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 amendment filed 12/26/2025 has been entered. Claims 1, 11-13 and 19 have been amended. Claims 1-20 remain pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on Davis for any teaching or matter specifically challenged in the argument. Claim 1 has been amended to recite that the second port extends partially along an axial length of the shield. A new grounds of rejection is made over Schultz which discloses such limitation.
Applicant’s arguments with respect to claim(s) 11 have been considered but are moot because the new ground of rejection does not rely on Davis for any teaching or matter specifically challenged in the argument. Claim 11 has been amended to recite the second port extending partially within an interior space defined by a lateral side wall of the shield. A new grounds of rejection is made over Schultz which discloses such limitation.
Applicant’s arguments with respect to claim(s) 19 have been considered but are moot because the new ground of rejection does not rely on Kyle alone for any teaching or matter specifically challenged in the argument. Claim 19 has been amended to recite the second port extending partially within an interior space defined by a lateral side wall of the shield. A new grounds of rejection is made citing Kyle in view of Schultz which discloses such limitation.
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.
Claim(s) 1, 7-8 and 11-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schultz (Pub. No.: US 2014/0276651 A1).
Regarding claim 1, Shultz discloses (fig. 1-2, 5A) a fluid transfer shield (reduced-touch contamination device 102) to facilitate transferring fluid from a first container (syringe 103) to a secondary container (¶ 0080), the fluid transfer shield comprising:
A shield (luer locking collar 116) having an exterior and defining an interior space (fig. 5);
A first port (see portion comprising female luer-type connector 110) extending from the exterior of the shield (fig. 5A), the first port configured to be fluidly coupled to the first container (¶ 0078-¶ 0079);
A second port (male 6% conical fitting 125 with a male distal tip 104) extending opposite the first port (fig. 5A), partially along an axial length of the shield (fig. 5A), and into the interior space of the shield so that the shield laterally surrounds the second port (fig. 5A), the second port configured to be fluidly coupled to the secondary container (¶ 0080); and
A passageway extending between the first port and the second port fluidly coupling the first container and the second container when the first container is fluidly coupled to the first port and the secondary container is fluidly coupled to the second port (fig. 2, 5A, ¶ 0080).
Regarding claim 7, Schultz discloses wherein the second port includes an interior surface that defines the passageway and an exterior surface (fig. 5A), the exterior surface having a tapered geometry so that a distal end of the second port is narrower than a proximal end of the second port (the second port is a male 6% conical fitting, ¶ 0009, ¶ 0073).
Regarding claim 8, Shultz discloses wherein the first port includes a female luer lock connector configured to receive a syringe (103) having a male luer lock connector as a first container to fluidly couple the syringe to the first port via the luer lock connector (¶ 0078-¶ 0079).
Regarding claim 11, Shultz discloses (fig. 1-2, 5A) a blood transfer shield (reduced-touch contamination device 102, see table 2) for fluidly coupling a syringe (103) to a secondary container (¶ 0080), the blood transfer shield comprising:
A shield (luer locking collar 116) having a cylindrical body and a base that defines an opening at a first end of the cylindrical body (fig. 5A);
A passageway extending through the cylindrical body of the shield, the passageway formed at a second end of the cylindrical body opposite the base (fig. 5A);
A first port (see portion comprising female luer-type connector 110) that forms a first end of the passageway (fig. 5A), the first port configured to securely engage the syringe to fluidly couple the syringe to the passageway (fig. 2, ¶ 0078-¶ 0080); and
A second port (male 6% conical fitting 125 with a male distal tip 104) extending opposite the first port (fig. 5A), partially within an interior space defined by a lateral sidewall of the shield (fig. 5A, ¶ 0074).
Regarding claim 12, Schultz discloses wherein the second port forms a second end of the passageway (fig. 5A).
Regarding claim 13, Schultz discloses wherein the second port defines an exterior surface opposite the passageway (fig. 5A), the exterior surface configured to be inserted into an opening of the secondary container to fluidly couple the secondary container with the passageway (the second port is a male distal tip, ¶ 0073).
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(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 1 above, and further in view of Davies et al. (Pub. No.: US 2020/0146936 A1).
Regarding claim 2, Schultz fails to disclose wherein the second port includes a relief path to allow airflow from the interior space to or from at least one of the passage or the second port.
Davies teaches (fig. 6) a fluid transfer shield (characterized by funnel 3 and adaptor 2) and thus in the same field of endeavor, comprising:
a shield (cylinder portion 214) having an exterior and defining an interior space (fig. 6);
a second port (lower neck portion 31) extending into the interior space of the shield so that the shield laterally surrounds the second port (fig. 6);
wherein the second port includes a relief path (degassing channel formation 32) to allow airflow from the interior space to or from at least one of the passage or the second port (¶ 0059).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second port of Schultz such that it includes a relief path to allow airflow from the interior space to or from at least one of the passage or the second port, as taught by Davies, in order to allow gases generated to exit (Davies ¶ 0059).
Regarding claim 3, Schultz in view of Davies disclose wherein the relief path is formed by a planar face, the planar face configured to form a channel between an exterior surface of the second port and an interior surface of a secondary container (Davies, bottle 4) when the secondary container is engaged with the second port (Davies ¶ 0059).
Schultz in view of Davies fail to disclose the relief path being formed by a pair of planar faces on opposing sides of the second port.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the planar face of Schultz in view of Davies such that the relief path is formed by a pair of planar faces on opposing sides of the second port in order to provide an even distribution of relief paths.
Further, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 124 USPQ 70, see MPEP § 2144.04 VI. B.).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 1 above, and further in view of Naftalovitz et al. (Pub. No.: US 2012/0065626 A1).
Regarding claim 4, Schultz fails to disclose a flange extending radially from the exterior of the shield proximate a base of the shield.
Naftalovitz teaches (fig. 1, 6A) a fluid transfer shield (fluid flow connector 100) and thus in the same field of endeavor, comprising a shield (generally cylindrical body 189), a flange (190) extending from the exterior of the shield proximate to a base of the shield (¶ 0232, fig. 6A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid transfer shield of Schultz such that it comprises a flange extending radially from the exterior of the shield proximate a base of the shield, as taught by Naftalovitz, in order to facilitate handling of the fluid transfer shield.
Regarding claim 5, Schultz in view of Naftalovitz fail to disclose wherein first and second support ribs extend from the exterior of the shield to the flange to rigidly support the flange.
Naftalovitz teaches wherein first and second support ribs (axial ribs 191) extend from the exterior of the shield to the flange.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid transfer shield of Schultz in view of Naftalovitz such that first and second support ribs extend from the exterior of the shield to the flange, as taught by Naftalovitz, in order to provide prevent the flange from collapsing.
While Schultz in view of Naftalovitz fail to disclose that the ribs extend exterior of the shield to the flange to “rigidly support the flange”, such limitation of claim 5 relate to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The ribs of Davis in view of Naftalovitz are capable of rigidly supporting the flange and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 1 above, and further in view of Iibuchi et al. (Pub. No.: US 2018/0008513 A1).
Regarding claim 6, Schultz fails to disclose a flange extending radially from the exterior of the shield proximate a base of the shield, wherein a perimeter of the fluid transfer shield that includes the shield and the flange adjacent to the base of the shield forms an oblong footprint.
Iibuchi teaches (fig. 1, 5) a fluid transfer shield (resin hollow needle 1) and thus in the same field of endeavor, comprising a flange (ribs 8a, 8b) extending radially from an exterior of a shield (hub section 5) proximate a base of the shield, wherein a perimeter of the fluid transfer shield that includes the shield and the flange adjacent to the base of the shield forms an oblong footprint (fig. 5) (¶ 0053).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid transfer shield of Schultz such that it comprises a flange extending radially from the exterior of the shield proximate a base of the shield, wherein a perimeter of the fluid transfer shield that includes the shield and the flange adjacent to the base of the shield forms an oblong footprint, as taught by Iibuchi, in order to provide a surface for handling the fluid transfer shield.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 1 above, and further in view of Davis et al. (Pub. No.: US 2017/0014616 A1).
Regarding claim 9, Schultz fails to disclose wherein the second port extends between approximately 7 millimeters and 11 millimeters into the interior space and the shield defines a body height between approximately 16 and 24 mm.
Davis teaches (fig. 3A-3D) a fluid transfer shield (enteral adapter coupling 30) and thus in the same field of endeavor, comprising a shield (collar 44) having an exterior and defining an interior space (fig. 3D) and a second port (first end 40) extending into the interior space of the shield (fig. 3D).
Davis teaches that the interior space has a diameter of larger than 10.23 mm while the diameter of the second port is 5.41 mm (¶ 0057). Since the diameter of the interior space can be larger than 10.23 mm, it can be between 19.41 mm and 32.82 mm, thus resulting in the second port extending between 7 mm and 11 mm. Davis further teaches the shield having a body height of 6.82 mm or greater (¶ 0057) which overlaps with the claimed range of between approximately 16 and 24 mm.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second port of Schultz such that it extends between approximately 7 millimeters and 11 millimeters into the interior space and the shield defines a body height between approximately 16 and 24 mm, as suggested by Davis, in order to dimension the second port and shield to receive the secondary container (Davis, ¶ 0056-¶ 0057).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
Regarding claim 10, Schultz fails to disclose wherein an opening diameter of the shield is between approximately 14 mm and 22 mm and an overall height of the fluid transfer shield in an axial direction is between 22 mm and 33 mm.
Davis teaches (fig. 3A-3D) a fluid transfer shield (enteral adapter coupling 30) and thus in the same field of endeavor, comprising a shield (collar 44) having an exterior and defining an interior space (fig. 3D).
Davis teaches that an opening diameter of the shield can be larger than 10.23 mm (¶ 0057) which overlaps with the claimed range of between approximately 14 mm and 22 mm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the opening of the diameter of the shield of Schultz such that it is between approximately 14 mm and 22 mm, as taught by Davis, in order to configure the fluid transfer shield to receive the secondary container (Davis, ¶ 0056-¶ 0057).
In this case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art”, a prima facie case of obviousness exists (MPEP §2144.05 I.).
Further, Davis teaches that the fluid transfer shield has an extension portion (70) to vary the length of the fluid transfer shield as desired for engagement with equipment (¶ 0056). Thus, Davis discloses that the length of the fluid transfer shield is a result-effective variable and discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (See MPEP §2144.05). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the fluid transfer shield of Schultz such that it has an overall height of the fluid transfer shield in an axial direction is between 22 mm and 33 mm, as taught by Davis, in order configure the fluid transfer shield for engagement with desired equipment.
Absent any showing of critical or unexpected results, such limitations appear to be routine optimization within the skill of the ordinary artisan before the effective filing date of the invention are therefore prima facie obvious.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 13 above, and further in view of Davies.
Regarding claim 14, Schultz fails to disclose wherein the exterior surface includes a first pair of faces and a second pair of faces, the first pair of faces configured as curved surfaces that extend along the second port in an axial direction and the second pair of faces configured as flat surfaces that extend along the second port in the axial direction.
Davies teaches (fig. 6-7) a transfer shield (characterized by funnel 3 and adaptor 2) and thus in the same field of endeavor, comprising: a second port (lower neck portion 31), wherein the second port defines an exterior surface (fig. 7), wherein the exterior surface includes a first face and a second face, the first face configured as a curved surface that extends along the second port in an axial direction (fig. 7) and the second face configured as a flat surface (degassing channel formation 32) that extends along the second port in the axial direction (fig. 6-7, ¶ 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the exterior surface of Schultz such that it includes a first face and a second face, the first face configured as a curved surface that extends along the second port in an axial direction and the second face configured as a flat surface that extends along the second port in the axial direction, as taught by Davies, in order to allow gasses generated to smoothly exit (Davies ¶ 0059).
Schultz in view of Davies fail to disclose that the first face is a first pair of faces and the second face is a second pair of faces.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the planar face of Schultz, thus resulting in a first pair of faces configured as curved surfaces and a second pair of faces configured as flat surfaces, in order to provide an even distribution of gas relief.
Further, a mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 124 USPQ 70, see MPEP § 2144.04 VI. B.).
Regarding claim 15, Schultz in view of Davies disclose wherein the second pair of faces are configured to form an air relief channel with an opening of the secondary container when the secondary container is fluidly coupled with the passageway (Davies ¶ 0016).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 11 above, and further in view of Naftalovitz.
Regarding claim 16, Schultz fails to disclose a flange extending radially from the cylindrical body of the shield adjacent to the opening; and first and second buttresses extending downward from the second end of the cylindrical end of the cylindrical body to the flange.
Naftalovitz teaches (fig. 1, 6A) a fluid transfer shield (fluid flow connector 100) and thus in the same field of endeavor, comprising a shield (generally cylindrical body 189), a flange (190) extending radially from the cylindrical body of the shield adjacent to the opening (¶ 0232, fig. 6A); and first and second buttresses (axial ribs 191) extending downward from a second end of the cylindrical body to the flange (fig. 6A, ¶ 0232).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the transfer shield of Schultz such that it comprises a flange extending radially from the cylindrical body of the shield adjacent to the opening; and first and second buttresses extending downward from the second end of the cylindrical end of the cylindrical body to the flange, as taught by Naftalovitz, in order to facilitate handling of the fluid transfer shield.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 11 above, and further in view of Di Ubaldi et al. (Pub. No.: US 2018/0289941 A1).
Regarding claim 17, Schultz fails to disclose wherein the shield comprises a semi-translucent polymer.
Di Ubaldi teaches (fig. 1-3) a transfer shield (connector 100) and thus in the same field of endeavor, comprising a semi-translucent polymer (¶ 0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shield of Schultz such that it comprises the semi-translucent polymer of Di Ubaldi, in order to allow the user to visualize the transfer of blood.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz, as applied to claim 12 above, and further in view of Davis.
Regarding claim 18, Schultz discloses wherein the second port is tapered so that a respective distal end is narrower than a respective proximal end of the second port (the second port is a male 6% conical fitting, ¶ 0009, ¶ 0073).
Schultz fails to disclose that the first port is tapered so that a respective distal end is narrower than a respective proximal end of the first port.
Davis teaches (fig. 3A-3D) a fluid transfer shield (enteral adapter coupling 30) and thus in the same field of endeavor, comprising a first port (second end 50), the first port is tapered so that a respective distal end is narrower than a respective proximal end of the first port (¶ 0008) in order to configure the first port to mate with and connect with a coupling (¶ 0008).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first port of Schultz such that it is tapered so that a respective distal end is narrower than a respective proximal end of the first port, as taught by Davis, in order to configure the first port to mate with and connect with a coupling (Davis ¶ 0008).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyle in view of Schultz.
Regarding claim 19, Kyle discloses (fig. 1-2) a method of transferring blood (fluid 38, ¶ 0047) from a first container (second syringe 16) to a secondary container (first syringe 12), the method comprising:
Drawing blood (fluid 38, ¶ 0047) into the first container (second syringe 16 is provided with a volume of fluid, which may have been transferred by positioning a tip element into fluid, ¶ 0044);
Fluidly coupling the first container to a first port (second end 24) of a blood transfer shield (connector component 20) (the second syringe 16 is inserted into the second end ¶ 0045), the first port extending from an exterior surface of the blood transfer shield (Fig. 1);
Fluidly coupling the secondary container to a second port (first end 32) of the blood transfer shield (the first syringe is inserted into the first end 32, ¶ 0044); and
Expelling blood from the first container into the secondary container via a passageway (channel 36) extending between the first port and the second port (¶ 0046).
Kyle fails to disclose the second port extending partially within an interior space defined by a lateral sidewall of a shield of the blood transfer device.
Shultz teaches discloses (fig. 1-2, 5A) a method of transferring fluid from a first container to a secondary container (¶ 0080) and thus in the same field of endeavor, the method comprising a blood transfer shield (reduced-touch contamination device 102) comprising a second port (male 6% conical fitting 125 with a male distal tip 104) extending partially within an interior space defined by a lateral sidewall of a shield (luer locking collar 116) of the blood transfer shield (fig. 5A), such configuration reducing a fluid-path contamination potential (¶ 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kyle such that the second port extends partially within an interior space defined by a lateral sidewall of a shield, as taught by Schultz, in order to reduce fluid-path contamination potential (Schultz, ¶ 0074).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kyle in view of Schultz, as applied to claim 19 above, and further in view of Davis.
Regarding claim 20, Kyle in view of Schultz fail to disclose wherein fluidly coupling the first container to the secondary container includes twisting the first container relative to the blood transfer shield.
Davis teaches (fig. 4A-4F) a method of transferring fluid from a first container to a second container (¶ 0009) and thus in the same field of endeavor, wherein fluidly coupling the first container to the second container includes twisting the first container relative to a blood transfer shield (adapter coupling 130, ¶ 0071).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Kyle in view of Schultz such that wherein fluidly coupling the first container to the secondary container includes twisting the first container relative to the blood transfer shield, as taught by Davis, as the use of threads is commonly used for luer-type couplings (Davis ¶ 0055).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Choksi et al. (Pat. No.: 4,046,145) discloses a fluid transfer shield having a first port and a second port.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781