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 Interpretation
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.
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 19-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 discloses “a distal end of the shaft” in line 4. However, claim 19 has already recited “the shaft having a distal end” in line 2. Thus, it is unclear if the “distal end” in line 4 is the same as the “distal end” recited in line 2, or a completely separate and different “distal end”. Thus, said claim is unclear. It is suggested to amend to, “the distal end of the shaft” in line 4. Appropriate action is required.
Claims 20-24 are rejected merely due to their dependency from claim 19.
Claim Rejections - 35 USC § 102
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 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coffeen et al. (U.S. Publication No. 2020/0375444).
Coffeen discloses an apparatus, comprising:
A shaft (102/1102) defining a channel for receiving an instrument (Figures 1 & 11), the shaft having a distal end that is disposable within patient anatomy (paragraphs 10-12), the channel having an asymmetrical cross-section (Figures 1D & 11B) defined by a plurality of side walls where a first side wall of the plurality of side walls extends out further distally than one or more remaining side walls of the plurality of side walls (Figures 1B-1I & 11A-D); and
An ejection port disposed near a distal end of the shaft, the ejection port configured to eject a predetermined volume of liquid and gas into the channel when in response to a distal end of the instrument being is disposed near the ejection port (paragraphs 142-151 & 216-223), the ejection port being located in the channel on the first side wall (Figures 1B-1I & 11A-D).
Regarding claim 26, Coffeen also discloses that the asymmetrical cross-section has a shape corresponding to two overlapping circular cross-sections with offset centers, where a first circular cross-section of the two overlapping circular cross-sections has a larger diameter than a second circular cross-section of the two overlapping circular cross-sections (Figures 1D & 11B).
With respect to claim 27, Coffeen further discloses that the first circular cross-section is sized to receive the instrument such that the second circular cross-section provides a gap between the first side wall (1130) and an outer surface of the instrument when the instrument is received in the channel (Figures 1B-1G & 11B-11D).
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Document Identification No. CN-113925440-A (herein referred to as ‘440) in view of Holsten (U.S. Publication No. 2020/0163541).
It is first noted that the English Translation (provided by the Applicant in the information disclosure statement filed on April 14th, 2026) of the ‘440 document will be referenced herein.
‘440 discloses an apparatus, comprising:
A shaft (200) defining a channel for receiving an instrument (300) and a lumen (610) for delivering liquid and gas (page 5, last paragraph to page 6, paragraph 4), the shaft having a proximal end and a distal end, the distal end of the shaft being positionable in a body cavity of a patient that is disposable within patient anatomy (Figures 2-4; page 1, paragraph 3 to page 2, paragraph 2);
An interconnector (100) disposed outside of the body cavity, the interconnector (100) configured to couple to a liquid source and a gas source (page 5, last paragraph to page 6, 2nd paragraph), the interconnector including a second valve configured to control delivery of the gas (page 6, 2nd paragraph; page 9, 3rd paragraph), the second valve configured to open to in response to a pressurized flow of the gas to propel a volume of the liquid with the pressurized flow of the gas into the lumen (page 5, last paragraph to page 6, 2nd paragraph; page 9, 3rd paragraph); and
An ejection port (630) disposed near the distal end of the shaft (200), the ejection port (630) fluidically coupled to a distal end of the lumen (610) and configured to eject the combined volume of the liquid and the pressurized flow of the gas into the channel as an atomized spray (page 3, last paragraph; page 6, last paragraph). Note, dependent upon various factors such as the pressure provided by the gas source and the amount of liquid provided to the apparatus (among others), said apparatus of ‘440 is fully capable of producing an atomized spray.
‘440 does not appear to disclose a first valve configured to control delivery of the liquid. Holsten discloses an apparatus that includes a shaft defining a channel for receiving an instrument, a lumen (126) for delivering a liquid and a gas to the distal end of the channel, and an interconnector (Figure 14C) configured to couple to a liquid source (CS) and a gas source (FS) as set forth in the Abstract (Figures 1-11; paragraphs 67-72). The reference continues to disclose that the interconnector includes a second valve (150’) configured to control delivery of the gas, as well as a first valve configured to control delivery of the liquid, wherein said first valve is provided in order to prevent the gas from entering into the source of liquid (paragraph 80). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the interconnector of ‘440 with a first valve configured to control delivery of the liquid in order to prevent the gas from entering into the source of liquid as exemplified by Holsten.
Therefore, claim 1 is not patentable over ‘440 in view of Holsten.
Concerning claims 2 & 7, ‘440 continues to disclose that the interconnector (100) further includes a liquid flow path (110) configured to receive the liquid; and a gas flow path (120) configured to receive the gas, wherein the liquid flow path (110) is configured to intersect the gas flow path (120) at a T-shaped connection (Figure 1); and further wherein a diameter of the gas flow path (120) at the T-shaped connection is greater than a diameter of the liquid flow path (110) at the T-shaped connection (Figure 1; page 9, 1st paragraph).
With respect to claim 3, ‘440 when modified by Holsten will create a configuration such that the first valve (180; Figure 14C of Holsten) and the second valve (page 9, 3rd paragraph of ‘440) are disposed upstream of the T-shaped connection (See Figure 1 of ‘440 and Figure 14C of Holsten).
Therefore, claim 3 is not patentable over ‘440 in view of Holsten as well.
Regarding claim 4, ‘440 in view of Holsten further discloses that the apparatus is capable of operating in which the volume of the liquid includes a predetermined volume of the liquid, the first valve is configured to automatically open in response to a difference in pressure between an inlet and an outlet of the first valve to allow the predetermined volume of the liquid to flow into the liquid flow path (page 11, 3rd paragraph to page 13, 2nd paragraph of ‘440; paragraph 80 of Holsten).
As such, claim 4 is also not patentable over ‘440 in view of Holsten.
Concerning claim 5, ‘440 when modified by Holsten will provide a configuration such that the first valve is configured to prevent backflow of the predetermined volume of liquid through the first valve (paragraph 80 of Holsten).
Thus, claim 5 is not patentable over ‘440 in view of Holsten as well.
Regarding claim 8, ‘440 continues to disclose that the shaft (200) forms a part of a trocar, the trocar further including a hub (500), and the interconnector (100 is disposed on the hub (500) of the trocar (page 1, 3rd paragraph to page 2, 2nd paragraph). ‘440 does not appear to disclose that the interconnector is disposed in the hub however. Nonetheless, in In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device; and in In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). See MPEP 2144.04 [VI](C).
Similarly, the mere rearrangement of the interconnector from on said hub to in said hub is not considered to be a patentable distinction over the prior art of ‘440; as such is considered a mere matter of engineering design choice that would not affect the operation of the device.
Therefore, claim 8 is not patentable over ‘440 as well.
Claims 10 & 11 are rejected under 35 U.S.C. 103 as being unpatentable over Document Identification No. CN-113925440-A (herein referred to as ‘440) in view of Holsten (U.S. Publication No. 2020/0163541) as applied to claim 1 above, and further in view of Coffeen et al. (U.S. Publication No. 2020/0375444).
With respect to claims 10 & 11, while ‘440 discloses that the apparatus is capable of operating such that a wash sequence is activated by triggering delivery of the pressurized flow of the gas such that the pressurized flow of the gas mixes with and propels the volume of liquid into the lumen (610), in which the volume of liquid is a first volume, and the apparatus utilizes a pump mechanism to pump a second volume of liquid into the interconnector (page 9, 2nd paragraph; page 11, 3rd paragraph to page 13, 2nd paragraph); the reference does not appear to disclose a controller configured to perform these operations. Coffeen discloses an apparatus that includes a shaft defining a channel for receiving an instrument, a lumen for delivering a liquid and a gas, an interconnector configured to couple to a liquid and gas source (Figure 3; paragraphs 164-174), and an ejection port disposed near a distal end of the shaft configured to eject a mixture of the liquid and gas at a distal end of the channel (Figures 1C-1I) as set forth in paragraphs 139-150. The reference continues to disclose a controller configured to control operations of the apparatus in order to successfully control the amount of liquid and gas that is provided to the system for a given procedure (paragraphs 174, 175, 182, 209, 212 and 213). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a controller configured to perform the operations of the apparatus of ‘440 in order to successfully control the amount of liquid and gas that is provided to the system for a given procedure as exemplified by Coffeen.
As such, claims 10 & 11 are not patentable over ‘440 in view of Holsten and Coffeen.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Document Identification No. CN-113925440-A (herein referred to as ‘440) in view of Coffeen et al. (U.S. Publication No. 2020/0375444).
‘440 discloses an apparatus, comprising:
A shaft (200) defining a channel for receiving an instrument (300), the shaft having a distal end that is disposable within patient anatomy (page 1, 3rd paragraph to page 2, 2nd paragraph; Figures 2 & 3);
An ejection port (630) disposed near a distal end of the shaft, the ejection port configured to eject a predetermined volume of liquid and gas into the channel in response to a distal end of the instrument being disposed near the ejection port (page 3, last paragraph; page 6, last paragraph); and
A vent (720) fluidically coupled to the channel (Figures 2-4) and configured to vent gases from within the patient anatomy to an exterior of the patient anatomy (page 7, 1st full paragraph).
‘440 does not appear to disclose a filter disposed along a pathway of the vent and being configured to filter the gases being vented through the vent. Coffeen discloses an apparatus that includes a shaft defining a channel for receiving an instrument, wherein the shaft comprises a distal end that is disposable within a patient anatomy (paragraphs 11 & 30); a lumen for delivering a liquid and a gas (paragraph 30; Figures 1, 2, 7 & 11); an ejection port disposed near a distal end of the shaft configured to eject a mixture of the liquid and gas at a distal end of the channel (Figures 1C-1I; paragraphs 139-150), and a vent (432) fluidically coupled to the channel configured to vent gases from with the patient anatomy to an exterior of the patient anatomy (paragraph 179) . The reference continues to disclose a filter disposed along a pathway of the vent and being configured to filter the gases being vented through the vent in order to remove contaminants and debris from the gases prior to expulsion into the environment (paragraph 179). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the vent of ‘440 with a filter disposed along a pathway of the vent and being configured to filter the gases being vented through the vent in order to remove contaminants and debris from the gases prior to expulsion into the environment as exemplified by Coffeen.
Thus, claim 19 is not patentable over ‘440 in view of Coffeen.
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Document Identification No. CN-113925440-A (herein referred to as ‘440) in view of Coffeen et al. (U.S. Publication No. 2020/0375444) as applied to claim 19 above, and further in view of Duke (U.S. Publication No. 2009/0270818).
‘440 in view of Coffeen is relied upon as set forth above. ‘440 does not appear to disclose a valve disposed along a pathway of the vent, the valve being configured to open the vent in response to pressure within the patient anatomy being greater than a predefined threshold. Duke discloses an apparatus that includes a shaft defining a channel, in which the shaft has a distal end disposable within a patient anatomy (Abstract), an ejection port configured to deliver gases to the channel (Abstract), and a vent (700) fluidically coupled to the channel configured to vent gases from within the patient anatomy to an exterior of the patient anatomy (Figure 7A). The reference continues to disclose a valve disposed along a pathway of the vent, the valve being configured to open the vent in response to pressure within the patient anatomy being greater than a predefined threshold; wherein said valve is configured to prevent flow of fluids external to the patient anatomy into the channel (concerning claim 21) in order to selectively control the gases exiting from and entering said channel (paragraph 54). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a valve disposed along the pathway of the vent in ‘440; wherein the valve is configured to open the vent in response to pressure within the patient anatomy being greater than a predefined threshold; and further wherein said valve is configured to prevent flow of fluids external to the patient anatomy into the channel in order to selectively control the gases exiting from and entering into said channel as exemplified by Duke.
Therefore, claims 20 and 21 are not patentable over ‘440 in view of Coffeen and Duke.
With respect to claim 22, ‘440 in view of Coffeen and Duke do not appear to disclose that the filter is disposed downstream from the valve. However, as noted above, in In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950), claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device; and in In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). See MPEP 2144.04 [VI](C). Thus, the arrangement of the filter being disposed upstream or downstream of the valve is nothing more than a mere matter of design choice that would not modify the operation of the apparatus of ‘440 in view of Coffeen and Duke. As such, claim 22 does not create a patentable distinction over ‘440 in view of Coffeen and Duke. Therefore, claim 22 is not patentable over ‘440 in view of Coffeen and Duke as well.
Claims 23 & 24 are rejected under 35 U.S.C. 103 as being unpatentable over Document Identification No. CN-113925440-A (herein referred to as ‘440) in view of Coffeen et al. (U.S. Publication No. 2020/0375444) as applied to claim 19 above, and further in view of Poll et al. (U.S. Publication No. 2012/0022331).
Concerning claims 23 & 24, ‘440 is relied upon as set forth above. While the reference continues to disclose that the shaft (200) is coupled to a hub (500), ‘440 does not appear to disclose a stopcock switch, the stopcock switch disposed in the hub and configured to be rotated between a first and second position to open and to close the vent. Poll discloses an apparatus that includes a shaft defining a channel for receiving an instrument (Figure 6), an ejection port disposed near a distal end of the shaft (Figure 6), and a vent fluidically coupled to the channel to vent gases from within a patient anatomy (paragraphs 42, 47, 56 and 76). The reference continues to disclose a stopcock switch disposed in a hub and configured to be rotated between a first and second position to open and to close the vent in order to control the flow of gases being exhausted from the patient anatomy and channel (paragraphs 56, 110 and 111). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the apparatus of ‘440 with a stopcock switch disposed in a hub and configured to be rotated between a first and second position to open and to close the vent in order to control the flow of gases being exhausted from the patient anatomy and channel as exemplified by Poll.
As such, claims 23 & 24 are not patentable over ‘440 in view of Coffeen and Poll.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Coffeen et al. (U.S. Publication No. 2020/0375444) in view of Document Identification No. CN-113925440-A (herein referred to as ‘440).
Coffeen is relied upon as set forth above. Coffeen does not appear to disclose a vent fluidically coupled to the channel and configured to vent gases from within the patient anatomy to an exterior of the patient anatomy. ‘440 is relied upon as set forth above as well. As noted above, ‘440 continues to disclose a vent (720) fluidically coupled to the channel (Figures 2-4) and configured to vent gases from within the patient anatomy to an exterior of the patient anatomy in order to remove any unwanted gases from within the patient anatomy and the channel (page 7, 1st full paragraph). As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a vent fluidically coupled to the channel of Coffeen and configured to vent gases from within the patient anatomy to an exterior of the patient anatomy in order to remove any unwanted gases from within the patient anatomy and the channel as exemplified by ‘440.
Thus, claim 30 is not patentable over Coffeen in view of ‘440.
Allowable Subject Matter
Claim 9 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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