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 .
Response to Arguments
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive. Applicants’ argument with regard to IDS are not persuasive since examiner has reviewed all prior art references. Examiner cannot take a position on opinions (reason for search report or office actions not being considered).
Applicants’ argument with regard to the 112 rejection of claims 7-8 and 10 are not persuasive, see 112 rejection below. Again how can a seal having structure that the seal is trying to seal?
It is noted that applicant has amended claims to change the name of the invention and not provided any particular structure. (for example fuel injection seal or biotechnological seal or pharmaceutical seal does not add particular structure to the seal by just changing name). Applicant has not amended claims 1, 6-8 and 10 to disallow examiners interpretation. The below rejection teaches all structural limitations of amended claims and new claims.
Applicants’ argument that the rejection of claims based on prior art of McKay and Takeda should be reconsidered or withdrawal is not persuasive since the prior art references of McKay and Takeda teach all limitation of the claims (see rejection below).
Applicant has not removed any intended use limitation by just changing the nomenclature of the invention.
Applicants’ argument that the new claims provide tri-clamp connection is correct but this is well known in the art of pipe connection, evidence is provided by rejection(s) below of the new claims.
Applicants’ argument that McKay teaches seal in a high pressure or high-temperature environment, such as oil and gas maybe correct but applicant has not precluded the interpretation of claims and structure of McKay.
Applicants’ argument that McKay also provides additional structure than what is claimed is correct but applicant has not limited the invention to preclude examiner’s interpretation. The invention is open ended (e.g. comprising).
It is noted that to use seal between flanges in pharmaceutical or biotechnologies is well known in the art see references US 20100230962 paragraph 0004 and 0052 or US 10591097 column 3, line 29 or 11209293 column 1, lines 26-27 or 7950700 abstract, paragraph 0002, 0004, 0011, 0019 and other paragraphs.
Election/Restrictions
Newly submitted claims 20-22 and 11 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Applicant has presented new claims directed to method. Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: The process for using the product as claimed can be practiced with another materially different product (e.g. the apparatus claimed can be used in any environment other than what is stated in method claims and also can be used with a single flange connected to a housing or pressure vessel). See MPEP § 806.05(h). Furthermore the classification of method is in class 285 which would also burden the examiner to perform new search.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 20-22 and 11 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This restriction/election is made final.
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 7-8, 10 and 14-17 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, “a tri-clamp connection according to claim 1”, unclear how the seal of claim has structure that it may be used in? Claims are rejected as having a seal according to claim 1 and structure of 1st and 2nd flanges are intended use. Claims as rejected as best understood.
The reasoning for claim 7 is also applied to claims 8 and 10. All claims are directed to just a seal and the structure of the 1st and 2nd flanges are intended use.
Claim 14, “a second flange”, unclear how applicant has a second flange without claiming a first flange? Applicant should provide in claim 14 that the flange of claim 13 is a first flange.
Claim 14, “a second sloping face”, unclear how applicant has a second sloping face without claiming a first sloping face? Applicant should provide in claim 14 that the sloping face of claim 13 is a first sloping face.
Claim 15, “a second end face”, unclear how applicant has a second end face without claiming a first end face? Applicant should provide in claim 15 that the end face of claim 13 is a first end face.
Claim 17, “a second recess” and “a second circumferential surface”, unclear how applicant has a second recess and a second circumferential surface without claiming a first recess and a first circumferential surface? Applicant should provide in claim 17 that the recess of claim 13 is a first recess and that the circumferential surface of claim 13 is a first circumferential surface.
Claims are rejected as best understood.
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.
Claim(s) 1, 6-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mckay (GB2584145A).
Mckay discloses a biotechnological or pharmaceutical seal (e.g. figures 1a-1b) for a biotechnological or pharmaceutical tri-clamp connection (e.g. intended use, the structure of the seal is capable of being placed in a tri-clamp connection for biotechnological or pharmaceutical application, also see MPEP 2113-2114 with regard to intended use limitations), wherein the tri-clamp connection includes a first flange of a first conduit end with a first sloping face and a second flange of a second conduit end with a second sloping face as well as a tri-clamp bracket (e.g. intended use is capable by the seal of Mckay, again see MPEP 2113-2114), the seal comprising a sealing body (e.g. body having 30, 10 and O-rings 43a-43b) that can be placed onto a first end face of the first flange or onto a second end face of the second flange (e.g. intended use and the seal of Mckay is capable of being placed between flanges that are clamped by a clamp, see MPEP 2113-2114 with regard to intended use limitations), wherein the sealing body includes a fastening portion (e.g. 46) for a the form-fitting connection to the first flange (e.g. the function of fastening portion is intended use and the reference of Mckay is capable of this) or to the second flange, wherein the fastening portion includes a projection (e.g. projection 48) which, for the form-fitting connection, engages in a first recess (e.g. intended use but the figures in Mckay show how the projection is capable of being received in a recess receiving 48 for a form-fitting connection to the first flange or to the second flange, see figure 5b and other figures) arranged on a first circumferential surface of the first flange or in a second recess arranged on a second circumferential surface of the second flange (e.g. again structure of the first and/or second flange is intended and the seal of Mckay is capable of being received in a recess).
Regarding claim 6: The seal body includes a first sealing projection (e.g. 1st seal projection having 15), which engages in a first seal recess on the first end face when the sealing body is form-fittingly connected to the first flange (e.g. again structure of the first and/or second flange is intended and the seal of Mckay is capable of being received in a seal recess); or a second sealing projection (e.g. 2nd seal projection having 14), which engages in a second recess arranged on the second end face when the sealing body is form-fittingly connected to the second flange (e.g. again structure of the first and/or second flange is intended and the seal of Mckay is capable of being received in a seal recess).
Regarding claim 7: The first flange of the first conduit end includes the first sloping face (e.g. sloping face receiving 15), the second flange of the first conduit end includes the second sloping face (e.g. sloping face receiving 14), the tri-clamp bracket (e.g. structure in figures 5a-5b which hold the elements 60-70 together), wherein the tri-clamp connection is sealed by the seal (e.g. again the 1st and 2nd flange structure is considered to be intended use and the seal of Mckay is capable of this, see MPEP 2113-2114 regarding intended use limitations).
Regarding claim 8: Wherein (e.g. again the 1st and 2nd flange structure is considered to be intended use and the seal of Mckay is capable of this, see MPEP 2113-2114 regarding intended use limitations) the first flange includes the first recess or the second flange includes the second recess (e.g. recesses capable of receiving the seal projections 14 and 15), wherein the projection of the fastening portion form-fittingly engages in the first recess or in the second recess (e.g. see figures 5a-5b).
Regarding claim 10: Mckay discloses the tri-clamp connection comprising the first flange of the first conduit end including the first sloping face, the second flange of the second conduit end including the second sloping face, the tri-clamp bracket, which cooperates with the first sloping face and the second sloping face when tightened (e.g. again intended use and the reference of Mckay is capable of this), wherein the tri-clamp connection is sealed by the seal.
Again it is noted when and if applicant provides proper claims regarding tri-clamp connection, the claims are not allowable. Examiner is providing further rejections below.
Claim(s) 1, 6-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Willemstyn (US7950700B2).
Willemstyn discloses a biotechnological or pharmaceutical seal (e.g. figures 4a-4b) for a biotechnological or pharmaceutical tri-clamp connection (e.g. intended use, the structure of the seal is capable of being placed in a tri-clamp connection for biotechnological or pharmaceutical application, also see MPEP 2113-2114 with regard to intended use limitations and the biotechnological or pharmaceutical of Willemstyn is capable of being used on a flange as shown in figures), wherein the biotechnological or pharmaceutical tri-clamp connection includes a first flange (e.g. shown in figure 1) of a first conduit end with a first sloping face (e.g. sloping face at an end face of flange, see figure 1) and a second flange of a second conduit end with a second sloping face as well as a biotechnological or pharmaceutical tri-clamp bracket (e.g. intended use is capable by the biotechnological or pharmaceutical seal of Willemstyn, again see MPEP 2113-2114 and also background of the invention in Willemstyn), the biotechnological or pharmaceutical seal comprising a sealing body (e.g. body shown in figure 4a-4c) that can be placed onto a first end face of the first flange or onto a second end face of the second flange (e.g. intended use and the biotechnological or pharmaceutical seal of Willemstyn is capable of being placed between flanges that are clamped by a clamp, see MPEP 2113-2114 with regard to intended use limitations and also summary of the invention in Willemstyn), wherein the biotechnological or pharmaceutical sealing body includes a fastening portion (e.g. 420) for a the form-fitting connection to the first flange (e.g. the function of fastening portion is intended use and the reference of Willemstyn is capable of this and also see figure 6A-6B, where projection 420 is received in recess 610 of a flange by way of example) or to the second flange, wherein the fastening portion includes a projection (e.g. projection 420) which, for the form-fitting connection, engages in a first recess (e.g. intended use but the figures in Willemstyn show how the projection is capable of being received in a recess receiving for a form-fitting connection to the first flange or to the second flange, see figure 6A-6B) arranged on a first circumferential surface (e.g. see circumferential surface defined in figure 6A having 610 by way of example) of the first flange or in a second recess arranged on a second circumferential surface of the second flange. (e.g. again structure of the first and/or second flange is intended and the biotechnological or pharmaceutical seal of Willemstyn is capable of being received in a recess).
Regarding claim 6: The biotechnological or pharmaceutical seal body includes a first sealing projection (e.g. projection 400 similar to one shown as 500 in figures 5a-5d), which engages in a first seal recess on the first end face when the biotechnological or pharmaceutical sealing body is form-fittingly connected to the first flange (e.g. again structure of the first and/or second flange is intended and the seal of Willemstyn is capable of being received in a seal recess) or a second sealing projection (e.g. second flange not shown but stated throughout Willemstyn), which engages in a second recess arranged on the second end face when the sealing body is form-fittingly connected to the second flange (e.g. again structure of the first and/or second flange is intended and the seal of Willemstyn is capable of being received in a seal recess).
Regarding claim 7: The first flange of the first conduit end includes the first sloping face (e.g. sloping face shown in figure 1), the second flange of the first conduit end includes the second sloping face (e.g. sloping face similar to the first flange that is stated in Willemstyn), the tri-clamp bracket (e.g. stated in summary of the invention in Willemstyn), wherein the tri-clamp connection is sealed by the biotechnological or pharmaceutical seal (e.g. again the 1st and 2nd flange structure is considered to be intended use and the seal of Willemstyn is capable of this, see MPEP 2113-2114 regarding intended use limitations).
Regarding claim 8: Wherein (e.g. again the 1st and 2nd flange structure is considered to be intended use and the seal of Willemstyn is capable of this, see MPEP 2113-2114 regarding intended use limitations) the first flange includes the first recess or the second flange includes the second recess (e.g. recesses capable of receiving the seal projections, see figures 5a-5c by way of example), wherein the projection of the fastening portion form-fittingly engages in the first recess or in the second recess (e.g. see summary of the invention in Willemstyn).
Regarding claim 10: Willemstyn discloses the tri-clamp connection comprising the first flange of the first conduit end including the first sloping face, the second flange of the second conduit end including the second sloping face, the tri-clamp bracket, which cooperates with the first sloping face and the second sloping face when tightened (e.g. again intended use and the reference of Willemstyn is capable of this), wherein the tri-clamp connection is sealed by the seal. It is noted that the summary of invention in Willemstyn teaches to have a tri-clamp connection.
Claim(s) 1, 6-8, 10 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takeda (US8033579B2).
Takeda discloses a biotechnological or pharmaceutical tri-clamp connection having a biotechnological or pharmaceutical seal (e.g. 6, figures 1a-1b), wherein the tri-clamp connection includes a first flange (e.g. flange 5) of a first conduit end (e.g. conduit 3 having end) with a first sloping face (e.g. 5e) and a second flange (e.g. flange 4) of a second conduit end (e.g. conduit 2 having end) with a second sloping face (e.g. 4e) as well as a tri-clamp bracket (e.g. 7), comprising a sealing body (e.g. body of the seal 6) placed onto a first end face of the first flange or onto a second end face of the second flange (e.g. figure 1), wherein the sealing body includes a fastening portion (e.g. portion having 12a) for the form-fitting connection to the first flange (e.g. connection in recess having 12a) or to the second flange, wherein the fastening portion includes a projection (e.g. projection 12a) which, for the form-fitting connection, engages in a first recess (e.g. a recess receiving 12a, figures) arranged on a first circumferential surface of the first flange or in a second recess arranged on a second circumferential surface of the second flange (e.g. see figure 1).
Regarding claim 6: Wherein the seal body includes a first sealing projection (e.g. projection received in 5a), which engages in a first seal recess (e.g. recess 5a) on the first end face when the sealing body is form-fittingly connected to the first flange; or a second sealing projection (e.g. projection received in 4a), which engages in a second recess (e.g. recess 4a) arranged on the second end face when the sealing body is form-fittingly connected to the second flange.
Regarding claim 7: The first flange of the first conduit end includes the first sloping face (e.g. the sloping face 5e), the second flange of the first conduit end includes the second sloping face (e.g. sloping face 4e), the tri-clamp bracket (e.g. 7, figure 1), wherein the tri-clamp connection is sealed by the seal (e.g. figure 1).
Regarding claim 8: Wherein the first flange includes the first recess or the second flange includes the second recess.
Regarding claim 10: Takeda discloses the tri-clamp connection comprising the first flange of the first conduit end including the first sloping face, the second flange of the second conduit end including the second sloping face, the tri-clamp bracket, which cooperates with the first sloping face and the second sloping face when tightened, wherein the tri-clamp connection is sealed by the seal (e.g. figure 1).
Regarding claim 13: Takeda discloses a tri-clamp connection, comprising a flange (e.g. the flange 5) of a conduit end with a sloping face (e.g. 5e), a sealing body configured to be placed on an end face (e.g. end of flange 5) of the flange, wherein the sealing body includes a fastening portion (e.g. the portion having 12a) for a form fitting connection to the claims (see rejection of claim 1) and wherein the fastening portion includes a projection (e.g. projection of 12a) which, for the form-fitting connection, engages in a recess (e.g. recess on outer surface of the flange 5, recess after 5g) disposed at a circumferential surface of the flange.
Regarding claim 14: The tri-clamp connection further comprising a second flange (e.g. the flange 4) of a second conduit end with a second sloping face (e.g. 4e), and a tri-clamp bracket (e.g. 9).
Regarding claim 15: Wherein the sealing body is configured to be placed onto the end face of the flange or onto a second end face of the second flange (e.g. see figures of Takeda).
Regarding claim 16: Wherein the fastening portion of the sealing body is for the form-fitting connection to the flange or to the second flange (e.g. see rejection of claim 13 and figures of Takeda).
Regarding claim 17: Wherein the projection of the fastening portion engages in the recess disposed at the circumferential surface of the flange or in a second recess disposed at a second circumferential surface of the second flange (e.g. the projection of 12a received in the recess of the flange).
Regarding claim 18: Wherein the sealing body includes: a sealing projection, which engages in a seal recess disposed at the end face when the sealing body is form-fittingly connected to the flange (e.g. sealing projection of the seal received in seal recess of the end face of the flange 1).
Regarding claim 19: Wherein the projection of the fastening portion is configured to form-fittingly engage in the recess (e.g. see rejection of claims above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. When and if applicant claims a divisional application with regard to biotechnological or pharmaceutical system having a seal, 103 rejection are available in view of Willemstyn.
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 VISHAL A PATEL whose telephone number is (571)272-7060. The examiner can normally be reached 7:00 am to 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christine Mills can be reached at 571-272-8322. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VISHAL A PATEL/Primary Examiner, Art Unit 3675