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 .
Response to Arguments
Applicant's arguments filed 26 January 2026 have been fully considered but they are not persuasive. Applicant argues the introducer needle of Aho is not tubular. Examiner respectfully disagrees. The needle (850) has a distal end (854) and distal end (852) and the lumen in between. Needles are generally tubular and while the diameter of the needle changes, the changes diameter does not make the needle not tubular since tubular is defined as long, round, and hollow which Examiner submits the Aho needle fulfills.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, while Aho does not insist on using a valve, Parihar provides a valve to control the movement of fluid through the cylindrical device that accesses the body ([0057]). While the intended use of Aho and Parihar are different, the teaching suggest that the concept of a valve can be used to control movement. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho by adding a valve as taught by Parihar in order to control the movement of material through the chest device.
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 1-5, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Aho (US 2017/0368241) in view of Parihar (US 2004/0092965).
Regarding claim 1, Aho discloses a pneumothorax decompression system comprising:
a tubular needle (850, figure 9) having first and second ends and a lumen (lumen inside needle) extending there between and a connector (850, [0075]) affixed to one of said ends and,
an indicator assembly (832) including a tubular housing member (figure 9) having first and second ends and a lumen (first and second ends of the proximal end including the assembly) extending there between, and a color changing member (832, [0078]) having a first visual state and a second visual state being positioned within the lumen of said housing member between said valve assembly and said second end ([0080]),
said needle being coupled to said housing member first end such that the lumen of said needle are in fluid tight engagement (figure 8) and said color changing member is visually responsive to CO2, such that when said color changing member is in said first state and CO2 containing fluid flows through said needle lumen contacting said color changing member, said color changing member moves from said first state to said second state providing a visible visual appearance different from said first state ([0080, the state of the color changing member is moved from one color to another color, this can be used in conjunction with other indicators and visible through the hub 830).
Aho does not disclose a valve assembly secured within said housing member adjacent said first end, and said valve assembly are in fluid tight engagement.
Parihar discloses device for accessing the body and teaches a valve assembly (112) secured within the housing (106) adjacent the first end (figure 2A-2B, [0057]) the valve assembly is in fluid tight engagement with the lumen (figure 2A-2B).
Parihar provides a valve to control the movement of fluid through the cylindrical device that accesses the body ([0057]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho by adding a valve as taught by Parihar in order to control the movement of material through the chest device.
Regarding claims 2-4, while Aho is silent regarding the valve, Parihar further teaches wherein said valve assembly includes a valve having a low valve opening pressure ([0057], the valve can open with low and high pressure since valves functionally open when pressure overcomes the crack pressure), wherein said valve assembly includes a membrane valve ([0057]) and wherein said valve assembly is fixedly secured to said tubular housing member (figure 2A-2B).
Parihar provides a valve to control the movement of fluid through the cylindrical device that accesses the body ([0057]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho by adding a valve as taught by Parihar in order to control the movement of material through the chest device.
Regarding claim 5, Aho does not disclose wherein said first and second ends of said housing member include a connector.
Parihar discloses connectors (204 and 302) on opposite ends of the device that would connect to another element (figure 12-13).
Parihar provides the connectors to seal the device in the body and prevent movement ([0012], [0068]) It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho by adding a connector as disclosed by Parihar in order to maintain a fluid tight engagement with surrounding structure.
Regarding claim 9, Aho discloses said color changing member takes the form of a cylinder (figure 9).
Regarding claim 10, Aho discloses wherein said housing member is formed of transparent material ([0044]).
Regarding claim 11, Aho discloses wherein said indicator assembly includes liquid absorbing materials ([0071-0072], material at least absorbed in order to indicate whether it contains CO2).
Regarding claim 12, Aho discloses wherein said color changing member is reversible such that when in said second state and C02 is removed said member moves from said second state to said first state ([0071-0072]).
Regarding claim 13, Aho discloses an indicator assembly for use in pneumothorax decompression procedures comprising:
a tubular housing (810, figure 9) having first and second ends and a lumen (lumen inside needle) extending there between
a color changing member (832, [0078]) having a first color and a second color, wherein said color changing member moves from said first color to said second color when exposed to C02 ([0080]) positioned within the lumen of said housing between said valve assembly and said housing second end (figure 8),
Aho does not disclose a valve assembly including a valve having a low valve opening pressure, being positioned within and fixedly secured to said tubular housing first end, and said valve assembly controlling the flow of fluid through said second end to said first end.
Parihar discloses device for accessing the body and teaches a valve assembly (112) secured within the housing (106) adjacent the first end (figure 2A-2B, [0057]) the valve assembly is in fluid tight engagement with the lumen and controls flow of fluid from one end to the other (figure 2A-2B), the valve having a low valve opening pressure, ([0057], the valve can open with low and high pressure since valves functionally open when pressure overcomes the crack pressure).
Parihar provides a valve to control the movement of fluid through the cylindrical device that accesses the body ([0057]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho by adding a valve as taught by Parihar in order to control the movement of material through the chest device.
Claims 6-8, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Aho in view of Parihar further in view of Boyes (US 2019/0308005).
Regarding claims 6-8, Aho and Parihar do not teach:
wherein said housing member has a wall that includes ridges that define adjacent channels (claim 6),
wherein said ridges and channels extend longitudinally within the lumen of said housing member (claim 7),
wherein said color changing member is supported by said ridges (claim 8).
Boyes discloses a luer connector for indicating presence of Co2 and teaches wherein said housing member (2090) has a wall that includes ridges that define adjacent channels (figure 20, adjacent channel formed separated by projections, [0196])
wherein said ridges and channels extend longitudinally within the lumen of said housing member (channel and ridges extend longitudinally, the ridges are multi-dimensional, figure 20)
wherein said color changing member is supported by said ridges ([0196]).
Boyes provides a CO2 indicator structure to indicate desired material by the user ([0196]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho and substitute the construction of Aho with the structure of Boyes to similarly indicate CO2 since both are functionally equivalent.
Regarding claims 14-16, Aho and Parihar do not teach:
wherein said housing member has a wall that includes ridges that define adjacent channels (claim 14),
wherein said ridges and channels extend longitudinally within the lumen of said housing member (claim 15),
wherein said color changing member is supported by said ridges (claim 16).
Boyes discloses a luer connector for indicating presence of Co2 and teaches wherein said housing member (2090) has a wall that includes ridges that define adjacent channels (figure 20, adjacent channel formed separated by projections, [0196])
wherein said ridges and channels extend longitudinally within the lumen of said housing member (channel and ridges extend longitudinally, the ridges are multi-dimensional, figure 20)
wherein said color changing member is supported by said ridges ([0196]).
Boyes provides a CO2 indicator structure to indicate desired material by the user ([0196]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho and substitute the construction of Aho with the structure of Boyes to similarly indicate CO2 since both are functionally equivalent.
Regarding claim 17, while Aho is silent regarding the valve, Parihar further teaches wherein said valve assembly includes a membrane valve ([0057]).
Parihar provides a valve to control the movement of fluid through the cylindrical device that accesses the body ([0057]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Aho by adding a valve as taught by Parihar in order to control the movement of material through the chest device.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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