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
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.
Claims 1, 2, 11, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1).
In relation to independent claim 1, this claim recites: “An ampoule for delivering a fluid directly to a patient, the ampoule comprising: a body portion which is compressible to expel fluid from the ampoule, and a connector for fitting the ampoule to a cannula or a hollow needle to deliver fluid therethrough.” Claim 1 is rejected in the following manner:
An ampoule for delivering a fluid directly to a patient.
Ferreri II discloses a patient-connected delivery container but calls it a “manually deformable liquid container,” (Ferreri II ¶ [0034]) rather than an ampoule. Ferreri II states: “The method according to one embodiment comprises providing a VAD delivery device having a manually deformable liquid container, a male luer connector, and a one-way valve,” and further states that “The distal end of the VAD is placed in a blood vessel of a patient.” (Ferreri II ¶ [0012].) Ferreri II therefore discloses the direct patient-facing delivery context but does not expressly call its container an ampoule. Levinson fills that nomenclature and structure gap, stating: “Generally, the invention is a flexible Single-use ampoule, preferably having an opening with a Luer Lock connector fitting, which can be directly attached to indwelling venous lines for infusion of a sterile medical fluid.” (Levinson, col. 1, ll. 13–16.)
a body portion which is compressible to expel fluid from the ampoule.
Ferreri II discloses manual deformability and collapse: “The term ‘deformable’ refers to a wall or container that is structured to be flexible enough to collapse at least partially into the inner chamber under manual depression.” (Ferreri II ¶ [0032].) Levinson confirms the squeeze-to-expel arrangement in an ampoule: “the sides 14 and 15 of ampoule 10 are squeezed together forcing the medicinal fluid from container body 11 through channel 30, through the Luer Lock connectors and into the venous line.” (Levinson, col. 4, ll. 18–21.)
a connector for fitting the ampoule to a cannula or a hollow needle to deliver fluid therethrough.
Ferreri II discloses a male luer that connects to a patient-side vascular access device: “The male luer connector 25 projects from the outlet 80 on the distal end 60 of the container 20” and “is engagable with a luer connector of a VAD.” (Ferreri II ¶ [0034].) The Ferreri II disclosure expressly includes “catheters” and “hubbed needles” among the articles attached by a luer connector. (Ferreri II ¶ [0031].) To the extent this does not expressly label the primary device an ampoule attached to a hollow needle, Levinson fills the gap: “ampoule 10 can be connected to devices other than an indwelling venous line such as hypodermic needles, or other body structures to infuse the contents of ampoule 10 into the body or its structures.” (Levinson, col. 4, ll. 21–25.)
Motivation to combine.
Both references address sterile, prefilled medical-fluid devices that avoid a separate syringe transfer and use standardized luer interfaces. Ferreri II describes a deformable container delivering through a luer-connected vascular access device, while Levinson expressly teaches an ampoule directly connected to an indwelling line or hypodermic needle. A person of ordinary skill would have been motivated to adopt Levinson’s expressly named ampoule and direct line/needle application in Ferreri II’s anti-reflux luer delivery architecture to provide a sterile, prefilled direct-delivery ampoule with predictable luer interoperability and reduced intermediate handling.
In relation to claim 2, this claim recites: “An ampoule according to claim 1, wherein the ampoule further comprises a valve to prevent fluid flow into the ampoule.” Claim 2 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a valve to prevent fluid flow into the ampoule.
Ferreri II expressly discloses the required anti-reflux function: “The one-way valve 30 is configured to prevent fluid flow in the direction outside the inner chamber 40 to inside the inner chamber 40 when the container 20 is manually deformed and released.” (Ferreri II ¶ [0034].) Ferreri II further teaches that the valve “is sealed within the luer path” and is configured to limit flow “from within the container 20 to the vascular access connector.” (Ferreri II ¶ [0036].)
Motivation to combine.
Ferreri II expressly identifies prevention of fluid return into a manually deformable container as the purpose of its one-way valve. Adding that disclosed valve arrangement to the direct luer ampoule arrangement of claim 1 would predictably prevent reflux and preserve the desired outward-only fluid flow during direct administration.
In relation to claim 11, this claim recites: “An ampoule according to claim 1, wherein the body portion comprises a plastic material, and/or an elastomeric material.” Claim 11 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the body portion comprises a plastic material, and/or an elastomeric material.
Ferreri II expressly teaches the claimed material class: “The container may be made of any suitable thermoplastic elastomer and may be pre-filled with a solution.” (Ferreri II ¶ [0010].) Levinson independently describes the claimed flexible ampoule body as the part whose sides are compressed to urge medicinal fluid from the body. (Levinson, col. 3, ll. 60–65.)
Motivation to combine.
Selecting a thermoplastic elastomer for the manually deformable portion is expressly taught by Ferreri II and provides the expected flexibility needed for the squeeze-to-expel function of the Levinson ampoule. The material selection is directly aligned with the delivery container’s disclosed use.
In relation to claim 14, this claim recites: “An ampoule according to claim 1, wherein the connector is either: a luer slip fitting, or a luer lock fitting.” Claim 14 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a luer slip fitting, or a luer lock fitting.
Ferreri II expressly supplies both alternatives: “the VAD delivery device 10 may include a male luer connector 25 of a luer-lock or luer-slip design.” (Ferreri II ¶ [0039].) Levinson independently discloses a luer-lock connector on a flexible ampoule. (Levinson, col. 1, ll. 13–23.)
Motivation to combine.
Ferreri II identifies luer-lock and luer-slip as known fitting alternatives for the exact delivery-container interface. Employing either familiar luer fitting in the claim 1 ampoule is a predictable standard-interface selection that achieves compatible, leak-resistant medical-fluid connection.
In relation to claim 16, this claim recites: “An ampoule according to claim 1, wherein the fluid is an injectable medicament.” Claim 16 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the fluid is an injectable medicament.
Ferreri II discloses a flush solution but does not expressly label the solution an injectable medicament. Levinson fills the gap by identifying a medicinal fluid in a flexible ampoule connected to a patient line: “Generally, the invention is a flexible Single-use ampoule … directly attached to indwelling venous lines for infusion of a sterile medical fluid of various types and doses in a measured dose fashion.” (Levinson, col. 1, ll. 13–23.) Levinson further identifies “a medicinal fluid” as the preferred content of its container body. (Levinson, col. 2, ll. 15–16.)
Motivation to combine.
Ferreri II teaches a prefilled medical-fluid container directly attached to a vascular access device, while Levinson teaches a sterile medicinal fluid in a flexible luer ampoule used for infusion. Substituting a medicinal fluid for the Ferreri II flush solution would have been a predictable use of the same luer-connected, squeeze-delivery platform for direct drug administration.
In relation to claim 17, this claim recites: “An apparatus for delivering fluid to a patient, the apparatus comprising: an ampoule according to claim 1; and a cannula or a catheter.” Claim 17 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
an ampoule according to claim 1; and a cannula or a catheter.
Ferreri II's delivery device expressly operates with a patient-side vascular access device, and Ferreri II identifies the relevant patient-access structures: “Vascular Access Devices (VADs) are commonly used therapeutic devices and include intravenous catheters, syringes, extension sets, stop cocks, tubing, high pressure extension tubing, and needleless access devices.” (Ferreri II ¶ [0002].) Ferreri II further teaches that the luer connector is attached after the vascular access device’s distal end is placed in a patient’s blood vessel. (Ferreri II ¶ [0042].) Levinson supplies the ampoule of the base combination.
Motivation to combine.
Ferreri II expressly teaches use with intravenous catheters as part of a patient-side vascular access device. Combining that disclosed catheter/vascular-access-device environment with Levinson’s direct luer ampoule is the ordinary, expressly described way to administer a medical fluid through a patient access line.
Claims 3, 4, 5, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1), as discussed above with respect to claim 1, and in further view of Bane (US3340869A).
In relation to claim 3, this claim recites: “An ampoule according to claim 1, wherein the body portion is configured to maintain a compressed state after a compressing force has been applied.” Claim 3 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the body portion is configured to maintain a compressed state after a compressing force has been applied.
Neither Ferreri II nor Levinson expressly states that its container remains compressed after the compressing force is removed. Bane fills that gap. Bane states that one part of its collapsible bellows “has an inherent over-center bias which provides yielding resistance to initial displacement thereof out of the said inverted fully collapsed position.” (Bane, col. 1, ll. 40–60.) Bane further teaches: “During insertion of the needle, it remains in a stable collapsed condition due to its said inherent over-center bias.” (Bane, col. 1, ll. 49–53.)
Motivation to combine.
A stable post-compression configuration is a predictable modification to a manually deformable drug-delivery container because it reduces rebound and backflow after a dose is delivered. Bane expressly supplies that stability by an over-center bellows bias. Incorporating that known bellows behavior into the Ferreri II/Levinson delivery container would provide the claimed retained compressed state while maintaining the same squeeze-to-deliver function.
In relation to claim 4, this claim recites: “An ampoule according to claim 1, wherein the body portion comprises: a rigid portion, and a flexible portion, wherein the body portion is compressible by applying pressure to the flexible portion.” Claim 4 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a rigid portion, and a flexible portion.
Ferreri II and Levinson disclose deformable containers but do not expressly distinguish comparatively rigid and flexible body portions in the claimed relationship. Bane fills that gap. Bane explains that its bellows has two walls and that “The wall 10 is structurally stiffer than the wall 9 and undergoes relatively little deformation during the collapse of the end section 9, 10.” (Bane, col. 2, ll. 33–36.) It also teaches that “The relatively greater deformability of the wall 9 as compared with the wall 10 may be achieved in various ways.” (Bane, col. 2, ll. 41–43.)
the body portion is compressible by applying pressure to the flexible portion.
Bane describes a lower-force wall as the collapsible element: “the wall 9 of the end section is resiliently deformed … into the collapsed position … against the inner surface of the wall 10.” (Bane, col. 2, ll. 29–33.) This expressly supplies a flexible/collapsible portion relative to a stiffer portion.
Motivation to combine.
A skilled person would have been motivated to use Bane’s relatively deformable wall and structurally stiffer supporting wall in the Ferreri II/Levinson container to make manual fluid expression more controlled while preserving structural integrity. Bane itself identifies the different stiffnesses as a way to control which wall collapses under an applied force, a directly relevant and predictable benefit.
In relation to claim 5, this claim recites: “An ampoule according to claim 4, wherein either: the rigid portion and the flexible portion comprise the same material, or the rigid portion and the flexible portion comprise different materials.”
Base rejection incorporated.
The proposed rejections of claims 1 and 4 are incorporated herein.
either … the same material … or … different materials.
The operative wording covers the complete set of possible material relationships between two portions and does not select a material pair, an arrangement, or a performance result beyond the rigid/flexible structure already recited in claim 4. The Bane structure supplies differently stiff walls; Bane also discloses that “Suitable plastics materials for the ampoule 4 and stud 5 include nylon polymers, polyethylene, polypropylene and Surgical grades of polyvinyl chloride.” (Bane, col. 2, ll. 56–58.) Ferreri II independently teaches that “The container may be made of any suitable thermoplastic elastomer.” (Ferreri II ¶ [0010].) Thus, the cited art expressly makes conventional material selection available to the skilled person, while the asserted same-or-different alternative does not require a selected relationship beyond claim 4.
Motivation to combine.
The selection of one material or different materials for comparatively flexible and stiff portions was a routine materials choice informed by stiffness, compatibility, manufacturability, and sterility. The cited references expressly teach thermoplastic-elastomer and plastic material choices for the relevant delivery structures.
In relation to claim 6, this claim recites: “An ampoule according to claim 1, wherein the body portion is preferentially compressible in one dimension.” Claim 6 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the body portion is preferentially compressible in one dimension.
The Ferreri II/Levinson combination does not expressly identify preferential one-dimensional compression. Bane fills that gap by describing an independently collapsible bellows section under axial force: “The end section 9, 10 of the ampoule bellows is of larger diameter than the remaining bellows sections 11 and consequently is independently collapsible by applying against the end surface 12 of the stud 5 an axial force which is smaller than that required to collapse the said remaining bellows sections.” (Bane, col. 2, ll. 22–27.)
Motivation to combine.
Using a body that responds preferentially to an axial squeezing force would provide a predictable means to control deformation and dose delivery. Bane teaches exactly that relative-force relationship between bellows portions. Applying it to the manually deformable Ferreri II/Levinson ampoule would improve controlled expression without changing the direct luer-delivery principle.
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1) and Bane (US3340869A), as discussed above with respect to claims 1 and 6, and in further view of Brandenburger (US20160151240A1).
In relation to claim 7, this claim recites: “An ampoule according to claim 6, wherein the body portion is generally tubular with an elliptical cross-section.” Claim 7 has been rejected in the following manner:
Base rejection incorporated.
The proposed rejections of claims 1 and 6 are incorporated herein.
the body portion is generally tubular with an elliptical cross-section.
The base combination does not expressly disclose an elliptical cross-section. Brandenburger fills that gap: “The ampoule body 10 has a basic shape which is substantially elliptic in cross section and of which the ratio of breadth D to width E is not equal to 1 and in particular is at least approximately constant independently of the nominal capacity.” (Brandenburger ¶ [0078].) This describes an ampoule body having an essentially elliptical base form in cross-section, with an unequal width-to-depth ratio.
Motivation to combine.
Brandenburger teaches an expressly elliptical ampoule-body cross-section in the same medical-ampoule field. Incorporating that known form into the Bane-controlled, manually deformable delivery body would have been a predictable shape selection to obtain the claimed non-circular body geometry and facilitate the directional deformation addressed in claim 6.
In relation to claim 12, this claim recites: “An ampoule according to claim 1, wherein the ampoule tapers towards a first end and wherein liquid is expelled from the ampoule through the first end.” Claim 12 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the ampoule tapers towards a first end.
The Ferreri II/Levinson combination does not expressly describe an ampoule body tapering toward an end. Brandenburger fills that geometry gap by stating “in such a way the ampoule body, starting from the central portion, thus tapers toward both ends substantially to a point. This corresponds approximately to the shape of a ship's hull, hence the expression ship-shape
body.” (Brandenburger ¶ [0025].) The verified disclosure therefore expressly provides tapering from the central section toward each end, including toward a first end.
liquid is expelled from the ampoule through the first end.
Ferreri II discloses the fluid outlet at a container end: “The container 20 defines an inner chamber 40 and has a distal end 60, a proximal end 70, and an outlet 80 on the distal end 60.” (Ferreri II ¶ [0034].) It further teaches that force deforms the container so flush solution flows through the valve into the patient-side vascular access device. (Ferreri II ¶ [0042].)
Motivation to combine.
Brandenburger teaches a tapered medical ampoule body; Ferreri II teaches an outlet at the distal, patient-facing end of a deformable container. Using Brandenburger’s known taper with Ferreri II’s distal outlet would have been a predictable geometrical adaptation for guiding liquid toward the dispensing end while preserving the proven direct-delivery fluid path.
Claims 8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1), as discussed above with respect to claim 1, and in further view of Trude et al. (US20070045221A1; hereinafter “Trude”).
In relation to claim 8, this claim recites: “An ampoule according to claim 1, further comprising a circumferential ridge around the body portion for stiffening the body portion.” Claim 8 has been rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a circumferential ridge around the body portion for stiffening the body portion.
Ferreri II and Levinson do not expressly disclose a circumferential body ridge having the claimed stiffening function. Trude fills that limitation at the container-sidewall level. Trude states: “container 10 includes a reinforcing ring 24 that extends from sidewall 16 around the circumference of container 10.” (Trude ¶ [0027].) Trude then expressly identifies the stiffening result: “Reinforcing ring 24 can increase the hoop strength of sidewall 16 without significantly reducing the top load capacity of container 10.” (Trude ¶ [0027].) Trude further teaches that the reinforcing ring “may comprise a crease that is formed in sidewall 16.” (Trude ¶ [0029].) Thus, Trude describes a body-circumferential reinforcing ridge formed in the container sidewall and functioning to strengthen that sidewall.
Motivation to combine.
Ferreri II/Levinson provides the manually deformable direct-delivery ampoule arrangement. Trude addresses the closely related mechanical container-body problem of increasing sidewall hoop strength while retaining a container body. A person of ordinary skill would have had reason to use Trude’s known circumferential sidewall reinforcement in the Ferreri II/Levinson container to resist undesired sidewall distortion during handling, filling, connection, or storage while preserving an available manually deformable region for fluid expression. The modification is a predictable container-wall reinforcement.
In relation to claim 10, this claim recites: “An ampoule according to claim 8, wherein either: the circumferential ridge is formed of a different material to the body portion, or the circumferential ridge is formed of the same material as the body portion.” Claim 10 has been rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 8 is incorporated herein.
the circumferential ridge is formed of … the same material as the body portion.
Claim 10 is written in the disjunctive: a ridge formed of a different material or a ridge formed of the same material as the body portion. The incorporated Trude combination expressly teaches the same-material alternative. Trude states that its “reinforcing ring 24 may comprise a crease that is formed in sidewall 16.” (Trude ¶ [0029].) Trude also explains that the ring may comprise “a first portion of the sidewall and a second portion of the sidewall that are folded over one another.” (Trude ¶ [0029].) The claimed same-material branch is therefore met by Trude’s ridge made from the container sidewall itself. Trude’s sidewall-derived crease/fold construction is not relied on to prove the separate different-material branch, which need not be shown where the claim expressly recites alternatives.
Motivation to combine.
Trude’s sidewall-crease construction offers a predictable unitary way to incorporate the claim-8 reinforcement into a manually deformable ampoule body without adding a separate material or attachment operation. Applying that known unitary container-sidewall reinforcement to the Ferreri II/Levinson arrangement would provide the same predictable hoop-strength benefit identified for claim 8 while simplifying fabrication and preserving the base device’s direct-delivery architecture.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1), as discussed above with respect to claim 1, and in further view of Caldwell et al. (US20130084367A1; hereinafter “Caldwell”).
In relation to claim 9, this claim recites: “An ampoule according to claim 8, wherein the circumferential ridge is a planar flange which extends outwardly from the ampoule.” Claim 9 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein. The Caldwell disclosure below supplies both claim 8’s circumferential stiffening-ridge requirement and claim 9’s planar, outwardly extending flange requirement.
a circumferential ridge around the body portion for stiffening the body portion; a planar flange which extends outwardly from the ampoule.
The Ferreri II/Levinson combination does not expressly disclose the added geometry or stiffening function. Caldwell fills both. It teaches that its “container portion preferably includes a flange extending substantially continuously around the receptacle” and that the flange “is generally planar.” (Caldwell ¶ [0012].) It further states: “The flange 26 extends generally radially from the edge 40.” (Caldwell ¶ [0056].) Most specifically, Caldwell states that “the generally planar flange 26 extending outwardly from the perimeter 40 of the receptacle also functions to stiffen the receptacle region of the cup portion.” (Caldwell ¶ [0058].) The same paragraph identifies a cup portion sufficiently pliable to be deflected by hand squeezing, while the flange stiffens the receptacle region. (Caldwell ¶ [0058].) These passages expressly provide a perimeter-circumferential, outwardly extending, generally planar flange having the required stiffening function.
Motivation to combine.
Caldwell teaches a specific outward, planar perimeter-flange profile that stiffens a container region while the container remains sufficiently pliable for hand squeezing. A person of ordinary skill in the art seeking the body reinforcement of claim 8 in the Ferreri II/Levinson manual-delivery container would have had reason to select that known flange profile to add predictable body stiffness and a handling surface while preserving a deformable body portion.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1), as discussed above with respect to claim 1, and in further view of Ward (US20170354792A1).
In relation to claim 13, this claim recites: “An ampoule according to claim 1, further comprising a tamper evident closure.” Claim 13 has been rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
a tamper evident closure.
Ferreri II discloses a molded cap sealing the luer connector but does not expressly identify it as tamper-evident: The molded cap may be configured to encase the male luer connector 25 and seal the inner chamber of the container. (Ferreri II ¶ [0038].) Ward fills the missing tamper-evidence function, stating: “The above-listed needs are met or exceeded by the present tamper evident syringe tip cap, engageable on a conventional syringe male Luer lock, which features a visible tamper evident feature, that once breached, prevents reuse of the cap, and provides a visible condition indicator to the medial practitioner that the syringe has been accessed and is no longer sterile.” (Ward ¶ [0004].)
Motivation to combine.
Both Ferreri II and Ward concern a cap on a male luer medical connection. Adding Ward’s visible, nonreusable tamper-evident cap feature to Ferreri II’s molded luer cap would provide the predictable benefit Ward identifies: a user can determine that the sterile connection has been accessed. This improves sterility assurance without altering the container’s fluid-delivery mechanics.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1), as discussed above with respect to claim 1, and in further view of Ferreri et al. (US20180280631A1; hereinafter “Ferreri”).
In relation to claim 15, this claim recites: “An ampoule according to claim 1, wherein the ampoule is made of a single material.” Claim 15 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
the ampoule is made of a single material.
Neither Ferreri II nor Levinson expressly states that the complete ampoule is made of a single material. Ferreri fills that gap: “The deformable container 20, tip 27 and primer element 30 may be made of thermoplastic elastomers, natural rubber, synthetic rubber, thermoplastic materials, or other easily disposable and/or recyclable material and combinations thereof. … It is envisioned that in one or more embodiments, the delivery device 10 of the present invention may be made of a single material to facilitate recycling of the device.” (Ferreri ¶ [0071].)
Motivation to combine.
Ferreri expressly identifies single-material construction as facilitating recycling. A person of ordinary skill would have been motivated to apply that known recyclable construction to the Ferreri II/Levinson deformable direct-delivery ampoule to reduce material separation and disposal complexity while retaining the same luer delivery function.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ferreri et al. (WO2014004655A1; hereinafter “Ferreri II”) in view of Levinson (US6379342B1), as discussed above with respect to claim 1, and in further view of Unsworth et al. (EP0612255B1; hereinafter “Unsworth”).
In relation to claim 18, this claim recites: “An apparatus for delivering fluid to a patient, the apparatus comprising: an ampoule according to claim 1; and a hollow needle.” Claim 18 is rejected in the following manner:
Base rejection incorporated.
The proposed rejection of claim 1 is incorporated herein.
an ampoule according to claim 1; and a hollow needle.
Levinson identifies an ampoule that may be connected to “hypodermic needles” to infuse the contents into a body. (Levinson, col. 4, ll. 21–25.) To the extent Levinson does not expressly describe the hypodermic needle as hollow, Unsworth supplies that direct fluid-conduit needle disclosure: “At one end of the body there is located an injection needle having a fluid conduit passing therethrough, the needle of the kind well known in the art.” (Unsworth, Description, col. 2, p. 2, right column, starting in line 25.) Unsworth also describes the direct combination: “the needle is inserted into the patient and the ampoule is squeezed to express its contents through the needle into the patient.” (Unsworth, Description, col. 2, p. 2, right column, lines 19-21.)
Motivation to combine.
Levinson already teaches the luer ampoule’s connection to a hypodermic needle. Unsworth expressly teaches a needle with a fluid conduit and squeezing a deformable ampoule to deliver its contents through the needle to a patient. Applying Unsworth’s known fluid-conduit needle to Levinson’s luer-connected ampoule is a predictable implementation of direct injection and supplies the expressly recited hollow-needle fluid path.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
Prosecution Insights