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 Arguments
Applicant’s amendments filed 21 November 2025 with respect to the rejection(s) of claim(s) 1-18, 20-31 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Applicant has further amended the claims to further claim the viewing window. However, upon further consideration, a new ground(s) of rejection is made in view of Barnett, Bantug and Parker.
Examiner notes Applicant argues the cited prior art does not teach a plastic material having a cryogenic operating temperature range. Examiner reiterates that the term “a plastic material having a cryogenic operating temperature range” does not require that the entire device be exposed to cryogenic temperatures but interpreted in this case in the broadest reasonable interpretation which is a material that can operate in cryogenic temperatures. This silicone is the material similarly cited by Applicant as being able to operate in such an environment. Examiner believes this material would operate under cryogenic temperatures.
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 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.
Claims 1-6, 8-16, 18, 20-24, 26-31 are rejected under 35 U.S.C. 103 as being unpatentable over Barnett (US 2019/0225378) in view of Parker (US 20090157219) further in view of Bantug (US 2019/0152650).
Regarding claim 1, Barnett discloses a vial jacket ([0002]) configured to receive a label (the sleeve can have the intended use of receiving a label), the vial jacket (132) comprising:
a plastic material (equivalent part 32 described as being made of silicone ,[0053]) having a cryogenic operating temperature range (silicone has a cryogenic operating temperature range), the plastic material dimensioned to surround only a portion of a vial not including a bottom of the vial (figure 17-18, the sleeve does not surround the bottom of a container);
a hinge (786, figure 18, [0070]) formed in the plastic material along a longitudinal axis of the vial jacket, the hinge defining a first half shell (788) comprising a first edge (edge of 788) and a second half shell (790) comprising a second edge (edge of 790);
Barnett does not disclose a locking mechanism configured to secure the first edge of the first half shell to the second edge of the second half shell, and a viewing window formed in a sidewall of the plastic material and present when the vial jacket is in a closed configuration, wherein the viewing window comprises an axial length and a traverse length and permits a user to inspect the contents of the vial.
Parker discloses a container with a locking mechanism (3006) configured to secure the first edge of the first half shell to the second edge of the second half shell ([0038]).
Parker utilizes a lock to secure ends of a hinge shell ([0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with Parker in order to allow the shell ends to be secured and prevent the inadvertent opening of the shell.
Barnett and Parker do not teach a viewing window formed in a sidewall of the plastic material and present when the vial jacket is in a closed configuration, wherein the viewing window comprises an axial length and a traverse length and permits a user to inspect the contents of the vial.
Bantug discloses a vial sleeve assembly in the same field of art as the Applicant. Bantug teaches viewing window (308) formed in a sidewall of the plastic material (300, [101]) and present when the vial jacket is in a closed configuration (viewing window exists on the shell regardless of closed/open configuration), wherein the viewing window comprises an axial length and a traverse length (figure 3B-3C) window has axial and traverse dimensions) and permits a user to inspect the contents of the vial ([0113]).
Bantug provides a viewing window to allow the user to inspect the contents interior to the sleeve ([0113]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with the viewing window of Bantug to allow the user to see the interior contents of the sleeve to identify the material/content inside of the sleeve.
Regarding claim 2-3, Barnett and Parker do not specifically disclose the cryogenic operating temperature range comprises a range of about -150c to about -135c or about -190c to about -135c.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of the cited prior art to have a cryogenic operating temperature range comprises a range of about -150c to about -135c or about -190c to about 135c since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Parker would not operate differently with the claimed temperature range and since the device is made of rigid plastic it could operate in those temperature ranges ([0061]). Further, applicant places no criticality on the range claimed, indicating simply that the temperature “approximately” be within the claimed ranges (specification pp. [0003]).
Regarding claim 4, Barnett does not teach the hinge formed by thinning of plastic material.
Parker discloses the hinge formed by thinning of plastic material (figure 3b, [0038] the hinge is formed by plastic material in a thin manner and the sleeve material being sufficiently flexible to avoid mechanical hinge).
Both Barnett and Parker discloses functionally equivalent ways to create a hinge, one using a pivot, joint, hinge and the other using thinning of material. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett by substituting the hinge with a thinning of material as disclosed by Parker in order to provide a close and open the shell since both references discloses a hinge and they appear to be functionally equivalent.
Regarding claim 5, Barnett discloses suitable plastic ([0053]) for the plastic material.
Regarding claim 6, Barnett does not disclose a locking mechanism.
Parker teaches the locking mechanism secures the vial jacket to the vial (figure 2a-2b showing the sleeve on the vial, [0038]).
Parker utilizes a lock to secure ends of a hinge shell ([0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with Parker in order to allow the shell ends to be secured and prevent the inadvertent opening of the shell.
Regarding claim 8, the cited prior art does not discloses the axial length of opening is greater than transverse length.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of cited prior art to have a axial length of opening is greater than transverse length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Barnett would not operate differently with the claimed opening dimensions and the opening would still work properly. Further, applicant places no criticality on the range claimed, indicating simply that the opening size could have a larger axial length or transverse length (specification pp. [0010]).
Regarding claim 9, Bantug further teaches wherein the transverse length of the opening is greater than the axial length (figure 3C).
Bantug provides a viewing window to allow the user to inspect the contents interior to the sleeve ([0113]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with the viewing window of Bantug to allow the user to see the interior contents of the sleeve to identify the material/content inside of the sleeve.
Regarding claim 10, Barnett discloses the shells but does not disclose the viewing window is proximate to at least one of the first edge of the first half shell or the second edge of the second half shell.
Bantug teaches viewing window (308) formed in a sidewall of the plastic material (300, [101]) which would be proximate any edge of the first half shell or second edge of the second half shell when combined since Bantug teaches the distribution of the opening around the sleeve (figures 3B-3C).
Bantug provides a viewing window to allow the user to inspect the contents interior to the sleeve ([0113]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with the viewing window of Bantug to allow the user to see the interior contents of the sleeve to identify the material/content inside of the sleeve.
Regarding claim 11, Barnett discloses a vial jacket ([0002]) configured to receive a label (the sleeve can have the intended use of receiving a label), the vial jacket (132) comprising:
a plastic material (equivalent part 32 described as being made of silicone ,[0053]) having a cryogenic operating temperature range (silicone has a cryogenic operating temperature range), the plastic material dimensioned to surround only a portion of a vial not including a bottom of the vial (figure 17-18, the sleeve does not surround the bottom of a container);
a hinge (786, figure 18, [0070]) formed in the plastic material along a longitudinal axis of the vial jacket, the hinge defining a first half shell (788) comprising a first edge (edge of 788) and a second half shell (790) comprising a second edge (edge of 790), the hinge positioned along a length of container when received in the container (figure 18-19);
Barnett does not disclose containers in general but not specifically a vial, a locking mechanism configured to secure the first edge of the first half shell to the second edge of the second half shell, a viewing window formed in a sidewall of the plastic material and present when the vial jacket is in a closed configuration, wherein the viewing window comprises an axial length and a traverse length and permits a user to inspect the contents of the vial.
Parker discloses a vial (1003) and a jacket with a locking mechanism (3006) configured to secure the first edge of the first half shell to the second edge of the second half shell ([0038]).
Parker utilizes a lock to secure ends of a hinge shell ([0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with Parker in order to allow the shell ends to be secured and prevent the inadvertent opening of the shell.
Barnett and Parker do not teach a viewing window formed in a sidewall of the plastic material and present when the vial jacket is in a closed configuration, wherein the viewing window comprises an axial length and a traverse length and permits a user to inspect the contents of the vial.
Bantug discloses a vial sleeve assembly in the same field of art as the Applicant. Bantug teaches viewing window (308) formed in a sidewall of the plastic material (300, [101]) and present when the vial jacket is in a closed configuration (viewing window exists on the shell regardless of closed/open configuration), wherein the viewing window comprises an axial length and a traverse length (figure 3B-3C) window has axial and traverse dimensions) and permits a user to inspect the contents of the vial ([0113]).
Bantug provides a viewing window to allow the user to inspect the contents interior to the sleeve ([0113]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with the viewing window of Bantug to allow the user to see the interior contents of the sleeve to identify the material/content inside of the sleeve.
Regarding claim 12-13, Barnett and Parker do not specifically disclose the cryogenic operating temperature range comprises a range of about -150c to about 0c or about -190c to about 0c.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of the cited prior art to have a cryogenic operating temperature range comprises a range of about -150c to about 0c or about -190c to about 0c since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Parker would not operate differently with the claimed temperature range and since the device is made of rigid plastic it could operate in those temperature ranges ([0061]). Further, applicant places no criticality on the range claimed, indicating simply that the temperature “approximately” be within the claimed ranges (specification pp. [0003]).
Regarding claim 14, Barnett does not teach the hinge formed by thinning of plastic material.
Parker discloses the hinge formed by thinning of plastic material (figure 3b, [0038] the hinge is formed by plastic material in a thin manner and the sleeve material being sufficiently flexible to avoid mechanical hinge).
Both Barnett and Parker discloses functionally equivalent ways to create a hinge, one using a pivot, joint, hinge and the other using thinning of material. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett by substituting the hinge with a thinning of material as disclosed by Parker in order to provide a close and open the shell since both references discloses a hinge and they appear to be functionally equivalent.
Regarding claim 15, Barnett discloses suitable plastic ([0053]) for the plastic material.
Regarding claim 16, Barnett does not disclose a locking mechanism.
Parker teaches the locking mechanism secures the vial jacket to the vial (figure 2a-2b showing the sleeve on the vial, [0038]).
Parker utilizes a lock to secure ends of a hinge shell ([0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with Parker in order to allow the shell ends to be secured and prevent the inadvertent opening of the shell.
Regarding claim 18, the cited prior art does not discloses the axial length of opening is greater than transverse length.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of cited prior art to have a axial length of opening is greater than transverse length since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Barnett would not operate differently with the claimed opening dimensions and the opening would still work properly. Further, applicant places no criticality on the range claimed, indicating simply that the opening size could have a larger axial length or transverse length (specification pp. [0010]).
Regarding claim 10, Barnett discloses the shells but does not disclose the viewing window is proximate to at least one of the first edge of the first half shell or the second edge of the second half shell.
Bantug teaches viewing window (308) formed in a sidewall of the plastic material (300, [101]) which would be proximate any edge of the first half shell or second edge of the second half shell when combined since Bantug teaches the distribution of the opening around the sleeve (figures 3B-3C).
Bantug provides a viewing window to allow the user to inspect the contents interior to the sleeve ([0113]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with the viewing window of Bantug to allow the user to see the interior contents of the sleeve to identify the material/content inside of the sleeve.
Regarding claim 21, Barnett discloses the hinge is positioned along a longitudinal axis of the vial when a portion of the vial is received in the vial jacket (figure 18).
Regarding claim 22, Barnett discloses wherein a longitudinal axis of the hinge is parallel to a longitudinal axis of the vial when a portion of the vial is received in the vial jacket (figure 18-19).
Regarding claim 23, Barnett discloses wherein the hinge is formed along a longitudinal axis of the vial jacket (figure 18).
Regarding claim 24, Barnett discloses wherein a longitudinal axis of the hinge is parallel to a longitudinal axis of the vial when the portion of the vial is received in the vial jacket (figure 18-19).
Regarding claim 26, Parker further teaches wherein the locking mechanism is configured to secure the first edge of the first half shell to the second edge of the second half shell to place the vial jacket in a closed configuration ([0038]), and wherein in the closed configuration, inner surfaces of the first half shell and the second half shell of the vial jacket are in contact with an outer surface of the vial along the first and second edges respectively (when the edges contact the surfaces of the shell are in contact due to joint connecting the edges).
Parker utilizes a lock to secure ends of a hinge shell ([0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with Parker in order to allow the shell ends to be secured and prevent the inadvertent opening of the shell.
Regarding claim 27, Parker further teaches wherein the locking mechanism is configured to secure the first edge of the first half shell to the second edge of the second half shell to place the vial jacket in a closed configuration ([0038]), and wherein in the closed configuration, inner surfaces of the first half shell and the second half shell of the vial jacket are in contact with an outer surface of the vial along an entire length of the vial jacket ([0038], the joint secures the halfs together which would include being secured along the entire jacket).
Parker utilizes a lock to secure ends of a hinge shell ([0038]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with Parker in order to allow the shell ends to be secured and prevent the inadvertent opening of the shell.
Regarding claim 10, Barnet discloses the shells but does not disclose the opening is positioned between the hinge and the first edge or the second edge.
Bantug teaches viewing window (308) formed in a sidewall of the plastic material (300, [101]) and the opening would be positioned between the hinge and the first edge or the second edge since Bantug teaches the distribution of the opening around the sleeve (figures 3B-3C).
Bantug provides a viewing window to allow the user to inspect the contents interior to the sleeve ([0113]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett with the viewing window of Bantug to allow the user to see the interior contents of the sleeve to identify the material/content inside of the sleeve.
Regarding claim 30, Barnett discloses the vial jacket configured to be positioned adjacent to bottom of the vial (figure 18).
Regarding claim 31, Barnett does not disclose the vial comprises a volume of 1mL to 6mL.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of cited prior art to have a volume of 1mL to 6mL since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Barnett would not operate differently with the claimed volume. Further, applicant places no criticality on the range claimed, indicating simply that volume can be in the range (specification pp. [0037]).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Barnett in view of Parker further in view of Bantug further in view of Yves (FR 2766980).
Regarding claims 7 and 17, Barnett and Parker while disclosing a mechanical joint (3006) does not disclose wherein the locking mechanism is configured to snap fit the first edge of the first half shell to the second edge of the second half shell.
Yves discloses a securing shell device relatively pertinent to problem posed by Applicant of holding and maintaining material inside a shell. Yves teaches a plastic shell (line 212 of accompanying translation) having a locking mechanism (8, 8’) configured to secure the first edge of the first half shell to the second edge of the second half shell (lines 212-224). Yves teaches wherein the locking mechanism is configured to snap fit the first edge of the first half shell to the second edge of the second half shell (lines 241-250). The combined prior art device that adds the snap fit mechanism to the device of Parker would secure the vial jacket to the vial.
Yves provides the locking mechanism in order to protect the interior of the shell and avoid unintended opening (lines 241-250). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify the cited prior art with the locking mechanism of Yves in order to easily couple the halves of the holder together and control the opening to avoid unintended opening. The simple substitution would allow the device to function normally from unintended opening.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Barnett in view of Parker further in view of Bantug further in view of Kaplan (US 2012/0006712).
Regarding claim 25, Barnett and Parker do not disclose a label on the jacket.
Kaplan discloses the vial and jacket and teaches a label on the jacket ([0014]).
Kaplan provides the label to provide accurate information about the contents ([0042-0043]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Barnett and Parker with the label of Kaplan in order to provide more information regarding the contents of the vial.
Conclusion
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 KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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/KAI H WENG/Primary Examiner, Art Unit 3781