82DETAILED 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 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 1-3, 5-15 and 17-20 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 1, 13 and 19 are single claims which claims both an apparatus and a method step. Such is indefinite because it is not directed to the system, but the actions of a user, which creates confusion as to when direct infringement occurs. See MPEP 2173.05(p). More specifically, the “wherein the second flow rate is different than the first flow rate”. As the hand pumps are manually operated, the flow rates are a function of various factors, including how fast the hand pumps are pumped by the user. As such, in at least one embodiment, the second flow rate being different than the first flow rate is a method step. Specifying that the flow rate is different due to the material of the handpumps such as in Applicant’s specification ¶45 would overcome this rejection and be allowable.
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.
Claim(s) 1-3, 9, 12-15, 18 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salgia et al (US 2010/0249717).
Regarding claim 1, Salgia discloses an infusion device having multiple pumping segments (figs 5, 6A and 6B) connected to a common fluid source (¶61, single input line which connects to two inputs, inputs are unlabeled in fig 5 and 630a/b in figs 6A and 6B; as per ¶62, figs 6A and 6B are examples of 510 from fig 5) and configured to operate in parallel with each other (figs 6A and 6B) to pump a fluid from the common fluid source (see alternating movement and inputs 630a/b which connect to the common fluid source), comprising: a first hand pump including a first deformable body 610a fluidically coupled between the fluid source 630a and an intravenous (IV) set (¶61, outputs may be connected to a single output line; device is used for intravenous infusion – abstract; ¶31 – needle or IV catheters are given as an example), the first deformable body configured to be hand-compressed by a user (hand-cranking of level arm 520) and, when compressed, direct a first portion of the fluid from the fluid source from the first deformable body to an outlet of the IV set for administering the fluid to a patient at a first flow rate (hand-cranking of lever arm 520); and a second hand pump including a second deformable body 610b fluidically coupled between the fluid source 630b and the IV set in parallel with the first deformable body (figs 6A and 6B), the second deformable body configured to be hand-compressed by the user (hand-cranking of level arm 520) and, when compressed, direct a second portion of the fluid from the fluid source from the second deformable body to the outlet of the IV set for administering the fluid to the patient at a second flow rate (fig 6B), wherein the second flow rate is different than the first flow rate (when pumped at different rates or with different forces), wherein the first hand pump and the second hand pump are configured to, when compressed according to respective timing patterns offset from each other, deliver the first portion of the fluid from the fluid source through the first deformable body to the IV set while the second deformable body is filled with the second portion of the fluid from the fluid source (fig 6A), and to deliver the second portion of the fluid through the second deformable body to the IV set while the first deformable body is filled from the fluid source (fig 6B).
Regarding claim 2, wherein the first deformable body and the second deformable body are simultaneously compressible (reference claim 4, first and second facilitating members operate in phase with each other).
Regarding claim 3, wherein the first deformable body and the second deformable body are compressible in an alternating sequence (figs 6A and 6B).
Regarding claim 9, wherein the first and second deformable bodies comprise a resilient material such that the first and second deformable bodies rebound to an uncompressed state (figs 6A and 6B).
Regarding claim 12, wherein the first deformable body is fluidically coupled between the fluid source and the IV set via a first inlet 630a and the second deformable body is fluidically coupled between the fluid source and the IV set via a second inlet 630b.
Regarding claim 13, Salgia discloses an infusion system having multiple pumping segments (figs 5, 6A and 6B) connected to a common fluid source (¶61, single input line which connects to two inputs, inputs are unlabeled in fig 5 and 630a/b in figs 6A and 6B; as per ¶62, figs 6A and 6B are examples of 510 from fig 5) and configured to operate in parallel with each other (figs 6A and 6B) to pump a fluid from the common fluid source (see alternating movements in figs 6A and 6B and inputs 630a/b which connect to common fluid source), comprising: a first portion of tubing (input line/tubing which includes single input line connected to two input lines by a y-connector, from ¶61) connected to a fluid source; a second portion of tubing (output line/tubing which includes single output line connected to two output lines by a y-connector, from ¶61); a plurality of hand pumps configured to operate in parallel (figs 6A and 6B, segments are ‘a’ side and ‘b’ side) with other to pump the fluid from the fluid source (figs 6A and 6B) and comprising: a first hand pump including a first deformable body 610a fluidically coupled to the first portion of tubing (fig 6A via inlet 630a), the first deformable body configured to be hand-compressed by a user (hand-cranking of level arm 520) and, when compressed, direct a first portion of the fluid from the fluid source through the first deformable body to an outlet (y-connector of outlet from ¶61) fluidically coupled to the second portion of tubing for administering the fluid to a patient at a first flow rate (fig 6A); and a second hand pump including a second deformable body 610b fluidically coupled to the first portion of tubing in parallel with the first deformable body (fig 6A), the second deformable body configured to be hand-compressed by the user (hand-cranking of level arm 520) and, when compressed, direct a second portion of the fluid from the fluid source through the second deformable body to the outlet fluidically coupled to the second portion of tubing (outlet y-connector in ¶61) for administering the fluid to the patient at a second flow rate (fig 6B), wherein the second flow rate is different than the first flow rate (when compressed at different rates and or forces), wherein the plurality of hand pumps is configured to, when compressed according to respective timing patterns offset from each other, deliver the first portion of the fluid from the fluid source through the first deformable body to an IV set while filling the second deformable body with the second portion of the fluid from the fluid source (fig 6A), and to deliver the second portion of the fluid from the fluid source through the second deformable body to the IV set while the first deformable body is filled from the fluid source (fig 6B).
Regarding claim 14, wherein the first deformable body and/or the second deformable body are simultaneously compressed (reference claim 4, first and second facilitating members operate in phase with each other).
Regarding claim 15, wherein the first deformable body and/or the second deformable body are compressed in an alternating sequence (figs 6A and 6B).
Regarding claim 18, wherein the first and second deformable bodies comprise a resilient material such that the first and second deformable bodies rebound to an uncompressed state (figs 6A and 6B).
Regarding claim 19, Salgia discloses a method of forming an apparatus for accelerating a fluid pumped by a separate intravenous infusion pump from a fluid source to a patient (figs 5, 6A and 6B; figs 6A and 6B are examples of 510 from fig 5), comprising: connecting, between a first union connector (¶61, y-connector on inputs) configured to fluidly connect with an upstream infusion line for receiving the fluid from the fluid source (¶61, single input line) and a second union connector (¶61, y-connector on output), downstream from the first union connector, configured to connect to a downstream infusion line for providing the fluid to an IV set (¶61, single output line; ¶31 gives example of intravenous needle or catheter for IV set), a first hand pump including a first deformable body 610a configured to be hand-compressed by a user (hand-cranking of lever arm 520) and, when compressed, direct a first portion of the fluid from the first deformable body to the IV set for administering the first portion of the fluid to the patient at a first accelerated flow rate (fig 6A); and connecting, between the first and second union connectors, a second hand pump including a second deformable body 610b in parallel with the first deformable body (fig 6A), the second deformable body configured to be hand-compressed by the user (hand-cranking of lever arm 520) and, when compressed, direct a second portion of the fluid from the second deformable body to the IV set for administering the fluid to the patient at a second accelerated flow rate (fig 6B), wherein the second accelerated flow rate is different than the first acceleration flow rate (when operated with different speeds and/or forces), wherein the first and second deformable bodies are configured to, when compressed according to respective timing patterns offset from each other, operate together to deliver fluid from the fluid source by delivering the first portion of the fluid from the first deformable body to the IV set while filling the second deformable body with the second portion of the fluid from the fluid source (fig 6A), and delivering the second portion of the fluid from the second deformable body to the IV set while the first deformable body is filled with the first portion of the fluid from the fluid (fig 6B), such that the fluid is delivered from the fluid source to the patient at a flow rate greater than first and second default flow rates and a default flow rate of the fluid source (due to input of energy when cranking pump which causes greater pressure differentials and thus greater flow rates).
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.
Claim(s) 5-8, 10, 11, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salgia et al (US 2010/0249717) in view of Yamin et al (US 2022/0080109).
Regarding claim 5, while Salgia substantially discloses the invention as claimed, it does not disclose one or more filters fluidically coupled to the first deformable body and/or the second deformable body, wherein the one or more filters capture particulate from the fluid directed from the first deformable body and/or the second deformable body.
Yamin discloses a filter to prevent transfer of bacteria, microorganisms and/or other pathogens to the patient (¶27).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Salgia such that it includes one or more filters fluidically coupled to the first deformable body and/or the second deformable body, wherein the one or more filters capture particulate from the fluid directed from the first deformable body and/or the second deformable body as taught by Yamin to prevent transfer of bacteria, microorganisms and/or other pathogens to the patient.
Regarding claim 6, while Salgia substantially discloses the invention as claimed, it does not disclose the first deformable body and/or the second deformable body, when compressed, direct back flow from the first deformable body and/or the second deformable body through the one or more filters, agitating particulate captured in the one or more filters.
Yamin discloses the first deformable body and/or the second deformable body, when compressed, direct back flow from the first deformable body and/or the second deformable body through the one or more filters, agitating particulate captured in the filter (¶45). This increases flow through the filter and IV set (¶16).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Salgia such that the first deformable body and/or the second deformable body, when compressed, direct back flow from the first deformable body and/or the second deformable body through the one or more filters, agitating particulate captured in the filter as taught by Yamin to increase the flow through the filter(s) and the IV set.
Regarding claim 7, wherein the one or more filters are disposed adjacent to first and/or second inlets of the first and second deformable bodies, respectively (see combination in claim 5 of Yamin adding a filter to Salgia, Yamin shows the filter 243 in the inlet to the deformable body 246).
Regarding claim 8, wherein the one or more filters are disposed within first and/or second inlets of the first and second deformable bodies, respectively (see combination in claim 5 of Yamin adding a filter to Salgia, Yamin shows the filter 243 within the inlet to the deformable body 246).
Regarding claim 10, while Salgia substantially discloses the invention as claimed, it does not disclose wherein the first and second deformable bodies comprise a transparent material or a semi-transparent material.
Yamin discloses making the deformable body of a transparent or semi-transparent material to observe flow of fluid therethrough.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Salgia such that the first and second deformable bodies comprise a transparent material or a semi-transparent material as taught by Yamin to allow a user to observe the contents of the deformable bodies.
Regarding claim 11, while Salgia substantially discloses the invention as claimed, it does not disclose wherein the first and second deformable bodies comprise a substantially cylindrical shape.
Yamin discloses a hand pump 120 which has a cylindrical shape (fig 2).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Salgia such that the first and second deformable bodies comprise a substantially cylindrical shape as taught by Yamin as it is a known shape for an IV hand-driven pump.
Regarding claim 17, further comprising: one or more filters fluidically coupled to the first deformable body and/or the second deformable body, wherein the one or more filters capture particulate from the fluid directed from the first deformable body and/or the second deformable body (see claim 5 above).
Regarding claim 20, while Salgia substantially discloses the invention as claimed, it does not disclose connecting, a drip chamber upstream of the first union connector that is configured to provide a visual indicator of the default flow rate of the fluid source.
Yamin discloses a connecting, a drip chamber 110 upstream of the first union connector that is configured to provide a visual indicator of the default flow rate of the fluid source (fig 2; ¶20).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Salgia by connecting, a drip chamber upstream of the first union connector that is configured to provide a visual indicator of the default flow rate of the fluid source as taught by Yamin to allow a user to monitor and adjust the flow rate as desired.
Response to Arguments
Applicant’s arguments have been considered but are not persuasive. There is an interpretation that the hand pumps may be operated manually but differently (different forces and/or actuation speeds) which reads upon Applicant’s amendment. Should Applicant clarify that the flow rates are different due to physical aspects (such as materials and/or size) of the hand pump, such would be considered allowable.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
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