DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/19/2025 has been entered.
Claims 21-25,29,32-33,35,38 and 41-43 remain pending and under prosecution.
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 .
Election/Restrictions
Applicant’s election of Group 10 in the reply filed on 5/15/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 26-28, 30-31, 34, 36, and 39-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/2025.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 21-25, 29, 32-33, 35, 38, and 41-43 remain pending and under prosecution.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
No claim elements are interpreted under 112(f).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 21-25, 29, 32-33, 35, 38, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Percarpio (US Pat No. 4106497 or ’97 – cited by applicant) in view of Kaufman (US Pat No. 4312362).
In regard to Claim 21, Percarpio ’97 disclose a device comprising:
an inlet (corresponding to proximal location of needle 22 by passageway 28), best seen in Figure 3 (Col.2: 58-Col.3: 23);
an outlet (defined as starting at the distal part of central passageway to the bottom) 42, best seen in Figure 3 (Col.2: 66-Col.3: 10);
a sample path (defined as the pathway within check valve 78 shown by the arrow in Figure 3 reproduced below) connected between the inlet and the outlet, best seen in Figure 3 (Col.2: 66-Col.3: 10);
a chamber (one channel) 92 connected between the inlet and the outlet, the chamber having an air permeable (due to vents) fluid resistor 90 proximate the outlet – expansible material 90 is proximate the distal part of central passageway 42, best seen in Figure 3 – “film of water expansible material 90… Three spaced channels 92 are formed in the film to provide air passageways for facilitating venting of the assembly and flow of blood into the indicator area where film 90 is located. The number of channels is a matter of choice. Thereafter, expansion of the film due to contact with the liquid closes channels 92 and locks the blood into the area of the location of the film” (Col.4: 16-39),
the chamber being arranged to receive, when a pressure differential is applied between the inlet and the outlet – from the pressure within the blood vessel of the patient, a first portion of a fluid sample to displace air therein through the air permeable fluid resistor and the outlet – “Three spaced channels 92 are formed in the film to provide air passageways for facilitating venting of the assembly and flow of blood into the indicator area where film 90 is located…by capturing the blood within the indicator area including channels 92, there is no danger of contamination of blood being collected into chamber 32 and ultimately into an evacuated container through the passageway interconnected with rear needle 50” (Col.4: 16-39),
with subsequent portions of the fluid sample conveyed by the sample path from the inlet to the outlet – after blood is collected in channel 92 and the water expansible material forming the film expands sufficiently to close channel 92 and stops the blood flow to channel 92, tube 94 is then advanced in holder 62 until the pointed end 54 of needle 50 pierces the stopper 96 and enters the evacuated tube…The difference in pressure caused by the vacuum within tube 94 causes the flaps of check valve 82 and 84 to separate permitting flow of blood through the check valve 78 and through passageway 42 and communicating needle 50 into the evacuated tube 94 for blood collection purposes (Col.5: 1-47), and
a plug 78 proximate the inlet (proximate being relative and broad) that allows the subsequent portions of the fluid sample to be conveyed through the sample path – “The difference in pressure caused by the vacuum within tube 94 causes the flaps of check valve 82 and 84 to separate permitting flow of blood through the check valve 78 and through passageway 42 and communicating needle 50 into the evacuated tube 94 for blood collection purposes” (Col.5: 1-47).
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However, Percarpio ’97 do not expressly disclose the plug is displaceable such that when the displaceable plug is displaced from a first location in the device to a second location in the device, allows the subsequent portions of the fluid sample to be conveyed through the sample path.
Kaufman teach that it is well-known in the art to provide an analogous device comprising displaceable plug 26, best seen in Figure 2 and 4, such that when displaced to the position in Figure 7, the displaceable plug is displaced from a first location in the device, best seen in Figure 2 – “distal side hole 49 is initially covered by the plug, while side hole 48 is uncovered” (Col.6: 44-53) to a second location in the device, best seen in Figure 7 – “Under the influence of this negative pressure gradient, plug 26 is drawn toward the source of the negative pressure so that it slides inside the chamber and along interior portion 44 of the second cannula” (Col.7: 20-26), which allows portions of the fluid sample to be conveyed through the sample path – “The significant feature is that distal side hole 49 is uncovered due to the sliding movement of the plug which now results in a free path for blood inside forward chamber 40a to flow into the second needle cannula. Blood will now flow through the needle assembly and into the blood collection container until a sufficient quantity has been collected” (Col.7: 30-39).
Thus, Kaufman teach an alternate mechanism for the plug of Percarpio that includes displacement from a first location in the device to a second location in the device to allow the subsequent portions of the fluid sample to be conveyed through the sample path, wherein the sample path in Kaufman is defined a similar manner as that in Percarpio – through interior portion 44 of second cannula, through portion 42, and toward needle cannula 15, best seen in Figure 2 (Col.6: 44-68).
Since Percarpio ’97 already discloses a plug 78 proximate the inlet as broadly as has been claimed that allows the subsequent portions of the fluid sample to be conveyed through the sample path, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the plug such that it is displaceable from a first location in the device to a second location in the device to allow the subsequent portions of the fluid sample to be conveyed through the sample path, as taught by Kaufman as an equally as effective mechanism for the plug to provide the desired fluid flow.
22. Kaufman teach the device in accordance with claim 21, further comprising a recess 40 for receiving the displaceable plug 26, best seen in Figure 2 and 7.
23. Percarpio ’97 teach the device in accordance with claim 21, wherein the chamber includes a tortuous path, as the film 92 which creates chamber 92 is disposed along the side of the device along rim 36, best seen in Figure 3.
24. Kaufman teach the device in accordance with claim 21, wherein the displaceable plug 26 is initially secured by a friction-fit, best seen in Figure 2 – “Flange 52 has an outer diameter which provides a liquid-tight fit against the wall portion of the housing surrounding chamber 40” (Col.5: 68-Col.6: 2).
25. Kaufman teach the device in accordance with claim 24, wherein the displaceable plug 26 is initially secured by a seat 52, best seen in Figure 2 and 4 – “Flange 52 has an outer diameter which provides a liquid-tight fit against the wall portion of the housing surrounding chamber 40” (Col.5: 68-Col.6: 2).
29. Kaufman teach the device in accordance with claim 21, wherein the displaceable plug 26 is formed of an elastomeric material (Col.5: 62-66).
32. Kaufman teach the device in accordance with claim 21, wherein the displaceable plug 26 has a bottom surface that is curved – at annular flange 52 – to facilitate displacement from a conduit, best seen in Figure 4.
33. Kaufman teach the device in accordance with claim 21, wherein the displaceable plug 26 is hollowed out towards the sample path due to the cylindrical shape of cylindrical member 60, best seen in Figure 4 (Col.6: 26-27). Also see plug 78 in Percarpio, best seen in Figure 3.
35. Percarpio ’97 teach the device in accordance with claim 21, wherein the displaceable plug 78 when modified by Kaufman is collapsible in response to a pressure, i.e. pressure change from when evacuated vacuum in tube 94 is fluidly connected vs. not connected, best seen in Figure 1 of Percarpio (Col.5: 30-62).
38. Kaufman teach the device in accordance with claim 21, wherein the displaceable plug 26 has a cylindrical shape – “A second component of composite plug 26 is a substantially cylindrical member 60,” best seen in Figure 4 (Col.6: 26-27).
43. Kaufman teach the device in accordance with claim 21, wherein the displaceable plug 26 is configured to inhibit a flow of the subsequent portions of the fluid sample into the sample path, i.e. because distal side hole 49 is covered by plug 26 –
“At this stage, plug 26 is positioned inside chamber 40, in liquid-tight contact with the wall surrounding the chamber and interior portion 44 of the second cannula, in the position illustrated in FIG. 2. In this regard, distal side hole 49 is initially covered by the plug, while side hole 48 is uncovered. Also at this stage, since no vacuum is being applied to needle cannula 15… Once vein entry has been made by needle cannula 14, blood will flow under normal tourniquet pressure through cannula 14 and will fill a forward part 40a of chamber… Blood in the forward chamber is prevented from flowing into the second needle cannula due to both the liquid-tight seal formed by the impermeable outer envelope and by the blood impermeability characteristics of the porous member inside the envelope” (Col.6: 48-Col.7: 5),
until the first portion has entered the chamber 92 of Percarpio ‘97, after which – “Once this visual observation of vein entry is confirmed by the user, evacuated tube 16 is then inserted into holder 19 so that penetrable stopper 21 is penetrated by hollow cannula 15… Once second cannula 15 is into the vacuum area inside container 16, a negative pressure gradient is transmitted into chamber 40 through side hole 48. Under the influence of this negative pressure gradient, plug 26 is drawn toward the source of the negative pressure so that it slides inside the chamber and along interior portion 44 of the second cannula. The effect of this sliding causes side hole 49 to become uncovered, with side hole 48 now becoming covered by the plug… which now results in a free path for blood inside forward chamber 40a to flow into the second needle cannula. Blood will now flow through the needle assembly and into the blood collection container until a sufficient quantity has been collected” (Col.7: 13-39) occurs in Kaufman, which similarly happens in Percarpio ’97 when flow is enabled to the sample path as defined above of Percarpio ’97.
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Percarpio (US Pat No. 4106497 or ’97 – cited by applicant) in view of Kaufman (US Pat No. 4312362) as applied to Claim 21, further in view of Owen et al (US Pat No. 6063040).
Percarpio in combination with Kaufman teach the invention but do not expressly disclose the sample path has a shape that changes to not allow traversal of the displaceable plug along a length of the sample path.
Owen et al teach that it is well-known in the art to provide an analogous blood collection device comprising a sample path (192, 246, 148, 100) that is not linear due to slot 192 which connects to proximal needle 100 to create an offset flow path from needle 70, best seen in Figure 8-10, which is analogous to the sample path defined in Percarpio ‘97 –
“When latch leg 194 is disposed against catch ledge 260, slot 192 communicates with duct 246 to form a continuous fluid pathway from the bore of needle 70 through slot 192 to conduit 148 and finally to proximal needle 100. Note that the long axis of needle 70 is offset from the long axis of needle 100. This offset requires a non-linear fluid path between the needles, but permits needle 70 to be disposed in an inferior location relative to needle 100, thereby permitting a shallow percutaneous entry angle. Further, the transverse orientation of the pathway comprising slot 192 and duct 148 permits the slot 192/duct 148 pathway to be broken as hub 80 and needle 70 are retracted…
It is important to note that the pathway from needle 70 through slot 192 is totally closed as the distal o-ring 130 moves proximally past duct 246 during needle 70/hub 80 retraction. This closure severely restricts spatter of blood which might otherwise be ejected from tip 280 during retraction.
Needle 70 is seen retracted into safety of housing 20) in FIG. 10. As there is no simple way to reengage hook 206 into slot 199, without extraordinary measures, device 10 can only be used once” (Col.8: 58-Col.9: 15). As disclosed by Owen et al, the offset flow path to create the sample path with a shape that changes provides benefits such as a shallow percutaneous entry angle, ability for the needle 70 to retract into the device to prevent blood spatter and needle pricks, as well as advantageously provide single-use device.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Percarpio as modified by Kaufman such that the sample path has a shape that changes as taught by Owen et al to effectively provide a shallow percutaneous entry angle, ability for the needle to retract into the device to prevent blood spatter and needle pricks, as well as advantageously provide single-use device, wherein in combination due to the non-linear flow path, would not allow traversal of the displaceable plug of Percarpio as modified by Kaufman above along a length of the sample path.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Percarpio (US Pat No. 4106497 or ’97 – cited by applicant) in view of Kaufman (US Pat No. 4312362) as applied to Claim 21, further in view of Percarpio ’56 (US Pat No. 4317456).
Percarpio in combination with Kaufman teach the invention including the device is configured to allow a free flow of fluid from the inlet to the sample path taught by Percarpio when the displaceable plug 26 of Kaufman moves in the manner above. However, Percarpio as modified do not expressly disclose a receptacle for the displaceable plug.
Percarpio ’56 teach that it is well-known in the art to provide an analogous blood collection device, wherein the device is configured to allow a free flow of fluid from the inlet to the sample path when the displaceable plug 26 moves into a receptacle 44, 45 as broadly as has been claimed, best seen in Figure 6, as an effective structure to hold the plug – “specifically recess 45, prevent movement of valve member 26” (Col.5: 13-61).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Percarpio as modified by Kaufman such that the device includes a receptacle for the displaceable plug as taught by Percarpio ’56 to provide a structure to effectively hold the plug after it moves in the manner already taught by Kaufman.
Response to Arguments
Applicant’s arguments with respect to claim(s) above have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Kaufman has been set forth to teach the new amendments above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached on 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at 5712723672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/ Supervisory Patent Examiner, Art Unit 3791