DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendments filed 11/18/2025 have been entered.
Claims 1-3 have thereby been amended.
Claims 8-20 have been added.
Claims 1-20 are being examined in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14, 15, 18 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 14, 15 and 18 recite the limitation “a cannula receiving extension extending internally and longitudinally from a first end…” Here, “internally” is a relative term, and it is unclear what the cannula receiving extension must be internal relative to. Further, it is unclear, and thereby indefinite, how the cannula receiving extension could extend internally from an end structure. Without a more specific limitation to define what the cannula receiving extension is relative to (for example, being internal relative to housing of the syringe interface, being internal relative to surrounding exterior walls of the syringe interface, etc.), Examiner interprets this limitation to mean that the cannula receiving extension must be internal relative to the entire, assembled interface system. This is the interpretation by which claims 14, 15 and 18 will be examined below.
Additionally, claim 19 should be included in the rejection because any claims that depend on a rejected claim inherit the problems of their parent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 9-11, 13-15, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deuse (US 20220260189).
Regarding claim 1, Deuse discloses a sterile interface system for placement between a syringe and an IV port to provide a closed system for drawing up and injecting liquid drugs, comprising: a) an IV cannula interface (Fig. 9: 5; housing 13a-b and cannula 9 with covering 23) including a first end configured to receive an IV tube connection (Fig. 9: end 7, configured to receive tube 26 seen in Fig. 6), a bung piercing cannula (9) mounted longitudinally within the IV cannula interface and extending from the first end toward a second end of the IV cannula interface (Fig. 9: cannula 9 extends from first end 13a of interface 5), b) a syringe interface (Fig. 9: 6), and c) a shrouded interface between the IV cannula interface and the syringe interface (Fig. 9: shrouded interface being the cylindrical sides of 12, see annotated Fig. 9a below), the shrouded interface configured to abuttingly engage an exterior end surface of the second end of the IV cannula interface (see annotated Fig. 9a above: the base labeled and cannula shroud surrounding the shrouded interface are part of the second end of the IV cannula interface, and abut the shrouded interface 12).
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Annotated Fig. 9a, Deuse
Regarding claim 2, Deuse discloses the sterile interface system of claim 1, as described above, further comprising a first pierceable silicone disc covering the second end of said the IV cannula interface (23 covering second end of cannula at 8; para. [0065], sentence 2, 23 being made of silicone).
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Annotated Fig. 8a, Deuse
Regarding claim 3, Deuse discloses the sterile interface system of claim 2, as described above, wherein the syringe interface includes a cannula receiving extension (Fig. 9: 17) extending internally and longitudinally from a first end thereof (Fig. 9: 17 extends from first end 14a of interface 6) and a self-sealing, pierceable bung mounted therein (11), said bung configured to receive the bung piercing cannula within the IV cannula interface (Fig. 9c: cannula 9 pierces bung 11), the syringe interface configured to receive the shrouded interface positioned in the second end of the syringe interface (Figs. 9a-c: second end at 18 of interface 6 receives 12 upon insertion), the syringe interface further including a spring therein (Fig. 9: spring being the bellowed sides of 18) compressible upon insertion of the IV cannula interface into the second end of the syringe interface (compression of bellowed spring 18 seen in Figs. 9a-c upon connection of interfaces 5 and 6).
Regarding claim 4 Deuse discloses the sterile interface system of claim 3, as described above, wherein the shrouded interface comprises a structure located within the second end of the syringe interface (Fig. 9b: shrouded interface 12 located within the second end of 6 upon connection), the second end of the syringe interface further configured to receive the second end of the IV cannula interface in a connecting manner (Figs. 9a-b: the second end of 6 receives the second end of 5 upon the connecting/insertion process), the shrouded interface configured to receive the bung piercing cannula therethrough (Figs. 9a-c: cannula 9 is received and located within 12).
Regarding claim 5, Deuse discloses the sterile interface system of claim 4, as described above, wherein connection of the IV cannula interface in a locking manner to the syringe interface (locking connection via the snap-fit mechanism of elements 31; para. [0096], sentences 1-2; and optionally the locking mechanism of para. [0069] – [0070] and Figs. 3a-c) causes the shrouded interface previously placed in the syringe interface to slide within the syringe interface (Figs. 9a-c: the sides of shrouded interface 12 begin at the second end of syringe interface 6 upon the beginning of the connection, and slide within syringe interface 6 towards its first end during the insertion process), compressing said spring (compression of bellowed spring 18 seen in Figs. 9a-c via the sides of shrouded interface 12 upon connection of interfaces 5 and 6), the bung piercing cannula mounted within the cannula interface extending into the cannula receiving extension and to pierce the bung (Fig. 9c: cannula 9 pierces bung 11 of extension 17).
Regarding claim 9, Deuse discloses the sterile interface system of claim 1 as described above, wherein the syringe interface includes a cannula receiving extension (Fig. 9: 17+6) extending internally and longitudinally from a first end thereof (Fig. 9: 17 and 6 extend longitudinally from 14a, and are internal relative to the whole assembled device) and a self-sealing, pierceable bung mounted therein (11), said bung configured to receive the bung piercing cannula within the IV cannula interface (Fig. 9c: cannula 9 pierces bung 11), the syringe interface configured to receive the shrouded interface positioned at a second end of the syringe interface (Figs. 9a-c: second end at 18 of interface 6 receives 12 upon insertion), the syringe interface further including a spring (Fig. 9: spring being the bellowed sides of 18) therein compressible upon insertion of the IV cannula interface into the second end of the syringe interface (compression of bellowed spring 18 seen in Figs. 9a-c upon connection of interfaces 5 and 6), the spring is configured to bias the shrouded interface toward the second end of the syringe interface (Fig. 9: spring pushes against shrouded interface seen in annotated Fig. 9a above, in the direction of the second end of the syringe interface), and the second end of the syringe interface is configured to engage a shoulder of the shrouded interface to stop the shrouded interface from exiting the second end of the syringe interface (Fig. 9: the shoulder of the shrouded interface being the hard base under the sides of the shrouded interface 12, which engage with the second end of the syringe interface when assembled).
Regarding claim 10, Deuse discloses the sterile interface system of claim 1 as described above, wherein a second end of the syringe interface is configured to engage a shoulder of the shrouded interface to stop the shrouded interface from exiting the syringe interface at the second end of the syringe interface (see annotated Fig. 9a above, the second end of the syringe interface engages the outer labeled shoulder).
Regarding claim 11, Deuse discloses the sterile interface system of claim 2 as described above, wherein the shrouded interface comprises a distal sealing surface (labeled as the second disc in the annotated Fig. 9a above) positioned to form a planar, face-to-face engagement with the first pierceable silicone disc at the second end of the IV cannula interface (Fig. 9a: face-to-face with the first disc over the end of 8).
Regarding claim 13, Deuse discloses the sterile interface system of claim 2, as described above, further comprising a second silicone disc covering a first end of the shrouded interface (the second disc in the annotated Fig. 9a above), wherein the second silicone disc is positioned to form a planar, face-to-face engagement with the first pierceable silicone disc at the second end of the IV cannula interface (Fig. 9a: face-to-face with the first disc over the end of 8).
Regarding claim 14, Deuse discloses the sterile interface system of claim 1 as described above, wherein the syringe interface includes: a cannula receiving extension (Fig. 9: 17+6) extending internally and longitudinally from a first end thereof (Fig. 9: 17 and 6 extend longitudinally from 14a, and are internal relative to the whole assembled device), the cannula receiving extension includes an inner portion (17) received within and surrounded by an outer portion (6) to form a nested configuration; and a self-sealing, pierceable bung mounted in the inner portion of the cannula receiving extension (Fig. 9: bung 11 mounted within 17), said bung configured to receive the bung piercing cannula within the IV cannula interface (Fig. 9c: cannula 9 pierces bung 11).
Regarding claim 15, Deuse discloses the sterile interface system of claim 14 as described above, wherein the IV cannula interface further includes a cannula shroud extension extending internally and longitudinally within the IV cannula interface (see annotated Fig. 9a above) and extending from the first end toward the second end of the IV cannula interface (see annotated Fig. 9a above), the bung piercing cannula is mounted at least partially within the cannula shroud extension (see annotated Fig. 9a above, cannula 9 within the cannula shroud walls), and an end of the cannula shroud extension is configured to be received between the inner portion and the outer portion of the cannula receiving extension (Fig. 9: cannula shroud is received between 6 and 17 when assembled).
Regarding claim 18, Deuse discloses a sterile interface system for placement between a syringe and an IV port to provide a closed system for drawing up and injecting liquid drugs, comprising: a) an IV cannula interface (Fig. 9: 5; housing 13a-b and cannula 9 with covering 23) including a first end configured to receive an IV tube connection (Fig. 9: end 7, configured to receive tube 26 seen in Fig. 6), a bung piercing cannula mounted longitudinally within the IV cannula interface and extending from the first end toward a second end of the IV cannula interface (), and a cannula shroud extension at least partially surrounding the bung piercing cannula (see annotated Fig. 9a above), b) a syringe interface (Fig. 9: 6+14a-b portion) including a cannula receiving extension extending internally and longitudinally from a first end thereof (Fig. 9: 17 and the walls of 6) and a self-sealing, pierceable bung mounted therein (Fig. 9: bung 11 mounted in 17), said bung configured to receive the bung piercing cannula within the IV cannula interface (Fig. 9c: cannula 9 pierces bung 11), the cannula receiving extension includes an inner portion (17) received within and surrounded by an outer portion (6) to form a nested configuration, the outer portion extending past the inner portion (Fig. 9: ends of walls of 6 extend past the end of 17), and an end of the cannula shroud extension is configured to be received between the inner portion and the outer portion of the cannula receiving extension (see annotated Fig. 9a above: cannula shroud is received between 6 and 17 when assembled), and c) a shrouded interface between the IV cannula interface and the syringe interface (Fig. 9: shrouded interface being the cylindrical sides of 12, see annotated Fig. 9a above).
Regarding claim 19, Deuse discloses the sterile interface system of claim 18 as described above, wherein: the IV cannula interface further includes a first pierceable silicone disc covering the second end of the IV cannula interface (23 covering second end of cannula at 8; para. [0065], sentence 2, 23 being made of silicone), the shrouded interface includes a second silicone disc covering a first end of the shrouded interface (see annotated Fig. 9a above), and the syringe interface is configured to receive the shrouded interface positioned in the second end of the syringe interface (Figs. 9a-c: second end at 18 of interface 6 receives 12 upon insertion), the syringe interface further including a spring therein (Fig. 9: spring being the bellowed sides of 18) compressible upon insertion of the IV cannula interface into the second end of the syringe interface (compression of bellowed spring 18 seen in Figs. 9a-c upon connection of interfaces 5 and 6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Deuse (US 20220260189) in view of Deuse Figure 4 Embodiment (US 20220260189).
Regarding claim 6, Deuse discloses the sterile interface system of claim 3, as described above, wherein a second silicone disc covers a first end of the shrouded interface (Fig. 9a: the disc covering the first end of the shrouded interface being the end disc of 12, see annotated Fig. 9a above; para. [0042], sentences 1-3, 12 being made of silicone), the second silicone disc pierced by the cannula receiving extension as the IV cannula interface is connected to the syringe interface (Figs. 9b-c: extension 17 pierces disc of 12). However, this embodiment of Deuse fails to disclose that the silicone disc 12 is also pierced by the cannula 9.
The Deuse embodiment shown in Figs. 4a-c discloses the shrouded interface as 19 which slides axially toward the first end of the IV interface 5 when interfaces 5 and 6 are connected, such that cannula 9 extends all the way through syringe interface 6 to its first end. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Deuse embodiment shown in Figs. 8a-c and 9a-c by incorporating the sliding structure of 19 in the Deuse Fig. 4 embodiment, such that shroud 12 of the Fig. 9 embodiment is pushed toward the first end of IV interface 5 when interfaces 5 and 6 are connected, allowing cannula 9 to also pierce through disc 12 and extend farther down extension 17 to reach the first end of syringe interface 6, in order to create a shorter and less obstructed pathway for the fluid to pass through, just as taught by the Fig. 4 embodiment.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Deuse (US 20220260189) in view of Deuse Figure 4 Embodiment (US 20220260189) in further view of Sanders (US 20150126958).
Regarding claim 16, Deuse in view of Deuse Figure 4 Embodiment teaches the sterile interface system of claim 6 as described above, wherein the first end of the shrouded interface faces the second end of the IV cannula interface (Fig. 9c: first end of shrouded interface where second disc is, facing outwards to the second end of the IV cannula interface), however, Deuse fails to teach the relational structure of the shrouded interface such that the first end of the shrouded interface contacts the second end of the IV cannula interface upon insertion of the IV cannula interface into the second end of the syringe interface.
Sanders teaches an analogous interface system having a shrouded interface (Fig. 3B: 54) placed at the end of the spring (68) and containing a pierceable disk at both of its ends (58 and 64). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the sliding feature (54) taught by Sanders into the Deuse device, such that 54 of Sanders be placed at the end of the Deuse spring within the syringe interface and act as the shrouded interface, in order to provide increased structure to the end of the bellowed spring of Deuse where the pierceable membrane is located. Upon this combination, this shrouded interface as taught by Sanders would contain a second silicone disc covering the end of the shrouded interface (Sanders: Fig. 3B: 58), would abuttingly engage an exterior end surface of the second end of the IV cannula interface when assembled as the end of the syringe interface having the Sanders shrouded interface connects with the exterior end of the IV cannula interface, or in other words, the first end of the shrouded interface would contact the second end of the IV cannula interface upon insertion of the IV cannula interface into the second end of the syringe interface.
Claims 17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Deuse (US 20220260189) in view of Hino (JP 2013042859).
Regarding claim 17, Deuse discloses the sterile interface system of claim 1, as described above, but fails to disclose the closer structure as a tab and notch/channel assembly.
Hino teaches an analogous connector interface, further comprising: a tab extending from an outer surface of the interface (Figs 3a-b: tab 37 on interface 33+32); and a notch and a connected channel disposed on a distal end of the other interface (Fig 4: notch 54 and channel 48), wherein the IV cannula interface is configured to be connected to the shrouded interface and the syringe interface by pushing the IV cannula interface into the syringe interface such that the tab enters the connected channel via the notch to form a sliding lock (Figs. 5a-1 and 6b1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the snap locking structure of Deuse by incorporating the sliding tab locking structure taught by Hino, such that the Deuse cannula interface has the tab structure on the inner surface at 31 that slides into the notch/channel of 6 of the syringe interface, in order to provide a more secure locking method that cannot be easily or accidentally pulled apart.
Regarding claim 20, Deuse discloses a sterile interface system for placement between a syringe and an IV port to provide a closed system for drawing up and injecting liquid drugs, comprising: a) an IV cannula interface (Fig. 9: 5; housing 13a-b and cannula 9 with covering 23) including a first end configured to receive an IV tube connection (Fig. 9: end 7, configured to receive tube 26 seen in Fig. 6), a bung piercing cannula (9) mounted longitudinally within the IV cannula interface and extending from the first end toward a second end of the IV cannula interface (Fig. 9: cannula 9 extends from first end 13a of interface 5), b) a syringe interface (Fig. 9: 6) including a cannula receiving extension extending internally and longitudinally from a first end thereof (Fig. 9a: 17), a self-sealing, pierceable bung mounted therein (11), said bung configured to receive the bung piercing cannula within the IV cannula interface (Fig. 9c: cannula 9 pierces bung 11), however, Deuse fails to disclose the closer structure as a tab and notch/channel assembly.
Hino teaches an analogous connector interface with a tab extending from an outer surface of an interface (Figs 3a-b: tab 37 on interface 33+32); and a notch and a connected channel disposed on a distal end of the other interface (Fig 4: notch 54 and channel 48), wherein the IV cannula interface is configured to be connected to the shrouded interface and the syringe interface by pushing the IV cannula interface into the syringe interface such that the tab enters the connected channel via the notch to form a sliding lock (Figs. 5a-1 and 6b1). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the snap locking structure of Deuse by incorporating the sliding tab locking structure taught by Hino, such that the Deuse cannula interface has the tab structure on the inner surface at 31 that slides into the notch/channel of 6 of the syringe interface, in order to provide a more secure locking method that cannot be easily or accidentally pulled apart.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Deuse (US 20220260189) in view of Balamurugan (US 20220226616) in further view of Hosac (US 10980296).
Regarding claim 7, Deuse discloses the sterile interface system of claim 3, as described above, wherein the bung and the silicone discs are formed from a silicone material (para. [0042], sentences 1-3; para. [0058], last sentence; para. [0065], sentence 3), but fails to explicitly disclose that silicone as being food-grade.
Balamurugan teaches an analogous sterile fluid delivery device with an analogous silicone bellow made of a food-grade silicone material (bellow spring 48; para. [0052], sentence 3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bellow spring and its top pierceable cover of Deuse by making them from a, specifically, food-grade silicone as taught by Balamurugan, in order to provide greater resistance to degradation and heat.
Although Deuse in view of Balamurugan fails still to explicitly teach pierceable discs and bungs made of food-grade silicone, it would be obvious to one of ordinary skill in the art to apply the food-grade silicone taught by Balamurugan to the bung and discs disclosed by Deuse in addition to the bellow spring described above, as evidenced by Hosac. Hosac teaches a medical access port assembly of a facemask, with an analogous pierceable membrane/gasket formed from a silicone material (132; col. 6, lines 11-12). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified all the pierceable membranes and discs as well as the bung of the Deuse-Balamurugan device by making them from a, specifically, food-grade silicone as taught by Hosac, in order to provide greater resistance to degradation and heat.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Deuse (US 20220260189) in view of Kriesel (US 20100312187).
Regarding claim 12, Deuse discloses the sterile interface system of claim 2, further comprising a second silicone disc covering a first end of the shrouded interface (see annotated Fig. 9a above), but fails to disclose that the shrouded interface walls of 12 and the second silicone disc end of 12 are formed from different materials.
Kreisel teaches a medicament dispenser which comprises an analogous structure of the shrouded interface walls (Fig. 23: walls 56c) and second pierceable disc (Fig. 23: 64), wherein the shrouded interface is made of a material different from that of the second silicone disc (Figs. 23-24: 64 is separate and different than 56c; Fig. 23A displays the different, 5-layer material of 56c, different than 64). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teaching of Kreisel of having a separate disc member of a different material over the end of the cylindrical walls of 56, into Deuse, such that the second pierceable disc of Deuse would be made of a separate and different material from the walls of the shrouded interface, in order to have a second disc that is easily penetrable without causing stress or damage to the cannula, while maintaining the structural properties of the shrouded interface.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Applicant argues that Deuse fails to disclose “a shrouded interface between the IV cannula interface and the syringe interface, the shrouded interface configured to abuttlingly engage an exterior end surface of the second end of the IV cannula interface” of claim 1, and its depending claims including claims 6 and 7. However, as described in the rejection of claim 1 above, Examiner interprets the base below which the shrouded interface walls 12 are located, as part of the second end (facing the second outward end and therefore an exterior end surface), which abuts the shrouded interface. Examiner interprets this as part of the second end of the IV cannula interface because the second end is not explicitly defined as a certain structure of the IV cannula interface, and therefore Examiner interprets the end-most portion of each element/structure of that interface as being part of its second end.
Regarding newly added claims 9-20, Examiner maintains the rejections of these claims as recited in the rejections above, in light of the claim interpretation as described in section 35 USC § 112 above. Claim 8 has been identified as containing allowable subject matter in that “the spring is disposed at least partially within the shrouded interface,” and has been objected to as recited above.
As such, given the breadth of the claims as they are written and their broadest reasonable interpretation, Examiner maintains the rejections of claims 1-7 and 9-20, as they are currently written. Examiner notes the nested structure of the cannula receiving extension as depicted in the drawings, but claimed indefinitely as described above, of interest.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783