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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/26/2026 has been entered.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a pressure element” in claims 1 and 11-13 (interpreted to be a pin-like piston, a circular-cylindrical pin, cuboid, circular-cylindrical disk or plate, see for example Para. 0022 of Applicant’s specification) and “a counter element” in claims 1 and 11-13 (interpreted to be a pin-like piston, a circular-cylindrical pin, cuboid, circular-cylindrical disk or a plate, see for example Para. 0023 of Applicant’s specification).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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.
Regarding claim 1, “the movable mounting”, “the container”, “the closure”, “the closing process”, “the predetermined maximum contact force”, “the direction”, “the maximum”, “the specified predetermined maximum contact force”, “the press-on/press-in process”, “the pressure or force”, “the distance”, and “the direction of the pressure unit” lack antecedent basis.
Additionally, “it can reduce or completely release the contact force” is indefinite because it is unclear what “it” refers to. For examination purposes, “it can reduce or completely release the contact force” is being interpreted to mean “the pressure element can reduce or completely release”.
Regarding claims 2-9 and 16-18, claims 2-9 and 16-18 are rejected because they depend from rejected claim 1.
Regarding claim 10, “the container”, “the closing process”, “the predetermined maximum contact force”, “the specified predetermined maximum contact force”, “the press-on/press-in process”, “the pressure or force” lack antecedent basis.
Regarding claims 11-15 and 19-20, claims 11-15 and 19-20 are rejected because they depend from rejected claim 10.
Response to Arguments
Applicant’s arguments, see pages 9-11, filed 01/26/2026, with respect to the 35 USC 103 rejection of claims 1-20 have been fully considered and are persuasive, as Applicant has amended the claims to overcome the rejection. The 35 USC 103 rejection of claims 1-20 has been withdrawn.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art of record fails to disclose, teach, or fairly suggest a device for closing pharmaceutical containers via closures, the device comprising: a first holding device, which lies in a first plane, for receiving at least one pharmaceutical container a second holding device, which lies in a second plane parallel to and spaced apart from the first plane, for receiving at least one closure of the closures for closing an opening of the at least one pharmaceutical container, wherein the first and the second holding devices are alignable or aligned with each other such that the at least one closure and the opening of the at least one pharmaceutical container are aligned with each other, the device further comprising at least one pressure unit with a pressure element and a counter element, wherein the device comprises a drive device, by which the counter element and the at least one pressure unit can be moved relative to one another along a closure movement axis orthogonal to the first and second planes, wherein during a closure movement the at least one pressure unit and the counter element both move towards one another, the at least one closure and the at least one pharmaceutical container are brought into contact between the pressure element and the counter element and are pressurized between the pressure element and the counter element in such a way that the at least one closure is pressed onto or into the at least one pharmaceutical container with a contact force in a direction of the closure movement axis in order to close the opening of the at least one pharmaceutical container, wherein the pressure element is mounted to be translationally movable relative to the at least one pressure unit in the direction of the closure movement axis, and the movable mounting of the pressure element is configured in such a way that a maximum contact pressure force exerted on the at least one pharmaceutical container and the at least one closure during the closure movement is predetermined, wherein the movable mounting of the pressure element is designed in such a way that the maximum contact force on the container and the closure is specified by the movable mounting of the pressure element, such that when a closure is pressed onto or into the container, the contact force or the contact force for the closing process results when the closure comes into contact with the container and the closing process for a container continues until the predetermined maximum contact force is reached and that when the maximum contact force specified by the movable mounting is exceeded, the pressure element moves translationally in the direction opposite to the direction in which the closure and container are moved towards each other along the closure movement axis towards the pressure unit, such that the contact force applied by the pressure element to the closure and the container is not increased further and the closing process is completed, such that during this movement towards or into the pressure unit, the pressure element can maintain the maximum contact force or it can reduce or completely release the contact force but not increase the contact force over the maximum, such that the closing process of a container is dependent on the specified predetermined maximum contact force, which is specified by the movable mounting, and is not path-dependent and when the maximum contact force is reached, the press-on/press-in process is terminated, and the pressure or force with which the container and closure are pressed onto each other is not increased any further, wherein this termination criterion is independent of the distance the pressure element or pressure unit has already moved and wherein after the maximum contact force has been reached, the pressure element gives way in the direction of the pressure unit.
The prior art of record that comes closest to teaching these limitations is Okihara et al (US 2015/0190578). Okihara teaches a device for closing pharmaceutical containers via closures, the device comprising: a first holding device, which lies in a first plane, for receiving at least one pharmaceutical container a second holding device, which lies in a second plane parallel to and spaced apart from the first plane, for receiving at least one closure of the closures for closing an opening of the at least one pharmaceutical container, wherein the first and the second holding devices are alignable or aligned with each other such that the at least one closure and the opening of the at least one pharmaceutical container are aligned with each other, the device further comprising at least one pressure unit with a pressure element and a counter element, wherein the device comprises a drive device, by which the counter element and the at least one pressure unit can be moved relative to one another along a closure movement axis orthogonal to the first and second planes, wherein during a closure movement the at least one pressure unit and the counter element both move towards one another, the at least one closure and the at least one pharmaceutical container are brought into contact between the pressure element and the counter element and are pressurized between the pressure element and the counter element in such a way that the at least one closure is pressed onto or into the at least one pharmaceutical container with a contact force in a direction of the closure movement axis in order to close the opening of the at least one pharmaceutical container, wherein the pressure element is mounted to be translationally movable relative to the at least one pressure unit in the direction of the closure movement axis, and the movable mounting of the pressure element is configured in such a way that a maximum contact pressure force exerted on the at least one pharmaceutical container and the at least one closure during the closure movement is predetermined. However, Okihara fails to teach wherein the movable mounting of the pressure element is designed in such a way that the maximum contact force on the container and the closure is specified by the movable mounting of the pressure element, such that when a closure is pressed onto or into the container, the contact force or the contact force for the closing process results when the closure comes into contact with the container and the closing process for a container continues until the predetermined maximum contact force is reached and that when the maximum contact force specified by the movable mounting is exceeded, the pressure element moves translationally in the direction opposite to the direction in which the closure and container are moved towards each other along the closure movement axis towards the pressure unit, such that the contact force applied by the pressure element to the closure and the container is not increased further and the closing process is completed, such that during this movement towards or into the pressure unit, the pressure element can maintain the maximum contact force or it can reduce or completely release the contact force but not increase the contact force over the maximum, such that the closing process of a container is dependent on the specified predetermined maximum contact force, which is specified by the movable mounting, and is not path-dependent and when the maximum contact force is reached, the press-on/press-in process is terminated, and the pressure or force with which the container and closure are pressed onto each other is not increased any further, wherein this termination criterion is independent of the distance the pressure element or pressure unit has already moved and wherein after the maximum contact force has been reached, the pressure element gives way in the direction of the pressure unit. Additionally, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Regarding claims 2-9 and 16-18, claims 2-9 and 16-18 would be allowable because they contain the allowable subject matter of claim 1.
Regarding claim 10, the prior art of record fails to disclose, teach, or fairly suggest a method for closing pharmaceutical containers via closures, the method comprising: providing at least one pharmaceutical container of the pharmaceutical containers and at least one closure of the closures for closing an opening of the at least one pharmaceutical container, aligning the at least one pharmaceutical container and the at least one closure relative to each other so that the at least one closure and the opening of the at least one pharmaceutical container are aligned with each other, pressing the at least one closure onto or into the at least one pharmaceutical container along a closure movement axis to close the opening, wherein the at least one pharmaceutical container and the at least one closure are pressed into or onto each other in a force-controlled manner, so that a contact force exerted on the at least one pharmaceutical container and the at least one closure is exerted only up to a predetermined value of a maximum contact force, wherein when a closure is pressed onto or into the container, the contact force or the contact force for the closing process results when the closure comes into contact with the container and the closing process for a container continues until the predetermined maximum contact force is reached, wherein the closing process of the container is dependent on the specified predetermined maximum contact force and is not path- dependent and when the maximum contact force is reached, the press-on/press-in process is terminated, and the pressure or force with which the container and closure are pressed onto each other is not increased any further.
The prior art of record that comes closest to teaching these limitations is Okihara et al (US 2015/0190578). Okihara teaches a method for closing pharmaceutical containers via closures, the method comprising: providing at least one pharmaceutical container of the pharmaceutical containers and at least one closure of the closures for closing an opening of the at least one pharmaceutical container, aligning the at least one pharmaceutical container and the at least one closure relative to each other so that the at least one closure and the opening of the at least one pharmaceutical container are aligned with each other, pressing the at least one closure onto or into the at least one pharmaceutical container along a closure movement axis to close the opening, wherein the at least one pharmaceutical container and the at least one closure are pressed into or onto each other in a force-controlled manner, so that a contact force exerted on the at least one pharmaceutical container and the at least one closure is exerted only up to a predetermined value of a maximum contact force. However, Okihara fails to teach wherein when a closure is pressed onto or into the container, the contact force or the contact force for the closing process results when the closure comes into contact with the container and the closing process for a container continues until the predetermined maximum contact force is reached, wherein the closing process of the container is dependent on the specified predetermined maximum contact force and is not path-dependent and when the maximum contact force is reached, the press-on/press-in process is terminated, and the pressure or force with which the container and closure are pressed onto each other is not increased any further. Additionally, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Regarding claims 11-15 and 19-20, claims 11-15 and 19-20 would be allowable because they contain the allowable subject matter of claim 10.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERONICA MARTIN whose telephone number is (571)272-3541. The examiner can normally be reached Monday-Thursday 8:00-6:00.
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731