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 .
Information Disclosure Statement
The information disclosure statement filed March 24, 2026 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because references do not include a date. See MPEP 609.04(a) I. “For publications obtained from the internet… Where the actual publication date of a non-patent document is not known, the applicant must, at a minimum, provide a date of retrieval (e.g., the date a webpage was retrieved) or a time frame (e.g., a year, a month and year, a certain period of time) when the document was available as a publication.” For references where a date was visible the Examiner has updated the IDS with the retrieval date. References which were not considered did not have a readily apparent date. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim 21 is objected to because of the following informalities: “the first end” lacks antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 8, 10, 14, 17, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luna (US 2016/0194114 A1).
With regard to claims 1, 3, 8, 10, 14, and 17, Luna teaches a medical device assembly, comprising: a glass cartridge to house a substance therein (pharmaceutical vial, [0014], [0015]); and an unbonded protective sheath detachably coupled to the glass cartridge and movable by micromovements with respect to the glass cartridge, wherein the sheath imparts a compressive force and hoop stress upon the glass cartridge sufficient to propagate a defect in the glass cartridge for quality control inspection and to resist structural damage to the glass cartridge during activation of the medical device assembly and is configured to at least one of protect the glass cartridge, increase visual detection of trauma to the medical device assembly, and increase visual detection of defects of the glass cartridge (Fig. 1, [0024], [0028], [0033], [0034], the transparent sheath is stretched to fit tightly/compress around the glass to protect the cartridge, this also resists damage during activation, and provide visual detection, as the sheath is compressed around the glass depending on the severity of the defect/crack the sheath would be able to propagate a defect).
With regard to claim 21, as ends of the sheath are open a first end of the cartridge would be uncovered (Fig. 4).
Claim(s) 1, 3-5, 8, 12, 13, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Conant et al. (US 4,125,640).
With regard to claims 1, 3-5, 8, 12, and 13, Conant et al. teach a medical device assembly, comprising: a glass cartridge to house a substance therein (abstract, Col. 4 lines 12-21, Fig. 1 see neck and shoulder of the cartridge); and an unbonded protective sheath detachably coupled to the glass cartridge and movable by micromovements with respect to the glass cartridge, wherein the sheath imparts a compressive force and hoop stress upon the glass cartridge sufficient to propagate a defect in the glass cartridge for quality control inspection and to resist structural damage to the glass cartridge during activation of the medical device assembly and is configured to at least one of protect the glass cartridge, increase visual detection of trauma to the medical device assembly, and increase visual detection of defects of the glass cartridge (Col. 4 lines 35-44, Col. 6 lines 24-27, and 62-66, metal armor sheath is not bonded to the glass, provides a compressive force, and protects the glass by absorbing the shock through deformation of the casing as the sheath is compressed around the glass this also resists damage during activation, depending on the severity of the defect the sheath would be able to propagate a defect).
With regard to claim 17, windows may be provided.
Claim(s) 1, 3-5, 8, 10, 12, 14, 16, and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tischlinger (US 3,978,858).
With regard to claims 1, 3-5, 8, 10, 14, 21, Tischlinger teaches a medical device assembly, comprising: a glass cartridge to house a substance therein (abstract, Col. 1 lines 6-10, Fig. 1 member 11); and an unbonded protective sheath (Fig. 1 member 21 is a thermoplastic polypropylene resin which would permanently deform depending on a force exerted, Col. 1 lines 10-14) detachably coupled to the glass cartridge and movable by micromovements with respect to the glass cartridge, wherein the sheath imparts a compressive force and hoop stress upon the glass cartridge sufficient to propagate a defect in the glass cartridge for quality control inspection and to resist structural damage to the glass cartridge during activation of the medical device assembly and is configured to at least one of protect the glass cartridge, increase visual detection of trauma to the medical device assembly, and increase visual detection of defects of the glass cartridge (Col. 1 lines 45-61, abstract, Col. 7 lines 25-30, 21 is heated and then stretched to compress around the glass, the sheath protects from breakage providing resistance to damage during use, depending on the severity of the defect/crack the sheath would be able to propagate a defect).
With regard to claim 12, see Fig. 1 extent is taken form a first to a second end, Col. 3 line 11 a nose tip would provide a shoulder and neck section.
With regard to claim 16, Col. 5 lines 26-27, a plunger is present and depending on the force by the plunger the compressive force may counterbalance it.
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.
Claim(s) 12, 13, 18, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luna (US 2016/0194114 A1) as applied to claim 1 above, and further in view of Perrot (US 2016/0206508 A1).
With regard to claims 12, 13, 18, and 22, Luna teaches a device substantially as claimed but does not disclose a sheath location or material as recited. However, Perrot teaches a similar container protector for protecting a glass cartridge with a neck and shoulder (Fig. 1) which is less than .2mm ([0052]) and is sufficient for protecting a glass container against impact ([0052]) and may be polyurethane or a fluoropolymer including PTFE which allows the device to be sterilized (abstract, [0041], PTFE). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention that the pharmaceutical vial of Luna would have a neck and shoulder and to dispose the sheath over this portion and to have a sheath with a material as taught by Perrot as this would be effective for protecting the glass container against impact and allows for sterilization. The material properties of PTFE meet the limitations of claim 22 as shown by Applicant’s Table 1 on Pg. 14 of the specification.
Claim(s) 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luna (US 2016/0194114 A1) as applied to claim 1 above.
With regard to claims 7, 9, and 11, Luna does not disclose a particular compressive force, impact force, or hardness. However, as the device is disclosed as designed to protect the vial by absorbing shock (see at least the abstract, [0017]) it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select a compressive force and material hardness as needed to achieve the desired impact force absorption for protection as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luna (US 2016/0194114 A1) as applied to claim 1 above, and further in view of Gutierrez (US 2016/075532 A1).
With regard to claims 15 and 16, Luna teaches a vial for holding a therapeutic agent (abstract) but does not disclose the protected container to be an auto-injector or comprising a plunger. However, Gutierrez teaches a syringe which is fully covered by a protective gripping layer (Fig. 4). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use the sheath with a cartridge for a syringe or auto-injector as Gutierrez teaches surrounding such a device and the sheath would provide protection to glass pharmaceutical members.
Claim(s) 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conant et al. (US 4,125,640) as applied to claim 1 above.
With regard to claims 7, 9, and 11, Conant et al. do not disclose a particular compressive force, impact force, or hardness. However, as the device is disclosed as designed to protect the vial by absorbing shock (Col. 6 lines 24-27, and 62-66) it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select a compressive force and material hardness as needed to achieve the desired impact force absorption for protection as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tischlinger (US 3,978,858) as applied to claim 1 above.
With regard to claims 7, 9, and 11, Tischlinger does not disclose a particular compressive force, impact force, or hardness. However, as the device is disclosed as designed to protect the vial (by preventing breakage and providing a secure fit which resists removal) it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select a compressive force and material hardness as needed to achieve the desired impact fit and protection as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The new limitations are addressed as above. Regarding Applicant’s arguments that the compressive forces distinguish over the references, the independent claim has only been amended to recite sufficient to propagate a defect, there is no specificity given to what constitutes the defect. Further Applicant remarks to the how those compressive forces are imparted into the material via shrinking, this is not reflected in the claim. Regarding Luna, Applicant remarks, the cover would not function with a compressive force as recited, the Examiner notes specific force values are not present in the independent claim but are only present in the dependent claims. In Luna, compression is also provided by the silicone bands. Applicant remarks Luna provides no motivation to provide a particular compressive force. As Luna specifically provides compression for storage protection, though this reason may be different than Applicant’s, given Luna’s disclosure one would be motivated to achieve certain values to yield the protective and shock absorption qualities discussed by Luna. Regarding Conant, Applicant remarks Conant’s compression is a byproduct of thermal contraction than a deliberately engineered feature. Conant is specifically engineered to prevent stress, though the reasons may be different than Applicant they would still motivate one of ordinary skill in the art to design the sheath for protection as needed. Again, the independent claim is not drawn to specific defect characteristics, forces, or material properties.
Previous objections are withdrawn.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/ Primary Examiner, Art Unit 3783
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