DETAILED 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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/02/2025 has been entered.
The general policy of the Office is not to permit the applicant to shift to claiming another invention after an election is once made and action given on the elected subject matter. Note that the applicant cannot, as a matter of right, file a request for continued examination (RCE) to obtain continued examination on the basis of claims that are independent and distinct from the claims previously claimed and examined (i.e., applicant cannot switch inventions by way of an RCE as a matter of right). When claims are presented which the examiner holds are drawn to an invention other than the one elected, he or she should treat the claims as outlined in MPEP § 821.03.
Election/Restrictions
Newly submitted claim 80 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Inventions claim 68 and claim 80 are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because claim 68 does not require the test cartridge comprising a pair of plate carriers configured to hold a pair of plates substantially parallel with a small gap in between, the pair of plate carriers defining the blood introduction channel of the test cartridge, and the subcombination has separate utility such as a plate carrier. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above (see also the 12/12/2024 Restriction Requirement) and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries); (d) the prior art applicable to one invention would not likely be applicable to another invention; and (e) the inventions are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112, first paragraph.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 80 has been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 68 is objected to because of the following informalities: Examiner suggests amending “the blood introduction apparatus” to read “the disposable blood introduction apparatus”. Appropriate correction is required.
Claim Interpretation
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. In the specification as originally filed at P23/L5-9 states: All exemplary dimensions shown in FIG. 13 and FIG. 14 are in millimeters (mm). In one example, the diameter of inlet 168 of disposable blood introduction device 160 is about 8 mm, the diameter of outlet 170 is about 1.5 mm, and the narrowest portion of fluid channel 162 has a diameter of about 0.6 mm (see FIG.14). However, the claim does not specify dimensions of the capillary, and it is known that capillary action for blood in vitro varies with parameters such as, the viscosity and composition of the blood, as well as the channel geometry and surface properties. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore the term ‘capillary’ is given its broadest reasonable interpretation as a tube having a very small bore, as defined by Merriam-Webster, see Applicant’s Remarks P10.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 68, 69, 72-74, 79 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Braun, Sr. et al. (US 6,613,286).
Regarding claim 68, Braun, Sr. et al. teach:
68. A disposable blood introduction apparatus (e.g., syringe 22) for the introduction of a predetermined amount of blood into a test cartridge (e.g., 10; see i.e., a syringe 22 is used to fill the cartridge 10 with a liquid to be tested C8/L1-2; see also the liquid sample being tested is human blood, each fluid receiving chamber 32A, 32B, 32C, etc. will preferably have a volume of about 100 μl to about 250 μl, C9/L29-31) having a blood introduction channel (e.g., injection port 24), the disposable blood introduction apparatus comprising:
an open top defining an inlet of the blood introduction apparatus (see annotated Fig. 14);
a lower cylindrical portion (see annotated Fig. 14) configured to be removably fitted within the blood introduction channel of the test cartridge (see i.e., A syringe 22 is depicted as being threaded into an injection port 24 in the cartridge 10(B). It could be compression fitted as well. Such a compression fit also could be augmented by use of a locking device that mechanically connects the syringe 22 to the injection port 24. C13/L5-9; see also FIG. 5 is a side view of the cartridge shown in FIG. 2 with a syringe attached to said cartridge, C7/L6-7), the lower cylindrical portion comprising a capillary (i.e., tube having a very small bore; see i.e., a syringe 22 is used to fill the cartridge 10 with a liquid to be tested C8/L1-2; see also the liquid sample being tested is human blood, each fluid receiving chamber 32A, 32B, 32C, etc. will preferably have a volume of about 100 μl to about 250 μl, C9/L29-31) defining an outlet of the blood introduction apparatus (see annotated Fig. 14);
a funnel shaped portion extending downward from the open top to the lower cylindrical portion (see annotated Fig. 14); and
a fluid channel extending through the disposable blood introduction apparatus and configured to fluidicly couple the inlet and the outlet (see annotated Fig. 14),
wherein, when the lower cylindrical portion is removably fitted within the blood introduction channel of the test cartridge such that the capillary is in contact with the blood introduction channel of the test cartridge, blood introduced through the inlet is capable of being moved through the funnel shaped portion and out the outlet of the capillary into the blood introduction channel of the test cartridge (see i.e., The fluid injection can be done manually or automatically through an injection port in said cartridge. Loading the cartridge by means of a syringe is a preferred method of introducing a liquid such as a blood sample into the cartridge. C3/L38-42), and
wherein a diameter of the inlet of the open top is larger than a diameter of the outlet (see annotated Fig. 14).
Annotated Fig. 14 of Braun, Sr. et al. (US 6,613,286)
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With regard to limitations in claims 68, 70, 71, 79, (e.g., [...] disposable [...]; [...] wherein, when [...] blood introduced through the inlet moves through the funnel shaped portion and out the outlet of the capillary into the blood introduction channel of the test cartridge via capillary action until the test cartridge is filled with the predetermined amount of blood [...]; [...] to prevent movement of blood, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 69, 72-74, 79, Braun, Sr. et al. teach:
69. The blood introduction apparatus of claim 68, further comprising: a solid plug cap (i.e., plunger of the syringe 22) attached to the blood introduction apparatus and configured to transition between an open state and a closed state, wherein the solid plug cap is configured to sealingly nest within the inlet of the open top in the closed state (see Fig. 5 for example).
72. The blood introduction apparatus of claim 68, further comprising a pair of alignment features disposed on the funnel shaped portion (see i.e., threads of the threaded nose 25; see also bayonet lock C13/L3-15), the pair of alignment features configured to be fitted against the test cartridge when the outlet is fitted within the blood introduction channel of the test cartridge (see Fig. 14 & C13/L13-15).
73. The disposable blood introduction apparatus of claim 68, further comprising a lip attached to an upper portion of the funnel shaped portion (see annotated Fig. 14).
74. The blood introduction apparatus of claim 68, wherein a wall of the funnel shaped portion gradually tapers from the inlet towards the outlet (see Fig. 14 for example).
79. The blood introduction apparatus of claim 68, wherein the diameter of the outlet is sized and shaped capable of preventing movement of blood (Abstract+) from the blood introduction apparatus into the test cartridge unless the blood introduction apparatus is in contact with the blood introduction channel of the test cartridge (see C3/L31-42 for example).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 70-71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braun, Sr. et al. (US 6,613,286) in view of Pal et al. (US 2006/0259118), or Clague et al. (US 2005/0233460).
Regarding claims 70-71, Braun, Sr. et al. teach the use of a plastic or acrylic material. However, Braun, Sr. et al. do not explicitly teach: wherein the blood introduction apparatus is formed of a disposable material selected from a group consisting of a polymer and glass; wherein the blood introduction apparatus is formed of a disposable material selected from a group consisting of polyamide, polycarbonate, polypropylene, and polyester.
Pal et al. teach a blood introduction apparatus ; wherein the blood introduction apparatus is formed of a disposable material selected from a group consisting of a polymer and glass (¶ 0186), wherein the blood introduction apparatus is formed of a disposable material selected from a group consisting of polyamide, polycarbonate, polypropylene, and polyester (¶ 0186).
Clague et al. teach: A disposable blood introduction apparatus (e.g., test cartridge 50): wherein the disposable blood introduction apparatus is formed of a disposable material selected from a group consisting of a polymer and glass (¶ 0078+), wherein the disposable blood introduction apparatus is formed of a disposable material selected from a group consisting of polyamide, polycarbonate, polypropylene, and polyester (¶ 0079).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the syringe (blood introduction apparatus) of Braun, Sr. et al., formed of a polymer or glass material, such as polyamide, polycarbonate, polypropylene, or polyester, as taught by Pal et al. (¶ 0186)/Clague et al. (¶ 0078-0079), since polymer materials such as polyamide, polycarbonate, polypropylene, and polyester are notoriously well known in the analytical art as excellent choices for a blood introduction apparatus, because they are inert and readily available. Additionally, the selection of a known material based upon its suitability of intended use would have been within the skill of the art, In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960) & see MPEP 2144.07. The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396.
Response to Arguments
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive.
The Applicant’s arguments and amendments have been considered and have been addressed within the above art rejection(s).
35 USC § 112 rejection to claim 80 has been withdrawn. Examiner notes that the general policy of the Office is not to permit the applicant to shift to claiming another invention after an election is once made and action given on the elected subject matter. Note that the applicant cannot, as a matter of right, file a request for continued examination (RCE) to obtain continued examination on the basis of claims that are independent and distinct from the claims previously claimed and examined (i.e., applicant cannot switch inventions by way of an RCE as a matter of right). When claims are presented which the examiner holds are drawn to an invention other than the one elected, he or she should treat the claims as outlined in MPEP § 821.03.
In response to the Applicant's argument to an open top defining an inlet, Examiner notes that the prior art teaches an open top defining an inlet with sufficient specificity which constitutes an anticipation of the claim, as an open top does not require the inlet/open top body to have an end that is directly exposed to the environment, or limit that the open top precludes a plunger in the body.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., an inlet that is separate from and fluidicly coupled to an outlet of the syringe) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to the Applicant's argument to a capillary defining an outlet, as noted in the Claim Interpretation above, the claim does not specify dimensions of the capillary. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore the term ‘capillary’ is given its broadest reasonable interpretation as a tube having a very small bore, as defined by Merriam-Webster, see Applicant’s Remarks P10.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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, 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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798