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 without traverse of Group I (claims 1-9 & 20) in the reply filed on 12/18/2025 is acknowledged.
Claims 10-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim.
Claims Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means for interlocking said sleeve with at least one additional sleeve” in claim 20. Further structures are recited at the end of claim 20 to further define said “means for” limitation.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Objections
Claims 1-8 & 20 are objected to because of the following informalities:
Re Claim 1, it appears that the Applicant is reciting two similar terms for the same structures, i.e., “pliable sleeve” and “(protective sleeve)”. Examiner recommends amending the claim language to recite “a pliable first sleeve” since the protective function is already captured with the language “configured for protectively encasing a medical vial.” All subsequent reference to said sleeve should be “the first sleeve.” This will make it easy to distinguish the first sleeve from the “second protective sleeve” that is recited in the intended use language at the end of Claim 1.
Re Claim 2, Examiner recommends amending “the interlocking component” to “the at least one interlocking surface comprises an interlocking component.”
Re Claim 3, Examiner recommends amending “the remaining sleeve” to “a remaining portion of the first sleeve.” Additionally, Examiner believes “silicon” (an element on the periodic table) should be “silicone” (a thermoplastic elastomer widely used in medical applications).
Re Claim 4, “the protective sleeve” should be “the first sleeve.”
Re Claims 5-6, “the sleeve” should be “the first sleeve.”
Re Claim 7, “each sleeve” should be “the first sleeve.”
Re Claim 8, for consistency in claim terms, “wherein said syringe housing surface is adjacent to at least one of the aperture surface or interlocking vial surface” can be rephrased to read “wherein the at least one surface dedicated to housing a syringe is adjacent to one or both of the at least one surface with an aperture and the at least one surface dedicated to interlocking with a counter surface.” Alternatively, Applicant may wish to recite “at least one aperture surface” and “at least one interlocking surface” in Claim 1 and then recite “at least one syringe housing surface” in Claim 8. This way, it will be very clear which surface is being referenced.
Re Claim 20, it appears that the Applicant is reciting two terms for the same structures, i.e., “an enclosure” and “(sleeve)”. Examiner recommends amending the claim language to recite “a sleeve”. Additionally, when “at least one of” is used with a list of alternatives, the alternatives should be joined by “and”. That is, the recitation “at least one of a positive and negative feature interlocking, magnetic coupling, clips, hook and loop closure, snap-fit connection, or bonded assembly” should be amended to “at least one of a positive and negative feature interlocking, magnetic coupling, clips, hook and loop closure, snap-fit connection, and bonded assembly”.
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 4 & 9 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.
Re Claim 4, the claim recites “the interlocking component” which lacks antecedent basis. For examination, Examiner assumes that Claim 4 depends from Claim 2.
Claim 9 recites “wherein the multiple vial carriage or vial chaining comprises any number of vials” and this is confusing because any number can include one but the terms “multiple” and “chaining” implies that there should be more than one. Examiner recommends rephrasing the claim to read “wherein the multiple vial carriage or vial chaining comprises at least two sleeves.”
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.
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 1-7, 9, & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Larson et al. (US 2017/0095403) in view of Paulick (US 2022/0408917).
Re Claim 1, Larson discloses a protective sleeve apparatus, said apparatus comprising:
a pliable first sleeve (secondary packaging holder 102, see e.g., Figs. 1-2, [0062] “secondary packaging holder 102 can be made of … resilient materials”) configured for protectively encasing a medical vial (primary packaging holder 120, see [0024] “The primary packaging holder can be a vial.”), wherein said first sleeve is further comprised of:
at least one aperture surface or point on the first sleeve with an aperture (at receiving portion 110, see e.g., Fig. 2) for at least one of vial insertion into the protective sleeve, vial access for drawing vial contents, or viewing a label and/or quantity of content in the vial.
Larson does not disclose at least one interlocking surface or point on the sleeve dedicated to interlocking with a counter surface or point of at least a second protective sleeve for vial chaining and subsequently does not disclose that the apparatus is for multiple vial carriage or vial chaining.
Paulick discloses a rack (180, Fig. 6C) having a chain of multiple bottle sleeves (each hexagon shown in Fig. 6C is one sleeve that can accommodate a wine bottle), the rack being formed of modular components (100) having surface features (connection feature 127, see [0047] and Fig. 3) that allow releasable interlocking with an adjacent modular component (see Figs. 6A-6B). It would have been obvious to one skilled in the art at the time of filing to modify Larson with the connection feature shown in Paulick such that it would be easier to keep track of multiple vials together.
Re Claim 2, Larson and Paulick combine to disclose claim 1, and Paulick further discloses wherein the at least one interlocking surface comprises an interlocking component employing a positive (tabs 131 & 132, Fig. 3) and negative (grooves 177a and 177b) feature coupling mechanism.
Re Claim 3, Larson and Paulick combine to disclose claim 1. Larson does not explicitly disclose the material of the sleeve or the interlocking component wherein the interlocking component is made of a pliable material comprising at least one of a thermoplastic polyurethane or silicone, with higher tensile value than a remaining portion of the first sleeve. Paulick discloses the modular components of the rack be made of polyurethane ([0040]). While Paulick also does not disclose that the interlocking component (tabs 131 & 132 as well as grooves 177a & 177b) have higher tensile value than a remaining portion of the modular component, a person of ordinary skill has good reason to pursue the known options (made the interlocking component of a material that has the same, less, or more tensile strength compared to the rest of the modular component) within his or her technical grasp. If this leads to the anticipated success (the modular components stay interlocked), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Re Claim 4, Larson and Paulick combine to disclose claim 2. Larson does not disclose an interlocking component and therefore does not disclose wherein the interlocking component and the first sleeve are comprised of the same pliable material with similar tensile values. Paulick discloses that the interlocking component (tabs 131 & 132 as well as grooves 177a & 177b) are formed as a unitary piece with the rest of the modular component. It would have been obvious to one skilled in the art at the time of filing to glean from Paulick such that the manufacturing process can be simpler when only one material is needed.
Re Claim 5, Larson and Paulick combine to disclose claim 2, and in the combination, Paulick further discloses wherein the positive feature coupling mechanism (131 or 132) is disposed on a fixed side of the first sleeve and includes a protruding, interlocking component (Figs. 3 & 6A-C).
Re Claim 6, Larson and Paulick combine to disclose claim 2, and in the combination, Paulick further discloses wherein the negative feature coupling mechanism (grooves 177a & 177b) is disposed on a fixed opposing side of the first sleeve and includes a recessed, interlocking component (Figs. 3 & 6A-C).
Re Claim 7, Larson and Paulick combine to disclose claim 2, and in the combination, Paulick further discloses wherein the first sleeve includes a positive feature coupling mechanism on one side and a negative feature coupling mechanism on an opposing side, enabling interlocking with additional sleeves (see Figs. 3 & 6A-6C).
Re Claim 9, Larson and Paulick combine to disclose claim 1, and in the combination, the multiple vial carriage or vial chaining comprises at least two sleeves (because Larson’s sleeve is modified with interlocking components as taught by Paulick and thus capable of joining with another sleeve that would also have the same interlocking components).
Re Claim 20, Larson discloses a protective sleeve apparatus, said apparatus comprising:
a sleeve (secondary packaging holder 102, see e.g., Figs. 1-2, but not limited to said embodiment) fabricated from at least one of an elastomeric, thermoplastic, synthetic rubber, specialty polymer, or composite material ([0062] “secondary packaging holder 102 can be made of … resilient materials”) conferring the sleeve with at least one of a shock-absorption (implied because the Background section discloses the need for packaging that can protect fragile vials), flexibility (at least [0102]), thermal stability, and UV-resistant property.
Larson does not disclose a means for interlocking said sleeve with at least one additional sleeve, said means for interlocking including at least one of a positive and negative feature interlocking, magnetic coupling, clips, hook and loop closure, snap-fit connection, or bonded assembly disposed on at least one of opposable side walls for each of the interlocked sleeves, whereby the interlocked sleeves enable vial chaining.
Paulick discloses a rack (180, Fig. 6C) having a chain of multiple bottle sleeves (each hexagon shown in Fig. 6C is one sleeve that can accommodate a wine bottle), the rack being formed of modular components (100) having positive and negative interlocking features (tabs 131 & 132 and grooves 177a & 177b, see [0047] and Fig. 3) that allow releasable interlocking with an adjacent modular component (see Figs. 6A-6C). It would have been obvious to one skilled in the art at the time of filing to modify Larson with the interlocking feature shown in Paulick such that it would be easier to keep track of multiple vials together, and subsequently enabling vial chaining.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Larson and Paulick as applied to claim 2 above, and further in view of Born (US 10,898,411).
Re Claim 8, Larson and Paulick combine to disclose claim 2, but neither discloses at least one syringe housing surface dedicated to housing a syringe, wherein said syringe housing surface is adjacent to at least one of the aperture surface or interlocking surface. Born discloses a clip for attaching a syringe to a bottle (see Figs. 1 & 1A) such that accessories can be made readily available when using the contents of the bottle. It would have been obvious to one skilled in the art at the time of filing to modify Larson further with Born’s teachings such that a caretaker can have a syringe handy to access the contents in the vial. After the modification, given that there are only a limited number of surfaces on the Larson sleeve, the options for the location of the syringe housing surface is also very limited. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success (making the syringe easily accessible and the multiple vials together such that vials are not easily misplaced), it is likely that product was not of innovation but of ordinary skill and common sense. In that instant the fact that a combination was obvious to try might show that it was obvious under § 103. See MPEP 2143 (E).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Dallman discloses a structure (key member 14, see Fig. 2) for attachment to a vial, wherein the structure is configured to interlock with a storage chamber that houses the vial (clearly seen in Fig. 2).
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/SUSAN S SU/Primary Examiner, Art Unit 3781 24 January 2026