a borosilicate glass having the following composition (in weight %): SiO2 65% to 82%; B2O3 5% to 13%; ∑ Na2O + K2O 4% to 10%; Al2O3 2% to 9%; and ∑ CaO + MgO + BaO + SrO 0% to 5%.
Kimura discloses all of the chemicals in overlapping ranges and reasons to move the particular percentages up or down based on desired properties (¶67 especially and ¶68-¶89 for specific details).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hamilton such that the transparent material comprises borosilicate glass with the claimed composition as taught by Kimura as part of customizing the receptacles desired properties (such as hydrolytic resistance - ¶72 of Kimura).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,865,319. Although the claims at issue are not identical, they are not patentably distinct from each other because they are generally broader, with the exception of the pending claims requiring an adapter. Said adapter is obvious in view of Hamilton and Iwase (see above) to allow the cannula assembly to attach (preferably removably) to a syringe/medical device.
Response to Arguments
Applicant’s arguments with respect to all claim(s) 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.
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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783