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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/29/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 09/26/25. As directed by the amendment: claims 1-3 have been amended, claims 6 and 7 have been cancelled and claims 17-19 have been added.
Thus, claims 1-5 and 8-19 are pending in this application.
Claim 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 of forming rollers” in claims 11 and 14, “means of pressure” in claim 13 and “means of the non-circular pin” claim 14.
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 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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-5, 8-10, 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Glocker et al (US 20130338575 A1) in view of Leonardi et al (US 20190329944 A1).
Regarding claim 1, Glocker et al disclose a medical hollow container (1, fig 1), wherein the medical hollow container (1) has a fastening portion (37) and a receiving portion (19/17), wherein the fastening portion (37) has a shoulder region (see annotated figure below) on a side facing the receiving portion (19) and has a head region (see annotated figure below) on a side facing away from the receiving portion (19), and wherein the head region has an opening (9) on which a closure cap (3) can be arranged (fig 2), characterized in that the fastening portion (37) has at least one rotation inhibiting structure (41) which is designed to at least inhibit relative rotation between the medical hollow container (1) and the closure cap (3) with respect to each other (para 0040-41 and 0077), wherein the rotation inhibiting structure (41) has rotation inhibiting elements (43, 101) spaced apart from one another (fig 2, 9) and complementary to and configured to engage with complementary rotation inhibiting elements (39, 39') of the closure cap (para 0058-59 and 0077), wherein each of the rotation inhibiting (43, 101) comprise an elevation or a depression, or is designed as a non- circular shape of the opening or a non-circular edge of the opening (groove 43 or 101 are designed depression or non-circular shape, figs 2, 9), wherein the medical hollow container (1) further includes the closure cap (3) arranged on the fastening portion (37) of the medical hollow container (1), the closure cap (3) being arranged on the side of the fastening portion (37) facing away from the receiving portion of the medical hollow container (see fig 2), wherein the medical hollow container (1) can be closed by the closure cap (3), wherein a cavity (9) is formed in the region between the closure cap (3) and the fastening portion (37) of the medical hollow container (1), wherein a sealing element (35) is at least partially arranged in the cavity (para 0037, fig 2), characterized in that the fastening portion (37) of the medical hollow container (1) has at least one rotation inhibiting element (para 0038, mouth 37 has internal contour) on the inside, and the sealing element (37) is flexible (para 0038), wherein the sealing element (35) engages in the at least one rotation inhibiting element of the fastening portion (para 0038), such that the sealing element (35) and the medical hollow container (1) cannot be rotated relative to each other (para 0038-40).
Glocker et al fail to teach wherein the medical hollow container is made of glass.
However, Leonardi et al disclose a medical hollow container (110) wherein the medical hollow container is made of glass (para 0003 and 0028).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the medical hollow container of Glocker et al to made of glass as taught by Leonardi et al. This would provide the benefit of having a container made impervious materials which are commonly used to store liquids in a number of applications (para 0003).
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Regarding claim 2, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) according to claim 1, characterized in that each of the rotation inhibiting elements (41) is at least one elevation (elevation between grooves 101, fig 9), wherein the at least one elevation has a geometric shape selected from a group consisting of: a roof shape, a pyramidal shape, a tetrahedral shape, a cylindrical shape, and a hemispherical shape (elevation between grooves 101, fig 9 is a roof shape).
Regarding claim 3, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) according to claim 1, the rotation inhibiting elements being arranged, in the circumferential direction around the central axis of the medical hollow container (figs 2 and 9, groove in flange 41 and groove 43 are arranged in the circumferential direction around the central axis of the medical hollow container).
Regarding claim 4, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) according to claim 1, characterized in that the non-circular shape of the opening (9) or the non-circular edge is elliptical, polygonal, jagged, or grooved (para 0038, mouth 37 has internal contour, see fig 2).
Regarding claim 5, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) according to claim 1, characterized in that the medical hollow container (1) is a carpule, a syringe or a vial (syring1, fig 1).
Regarding claim 8, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) having the closure cap (3) according to claim 1, characterized in that the sealing element (35) is fixed at least in portions thereof relative to the closure cap (3), such that the closure cap (3) and the sealing element (35) cannot be rotated relative to each other (fig 2, para 0038-40).
Regarding claim 9, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) having the closure cap (3) according to claim 1, characterized in that the sealing element (35) is made of elastic material (para 0038).
Regarding claim 10, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) having the closure cap (3) according to claim 1, characterized in that the closure cap (3) is designed as a coupling element (33), the coupling element (33) being designed for axially connecting the medical hollow container (1) to a medical apparatus (91, para 0052, fig 6).
Regarding claim 15, Glocker et al in view of Leonardi et al disclose a medical hollow container (1) according to claim 1, in combination with a medical apparatus (91), wherein the medical hollow container (1) is connected to the medical arrangement (see fig 6).
Regarding claim 17, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) having the closure cap (3) according to claim 1, wherein the rotation inhibiting elements a first rotation inhibiting element (41) disposed in a head region of a fastening portion of the medical hollow container (1) and a second rotation inhibiting element (43) disposed in a shoulder region of the fastening portion (figs 2 and 9).
Regarding claim 18, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) having the closure cap (3) according to claim 1, wherein the rotation inhibiting elements are evenly spaced apart along a circumferential direction of the medical hollow container (figs 2 and 9, grooves 43 are evenly arranged in the circumferential direction around the central axis of the medical hollow container).
Regarding claim 19, Glocker et al in view of Leonardi et al disclose the medical hollow container (1) having the closure cap (3) according to claim 1, wherein the rotation inhibiting elements comprise grooves (43) and the complementary rotation inhibiting elements comprise ridges (39) configured to tightly fit into the grooves (para 0040 and 0058, fig 2).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Glocker et al (US 20130338575 A1) in view of Leonardi et al (US 20190329944 A1) and further in view of Moriuchi et al (US 20220024799 A1).
Regarding claim 11, Glocker et al in view of Leonardi et al disclose the limitations of claim 1 but fail to teach a method for producing a medical hollow container according to claim 1 in a rotary process, wherein a rotating glass tube is heated, wherein the receiving portion and the fastening portion with the head region and the shoulder region are shaped by means of forming rollers, such that a molded glass container is obtained, characterized in that the at least one elevation or the at least one depression is molded from the molded glass container or molded into the molded glass container, or the opening or the edge of the opening is not round.
However, Moriuchi et al disclose a method for producing a medical hollow container (10, see abstract and fig 1), in a rotary process (see fig 1), wherein a rotating glass tube is heated (para 0007), wherein the receiving portion (see fig 1, body of container 10) and the fastening portion with the head region and the shoulder region (mouth portion 12) are shaped by means of forming rollers (para 0013 and 0023), such that a molded glass container is obtained (10), characterized in that the at least one elevation or the at least one depression is/are molded from the molded glass container or molded into the molded glass container or the opening or the edge of the opening are not round (flange portion 18).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Glocker et al in view of Leonardi et al and incorporate the teachings of Moriuchi et al to have a method for producing a medical hollow container, in a rotary process, wherein a rotating glass tube is heated, wherein the receiving portion and the fastening portion with the head region and the shoulder region are shaped by means of forming rollers, such that a molded glass container is obtained, characterized in that the at least one elevation or the at least one depression is/are molded from the molded glass container or molded into the molded glass container. This would provide the steps of producing said medical container since it is made of glass and it is desired that the surface of the manufactured glass container has a better smoothness and a better light reflectivity (see fig 1 and para 0006).
Regarding claim 12, Glocker et al in view of Leonardi et al and Moriuchi et al disclose the method according to claim 11,
Moriuchi et al further disclose said method, characterized in that, to form the at least one elevation (18), the molded glass container is partially heated (para 0020), a mold for forming the at least one elevation being applied from the outside to the shaped (see fig 1b, flange 18), partially heated glass container (see fig 1c), and a pressure medium (24) inside the hollow container (see fig 2, and para 0036, shaft 24 can be made of the impregnated graphite material, for example a glassy carbon impregnated graphite material due to its ability to withstand high pressure while maintaining its shape and flexibility) pressing the molded, partially heated glass container against the mold, such that the at least one elevation is formed in the molded glass container (see para 0069).
Regarding claim 13, Glocker et al in view of Leonardi et al and Moriuchi et al disclose the method according to claim 11,
Moriuchi et al further disclose, characterized in that the molded glass container is partially heated (para 0020 and fig 1a) to form the at least one depression (18), a mold for forming the at least one depression being applied from the outside (see fig 1b) or from the inside to the molded, partially heated glass container, and the mold being pressed against the molded, partially heated glass container by means of pressure, such that the at least one depression is formed in the molded glass container (see figures 1 and 2, para 0038-39).
Regarding claim 14, Glocker et al in view of Leonardi et al and Moriuchi et al disclose the method according to claim 11,
Moriuchi et al fail to expressly disclose the method, characterized in that, in order to form the non-circular shape of the opening, a non-circular pin is arranged in the opening in the head region of the molded glass container when the shape of the head region is rolled by means of forming rollers, wherein the non-circular pin is rotated at the same speed as the glass tube being formed, such that the non-circular shape of the opening is formed by means of the non-circular pin.
However, “forming the non-circular shape of the opening and the non-circular pin is rotated at the same speed as the glass tube being formed, such that the non-circular shape of the opening is formed by means of the non-circular pin” appears to be part of manufacturing process.
Glocker et al in view of Leonardi et al and Moriuchi et al disclose a medical container (1), characterized in that the non-circular shape of the opening (9) is elliptical, polygonal, jagged, or grooved (see fig 2).
See MPEP 2113, The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the non-circular shape of the opening, a non-circular pin is arranged in the opening in the head region of the molded glass container when the shape of the head region is rolled by means of forming rollers, wherein the non-circular pin is rotated at the same speed as the glass tube being formed, such that the non-circular shape of the opening is formed by means of the non-circular pin since resultant container of Glocker et al has a non-circular shape of the opening (see fig 2).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Glocker et al (US 20130338575 A1) in view of Leonardi et al (US 20190329944 A1) and further in view of Macinnes et al (US 20110233079 A1).
Regarding claim 16, Glocker et al in view of Leonardi et al disclose the limitations of claim 1, but fail to teach a kit for medical use, wherein the medical hollow container is present in sterile packaging, and the kit comprising instructions for use for the medical hollow container.
However, Macinnes et al disclose a medical kit and packing system (see fig 3) wherein a medical hollow container (301) is present in sterile packaging (100 and para 0040), and the kit comprising instructions for use for the medical hollow container (see fig 10 and abstract).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Glocker et al in view of Leonardi et al and incorporate the teachings of Macinnes et al to have the medical hollow container present in sterile packaging, and the kit comprising instructions for use for the medical hollow container. This helps minimize the risk of contaminating the patient or the sterile field during the procedure and minimize the risk of contaminating when moving devices from shipping container to procedure site (para 0040) and having the instructions would help the user to follow step-by-step instructions for using the medical procedure kit to ensure safe usage of the medical procedure kit (see abstract).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 12/29/2025, with respect to the rejection(s) of claim(s) 1-5 and 8-16 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Glocker et al (US 20130338575 A1) in view of Leonardi et al (US 20190329944 A1).
Conclusion
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783