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 (IDS) submitted on 07/22/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 07/02/2026. As directed by the amendment: claims 1 has been amended, claims 6 and 7 have been previously cancelled.
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.
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 1-5, 8-10, 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Roedle (US 20130338604 A1) in view of Imai et al (US 20140183094 A1) and further in view of Leonardi et al (US 20190329944 A1).
Regarding claim 1, Roedle discloses a medical hollow container (47 in fig 3), wherein the medical hollow container (47) has a fastening portion (see annotated figure below) and a receiving portion (see annotated figure below), wherein the fastening portion has a shoulder region (see annotated figure below) on a side facing the receiving portion and has a head region (see annotated figure below) on a side facing away from the receiving portion (fig 3), and wherein the head region has an opening (49) on which a closure cap (1) can be arranged, characterized in that the fastening portion has at least one rotation inhibiting structure (51) which is designed to at least inhibit relative rotation between the medical hollow container (47) and the closure cap (1) with respect to each other (para 0040), wherein the rotation inhibiting structure (51) has rotation inhibiting elements (groove all around neck of 47) configured to engage with complementary rotation inhibiting elements ( 15, 15', 15'') of the closure cap (1), wherein the rotation inhibiting element (51) and the complementary rotation inhibiting elements (15, 15', 15'') of the closure cap (1) are configured to abut one another at circumferentially facing surfaces in a circumferentially interlocking positive-fit engagement to mechanically block relative rotation in a circumferential direction (para 0024-25, 0037 and 0040, examiner note: in para 0037 once said projections engage with groove 51, it is hardly possible any longer in the depicted sample embodiment to remove the closure 1 from the syringe or carpule without destruction or to move it out of its sealing position, thus this mechanically blocks relative rotation in a circumferential direction), wherein each of the rotation inhibiting elements (51) 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 (figs 1-3, groove is a designed a depression), wherein the medical hollow container (47) further includes the closure cap (1) arranged on the fastening portion (fig 3) of the medical hollow container (47), the closure cap (1) being arranged on the side of the fastening portion facing away from the receiving portion of the medical hollow container (fig 3), wherein the medical hollow container (47) can be closed by the closure cap (1), wherein a cavity is formed in the region between the closure cap and the fastening portion of the medical hollow container (fig 3), wherein a sealing element (5) is at least partially arranged in the cavity, characterized in that the fastening portion of the medical hollow container (47) has at least one rotation inhibiting element (see annotated figure below) on the inside, and the sealing element (5) is flexible (para 0021), wherein the sealing element (5) engages in the at least one rotation inhibiting element of the fastening portion in a circumferentially interlocking positive-fit manner via abutment of circumferentially facing surfaces, such that the sealing element (5) and the medical hollow container (37) cannot be rotated relative to each other (para 0008 and 0034).
Roedle fails to teach wherein the medical hollow container is made of glass.
However, Leonardi et al disclose a medical hollow container (110 in fig 1) 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 Roedle to be made of glass as taught by Leonardi et al. This would provide the benefit of having a container made of impervious materials which are commonly used to store medical liquids (para 0003 and 0028).
Roedle fails to teach wherein the rotation inhibiting structure has rotation inhibiting elements circumferentially spaced apart from one another.
However, Imai et al disclose a medical container (10 in figure 3) comprising a hollow medical container (2) and closure cap (30) wherein the closure cap (30) can be arranged, characterized in that a fastening portion has at least one rotation inhibiting structure (24) which is designed to at least inhibit relative rotation between the medical hollow container (2) and the closure cap (30) with respect to each other (para 0063), wherein the rotation inhibiting structure (24) has rotation inhibiting elements (241+242) circumferentially spaced apart from one another (fig 2) and complementary to and configured to engage with complementary rotation inhibiting elements (405+403) of the closure cap (para 0115), wherein the rotation inhibiting elements (241+242) and the complementary rotation inhibiting elements (405+403) of the closure cap (30) are configured to abut one another at circumferentially facing surfaces in a circumferentially interlocking positive-fit engagement to mechanically block relative rotation in a circumferential direction (para 0063 and 0115 and 0128, figs 4, 7).
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 fastening portion of the hollow medical container to have rotation inhibiting elements circumferentially spaced apart from one another. This would provide the benefit of alternative rotation inhibiting elements to engage with complementary rotation inhibiting elements of the closure cap to ensure that said closure cap can be prevented from unexpectedly being disengaged from said hollow medical container (para 0116).
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Regarding claim 2, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container according to claim 1,
Imai et al further disclose that each of the rotation inhibiting elements (241) is at least one elevation (fig 2), 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 (fig 2).
Regarding claim 3, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container according to claim 1,
Imai et al further disclose the rotation inhibiting elements (241) being arranged, in the circumferential direction around the central axis of the medical hollow container (fig 2).
Regarding claim 4, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container according to claim 1,
Roedle further discloses that the non-circular shape of the opening (49) or the non-circular edge is elliptical, polygonal, jagged, or grooved (fig 3 of Roedle).
Regarding claim 5, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container according to claim 1,
Roedle further discloses the medical hollow container (47) is a carpule, a syringe or a vial (abstract, fig 3 and para 0040).
Regarding claim 8, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container according to claim 1,
Roedle further discloses that the sealing element (5) is fixed at least in portions thereof relative to the closure cap (1), such that the closure cap (1) and the sealing element (5) cannot be rotated relative to each other (fig 3, para 0008 and 0034).
Regarding claim 9, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container (47) according to claim 1,
Roedle further discloses the sealing element (5) is made of elastic material (para 0021 and 0030).
Regarding claim 10, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container (47) according to claim 1,
Roedle further discloses the closure cap (1) is designed as a coupling element (3), the coupling element being designed for axially connecting the medical hollow container (47) to a medical apparatus (para 0042).
Regarding claim 15, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container (47) according to claim 1,
Roedle fails to disclose wherein the medical hollow container is connected to the medical arrangement but teaches the main body of said closure is used to couple with a dispensing element (para 0042).
Imai et al disclose a medical hollow container (2 in figure 3) wherein the medical hollow container is connected to a medical arrangement (20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to couple the hollow medical container of Roedle with a medical arrangement as taught by Imai et al. This would provide the benefit of allowing fluid transfer between two medical containers to have mixing of the medicines to be sufficiently and reliably performed (para 0087).
Regarding claim 17, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container having the closure cap according to claim 1,
Imai et al further disclose wherein the rotation inhibiting elements a first rotation inhibiting element (212) disposed in a head region of a fastening portion of the medical hollow container (fig 3, para 0116) and a second rotation inhibiting element (241+242) disposed in a shoulder region of the fastening portion (fig 2).
Regarding claim 18, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container having the closure cap according to claim 1,
Imai et al further disclose wherein the rotation inhibiting elements (241+242) are evenly spaced apart along a circumferential direction of the medical hollow container (fig 2).
Regarding claim 19, Roedle in view of Leonardi et al and Imai et al discloses the medical hollow container having the closure cap according to claim 1,
Imai et al further disclose wherein the rotation inhibiting elements comprise grooves (242) and the complementary rotation inhibiting elements comprise ridges (405) configured to tightly fit into the grooves (fig 7).
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Roedle (US 20130338604 A1) in view of Imai et al (US 20140183094 A1) and further in view of Leonardi et al (US 20190329944 A1) and further in view of Moriuchi et al (US 20220024799 A1).
Regarding claim 11, Roedle in view of Leonardi et al and Imai et al discloses the limitations of claim 1 but fails 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 device of Roedle in view of Leonardi et al and Imai 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, Roedle in view of Leonardi et al and Imai et al discloses 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, Roedle in view of Leonardi et al and Imai et al discloses 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, Roedle in view of Leonardi et al and Imai et al discloses 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 the manufacturing process.
Roedle in view of Leonardi et al and Imai et al disclose a medical container (47), characterized in that the non-circular shape of the opening (49) is elliptical, polygonal, jagged, or grooved (see fig 3).
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 Roedle has a non-circular shape of the opening (see fig 3).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Roedle (US 20130338604 A1) in view of Imai et al (US 20140183094 A1) and further in view of Leonardi et al (US 20190329944 A1) and further in view of Macinnes et al (US 20110233079 A1).
Regarding claim 16, Roedle in view of Leonardi et al and Imai et al discloses the limitations of claim 1, but fails 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 device of Roedle in view of Leonardi et al and Imai 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 07/02/2026, with respect to the rejection(s) of claim(s) 1-5 and 8-19 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 Roedle (US 20130338604 A1) in view of Imai et al (US 20140183094 A1) and further in view of Leonardi et al (US 20190329944 A1)
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 FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /JASON E FLICK/Primary Examiner, Art Unit 3783 09/28/2026
