DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. The Applicant claims that the amendments to claims 8-15 now depend from claim 1 and are now part of Group I. However, claim 8, with the instant device of claim 1, still recites a method of sterilizing the filter device of claim 1. The inventions can still be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed (claim 1) can be used in a materially different process of using that product (method claim limitations of claim 8) such as a method of using a filter device that does not require subjecting the filter device to a sterilization or bioburden-reduction process (e.g., filtration of fluid flow through the filter device).
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
The Applicant has elected Species A1, directed to claim 3, wherein the sealable component is a spring-actuated valve.
Claims 4-7 are directed to Species A2-A5 which were not elected, and are thus withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
The requirement is deemed proper and is therefore made FINAL.
Applicant’s election without traverse of Group I, Species A1 (claims 1-3 and 16-20) in the reply filed on 05/26/2026 is acknowledged.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Proulx et al. (US 9482351 B2), further in view of Fukada (US 20160310906 A1).
Regarding claim 1, Proulx teaches a tubing arrangement for sterilizing or bioburden-reducing (Fig. 17-18, where the device of Fig. 17 is the devices 306 and 308 of Fig. 18), the tubing arrangement comprising:
a first tube (one end of process pipe 206, see Fig. 17 drawing below) coupled to a connector (300, Fig. 18);
a second tube (other end of T-shaped process pipe 206, see Fig. 17 drawing below); and
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a sealable component disposed in the tubing arrangement between the first and second tubes (clamp/valve assembly 202 and 219, Fig. 17), wherein the sealable component is reconfigurable between an open configuration, which facilitates entry of a sterilization vapor into the tubing arrangement and the filter device when subjected to a sterilization or bioburden-reduction process, and a closed configuration, where the tubing arrangement is sealed from a surrounding environment (col.8, 1st paragraph).
The limitations of “a tubing arrangement for sterilizing or bioburden-reducing a filter device” and “a first tube coupled to a connector of the filter device” are directed to the manner of operating the apparatus. All the structural limitations of the claim has been disclosed by Proulx and the tubing arrangement is capable of sterilizing a filter device. As such, it is deemed that the claimed apparatus is not differentiated from the applicant' s invention (see MPEP §2114).
NOTE: this is a recitation of intended use / functional language, and so long as the prior art structure reads on the instant claimed structure, this limitation would be met because the same structure would be capable of the same function; in this case, a filter device is fully capable of being sterilized due to the steam line (310, Fig. 18) in fluid connection with all fluid conduits of the entire arrangement of Fig. 17-18.
Per MPEP 2114,II, claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim.
Proulx teaches a second tube (other end of T-shaped process pipe 206, see Fig. 17 drawing above), emphasizing the closed/sealed arrangement of the device and pipe setup of Fig. 17 (“A clamp 202 holds the adjoining and mating faces of the device and the pipe 206 together in a liquid tight arrangement” col.7, lines 58-61), but is silent to how the other end of the process pipe is sealed via this “liquid tight arrangement” and thus, fails to teach a second tube coupled to an aseptic connector.
Fukada teaches a steam sterilization system (Fig. 3) for a filter device (membrane module 10, Fig. 3), teaching an aseptic connector with a seal (130, Fig. 5, having sealing tape 142) inserted into a connecting tube (12, Fig. 3 and 5) that would otherwise be exposed to the environment if not sealed ([0050]), providing not only a sealing functionality alone (Fig. 5), but also providing an aseptic connection when mated with another aseptic connector ([0071] and Fig. 6).
Proulx and Fukada are both considered to be analogous to the claimed invention because they are in the same field of steam sterilization systems with criticality in regards to maintaining a sterile connection within its conduits/tubings.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second tube’s sealed end of Proulx by incorporating an aseptic connector coupled to the tube as taught by Fukada, because doing so would not only provide a sealing functionality alone (Fukada, Fig. 5), but also providing an aseptic connection when mated with another aseptic connector (Fukada, [0071] and Fig. 6) with a reasonable expectation of success.
Regarding claim 2, modified Proulx teaches a tee fitting (process pipe 206, Fig. 17) having a first end, a second end, and a third end, the first end being coupled to the first tube and the second end being coupled to the second tube (see drawing below).
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5. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Proulx et al. (US 9482351 B2), further in view of Fukada (US 20160310906 A1) as applied to claim 2 above, further in view of Whall (US 20050076964 A1).
Regarding claim 3, modified Proulx teaches wherein the sealable component (clamp/valve assembly 202, Fig. 17) is coupled to the third end of the tee fitting (third end, see drawing above) and the sealable component is a valve component (“A clamp 202 holds the adjoining and mating faces (not shown, but see FIG. 3 for details of the mating assembly)”, col.7, lines 58-60, where Fig. 3’s device 2 is a valve) with an open (Fig. 2) and closed configuration (Fig. 1 or 3) selected by the handle (219, Fig. 17) comprising:
a male portion (plunger 18, Fig. 1-3); and
a female portion removably coupled to the male portion (bore 10, Fig. 1-3).
Modified Proulx fails to each wherein the sealable component is a spring-actuated valve component, wherein when the female portion is coupled to the male portion, the sealable component is in the open configuration, and when the female portion is uncoupled from the male portion, the sealable component is in the closed configuration.
Whall teaches a connector apparatus (50, Fig. 1-12) with a valve-based functionality (valve member 40 and valve 10, Fig. 1-12) for a steam sterilization system between a bioprocessing assembly (steam source for sterilization, [0055]) and a media source (media bag/vessel, [0055]) similar to Proulx’s steam line and bag setup of Fig. 17, teaching:
a male portion (valve member 40, Fig. 1-12); and
a female portion removably coupled to the male portion (valve 10, Fig. 1-3).
wherein when the female portion is coupled to the male portion (Fig. 7-12), the sealable component is in the open configuration ([0045]), and when the female portion is uncoupled from the male portion (Fig. 1-6), the sealable component is in the closed configuration ([0045]), where there is a biasing spring arm (tab 266, Fig. 18).
Modified Proulx and Whall are both considered to be analogous to the claimed invention because they are in the same field of steam sterilization systems utilizing clamp/valve assemblies to selectively switch from an open/closed configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the clamp/valve assembly of modified Proulx with the male/female valve assembly as taught by Whall, because doing so would yield the predictable result of selectively opening/closing the steam fluid path (Whall, [0045]) with a reasonable expectation of success.
6. Claims 16 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Proulx et al. (US 9482351 B2), further in view of Cappia et al. (JP 2005329407 A), further in view of Fukada (US 20160310906 A1).
Regarding claim 16, Proulx teaches a system for sterilizing or bioburden-reducing (Fig. 17-18, where the device of Fig. 17 is the devices 306 and 308 of Fig. 18), the system comprising a tubing arrangement (Fig. 17-18), the tubing arrangement comprising:
a first tube (one end of process pipe 206, see Fig. 17 drawing below) coupled to a connector (300, Fig. 18);
a second tube (other end of T-shaped process pipe 206, see Fig. 17 drawing below); and
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a port (304d, Fig. 18),
a sealable component disposed in the tubing arrangement between the first and second tubes (clamp/valve assembly 202 and 219, Fig. 17), wherein the sealable component is reconfigurable between an open configuration, which facilitates entry of a sterilization vapor into the tubing arrangement and the filter device when subjected to a sterilization or bioburden-reduction process, and a closed configuration, where the tubing arrangement is sealed from a surrounding environment (col.8, 1st paragraph).
Proulx fails to teach a filter device having at least one opening; and
the tubing arrangement coupled to the at least one opening of the filter device, the tubing arrangement further comprising:
an aseptic connector;
the port in fluid communication with the aseptic connector; and
the sealable component disposed in the tubing arrangement between the at least one opening of the filter device and the aseptic connector, the sealable component being in fluid communication with the at least one opening of the filter device, the aseptic connector, and the port; and
a breathable microbial barrier at least partially enclosing the port of the tubing arrangement.
It is important to note that Proulx teaches a steam trap (312, Fig. 18) on the port of the tubing arrangement, alternatively citing a sterile barrier filter (i.e., Cappia et al.) replacing the steam trap to also remove the condensate after steaming (col.8, lines 22-26).
Cappia consequently teaches a barrier filter (10, Fig. 3) to aseptically discharge fluids from a steam sterilization system (Fig. 4 and p.3, 3rd to last paragraph of English translation), additionally citing a microbial capture function with regards to the barrier filter (p.5, 1st paragraph of English translation). The barrier filter assembly has supports with pores (i.e., a filter, 17 and 18, Fig. 3) acting as a filter device, and sheets of hydrophobic and hydrophilic sheets acting as microbial barriers (B and A, respectively, Fig. 3).
Proulx and Cappia are both considered to be analogous to the claimed invention because they are in the same field of means to remove condensate after a steam sterilization process.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the steam trap of Proulx with the sterile barrier filter as taught by Cappia, because this substitution would yield the predictable result of removing condensate after steaming (Cappia, col.8, lines 22-26) and provide a microbial capture function (Cappia, p.5, 1st paragraph of English translation) with a reasonable expectation of success.
With this modification, Proulx in view of Cappia teaches a filter device (Cappia, supports 17-18, Fig. 3) having at least one opening (Cappia, pores on supports 17 and 18, Fig. 3); and
the tubing arrangement (Fig. 17-18) coupled to the at least one opening of the filter device (the barrier filter having a plurality of openings of Cappia is element 312 of Proulx’s Fig. 18, to which the port 304d is in connection to the remainder of Fig. 180), and
a breathable microbial barrier (Cappia, hydrophobic and hydrophilic sheets B and A, respectively, Fig. 3) at least partially enclosing the port of the tubing arrangement (Proulx, 304d, Fig. 18).
Modified Proulx still fails to teach:an aseptic connector;
the port in fluid communication with the aseptic connector; and
the sealable component disposed in the tubing arrangement between the at least one opening of the filter device and the aseptic connector, the sealable component being in fluid communication with the at least one opening of the filter device, the aseptic connector, and the port.
Modified Proulx teaches a second tube (other end of T-shaped process pipe 206, see Fig. 17 drawing above), emphasizing the closed/sealed arrangement of the device and pipe setup of Fig. 17 (“A clamp 202 holds the adjoining and mating faces of the device and the pipe 206 together in a liquid tight arrangement” col.7, lines 58-61), but is silent to how the other end of the process pipe is sealed via this “liquid tight arrangement” and thus, fails to teach a second tube coupled to an aseptic connector.
Fukada teaches a steam sterilization system (Fig. 3) for a filter device (membrane module 10, Fig. 3), teaching an aseptic connector with a seal (130, Fig. 5, having sealing tape 142) inserted into a connecting tube (12, Fig. 3 and 5) that would otherwise be exposed to the environment if not sealed ([0050]), providing not only a sealing functionality alone (Fig. 5), but also providing an aseptic connection when mated with another aseptic connector ([0071] and Fig. 6).
Modified Proulx and Fukada are both considered to be analogous to the claimed invention because they are in the same field of steam sterilization systems with criticality in regards to maintaining a sterile connection within its conduits/tubings.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second tube’s sealed end of modified Proulx by incorporating an aseptic connector coupled to the tube as taught by Fukada, because doing so would not only provide a sealing functionality alone (Fukada, Fig. 5), but also providing an aseptic connection when mated with another aseptic connector (Fukada, [0071] and Fig. 6) with a reasonable expectation of success.
With this modification, the instant combination teaches:
an aseptic connector (Fukada, 130, Fig. 5);
the port (Proulx, 304d, Fig. 18) in fluid communication with the aseptic connector (devices 306 and 308 are Fig. 17’s devices, which now include the aseptic connector of Fukada); and
the sealable component (clamp/valve assembly 202 and 219, Fig. 17) disposed in the tubing arrangement (Proulx, Fig. 17-18) between the at least one opening of the filter device (Cappia, supports 17 and 18, Fig. 3) and the aseptic connector (Fukada, 130, Fig. 5), the sealable component being in fluid communication with the at least one opening of the filter device, the aseptic connector, and the port (Fig. 18’s connector allows for fluid communication, and Fig. 17’s components are also in fluid communication).
Regarding claim 18, the instant combination teaches wherein the breathable microbial barrier (Cappia, hydrophobic and hydrophilic sheets B and A, respectively, Fig. 3) includes an elasticized band (Cappia, “A preferred membrane material is a hydrophobic polyvinylidene fluoride (PVDF) membrane”, p.4, 2nd to last paragraph of English translation, which is an elastic material and is in the form of a sheet/band, Fig. 3) that enables the breathable microbial barrier to be disposed over the port of the tubing arrangement (Proulx, port 304d, Fig. 18).
Regarding claim 19, the instant combination teaches a tee fitting (process pipe 206, Fig. 17) having a first end, a second end, and a third end (see drawing of Proulx below);
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a first tubing connecting the first end of the tee fitting to the at least one opening of the filter device (first tube is in fluid communication with the barrier filter of Cappia substituted for Proulx’s steam trap 312 of Fig. 18);
a second tubing connecting the second end of the tee fitting to the aseptic connector (Fukada, aseptic connection member 130, Fig. 5); and
a third tubing coupled to the third end of the tee fitting (Proulx, 210, Fig. 17).
7. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Proulx et al. (US 9482351 B2), further in view of Cappia et al. (JP 2005329407 A), further in view of Fukada (US 20160310906 A1) as applied to claim 19 above, further in view of Whall (US 20050076964 A1).
Regarding claim 3, modified Proulx teaches wherein the sealable component (clamp/valve assembly 202, Fig. 17) is coupled to the third end of the tee fitting (third end, see drawing above) and the sealable component is a valve component (“A clamp 202 holds the adjoining and mating faces (not shown, but see FIG. 3 for details of the mating assembly)”, col.7, lines 58-60, where Fig. 3’s device 2 is a valve) with an open (Fig. 2) and closed configuration (Fig. 1 or 3) selected by the handle (219, Fig. 17) comprising:
a male portion (plunger 18, Fig. 1-3); and
a female portion removably coupled to the male portion (bore 10, Fig. 1-3).
Modified Proulx fails to each wherein the sealable component is a spring-actuated valve component, wherein when the female portion is coupled to the male portion, the sealable component is in the open configuration, and when the female portion is uncoupled from the male portion, the sealable component is in the closed configuration.
Whall teaches a connector apparatus (50, Fig. 1-12) with a valve-based functionality (valve member 40 and valve 10, Fig. 1-12) for a steam sterilization system between a bioprocessing assembly (steam source for sterilization, [0055]) and a media source (media bag/vessel, [0055]) similar to Proulx’s steam line and bag setup of Fig. 17, teaching:
a male portion (valve member 40, Fig. 1-12); and
a female portion removably coupled to the male portion (valve 10, Fig. 1-3).
wherein when the female portion is coupled to the male portion (Fig. 7-12), the sealable component is in the open configuration ([0045]), and when the female portion is uncoupled from the male portion (Fig. 1-6), the sealable component is in the closed configuration ([0045]), where there is a biasing spring arm (tab 266, Fig. 18).
Modified Proulx and Whall are both considered to be analogous to the claimed invention because they are in the same field of steam sterilization systems utilizing clamp/valve assemblies to selectively switch from an open/closed configuration.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the clamp/valve assembly of modified Proulx with the male/female valve assembly as taught by Whall, because doing so would yield the predictable result of selectively opening/closing the steam fluid path (Whall, [0045]) with a reasonable expectation of success.
Allowable Subject Matter
8. Claim 17 is 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 17, the prior art, alone or in combination, fails to teach or fairly suggest the structural limitations of the present claim. The closest prior art to the claimed invention (Proulx - of record), alone or in combination, is set forth above but does not teach or suggest wherein the breathable microbial barrier is incorporated into a header of a header bag that defines an interior volume, wherein the filter device and the tubing arrangement are disposed within the interior volume of the header bag.
The entire assembly of modified Proulx is directed to a steam sterilization system, and incorporating the entire assembly into a bag for it to be subject to steam sterilization is impossible, because Proulx already teaches a steam line (310, Fig. 18). The steam line is connected to an external source of steam. The header bag would then hypothetically have to encompass the entire steam generating means, but because the steam line is connected to an external source of steam, the steam generating means cannot be external and internal at the same time.
Conclusion
9. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liu et al. (CN 111298151 A), directed towards a steam sterilization system including a filter device, and Kermode et al. (US 20170182305 A1), directed towards a connector disinfection system for catheters.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aham Lee whose telephone number is (703)756-5622. The examiner can normally be reached Monday to Thursday, 10:00 AM - 8:00 PM EST.
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, Maris R. Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Aham Lee/Examiner, Art Unit 1758
/SEAN E CONLEY/Primary Examiner, Art Unit 1799
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