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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-15 in the reply filed on 6 Oct. 2025 is acknowledged.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “48” has been used to designate the first connector (¶46), second connector (¶48), integrity test connector (¶49), and second integrity test connector (¶49). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 50.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “sample bag” of claim 5 must be shown or the feature(s) canceled from the claim(s). The drawings do show “sampling bag” 19. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Applicant’s ¶49 recites “peristatic pump” which should recite “peristaltic pump”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-15 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 1 recites “the main conduit further comprises … a primary final fill filter disposed within the main conduit”. It is unclear how a portion of the main conduit can be disposed within itself.
Claim 1 recites “the main conduit further comprises … a clamp is disposed within the main conduit”. It is unclear how a portion of the main conduit can be disposed within itself.
Claim 1 recites “the main conduit further comprises … a redundant final fill filter is disposed within the main conduit”. It is unclear how a portion of the main conduit can be disposed within itself.
Claim 1 recites “the main conduit further comprises … an air line … is joined to the main conduit”. It is unclear how a portion of the main conduit can be joined to itself.
Claim 1 recites “optional clamps and a gas filter”. The phrase "optional " renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 recites “a clamp” multiple times, “two clamps”, and “the two clamps”. It is unclear if the clamps are the same or different. Examiner suggests that if the clamps are intended to be different clamps, that modifiers (such as “first”, “second”, etc) should be used.
Claim 1 recites “the main conduit further comprises … a clamp is disposed in the main conduit”. It is unclear how a portion of the main conduit can be disposed in itself.
Claim 1 recites “the main conduit further comprises … a secondary conduit is jointed to the main conduit”. It is unclear how a portion of the main conduit can be jointed to itself.
Claim 1 recites “the main conduit further comprises … a secondary conduit … further comprise a barrier filter, the barrier filter and the secondary conduit are jointed to the main conduit”. It is unclear how a portion of the main conduit can be jointed to itself.
Claim 1 recites “a pinch clamp” multiple times. It is unclear if the clamps are the same or different. Examiner suggests that if the clamps are intended to be different clamps, that modifiers (such as “first”, “second”, etc) should be used.
Claim 1 recites “at least one vent bag” and then further recites “two vent bags”. It is unclear if the two vent bags are the same or different than the at least one vent bag.
Claim 1 recites “at least one vent bag” and then further recites “two vent bags”. It is unclear if the two vent bags are the same or different than the at least one vent bag.
Claim 1 recites “an air line” twice. It is unclear if the two air lines are the same or different.
Claims 2-15 depend upon claim 1.
Claim 8 recites “a conduit”. It is unclear if the “a conduit” is the same or different than the main conduit or the secondary conduit.
Claim 10 recites “the conduit” twice. It is unclear if the limitation refers to main conduit or the secondary conduit.
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 1-7, 9-11, and 13 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Applicant’s admitted prior art as represented in Figs 1-2 and ¶42-44).
Regarding claim 1, Applicant’s admitted prior art teaches a streamlined redundant filtration assembly, comprising:
a main conduit (44) for delivering a biological product, the main conduit further comprises:
a primary final fill filter (Final fill filter 30, primary filter) disposed within the main conduit;
a first connector (48 near F1) and a second connector (48 at the right end of the main conduit) at terminal ends of the main conduit;
a clamp (20 nearest first connector) is disposed within the main conduit downstream of the first connector;
a redundant final fill filter (Final fill filter 30, redundant filter) is disposed within the main conduit;
an air line (line comprising gas filter 12 closest to F1) in fluid communication with the redundant final fill filter is joined to the main conduit, the air line further comprising an integrity test connection (integrity tester connection 10) at a distal end;
a vent (AMPP) connected (via main conduit 44) to the air line;
at least one vent bag (16 above redundant filter) is in fluid communication with the redundant final fill filter;
two clamps (two clamps 20 between AMPP units on main conduit 44) are disposed downstream of the redundant final fill filter, wherein a pinch clamp (pinch claim 46 between the two clamps and between the two AMPP units) is disposed between the two clamps;
two vent bags (16, where there 2 vent bags closest to primary filter) and an air line (line comprising gas filter 12 closest to primary filter) are in fluid communication with the primary filter (where when the valve are open the system is in full fluid communication);
a clamp (20 closest to second connector 48) is disposed in the main conduit downstream of the primary filter;
a secondary conduit (34) is joined to the main conduit; the secondary conduit further comprises a barrier filter (40), the barrier filter and the secondary conduit are joined with the main conduit, a pinch clamp (46 close to redundant filter AMPP) is disposed on the main conduit, wherein the main conduit terminates at the second connector.
Regarding claim 2, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein the integrity test connection is connected to an air supply (¶42, pressurized air).
Regarding claim 3, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein a gas filter (12) is downstream of the integrity test connection.
Regarding claim 4, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein there are two vent bags (two vent bags near redundant filter AMPP).
Regarding claim 5, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches a sampling bag (second bag 16 above redundant filter AMPP).
Regarding claim 6, Applicant’s admitted prior art teaches all the limitations of claim 4. Applicant’s admitted prior art further teaches a clamp (20 below filter 12) is disposed on the air line between the two vent bags (where the clamp is between the integrity test connection and the two vent bags).
Regarding claim 7, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein the vent is an aseptic multi-purpose port (AMPP, as shown in Figs 1-2).
Regarding claim 9, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches more than one integrity test connection (as shown in Figs 1-2).
Regarding claim 10, Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein a second end (right end in Figs 1-2) of the conduit (44) is connected to a different integrity test connection (integrity test on the right side of Figs 1-2) than the first end (left end) of the conduit.
Regarding claim 11. Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches a recirculation vessel ((second bag 16 above redundant filter AMPP, where the vessel is fully capable of recirculating).
Regarding claim 13. Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein the redundant filtration assembly is single-use (where the assembly of the admitted prior art is fully capable of being used a single time; see MPEP 2114, 2115, 2143.05(g)).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Applicant’s admitted prior art as applied to claim 1 above, and further in view of Collins et al. US 2002/0104800 (hereafter Collins) and Burbank et al. US 2009/0182263 (hereafter Burbank).
Regarding claim 8, Applicant’s admitted prior art teaches all the limitations of claim 1.
Applicant’s admitted prior art does not teach a peristaltic pump having a conduit connected to the integrity test connection at a first end of the conduit.
Collins teaches a redundant filtration assembly (¶10) comprising an integrity test (¶15) and a peristaltic pump having a conduit connected to the integrity test connection at a first end of the conduit to pump fluid such as blood (¶55).
Burbank teaches a redundant filtration assembly (¶203) comprising an integrity test (¶209) and a peristaltic pump having a conduit connected to the integrity test connection at a first end of the conduit for sterility reasons (¶226).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Applicant’s admitted prior art system (Figs 1-2) by incorporating the peristaltic pump (Collins ¶55; Burbank ¶226) for sterility reasons (¶226).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Applicant’s admitted prior art as applied to claim 1 above.
Regarding claim 12. Applicant’s admitted prior art teaches all the limitations of claim 1.
Applicant’s admitted prior art does not teach a data acquisition system.
Applicant’s admitted prior art further teaches integrity pressure testing (¶43).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Applicant’s admitted prior art system (Figs 1-2) by incorporating a data acquisition system such as a pressure and/or flow gauge in order to monitor the integrity/pressure/leaks of the system.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Applicant’s admitted prior art as applied to claim 1 above, and further in view of Perreault et al. US 2017/0319985 (hereafter Perreault).
Regarding claim 14. Applicant’s admitted prior art teaches all the limitations of claim 1.
Applicant’s admitted prior art does not teach wherein the redundant filtration system comprises stainless steel.
Perreault teaches a redundant filtration system (abstract) wherein the redundant filtration system comprises stainless steel because the material is accepted by the pharmaceutical industry (¶40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Applicant’s admitted prior art system (Figs 1-2) by incorporating stainless steel because the material is accepted by the pharmaceutical industry (¶40).
Regarding claim 15. Applicant’s admitted prior art teaches all the limitations of claim 1. Applicant’s admitted prior art further teaches wherein the redundant filtration system comprises single-use components (where the assembly components of the admitted prior art are fully capable of being used a single time; see MPEP 2114, 2115, 2143.05(g)).
Applicant’s admitted prior art does not teach wherein the redundant filtration system comprises stainless steel.
Perreault teaches a redundant filtration system (abstract) wherein the redundant filtration system comprises stainless steel because the material is accepted by the pharmaceutical industry (¶40).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Applicant’s admitted prior art system (Figs 1-2) by incorporating stainless steel because the material is accepted by the pharmaceutical industry (¶40).
Prior Art
Applicant is made aware of Hunt et al. US 2018/0275012 and Matkovich US 5,863,436. Hunt teaches where the integrity test assembly may be attached to a venting bag (¶39). Matkovich teaches where the integrity test connection (32) in the air line (31) may be connected to the same air line (12) as the bag (11) and where the system may have appropriate valves (col 10 line 66 – col 11 line 20).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN HOBSON whose telephone number is (571)272-9914. The examiner can normally be reached 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached at 571-270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/STEPHEN HOBSON/Examiner, Art Unit 1776