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 .
Applicant' s arguments, filed 1/23/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 1/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 54-64 are the currently pending claims hereby under examination. Claims 40-53 have been canceled; and claims 60-64 have been newly added.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 60-64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 60 recites that the beveled distal surface includes a “bevel angle” (line 1), and that the bevel angle “remains the same” (line 2) in both the first configuration and the second configuration. The specification does not describe any bevel angle, does not describe measuring or defining such an angle, and does not describe maintaining the same bevel angle during the transformation between the first and second configurations. (Instant Application, ¶[0100]-¶[0101]; the term "bevel" only appears in the following context: "the distal end portion can include a tip with a sharp point (e.g., a beveled tip) configured to pierce a portion of the patient" (Instant Application, [0048])).
Claims 61-63 are rejected by virtue of their dependence from claim 60.
Claim 61 recites that “opposing sidewalls of the beveled distal surface are configured to connect along a central, vertical plane” (lines 1-2) in the first configuration, and further recites that “a width of the beveled distal surface is smaller in the first configuration than in the second configuration” (lines 3-4). The specification describes a distal tip 724 that is transformable between a first configuration (FIG. 29) and a second configuration (FIG. 30), where in the first configuration the distal tip 724 “can be substantially closed” such that “the lumen 723 is substantially obstructed”, and in the second configuration the distal tip 724 transforms to an open configuration such that the lumen 723 is “substantially unobstructed”. (Instant Application, ¶[0100]-¶[0101]; FIGS. 29-30). Thus, the disclosure supports the general concept of a substantially closed distal tip in a first configuration and a more open distal tip in a second configuration, and FIGS. 29-30 visually suggest a larger interior opening region in FIG. 30 than in FIG. 29. However, the specification does not describe opposing sidewalls of a beveled distal surface, does not describe a closure mechanism in which opposing sidewalls connect along any plane, and does not describe any “central, vertical plane” as a structural constraint. Further, the disclosure does not define or describe a “width of the beveled distal surface” as a parameter that is smaller in the first configuration than in the second configuration. Accordingly, the originally filed disclosure does not reasonably convey possession of the specific “central, vertical plane” sidewall connection and “width of the beveled distal surface” limitations recited in claim 61. (Instant Application, ¶[0100]-¶[0101]; FIGS. 29-30).
Claims 62 is rejected by virtue of its dependence from claim 61.
Claim 62 recites that “a length of the beveled distal surface remains the same” (lines 1-2) in both configurations. The specification does not describe any length of a beveled distal surface, does not describe measuring such length, and does not describe maintaining such length while transitioning configurations. Further, FIGS. 29-30 do not clearly and unequivocally depict that any defined “length of the beveled distal surface” remains the same during the transformation as a disclosed design constraint, rather than being an inference drawn from an illustrative depiction. (Instant Application, ¶[0100]-¶[0101]).
Claim 63 recites that the beveled distal surface is configured to open and close “along a single axis” (line 2) when transitioning between the first and second configurations. The specification does not describe any axis of motion for the transformation, and FIGS. 29-30 do not clearly and unequivocally depict that the opening and closing occurs along a single axis as a disclosed kinematic constraint. (Instant Application, ¶[0100]-¶[0101]).
Claim 64 recites that “only the beveled distal surface of the needle changes configuration” (lines 1-2) when transitioning between configurations. The specification describes the distal tip 724 as being transformable and does not describe that only a beveled distal surface changes configuration while all other portions of the needle remain unchanged. (Instant Application, ¶[0100]-¶[0101]). Similarly, figures 29 and 30 depict the area between the distal surface and tubular lumen as distorting between configurations to account for the change in shape of the distal surface (Instant Application, FIG. 29-30). The term “only” affirmatively requires that the configuration change is limited to the beveled distal surface to the exclusion of other portions of the needle. The specification does not reasonably convey possession of this exclusivity, because the written description and figures indicate that portions adjacent the distal surface are also deformed to achieve the transition. Therefore, claim 64 lacks written description support under 35 U.S.C. 112(a).
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.
Claim 64 is 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.
Claim 64 recites that “only the beveled distal surface of the needle changes configuration” (lines 1-2) when transitioning between configurations. However, the claim also recites transitioning between a configuration in which the beveled distal surface is closed and a configuration in which the beveled distal surface defines an opening such that the lumen is unobstructed by the beveled distal surface. The claim does not specify what structural boundary is encompassed by the “beveled distal surface” versus what structural boundary is encompassed by the lumen proximal to the beveled distal surface, even though the beveled distal surface is located at the distal end of the lumen and necessarily defines, at least in part, whether an opening exists at the distal end of the lumen. As a result, a person of ordinary skill in the art cannot determine with reasonable certainty what it means for “only” the beveled distal surface to change configuration without also changing at least a portion of the lumen-defining structure adjacent the distal end. The Examiner interprets “only the beveled distal surface changes configuration” as requiring that the configuration change is limited to the distal tip region and does not extend along the proximal shaft in a manner that changes its operative structure; however, even under this interpretation, the scope remains unclear because the claim does not define the boundary between the beveled distal surface and the lumen-defining structure adjacent the beveled distal surface. Accordingly, the scope of claim 64 is unclear and claim 64 is indefinite under 35 U.S.C. 112(b).
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 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over by Barkhahn et al. (US 20050283125 A1), hereto referred as Barkhahn, and further in view of Kaufman et al. (US 4416291 A), hereto referred as Kaufman, and further in view of Saulenas et al. (US7294118 B2), hereto referred as Saulenas, and further in view of Aves et al. (US 20030028147 A1), hereto referred as Aves.
Regarding claim 54, Barkhahn teaches a device for parenterally transferring fluid to or from a patient (Barkhahn, [0002]: "it relates to an injection needle for injection into body tissue, preferably into or through the human skin, which injection needle is flexible in the inserted State and conveys a fluid to be administered into the tissue. The injection needle preferably forms an inner channel through which the fluid is conveyed, i.e. it preferably forms an injection cannula", this shows that Barkhahn teaches a device for parenterally transferring fluid to or from a patient), the device comprises: a needle having a distal end portion, a proximal end portion, and defining a lumen therebetween, the distal end portion configured for insertion into the patient (Barkhahn, FIG. 1a-d, [0018]: "The shape-memory material is preferably of tubular configuration for the formation of the injection needle, so that an inner space can be formed as an inner channel for passage of the fluid. In the first state, the tube made from shape-memory material has a form in which at least one pointed edge is formed on the circumference of the tube or injection needle, that is to say the edge has an acute angle so that it can serve as, a kind of cutting edge for insertion of the injection needle", this teaches an injection needle having a distal end portion (pointed edge for insertion), a proximal end portion, and a lumen/channel for fluid flow).
Also regarding claim 54, Barkhahn does not explicitly teach that the device comprises a housing that defines a fluid flow path fluidically coupleable to a fluid reservoir, and the proximal end portion coupled to the housing such that the lumen of the needle is in communication with the fluid flow path. Rather, Barkhahn teaches a device for parenterally transferring fluid, having an injection needle with a distal end portion configured for insertion, a proximal end portion, and a lumen/channel for fluid passage as described above. Barkhahn further teaches a needle configured to transition from a first configuration (closed distal tip during insertion) to a second configuration (the tip opens after insertion for fluid transfer) (Barkhahn, [0002], [0018], [0021]). However, Barkhahn does not explicitly disclose a housing that defines a fluid flow path fluidically coupleable to a fluid reservoir and the proximal end portion of the needle; it discloses only an injection needle with an inner channel for fluid transfer.
Such a housing and flow-path interface is a conventional feature of parenteral fluid transfer assemblies, as evidenced by Kaufman’s needle assembly having a housing and a chamber in fluid communication with a cannula (see below). One of ordinary skill in the art would readily recognize that a needle of the type taught by Barkhahn would require such a connection to be operable for its intended purpose (i.e., transferring fluid), and the inclusion of a housing or chamber to accommodate a reservoir or supply would be a routine design choice. In particular, Kaufman teaches a needle assembly comprising a housing with a chamber therein for collecting liquid samples, and a cannula in fluid communication with the chamber for collection via a needle (Kaufman, FIG. 1, Col. 2, Il. 20-33). This teaches the element of a housing that defines a fluid flow path fluidically coupleable to a fluid reservoir and the proximal end of the needle.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Barkhahn in view of Kaufman to provide a housing that defines a fluid flow path fluidically coupleable to a fluid reservoir and the proximal end of the needle that is also in communication with the fluid flow path. Kaufman is relied upon to supply the conventional housing/flow-path interface necessary for a parenteral fluid-transfer needle to be fluidically coupleable to a reservoir, because Barkhahn’s injection needle is expressly for conveying a fluid via an inner channel and would have been understood by a person of ordinary skill in the art to require a proximal hub/housing interface to a fluid source or collection volume for operability. One of ordinary skill in the art would have recognized that integrating Barkhahn's flexible, shape-memory needle into the housing and flow path arrangement taught by Kaufman would be a routine design adaptation to facilitate connection with a fluid source or reservoir to the needle itself. Such integration is possible because both references teach parenteral devices and standard needle/housing assemblies, and it would have been obvious to combine the fluid channeling and coupling functions of Kaufman's housing with Barkhahn's advanced needle structure. The benefit of this combination would be to enable improved parenteral administration or sampling with both enhanced patient comfort (via Barkhahn's flexible needle) and reliable fluid management (via Kaufman's housing and reservoir coupling arrangement), ensuring safe, effective, and controllable delivery or withdrawal of fluids to or from a patient.
Also regarding claim 54, the modified Barkhahn does not explicitly teach that the distal end portion includes a beveled distal surface. Rather, the modified Barkhahn teaches "at least one pointed edge is formed on the circumference of the tube or injection needle, that is to say the edge has an acute angle so that it can serve as, a kind of cutting edge for insertion of the injection needle... One end of the tubular shape-memory material forms a tip 3 of the injection needle 1. At the tip 3, the edges 2 run together to a point... in order to pierce the tissue surface" (Barkhahn, [0018]). However, it does not expressly teach a beveled tip needle.
Saulenas teaches a beveled needle tip, including a "beveled tip" of a needle cannula (Saulenas, Col. 5-6, ll. 66-2: "...a plane passing symmetrically through actuator arm 60 would also bisect the ellipse defined by beveled tip 42...").
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Barkhahn in view of Saulenas to have the distal tip be beveled because beveling is a known, predictable geometry for piercing and insertion. Such modification would have been technically straightforward because Barkhahn already teaches a pointed distal tip for piercing insertion and Saulenas expressly teaches a beveled needle tip suitable for tissue penetration. This modification would have provided the predictable benefit of improving penetration efficiency and reducing insertion force by utilizing the known cutting geometry of a beveled distal surface, while maintaining compatibility with Barkhahn’s transformable closed-to-open tip structure.
Also regarding claim 54, the modified Barkhahn does not explicitly teach that the needle is configured to be transitioned between a first configuration in which the distal beveled surface of the needle is closed while the lumen proximal to the beveled distal surface is open, the needle being in the first configuration during the insertion into the patient, and a second configuration in which the beveled distal surface of the needle transitions to define an opening after the needle has been inserted into the patient such that the needle is unobstructed be the bevel distal surface to allow fluid transfer to or from the patient. Rather, the modified Barkhahn teaches a first state in which “a solid and preferably closed tip is formed” and “[t]he tip of the injection needle then has no opening,” and further teaches that in a preferred first state “it is preferable for no hollow Space or channel to be formed in the first State” because “the inner surfaces of the wall of the tube bear on one another" (Barkhahn, [0018]). The modified Barkhahn also teaches that this solid, fully-collapsed interior in the first state is not required in all embodiments, stating that the modifiable material “can also be tubular in the first state if it is stiffened to acquire the necessary rigidity,” and that the injection needle “can be, but does not have to be, pipe-like in the first state” (Barkhahn, [0019]). Additionally, it contemplates a modification of the first state in which the tube is not fully collapsed throughout its length, stating: “In the inside of the tubular shape-memory material, there is no hollow space in the first form. In a modification of this, however, a hollow space may be formed in the first state” (Barkhahn, [0054]). The modified Barkhahn further teaches that "After insertion of the injection needle, the shape memory material changes from the first form, which constitutes the first State, to a Second form, which constitutes the Second State of the injection needle. In this second form... an inner channel is formed extending along the longitudinal axis of the injection needle, and an opening is formed in the direction of the longitudinal axis of the injection needle... a fluid can be introduced into the tissue by way of the inner channel and the opening", which defines an opening for fluid transfer (Barkhahn, [0021]). Accordingly, the modified Barkhahn teaches both a closed first state and an open second state, where the first state has no-opening at the distal tip. However, the modified Barkhahn does not expressly state, in haec verba, that the distal tip is closed while a proximal lumen remains open in the first state.
Instead, Barkhahn teaches a closed, no-opening distal tip in the first state and separately teaches that the needle can be tubular in the first state and does not have to be pipe-like or fully collapsed throughout its length, such that (for a person of ordinary skill in the art) selecting a first-state configuration with a localized distal closure and an open proximal lumen would have been an obvious implementation of Barkhahn’s disclosed alternatives (Barkhahn, [0018]-[0021]; [0054]).
It would have been prima facie obvious before the effective filing date of the claimed invention to have configured the first state such that only the distal surface is closed while the remainder of the tubular member retains a lumen, because Barkhahn already teaches that the degree of collapse and tubular configuration in the first state is selectable and not mandatory. Preserving a proximal lumen while closing only the distal surface represents a predictable implementation of Barkhahn’s disclosed alternatives and allows the needle to maintain structural rigidity and internal channel continuity while the closed and pointed tip "can be easily pushed into the tissue surface by means of its tip" (Barkhahn, [0020]). This modification constitutes a predictable implementation of Barkhahn’s disclosed two-state concept, because Barkhahn already teaches both the functional role of the distal tip (closure and penetration) from the structural characteristics of the tubular shaft (stiffness and inertia selection) (Barkhahn, [0018]-[0021]; [0054]). After insertion, the material transitions to a second state in which an inner channel is formed and an opening is formed at the tip to allow fluid introduction (Barkhahn, [0021]). Thus, it would have been obvious to employ a first state in which the distal surface closes the opening while the remainder of the lumen remains available, and a second state in which the distal surface transitions to define an opening such that fluid may pass through the lumen and out of the distal end, as explicitly taught for the second state. The modification merely involves selecting among Barkhahn’s disclosed first-state structural alternatives and implementing them in a manner consistent with its expressly described second-state opening behavior, yielding a predictable and functional closed-to-open parenteral needle configuration. The benefit of this configuration is that it preserves the structural rigidity and piercing characteristics expressly emphasized by Barkhahn for the first state, while maintaining the tubular architecture consistent with forming the inner channel in the second state. By selecting among Barkhahn’s disclosed first-state alternatives, a person of ordinary skill in the art would have predictably implemented a configuration in which the distal tip is closed for insertion while the remainder of the tubular member retains lumen continuity, thereby ensuring that the subsequent transition to the second state yields an immediately functional inner channel and opening as expressly taught in Barkhahn.
Also regarding claim 54, the modified Barkhahn does not teach that the beveled distal surface obstructs the lumen to isolate the lumen from potential dermally-residing contaminants and to allow transfer of a fluid substantially free from dermally-residing contaminants.
Aves teaches occluding the lumen opening during penetration through tissue to prevent tissue ingress, stating that a stylet "performs the function with the needle (10) of preventing body tissue from blocking or clogging the lumen (28) during penetration of the needle through the tissue of the patient" (Aves, [0056]), where "the needle (10) pierces the skin" (Aves, [0115]). Such prevention of tissue ingress predictably reduces introduction of dermally-residing material into the lumen during insertion, which corresponds to isolating the lumen from potential dermally-residing contaminants during insertion and enabling subsequent fluid transfer after opening without such contaminants.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Barkhahn in view of Aves to use a closed-tip first state as an occlusion mechanism for the same predictable purpose taught by Aves, namely preventing ingress of tissue material into the lumen during penetration. Such combination is possible because the modified Barkhahn provides the closed-to-open transformable distal tip structure and Aves provides the known rationale and use-case for occluding a lumen during penetration to prevent ingress of tissue. The benefit of the combination is a parenteral device that is insertable with a closed, occluding beveled distal surface and that opens after insertion to allow fluid transfer through an unobstructed lumen, while reducing tissue ingress into the lumen during insertion. Because dermal tissue and surface biological matter are encountered during skin penetration, preventing ingress at the distal opening during insertion predictably reduces contamination of the lumen, thereby improving the cleanliness of the lumen for subsequent fluid communication once the distal surface transitions to the open state.
Regarding claim 55, the modified Barkhahn teaches that the distal end portion of the needle transforms between a first shape and a second shape when the needle transitions from the first configuration to the second configuration (Barkhahn, FIG. 1a-d; ¶[0021]: “After insertion of the injection needle, the shape memory material changes from the first form, which constitutes the first State, to a Second form, which constitutes the Second State of the injection needle... To do this, the tube made from shape-memory material unfolds, for example, so that the edges formed by the folds are smoothed out. This unfolding results in the inner channel which extends along the longitudinal axis of the injection needle and which emerges as an opening from the end of the injection needle in the direction of the longitudinal axis”, this teaches that the distal end portion transforms between a first (insertable, closed) shape and a second (open, fluid-transferring) shape when the needle transitions from the first configuration to the second configuration).
Regarding claim 56, the modified Barkhahn teaches that the distal end portion of the needle is configured to transform from the first shape to the second shape after insertion of the needle into the patient and at least partially in response to contact with a bodily fluid (Barkhahn, [0021]: "After insertion of the injection needle, the shape-memory material changes from the first form... to a second form” and ¶[0014]: “The transition can in particular be based on the change in temperature or pH or on a chemical reaction of the material with a surrounding medium, or on a combination of several of these factors”, this teaches that transformation from the first to the second shape can be triggered by contact with a bodily fluid (e.g., pH change or other environmental factor) after insertion into the patient).
Regarding claim 57, the modified Barkhahn teaches that the distal end portion of the needle is configured to transform from the first shape to the second shape after insertion of the needle into the patient and at least partially in response to heating the distal end portion of the needle to a given temperature (Barkhahn, [0021]: "After insertion of the injection needle, the shape-memory material changes from the first form... to a second form” and ¶[0014]: “The transition can in particular be based on the change in temperature or pH or on a chemical reaction of the material with a surrounding medium, or on a combination of several of these factors”, this teaches that transformation from the first to the second shape can be triggered by a given temperature (e.g., body temperature) after insertion into the patient).
Claim 58 is rejected under 35 U.S.C. 103 as being unpatentable over by Barkhahn et al. (US 20050283125 A1), hereto referred as Barkhahn, and further in view of Kaufman et al. (US 4416291 A), hereto referred as Kaufman, and further in view of Saulenas et al. (US7294118 B2), hereto referred as Saulenas, and further in view of Aves et al. (US 20030028147 A1), hereto referred as Aves, and further in view of Hwang et al. (US 20090259201 A1), hereto referred as Hwang.
The modified Barkhahn teaches claim 54 as described above.
Regarding claim 58, the modified Barkhahn does not explicitly teach that the distal end portion of the needle is formed from a shape memory alloy. Rather, the modified Barkhahn teaches a needle device having a distal end portion formed from a shape-memory material, which enables the transformation of the needle tip as required by the claim (Barkhahn, ¶[0012]). the modified Barkhahn states a preference for polymers as the shape-memory material, but does not expressly exclude the use of shape memory alloys and does not teach away from their use. Therefore, the modified Barkhahn contemplates the use of any class of shape-memory material, including alloys, as recognized in the art. Hwang teaches that shape memory materials alloys (including copper-zinc-aluminum-nickel alloys, copper-aluminum-nickel alloys, and nickel-titanium (NiTi) alloys) are conventional and well-known examples of shape memory materials suitable for use in needle assemblies (Hwang, ¶[0041]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Barkhahn in view of Hwang to provide that the distal end portion of the needle is formed from a shape memory alloy. One of ordinary skill would have recognized that shape memory alloys were a known and interchangeable subset of shape-memory materials, and their use as the tip or body of a medical needle was routine in the art for achieving transformation or actuation upon thermal or environmental stimulus. Incorporating Hwang’s teaching of alloys into Barkhahn’s device would have been straightforward and required no inventive skill, given the absence of any teaching away or restriction in Barkhahn. The benefit of this combination would be to provide predictable and robust transformation properties (such as enhanced mechanical strength and precise thermal responsiveness) using well-established shape-memory alloys in medical needle applications.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over by Barkhahn et al. (US 20050283125 A1), hereto referred as Barkhahn, and further in view of Kaufman et al. (US 4416291 A), hereto referred as Kaufman, and further in view of Saulenas et al. (US7294118 B2), hereto referred as Saulenas, and further in view of Aves et al. (US 20030028147 A1), hereto referred as Aves, and further in view of Chevalier et al. (US 5049138 A), hereto referred as Chevalier.
The modified Barkhahn teaches claim 54 as described above.
Regarding claim 59, the modified Barkhahn does not teach that the distal end portion of the needle includes a coating configured to close the distal end portion of the needle, the coating configured to dissolve after insertion of the needle into the patient and in response to contact with a bodily fluid, the dissolving of the coating transitioning the needle from the first configuration to the second configuration. Rather, the modified Barkhahn teaches a needle device having a distal end portion formed from a shape-memory material that transforms in response to environmental stimulus, including chemical reaction with a surrounding medium (Barkhahn, ¶[0012], ¶[0014]). However, the modified Barkhahn does not teach a coating configured to close the distal end portion and dissolve after insertion to open a closed tip for fluid transfer. Chevalier teaches a catheter with a distal tip formed of a polymeric material that is dissolvable in bodily fluids. The tip initially closes the catheter’s lumen and, after placement in the patient, dissolves upon contact with bodily fluid, allowing the full lumen to open for drainage (Chevalier, Col. 1, lines 1–15; Col. 1-2, lines 55–12). Chevalier’s disclosure makes clear that drainage through the main lumen only occurs after the tip has dissolved: “once there, the catheter tip will dissolve in the bodily fluids and eventually the entire lumen of the catheter will be available for drainage from the opening that is left when the tip dissolves... More efficient drainage is now available because the entire lumen is open to receive the bodily fluids that can be drained after the tip dissolves” (Chevalier, Col. 1-2, lines 55–12). Although Chevalier describes a solid tip made entirely of dissolvable material rather than a separate coating, the result is the same: both structures cause the distal end of the device to remain closed during insertion and only become open for fluid transfer after exposure to bodily fluid causes dissolution. One of ordinary skill in the art would recognize that, for purposes of achieving a controlled transition from a closed to open state after placement, forming the tip itself from dissolvable material or providing a dissolvable coating on the tip are structurally and functionally equivalent solutions. Both serve to block fluid transfer during insertion and to enable it only after placement in the body. Therefore, Chevalier’s teaching of a dissolvable tip renders obvious the use of a dissolvable coating as recited in the claims. Chevalier also describes a solid tip with a passageway for a guide wire, but this feature is specific to catheter placement and would not be necessary in the context of a needle for fluid transfer. A person of ordinary skill in the art would understand that inclusion or omission of such a passageway is a matter of routine design choice, depending on the intended clinical use. The key functional requirement (closure during insertion and opening only after dissolution) remains fully satisfied regardless of this detail. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Barkhahn in view of Chevalier to provide a distal end portion of a needle or catheter that is closed by a dissolvable material or coating, which dissolves after insertion and exposure to bodily fluid to open the lumen for fluid transfer. One of ordinary skill in the art would have recognized the rationale for using a dissolvable coating or tip for controlled opening after placement, as Chevalier explicitly describes the advantages: safe advancement and placement, prevention of premature fluid flow, and maximized post-placement drainage efficiency. It would have been straightforward to adapt Chevalier’s dissolvable tip concept to Barkhahn’s transforming needle device, given that both references address similar challenges related to controlled delivery, placement safety, and reliable activation of fluid transfer. The benefit of this combination would be to enable a device that maintains a closed lumen during insertion (enhancing patient safety or preventing fluid ingress/egress) and then transitions to an open state after exposure to body fluid, thus providing reliable and controlled access for parenteral fluid transfer.
Claims 60-64 are rejected under 35 U.S.C. 103 as being unpatentable over by Barkhahn et al. (US 20050283125 A1), hereto referred as Barkhahn, and further in view of Kaufman et al. (US 4416291 A), hereto referred as Kaufman, and further in view of Saulenas et al. (US7294118 B2), hereto referred as Saulenas, and further in view of Aves et al. (US 20030028147 A1), hereto referred as Aves, and further in view of Galt et al. (US 20020169420 A1), hereto referred as Galt.
The modified Barkhahn teaches claim 54 as described above.
Regarding claim 60, the modified Barkhahn does not explicitly teach that the beveled distal surface includes a bevel angle, the beveled distal surface configured such that the bevel angle remains the same when the needle is in the first configuration and the second configuration. The modified Barkhahn teaches a two-state needle having a closed, no-opening tip in the first state and an opening for fluid transfer in the second state (Barkhahn, [0018]-[0021]). It further teaches that the injection needle is inserted in the rigid first state by means of its tip (Barkhahn, [0020]: "In the rigid, first state, the injection needle can be easily pushed into the tissue surface by means of its tip"). However, it does not expressly teach that the angle of the bevel remains the same in both configurations, nor does it describe altering the bevel geometry between states.
Galt teaches a needle tip and an internal cannula tip in a needle assembly, and teaches that “the needle tip 112′ and cannula tip 116′ are both formed at the same angle” (Galt, [0050]). Galt further illustrates that the internal cannula may be positioned differently relative to the needle tip between configurations (Galt, Figs. 15–16). Accordingly, Galt evidences that a needle may transition between configurations associated with occlusion and fluid communication while maintaining a consistent bevel angle at the distal end, even where an internal member is moved relative to the needle tip.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Barkhahn in view of Galt to configure the beveled distal surface such that the bevel angle remains the same in both the first configuration and the second configuration. Galt is relied upon for the teaching that the bevel angle at the distal end may be maintained as a consistent angular cutting geometry across configurations, and not for modifying Barkhahn’s shape-memory transition mechanism. Barkhahn’s transition between the first and second states concerns opening or closing of the distal tip to permit fluid communication and does not involve altering the angular cutting geometry of the distal surface. A person of ordinary skill in the art would have therefore recognized that, once a beveled distal surface is selected for insertion, maintaining the same bevel angle across configurations provides predictable penetration and insertion performance while still permitting the distal end to transition between closed and open states for post-insertion fluid communication. The benefit of maintaining the same bevel angle is preserving consistent distal piercing geometry and predictable insertion performance while still enabling the distal opening to transition for post-insertion fluid communication.
Regarding claim 61, the modified Barkhahn does not explicitly teach that opposing sidewalls of the beveled distal surface are configured to connect along a central, vertical plane in the first configuration, and that a width of the beveled distal surface is smaller in the first configuration than in the second configuration. The modified Barkhahn teaches that in the first state “at least one pointed edge is formed on the circumference of the tube” (Barkhahn, [0018]) and further describes embodiments having three, four, or five folds forming corresponding longitudinal edges. Barkhahn does not require a specific minimum number of folded edges beyond “at least one,” and expressly teaches that “the cross-sectional shape and/or the size of the injection needle in the first state can be chosen” (Barkhahn, [0054]). The structural principle disclosed in Barkhahn is that the tubular wall is deformed inwardly so that “the inner surfaces of the wall of the tube bear on one another” to form a closed distal tip (Barkhahn, [0018]; FIG. 1a-d). However, the modified Barkhahn does not explicitly say that the opposing walls connect along a central, vertical plane and a width of the beveled distal surface is smaller in the first configuration than in the second configuration.
A person of ordinary skill in the art would have understood that the disclosed folded configurations represent particular implementations of inward wall collapse and that alternative collapse geometries within the expressly selectable cross-sectional shapes are contemplated. In particular, a simpler collapse geometry in which opposing wall regions of the tube are brought into contact to form a principal longitudinal seam constitutes a predictable variant of the disclosed inward folding mechanism (i.e. a collapse configuration in which the number of fold regions is reduced relative to the multi-fold embodiments). Such a configuration still forms “at least one pointed edge” along the longitudinal direction and satisfies Barkhahn’s teaching that wall surfaces bear on one another to create a closed first state. Further, because the first state is formed by inward collapse of the tubular wall, the transverse width of the distal region in the first configuration would necessarily be smaller than in the second configuration in which an inner channel and distal opening are formed (Barkhahn, [0021]).
When this inward collapse is applied to a needle having a beveled distal surface as taught by Saulenas in claim 54 above (Saulenas, Col. 5-6, ll. 66-2: "...a plane passing symmetrically through actuator arm 60 would also bisect the ellipse defined by beveled tip 42..."), the principal longitudinal seam would lie along a plane extending through the longitudinal axis and bisecting the bevel geometry as defined by its tip, thereby corresponding to a central vertical plane of the beveled distal surface (Saulenas, FIG. 18: depicts centerline of the plane through the center of the needle and bevel with the bevel oriented such this plane would be vertical).
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Barkhahn in view Saulenas to characterize the contacting wall regions of the first-state configuration as connecting along a central plane. This modification concerns the geometric arrangement of the folded wall regions and does not alter Barkhahn’s disclosed shape-memory transition between first and second states. Saulenas is relied upon for the teaching that a beveled distal surface may be defined with reference to a central vertical bisecting plane, and not for modifying Barkhahn’s shape-memory transformation mechanism. A person of ordinary skill in the art would have recognized that, when Barkhahn’s tubular needle is collapsed into its closed first state such that opposing inner wall surfaces bear on one another, the contacting regions would define a principal longitudinal contact interface corresponding to a plane extending through the longitudinal axis of the needle, which corresponds to a central vertical plane relative to the bevel geometry. Further, because Barkhahn’s first state involves inward collapse of the tubular wall portions, the transverse dimension or width of the distal region in the first configuration would be smaller than in the second, open configuration in which an inner channel and distal opening are formed (Barkhahn, [0021]). The benefit of this configuration is that the closed first state achieves a reduced transverse profile at the distal region while still providing a longitudinal edge suitable for insertion, and the second state restores an open distal geometry for fluid transfer, yielding a predictable closed-to-open operating sequence using the same deformable tubular wall principle taught by Barkhahn.
Regarding claim 62, the modified Barkhahn does not explicitly teach that a length of the beveled distal surface remains the same in both the first configuration and the second configuration. As discussed above, the modified Barkhahn teaches a two-state injection needle in which, in the first state, “a solid and preferably closed tip is formed” and the inner wall surfaces bear on one another, and in the second state “an inner channel is formed” and “an opening is formed” to permit fluid transfer (Barkhahn, [0018]-[0021]). However, it is silent on the bevel length as it relates to both configurations.
Galt teaches that “the needle tip 112′ and cannula tip 116′ are both formed at the same angle” (Galt, [0050]) and illustrates configurations in which the internal cannula tip 116′ moves distally and proximally relative to the needle tip 112′ (Galt, Figs. 15–16). In the illustrated embodiments, the geometry and size of the beveled needle tip 112′ and the beveled cannula tip 116′ themselves, as depicted, do not change between configurations; rather, only the spatial relationship between the two components changes. Accordingly, the axial length of each beveled surface remains fixed, and the combined beveled distal region presented at the distal end maintains the same surface extent even though one component is extended relative to the other (the recited “length of the beveled distal surface” is satisfied by a fixed-length bevel surface presented at the distal end, even if composed of multiple parts). Thus, Galt evidences that a tip assembly may transition between configurations associated with occlusion and fluid communication while maintaining a consistent bevel angle and bevel surface length at the distal end.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Barkhahn to maintain the length of the beveled distal surface unchanged between the first and second configurations. Once the beveled distal surface is defined to have a bevel angle that remains the same between configurations, as recited in claim 60, a person of ordinary skill in the art would have recognized that maintaining the same beveled surface extent across configurations helps to preserve the same distal cutting profile and insertion geometry, while allowing the distal opening condition to change for fluid communication as Barkhahn teaches (Barkhahn, [0020]-[0021]). Galt supports this predictable implementation approach by evidencing that occlusion and opening functionality may be achieved without changing the defined bevel angle and length at the distal end (Galt, [0050]). Accordingly, maintaining the bevel length unchanged between configurations would have been an obvious design choice to preserve consistent insertion behavior while still enabling post-insertion fluid transfer. The benefit of maintaining bevel length unchanged across configurations is that the insertion-relevant axial bevel profile can remain consistent while the distal region still expands transversely to increase the opening for fluid communication, thereby separating ‘penetration geometry’ (axial bevel extent) from ‘flow geometry’ (open-state width).
Regarding claim 63, the modified Barkhahn does not explicitly teach that the beveled distal surface is configured to open and close along a single axis when transitioning between the first configuration and the second configuration. The modified Barkhahn teaches a two-state injection needle as shown in claim 54 and 60. It describes the first state as being formed by deformation of tubular material such that “the inner surfaces of the wall of the tube bear on one another” (Barkhahn, [0018]) and contemplates variability in the folded cross-sectional geometry, including selectable cross-sectional shapes and different fold arrangements (Barkhahn, [0018]; [0054]). Barkhahn further teaches that, “in this first state, a solid and preferably closed tip is formed at an end of the injection needle,” such that “[t]he tip of the injection needle then has no opening” (Barkhahn, [0018]). However, the modified Barkhahn does not expressly characterize the opening and closing transition as occurring along a single axis.
A person of ordinary skill in the art would have understood that Barkhahn’s disclosed folded configurations represent particular implementations of inward wall collapse and that alternative collapse geometries within the expressly selectable cross-sectional shapes are contemplated. Barkhahn expressly teaches that “at least one pointed edge is formed on the circumference of the tube” (Barkhahn, [0018]), which does not require a specific number of folds, and further teaches that “the inner surfaces of the wall of the tube bear on one another” in the first state and specifically calls out the tip as a region doing the closing (Barkhahn, [0018]) and that “the cross-sectional shape and/or the size of the injection needle in the first state can be chosen” (Barkhahn, [0054]). The phrase “at least one pointed edge” reasonably encompasses a configuration in which a single principal longitudinal edge of the tip is formed as a result of opposing wall regions being brought together. In such a simplified collapse implementation, the transition between the closed first state and the open second state is characterized by opposing wall regions moving together and apart in a single principal direction of motion while still satisfying Barkhahn’s requirement that the inner surfaces contact to form a closed distal tip and separate to form an inner channel and distal opening (Because the distal tip is the beveled distal surface, the motion of the wall regions that form the tip corresponds to the beveled distal surface opening and closing) (Barkhahn, [0018]; [0021]). Thus, at the tip (where Barkhahn teaches the first state forms ‘a solid and preferably closed tip’ such that the tip ‘has no opening’) the closure and subsequent reopening necessarily occur by opposing wall regions moving together and apart in a single principal direction of motion, which corresponds to the beveled distal surface opening and closing along a single axis. (Barkhahn, [0018]; [0021]).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to further configure the modified Barkhahn such that the beveled distal surface opens and closes along a single axis when transitioning between configurations, as a predictable variant of Barkhahn’s disclosed inward-collapse mechanism. The benefit of configuring the opening and closing to occur along a single axis is constraining the transition to one principal direction of motion, thereby providing a mechanically simplified and repeatable closing and reopening behavior while still achieving Barkhahn’s closed insertion state and open fluid-transfer state (Barkhahn, [0018]-[0021]).
Regarding claim 64, the modified Barkhahn does not explicitly teach that only the beveled distal surface of the needle changes configuration when transitioning between the first configuration and the second configuration. The modified Barkhahn, as shown above in claim 54, teaches a two-state injection needle in which, in the first state, “a solid and preferably closed tip is formed at an end of the injection needle serving for insertion into the body tissue,” such that “[t]he tip of the injection needle then has no opening" (Barkhahn, [0018]), and in the second state “an inner channel is formed extending along the longitudinal axis of the injection needle, and an opening is formed in the direction of the longitudinal axis of the injection needle,” such that fluid may be introduced through the inner channel and opening (Barkhahn, [0021]). Barkhahn’s transition between states is achieved by shape-memory transformation of the tubular material, and Barkhahn describes that, in the first state, “the inner surfaces of the wall of the tube bear on one another” (Barkhahn, [0018]), while in the second state an inner channel and distal opening are formed (Barkhahn, [0021]). As established above for claim 54, the modified Barkhahn further includes a first-state configuration in which the distal tip is closed (no opening at the tip) while the lumen proximal to the distal tip remains open, based on Barkhahn’s disclosed alternatives that the injection needle “can also be tubular in the first state” and that “in a modification… a hollow space may be formed in the first state” (Barkhahn, [0019]; [0054]). Thus, in the modified Barkhahn relied upon for this rejection, the closed condition is localized at the distal tip region while the proximal lumen remains open (Barkhahn, [0018]-[0021]; [0054]). However, Barkhahn does not expressly describe the configuration change as being limited such that only a beveled distal surface changes configuration while the remainder of the needle structure does not change configuration.
A person of ordinary skill in the art would have understood from the modified Barkhahn that the functional distinction between the first and second states is defined at the distal tip region, because the first state is characterized by a closed tip that “has no opening” and is used for insertion “by means of its tip” (Barkhahn, [0018]; [0020]), whereas the second state is characterized by formation of “an inner channel” and “an opening” at the distal end to permit fluid transfer (Barkhahn, [0021]). Although the modified Barkhahn also teaches that cross-sectional shape and size may be selected to achieve desired stiffness or inertia characteristics (Barkhahn, [0054]), a person of ordinary skill in the art would have recognized that the structural feature that changes the functional state from closed to open is the distal tip geometry that defines whether an opening exists, where the distal tip is the area containing the beveled surface. Accordingly, a person of ordinary skill in the art would have understood that the state transition can be implemented such that the transformation is confined to the distal region that defines the tip opening condition, while the proximal shaft may remain structurally unchanged to preserve its selected stiffness and handling characteristics.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further modified the modified Barkhahn to limit the configuration change to the distal tip region corresponding to the beveled distal surface, such that only that distal region changes configuration between the closed and open conditions while the remainder of the needle shaft remains structurally unchanged for insertion and handling. This modification constitutes a predictable implementation of Barkhahn’s disclosed two-state concept, because Barkhahn already teaches both the functional role of the distal tip (closure and penetration) from the structural characteristics of the tubular shaft (stiffness and inertia selection) (Barkhahn, [0018]-[0021]; [0054]). Confining the transformation to the distal tip region is technically feasible within Barkhahn’s shape-memory framework and would have been recognized as a straightforward design constraint to ensure that the shaft properties selected for insertion are maintained while the beveled distal surface transitions between a closed insertion condition and an open fluid-transfer condition. The benefit of this modification is improved controllability and predictability of the state transition at the distal tip while preserving the shaft rigidity and handling characteristics emphasized by Barkhahn for insertion in the first state and fluid transfer in the second state (Barkhahn, [0018]-[0021]; [0054]).
Response to Arguments
Objections
Applicant's arguments filed 1/23/2026, page 5, regarding the previous Objections of claims 54, 56-57, and 59 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's arguments filed 1/23/2026, pages 5-6, regarding the previous 112(b) Rejections of claims 55-57 and 59 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 1/23/2026, pages 6-7, regarding the previous 103 Rejections of claims 54-57, 58, and 59 have been fully 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. That is, there are new grounds of rejection.
Argument: Applicant asserts that Barkhahn “fails to teach or suggest” amended claim 54, including “a needle configured to be transitioned between a first configuration in which the beveled distal surface of the needle is closed while the lumen proximal to the beveled distal surface is open such that the beveled distal surface obstructs the lumen, and a second configuration in which the beveled distal surface of the needle transitions to define an opening such that the lumen of the needle is unobstructed by the beveled distal surface to allow fluid transfer.” Applicant further argues that Kaufman “fails to remedy the deficiencies of Barkhahn,” and that Kaufman provides “no motivation for modifying” Barkhahn to arrive at the claimed invention.
Examiner’s response: Applicant’s argument that Barkhahn fails to teach the amended first-configuration limitation is not persuasive because the rejection does not rely on Barkhahn alone. Rather, the rejection relies on the combined teachings of Barkhahn, Saulenas, Kaufman, and Aves, and the cited combination collectively teaches or renders obvious the amended limitations.
With respect to the first configuration limitation, Barkhahn teaches a first state suitable for insertion in which a solid and closed distal tip is formed with no opening, and a second state in which an opening and inner channel are formed for fluid transfer. Applicant emphasizes Barkhahn’s preferred embodiment in which the tube walls bear on one another and a hollow space “does not have to be” present in the first state. However, Barkhahn also teaches that, in a modification of the first state, a hollow space may be formed within the tubular needle. Thus, Barkhahn teaches (i) a first state having a closed distal tip with no opening and (ii) that the first state may include a hollow space within the tubular member. Applicant’s reliance on Barkhahn’s preferred embodiment is not persuasive because the rejection relies on Barkhahn’s expressly disclosed alternatives, and a person of ordinary skill in the art would have been permitted to select from Barkhahn’s described first-state variations to meet known implementation needs without changing Barkhahn’s fundamental two-state operation. In view of these teachings, it would have been prima facie obvious before the effective filing date of the claimed invention to configure the first state such that the distal tip remains closed during insertion while the lumen proximal to the distal surface remains open, as this represents a predictable implementation of Barkhahn’s disclosed first-state alternatives in combination with its expressly described second-state opening behavior.
Applicant’s argument that Barkhahn does not expressly disclose a beveled distal surface is likewise not persuasive because Saulenas is relied upon to teach a beveled needle tip geometry suitable for insertion. The rejection does not assert that Barkhahn alone teaches a beveled distal surface, but instead relies on Saulenas for this feature.
Applicant’s argument that Kaufman fails to remedy the alleged deficiencies is also not persuasive. Kaufman is relied upon to teach a housing defining a fluid flow path fluidically coupleable to a fluid reservoir and to the proximal end of a needle. One of ordinary skill in the art would have been motivated to integrate Barkhahn’s needle structure into the housing and flow path arrangement taught by Kaufman in order to provide a complete and operable parenteral fluid transfer device, which is consistent with the intended purpose of Barkhahn’s injection needle. Further, once Barkhahn’s needle is combined with Kaufman’s housing/flow-path arrangement (which requires a fluid communication path to the needle lumen), it would have been an ordinary implementation choice to maintain a patent lumen proximal to the distal tip region during insertion while the distal region remains closed, because otherwise the combined device would not provide a practical fluid flow path immediately upon transition to the open state.
Aves is relied upon for the well-known reason to occlude a needle lumen during penetration (preventing ingress/clogging) and applying that known reason to Barkhahn’s closed first-state distal condition would have been a predictable use of the known technique to improve performance during insertion. Applying this teaching to Barkhahn’s closed first-state configuration would have been an obvious use of a closed distal surface to isolate the lumen from dermally-residing material during insertion, thereby enabling subsequent transfer of fluid substantially free from such contaminants after the distal surface transitions to define an opening in the second state.
Accordingly, for at least the reasons above, the rejection of claim 54 under 35 U.S.C. 103 remains proper.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791