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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 20 January 2026 has been entered.
Examiner notes that the aforementioned RCE refers to a Response After Final Action, to include a new set of Claims and related arguments, filed 15 January 2026. The present Office Action addresses both filings.
Response to Amendments
Receipt of Applicant’s Amendment, filed on 15 January 2026 is acknowledged and entered.
By this Amendment, the Applicant added Claim 51. Claims 30-51 remain pending in the application.
Response to Arguments
Applicant’s arguments (see pages 6-15 of the Response After Final, filed 15 January 2026) have been fully considered and are ultimately unpersuasive.
Specifically, Applicant’s assertions for the record raises several new issues, as detailed below in the revised rejections under 35 U.S.C. 112.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33, 35-36, 39-40, 44, and 46-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As stated above, Applicant’s arguments filed 15 January 2026 have been considered and are found unpersuasive.
Specifically:
- Examiner notes that the present application discloses two embodiments of a sterile connector (see at least Figs 1 and 4 for the first embodiment, and Figs 6 and 9 for the second embodiment).
- Applicant’s independent Claim 1 requires, in part “a surface of the first septum axially facing away from the fluid passage is arranged in a particular sterile region of the second coupling device which is hermetically sealed against an environment of the second coupling device by at least one body carried by the second coupling device”.
- Applicant asserts for the record (see “Arguments”, filed 15 January 2026, pgs 6-7) that the “at least one body” has support in the specification as being
“second septum 12” in the first embodiment (Fig 4),
“sealing envelope” or “bellows” 18 in the second embodiment (Fig 9).
- Examiner further notes that Fig 4, item 12 and Fig 9, item 18 are both shown as being located within the “second coupling device 6”, and therefore acknowledges Applicant’s assertion that the independent, “amended claim 30, including the claimed "body", encompassed the non-limiting examples of both FIG 4 and FIG 9.”
However, none of Applicant’s dependent claims further definitively limit or define the “at least one body” of Claim 30 to be either the “second septum 12”, or the “sealing envelope” or “bellows” 18.
In fact, there are only two mentions of the word “body” in the entire set of claims (Claim 1 and newly added Claim 51), and no indication within the claims that the “body” is further intended to be equated with either a “second septum”, “sealing envelope”, and/or “bellows”.
This failure of the claim set introduces indefiniteness in the dependent claims, as “a second septum”, several versions of “a sealing envelope” and “a bellows” are all independently introduced in one or more dependent claims.
For example:
- Claim 33 depends on Claim 30, and contains a limitation of “a second septum” that is located in the second coupling device. In light of Applicant’s assertion for the record that the “at least one body carried by the second coupling device” is in fact the “second septum”, then the phrase/limitation of “a second septum” of Claim 33 lacks antecedent basis.
- Claim 40 depends on Claim 30, and contains a limitation of “a sealing envelope”. The claim does not limit the location of this “sealing envelope”. In light of Applicant’s assertion for the record that the “at least one body carried by the second coupling device” is in fact the “sealing envelope”, then the phrase/limitation of “a sealing envelope” of Claim 40 lacks antecedent basis.
- Claim 44 depends on Claim 30, and contains a limitation of “a first sealing envelope in the form of a bellows”, located in the second coupling device. In light of Applicant’s assertion for the record that the “at least one body carried by the second coupling device” is in fact the “sealing envelope” or “bellows”, then the phrase/limitation of “a first sealing envelope in the form of a bellows” of Claim 44 lacks antecedent basis.
- Claim 47 depends on Claim 30, and contains a limitation of “a first sealing envelope”, located in the second coupling device. In light of Applicant’s assertion for the record that the “at least one body carried by the second coupling device” is in fact the “sealing envelope” or “bellows”, then the phrase/limitation of “a first sealing envelope” of Claim 47 lacks antecedent basis. Claim 48 depends on Claim 47, and therefore suffers the same deficiencies.
Examiner further notes that several dependent claims contain verbiage that do not fully support Applicant’s argued assertion of the “at least one body” of Claim 30 is equated to a second septum, sealing envelope, and/or bellows, carried by a second coupling device.
- Claim 35 requires “at least one sealing envelope” as part of the first coupling device. This limitation is at odds with Applicant’s statement of these components being part of the second coupling device.
- Claim 36 requires “first sealing envelope in the form of a bellows” and “a second septum” as part of the first coupling device. This limitation is at odds with Applicant’s statement of these components being part of the second coupling device.
- Claim 39 requires “a first sealing envelope and a second sealing envelope” as part of the first coupling device. This limitation is at odds with Applicant’s statement of these components being part of the second coupling device.
- Claim 46 requires “at least one of a second septum and a sealing envelope” as part of the first coupling device. This limitation is at odds with Applicant’s statement of these components being part of the second coupling device.
- Claim 48 requires “a second sealing envelope” as part of the first coupling device. This limitation is at odds with Applicant’s statement of these components being part of the second coupling device.
Since Claims 35, 36, 39, 46, and 48 each depend upon Claim 1, Applicant’s assertion of the “at least one body carried by the second coupling device” meaning “a second septum, sealing envelope, and/or bellows, carried by a second coupling device” places these claims in direct contrast with antecedent Claim 1. It is unclear from the disclosure how the aforementioned components can simultaneously be part of both the “first” and “second coupling devices”, as would be required by this claim structure.
Examiner concludes that with respect to Claims 35, 36, 39, 46, and 48, Applicant’s assertion regarding “at least one body carried by the second coupling device” above continues to present the claimed invention as a “hybrid apparatus” that is a mixture of two distinct species; it is unclear to one of ordinary skill in the art how to make and or use the claimed invention.
Examiner further notes (for the sake of clarity to the record) that Applicant’s disclosure establishes both first and second “sealing envelopes”. As best understood by Examiner,
- Applicant’s Specification equates (in some, but not all, embodiments) the “first sealing envelope” to be “bellows 18”.
- The Specification also equates (in some, but not all, embodiments) the “second sealing envelope” to be “in the form of a hose closed at one end”. See Figs 4a-4c, and at least para 65 of the Specification. The Specification goes on to list the “second sealing envelope” as item 23.
However, Claims 35, 40, and 46 merely refer to “the sealing envelope” (other claims refer to one or more of the “first sealing envelope” and “second sealing envelope”). In light of Applicant’s assertion above that the "at least one body carried by the second coupling device" of Claim 30 is equated to “the sealing envelope 18”, it is unclear if item 18 actually refers to “the sealing envelope” of Claims 35, 40, and 46. Examiner reserves further comment on this issue pending resolution of the deficiencies identified above.
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 33, 35-36, 39-40, 44, and 46-48 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.
Regarding Claims 33, 35-36, 39-40, 44, and 46-48, the claims present issues as explained above, that render their scope indefinite.
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.
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:
- “first coupling device”, “second coupling device”, introduced at Claim 30,
- “guide device”, introduced at Claim 38,
- “first sealing envelope”, “second sealing envelope”, introduced at Claim 39,
- “actuation element”, introduced at Claim 41,
- “mechanism...for indication of at least one defined axial position of the first coupling device relative to the second coupling device”, introduced at Claim 50.
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 § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 30-32, 34-35, 38, 43, 46, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Imai (JP 2012192047 A), in view of Py (2017/0202741).
The following claims rejections stand from the previous Non-Final Rejection dated 13 February 2025. Examiner reserves any further comment on patentability, pending resolution of the aforementioned claim rejections under 35 USC 112.
Regarding Claim 30, Imai discloses a connector (Figs 3-4, items 2,3) for the transfer of a liquid, in particular a biological medium (pg. 2, fifth paragraph, "liquid P", defined as "a dissolution liquid in which the drug is dissolved" per pg. 1, last paragraph; this is broadly interpreted by Examiner as a "biological medium"), from a liquid container (pg. 1, last paragraph, "syringe") into a fluid chamber ("vial container"), for example of a bioprocess-technical system (the overall invention is drawn to medical use in providing drug solutions, per pg. 1, third paragraph), in particular of a bioreactor, wherein the connector comprises:
- a first coupling device (“first connector 2” and a second coupling device “second connector 3”),
- wherein the first coupling device has a fluid inlet (pg. 3, second paragraph, "tubular port 421") and a fluid outlet (pg. 4, sixth paragraph, "passage 73") fluidically connected thereto (see Figs 3-4),
- wherein the first coupling device has a first cannula (pg. 4, first para, "hollow needle 5") having an end which faces away from the fluid inlet and forms the fluid outlet (per Figs 3-4 and pg. 4, sixth para, "The hollow needle 5 can pass through the passage 73"); and
- the second coupling device (3) has a fluid passage (pg. 4, fourth para, "second flow path 102") which, in an initial state of the sterile connector, is axially covered by a first septum (pg. 4, fourth paragraph, "second sealing member 11");
- wherein the sterile connector has a fluidic connection state in which a fluidic connection is created between the fluid inlet of the first coupling device and the fluid passage of the second coupling device when the end of the first cannula forming the fluid outlet pierces the first septum of the second coupling device (shown at Fig 5 and described at pg. 4, third para).
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Further regarding Claim 30, Imai teaches the claimed invention, drawn to “connector assembly allowing safe and certain transfer of a liquid”, but doesn’t explicitly state that the connector is “sterile”, as claimed by Applicant. Although Imai teaches a first cannula and a first septum, Imai is also silent on a first cannula “arranged in a particular sterile region”, and “a surface of the first septum... arranged a particular sterile region”.
Examiner applies Broadest Reasonable Interpretation (BRI) to the phrase “arranged in a particular sterile region”, and concludes the verbiage includes any component packaged under sterile conditions. Examiner further asserts that it is well known across several arts to package components under sterile conditions, as evidenced by Py, who teaches a “piercing member” (e.g., “cannula”) sealed within second piece 312 of a connector assembly, said piercing member “thereby maintained in a sterile state prior to use” (see Figs 3A-3B and para 72). Py additionally teaches (Fig 9A, 9C and para 83) sealed dispensing head 993 (substantially similar to the dispensing head 393 shown in FIG. 3A) and sealed tube 994 packed together in a dispensing kit.
Imai and Py both teach fluid connector assemblies for use in medical situations. Py additionally teaches sealing components of said connector assembly to permit use in in harsh environments, such as in hospitals and in non-sterile open environments. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to aseptically seal and/or package the individual components of Imai (to include cannulas and septums) as explicitly taught by Py in order to gain the advantages of use in in harsh environments, such as in hospitals and in non-sterile open environments.
Further regarding Claim 30, therefore, Imai, as modified by Py above, also teaches a sterile connector for the sterile transfer of a liquid (the connector of Imai wherein said components are sealed and/or packed in sterile conditions as taught by Py)... wherein in the initial state of the sterile connector,
- the fluid outlet formed by the first cannula (Imai, 5) is arranged in an in particular sterile region of the first coupling device (Imai, 2) which is hermetically sealed against an environment of the first coupling device (as taught by Py), and
- a surface of the first septum (Imai, 11) axially facing away from the fluid passage (Imai, 102) is arranged in an in particular sterile region of the second coupling device which is hermetically sealed against an environment of the second coupling device (as taught by Py).
Regarding Claim 31, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein in the fluidic connection state, the first coupling device (Imai, 2, which features "first connector body 4") is mechanically connected to the second coupling device (3), in particular the second coupling device is plugged into the first coupling device, and thereby the sterile connector is brought from an initial state into a coupled state (Imai, pg. 2, last paragraph - pg. 3, first paragraph: "As shown in FIG 1, the first connector 2 is slidable into the first connector body 4...The second connector 3 is inserted from the front end opening of the first connector body 4.")
Regarding Claim 32, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein the first coupling device is linearly and rotatably adjustable relative to the second coupling device (Imai, connectors 2 and 3 join both linearly and rotatably via the screw interaction of "annular threaded portion 76" of connector 2 and "female screw 104" of connector 3, as described at least at Fig 1 and pg. 4, last paragraph).
Regarding Claim 34, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein the first coupling device has a second cannula (Imai, "slide member 7"; Examiner broadly interprets "cannula" to be a tube.) which is arranged coaxially to the first cannula (Imai, 5) and through which the first cannula can be moved (Per Imai, slide member 7 contains "tubular portion 72" and "passage 73", and "the hollow needle 5 is slid in the enlarged diameter portion 731 when the slide member 7 slides." Please see Fig 3 and pg. 4, paragraphs 5-7).
Regarding Claim 35, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein the region of the first coupling device (Imai, 2), which is hermetically sealed in the initial state of the sterile connector (as taught by Py), is delimited towards the environment at least partially by at least one sealing envelope ("sliding member 74"; see Fig 3 and pg. 4, seventh paragraph) of the first coupling device.
Regarding Claim 38, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber further comprising a guide device (Imai, "rib 83") selected from the group consisting of a protrusion (per pg. 3, ninth paragraph, rib 83 is described as "protruding inward"), an axially running web and an axially running groove provided on a wall portion of the first coupling device.
Regarding Claim 43, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein the fluid passage (Imai, "second flow path 102") of the second coupling device (Imai, 3) opens into a fluid chamber of the second coupling device which has a fluid outlet fluidically connected to the fluid passage of which is otherwise closed (Imai teaches "second connection portion 103" as a thread groove, which can be connected to tube 50 (see Fig 1 and pg. 5, last paragraph). Tube 50 is further taught (see pg. 2, seventh paragraph) to be connected to a three-way stopcock, thereby reading upon Applicant's limitation of "otherwise closed").
Regarding Claim 46, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein the region of the first coupling device (Imai, 2) is hermetically sealed in the initial state of the sterile connector (as taught by Py), and is at least partially delimited against the environment by at least one of a second septum (Imai, 6) and a sealing envelope.
Regarding Claim 49, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber wherein the end of the first cannula (Imai, 5) forming the fluid outlet protrudes axially into the region of the second coupling device (Imai, 3) which is hermetically sealed (as taught by Py) in the initial state (Imai shows this protrusion action at Fig 5 and describes such at pg. 4, third para).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Imai as modified by Py, and in further view of Sanders et al. (US 2015/0126958).
Regarding Claim 50, Imai as modified above teaches a sterile connector for the sterile transfer of a liquid from a liquid container into a fluid chamber, wherein the first coupling device (Imai, 2) is configured such that it can be brought from the initial state into the respective defined axial position relative to the second coupling device (Imai, 3). Specifically, Imai teaches (see pg. 2, sixth paragraph) “a first connector 2 in which the second connector 3 is inserted from the distal end side, and these connectors are assembled (connected) in a first state (shown in FIG 5). It is used to transfer liquid from the connector 2 side to the second connector 3 side or in the opposite direction.”
However, Imai is silent on a mechanism is provided for indication of at least one defined axial position of the first coupling device relative to the second coupling device, and a defined axial position corresponds to a starting position in coupled state, and a defined axial position corresponds to an operating position in the coupled state, as claimed by Applicant.
However, Sanders et al. teaches
- a mechanism (that) is provided for indication of at least one defined axial position of the first coupling device relative to the second coupling device (see Abstract, “The connectors may include indicators to show when the connector system is in the locked position.” Also see Claim 17 and paras 107-110), and
- a defined axial position corresponds to a starting position in coupled state, and a defined axial position corresponds to an operating position in the coupled state. Specifically, at paras 107-110, Sanders et al. teaches indicator bands 98, 100 placed on the cam member 44 (of first connector 16, per para 87) and the second connector 18. Per para 108, “The indicator line 98 may extend the full length of the cam member 44 and the second connector 18 as shown in FIGS 8 and 11”. Per para 107, “when the first connector 16 is in locking engagement with the second connector 18, the indicator band 98 on the cam member 44 which will be visible through the transparent housing 20 will be aligned with the indicator band 100 on the second connector 18 to give a visual indication to the user that the connector system is locked”. Examiner broadly interprets this teaching as reading upon Applicant’s limitation, as one of ordinary skill in the art would be able to use this method to determine “a defined axial position corresponds to a starting position in coupled state” (e.g., when the connectors are first joined, but not yet finally connected), and “defined axial position corresponds to an operating position in the coupled state” (e.g., when the connectors are finally connected).
The Imai, Py, and Sanders references each teach fluid connector assemblies for use in medical situations. The Sanders reference additionally teaches a simple, low-cost method of ensuring connection prior to use of the assembly. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add indicator bands 98 and 100 as taught by Sanders et al. to the sterilized connectors 2 and 3 of Imai et al., in order to gain the advantages of a simple, low-cost method of ensuring connection prior to use of the assembly.
Regarding new Claim 51, the claim further limits “the body” of independent Claim 30. In light of the extensive issues regarding this limitation and Applicant’s stated assertion on what defines “the body”, Examiner reserves comment on the patentability of Claim 51 pending resolution of the issues identified in rejections of the other dependent claims, outlined above.
Allowable Subject Matter
In the previous claim set filed 12 July 2022, (see Non-Final Rejection, pgs 14-15) Claims 33, 36-37, 39-42, 44-45, and 47-48 were indicated as being allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in the previous Office action, and to include all of the limitations of the base claim and any intervening claims.
With regards to the present claim set, filed 15 January 2026, Examiner reserves comment on allowability pending resolution of the aforementioned rejections under 35 USC 112.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M AFFUL whose telephone number is (571)272-8421. The examiner can normally be reached Monday - Thursday: 7:30 AM - 5:00 PM Eastern Time.
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/CHRISTOPHER M AFFUL/Primary Examiner, Art Unit 3753