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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 01/20/2023, 04/21/2023, 06/06/2025, and 09/10/2025 have been considered by the Examiner.
Status of the Claims
Claims 29-49 are currently pending. Claims 29-49 are currently rejected.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “104” and “105” have been used to designate both “inlet ports” (claim 29, instant specification pg. 10. ln. 16; [0073] of related PGPUB) and “inflow tubes” (claim 29, instant specification pg. 10 ln. 11; [0072] of related PGPUB). 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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the simultaneous presence of “a plurality of inlet ports” and “an inflow tube”, both recited in claim 29 and noted above as being referred to with the same reference numbers in the specification, as well as the “common conduit” in claim 37 and claim 38, must be shown or the feature(s) canceled from the claim(s). 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 specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim limitation “a mechanism for interconnection of the valves and their synchronized operation” in claim 34 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claimed subject matter lacks proper antecedent basis in the specification.
Claim limitation “a common conduit” in claim 37 and claim 38 is not shown or described in the specification such that the structure can be identified.
Claim Objections
Applicant is advised that should claim 40 be found allowable, claim 42 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 47 is objected to because of the following informalities:
Claim 47 line 1 recites “a gas trap apparatus of claim 29”. This should read “the gas trap apparatus of claim 29”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a mechanism for interconnection of the valves and their synchronized operation” in claim 34.
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 limitation “a mechanism for interconnection of the valves and their synchronized operation” in claim 34 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claim 43 is 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.
Claim 43 recites the limitation “without a hand grip”. However, although the specification [0101] (see related PGPUB) notes that a cap may be shaped so that it “is intentionally difficult to grip or pull”, being difficult to grip does make the cap impossible to grip. No special definition of “hand grip” is provided which could reasonably allow any embodiment shown or described in the instant specification to be “without a hand grip”, since any three-dimensional object, particularly one sized as a cap would be, can be gripped by hand to some extent.
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 29-49 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 29 recites the limitation “the inlet ports are adapted to allow fluid flowing through the inlet ports to mix as they enter the chamber”. From the phrasing, it is unclear to which element “they” refers. Only one fluid is recited in this limitation, and multiple inlet ports are recited. However, “to mix as they enter” seems to imply that multiple fluids are mixing, not multiple inlet ports. Rewording the limitation to remove “they” would best clarify the issue. Consider rewording this limitation to read “the inlet ports are adapted to allow fluids to mix when entering the chamber through the inlet ports”, or something else to that effect. For the purposes of examination, this limitation has been interpreted to read “the inlet ports are adapted to allow fluids flowing through the inlet ports to mix as they enter the chamber”, wherein “they” refers to “fluids”.
Claim 29 recites the limitation “a plurality of inlet ports” on line 7, but this limitation was already introduced on lines 2-3. It is unclear whether the second instance of “a plurality of inlet ports” is meant to refer back to the “plurality of inlet ports” on lines 2-3, introduce a different plurality of inlet ports in a different part of the chamber, or introduce a different plurality of inlet ports associated with a different structure than the chamber. Please either change the second instance of “a plurality of inlet ports” to read “the plurality of inlet ports”, or alter the naming convention to clarify that the second “plurality of inlet ports” is different than the first instance. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 29 recites the limitation “the port” on line 7. It is unclear whether “the port” on line 7 is meant to refer back to “a plurality of inlet ports” on lines 2-3, “a plurality of inlet ports” on line 7, “at least one outlet port” on line 3, or introduce a new separate port. Please alter the naming convention of “the port” to clarify which port is being referred back to or what kind of different port is being introduced. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 29 recites the limitation “inflow of fluids into the chamber with a lateral dimensional component” on lines 8-9. It is unclear whether this “lateral dimensional component” refers to the chamber, which being a three-dimensional structure inherently has a lateral dimensional component, or to a characteristic of the inflow of fluids. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 29 recites the limitation “a lateral dimensional component” on line 11. It is unclear whether this “lateral dimensional component” is meant to refer back to the “lateral dimensional component” introduced in line 9 of claim 29, or introduce a different lateral dimensional component of the flow/chamber, or introduce a lateral dimensional component of a different structure/flow. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 32 recites the limitation “at least one inlet port” on line 1. Claim 29, on which claim 32 depends, already introduced “a plurality of inlet ports” on lines 2-3 and line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to “at least one inlet port of the plurality of inlet ports”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 33 recites the limitation “a diverter” in line 2. Claim 29, on which claim 33 depends, introduced “a flow diverter” on line 10. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 34 recites the limitation “a mechanism for interconnection of the valves and their synchronized operation”, which as noted above invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function in the claim. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For the purposes of examination, any structure which operates two or more valves is interpreted to meet the claim limitation.
Claim 35 recites the limitation “a plurality of the inlet ports” on line 2. Claim 29, on which claim 35 depends, already introduced “a plurality of inlet ports” on lines 2-3 and line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a separate plurality of inlet ports, a subset of the previously introduced plurality of inlet ports, or a new plurality of inlet ports. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 36 recites the limitation “an inlet port” on line 2. Claim 29, on which claim 36 depends, already introduced “an inlet” on line 2 and “a plurality of inlet ports” on lines 2-3 and line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to “at least one inlet port of the plurality of inlet ports”, or an equivalent). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 36 recites the limitation “a port” on line 3. Claim 29, on which claim 36 depends, already introduced “a plurality of inlet ports” on lines 2-3 and line 7, and “at least one outlet port” on line 3. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to match the wording of the earlier introduced structure and “the” should be used as the article). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 36 recites the limitation "the purpose" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the phrase “for the purpose of transferring” has been interpreted to read “for transferring”.
Claim 37 recites the limitation “a plurality of inlet ports” on line 2. Claim 29, on which claim 37 depends, already introduced “a plurality of inlet ports” on lines 2-3 and line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to “at least one of the plurality of inlet ports” or “at least two of the plurality of inlet ports” or similar language). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 37 recites the limitation “common conduit” in line 1. This limitation lacks antecedent basis in the specification, and it is unclear whether the “common conduit” in claim 37 is supposed to refer back to the “confluence space” or “inflow tube” or claim 29 or introduce a new structure somehow separate from the inlet, inlet ports, inflow tube, and confluence space of the independent claim 29. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 38 recites the limitation “a plurality of inlet ports” on line 2. Claim 29, on which claim 38 depends, already introduced “a plurality of inlet ports” on lines 2-3 and line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to “at least one of the plurality of inlet ports” or “at least two of the plurality of inlet ports” or similar language). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 38 recites the limitation “common conduit” in line 1. This limitation lacks antecedent basis in the specification, and it is unclear whether the “common conduit” in claim 38 is supposed to refer back to the “confluence space” or “inflow tube” or claim 29 or introduce a new structure somehow separate from the inlet, inlet ports, inflow tube, and confluence space of the independent claim 29. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 38 recites the limitation "the longitudinal direction" in line 3. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this limitation is meant to refer back to the “longitudinal flow direction” introduced in claim 29, or introduce a different longitudinal direction. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 41 recites the limitation “wherein the cap and the opening comprise inter-engaging ridge and groove”. It is unclear whether the cap has both a ridge and a groove and the opening also has a ridge and a groove, or whether the cap has one of a ridge and a groove and the opening has the other of the ridge and the groove. Please clarify the claim language and add articles (“a ridge” and “a groove”, not just “ridge” and “groove”) to properly introduce the limitations. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 44 recites the limitation “the cap is configured to closure only without removal” on lines 3-4. It is unclear what “configured to closure” means, since “closure” is not a verb. Furthermore, “closure only without removal” also introduces uncertainty, since this could be interpreted as “closure only, without removal”, possibly meaning that the cap cannot be removed, or perhaps interpreted as “closure, only without removal”, possibly meaning that the cap doesn’t have an “open” configuration unless it is completely removed? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 45 similarly recites the limitation “the cap is configured to closure only without removal” on lines 3-4. Likewise, it is unclear what “configured to closure” means, since “closure” is not a verb. Furthermore, “closure only without removal” also introduces uncertainty, since this could be interpreted as “closure only, without removal”, possibly meaning that the cap cannot be removed, or perhaps interpreted as “closure, only without removal”, possibly meaning that the cap doesn’t have an “open” configuration unless it is completely removed? For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 46 recites the limitation "the distance" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “a distance”.
Claim 46 recites the limitation “a confluence space” in lines 2-3. Claim 29, from which claim 46 depends, introduces “a confluence space” on line 6. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 49 recites the limitation “an inlet port” on line 2. Claim 29, the subject matter of which claim 49 incorporates, already introduced “a plurality of inlet ports” on lines 2-3 and line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to one of the plurality of structures earlier introduced (in which case the limitation should be changed to “at least one of the plurality of inlet ports” or similar language). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 30-49 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 29-30, 33, 36-38, and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Kay (GB 2059776 A; hereafter Kay) in view of Wojke (US 5849065 A; hereafter Wojke).
Regarding claim 29, Kay discloses a gas trap apparatus for medical fluids, the apparatus comprising a bubble entrapment chamber (junction device 40, fig. 2, pg. 6/8 ln. 120-130), an inlet (inlets 44 and 50, opening covered by filter 58, and chambers 42, 48, and 54; fig. 2, pg. 6/8 ln. 120-pg. 7/8 ln. 4) to the bubble entrapment chamber (40) with a plurality of inlet ports (44, 50, and opening covered by filter 58; see fig. 2, pg. 6/8 ln. 120-130), and an outlet (outlet chamber 62, fig. 2) with at least one outlet port (outlet 64, fig. 2), wherein:
the inlet ports (44, 50) are adapted to allow fluid flowing through the inlet ports to mix as they (see 112b interpretation above) enter the chamber (40) (see fig. 2, both primary and secondary fluids drain into chamber 54 of junction device 40; pg. 6/8 ln. 120-pg. 7/8 ln. 4 “Chambers 42 and 48 drain into intermediate chamber 54 which is separated from the former by a hydrophilic microporous membrane valve 56.”),
the inlet ports merge at a confluence space (interior of chamber 54, fig. 2, pg. 6/8 ln. 120-pg. 7/8 ln. 4),
a plurality of inlet ports (see 112b interpretation above, this plurality of inlet ports is interpreted to be the same as that claimed earlier in claim 29) each comprises a valve (penetrable seal 52, membrane valve 56, hydrophobic vent filter 58; see fig. 2) for fully or partly closing the port (see 112b interpretation above) (see fig. 2, seal 52 covers inlet port 50 and membrane valve 56 covers exit of inlet port 44; pg. 6/8 ln. 120- pg. 7/8 ln. 4),
the apparatus comprises a flow diverter (support 60, fig. 2, pg. 7/8 ln. 5-12) in the chamber (40, fig. 2) arranged to divert flow from the inlet to have a lateral directional component (see 112b interpretation above) with respect to a longitudinal flow direction from the inlet (see fig. 2, liquid is directed through hydrophilic annulus 72 at the edge of the chamber 40, pg. 7/8 ln. 13-27), and away from the outlet port (64, see fig. 2, outlet port 64 is located radially inwardly of annulus 72) and towards an internal surface of the chamber (see fig. 2, hydrophilic annulus 72 leads to an annular chamber 70 formed with an internal surface of the chamber 40, pg. 7/8 ln. 13-27).
Kay is silent to wherein the chamber comprises a diffuser comprising apertures around an inflow tube for inflow of fluids into the chamber with a lateral dimensional component (see 112b interpretation above).
Wojke, directed to a device for separating gas bubbles from fluids, teaches wherein a chamber (chamber 1, fig. 1, col. 4 ln. 23-29) comprises a diffuser (flow guide member 10, fig. 2, col. 4 ln. 44-col. 5 ln. 7) comprising apertures (two orifices 17 and 18 of flow-guide tubes 15 and 16, fig. 2, col. 4 ln. 44-col. 5 ln. 7) around an inflow tube (central flow channel 12, fig. 2, col. 4 ln. 44-col. 5 ln. 7) for inflow of fluids into the chamber (chamber 1, fig. 1) with a lateral dimensional component (see 112b interpretation above) (col. 5 ln. 8-16 describes flow guide tubes 15 and 16 redirecting fluid inflow from a primarily vertical flow to a primarily horizontal flow).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air removal device of Kay to include the diffuser taught by Wojke after the confluence space formed in chamber 54 of Kay and before the flow diverter 60 of Kay since both references deal with removing air from medical fluids. One would have been motivated to make the modification because the diffuser of Wojke helps to prevent bubble formation by establishing a helical flow which forces bubbles toward the central longitudinal axis and the fluid toward the periphery of the chamber (see col. 5 ln. 17-25 of Wojke). This flow situation would better facilitate the transference of liquid through the hydrophilic annulus 72 at the edge of the chamber 40 (Kay pg. 7/8 ln. 13-27) and allow the bubbles to exit through the hydrophobic center portion of the filter of Kay.
Regarding claim 30, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above. Kay further discloses wherein the inlet ports (44, 50, and opening covered by filter 58; see fig. 2) include a dedicated venting port (opening covered by hydrophobic vent filter 58, see fig. 2, pg. 7/8 ln. 28-30 “air being vented at 58”).
Regarding claim 33, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above. Kay further discloses wherein the chamber includes a hydrophilic membrane (final sterilizing filter 74, fig. 2) mounted at a distal end of a diverter (see 112b interpretation, this is interpreted to be the same diverter introduced in claim 29) (central support 60, fig. 2 shows that final sterilizing filter 74 extends to the distal end of diverter/support 60) (pg. 7/8 ln. 5-12 “Central support 60 is of the construction shown in the referenced patent and carries on its outer surface a final sterilizing filter 74 of a hydrophilic, a microporous membrane which will pass liquid but, when wet, will prevent passage of air.”).
Regarding claim 36, Kay modified by Wojke discloses the apparatus of claim 29, as described above. Kay further discloses further comprising a membrane (penetrable seal 52, fig. 2) which is selectively sealable (pg. 6/8 ln. 124-130 resilient penetrable seal 52 may optionally be breached by a secondary tube) at an inlet port (see 112b interpretation above) (inlet 50, fig. 2) or the outlet port, to maintain a closed system integrity when an external device (secondary tube noted in pg. 6/8 ln. 124-130) is connected to a port (see 112b interpretation above; inlet 50) for the purpose (see 112b interpretation above) of transferring liquids or gases into or out of the chamber (40, fig. 2) (pg. 6/8 ln. 124-130 “Fig. 2 herein illustrates a vertical, generally diametric section of the modification wherein the top is modified to provide a primary liquid chamber 42 having an inlet 44 for connection to primary tubing 46 and a secondary liquid chamber 48 having an inlet 50 for insertion of a secondary tube (not shown) through resilient, penetrable seal 52.”).
Regarding claim 37, Kay modified by Wojke discloses the apparatus as claimed in claim 29, wherein the inlet comprises a common conduit (see 112b interpretation above) (walls forming chamber 54, see fig. 2, both inlet ports drain into chamber 54) for a plurality of inlet ports (see 112b interpretation above) (pg. 6/8 ln. 124-pg. 7/8 ln. 4 “a primary liquid chamber 42 having an inlet … and a secondary liquid chamber 48 having an inlet 50 … Chambers 42 and 48 drain into intermediate chamber 54).
Regarding claim 38, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above. Key further discloses wherein the inlet comprises a common conduit (see 112b interpretation above) (walls forming chamber 54, see fig. 2, both inlet ports drain into chamber 54) for a plurality of inlet ports (see 112b interpretation above) (pg. 6/8 ln. 124-pg. 7/8 ln. 4 “a primary liquid chamber 42 having an inlet … and a secondary liquid chamber 48 having an inlet 50 … Chambers 42 and 48 drain into intermediate chamber 54), and wherein said common conduit extends parallel to the longitudinal direction (see 112b interpretation above) (see fig. 2, inlet ports drain into top of chamber 54 and exit through the bottom, thus the common conduit (the walls forming chamber 54) extend parallel to the longitudinal direction).
Regarding claim 47, Kay modified by Wojke discloses an infusion apparatus comprising a gas trap apparatus of claim 29, as described above. Key further discloses infusion lines (primary tubing 46, fig. 2, and secondary tubing (not shown; pg. 6/8 ln. 120-130), linked with the inlet ports (44, 50; fig. 2) (pg. 6/8 ln. 120-130 “an inlet 44 for connection to primary tubing 46 and … an inlet 50 for insertion of a secondary tube (not shown)”) and an infusion line (outlet tubing mentioned on pg. 7/8 ln. 5-12) linked with the outlet (64, fig. 2) (pg. 7/8 ln. 5-12 “outlet chamber 62 which communicates with outlet 64 for connection with outlet tubing (not shown) for passing liquid to the patient”).
Regarding claim 48, Kay modified by Wojke discloses a method of use of the apparatus of claim 29, as described above. Key further discloses comprising steps of directing flows of different fluids via the inlet ports (pg. 7/8 ln. 28-64 describes directing primary a primary liquid through inlet port 44 and a secondary fluid through seal 52 of inlet 50), with mixing (pg. 7/8 ln. 58-61 notes liquid mixing below membrane 56) and entrapment of gases (pg. 7/8 ln. 28-30 “air being vented at 58”) from the plurality of fluids in the chamber (40) (pg. 7/8 ln. 47-58 “any air drawn through the secondary tubing is vented through passageway 68 and is prevented from reaching outlet 64 by the wetted annulus 72 and final filter 74”) and as they enter the chamber (pg. 7/8 ln. 28-30 “In operation, primary liquid from an elevated source enters through inlet 44 to primary chamber 42, priming or other entrained air being vented at 58.”).
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Sun et al (CN 107115579 A; hereafter Sun). Text reference is made to the attached pdf of Sun.
Regarding claim 31, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the inlet includes a turbulence-inducing flow barrier.
Sun, in the art of infusion devices, teaches wherein the inlet (infusion tethering 5, fig. 1, pg. 3 para. 3, “the top of the hopper 6 is connected with a infusion tethering 5”) includes a turbulence-inducing flow barrier (disturbing flow columns 9, fig. 1 and fig. 4, pg. 4 last paragraph “A plurality of disturbing flow columns 9 in the body 7 of the transfusion tube are dispersed and mixed to form a plurality of disturbing flows, which not only sufficiently mix the three kinds of liquid, but also prevent the medicine in the liquid to be precipitated or deposited on the inner wall of the body 7”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the flow disturbing columns 9 taught by Sun in the inlet of Kay modified by Wojke since Sun also deals with delivery of medical fluid. One would have been motivated to make the modification because including the flow disturbing columns 9 taught by Sun in the inlet of Kay modified by Wojke to encourage fluid mixing between the primary and secondary fluids of Kay and prevent medicine in the primary and secondary fluids from precipitating on the inner walls of the inlet portions.
Regarding claim 32, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein at least one inlet port (see 112b interpretation above) includes a turbulence-inducing flow barrier.
Sun, in the art of infusion devices, teaches wherein the inlet (infusion tethering 5, fig. 1, pg. 3 para. 3, “the top of the hopper 6 is connected with a infusion tethering 5”) includes a turbulence-inducing flow barrier (disturbing flow columns 9, fig. 1 and fig. 4, pg. 4 last paragraph “A plurality of disturbing flow columns 9 in the body 7 of the transfusion tube are dispersed and mixed to form a plurality of disturbing flows, which not only sufficiently mix the three kinds of liquid, but also prevent the medicine in the liquid to be precipitated or deposited on the inner wall of the body 7”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to include the flow disturbing columns 9 taught by Sun in the inlet of Kay modified by Wojke since Sun also deals with delivery of medical fluid. One would have been motivated to make the modification because including the flow disturbing columns 9 taught by Sun in the inlet of Kay modified by Wojke to encourage fluid mixing between the primary and secondary fluids of Kay and prevent medicine in the primary and secondary fluids from precipitating on the inner walls of the inlet portions.
Kay as modified by Wojke and Sun teaches all elements of the claimed invention except wherein at least one inlet port, specifically, not just the inlet, includes a turbulence-inducing flow barrier. It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange flow disturbing columns along all parts of the inlet including the inlet ports since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of supplying fluids through the inlet ports to the chamber. One would have been motivated to make the modification because, as noted by Sun in the last paragraph of page 4, including the columns prevents any medicine in the fluid from precipitating or being deposited on the inner surfaces of the apparatus, which would be an issue at all points, including the inlet ports. Additionally, establishing a turbulent flow prior to mixing of fluids helps to better encourage the fluids to mix upon meeting.
Claim(s) 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Reilly et al (US 20100298699 A1; hereafter Reilly).
Regarding claim 34, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke are silent to wherein the apparatus comprises a mechanism for interconnection of the valves and their synchronized operation.
Reilley, in the art of mixing and delivery multiple fluids, teaches wherein the apparatus comprises a mechanism (see 112b interpretation above) (pinch block 226, fig. 3, [0046]) for interconnection of the valves (channels 222 and 224 of valve device 210, fig. 4, [0046] valve device 210 may be a dual pinch valve that includes a valve actuator 212 operably associated with the first and second fluid lines 202 , 204 associated with valve device 220) and their synchronized operation ([0048] Such controlled movement of pinch block 226 controls with generally equal precision the amount of compression or restriction in one or both of fluid lines 202 , 204 .).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the inlet of Kay modified by Wojke to include the dual pinch valve with the pinch block 226 taught by Reilly, since Reilly also deals with delivery of multiple medical fluids. One would have been motivated to make the modification because Reilly allows not only for alternative delivery of fluids but provides a clearly usable interface for choosing one fluid or a mixture of two fluids for delivery, thus increasing the versatility of the system of Kay modified by Wojke.
Regarding claim 35, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke are silent to wherein the inlet comprises a single valve which is mounted to alternatively open and close a plurality of the inlet ports.
Reilly, in the art of mixing and delivery multiple fluids, teaches wherein the inlet (mixing stopcock valve 300, fig. 10a-e, [0052]) comprises a single valve (stopcock body 302, fig. 10a-e, [0052]) which is mounted to alternatively open and close a plurality of the inlet ports (see 112b interpretation above) ([0052] stopcock body 302 defines a plurality of input ports; see figs. 10a-e and [0054] which describe various open/close positions for the plurality of inlet ports).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the inlet of Kay modified by Wojke to include the mixing stopcock valve 300 taught by Reilly, since Reilly also deals with delivery of multiple medical fluids. One would have been motivated to make the modification because Reilly allows not only for alternative delivery of fluids but provides a clearly usable interface for choosing one fluid or a mixture of two fluids for delivery, thus increasing the versatility of the system of Kay modified by Wojke.
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Woodard (US 6013060 A; hereafter Woodard).
Regarding claim 39, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the apparatus comprises a bracket for attachment to a support as part of an infusion set.
Woodard, in the field of intravenous liquid flow systems with a bubble separator (see col. 5 ln. 26-47), teaches wherein the apparatus comprises a bracket (clamp bracket 74, figs. 10 and 11, col. 5 ln. 26-47) for attachment to a support (I.V. stand 12, figs. 10 and 11, col. 5 ln. 26-47) as part of an infusion set (see fig. 1 which shows bubble separator 32 as part of an IV set) (col. 5 ln. 26-47 “bubble separator 32 includes a housing or container 70 consisting of a container, having a cover 72 that includes a clamp bracket 74 connected or formed therein, which is snapped onto the I.V. stand 12 … to insure [sic] that the bubble separator 32 is retained in an upright position”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the apparatus of Kay modified by Wojke to include the bracket for attachment to a support as part of an infusion set as taught by Woodard since Woodard also deals with an infusion system including an air elimination system. One would have been motivated to make the modification because, as noted by Woodard col. 5 ln. 26-47, the bracket ensures that the bubble separator is retained in an upright position. Maintaining the air elimination system of Kay modified by Wojke in an upright position would aid in ensuring that bubbles vent correctly through the hydrophobic filter 58.
Claim(s) 40-42 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Jess (US 4013072 A; hereafter Jess).
Regarding claim 40 (and regarding claim 42, which is identical), Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the apparatus comprises a venting port which is sealable, and the venting port comprises a vent opening and a cap which is engageable with the vent opening.
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) which is sealable (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”), and the venting port (62/60/66) comprises a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6) which is engageable with the vent opening (see fig. 5).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Kay modified by Wojke to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Regarding claim 41, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the apparatus comprises a venting port which is sealable, and the venting port comprises a vent opening and a cap which is engageable with the vent opening, and wherein the cap and the vent opening have inter-engaging features which are engageable by pushing the cap into the opening, and wherein the cap and the opening comprise inter-engaging ridge and groove (see 112b interpretation above).
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) which is sealable (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”), and the venting port (62/60/66) comprises a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6) which is engageable with the vent opening (see fig. 5), and wherein the cap (66) and the vent opening (62) have inter-engaging features (col. 5 ln. 5-10, “closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”) which are engageable by pushing the cap into the opening (see fig. 5), and wherein the cap and the opening comprise inter-engaging ridge (nipple 68, fig. 6) and groove (opening formed within annular flange 70, fig. 6) (see 112b interpretation above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Kay modified by Wojke to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Regarding claim 44, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the apparatus comprises a venting port which is sealable, and the venting port comprises a vent opening and a cap which is engageable with the vent opening, and wherein the cap is configured to closure only without removal (see 112b interpretation above).
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) which is sealable (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”), and the venting port (62/60/66) comprises a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6) which is engageable with the vent opening (see fig. 5), and wherein the cap (66) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to closure only without removal (see 112b interpretation above, Examiner interprets this limitation to mean that the cap is closed until the cap is removed from engagement with the vent opening, as shown in fig. 5 (closed) vs fig. 6 (open). Note Jess col. 5 ln. 5-26 describes optionally removing the cap.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Kay modified by Wojke to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Jess and Hoang et al (US 20120016318 A1; hereafter Hoang).
Regarding claim 43, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the apparatus comprises a venting port which is sealable, and the venting port comprises a vent opening and a cap which is engageable with the vent opening, wherein the cap has a curved exposed surface without a hand grip, and wherein the cap is linked with the vent opening by a ribbon comprising a ring engaged around the vent opening to allow rotation about an axis of the vent opening.
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) which is sealable (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”), and the venting port (62/60/66) comprises a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6) which is engageable with the vent opening (see fig. 5), wherein the cap has a curved exposed surface (see curved edge of cap 66 in figs. 5 and 6) without a hand grip (Examiner notes that the curved edge of cap 66 lacks any handle or ridges for gripping as shown.) (see 112a rejection above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Kay modified by Wojke to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Kay modified by Wojke and Jess is silent to wherein the cap is linked with the vent opening by a ribbon comprising a ring engaged around the vent opening to allow rotation about an axis of the vent opening, although Jess figs. 5 and 6 do appear to show a flexible linkage between the cap and the vent opening.
Hoang, in the field of portable aspirators with vents for medical use, teaches wherein a cap (cap 10, fig. 6, [0038]) is linked with an opening (adaptor 50, fig. 6, [0038]) by a ribbon (tether 70, fig. 6, [0038]) comprising a ring (loop 72, fig. 6, [0038]) engaged around the vent opening (50) to allow rotation about an axis (axis through center of adaptor 50 in fig. 6, from left to right) of the vent opening (50) ([0038] tether 70 with loops 72 and 74 permitting free rotation of access cap 10 when threadedly coupling access cap 10 proximal end 52 of adapter 50).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further modify the vent opening and cap of Kay modified by Wojke and Jess to include the ribbon and ring tether taught by Hoang, since Hoang also deals with medical fluid delivery. One would have been motivated to make the modification because the ribbon ensures that the cap is not lost (see Hoang [0031]), and the ring, allowing the cap to rotate, ensures that the ribbon is not easily damaged from rotating during use of the cap, thus better ensuring the cap is not lost longer by preventing the ribbon from fracturing.
Claim(s) 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Jess and Singer et al (US 20090227987 A1; hereafter Singer).
Regarding claim 45, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein the apparatus comprises a venting port which is sealable, and the venting port comprises a vent opening and a cap which is engageable with the vent opening, and wherein the cap is configured to closure only without removal (see 112b interpretation above), and wherein the cap and the vent opening have inter-engaging features which provide a snap-fit lock with pushing of the cap into the vent opening.
Jess, directed to a drip chamber for air elimination during intravenous administration (col. 4 ln. 37-41, fig. 5), teaches wherein the apparatus (drip chamber 44, fig. 5, col. 4 ln. 38-64) comprises a venting port (opening 62, hydrophobic filter element 60, and closure 66, fig. 5 and 6, col. 4 ln. 65-col. 5 ln. 4, hydrophobic filter element can be mounted over the opening 62) which is sealable (col. 5 ln. 5-26, “hydrophobic filter element 60 is provided with a closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”), and the venting port (62/60/66) comprises a vent opening (opening 62, fig. 5) and a cap (closure 66, fig. 6) which is engageable with the vent opening (see fig. 5), and wherein the cap (66) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to closure only without removal (see 112b interpretation above, Examiner interprets this limitation to mean that the cap is closed until the cap is removed from engagement with the vent opening, as shown in fig. 5 (closed) vs fig. 6 (open). Note Jess col. 5 ln. 5-26 describes optionally removing the cap.), and wherein the cap and the vent opening have inter-engaging features (annular flange 70 and nipple 68, see fig. 6) which provide a snap-fit lock with engagement of the cap (66) and the vent opening (62) (col. 5 ln. 5-10, “closure 66 … adapted to engage in a sealing relationship with the nipple 68 in which the hydrophobic filter is mounted by means of an annular flange 70”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the air elimination device of Kay modified by Wojke to include a venting port with a cap as taught by Jess since Jess also deals with air elimination from medical fluid. One would have been motivated to make the modification because, as noted in Jess col. 5 ln. 5-26, such an arrangement of a cap can be used to operate the venting port as either air blocking, if desired, or air eliminating, to vent air during infusion. Thus, the modification makes the device more versatile. Additionally, having a cap over the air filter may allow for better protecting against bacteria or other contaminants which may contact the hydrophobic filter if the filter is left uncovered when not in use. Additionally, the cap can be used to protect against perforation of the hydrophobic filter during storage or transport.
Kay modified by Wojke and Jess is silent to engagement of the cap and the vent opening being pushing of the cap into the vent opening, rather Jess shows pushing the vent opening into the cap (see figs. 5 and 6 of Jess).
Singer, in the art of valve closures, teaches wherein a cap (cap D2a, fig. 7, [0058]) and an opening (upper port D1, fig. 7, [0038]) have inter-engaging features ([0058] Cap D2a is removable to expose Luer Lok fitting LF for fluid suction) which provide a snap-fit lock with pushing of the cap (D2a) into the vent opening (D1) ([0058] cap has a descending stopper DS on its lower portion of said cap that fits inside opening of upper port D1).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the cooperation of the cap and vent opening of Kay modified by Wojke and Jess to have the descending stopper DS included in the cap and engageable with an upper port D1 as taught by Singer, since Singer also deals with closing/opening medical valves. One would have been motivated to make the modification because this modification amounts to a rearrangement of parts or a simple substitution of one closure kind for another, and the extended engagement feature, the descending stopper DS shown in fig. 7 of Singer, provides additional frictional contact which may provide a better seal less likely to become accidentally disengaged due to the length of the engaged portions of the vent opening and the cap. Note that it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of optional engagement between the cap and the vent opening just as well with the described arrangement.
Claim(s) 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Kawano et al (US 20040087885 A1; hereafter Kawano).
Regarding claim 46, Kay modified by Wojke discloses the apparatus as claimed in claim 29, as described above.
Kay modified by Wojke is silent to wherein, the inlet ports have a diameter in the range of 1.5 mm to 8.0 mm, and the distance (see 112b interpretation above) between an upper end of a confluence space (see 112b interpretation above) between the ports and the diffuser apertures is no more than 20mm.
Kawano, in the art of medical tubing, teaches wherein, the inlet ports have a diameter in the range of 1.5 mm to 8.0 mm ([0106] inner diameter of tubing is standard for blood infusion, for example between 3.2-4.7 mm).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to have the diameter of the inlet port be 3.2-4.7mm as taught by Kawano since Kawano is also in the field of fluid delivery and notes that this is a standard range. One would have been motivated to make the modification because Kawano notes that 3.2-4.7mm is a typical tubing size and thus is likely cheaper and more easily accessible than other tubing sizes.
Kay modified by Wojke and Kawano teaches all elements of the claim except wherein the distance between an upper end of a confluence space between the ports and the diffuser apertures is no more than 20mm. The distance between an upper end of a confluence space between the ports and the diffuser apertures is a result effective variable because the length of the confluence space influences how much the fluids mix before going through the diffuser apertures. It would have been obvious to one of ordinary skill in the art at the time the invention was made to make the distance between an upper end of a confluence space between the ports and the diffuser apertures no more than 20mm, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. (In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Claim(s) 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kay modified by Wojke as applied to claim 29 above, and further in view of Block, JR (US 4976685 A; hereafter Block).
Regarding claim 49, Kay modified by Wojke discloses the method of claim 48, as described above.
Kay modified by Wojke is silent to comprising the further step of aspirating the gases via an inlet port or a dedicated venting port.
Block, in the art of surgical gas traps, teaches the further step of aspirating the gases via an inlet port (see 112b interpretation above) (Y-access port 112, fig. 1, col. 6 ln. 63-col. 7 ln. 4) or a dedicated venting port (col. 7 ln. 2-4, “By withdrawing the plunger of syringe 114, negative pressure may be asserted from the access port at 112 to remove the gases above the interface 84”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kay modified by Wojke to include aspiration of gases via an inlet port as taught by Block, since Block also deals with gas removal from infusion fluid. One would have been motivated to make the modification because applying negative pressure to remove gas may facilitate faster gas removal and create more space for infusion liquid to pass through the chamber.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Monzen (US 4664682 A) - fig. 3, col. 4 ln. 59-col. 5 ln. 16, defoamer with filter, vent, diverter, and multiple inlets
Chen and Chong (US 20190083906 A1) - fig. 13, [0056], bubble removing chamber with diffuser and diverter
Brugger (US 5503801 A) - fig. 3, col. 3 ln. 64-col. 4 ln. 5 multiple inlets, diffuser and diverter
Bryan (US 9533109 B2) - fig. 31 and 32, bubble entrapment device with lateral openings (diffuser)
Varga et al (WO 2017205625 A1) - fig. 9a-9c, [0088], gas elimination with flow diversion member and lateral openings through cage 913
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/06/2026