DETAILED ACTION
This office action is responsive to the amendment filed 2/4/2026. Claim 1-6 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 without traverse of Group I in the reply filed on 9/29/2025 is acknowledged. Claims 1-8 are drawn to Group 1.
In view of the amendments to Claim 9, the shared technical feature has been updated to include the totality of claim 1; however, the shared technical feature is not deemed "special" as it does not make a contribution over the prior art as seen in the rejections below. Therefore the restriction is maintained and made final.
Claims 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/29/2025
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 § 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 1-6 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.
In regard to Claim 1, it is unclear if the claim means to include ribs in the chamber. The chamber recites “a plurality of mixing ribs” in line 4, however, the limitation was deleted in line 17 in the recent amendment. Clarification is requested.
Claims 2-6 are rejected by virtue of dependence on Claim 1.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being obvious over Carse et al (US Pub No. 20230320637) in view of Blekher et al (US Pub No. 20090308184).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to Claim 1, Carse et al disclose a blood collection tube, comprising:
a body 102 including a proximal end (top) and a distal end (bottom), and defining an axial extent between the proximal end and the distal end, best seen in Figure 1B;
a chamber 112 within the body, best seen in Figure 1B (0083);
a vacuum port 114, best seen in Figure 1B (0084); and
a cap 103 arranged on the proximal end, wherein the cap comprises: a top face including a first septum 106, best seen in Figure 1B (0086);
a first conduit 120 having an inlet extending from the first septum and an outlet in fluid communication with the chamber, best seen in Figure 3B (0088-0089);
a lateral face including a second septum 108, best seen in Figure 1B (0086);
a second conduit 122 extending radially from the second septum to the first conduit, best seen in Figure 3B (0088-0089); and
a plurality of mixing ribs – the cap includes labyrinth 124 with turns 138a-g, which are considered mixing ribs and are in communication with the chamber, best seen in Figure 5A (0091);
wherein, when a fluid source is fluidically connected to the first septum or the second septum, and a vacuum is applied at the vacuum port, the vacuum draws fluid from the fluid source, through the first or second septum, and into the first conduit 120 (0089-0090, 0095); and
when the tube is rotated around an axis defined by the axial extent, wherein the tube is capable of such, the mixing ribs of the cap cause fluids therein to swirl, thereby effecting mixing of the fluids therein.
However, Carse et al do not expressly disclose the chamber including a plurality of mixing ribs.
Blekher et al teach mixing ribs 247 within chamber 240 of analogous blood collection tube 20 to effectively mix the blood sample with the additive, best seen in Figure 3, 4b, and 6 (0088, 0100, 0121). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Carse et al to include the mixing ribs of Blekher et al within the chamber of Carse et al to effectively enable mixing of the blood sample with the additive, already taught by Carse et al, within the chamber as well, such that in combination, the mixing ribs of the cap and the mixing ribs of the chamber cause fluids therein to swirl, thereby effecting mixing of the fluids therein.
Claim 2 is rejected under 35 U.S.C. 103 as being obvious over Carse et al (US Pub No. 20230320637) in view of Blekher et al (US Pub No. 20090308184), further in view of Van Valkenburg (US Pat No. 4791938).
Carse et al in combination with Blekher et al disclose the invention above but do not expressly disclose a relief channel configured to enable air to escape from the chamber during filling of blood into the chamber.
Van Valkenburg teach that it is well-known in the art to provide a relief channel 34 to enable air to escape chamber of an analogous blood collection tube 24 as required during use, best seen in Figure 1 (Col.3: 37-50).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Carse et al as modified by Blekher et al such that there is a relief channel configured to enable air to escape from the chamber during filling of blood into the chamber as taught by Van Valkenburg to effectively enable venting of air as necessary during use.
Claim 3 is rejected under 35 U.S.C. 103 as being obvious over Carse et al (US Pub No. 20230320637) in view of Blekher et al (US Pub No. 20090308184) and North Jr (US Pat No. 6302836).
Carse et al in combination with Blekher et al disclose a system for collecting blood, comprising the blood collection tube of claim 1 as above, and a device for collecting blood into said blood collection tube, the device comprising in Carse et al:
a first slot 208 for securing a blood collection tube therein, best seen in Figure 8A (0100);
a vacuum pump 240, best seen in Figure 8D (0021, 0113);
a second slot 210 for securing a needle 304 therein, best seen in Figure 8A-B (0100);
a plurality of conduits 222a, b, c, each conduit connected at a distal end thereof to a reservoir 220a, b, c, best seen in Figure 8D and 11A (0111);
a processor configured to specify a predetermined volume of additive to be delivered into a blood collection tube from one of the plurality of reservoirs and a predetermined volume of blood to be delivered into the blood collection tube via the needle (0021, 0111);
wherein, the vacuum pump, plurality of conduits, and second slot are arranged around the first slot, best seen in Figure 8A-B such that when a blood collection tube 100 having a vacuum port 114, first septum 106, and second septum 108 (from claim 1) is inserted into the first slot:
the vacuum pump is configured to draw a vacuum through the vacuum port (0021);
each conduit is fluidically connectable to an interior of the blood collection tube via the second septum (0021); and
a needle secured within the second slot is fluidically connectable to an interior of the blood collection tube via the first septum (0021);
the processor is configured to control a vacuum delivered from the vacuum pump so as to draw the predetermined volumes of additive and blood into the blood collection tube (0021).
However, Carse et al in combination with Blekher et al do not expressly disclose a set of gears arranged at an end of the first slot, for rotating the blood collection tube.
North Jr teach that it is well-known in the art that a set of gears can be used to rotate an analogous blood collection tube – “the vacuum blood collection tube assembly can be rotated about other than a vertical axis and by means other than an electric motor and a drive belt such as by an air motor or by gears or by means integral with the tube support” (Col.9: 22-27). The recitation of gears is plural, which constitutes a set.
Since Carse et al as modified already disclose an end of the first slot as shown in Figure 8A, it would have been obvious to one of ordinary skill in the art at the time of filing modify Carse et al as modified by Blekher et al such that a set of gears arranged at an end of the first slot, for rotating the blood collection tube as taught by North Jr, to provide an effective automated system to rotate the blood collection tube such as for mixing, as already taught by Carse et al. Furthermore, since North Jr teach that automation of the process is preferred (abst), it would have been obvious in combination that following drawing of the predetermined volumes of additive and blood into the blood collection tube in the manner above in Carse et al, the processor of Carse et al is thus configured to operate the gears when combined with North Jr so as to rotate the blood collection tube a plurality of rotations within the first slot, thereby mixing the additive and blood within the blood collection tube as already taught by Carse et al.
Claims 4-5 are rejected under 35 U.S.C. 103 as being obvious over Carse et al (US Pub No. 20230320637) in view of Blekher et al (US Pub No. 20090308184) and North Jr (US Pat No. 6302836), further in view of Moh et al (US Pat No. 6165594).
Carse et al in combination with Blekher et al and North Jr disclose the invention above but do not expressly disclose a laser etching tool situated parallel to the axial extent of the blood collection tube, and, wherein, during rotation of the blood collection tube, the laser etching tool is configured to etch patient information onto the axial extent of the blood collection tube.
Moh et al teach that it is well-known in the art that a laser etching tool is used to etch marking information onto a coating of sizing (ceramic) as an effective manner of doing so (abst, Col.28: 10-22). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Carse et al as modified by Blekher et al and North Jr such that there is a laser etching tool as taught by Moh et al would necessarily be situated parallel to the axial extent of the blood collection tube as broadly as has been claimed and also suggested by Figures 8D-E of Carse et al, such that during rotation of the blood collection tube, the laser etching tool is configured to etch patient information onto the axial extent of the blood collection tube, as an effective means to do as taught by Moh et al, wherein the blood collection tube further includes a coating of sizing (ceramic) in a region onto which the laser etching is applied as taught by Moh et al.
Claim 6 is rejected under 35 U.S.C. 103 as being obvious over Carse et al (US Pub No. 20230320637) in view of Blekher et al (US Pub No. 20090308184) and North Jr (US Pat No. 6302836), further in view of Sundvor et al (US Pub No. 20170097342).
Carse et al in combination with Blekher et al and North Jr disclose the invention above but do not expressly disclose a gyroscope for measuring orientation, and the processor is configured to permit operation of the vacuum only when the orientation of the device is within a prescribed range.
Sundvor et al teach that it is well-known in the art to provide a gyroscope for measuring orientation of an analogous blood collection tube, wherein operation of the device is only permitted when the blood collection tube is oriented upright – “In one embodiment, the sample analyzer can be deemed to be in a testable state when the sample analyzer is upright (e.g., oriented upright; oriented with the retained test container between o and 90 degrees of a gravity vector, etc.) and be deemed to be in a nontestable state when the sample analyzer is horizontal or otherwise arranged. Alternatively, the orientation sensor and/or other sensors of the system can be used to trigger sample mixing (e.g., the sample is mixed in response to orientation, insertion, or other preconditions being met)” (0125).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Carse et al as modified by Blekher et al and North Jr such that a gyroscope for measuring orientation is included as taught by Sundvor et al, and wherein in combination, the processor of Carse et al would thus be configured to permit operation of the vacuum only when the orientation of the device is within a prescribed range as suggested by Sundvor et al such as when the device is upright.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive. Applicant contends that Carse et al do not disclose mixing ribs on the cap because “the labyrinth of Carse functions to mix fluid passing therethrough. Since the fluid is passing therethrough only one time and Carse desires mixing at least ten times before delivering the liquid to the chamber the labyrinth of Carse comprises both lateral turns and axial turns. In order to achieve ten passive mixing events, ten turns must be provided in the labyrinth. This makes construction of the labyrinth complex. In sharp contrast, mixing ribs (107) in cap (103) can each participate in multiple active mixing events because they act when the tube is rotated around an axis defined by the axial extent as the claimed "mixing ribs of the cap" explicitly recited in the claim. Thus, substitution of the claimed active ribs for Carse's passive labyrinth simplifies both manufacture and operation of the claimed device. As a result, using the broadest reasonable interpretation (BRI) of the claim term "rib", it is not appropriate to equate the claimed active mixing ribs of the cap with the passive labyrinth of Carse, despite the fact that both contribute to mixing” (Remarks pg. 11-12).
However, it appears that applicant is reading limitations into the claim. It is noted that the apparatus claim does not define any particular structure for the rib. Since the broad definition of rib is simply “an elongated ridge” (https://www.merriam-webster.com/dictionary/rib), the turns 138a-g in Figure 5A of Carse et al constitute an elongated ridge and thus a rib, as broadly as has been claimed. In other words, there is no evidence that the labyrinth turns of Carse et al do not constitutes a plurality of mixing ribs. While applicant contends that the ”passive” mixing of Carse et al does not constitute “active mixing,” it is noted that the claims do not recite any specific manner of the mixing, other than that the ribs “cause fluids therein to swirl, thereby effecting mixing of the fluids therein.” This function is clearly performed by Carse et al.
In regard to Claim 3, applicant contends that “Carse teaches mixing using a passive labyrinth as discussed in detail hereinabove. The passive labyrinth of Carse would not benefit from addition of gears to provide rotation as taught by North Jr” because it would change the operation of the device (Remarks pg. 13). However, it is noted that the addition of a set of gears for rotating the blood collection tube does not mean the passive mixing of Carse et al cannot still occur, since the user may at times employ passive mixing. The addition of a set of gears to automate mixing would still provide desired advantages to Carse et al by providing additional automated mixing means. Moreover, the claims do not differentiate between “active” vs. “passive mixing,” nor that automated mixing would only constitute “active” mixing.
Furthermore, MPEP 2123 II states that “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Therefore, the rejection is maintained.
It is noted that Blekher et al has been maintained in the rejection because Claim 1 still recites that the chamber includes a plurality of mixing ribs, see new 112 rejection above.
The previous Drawing Objections and 112 rejections are withdrawn in light of applicant’s response/amendment. The Drawing and Specification amendment are also acknowledged and Entered.
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791