DETAILED CORRESPONDENCE
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 I in the reply filed on 3/23/26 is acknowledged, and the examiner notes that applicants have amended the claims. 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)).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/8/23, 2/6/24, 3/2/26 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The examiner notes that applicants have made statements regarding the consideration of various co-pending applications. The examiner notes that 37 CFR 1.98(a)(2)(iii) deals with unpublished applications and that MPEP 609.04(a) states that ‘If a U.S. application being listed in an IDS has been issued as a patent or has been published, the applicant should list the patent or application publication in the IDS instead of the application.’. If there are references/documents that have been cited in the co-pending application that applicant deems relevant to the instant application, then it is applicants responsibility to list those documents/references in the IDS of the instant application.
Claim Status
Claims 1, 4-6, 9-13, 22-35, 48, 60, 67-68 are pending, with claims 1, 4-6, 9-12, 67-68 being examined and claims 13, 22-35, 48, 60 deemed withdrawn.
Drawing Objections
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “desiccant” in claim 10, the “desiccant has a tubular shape and a portion of the conduit passes through the desiccant” of claim 10, and the “desiccant engages with an inner surface of the wall of the vessel and supports the conduit in the vessel” of claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 4-6, 9-12, 67-68 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 pre-AIA the applicant regards as the invention.
Regarding the last line of claim 1, it is unclear where the external environment is and is unclear how the external environment is related to or connected to the internal space or vessel. The amended claims recite a vessel, but it is unclear how fluid moves from the vessel to an external environment without clarification because a vessel is typically a walled off and sealed structure as known in the art. Are there other structures or outlets required in the vessel to achieve the recited function? Also, it is unclear what the difference between a fluid and blood sample is. A blood sample is recited as being moved to the internal space, and then fluid is described as moving from the internal space. However, the fluid is recited separately from blood, and it is unclear what the fluid is and also unclear whether or not the blood could also be the fluid.
Claims 4-6, 9-12, 67-68 are rejected based on further claim dependency.
Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-6, 67 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Robbins et al (US 2022006182; hereinafter “Robbins”; already of record).
As to claim 1, Robbins teaches a sample holder (Robbins; Fig. 1-13) comprising:
a vessel having a wall with an outer surface and defining an internal space (Robbins teaches vessel 14/18; Fig. 1-13, [74-75, 82, 96-98, 109-113]);
a conduit having a distal end positioned in the internal space and a proximal end extending from the internal space, the conduit configured to receive a blood sample into the proximal end of the conduit (Robbins teaches a conduit 15 with the distal end in the container 18 and with a proximal end extending away from 18 where the conduit receives blood from 12/20; Fig. 1-3, 10, [78, 85, 86, 103]); and
a cap configured to receive the proximal end of the conduit and configured to move relative to the vessel such that movement of the cap relative to the vessel from a first position toward a second position causes fluid pressure suitable to move a blood sample from the conduit into the internal space and to move fluid from the internal space to an external environment (Robbins teaches cap 16 which receives conduit 15, and moves toward the vessel to cause the blood to move into the space within 18, and where fluid can be vented; Fig. 1-3, 10-12, [88-89, 109-113]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 4, Robbins teaches the sample holder of claim 1, wherein the cap includes a cavity configured to receive a portion of the vessel to engage the cap with the vessel (Robbins teaches cap 16 having a cavity which receives a portion of the vessel 14; Fig. 1-3, 10-12, [80, 90]).
As to claim 5, Robbins teaches the sample holder of claim 4, wherein the cap and the vessel are configured to create a pressure above ambient pressure in response to movement of the portion of the vessel into the cavity (Robbins teaches that closing the cap increases pressure to move fluid to the cavity; [88, 89, 108, 110]).
As to claim 6, Robbins teaches the sample holder of claim 5, wherein the cavity is configured to receive the proximal end of the conduit when the cap is engaged with the vessel, and the pressure above ambient pressure is suitable to force a blood sample in the conduit to move through the distal end and into the internal space (Robbins teaches that closing the cap increases pressure to move fluid to the cavity; [88, 89, 108, 110]. Robbins teaches cap 16 which receives conduit 15, and moves toward the vessel to cause the blood to move into the space within 18, and where fluid can be vented; Fig. 1-3, 10-12, [88-89, 109-113]).
As to claim 67, Robbins teaches the sample holder of claim 1, further comprising a conduit holder arranged to support the conduit in the internal space of the vessel (Robbins teaches the conduit 15 is in 14; [78], Fig. 1-3, 10).
Claims 1, 4-6, 9-10, 67 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kluge et al (US 20210283597; hereinafter “Kluge”; already of record).
As to claim 1, Kluge teaches a sample holder (Kluge teaches various geometries in Fig. 24-32; [211]) comprising: a vessel having a wall with an outer surface and defining an internal space; a conduit having a distal end positioned in the internal space and a proximal end extending from the internal space, the conduit configured to receive a blood sample into the proximal end of the conduit; and a cap configured to receive the proximal end of the conduit and configured to move relative to the vessel such that movement of the cap relative to the vessel from a first position toward a second position causes fluid pressure suitable to move a blood sample from the conduit into the internal space and to move fluid from the internal space to an external environment (Kluge teaches a vessel as the bottom portion of Fig. 24, and a conduit capillary funnel at the top of the vessel and shown in the middle of Fig. 24 which collects blood at the top; [210]. See also various configurations in Fig. 24-32; [211]. As best understood, Kluge teaches a cap at the top which one pressed pushes the can apply pressure to fluid; [212, 222]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 4, Kluge teaches the sample holder of claim 1, wherein the cap includes a cavity configured to receive a portion of the vessel to engage the cap with the vessel (Kluge teaches the cap receiving the vessel; Fig. 24-32).
As to claim 5, Kluge teaches the sample holder of claim 4, wherein the cap and the vessel are configured to create a pressure above ambient pressure in response to movement of the portion of the vessel into the cavity (Kluge teaches a cap at the top which, one pressed, pushes the can apply pressure to fluid; [212, 222]).
As to claim 6, Kluge teaches the sample holder of claim 5, wherein the cavity is configured to receive the proximal end of the conduit when the cap is engaged with the vessel, and the pressure above ambient pressure is suitable to force a blood sample in the conduit to move through the distal end and into the internal space (Kluge teaches a cap at the top which, one pressed, pushes the can apply pressure to fluid; [212, 222]. See Fig. 24-32)
As to claim 9, Kluge teaches the sample holder of claim 1, wherein the conduit includes a capillary tube configured to draw a blood sample into the capillary tube by contacting blood to the proximal end (Kluge teaches a conduit capillary funnel; [210]).
As to claim 10, Kluge teaches the sample holder of claim 1, further comprising a desiccant in the internal space configured to dry a blood sample enclosed in the internal space (Kluge teaches a desiccant; [210]).
As to claim 67, Kluge teaches the sample holder of claim 1, further comprising a conduit holder arranged to support the conduit in the internal space of the vessel (Kluge teaches the funnel material as a holder which forms/holds the conduit; Fig. 24, [210-212]).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Robbins et al (US 2022006182; hereinafter “Robbins”; already of record).
As to claim 68, Robbins teaches the sample holder of claim 67, with the conduit holder (see claim 67 above).
Robbins does not specifically teach the conduit holder comprises a transparent material that permits a user to see the conduit. However, Robbins also teaches that transparent materials are advantageous to provide viewing of container contents (Robbins; [168, 169]). It would have been obvious to one of ordinary skill in the art to have modified the conduit holder of Robbins to have been transparent as suggested by Robbins because Robbins teaches that it is well-known to use laboratory vessels and components that are transparent so that the contents are easily viewable (Robbins; [168]) and because Robbins teaches that it is well known to make laboratory containers/components out of transparent materials (Robbins; [169]).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Robbins et al (US 2022006182; hereinafter “Robbins”; already of record) in view of Anderson et al (US 20190168210; hereinafter “Anderson”; already of record).
As to claim 9, Robbins teaches the sample holder of claim 1, where the conduit includes a tube to draw blood to the proximal end (Robbins; Fig. 1-3, 10, [78, 85, 86, 103]).
Robbins does not specifically teach the conduit includes a capillary tube configured to draw a blood sample into the capillary tube by contacting blood to the proximal end. However, Anderson teaches the analogous art of collecting fluid samples (Anderson; [331]), including blood where blood is collected via capillary action in a tube (Anderson; [117, 278], Fig. 6). It would have been obvious to one of ordinary skill in the art to have modified the tube that moves blood from the distal end to the proximal end of Robbins to have been a capillary tube to draw blood as in Anderson because Anderson teaches that it is well-known to draw blood samples via a capillary tube (Anderson; [278], Fig. 6).
As to claims 10-12, Robbins teaches the sample holder of claim 1, where the conduit has an internal space through which the blood sample flows, and that the conduit holder engages with an inner surface of the wall of the vessel to support the conduit in the vessel, where the conduit 15 is in conduit holder 14 (Robbins; Fig. 1-3, 10, [78, 85, 86, 103], see also claim 1 above).
Robbins does not teach a desiccant in the internal space configured to dry a blood sample enclosed in the internal space, or that the desiccant has a tubular shape and a portion of the conduit passes through the desiccant, or that the desiccant engages with an inner surface of the wall of the vessel and supports the conduit in the vessel. However, Anderson teaches the analogous art of collecting fluid samples in a conduit (Anderson; [331]), and a desiccant in the internal space configured to dry a blood sample enclosed in the internal space, or that the desiccant has a tubular shape and a portion of the conduit passes through the desiccant, or that the desiccant engages with an inner surface of the wall of the vessel and supports the conduit in the vessel (Anderson teaches conduit 24 enclosed by desiccant 18 which is tubular and inside the inner surface of the container 23; [278, 279], Fig. 6). It would have been obvious to one of ordinary skill in the art to have modified the conduit holder that supports the conduit of Robbins to have been formed of a desiccant material as in Anderson because Anderson teaches that using a desiccant helps to dry the sample (Anderson; [241, 254]) and that drying the sample with a desiccant helps to render the sample stable for transport and storage (Anderson; [275, 304]).
Claim 68 is rejected under 35 U.S.C. 103 as being unpatentable over Kluge et al (US 20210283597; hereinafter “Kluge”; already of record).
As to claim 68, Kluge teaches the sample holder of claim 67, with the conduit holder (Kluge teaches the funnel material as a holder which forms/holds the conduit; Fig. 24, [210-212]).
Kluge does not specifically teach the conduit holder comprises a transparent material that permits a user to see the conduit. However, Kluge also teaches that transparent materials are advantageous to provide viewing of container contents (Kluge; [172]). It would have been obvious to one of ordinary skill in the art to have modified the conduit holder of Kluge to have been transparent as suggested by Kluge because Kluge teaches that it is well-known to use laboratory vessels and components that are transparent so that the contents are easily viewable and can aid in the metering of the sample (Kluge; [172]).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kluge et al (US 20210283597; hereinafter “Kluge”; already of record) alone or in view of Anderson et al (US 20190168210; hereinafter “Anderson”; already of record).
As to claims 11-12, Kluge teaches the sample holder of claim 10, with the conduit holder including a capillary tube (Kluge teaches a conduit capillary funnel; [210]), and where a portion of the conduit passes through the desiccant, and the desiccant engages with an inner surface of the wall (Kluge; Fig. 24-32; [210-212]).
Kluge does not teach that the desiccant has a tubular shape and supports the conduit in the vessel. However, Kluge does teach various shapes of the vessel and where the desiccant is in a tubular compartment (Kluge; [210-212], Fig. 24-32). It would have been obvious to change the shape of the desiccant of Kluge to have been tubular to provide the advantage of filling the entire tubular compartment in Kluge and also to help support the conduit since it has been held that changes in shape are not patentably distinct from prior art (MPEP 2144.04 IV). However, Anderson teaches the analogous art of collecting fluid samples in a conduit (Anderson; [331]), and a desiccant has a tubular shape and supports the conduit in the vessel (Anderson teaches conduit 24 enclosed by desiccant 18 which is tubular and inside the inner surface of the container 23; [278, 279], Fig. 6). It would have been obvious to one of ordinary skill in the art to have modified the conduit holder that supports the conduit of Kluge to have been formed of a desiccant material to support the conduit as in Anderson because Anderson teaches that using a desiccant helps to dry the sample (Anderson; [241, 254]) and that drying the sample with a desiccant helps to render the sample stable for transport and storage (Anderson; [275, 304]), and further because it has been held that changes in shape are not patentably distinct from prior art (MPEP 2144.04 IV).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Seymour, E (US 5494646; hereinafter “Seymour”; already of record) teaches a capillary collector which collect blood at the bottom of 1215 in Fig. 35 and then presses cap 1211 shown in Fig. 37 which moves the blood up through conduit with vent and into the vessel as the upper portion 1218.
Kluge et al (US 20210283597; hereinafter “Kluge”; already of record) teaches that a cap placing positive and negative pressure on the fluid are obvious variants; [222, 223].
Kloth, B (US 5833630; hereinafter “Kloth”; already of record) teaches blood at a peripheral end and then placing cap on the device to move fluid through the capillary holder into the vessel; Fig. 3-8.
Steiner et al (US 20200029878; hereinafter “Steiner”; already of record) teaches a cap pressed onto a capillary collection conduit which then moves the fluid into a vessel at the bottom; Fig. 1-2.
Luotola et al (US 20110020195; hereinafter “Luotola”; already of record) teaches a holder for conduit; Fig. 1-23.
Ivosevic et al (US 20160100783; hereinafter “Ivosevic”; already of record) teaches a holder for conduit; Fig. 1-23.
Morrison et al (US 20160100783; hereinafter “Morrison”; already of record) teaches a blood capillary to draw blood and a vacuum of negative suction pressure to pull fluid into vessel; Fig. 1-18. The device is transparent; [33].
McDade et al (US 20230074519; hereinafter “McDade”) teaches a desiccant built into the container to facilitate drying of the sample; [13].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of copending Application No. 18637702 (‘702). Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of ‘702 teaches a sample holder (see claim 1 of ‘702) comprising: a vessel having a wall with an outer surface and defining an internal space (see the vessel with a wall and internal space of claim 1 of ‘702 where any wall would also have an outer surface); a conduit having a distal end positioned in the internal space and a proximal end extending from the internal space, the conduit configured to receive a blood sample into the proximal end of the conduit (see the conduit with distal and proximal end of claim 1 of ‘702. Claim 10 of ‘702 teaches the sample is blood); and a cap configured to receive the proximal end of the conduit and configured to move relative to the vessel such that movement of the cap relative to the vessel from a first position toward a second position causes fluid pressure suitable to move a blood sample from the conduit into the internal space and to move fluid from the internal space to an external environment (In as much as claimed and as best understood, claim 1 of ‘702 teaches a cap moving relative to the vessel to cause pressure to move the blood into the internal space). Thus, all of the elements of the invention recited in the instant claims are encompassed by the claims of copending Application No. 18637702 (‘702).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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