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 .
The amendments filed 12/2/2025 have 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: “contact pressure means” in claims 1 and 25.
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, 2, 4, 6-11, 13, 14, 16, 18-25 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.
Claims 1 and 24 recite the limitation "the axial direction". There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the clamping ring". There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the flexible film". There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "wherein contact pressure means are continuous or discontinuous". It is not clear whether the limitation refers to the contact pressure means of claims 1 and 2, or are to refer to a new and additional contact pressure means. For the purposes of examination, the limitation will be interpreted as referring to the contact pressure means of claims 1 and 2.
Claim 23 recites the limitation "the flexible film". There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "wherein the sealed container has a container body formed by a flexible film fixed to the flange, said flange being made up of two parts that are separate from each other, respectively forming an external sleeve and an internal sleeve, the flexible film being kept engaged between the external sleeve and the internal sleeve". It is not clear whether this limitation is to refer to the flexible film and two part flange of claim 18 from which claim 25 currently depends, or refers to a new and additional film/flange. For the purposes of examination, the limitation will be interpreted as being redundant to that of claim 18.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US PG Pub No. 2014/0326725 (Clarkson hereinafter).
In re claim 1, with reference to Figs. 4-6, Clarkson discloses: A sealed container comprising: a through-opening in the container (defined within 10b), said through-opening having an axial axis; a door (includes 21a, defined inside of groove 21a on seal 2, see paragraph 0057) closing the through-opening; an assembly formed by a flange (10, 10, and 10b) that delimits said through-opening and a first annular seal (at 2 portion at 2a through 2f) borne by the flange (see Fig. 5); said door being removably mounted on the assembly, said door being fixed on the flange (in as much as Applicant’s door 7 is “fixed on the flange” 5/6 in Applicant’s Figs. 3, 5, and 8), said first annular seal being located between the flange and the door (See fig. 5 below); the flange, the door and the first annular seal forming a sealed connection device that can be connected to a complementary connection device on a sterile enclosure by bayonet connection means in order to allow sterile communication between the sealed container and the sterile enclosure (functional limitation, fully dependent upon specifics of unclaimed “complementary connection device”); characterized in that the container comprises: a protective cover (1) on the sealed connection device forcibly clipped onto the container (at 8 and 12, paragraph 0052); and contact pressure means (surfaces 1a, 1c, and 1d) arranged between the protective cover and the sealed connection device so as to apply contact pressure to the connection device in the axial direction proportional to a clipping force of the protective cover; wherein the contact pressure means are arranged to exert contact pressure directly on the first annular seal (paragraph 0055).
Please note that the claims are directed to apparatus which must be distinguished from the prior art in term of structure rather function [MPEP 2144]. Hence, the functional limitations “that can be connected to a complementary connection device on a sterile enclosure by bayonet connection means in order to allow sterile communication between the sealed container and the sterile enclosure” which are narrative in form have not been given any patentable weight. In order to be given patentable weight, a functional recitation must be supported by recitation in the claim of sufficient structure to warrant the presence of the functional language. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997)
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In re claim 4, with reference the Figs. noted above, Clarkson discloses the claimed invention including wherein the contact pressure means are continuous or discontinuous (pressure means at surfaces 1a, 1c, and 1d are continuous at least in the manner in which the surfaces continue to another, see Figs. 4 and 5).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarkson as applied to claim 1 above, and further in view of US Patent No. 2,520,335 (Piazze hereafter).
In re claim 7, with reference to the Figs. noted above, Clarkson discloses the claimed invention except wherein the sealed container has a container body formed by a flexible film fixed to the flange, said flange being made up of two parts that are separate from each other, respectively forming an external sleeve and an internal sleeve, the flexible film being kept engaged between the external sleeve and the internal sleeve.
However, with reference to Figs. 6 and 7 below, Piazze discloses wherein a sealed container has a container body (12) formed by a flexible film fixed to a flange (111, 117), said flange being made up of two parts that are separate from each other (111 and 117), respectively forming an external sleeve (117) and an internal sleeve (111), the flexible film (12/112) being kept engaged between the external sleeve and the internal sleeve, and a [third] annular seal located between the internal sleeve and external sleeve (at 116 in groove 115 of outer sleeve).
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Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have modified the container of Clarkson to have included a flexible film fixed to a two part flange as taught by Piazze for the purposes of ensuring reduction of volume of the container during dispensing of contents thereby preventing air ingress into the container/dispensing apparatus, and additionally maintaining a sterile environment within the container by said preventing of air ingress (Piazze column 1, lines 19-25, discusses advantages of collapsible container bodies vs. rigid bodies).
In re claim 10, with reference to the Figs. noted above, Clarkson in view of Piazze discloses the claimed invention including wherein the sealed container comprises a third annular seal housed in an internal peripheral groove of the external sleeve (as in re claim 7 above), the flexible film extending between the third annular seal and the external sleeve.
Clarkson in view of Piazze fails to disclose wherein the flexible film extending between the third annular seal and the internal sleeve.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have extended the flexible film instead between the third annular seal and the internal sleeve, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 167. Please note that in the instant application, paragraph 0022, applicant has not disclosed any criticality for the claimed limitations.
Response to Arguments
Applicant’s arguments with respect to the pending claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW T KIRSCH whose telephone number is (571)270-5723. The examiner can normally be reached Mon-Fri, 9a-5p EST.
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/ANDREW T KIRSCH/ Primary Examiner, Art Unit 3733