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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on December 11, 2025 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because the groups do require different fields of search and art applicable to one group of claims may not necessarily be applicable to another. For example, the method of making claims recite specific method step of heat or cold shrinking which are not require by the device claims and which would require search in different areas.
The requirement is still deemed proper and is therefore made FINAL.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 11, 2025.
Claim Objections
Claims 3 and 17 are objected to because of the following informalities: claim 3 recites “the body” and claim 17 recites “the agent” both of which lack 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, 6, 8, 10, 14, and 17 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, 6, 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 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 and provide visual detection).
Claim(s) 1-6, 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, 3-6, 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 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).
With regard to claim 2, see at least Col. 4 line 3.
With regard to claim 17, windows may be provided.
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) 2, 12, 13, and 18 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 2, 12, 13, and 18, Luna teaches a device substantially as claimed but does not disclose a thickness of the sheath. 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 which allows the device to be sterilized (abstract, [0041]). 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 thickness and material as taught by Perrot as this would be effective for protecting the glass container against impact and allows for sterilization.
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.
Conclusion
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