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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of group 1 in the reply filed on 1/31/2026 is acknowledged. The traversal is on the ground(s) that Piper does not disclose the claimed “relief valve” and “spontaneous-breathing valve”. This is not found persuasive because it is the examiner’s position that Piper does indeed disclose the valves as claimed. Applicant’s representative states that Piper’s valve allows exhaled air to flow in one direction and does not function to release pressure in the ventilation path. The relief valve 60 functions similarly to spontaneous breathing valve (col. 5, lines 8-14). Piper discloses the spontaneous breathing valve works via pressure (col. 4, lines 29-34). The examiner also notes that Piper discloses the resistance of valve 24 can be varied (col. 6, lines 1-3). Applicant’s representative seems to argue that Piper’s valves 60 and 24 are electronically controlled. The examiner cannot find support for this in Piper. While Piper does have an electronic unit 32 which monitors inhalation/exhalation, the unit 32 uses inhalation/exhalation signals to control aerosol delivery (see col. 5, lines 35-37).
Applicant’s representative asserts that Piper’s valve is a one-way valve for controlling aerosol flow from a nebulizer and is not a spontaneous breathing valve. The examiner notes that the valve allows for a user to breathe spontaneously and thus the examiner maintains that valve 24 reads on “a spontaneous breathing valve”. Applicant’s representative states the present invention is for cardiopulmonary resuscitation that does not require an electrical driving source. The examiner respectfully notes that this is not required by the instant claim language.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-10 are currently pending for examination. Claims 11-13 are withdrawn.
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.
Claim(s) 1, 2, 5 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piper et al. (US 5,479,920).
Regarding claim 1, Piper discloses: A ventilator (figure 1) comprising:
a pipe (50, 10) having a ventilation path (flow path within 50, 10);
a relief valve (60); and
a spontaneous-breathing valve (24);
wherein the pipe includes
a main port (56) allowing a gas that is to be inhaled by a patient and a gas exhaled by the patient to pass through the main port (see figure 1),
a relief valve port (62) communicating with the main port through the ventilation path (see figure 1), and
a spontaneous-breathing valve port (port at 24) communicating with the main port through the ventilation path (see figure 1),
wherein the relief valve (60) is mounted on the relief valve port (see figure 1) and configured to be pneumatically opened when an airway pressure of the patient exceeds a predetermined threshold in such a manner as to be capable of allowing communication between the ventilation path and an outside of the pipe and releasing the pressure (col. 5, lines 1-17), thereby suppressing an excessive increase in the airway pressure of the patient (60 functions similar to 24 as per col. 5, lines 8-14 and 24 works via pressure as per col. 4, lines 29-34 and thus releasing the pressure via 60 would result in the suppression of an excessive increase in the airway pressure of the patient), and
wherein the spontaneous-breathing valve (24) is mounted on the spontaneous-breathing valve port (see figure 1 opening where 24 is located), and the spontaneous-breathing valve is configured to be opened in accordance with an intake pressure at which the patient spontaneously breathes and configured to be capable of allowing communication between the ventilation path and the outside of the pipe and enabling inhalation (col. 4, lines 13-34).
Regarding claim 2, Piper further discloses wherein the spontaneous-breathing valve (24) includes an intake valve (flapper valve of 24) that operates in accordance with the intake pressure (col. 4, lines 13-34; inhalation by patient creates the intake pressure), and wherein the spontaneous-breathing valve port (port at 24) has a valve chamber (chamber surrounding flapper valve as described in col. 4, lines 22-28) in which the intake valve is accommodated in such a manner as to be openable and closable (col. 4, lines 22-28).
Regarding claim 5, Piper further discloses wherein the pipe (50, 10) is a branch pipe in which the ventilation path includes a plurality of branch paths (see figure 1).
Regarding claim 6, Piper further discloses wherein the pipe (50, 10) has an input port (at 12) through which a gas is introduced into the ventilation path (col. 4, line 15 describe 12 as an aerosol inlet port; as shown in figure 1: 48 also provides gas into the nebulizer which is then delivered through 12: col. 4, line 67).
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) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piper et al. (US 5,479,920) in view of Koch et al. (US 2006/0021661 A1).
Regarding claim 3, Piper discloses the claimed invention as set forth for claim 1 above. While Piper discloses the spontaneous-breathing valve (24) is a one way valve (col. 4, lines 13-34) with lid member (external housing of 24) having a mounting portion (right end of 24 as shown in figure 2) that is to be mounted on the spontaneous-breathing valve port (see figure 2), Piper does not go into the structure of the valve and therefore does not explicitly disclose wherein the spontaneous-breathing valve includes a lid member having an intake hole that allows communication between an inside of the spontaneous-breathing valve port and the outside of the pipe, and an intake valve that is operated by the intake pressure in such a manner as to open and close the intake hole.
However, Koch teaches a one-way valve (figure 1) wherein the valve includes a lid member (2) having a mounting portion (right end of 2 as shown in figure 2 similar to the right end of Piper’s 24 which connects to 14) and an intake hole (3) that allows communication between an inside of the spontaneous-breathing valve port and the outside of the pipe [0016] (see figure 2), and an intake valve (10) that is operated by the intake pressure in such a manner as to open and close the intake hole [0016] [0019] [0001].
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have substituted Piper’s check valve for the check valve disclosed by Koch. As evidenced by the cited disclosures of Piper and Koch, both valves (Piper’s 24 and Koch’s figure 1) had functions that were known in the art and one having ordinary skill in the art could have substituted one known element for another and the results of the substitution would have been predictable, making the combination obvious to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)
Regarding claim 4, Piper as modified by Koch further discloses wherein the spontaneous-breathing valve (figure 1 of Koch) includes a pressing member (Koch: 9) that presses the intake valve (Koch: 10) against the intake hole (Koch: 3) in such a manner as to close the intake hole and that elastically deforms such that the intake valve is displaced in accordance with the intake pressure, which is predetermined (Koch: [0018]-[0019]; claim 1).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piper et al. (US 5,479,920) in view of Retallick (US 5,988,162)
Regarding claim 7, Piper discloses the claimed invention as set forth for claim 1 above but does not explicitly disclose wherein the pipe is a 3D printed body made of a resin.
However, Retallick teaches it is known to make medical administration pipes (11, 12) from a resin (col. 2, lines 63-64).
Therefore, it would have been obvious to have modified Piper such that the pipe is made of a resin for its known suitability as a material in medical pipes and further since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Piper as modified is silent as to how the pipe is made. However, the recitation that the pipe is formed using 3D printing is considered to be a product by process limitation. In product-by-process claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference." MPEP 2113. MPEP 2113 clearly states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes." In this instance, the product taught by Piper as modified by Retallick is the same as or makes the product claimed obvious, meeting the limitation of the claims. This rejection is proper because the "patentability of a product does not depend on its method of production." In re Thorpe, 227 USPQ 964,966 (Fed. Cir.1985).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piper et al. (US 5,479,920) in further view of ISHIKITA (US 2019/0022346 A1).
Regarding claim 8, Piper further discloses wherein the relief valve (60) includes a pressure adjustment valve (60 flapper valve) that is openable and closable in accordance with the pressure in the ventilation path (col. 5, lines 6-13 describes 60 similar to inhalation valve which works according to pressure as set forth in col. 4, lines 28-34) and a main body portion (portion at 60 surrounding flapper valve) in which the pressure adjustment valve is accommodated (flapper valve as set forth in col. 5, lines 6-13).
Piper does not explicitly disclose wherein the pressure adjustment valve and the main body portion are each a 3D printed body made of a resin.
However, ISHIKITA teaches it is known to provide a valve (1) wherein an pressure adjustment valve (4) and main body portion (2) are both made of resin [0055]-[0056].
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified Piper wherein the pressure adjustment valve and the main body portion are each made of a resin since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Piper as modified is silent as to how the pressure adjustment valve and the main body portion are made. However, the recitation that the pressure adjustment valve and the main body portion are formed using 3D printing is considered to be a product by process limitation. In product-by-process claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference." MPEP 2113. MPEP 2113 clearly states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes." In this instance, the product taught by Piper as modified by ISHIKITA is the same as or makes the product claimed obvious, meeting the limitation of the claims. This rejection is proper because the "patentability of a product does not depend on its method of production." In re Thorpe, 227 USPQ 964,966 (Fed. Cir.1985).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piper et al. (US 5,479,920) in view of Bird et al. (US 3,726,274) in further view of ISHIKITA (US 2019/0022346 A1).
Regarding claim 9, Piper discloses the claimed invention as set forth for claim 1 above. Piper further discloses the spontaneous-breathing valve (24) includes an intake valve (flapper valve of 24) that operates in accordance with the intake pressure (col. 4, lines 13-34; inhalation by patient creates the intake pressure), and a lid member (external housing of 24) that is mounted on the spontaneous-breathing valve port (where 24 connects to 14).
Piper does not explicitly disclose wherein the lid member that is mounted on the spontaneous-breathing valve port in such a manner that the intake valve is accommodated in the spontaneous-breathing valve port.
However Bird teaches that it is known to have a valve (figure 2 shows a valve including a lid member (18) and an intake valve (49: flapper valve; col. 3, line 67) wherein the lid member that is mounted on a port (port on 17 which connects to 18) in such a manner that the intake valve (49) is accommodated in the spontaneous-breathing valve port (see figure 2).
Therefore it would have been obvious to one having ordinary skill in the art to have modified the connection of Piper between 24 and 14 such that the lid member is mounted on the spontaneous-breathing valve port in such a manner that the intake valve is accommodated in the spontaneous-breathing valve port as taught by Bird as there are a finite number of identified, predictable potential solutions for connecting 24 with 14 (male/female or female/male connection) of Piper with the location of flapper valve being either outside of 14 of within 14. One having ordinary skill in the art could have pursued the known potential solutions with a reasonable expectation of success and thus the connection taught by Bird would have been obvious to one having ordinary skill in the art since "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. "KSR, 550 U.S. at 421, 82 USPQ2d at 1397.
As modified Piper does not state wherein the intake valve and the lid member are each a 3D printed body made of a resin.
However, ISHIKITA teaches it is known to provide a valve (1) wherein an intake valve (4) and lid member (2) are both made of resin [0055]-[0056].
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified Piper wherein the intake valve and the lid member are each made of a resin since the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). See also In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious).
Piper as modified is silent as to how the intake valve and the lid member are made. However, the recitation that the intake valve and the lid member are formed using 3D printing is considered to be a product by process limitation. In product-by-process claims, "once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference." MPEP 2113. MPEP 2113 clearly states "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different processes." In this instance, the product taught by Piper as modified by ISHIKITA is the same as or makes the product claimed obvious, meeting the limitation of the claims. This rejection is proper because the "patentability of a product does not depend on its method of production." In re Thorpe, 227 USPQ 964,966 (Fed. Cir.1985).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piper et al. (US 5,479,920) in view of Peru (JP H06209997 A). The examiner notes the provided translation is relied upon in the rejection set forth below.
Regarding claim 10, Piper discloses the claimed invention as set forth for claim 1 above. Piper does not explicitly state the system comprises a heat-and-moisture exchanger unit communicating with the main port.
However, Peru teaches it is known to provide a heat-and moisture exchanger unit (16) communicating with main port (5). Peru teaches an alternative branching to that shown in Piper and this branching is modifying the prior art of Piper. This results in the exhalation path (60-64 of Piper) moving to 12 of Piper and the nebulization path (18) moving to 62. This is taught by Peru in figure 1 wherein the nebulization path is on a separate branch of 5 (page 5, paragraph 3). The resulting modification results in HME being located in the vicinity of 16 of Piper as taught by Peru.
It would have been obvious to have modified Piper to include a heat-and-moisture exchanger unit communicating with the main port in order to absorb moisture and heat from exhaled air and transfer it to the inhaled air (page 5, paragraph 8).
Conclusion
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/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785