DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 12-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/24/2026.
Applicant's election with traverse of invention I in the reply filed on 8/24/2026 is acknowledged. The traversal is on the ground(s) that regarding the invention I and invention III, the process is not used to make another and materially different product. The process includes forming a common component in a manufacturing or joining process based on a printing technology or 3D printing technology, wherein materials made of plastic materials, plastic composites, metal materials or metal composites are used in the manufacturing or joining process. The product includes a device that is manufactured as a single piece component, integrally and gas-tight in a manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology. As such, the process as claimed is used to make the product recited in the product claims. Further, the product as claimed is not made by another and materially different process since the product includes manufacturing a single piece component as recited in the process claim.
This is not persuasive because the inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the method can be used to make another and materially different product, such as a product comprising a laminar flow element and a gas volume buffering element. Alternatively, the product can be made by another and materially different process, such as a process comprising the step of providing a connection that is connectable to a breathing system of the anesthesia system. The applicant has not shown that the method cannot be used to make another and materially different product, such as a product comprising a laminar flow element and a gas volume buffering element or that the product cannot be made by another and materially different process, such as a process comprising the step of providing a connection that is connectable to a breathing system of the anesthesia system. Furthermore, the claim does not claim that the apparatus of invention I can only be made from the method of invention III and that the process of invention III can only be used to make the apparatus of invention I.
Therefore, the restriction requirement still stands.
Furthermore, the traversal is on the ground(s) that regarding the invention II and invention III, that the process is not made to make another and material different product. The process includes forming a common component in a manufacturing or joining process based on a printing technology or 3D printing technology, wherein materials made of plastic materials, plastic composites, metal materials or metal composites are used in the manufacturing or joining process. The product includes a device that is manufactured as a single piece component, integrally and gas-tight in a manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology. As such, the process as claimed is used to make the product recited in the product claims. Further, the product as claimed is not made by another and materially different process since the product includes manufacturing a single piece component as recited in the process claims.
This is not persuasive because the inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the method can be used to make another and materially different product, such as a product comprising a laminar flow element and a gas volume buffering element. Alternatively, the product can be made by another and materially different process, such as a process that does not require the step of including forming the device so as to comprise at least two functional components including a laminar flow element and a gas volume buffering element. The applicant has not shown that the method cannot be used to make another and materially different product, such as a product comprising a laminar flow element and a gas volume buffering element or that the product cannot be made by another and materially different process, such as a process that does not require the step of including forming the device so as to comprise at least two functional components including a laminar flow element and a gas volume buffering element. Furthermore, the claim does not claim that the apparatus of invention II can only be made from the method of invention III and that the process of invention III can only be used to make the apparatus of invention II.
Furthermore, the traversal is on the ground(s) that regarding the invention I and invention II, that invention I and invention II include a device that is manufactured as a single piece component, integrally and gas-tight in a manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology. As such, invention I and invention II do encompass overlapping subject matter.
This is not persuasive because the related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design or function, the device of group I is for calming gases or gas mixtures or mixing gases or gas mixtures for anesthesia system having a plurality of gas inlets while device of group II is a device for calming flowing gases or gas mixture comprising a gas inlet and a gas outlet. The applicant did not address how the examiner’s statement that the inventions as claimed have material different design or function. Furthermore, the inventions do not overlap in scope because invention I is drawn towards a device for calming gases for an anesthesia system and the device comprising a plurality of gas inlets and an outlet, while invention II is drawn to a device for calming of flowing gases that is not specifically for anesthesia system and that the device does not comprise two inlets, the process of making the device might be similar, however, how a product is made does not make the structure(s) being claimed overlap in scope. Furthermore, there is no evidence that the two inventions are obvious variant, one device is specifically for an anesthesia system with two gas inlets while the other invention is not specifically for anesthesia with one gas inlet. Therefore, the restriction requirement still stands.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because in fig. 11, the reference numeral “600” must be accompanied by a lead line, and the underline must be removed. Underlines are used to indicate a surface or cross section. See 37 C.F.R. 1.84(q).
The drawings are objected to because in fig. 2, the generic box for reference numeral “37” should be accompanied by descriptive text since the generic box is a generic graphic symbol and because in fig. 5, the rectangular box for reference numeral “703” should be accompanied by descriptive text since the rectangular box is a generic graphic symbol. See 37 CFR 1.83(a) and examiner note to Formed Paragraph 6.22 in MPEP section 608.02(b).
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.
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: the limitations “a mixing system comprising an integrated mixing geometry” (claim 1, line 3, the term “system” is a generic placeholder and the function is “mixing”, mixing geometry is not a structural modifier, since mixing geometry can be geometrical parameters), “breathing system” (claim 1, lines 8-9, the term “system” is a generic placeholder and the function in the current context is “breathing”), “a gas state measurement device” (claim 2, lines 2-3, the term “device” is a generic placeholder and the function is “gas state measurement”), “an element for flow calming” (claim 3, line 1, the term “element” is a generic placeholder and the function is “for flow calming”), “a flow resistance element” (claim 3, line 2, the term “element” is a generic placeholder and the function in the current context is “flow resistance”), “a laminar flow element” (claim 3, line 2, the term “element” is a generic placeholder and the function in the current context is “laminar flow”), “an element for a volume buffering is arranged in the mixing system or in or at the interface” (claim 3, lines 3-4, the term “element” is a generic placeholder and the function is “for a volume buffering is arranged in the mixing system or in or at the interface”), “the mixing system” (claim 3, line 3), “an element for flow calming” (claim 5, line 1, the term “element” is a generic placeholder and the function is “for flow calming”), “a flow resistance element” (claim 5, line 2, the term “element” is a generic placeholder and the function in the current context is “flow resistance”), “a laminar flow element” (claim 5, line 2, the term “element” is a generic placeholder and the function in the current context is “laminar flow”), “an element for a volume buffering is arranged in the mixing system” (claim 5, line 3, the term “element” is a generic placeholder and the function is “for a volume buffering is arranged in the mixing system”), “the mixing system” (claim 5, line 3).
It is noted that the limitation “mixing system” in claims 2 and 11 no longer invokes 112(f) because sufficient structural modifiers are present.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“a mixing system”: mixing system 400 comprising gas inlets 20, 21 and mixing geometry 200, see figs. 1-2, paragraph 0078.
“breathing system”: being labeled as 35, fig. 2, paragraphs 0078-0079, however, corresponding structure cannot be determined.
“a gas state measurement device”: gas state measurement unit 703, fig. 5, paragraph 0085, however, corresponding structure cannot be determined.
“an element for flow calming”: 600 comprising flow resistance 601, or an orifice element 602, or a laminar flow element 603, or an impact/baffle element 604, see fig. 9, paragraph 0092.
“a flow resistance element”: flow resistance element, 601 which is a body suspended within a tube, fig. 9, paragraph 0092.
“a laminar flow element”: laminar flow element 603 which is a body that has inlet and outlet, see fig. 9 and paragraph 0092.
“an element for a volume buffering”: element for a volume buffering 610, fig. 5, paragraph 0085.
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 1-11 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.
The limitation “a breathing system” (claim 1, lines 8-9) invokes 112(f), however, the specification fails to disclose the corresponding structure(s) of the breathing system. Fig. 1 shows a generic structure for a breathing system “35” (see paragraphs 0078 and 0079), but does not disclose the corresponding structure of the breathing system, therefore, the claim 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.
The limitation “a gas state measurement device” (claim 2, lines 2-3) invokes 112(f), however, the specification fails to disclose the corresponding structure of the gas state measurement device. Paragraph 0085 discloses “a gas state measurement unit 703” and may be configured to determine constituents in a gas mixture, however, the term “unit” is not a structural term, therefore, there is no disclosure on what the corresponding structure for the gas state measurement device/unit is/are. Therefore, the claim 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.
Any remaining claims are rejected for their dependency on a rejected base claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 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 pre-AIA the applicant regards as the invention.
Regarding claim 1, the limitation “gases or gas mixtures or mixing gases or gas mixtures for an anesthesia system” (lines 1-2) is unclear if the limitation “for an anesthesia system is applicable to each of “gases”, “gas mixtures”, “mixing gases” and “gas mixtures”, or only applicable to “gas mixtures” directly adjacent to the term “for an anesthesia system”. Furthermore, it is unclear if the second occurrence of “gas mixtures” is the same as or different from first occurrence of the term “gas mixtures”.
Regarding claim 1, the limitation “a gas or a gas mixture” (line 4) is unclear if the gas or the gas mixture being claimed in claim 1, line 4 is different or the same as “gases or gas mixtures or mixing gases or gas mixtures” being claimed in claim 1, line 1.
Regarding claim 1, the limitation “a mixed gas” (line 5) is unclear if the mixed gas is the same as or different from “gases or gas mixtures or mixing gases or gas mixtures” (line 1) and “a gas mixture” (line 2).
Regarding claim 1, the limitation “a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” (lines 12-14) is unclear as to where to apply the term “and/or” and “or”, multiple usage of “and/or”, “or”, and “as well” makes it confusing as to what limitation is required by the claim.
Regarding claim 1, the limitation “a device…wherein the device comprising the gas inlets, the gas outlet and the mixing system, comprising the integrated mixing geometry, is manufactured as a single piece component, integrally and gas-tight in a manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” (lines 1-14) is unclear if the applicant is trying to claim an apparatus claim or a method claim, the claim is claiming an apparatus, however, the limitation “is manufactured as a single piece component, integrally and gas-tight in a manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” appears to be claiming a method of manufacturing.
Regarding claim 1, the limitation “or gas mixtures for an anesthesia system…the anesthesia system” (lines 1-2 and 9) is unclear if the anesthesia system is being required by the claim or not. As best understood, in the scenario that the term “an anesthesia system” in lines 1-2 is only applicable to “or gas mixture” directly adjacent to “for an anesthesia system”, it is confusing and unclear if the anesthesia system is required by the claim since lines 1-2 makes it optional by the usage of the term “or”, however, line 9 then requires that the mixing system is fluidically connectable to at least one mixed gas inlet of a breathing system of the anesthesia system. The claim is making the anesthesia system both optional and required, therefore, the claim is unclear.
Regarding claim 3, the limitation “a flow resistance, a flow resistance element” (lines 1-2) is unclear if the intent of the underline limitation is to claim a structure. Furthermore, it is unclear as to the difference between “a flow resistance” (limitation being underlined) and “a flow resistance element”.
Regarding claim 4, the limitation “wherein the manufacturing or joining process based on 3D printing technology for manufacturing the interface, the gas inlets and the gas outlet forms the interface, the gas inlets and the gas outlet without use of support structures” (lines 1-3) is unclear if the applicant is trying to claim a method or an apparatus, the claim is claiming a device according to claim 2, however, the limitation in lines 1-3 appears to be claiming a method/process of manufacturing. Furthermore, it is unclear as to what the structural relationship is between the support structures and the device.
Regarding claim 5, the limitation “a flow resistance, a flow resistance element” (lines 1-2) is unclear if the intent of the underline limitation is to claim a structure. Furthermore, it is unclear as to the difference between “a flow resistance” (limitation being underlined) and “a flow resistance element”.
Regarding claim 6, the limitation “wherein the manufacturing or joining process based on 3D printing technology for manufacturing the gas inlets and the gas outlet forms the gas inlets and the gas outlet without use of support structures” (lines 1-3) is unclear if the applicant is trying to claim a method or an apparatus, the claim is claiming a device according to claim 1, however, the limitation in lines 1-3 appears to be claiming a method/process of manufacturing. Furthermore, it is unclear as to what the structural relationship is between the support structures and the device.
Regarding claim 7, the limitation “wherein in the manufacturing or joining process based on 3D printing technology, support structures are used for manufacturing the element for flow calming” (lines 1-3) is unclear if the applicant is trying to claim a method or an apparatus, the claim is claiming a device according to claim 3, however, the limitation in lines 1-3 appears to be claiming a method/process of manufacturing. Furthermore, it is unclear as to what the structural relationship is between the support structures and the device.
Regarding claim 7, the limitation “the element for flow calming” (lines 2-3) is unclear if the element is being positively claimed or not, claim 3 makes it optional, therefore, by claiming “the element” without stating that the device comprises the element, makes it unclear if the limitation “the element” is still optional.
Regarding claim 8, the limitation “the interface is configured to measure pressure” (lines 1-2) is unclear as to how an interface connected to the sensors can be able to measure pressure. In light of the specification, the interface is not a sensor and is merely a portion that is attached to the sensor, therefore, how can the interface be configured to measure pressure.
Regarding claim 9, the limitation “the device…the inner contour is produced in the manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” (lines 1-9) is unclear if the applicant is trying to claim an apparatus claim or a method claim, the claim is claiming an apparatus, however, the limitation “the inner contour is produced in the manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” appears to be claiming a method of manufacturing.
Regarding claim 9, the limitation “the formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” (lines 8-9) is unclear as to where to apply the term “and/or” and “or”, multiple usage of “and/or”, “or”, and “as well” makes it confusing as to what limitation is required by the claim.
Regarding claim 9, the limitation “with an essentially locally laminar flow” (line 5) is unclear as to how to determine the metes and bounds of the limitation, specifically, it is unclear as to what is considered as “an essentially locally laminar flow”, the limitation “essentially” is too relative.
Regarding claim 10, the limitation “the device…the cylindrical or tubular outer contour is produced in the manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” (lines 1-7) is unclear if the applicant is trying to claim an apparatus claim or a method claim, the claim is claiming an apparatus, however, the limitation “the cylindrical or tubular outer contour is produced in the manufacturing or joining process which is based on a formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” appears to be claiming a method of manufacturing.
Regarding claim 10, the limitation “the formation of a form-fitting and/or force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” (lines 5-7) is unclear as to where to apply the term “and/or” and “or”, multiple usage of “and/or”, “or”, and “as well” makes it confusing as to what limitation is required by the claim.
Regarding claim 11, the limitation “the device…the integral elements that form a common component with one another are produced in the manufacturing or joining process based on the printing technology or 3D printing technology; and materials made of plastic materials, plastic composites, metal materials or metal composites are used in the manufacturing or joining process based on the printing technology or the 3D printing technology” (lines 1-12) is unclear if the applicant is trying to claim an apparatus claim or a method claim, the claim is claiming an apparatus, however, the limitation “the integral elements that form a common component with one another are produced in the manufacturing or joining process based on the printing technology or 3D printing technology; and materials made of plastic materials, plastic composites, metal materials or metal composites are used in the manufacturing or joining process based on the printing technology or the 3D printing technology” appears to be claiming a method of manufacturing.
Regarding claim 11, the limitation “a common component” (line 7) is unclear if the common component is the same as or different from “a common component” being claimed in claim 11, line 2.
Claim limitation “wherein the mixing system is fluidically connectable to at least two gas supply sources by means of the gas inlets” (claim 1, lines 6-7) and “wherein the mixing system is fluidically connectable to at least one mixed gas inlet of a breathing system of the anesthesia system by means of the gas outlet” (claim 1, lines 8-9) has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it is unclear if the means in line 7 is referring to the gas inlets or the means is a subcomponent of the gas inlets. Furthermore, it is unclear if the means in line 9 is referring to the gas outlet of the means is a subcomponent of the gas outlet. The boundaries of this claim limitation are ambiguous; 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.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
Claim limitations “a breathing system” (claim 1, lines 8-9) and “a gas state measurement device” (claim 2, lines 2-3) invoke 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. Regarding the limitation “a breathing system”, fig. 1 shows a generic structure for a breathing system “35” (see paragraphs 0078 and 0079), but does not disclose the corresponding structure of the breathing system. Regarding the limitation “a gas state measurement device” (claim 2, lines 2-3), paragraph 0085 discloses “a gas state measurement unit 703” and may be configured to determine constituents in a gas mixture, however, the term “unit” is not a structural term. 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.
Any remaining claims are rejected for their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(2) as anticipated by Brewster (2025/0082877) or, in the alternative, under 35 U.S.C. 103 as obvious over Brewster (2025/0082877) in view of Cariola (2019/0374732).
Regarding claim 1, Brewster discloses a device (730 and 750, see figs. 7A and 11A-11B) and for calming gases or gas mixtures or mixing gases or gas mixtures for an anesthesia system (100, 900, 700 and associated anesthesia system, see figs. 2-7B and 17B, paragraphs 0105-0106, 0162, 0184), the device comprising: a mixing system (750, figs. 11A-11B, paragraphs 0163-0167) comprising an integrated mixing geometry (the geometry of 750 comprises channels comprising space/cavity, therefore, would allow mixing to take place), a plurality of gas inlets (see figs. 11A-11B, paragraphs 0163-0167, Brewster discloses flow channels 751, therefore, there is a plurality of gas inlets), the gas inlets each for supplying a gas or a gas mixture (see paragraphs 0163-0167, each gas inlets is for supplying a gas or gas mixture); and a gas outlet for providing an output of a mixed gas (see figs. 11A-11B and paragraphs 0163-0167, Brewster discloses that there are a plurality of gas outlets, therefore, there is a gas outlet for providing an output of a mixed gas, since the gas entering the inlet 510 is a mixed gas, mixed with ambient air (314) and oxygen (210, paragraph 0112), fig. 2), wherein the mixing system is fluidically connectable to at least two gas supply sources by means of the gas inlets (see paragraphs 0112 and 0163-0167, there are two gas supply sources, oxygen from 210 and ambient air from 314), wherein the mixing system is fluidically connectable to at least one mixed gas inlet of a breathing system of the anesthesia system by means of the gas outlet (since 700 is being interpreted as part of an anesthesia system (fig. 17B, paragraphs 0105-0106, 0162, 0184), therefore, 800/810/808/820/850/852 are part of a breathing system of the anesthesia system, and as shown in fig. 7A, the outlet of 750 when placed within 400 would be fluidically connectable to at least one mixed gas inlet (810 if 800, see paragraph 0168)), wherein the device comprising the gas inlets, the gas outlet and the mixing system, comprising the integrated mixing geometry, is manufactured as a single piece component integrally and gas-tight in a manufacturing or joint process which is based on a formation of a form-fitting (see paragraphs 0163-0167, Brewster discloses in paragraph 0166 that the gas flow conditioner 750 is formed integrally with the third component 730, furthermore, since 750 is part of 730 and is integrally formed for a metallic block, it would be formed as a single piece component integrally and gas tight in a manufacturing process which is based on a formation of a form-fitting), alternatively, if the claim requires either a material of plastic or metallic, Brewster discloses that the material of the device is metallic (see paragraph 0140, Brewster discloses that 730 is made of a metallic material), furthermore, if the limitation “3D printing” and “printing technology” in the limitation “force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” is required by the claim, it is noted that the claim is claiming a product, therefore, the device is capable of being made by 3D printing or printing technology.
If there is any doubt that the device can be made by 3D printing.
Cariola teaches a metallic component (see impeller 500, fig. 5C-5D, paragraph 0096) being made from 3D printing or printing technology (paragraph 0136).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Brewster to be made from a 3D printing or printing technology as taught by Cariola for the purpose of providing a well-known manufacturing process that is capable of producing the device of the claimed invention.
Regarding claim 2, Brewster or the modified Brewster discloses that the mixing system comprises an interface for a connection of a sensors (the mixing system includes 730 and 750 that are integrally formed, Brewster discloses that there is an interface for flow sensors 318, 418, and 218, fig. 7A and paragraphs 0145 of Brewster, wherein the portion that is connected to the sensors are the interface).
Regarding claim 3, Brewster or the modified Brewster discloses an orifice is arranged in the mixing system (see fig. 11A of Brewster, one opening of one flow channels of flow channels 751 is an orifice).
Regarding claim 4, Brewster or the modified Brewster discloses that the interface and the gas inlets and the gas outlet (see the rejection claim 2 above, the interface is part of 730 which forms with 750 of Brewster, which comprises the interface, the gas inlets and gas outlet), therefore, is capable of being made from the manufacturing or joining process based on 3D printing technology without use of support structures, alternatively, see the modification with Cariola, whatever structures not being used to support the manufacturing of the interface, gas inlets, and gas outlet via the 3D printing of Cariola would be considered as the “support structures”.
Regarding claim 5, Brewster or the modified Brewster discloses an orifice in the mixing system (see fig. 11A of Brewster, one opening of one flow channels of flow channels 751 is an orifice).
Regarding claim 6, Brewster or the modified Brewster discloses the gas inlets and the gas outlet, therefore, is capable of being made from the manufacturing or joining process based on 3D printing technology without use of support structures, alternatively, see the modification with Cariola, whatever structures not being used to support the manufacturing of the gas inlets, and gas outlet via the 3D printing of Cariola would be considered as the “support structures”.
Regarding claim 7, Brewster or the modified Brewster discloses an element for flow calming (portion of 750 comprising channels 751, see figs. 11A-11B and paragraphs 0163-0167), therefore, is capable of being made from the manufacturing or joining process based on 3D printing technology, where supports structures are used for manufacturing the element for flow calming. Alternatively, see the modification with Cariola, whatever structures being used to support the manufacturing of element for flow calming via the 3D printing of Cariola would be considered as the “support structures”, this can be structures of the 3D printer that support the part being printed and other associated structure that allows 3D printing to take place.
Regarding claim 8, Brewster or the modified Brewster discloses that the interface is configured to measure pressure (the interface is connected to sensors 218, 318 and 418 and is configured to provide air to pressure sensor 414, therefore, is configured to measure pressure, it is noted that in light of the instant invention, the interface does not do the pressure measuring, rather, the sensor attached to the interface is what is measuring the pressure, therefore, because the interface of Brewster conveys mixed gases to the pressure sensor 414 (see fig. 2), the interface that is connected to 414 would be configured to measure pressure), alternatively, the interface is redefined as 720 and 710 of the pneumatic block 700 and sensor 414 (see paragraph 0146), which can measure pressure via pressure sensor 414, since 720, 710, and 414 are connected to 730, the assembly of 720, 710 and 414 are being interpreted as part of the mixing system).
Regarding claim 9, Brewster or the modified Brewster discloses that the gas outlet is configured on an inside with geometry which forms an inner contour having no step or shoulder in a transition between the gas outlet and the breathing system so that, for a supply of quantities of gas from the gas outlet to the breathing system, a flow state is provided without a flow stall and/or with an essentially locally laminar flow at the transition of the gas outlet to the breathing system (see figs. 11A-11B and paragraphs 0163-0167 of Brewster, Brewster discloses that 750 is inside of 730 and that 750 and 730 can be integrally formed, therefore, the outlet formed by 750 would be inside with geometry which forms an inner contour having no step in a transition between the gas outlet and the breathing system, since the outlet comprises circular cross section, the inner contour formed by the circular opening would be an inner contour that does not have a step in a transition between the gas outlet and the breathing system (breathing system are the component downstream of the outlet), furthermore, Brewster discloses that 750 may be provided at or near mixed gas inlet and may straighten the flows, spread the flows across the mixed flow path 400 and break up large eddies that can develop, therefore, would produce a laminar flow at the transition of the gas outlet to the breathing system), and the inner contour is produced in the manufacturing or joining process which is based on the formation of a form-fitting (see paragraphs 0163-0167, Brewster discloses in paragraph 0166 that the gas flow conditioner 750 is formed integrally with the third component 730, furthermore, since 750 is part of 730 and is integrally formed, it would be formed as a single piece component integrally and gas tight in a manufacturing process which is based on a formation of a form-fitting), alternatively, if the claim requires either a material of plastic or metallic, Brewster discloses that the material of the device is metallic (see paragraph 0140, Brewster discloses that 730 is made of a metallic material), furthermore, if the limitation “3D printing” and “printing technology” in the limitation “force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” is required by the claim, it is noted that the claim is claiming a product, therefore, the device is capable of being made by 3D printing or printing technology, alternatively, see the modification with Cariola, after the modification, the inner contour which is part of the device is produced in a manufacturing or joining process which is based on the formation of a form-fitting as well as gas-tight connection of metallic materials using the printing technology or 3D printing technology.
Regarding claim 10, Brewster or the modified Brewster discloses that the gas outlet or the gas inlets are formed on an outside with a cylindrical contour (see fig. 7A and paragraphs 0163-0167 of Brewster, as shown, 750 has a cylindrical contour formed by the channel 751, furthermore, the gas outlet or the gas inlets are formed on an outside of the blower 310, see fig. 7A of Brewster), alternatively, the gas inlet and the gas outlet has a tubular outer contour because relative to the center channel 751, the outer hole forms a tubular outer contour, the cylindrical contour (or alternatively, the tubular outer contour) is produced in the manufacturing or joining process which is based on the formation of a form-fitting (see paragraphs 0163-0167, Brewster discloses in paragraph 0166 that the gas flow conditioner 750 and 730 are formed integrally, therefore, 750 would be formed as a single piece component integrally and gas tight in a manufacturing process which is based on a formation of a form-fitting), alternatively, if the claim requires either a material of plastic or metallic, Brewster discloses that the material of the device is metallic (see paragraph 0140, Brewster discloses that 730 is made of a metallic material), furthermore, if the limitation “3D printing” and “printing technology” in the limitation “force-fitting as well as gas-tight connection of plastic materials and/or metallic materials based on a printing technology or 3D printing technology” is required by the claim, it is noted that the claim is claiming a product, therefore, the device is capable of being made by 3D printing or printing technology, alternatively, see the modification with Cariola, after the modification, the cylindrical contour (or alternatively the tubular outer contour) which is part of the device is produced in a manufacturing or joining process which is based on the formation of a form-fitting as well as gas-tight connection of metallic materials using the printing technology or 3D printing technology.
Regarding claim 11, Brewster or the modified Brewster discloses that the mixing system comprises integral elements that form a common component with one another, the integral elements comprising at least two of functional components of the group comprising the gas inlets and the gas outlet (see gas inlets and gas outlet of 751 of 751, see figs. 11A-11B and paragraphs 0163-0167 of Brewster, the different portions comprising the inlets and the outlet form a common component with one another), the integral elements that form a common component with one another are made of metal materials (see paragraphs 0140 and 0142 and claim 77), are capable of being produced in the manufacturing or joining process based on the printing technology or 3D printing technology and the materials made of the metal materials are used are capable of being used in the manufacturing or joining process based on the printing technology or the 3D printing technology. Alternatively, see the modification with Cariola, after the modification, the integral elements that form the common component with one another are part of the device that is produced in a manufacturing or joining process which is based on the formation of a form-fitting as well as gas-tight connection of metallic materials using the printing technology or 3D printing technology.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mackie (2003/0108441) is cited to show a gas mixing apparatus.
Tappehorn (2021/0370008) is cited to show a flow conditioning device. Hogg (2023/0277797) is cited to show a vent for a respiratory system comprising external inlets and outlets.
Haroutunian (2014/0048065) is cited to show a flow modification device.
Cowans (3,747,598) is cited to show a flow conditioner.
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/TU A VO/Primary Examiner, Art Unit 3785
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