DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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 10 and 20 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.
Claim 10 recites a “floropolymer” which is an unknown compound and therefore indefinite. The material is interpreted to read “ fluoropolymer” for the purpose of examination.
Claim 20 is rejected based on its dependency.
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.
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.
Claim(s) 1, 3-5, 7-12, 14, 15, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20180021218 A1 (Brosch et al.) in view of CN 204501657 U (Cai et al.).
Regarding Claim 1, Brosch teaches a fitment for a bag, comprising:
a fitment body (200) (Fig. 2A) including first and second side walls (outer surface 280 defining first and second side walls), each of the first and second side walls extending between opposing end points (as seen in Fig. 2A), the fitment body comprising a fluoropolymer material [0056-0057]; and
a spike port (220), comprising:
a spike port body (222), said spike port body formed integrally with fitment body (Fig. 3B), said spike port body including an aperture configured to receive a spike (forming connection with various objects such as syringes or the like [0058]);
Brosch fails to teach a first puncture barrier comprising a fluoropolymer film; and
an internal gasket disposed within the spike port body, said internal gasket configured to provide a second puncture barrier.
Cai teaches a fitment for a bag (Fig. 1) comprising a first puncture barrier (9) comprising a polymer film (p. 3); and an internal gasket (5) disposed within the spike port body (Fig. 3), said internal gasket configured to provide a second puncture barrier (p. 3).
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 the fitting of Brosch with the puncture barriers of Cai to provide barriers which may be pierced for delivery of drugs or infusion material (Cai, p. 3).
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 the polypropylene film of Cai with a fluoropolymer film (as used by Brosch) as a simple substitution of one known polymer for another to ensure compatibility with the construction taught by Brosch [0046-0047] MPEP 2143 I.
Regarding Claim 3, Brosch further teaches the spike body being sized to include at least one 0.25 inch unit and at least one 0.125 inch unit. As the spike bodies are designed for the same use, Brosch is considered to teach a diameter of the aperture is in a range from 0.18 inches to 0.22 inches.
Regarding Claim 4, Brosch further teaches an additional port (230) formed integrally with the fitment body (200) (Fig. 2A).
Regarding Claim 5, Brosch in view of Cai fails to teach the first puncture barrier is joined to an end of the spike port body by a weld, the first puncture barrier covering the aperture.
Cai further teaches the first puncture barrier (9) is joined to an end of the spike port body (Fig. 3) by a weld (p. 2), the first puncture barrier covering the aperture (the weld achieving a sealing protection effect, p. 2).
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 the first puncture barrier of Brosch in view of Cai with the welding of Cai to provide a protecting effect through sealing the device (Cai, p. 2).
Regarding Claim 7, Brosch in view of Cai fails to teach the spike port body includes an annular projection and an exterior surface of the internal gasket includes an annular groove.
Cai further teaches the spike port body includes an annular projection and an exterior surface of the internal gasket (5) includes an annular groove (as seen where the gasket interfaces with step surface 7, Cai Annotated Fig. 3).
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Cai Annotated Fig. 3
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 the gasket of Claim 1 to incorporate the annular groove to ensure the gasket is retained in place, thereby preventing leakage (Cai, p. 3).
Regarding Claim 8, the device of Claim 1 is considered to teach the aperture has a first diameter (where Cai pressing disk 6 sits, Cai Figs. 3-4) in a first portion of the spike port body and a second diameter (below gasket 5, Cai Fig. 3), smaller than the first diameter in a second portion of the spike port body, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter (as seen in Cai Fig. 3).
Regarding Claim 9, Brosch in view of Cai fails to teach an internal surface of the spike port body includes one or more first engagement features and the internal gasket includes one or more second engagement features configured to engage with said first engagement features.
Cai further teaches an internal surface of the spike port body includes one or more first engagement features (where the body interfaces with the annular ring of gasket 5, Fig. 3) and the internal gasket (5) includes one or more second engagement features configured to engage with said first engagement features (Cai, p. 3).
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 the device of Claim 8 to incorporate the interfacing features of Cai to prevent leakage (Cai, p. 3).
Regarding Claim 10, Brosch further teaches a bag (100) [Abstract], comprising the fitment of claim 1, a first fluoropolymer sheet (176), and a second fluoropolymer sheet (178) [0047],
wherein a first portion of a perimeter of the first fluoropolymer sheet is welded to a first portion of a perimeter of the second fluoropolymer sheet (forming seam 154 [0049]),
a second portion of the perimeter of the first fluoropolymer sheet is welded to the fitment, a second portion of the perimeter of the second fluoropolymer sheet is welded to the fitment ([0049] describing the process of welding the sheets to the fitment),
the first portion of the perimeter of the first fluoropolymer sheet and the second portion of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet (the welds surrounding the device as described in [0049]), and
the first portion of the perimeter of the second fluoropolymer sheet and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet (the welds surrounding the device as described in [0049]).
Regarding Claim 11, Brosch teaches a method, comprising:
providing a fitment (Fig. 2A), the fitment including a fitment body (200) including first and second side walls (outer surface 280 defining first and second side walls), each of the first and second side walls extending between opposing end points (as seen in Fig. 2A), the first and second side walls defining a central opening (210), the fitment body comprising a fluoropolymer material [0056-0057] and a spike port body (222) formed integrally with the fitment body (Fig. 3B), said spike port body including an aperture configured to receive a spike (forming connection with various objects such as syringes or the like [0058]), the fitment comprising a fluoropolymer (the fitment body being a portion of the fitment).
Brosch fails to teach installing an internal gasket into the spike port body; and welding a fluoropolymer film to the fitment to provide a puncture barrier.
Cai teaches a method for providing a fitment for a bag (Fig. 1) comprising installing an internal gasket (5) into the spike port body (Fig. 3); and welding (p. 2) a fluoropolymer film (p. 3) to the fitment to provide a puncture barrier (the weld achieving a sealing protection effect, p. 2).
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 the method of Brosch by providing a fitting with the puncture barriers of Cai to provide barriers which may be pierced for delivery of drugs or infusion material (Cai, p. 3).
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 the polypropylene film of Cai with a fluoropolymer film (as used by Brosch) as a simple substitution of one known polymer for another to ensure compatibility with the construction taught by Brosch [0046-0047] MPEP 2143 I.
Regarding Claim 12, Brosch further teaches:
providing a first fluoropolymer sheet (176) [0047];
providing a second fluoropolymer sheet (178) [0047];
welding a first portion of a perimeter of the first fluoropolymer sheet to a first portion of the perimeter of the second fluoropolymer sheet (forming seam 154 [0049]); and
welding a second portion of the perimeter of the first fluoropolymer sheet and a second portion of the second fluoropolymer sheet to the fitment ([0049] describing the process of welding the sheets to the fitment),
wherein the first portion of the perimeter of the first fluoropolymer sheet and the second portion of the perimeter of the first fluoropolymer sheet are the entire perimeter of the first fluoropolymer sheet (encompassing edges 142, 144, 146, and 147 as described in [0049]), and
the first portion of the perimeter of the second fluoropolymer sheet and the second portion of the perimeter of the second fluoropolymer sheet are the entire perimeter of the second fluoropolymer sheet (the second sheet being welded to the first as previously described).
Regarding Claim 14, Brosch further teaches the spike body being sized to include at least one 0.25 inch unit and at least one 0.125 inch unit. As the spike bodies are designed for the same use, Brosch is considered to teach a diameter of the aperture is in a range from 0.18 inches to 0.22 inches.
Regarding Claim 15, Brosch in view of Cai fails to teach the fluoropolymer film is joined to an end of the spike port body and covers the aperture.
Cai further teaches the first puncture barrier (9) is joined to an end of the spike port body (Fig. 3) by a weld (p. 2), the first puncture barrier covering the aperture (the weld achieving a sealing protection effect, p. 2).
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 the first puncture barrier of Brosch in view of Cai with the welding of Cai to provide a protecting effect through sealing the device (Cai, p. 2).
Regarding Claim 17, Brosch in view of Cai fails to teach an internal surface of the spike port body includes an annular projection and an exterior surface of the internal gasket includes an annular groove and installing the internal gasket includes positioning the internal gasket such that the annular projection is received in the annular groove.
Cai further teaches the spike port body includes an annular projection and an exterior surface of the internal gasket (5) includes an annular groove (as seen where the gasket interfaces with step surface 7, Cai Annotated Fig. 3) and installing the internal gasket includes positioning the internal gasket such that the annular projection is received in the annular groove (p. 3).
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 the gasket of Claim 1 to incorporate the annular groove to ensure the gasket is retained in place, thereby preventing leakage (Cai, p. 3).
Regarding Claim 18, the method of Claim 11 is considered to teach the aperture has a first diameter (where Cai pressing disk 6 sits, Cai Figs. 3-4) in a first portion of the spike port body and a second diameter (below gasket 5, Cai Fig. 3), smaller than the first diameter in a second portion of the spike port body, and the internal gasket has an outer diameter that is smaller than the first diameter and larger than the second diameter (as seen in Cai Fig. 3) and installing the internal gasket includes inserting the internal gasket into the aperture from the first portion of the spike port body (as seen in Fig. 3).
Regarding Claim 19, Brosch in view of Cai fails to teach an internal surface of the spike port body includes one or more first engagement features and the internal gasket includes one or more second engagement features configured to engage with said first engagement features.
Cai further teaches an internal surface of the spike port body includes one or more first engagement features (where the body interfaces with the annular ring of gasket 5, Fig. 3) and the internal gasket (5) includes one or more second engagement features configured to engage with said first engagement features (Cai, p. 3).
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 the device of Claim 8 to incorporate the interfacing features of Cai to prevent leakage (Cai, p. 3).
Regarding Claim 20, Brosch further teaches a method of conducting a process, comprising:
providing a bag (100) according to claim 10;
adding a process fluid to the bag (storage of chemical, biological or biopharmaceutical materials [0068]; bringing the bag to a temperature of -800C or lower (as low as -190° C [0068]); and inserting the spike into the aperture of the spike port [0058].
Claim(s) 2 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brosch in view of Cai and further in view of US 5334178 A (Haber et al.).
Regarding Claim 2, Brosch in view of Cai fails to teach the internal gasket material.
Haber teaches a gasket for piercing by a syringe [Abstract] wherein the gasket comprises silicone (Col. 5: ll. 2-3) in order to ensure a seal.
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 the undisclosed gasket material of Brosch in view of Cai with the silicone taught by Haber to ensure a seal is maintained (Col. 5: ll. 1-2).
Regarding Claim 13, Brosch in view of Cai fails to teach the internal gasket material.
Haber teaches a gasket for piercing by a syringe [Abstract] wherein the gasket comprises silicone (Col. 5: ll. 2-3) in order to ensure a seal.
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 the undisclosed gasket material of Brosch in view of Cai with the silicone taught by Haber to ensure a seal is maintained (Col. 5: ll. 1-2).
Claim(s) 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brosch in view of Cai and further in view of US 20230190580 A1 (Shigemoto).
Regarding Claim 6, Brosch in view of Cai fails to teach the fluoropolymer film is disposed within the spike port body.
Shigemoto teaches a medical plug (1) (Figs. 2A, 2B) for use with an infusion bag [0002] wherein the film is disposed within the spike port body (formed by 3 and 5 [0078]).
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 the externally placed fluoropolymer film of Brosch in view of Cai with an internally placed film as taught by Shigemoto as it would be obvious to try when choosing from the two known possible locations for a the film (being internal or external) MPEP 2143 I.
Regarding Claim 16, Brosch in view of Cai fails to teach the fluoropolymer film is disposed within the spike port body.
Shigemoto teaches a medical plug (1) (Figs. 2A, 2B) for use with an infusion bag [0002] wherein the film is disposed within the spike port body (formed by 3 and 5 [0078]).
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 the externally placed fluoropolymer film of Brosch in view of Cai with an internally placed film as taught by Shigemoto as it would be obvious to try when choosing from the two known possible locations for a the film (being internal or external) MPEP 2143 I.
Conclusion
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/HANS KALIHER/Examiner, Art Unit 3781 /JESSICA ARBLE/Primary Examiner, Art Unit 3781