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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 20,2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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: sealing element in claim 2 and connecting element in claim 12.
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. The sealing element of claim 2 is given the broadest reasonable interpretation of an O-ring, profile seal, sealants, flat seal, or structural equivalents thereof, as disclosed on p. 4, para. 2 and p. 12, para. 1 of the instant specification. The connecting element of claim 12 is given the broadest reasonable interpretation of a union clamp or structural equivalents thereof, as disclosed on p. 15, para. 3 of the instant specification.
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 7 and 10 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.
Claim 7 recites the limitations “preferably polyethylene, PE 1000 PURE, PPSU, PES, PSU, PVDF, PET, POM-H, POM-C, PA 6 G 210, PA 66, PA 6, PP, PE-UHMW, PE 500, PE 300 and PE 100” and “preferably steel, especially polished steel”. The phrase “preferably” renders the scope of the claim as indefinite as it is unclear whether the limitations following the phrase are a part of the claimed invention. For examining purposes, these limitations are not required as a part of the claimed invention.
Claim 10 recites the limitation “the groove is preferably designed with a V-shape in the film-contacting surface and/or in a surface adjacent to the film-contacting surface and/or in a surface facing away from the film-contacting surface”. The phrase “preferably” renders the scope of the claim as indefinite as it is unclear whether the limitations following the phrase are a part of the claimed invention. For examining purposes, these limitations are not required as a part of the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 6-7, and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Scholz et al. (US 20180187811), hereinafter Scholz.
Regarding claim 1, Scholz discloses a coupling element for a sterile flange connection for connecting fluid channels (second body 3 of connection system of Figs. 2-4. Examiner note: [0012] first body 5 may have a fluid carrying interior space, thus second body 3/connection system connects fluid channels of first body 5 with fluid carrying system connected to second body 3 ([0086])), comprising: a fluid-contacting surface (Fig. 2-3, interior wall surface of circumferential wall 22), a first opening end (Fig. 2-3, outlet 43 opening end) and a second opening end of the fluid-contacting surface (Annotated Fig. 3, second opening of circumferential wall 22), a flange part at the first opening end and/or at the second opening end (Fig. 3, circumferential bead 62 and recess portion 28 of wall 22. Examiner note: Merriam Webster online dictionary defines flange as "a rib or rim for strength, for guiding, or for attachment to another object", therefore bead 62 forms a rib or rim on the circumferential wall 22 due to the recess portion 28 adjacent to bead 62, for a contact/attachment portion ([0024]). Therefore circumferential bead 62/recess portion 28 meets definition of flange), a connection plane (Fig. 2-3, plane of membrane contact portion 9), the connection plane being arranged normal to an axial coupling element axis of the coupling element and occluding the respective opening end of the coupling element in a delimiting manner (Fig. 2-3, plane of membrane contacting portion 9 is perpendicular/normal to the axis of the circumferential wall 22/interior space 23 and occludes the outlet end 43 in a delimiting manner), and a film (Fig. 3 and [0034, 0164], thin/flexible or film-like membrane 9), the film closing at least the first opening end of the fluid-contacting surface (Fig. 2-3, membrane 9 closes outlet 43 opening end), wherein the coupling element comprises at least one film holding element (Fig. 2-4, holding member 2 and connection member 4) separate from the coupling element (Fig. 4, holding member 2/connection member 4 are separate from second body 3) and comprising a film-contacting surface to which the film is removably connected (Fig. 3 and 5B and [0130, 0164], holding member 2 comprises wall 26 which forms a surface which contributes to the fixation of the membrane 1, which may be a removable connection for forming a removable barrier).
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Annotated Fig. 3 of Scholz
Regarding claim 2, Scholz discloses the coupling element according to claim 1, wherein at least one sealing element (Fig. 3-4, 5B and [0089], circumferential bead 41 of holding member 2 functions as a sealing member) surrounding the first opening end is formed in the area of the connection plane (Fig. 3, bead 41 surrounds the outlet 43 opening end and is formed near the surrounding area of plane of contact portion 9).
Regarding claim 3, Scholz discloses the coupling element according to claim 2, wherein the at least one sealing element is formed in at least one sealing element recess (Fig. 3, bead 41 is formed to fit within a groove on recess portion 28 ), the sealing element extending beyond the connection plane (Fig. 3, bead 41 extends beyond plane of membrane contact portion 9) and the sealing element recess being incorporated into the flange part (Fig. 3, groove is formed on recess portion 28, which forms part of the flange).
Regarding claim 4, Scholz discloses the coupling element according to claim 1, wherein the at least one film holding element is formed in the area of the connection plane (Fig. 3, holding member 2/connection member 4 are formed in area of plane of contact portion 9).
Regarding claim 6, Scholz discloses the coupling element according to claim 2, wherein a circumference of the film holding element is larger than a circumference of the sealing element (Fig. 3-4, overall circumference of holding member 2/connection member 4 is larger than circumference of circumferential bead 41).
Regarding claim 7, Scholz discloses the coupling element according to claim 1, wherein the film holding element is made of plastic (Fig. 4 and [0143], connection member 4 of film holding element is made of plastic), preferably polyethylene, PE 1000 PURE, PPSU, PES, PSU, PVDF, PET, POM-H, POM-C, PA 6 G 210, PA 66, PA 6, PP, PE-UHMW, PE 500, PE 300 and PE 100, and/or that the coupling element is made of metal, preferably steel, especially polished steel.
Regarding claim 10, Scholz discloses the coupling element according to claim 1, wherein the film holding element has at least one circumferential groove (Fig. 3-4, inner circumferential recesses/groove area of wall 26, which holds outer edge region of membrane 1 (see Fig. 3)), wherein the groove is preferably designed with a V-shape in the film-contacting surface and/or in a surface adjacent to the film-contacting surface and/or in a surface facing away from the film-contacting surface.
Regarding claim 11, Scholz discloses the coupling element according to claim 1, wherein a frustoconical widening is formed in the area of the first opening end (Fig. 2, circumferential bead 62 and recess 28 form a frustroconical widening of the wall of second body 3 in the area of the outlet opening 43 end).
Regarding claim 12, Scholz discloses a flange connection comprising two coupling elements according to claim 1 and one connecting element for detachably connecting the two coupling elements (Fig. 1-3, flange connection between first and second bodies 5 and 3 (and see claim 1 rejection above) with detachable connecting element comprised of holding member2 and connection member 4).
Allowable Subject Matter
Claims 5 and 8-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, Scholz discloses the coupling element according to claim 4, wherein the at least one film holding element is formed in at least one film holding element recess (Fig. 3, holding member 2 is formed in a recessed region of recess portion 28), with the film holding element recess being incorporated into the flange part (Fig. 3, recessed region of recess portion 28 forms a part of the flange).
Scholz is silent to the film-contacting surface of the film holding element ending with the connection plane.
The closest art for this limitation is Kuhn (US 20030200812), which shows a membrane 60 which has a rib 62 that is inserted into ring 64 for securement, see Fig. 1A, and the walls of ring 64 end with the connection plane of body 30. However, the ring 64 is a part of the body 30 and therefore doesn’t meet the limitations of claim 1.
Therefore, no reference was found that would have made it obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Scholz to satisfy these limitations in combination with the limitations of claim 4, which claim 5 depends from. Claims 8-9 depend from claim --5.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BHISMA MEHTA can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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