DETAILED ACTION
Priority
1. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/337,476, filed on March 28, 2019.
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 11 and 12 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 claim 11, there is no support for the singular break-off piece disconnecting from the cap body via breaking points (plural). Examiner notes the Specification only teaches plural breaking points (300) and (400) which are respectively associated with break-off pieces (30) and (40). For purposes of this examination, the claim will be construed such that the breaking point is singular.
Regarding claim 12, it is unclear what the metes and bounds of the phrase “in the form of a bottle” comprise. Examiner notes that bottles come in many different shapes and sizes, and thus there is no fixed criteria to rely in when construing the proper boundaries of the phrase.
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1, 5, 6, 8-14, 18, 19, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066941 (Tezuka) in view of US 2006/0138069 (Domkowski).
Regarding claim 1, Tezuka teaches a seal for a connector of a medical container, the seal comprising:
a seal body (10a and 12 radially inside of 13c in Figure 1b) having a bottom surface (bottom of 10a and bottom of 10b radially inside of 13c in Figure 1b) and a seal head (upper surface of 10a and 12 radially inside of 13c in Figure 1b) at a top surface opposite the bottom surface, the seal head being substantially flat (see upper surface of 10a and 12 radially inside of 13c being substantially flat in Figure 1b);
a ring collar (portion located radially outwardly of 13c in Figure 1b) extending circumferentially around the seal body, the ring collar extending between a bottom side (13b) and a top side (13a) opposite the bottom side (see 13a on an upper side of the seal and 13b on a lower side of the seal in Figure 1b), the top side of the ring collar being below the sealing head (not taught), and the bottom side of the ring collar being below the bottom surface of the seal body (13b located below 10b in Figure 1b); and
a flange (read as the portion radially within the span of 13c in Figure 1b) connecting the seal body to the ring collar (located radially between the identified seal body and the identified ring collar; see annotated Figure 1b below), the flange extending between a bottom side and a top side opposite the bottom side (see top side at 13c and bottom side at 10b), the top side of the flange being below the top side of the ring collar (13c is below 10c in Figure 1b), and the bottom side of the flange being aligned with the bottom surface of the seal body (the bottom of the radial span of 13c is coplanar with the bottom of 10a and 10b).
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Tezuka as applied fails to teach the top side of the ring collar being below the sealing head.
Domkowski, analogous to pierceable containers, teaches it is known to form seals (72) with the top side of a ring collar (84) being below a sealing head (80). See annotated Figure 4 below. Moreover, Examiner notes that Domkowski, like Tezuka (see Tezuka para. [0035]), is also concerned with protecting the upper surface of the seal before first use by way of a removable protective cover (44; see para. [0035]). Thus, modification of Tezuka in view of Domkowski would not render it inoperable for its intended purpose.
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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 seal of Tezuka, forming the sealing head to extend above the top of the ring collar as taught by Domkowski, motivated by the benefit of raising the piercing area to make it more visible to a user, and by an obvious change in shape of the prior art, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al. No. 04-1350, 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 (IV)(B).
Furthermore, regarding the physical combination, the question is not whether the prior art devices can be physically combined, but whether a person of ordinary skill in the art would have found it obvious to combine different features or elements of known devices in a predictable way. See Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983): "There is a distinction between trying to physically combine the two separate apparatus disclosed in two prior art references on the one hand, and on the other hand trying to learn enough from the disclosures of the two references to render obvious the claims in suit. ...Claims may be obvious in view of a combination of references, even if the features of one reference cannot be substituted physically into the structure of the other reference." See MPEP 2145(III).
Regarding claim 5, the bottom side of the ring collar is substantially flat (see flat bottom of 13b in Tezuka Figure 1b).
Regarding claim 6, a height of the entirety of the ring collar between the top side of the ring collar and the bottom side of the ring collar is consistent (see constant height of the ring collar from lower end 13b to top end 13a in Tezuka Figure 1b).
Regarding claim 8, the seal is configured to reseal automatically after being punctured (Examiner notes Tezuka teaches in para. [0004] that forming the seal of a hard plastic will reduce sealing after withdrawal of the needle; the reference then teaches solving this problem by forming the sealing body of a thermoplastic elastomer of a lower hardness to ensure sealability in para. [0010]; additionally, the reference teaches “tightly fitting” the sealing body in the cylindrical outer frame body in para. [0016], implying the existence of a compressive force on the seal which would further promote sealing after withdrawal of the needle).
Regarding claim 9, medical container comprising:
a container body (22) prefilled with a medical liquid (see “drug solution”; para. [0002]);
a connector (15) attached to the container body (see Figure 3); and
a seal (10) received within the connector, the seal comprising:
a seal body (10a and 12 radially inside of 13c in Figure 1b) having a bottom surface (bottom of 10a and bottom of 10b radially inside of 13c in Figure 1b) and a seal head (upper surface of 10a and 12 radially inside of 13c in Figure 1b) at a top surface opposite the bottom surface, the seal head being substantially flat (see upper surface of 10a and 12 radially inside of 13c being substantially flat in Figure 1b);
a ring collar (portion located radially outwardly of 13c in Figure 1b) extending circumferentially around the seal body, the ring collar extending between a bottom side (13b) and a top side (13a) opposite the bottom side (see 13a on an upper side of the seal and 13b on a lower side of the seal in Figure 1b), the top side of the ring collar being below the sealing head (not taught), and the bottom side of the ring collar being below the bottom surface of the seal body (13b located below 10b in Figure 1b); and
a flange (read as the portion radially within the span of 13c in Figure 1b) connecting the seal body to the ring collar (located radially between the identified seal body and the identified ring collar; see annotated Figure 1b above with regard to claim 1), the flange extending between a bottom side and a top side opposite the bottom side (see top side at 13c and bottom side at 10b), the top side of the flange being below the top side of the ring collar (13c is below 10c in Figure 1b), and the bottom side of the flange being aligned with the bottom surface of the seal body (the bottom of the radial span of 13c is coplanar with the bottom of 10a and 10b).
Tezuka as applied fails to teach the top side of the ring collar being below the sealing head.
Domkowski, analogous to pierceable containers, teaches it is known to form seals (72) with the top side of a ring collar (84) being below a sealing head (80). See annotated Figure 4 below. Moreover, Examiner notes that Domkowski, like Tezuka (see Tezuka para. [0035]), is also concerned with protecting the upper surface of the seal before first use by way of a removable protective cover (44; see para. [0035]). Thus, modification of Tezuka in view of Domkowski would not render it inoperable for its intended purpose, as Domkowski shows the raised head can still be covered by a protective cover, as seen in Figure 4 therein.
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 seal of Tezuka, forming the sealing head to extend above the top of the ring collar as taught by Domkowski, motivated by the benefit of raising the piercing area to make it more visible to a user, and by an obvious change in shape of the prior art, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al. No. 04-1350, 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.). See MPEP 2144.04 (IV)(B).
Furthermore, regarding the physical combination, the question is not whether the prior art devices can be physically combined, but whether a person of ordinary skill in the art would have found it obvious to combine different features or elements of known devices in a predictable way. See Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983): "There is a distinction between trying to physically combine the two separate apparatus disclosed in two prior art references on the one hand, and on the other hand trying to learn enough from the disclosures of the two references to render obvious the claims in suit. ...Claims may be obvious in view of a combination of references, even if the features of one reference cannot be substituted physically into the structure of the other reference." See MPEP 2145(III).
Regarding claim 10, the connector is a seal cap comprising a cap body (16) and a break-off piece (17); the cap body receives the seal (see Figure 2); and the break-off piece covers the seal head (see 17 covering the top of 10 in Figure 2; such would still be covered after modification in view of Domkowski which also shows a break-off piece 44 covering the raised seal head 80 in Figure 4 therein).
Regarding claim 11, Tezuka fails to explicitly teach the break-off piece is configured to be disconnected from the cap body via breaking points defined by the cap body.
Domkowski teaches breaking points (48 and 58) which allow separation of the removable cap (44) from the closure (22) in order to expose the seal head (80).
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 seal of Tezuka in view of Domkowski as applied above, provding breaking points in the cap body as taught by Domkowski, motivated by the benefit of a frangible area to assist in removal of the break-off piece from the cap body, and by an obvious change in shape of the prior art, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al. No. 04-1350, 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Regarding claim 12, the container body is in the form of a bottle (see “bottle” 20; para. [0033]).
Regarding claim 13, the connector is welded or bonded to the container body (see Tezuka para. [0036]).
Regarding claim 14, the seal is clampingly held within the connector (Tezuka seal 10 is clamped between cap 16 and inner frame body 18; see para. [0034] and Figure 2).
Regarding claim 18, the bottom side of the ring collar is substantially flat (see flat bottom of 13b in Tezuka Figure 1b).
Regarding claim 19, a height of the entirety of the ring collar between the top side of the ring collar and the bottom side of the ring collar is consistent (see constant height of the ring collar from lower end 13b to top end 13a in Tezuka Figure 1b).
Regarding claim 21, the bottom side of the ring collar is received within a circumferential recess defined by the connector (see 13b fit within a recess defined between inner fame 18 and outer frame 16 in Figure 2).
6. Claims 2, 3, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066941 (Tezuka) in view of US 2006/0138069 (Domkowski) as applied above to claim 9, and further in view of US 2003/0121878 (Finneran).
Regarding claims 2 and 17, Tezuka in view of Domkowski as applied above fails to teach that the seal head defines a slot extending at least partially through a height of the seal head.
Finneran, analogous to pierceable stoppers, teaches a puncture site (40) "can be provided with a slit (42; read as a “slot”) which permits plug (30) to be “easily pierced with thin-walled instrument needles" (para. [0041]).
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 puncture site of Tezuka in view of Domkowski, providing a partial X-shaped slit and circumferential marking, as taught by Finneran, motivated by the benefit of reducing the force needed to puncture the stopper with a needle. See KSR International Co. V. Teleflex Inc. et al. No. 04-1350, 550 U.S. (2007) at 13, lines 22-25 which states, "When a work is available in one field of endeavor, design incentives ..can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious".
Regarding claim 3, the slot is two slots that cross one another (see Finneran 42 in Figure 7).
7. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066941 (Tezuka) in view of US 2006/0138069 (Domkowski) and US 2003/0121878 (Finneran) as applied above to claim 3, and further in view of US 6,340,359 (Silverman).
Regarding claim 4, Tezuka in view of Domkowski and Finneran as applied above fails to teach that the seal head has one or more markings around the crossing of the two slots.
Silverman, analogous to pierceable stoppers, teaches providing a marking (9, taught to be a raised rim encircling the puncture site; col. 11, lines 53-54) which can be a visual identifier comprising a colored circle (col. 11, lines 37-40).
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 stopper of Tezuka in view of Domkowski and Finneran, providing a marking encircling the puncture site as taught by Silverman, motivated by the benefit of identifying where to stick the needle, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al. No. 04-1350, 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
8. Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066941 (Tezuka) in view of US 2006/0138069 (Domkowski) as applied above to claims 1 and 9, and further in view of JP 2012062104 (Kawachi).
Regarding claims 7 and 20, Tezuka in view of Domkowski as applied above fails to teach that the top side of the ring collar comprises a plurality of spacers extending axially from the top side of the ring collar; and/or the bottom side of the ring collar comprises a plurality of spacers extending axially from the bottom side of the ring collar.
Examiner notes the term "spacer" is described in the Specification as an elevation or web which extends radially outwardly. See spacers (318) in Figures 4A-4D.
Kawachi teaches the same structure (1H) which are taught to support the stopper in conjunction with a recess (1E) serving as a target for a needle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Domkowski OR Kajihara, in view of Silverman and Finneran, providing spacers as taught by Kawachi, motivated by the benefit of additionally providing a recess as a target for receiving a needle, and reinforcing the recess target. See KSR International Co. V. Teleflex Inc. et al. No. 04-1350, 550 U.S. (2007) at 13, lines 22-25 which states, "When a work is available in one field of endeavor, design incentives can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states "if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious".
Furthermore, regarding the physical combination, the question is not whether the prior art devices can be physically combined, but whether a person of ordinary skill in the art would have found it obvious to combine different features or elements of known devices in a predictable way. See Orthopedic Equip. Co. V. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983): "There is a distinction between trying to physically combine the two separate apparatus disclosed in two prior art references on the one hand, and on the other hand trying to learn enough from the disclosures of Claims may be obvious in view of a combination the two references to render obvious the claims in suit of references, even if the features of one reference cannot be substituted physically into the structure of the other reference." See MPEP 2145(III).
9. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066941 (Tezuka) in view of US 2006/0138069 (Domkowski) as applied above to claim 9, and further in view of EP1457429 (Classens).
Regarding claim 15, Tezuka in view of Domkowski as applied above fails to teach that the seal head is substantially in a same plane as an upper surface of the connector.
Classens, analogous to pierceable stoppers for dispensing medical fluids, teaches it is known to provide a raised seal head substantially in the same plane as an upper surface of the connector (see sealing head 17’ fit within opening 16 an flush with surface 9’ in Figure 8), in order to receive a planar seal (18).
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 medical container of Tezuka in view of Domkowski, forming the seal head to extend in substantially the same plane as an upper surface of the connector as taught by Classens, motivated by the use of an analogous sealing structure, having a predictable outcome absent a teaching of an unexpected result. See KSR International Co. v. Teleflex Inc. et al. No. 04-1350, 550 U.S. 2007 at 13, lines 22-25 which states, “When a work is available in one field of endeavor, design incentives ...can prompt variations of it, either in the same field or a different one. Furthermore, see id. at 13, lines 27-31 which states “if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious”.
Furthermore, regarding the physical combination, the question is not whether the prior art devices can be physically combined, but whether a person of ordinary skill in the art would have found it obvious to combine different features or elements of known devices in a predictable way. See Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1013 (Fed. Cir. 1983): "There is a distinction between trying to physically combine the two separate apparatus disclosed in two prior art references on the one hand, and on the other hand trying to learn enough from the disclosures of the two references to render obvious the claims in suit. ...Claims may be obvious in view of a combination of references, even if the features of one reference cannot be substituted physically into the structure of the other reference." See MPEP 2145(III).
10. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 2007/0066941 (Tezuka) in view of US 2006/0138069 (Domkowski) as applied above to claim 9, and further in view of WO 2013/176587 (Ohlin).
Regarding claims 16, Tezuka in view of Domkowski as applied above fails to teach that the seal is made of an elastic material that is softer than a material from which the connector is made from.
Ohlin teaches a sealing element (18) can be formed of thermoplastic elastomer ("barrier membrane", page 4, lines 1-5) and that it comprises a softer material than the surrounding cap body (page 12, lines 23-35).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the sealing element of Tezuka in view of Domkowski of thermoplastic elastomer, and softer than the material of the cap body, as taught by Ohlin, motivated by the benefit of allowing penetration by a needle. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ416. See MPEP 2144.07.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES N SMALLEY whose telephone number is (571)272-4547. The examiner can normally be reached M-F 9:00 am to 6:00 pm.
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/JAMES N SMALLEY/Examiner, Art Unit 3733