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 .
Claim Objections
Claims 16,19,20,25,29,32 and 34 objected to because of the following informalities: the clause includes the phrase “and/or” is ambiguous because elements in the clause are clearly defined. For example, “the micropores and/or nanopores contain an aqueous solution” can be read “the micropores or nanopores contain an aqueous solution” or “the micropores and nanopores contain an aqueous solution”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 18, 19, 20, 21, 22, 23, 27, 29, 31, 32, 33 and 34 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.
Claims 18, 19, 20, 21, 22, 23, 27, 29, 31, 32, 33 and 34 includes elements connected by the word “or” without punctuations, breaks and indentations. The scopes of these claims are not clear.
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.
Claims 16-17, 19-23, 25-26, 29-30 and 32-34are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ying et al. (US 2007/0218544 A1).
Re claims 16, 25, 29:
Ying teaches 16. A respiratory simulator comprising a rigid porous foam (Ying, Abstract; [0067], “structures (e.g., alveoli)”; [0087], “structures are fabricated to mimic portions of the respiratory system. The respiratory system includes the trachea and the lungs”), the rigid porous foam comprising an interconnected open-celled network (Ying, [0102], “non-polymeric materials can be used to form structures for tissue engineering and/or organ replacement. Non-limiting examples of such materials include organic and inorganic materials such as ceramics, glass, hydroxyapatite, calcium carbonate, buffering agents, as well as drug delivery carriers (e.g., gels)”; [0044], “the biocompatible structures are scaffolds for cells that can be used as tissue engineering templates and/or as artificial organs. The structures may be three-dimensional and can mimic the shapes and dimensions of tissues and/or organs, including the microarchitecture and porosities of the tissues and organs. For instance, certain embodiments of the invention can be fabricated to include very small features (e.g., less than 40 microns), such as small pore sizes, small cavities, and/or structures having thin walls”) of:
(i) macropores, and (ii) micropores and/or nanopores (Ying, [0114]; [0051], “pores having a cross sectional dimension of less than or equal to 1 mm, less than or equal to 100 microns, less than or equal to 50 microns, less than or equal to 40 microns, less than or equal to 30 microns, less than or equal to 10 microns, less than or equal to 5 microns, less than or equal to 1 micron, or less than or equal to 100 nm can be formed in a structure by a suitable printing technique”).
25. A method of simulating distal airways and alveoli of a respiratory simulator, the method comprising: simulating, using a rigid porous foam, the distal airways and alveoli of the respiratory simulator (Ying, Abstract; [0067], “structures (e.g., alveoli)”; [0087], “structures are fabricated to mimic portions of the respiratory system. The respiratory system includes the trachea and the lungs”), wherein the rigid porous foam comprises an interconnected open-celled network (Ying, [0102], “non-polymeric materials can be used to form structures for tissue engineering and/or organ replacement. Non-limiting examples of such materials include organic and inorganic materials such as ceramics, glass, hydroxyapatite, calcium carbonate, buffering agents, as well as drug delivery carriers (e.g., gels)”; [0044], “the biocompatible structures are scaffolds for cells that can be used as tissue engineering templates and/or as artificial organs. The structures may be three-dimensional and can mimic the shapes and dimensions of tissues and/or organs, including the microarchitecture and porosities of the tissues and organs. For instance, certain embodiments of the invention can be fabricated to include very small features (e.g., less than 40 microns), such as small pore sizes, small cavities, and/or structures having thin walls”) of:
(i) macropores and (ii) micropores and/or nanopores (Ying, [0114]; [0051], “pores having a cross sectional dimension of less than or equal to 1 mm, less than or equal to 100 microns, less than or equal to 50 microns, less than or equal to 40 microns, less than or equal to 30 microns, less than or equal to 10 microns, less than or equal to 5 microns, less than or equal to 1 micron, or less than or equal to 100 nm can be formed in a structure by a suitable printing technique”).
29. A rigid porous foam for a model of a distal airway and alveoli of a respiratory tract comprising an interconnected open-celled network (Ying, Abstract; [0067], “structures (e.g., alveoli)”; [0087], “structures are fabricated to mimic portions of the respiratory system. The respiratory system includes the trachea and the lungs”; [0102], “non-polymeric materials can be used to form structures for tissue engineering and/or organ replacement. Non-limiting examples of such materials include organic and inorganic materials such as ceramics, glass, hydroxyapatite, calcium carbonate, buffering agents, as well as drug delivery carriers (e.g., gels)”; [0044], “the biocompatible structures are scaffolds for cells that can be used as tissue engineering templates and/or as artificial organs. The structures may be three-dimensional and can mimic the shapes and dimensions of tissues and/or organs, including the microarchitecture and porosities of the tissues and organs. For instance, certain embodiments of the invention can be fabricated to include very small features (e.g., less than 40 microns), such as small pore sizes, small cavities, and/or structures having thin walls”) of:
(i) macropores, the macropores containing a gas or an aerosol (Ying, [0114]; [0051], “pores having a cross sectional dimension of less than or equal to 1 mm, less than or equal to 100 microns, less than or equal to 50 microns, less than or equal to 40 microns, less than or equal to 30 microns, less than or equal to 10 microns, less than or equal to 5 microns, less than or equal to 1 micron, or less than or equal to 100 nm can be formed in a structure by a suitable printing technique”), and
(ii) micropores and/or nanopores, the micropores and/or nanopores containing an aqueous solution or liquid, wherein the micropores and/or nanopores containing the aqueous solution or liquid form an aqueous or liquid layer covering a portion or all of the surface of the macropores (Ying, [0061], “structure can be coated with a porous material (e.g., a polymer such as a gel)”; [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”).
Re claims 17, 26, 30:
17. The respiratory simulator according to claim 16, wherein the rigid porous foam is:
(i) a ceramic or a metallic rigid porous foam (Ying, [0102], “non-polymeric materials can be used to form structures for tissue engineering and/or organ replacement. Non-limiting examples of such materials include organic and inorganic materials such as ceramics, glass, hydroxyapatite, calcium carbonate, buffering agents, as well as drug delivery carriers (e.g., gels)”), or
(ii) a ceramic and a metallic rigid porous foam.
26. The method according to claim 25, wherein the rigid porous foam is:
(i) a ceramic or a metallic rigid porous foam (Ying, [0102], “non-polymeric materials can be used to form structures for tissue engineering and/or organ replacement. Non-limiting examples of such materials include organic and inorganic materials such as ceramics, glass, hydroxyapatite, calcium carbonate, buffering agents, as well as drug delivery carriers (e.g., gels)”), or
(ii) a ceramic and a metallic rigid porous foam.
30. The rigid porous foam according to claim 29, wherein the rigid porous foam is:
(i) a ceramic or a metallic rigid porous foam (Ying, [0102], “non-polymeric materials can be used to form structures for tissue engineering and/or organ replacement. Non-limiting examples of such materials include organic and inorganic materials such as ceramics, glass, hydroxyapatite, calcium carbonate, buffering agents, as well as drug delivery carriers (e.g., gels)”), or
(ii) a ceramic and a metallic rigid porous foam.
Re claims 19 – 20, 32:
19. The respiratory simulator according to claim 16, wherein:
(i) the macropores contain a gas or an aerosol (Ying, [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”), or
(ii) the micropores and/or nanopores contain an aqueous solution or liquid (Ying, [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”), or
(iii) the macropores contain a gas or an aerosol and the micropores and/or nanopores contain an aqueous solution or liquid (Ying, [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”).
32. The rigid porous foam according to claim 29, wherein:
(i) the macropores contain a gas or an aerosol (Ying, [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”), or
(ii) the micropores and/or nanopores contain an aqueous solution or liquid (Ying, [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”), or
(iii) the macropores contain a gas or an aerosol and the micropores and/or nanopores contain an aqueous solution or liquid.
20. The respiratory simulator according to claim 19, wherein the micropores and/or nanopores containing the aqueous solution or liquid form an aqueous or liquid layer covering a portion or all of the surface of the macropores (Ying, [0065], “structures may be formed in the shape of organs that include a cavity portion. For instance, structures including a cavity portion may include hollow organs and/or epithelial organs such as vessels, lung … The cavity may be filled with fluid, air, or other components”; [0088], “The lungs also include the alveoli, the respiratory portions where gas exchange takes place”).
Re claims 21 – 22, 33 – 34:
21. The respiratory simulator according to claim 16, wherein the rigid porous foam comprises one or more cavities or sockets or indentations or a combination of two or more thereof (Ying, [0065]).
22. The respiratory simulator according to claim 21, wherein the one or more cavities or sockets or indentations or a combination of two or more thereof contain one or more sensory devices or probes or sampling devices or cell cultures (Ying, [0065]; [0006]; [0060], “a combination of cell-adhering and cell-inhibiting substances can be incorporated into various portions of a structure to simultaneously facilitate and inhibit cell growth”; [0070], “cells cultured on the structure and those of the host environment”).
33. The rigid porous foam according to claim 29, further comprising one or more cavities or sockets or indentations or a combination of two or more thereof (Ying, [0065]).
34. The rigid porous foam according to claim 29, wherein the one or more cavities or sockets or indentations or a combination of two or more thereof (Ying, [0065]) contain one or more modules configured to contain or to store a cell culture medium (Ying, [0006]; [0060], “a combination of cell-adhering and cell-inhibiting substances can be incorporated into various portions of a structure to simultaneously facilitate and inhibit cell growth”; [0070], “cells cultured on the structure and those of the host environment”) and/or at least one microsensor configured to monitor conditions in a chamber or for gas sampling or for gas characterization.
Re claim 23:
23. The respiratory simulator according to claim 16, further comprising at least two rigid porous foams each of different pore size distribution or each of different porosity or each of a different material (Ying, Abstract; [0067], “structures (e.g., alveoli)”; [0087], “structures are fabricated to mimic portions of the respiratory system. The respiratory system includes the trachea and the lungs”; [0114]; [0051], “pores having a cross sectional dimension of less than or equal to 1 mm, less than or equal to 100 microns, less than or equal to 50 microns, less than or equal to 40 microns, less than or equal to 30 microns, less than or equal to 10 microns, less than or equal to 5 microns, less than or equal to 1 micron, or less than or equal to 100 nm can be formed in a structure by a suitable printing technique”).
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.
Claims 24 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Ying et al. (US 2007/0218544 A1) in view of Craspser et al. (US 2006/0288871 A1).
Re claims 24, 35:
Ying does not explicitly disclose a pump. Craspser et al. (US 2006/0288871 A1) teaches systems for and methods of providing air purification and cleaning in combination with odor elimination in a single unit, such as a tabletop unit for home or office use. Craspser teaches 24. The respiratory simulator according to claim 16, further comprising a pump, wherein the rigid porous foam is contained or mounted inside the pump. 35. The rigid porous foam according to claim 29, wherein the rigid porous foam is contained or mounted inside a pump (Craspser, fig. 1; fig. 3; [0031]; [0065], “filter media 614b typically has a pleated, corrugated, or honeycomb structure”). Therefore, in view of Craspser, 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 simulator described in Ying, by providing pump as taught by Craspser, in order to generate airflow through the honeycomb filter (Craspser, [0031]).
Claims 18, 27 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Ying et al. (US 2007/0218544 A1) in view of Qi et al. (US 2022/0088572 A1).
Re claims 18, 27 and 31:
Ying does not explicitly disclose wherein the rigid porous foam is made of alumina or silicon carbide or oxygen bonded silicon carbide or sintered silicon carbide or a combination of two or more thereof. Qi et al. (US 20220088572 A1) teaches nano-structured composite materials for removing harmful chemical air pollutants and odors from the air to prevent people from breathing in disease-causing chemicals and provide them with clean indoor air (Qi, Abstract). Qi teaches 18. The respiratory simulator according to claim 17, wherein the rigid porous foam is made of alumina or silicon carbide or oxygen bonded silicon carbide or sintered silicon carbide or a combination of two or more thereof. 27. The method according to claim 26, wherein the rigid porous foam is made of alumina or silicon carbide or oxygen bonded silicon carbide or sintered silicon carbide or a combination of two or more thereof. 31. The rigid porous foam according to claim 30, wherein the rigid porous foam is made of alumina or silicon carbide or oxygen bonded silicon carbide or sintered silicon carbide or a combination of two or more thereof (Qi, [0008], “nano-porous alumina”; [0011], “The ceramic fillers are selected from silica, alumina, rare earth doped silica, rare earth doped alumina, aluminosilicate, silicon carbide, cordierite, mullite, or combinations”). Therefore, in view of Qi, 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 simulator described in Ying, by providing alumina and/or silicon carbide filter as taught by Qi, since it was known in the art that activated carbon has been used as a major adsorbent in air filters to remove certain organic air pollutants (Qi, [0006]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Ying et al. (US 2007/0218544 A1) in view of Cui et al. (US 2016/0166959 A1).
Re claim 28:
Ying teaches 28. A method for determining an effect of a test atmosphere on a simulated distal airway and alveoli of a respiratory tract … the test atmosphere on the simulated distal airway and alveoli of the respiratory tract (Ying, Abstract; [0067], “structures (e.g., alveoli)”; [0087], “structures are fabricated to mimic portions of the respiratory system. The respiratory system includes the trachea and the lungs”).
Ying does not explicitly disclose testing atmosphere. Cui teaches an air filter comprising a substrate and a network of polymeric nanofibers deposited on the substrate (Cui, Abstract). Cui teaches 28. A method for determining an effect of a test atmosphere on a simulated distal airway and alveoli of a respiratory tract, the method comprising: providing the respiratory simulator according to claim 16; contacting the respiratory simulator with the test atmosphere; and determining the effect of the test atmosphere on the simulated distal airway and alveoli of the respiratory tract (Cui, [0117], “A PM particle counter was used to measure the particle number concentration”; [0127]). Therefore, in view of Cui, 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 method described in Ying, by testing atmosphere as taught by Cui, in order to measure the air quality of the filter (Cui, [0007]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACK YIP whose telephone number is (571)270-5048. The examiner can normally be reached Monday thru Friday; 9:00 AM - 5:00 PM EST.
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/JACK YIP/Primary Examiner, Art Unit 3715
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