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 Objections
Claim 23 is objected to because of the following informalities: the claim lacks a period. Appropriate correction is required.
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 1-22 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.
Regarding claims 1, 10, and 16, the limitation “wherein the port comprises fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane, wherein the fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane has a critical shear rate of greater than 10 sec-1” is indefinite due to the portion underlined above. It is unclear if there should be an “and” between “alkane” and “has”, or if the shear rate limitation is only intended to be directed to the last option in the materials list. For the purposes of examination, the limitation will be interpreted with the missing “and”.
Regarding claims 5, 10, and 16, the limitations defining a radius of curvature from 0 to 1.02 mm are indefinite. These limitations appear to be worded to encompass a radius of curvature of 0 mm, which is a physical impossibility for anything other than a one-dimensional point.
Regarding claim 13, it is unclear if “a port cavity” is referring to the same port cavity or a different port cavity as “a port cavity” as recited in parent claim 12. For the purposes of examination, these are interpreted to be the same port cavity.
Remaining claims rejected under this statute are rejected due to dependency from claims addressed above.
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 –
Claim(s) 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosemeier et al. (US 4295495).
Regarding claim 23, Rosemeier et al. discloses a port (fig. 1-3) comprising: a conduit 2 extending along a longitudinal axis and configured to receive a spike therein (col. 4, ln. 42-52), the conduit configured to be fluidly connected to an inner compartment of a cryo-durable bag (capable of being connected to a bag 6, col. 3, ln. 4-9, and therefore fully capable of being connected to a bag that is cryo-durable), wherein the conduit comprises a first portion (portion above 15 in fig. 1-3) and a second portion (portion below 15, fig. 1-3) and is enclosed by a conduit wall (wall of 2, fig. 1); a septum 15 fluidly separating the first portion and the second portion of the conduit (see fig. 1-3); wherein the septum is configured to be punctured by the spike that is inserted into the first portion of the conduit so as to allow the spike to be inserted into the second portion of the conduit (col. 4, ln. 42-52); a removable snap portion 8 extending from a break point (“line of connection” 14, fig. 3) in the conduit wall to a tip of the port (see fig. 3); wherein the removable snap portion is configured to break away from the port at the break point (col. 4, ln. 25-41).
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.
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) 1-22 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosemeier et al. in view of Entegris (DE 202017006883).
Regarding claim 1, as best understood, and 7, Rosemeier et al. discloses a port (fig. 1-3) comprising: a conduit 2 extending along a longitudinal axis and configured to receive a spike therein (col. 4, ln. 42-52); wherein the conduit is configured to be fluidly connected to an inner compartment of a cryo-durable bag (capable of being connected to a bag 6, col. 3, ln. 4-9, and therefore fully capable of being connected to a bag that is cryo-durable); wherein the conduit is enclosed by a conduit wall (wall of 2, fig. 1); wherein the conduit comprises: i) a first portion (portion below 15, fig. 1-3) defining an inner surface (inner surface of portion below 15, fig. 1-3); and ii) a second portion (portion above 15, fig. 1-3); a septum 15 fluidly separating the first portion and the second portion of the conduit (see fig. 1-3); wherein the septum is configured to be punctured by the spike that is inserted into the first portion of the conduit so as to allow the spike to be inserted into the second portion of the conduit (col. 4, ln. 42-52); a removable snap portion 8 extending from a break point in the conduit wall (“line of connection” 14, fig. 3) to a tip of the port (see fig. 3); wherein the removable snap portion is configured to break away from the port at the break point such that the septum is accessible by the spike via the first portion of the conduit when the removable snap portion is broken away from the port (col. 4, ln. 25-41); and wherein the port is configured to be integrated to the cryo-durable bag (integration to a bag 6 illustrated in fig. 1 and 2, col. 3, ln. 4-9, and therefore fully capable of being integrated to a bag that is cryo-durable), except for specifically disclosing [claim 1] wherein the septum has a thickness from 0.25 mm to 0.64 mm; wherein an inner diameter of the first portion at the septum curve transition is from 3.9 mm to 5.7 mm; wherein the break point has a thickness from 0.06 mm to 0.76 mm; wherein the port comprises fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane; wherein the fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane has a critical shear rate of greater than 10 sec-1; and [claim 7] the port is cryo-durable.
However, Entegris teaches forming a connector port from cryo-durable ethylene tetrafluoroethylene (second full paragraph on page 4 of the English translation, as well as claims; see final paragraph beginning at the bottom of page 6 of the English translation). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize ethylene tetrafluoroethylene for the port of Rosemeier et al. for the purpose of adapting the port for a variety of applications, including cryogenic applications (final paragraph beginning at the bottom of page 6 of the English translation).
Furthermore, there is no evidence of record that establishes that utilizing a critical shear rate of 100 sec-1 as claimed, a septum thickness in the range as claimed, a break point thickness in the range as claimed, and/or an inner diameter of the first portion at the septum curve transition in the range as claimed would result in a difference in function of the Rosemeier et al. device. A person having ordinary skill in the art, being faced with modifying the port of Rosemeier et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that indicating that the critical shear rate, septum thickness, and inner diameter ranges are “optional” (par. 0027), and providing a variety of ranges for break point thickness while indicating that the ranges are only proposed “in some embodiments (par. 0058-0071), and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Regarding claim 2, Rosemeier et al. discloses an inlet 3 configured to be fluidly connected to the inner compartment of the cryo-durable bag (see fig. 2).
Regarding claim 3, Rosemeier et al. discloses a port cavity 17 configured to fluidly connect to the second portion of the conduit to the inner compartment of the cryo-durable bag when the port is bonded to the cryo-durable bag (see fig. 1 and 2).
Regarding claims 4 and 5, claim 5 as best understood, Richmeier et al. fails to specifically disclose the septum is from 4 mm to 20 mm away from the break point and a curve transition from the inner surface of the first portion to the septum has a radius of curvature from 0 mm to 1.02 mm. However, there is no evidence of record that establishes that changing the transition from the inner surface of the first portion to the septum to have a radius of curvature as claimed and/or utilizing a septum to break point distance in the range as claimed would result in a difference in function of the Rosemeier et al. device. A person having ordinary skill in the art, being faced with modifying the port of Rosemeier et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the radius of curvature ranges are appropriate “in some embodiments”, identifying a lack of any radius of curvature as an acceptable embodiment (par. 0082), and offering a variety of acceptable ranges (variety of ranges in par. 0056-0057 and par. 0061-0063), and indicating that the critical shear rate range is “optional” (par. 0027), and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Regarding claim 6, Richmeier et al. discloses the inner surface of the first portion is angled by between approximately 0 and 6.0 degrees with respect to the longitudinal axis (illustrated with no angle, which reads on 0 degrees) such that the inner surface of the first portion is configured to create a sterile seal with the spike when the spike is inserted into the second portion via the first portion (structure of fig. 1-3 is fully capable of performing this function).
Regarding claim 8, Richmeier et al. discloses the thickness of the break point is less than a thickness of a remainder of the conduit wall (see fig. 1-3).
Regarding claim 9, Richmeier et al. discloses the break point is positioned adjacent to the first portion of the conduit (see fig. 1-3).
Regarding claims 10, as best understood, and 15, Richmeier et al. discloses a port system (fig. 1-3) comprising: a port (fig. 1-3) comprising: a conduit 2 extending along a longitudinal axis and configured to receive a spike therein (col. 4, ln. 42-52); wherein the conduit is configured to be fluidly connected to an inner compartment of a cryo-durable bag (capable of being connected to a bag 6, col. 3, ln. 4-9, and therefore fully capable of being connected to a bag that is cryo-durable); wherein the conduit is enclosed by a conduit wall (wall of 2, fig. 1-3); wherein the conduit comprises: i) a first portion (portion below 15, fig. 1-3) defining an inner surface (inner surface of portion below 15, fig. 1-3); and ii) a second portion (portion above 15, fig. 1-3); a septum 15 fluidly separating the first portion and the second portion of the conduit (see fig. 1-3); wherein the septum is configured to be punctured by the spike that is inserted into the first portion of the conduit so as to allow the spike to be inserted into the second portion of the conduit (col. 4, ln. 42-52); a removable snap portion 8 extending from a break point in the conduit (“line of connection” 14, fig. 3) wall to a tip of the port (see fig. 3); wherein the thickness of the break point is less than a thickness of a remainder of the conduit wall (see fig. 1-3); wherein the break point is positioned adjacent to the first portion of the conduit (see fig. 1-3); wherein the removable snap portion is configured to break away from the port at the break point such that the septum is accessible by the spike via the first portion of the conduit when the removable snap portion is broken away from the port (col. 4, ln. 25-41); and a bag 6 integrated with the port (see fig. 1 and 2), except for specifically disclosing [claim 10] the septum has a thickness from 0.25 mm to 0.64 mm; a curve transition from the inner surface of the first portion to the septum has a radius of curvature from 0 mm to 1.02 mm; an inner diameter of the first portion at the septum curve transition is from 3.9 mm to 5.7 mm; the break point has a thickness from 0.06 mm to 0.76 mm; the port comprises fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane; wherein the fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane has a critical shear rate of greater than 10 sec-1; and the bag is cryo-durable, and [claim 15] the port is cryo-durable.
However, Entegris teaches forming a connector port from cryo-durable ethylene tetrafluoroethylene (second full paragraph on page 4 of the English translation, as well as claims; see final paragraph beginning at the bottom of page 6 of the English translation) for use in combination with a bag of the same material (abstract). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize ethylene tetrafluoroethylene for the port and bag of Rosemeier et al. for the purpose of adapting the port and bag for a variety of applications, including cryogenic applications (final paragraph beginning at the bottom of page 6 of the English translation).
Furthermore, there is no evidence of record that establishes that utilizing a septum thickness in the range claimed, a transition from the inner surface of the first portion to the septum to have a radius of curvature as claimed, an inner diameter of the first portion in the range claimed, a break point thickness in the range claimed, or a critical shear rate in the range claimed, would result in a difference in function of the Rosemeier et al. device. A person having ordinary skill in the art, being faced with modifying the port of Rosemeier et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the radius of curvature range is appropriate “in some embodiments”, identifying a lack of any radius of curvature as an acceptable embodiment (par. 0082), and offering a variety of acceptable ranges (variety of ranges in par. 0056-0057), indicating that the septum thickness, inner diameter, and critical shear rate ranges are “optional” (par. 0027), and providing a variety of ranges for break point thickness while indicating that the ranges are only proposed “in some embodiments (par. 0058-0071), and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Regarding claim 11, Richmeier et al. discloses the port further comprises an inlet 3 configured to be fluidly connected to the inner compartment of the cryo-durable bag (see fig. 2).
Regarding claim 12, Richmeier et al. discloses the port further comprises a port cavity 17 configured to fluidly connect with the inlet (see fig. 1-2).
Regarding claim 13, as best understood, Richmeier et al. discloses the port further comprises a port cavity 17 configured to fluidly connect the second portion of the conduit to the inner compartment of the cryo-durable bag when the port is bonded to the cryo-durable bag (see fig. 1-2).
Regarding claim 14, Richmeier et al. discloses the inner surface of the first portion is angled by between approximately 0 and 6.0 degrees with respect to the longitudinal axis (illustrated with no angle, which reads on 0 degrees) such that the inner surface of the first portion is configured to create a sterile seal with the spike when the spike is inserted into the second portion via the first portion (structure of fig. 1-3 is fully capable of performing this function).
Regarding claims 16, as best understood, and 21, Rosemeier et al. discloses a port (fig. 1-3) comprising: at least one conduit 2 extending along a longitudinal axis and configured to receive a spike therein (col. 4, ln. 42-52), wherein the at least one conduit is configured to be fluidly connected to an inner compartment of a cryo-durable bag (capable of being connected to a bag 6, col. 3, ln. 4-9, and therefore fully capable of being connected to a bag that is cryo-durable), wherein the at least one conduit is enclosed by a conduit wall (wall of 2, fig. 1) and comprises a first portion (portion below 15, fig. 1-3) defining an inner surface (inner surface of portion below 15, fig. 1-3) and a second portion (portion above 15, fig. 1-3); a septum 15 fluidly separating the first portion and the second portion of the at least one conduit (see fig. 1-3), wherein the septum is configured to be punctured by the spike that is inserted into the first portion of the at least one conduit so as to allow the spike to be inserted into the second portion of the at least one conduit (col. 4, ln. 42-52); a removable snap portion 8 extending from a break point (“line of connection” 14, fig. 3) in the conduit wall to a tip of the port (see fig. 3), the removable snap portion configured to break away from the port at the break point (col. 4, ln. 25-41); wherein the port is configured to be integrated to the cryo-durable bag (integration to a bag 6 illustrated in fig. 1 and 2, col. 3, ln. 4-9, and therefore fully capable of being integrated to a bag that is cryo-durable); wherein the inner surface of the first portion is angled by between approximately 0 and 6.0 degrees with respect to the longitudinal axis (illustrated with no angle, which reads on 0 degrees), except for disclosing [claim 16) the port comprises fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane, wherein the fluorinated ethylene propylene, ethylene tetrafluoroethylene, or perfluoroalkoxy alkane has a critical shear rate of greater than 10 sec-1; and a curve transition from the inner surface of the first portion to the septum has a radius of curvature of between approximately 0 mm and 1.02 mm and [claim 21] the port is cryo-durable.
However, Entegris teaches forming a connector port from cryo-durable ethylene tetrafluoroethylene (second full paragraph on page 4 of the English translation, as well as claims; see final paragraph beginning at the bottom of page 6 of the English translation). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize ethylene tetrafluoroethylene for the port of Rosemeier et al. for the purpose of adapting the port for a variety of applications, including cryogenic applications (final paragraph beginning at the bottom of page 6 of the English translation).
Furthermore, there is no evidence of record that establishes that changing the transition from the inner surface of the first portion to the septum to have a radius of curvature as claimed, or utilizing a critical shear rate of 100 sec-1 as claimed, would result in a difference in function of the Rosemeier et al. device. A person having ordinary skill in the art, being faced with modifying the port of Rosemeier et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the radius of curvature range is appropriate “in some embodiments”, identifying a lack of any radius of curvature as an acceptable embodiment (par. 0082), and offering a variety of acceptable ranges (variety of ranges in par. 0056-0057), and indicating that the critical shear rate range is “optional” (par. 0027), and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Regarding claim 17, Rosemeier et al. discloses an inlet 3 configured to be fluidly connected to the inner compartment of the cryo-durable bag (see fig. 2).
Regarding claims 18-20, Rosemeier et al. fails to specifically disclose the at least one conduit includes a first conduit and a second conduit, and wherein the inlet is arranged between the first conduit and the second conduit; a port cavity configured to fluidly connect to the inlet to fluidly connect the inner compartment of the cryo-durable bag and the inlet; and the port further comprises a port cavity configured to fluidly connect the second portion of the conduit to the inner compartment of the cryo-durable bag when the port is bonded to the cryo-durable bag. However, Entegris teaches providing up to three ports 220/230 connected to a port cavity 210 connectable/integratable to a bag/bag compartment. One of ports 220 is between port 230 and the other port 220. Each port, including the central port 220, comprises an inlet. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the port of Rosemeier et al. to comprise additional ports connected to a port cavity and arranged as claimed, as taught by Entegris, for the purpose of providing sufficient structure to enable multi-purpose access to the bag via a variety of connections, including various hoses, pipes, connectors, syringes, hose fittings, luer connectors, quick connectors, crimped connectors, etc., as identified in Entegris.
Regarding claim 22, Rosemeier et al. fails to specifically disclose the septum has a thickness from 0.25 mm to 0.64 mm and wherein an inner diameter of the first portion at the septum curve transition is from 3.9 mm to 5.7 mm. However, there is no evidence of record that establishes that changing the septum thickness and/or inner diameter of the first portion at the septum curve transition would result in a difference in function of the Rosemeier et al. device. A person having ordinary skill in the art, being faced with modifying the port of Rosemeier et al., would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed ranges. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the ranges are “optional” (par. 0027), and therefore there appears to be no criticality placed on the ranges as claimed such that it produces an unexpected result.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783