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 .
Claim Status
Claims 1-8, 10 and 13-14 are rejected.
Claims 9 and 11-12 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species B, as shown in Fig. 5 and Species a, as shown in Figs. 2A-2D, in the reply filed on September 14, 2026, is acknowledged.
Applicant indicated that claims 1-8, 10 and 12-14 are drawn to the elected species. Claim 12 is drawn to Species C, as shown in Fig. 6, and is therefore, withdrawn. Accordingly, claims 9 and 11-12 are withdrawn from further consideration because they are drawn to non-elected species.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-4, 6-8, 10 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guirguis (US 4,953,561).
With respect to claim 1, Guirguis discloses a testing device, as shown in Fig. 1, including the method steps of: urging a volume of the fluid from a sample container 11 (first reservoir) to a syringe 18 (second reservoir) through a port 38 (fluid channel), as shown in Figs. 1-2; passing the fluid and a volume of beads 50 (desiccant) between the first and second reservoirs 11, 18, until one or more components from the fluid are absorbed by the desiccant 50 (see col. 4, lines 47-65); and withdrawing the fluid through a port 36 (withdrawal channel) which is in fluid communication with the fluid channel 38 while preventing the desiccant 50 from passing into the withdrawal channel 36, as shown in Fig. 3.
With respect to claim 3, Guirguis discloses wherein urging the volume of the fluid comprises passing the volume from a first syringe 18 to a second syringe through the fluid channel defined through an end 14 (manifold) (see col. 5, lines 19-22).
With respect to claim 4, Guirguis discloses wherein passing the fluid and the volume of desiccant 50 comprises introducing desiccant beads 50, as shown in Figs. 1-2.
With respect to claim 6, Guirguis discloses wherein withdrawing the fluid comprises releasing a barrel 20 (valve) such that the withdrawal channel 36 comes into fluid communication with the fluid channel 38, as shown in Fig. 2.
With respect to claim 7, Guirguis discloses preventing the desiccant 50 from passing comprises passing the fluid through a filter or frit 12 such that the desiccant 50 is inhibited from entering into the withdrawal channel 36, as shown in Figs. 1-2.
With respect to claim 8, Guirguis discloses collecting the fluid from the withdrawal channel 36 via a collection syringe 18, as shown in Fig. 2.
With respect to claim 10, Guirguis discloses withdrawing the fluid comprises withdrawing from the withdrawal channel 36 by inducing a pressure into each of the first and second reservoirs 11, 18, as shown in Fig. 2.
With respect to claim 13, Guirguis discloses wherein urging the volume of fluid further comprises retaining the desiccant 50 within an end 14 (manifold) between the first reservoir 11 and the second reservoir 18 prior to passing the fluid and the volume of desiccant 50 between the first and second reservoirs 11, 18, as shown in Fig. 1.
With respect to claim 14, Guirguis discloses wherein the volume of fluid further comprises retaining the desiccant 50 within the first or second reservoir 11, 18, prior to passing the fluid and the volume of desiccant 50 between the first and second reservoirs 11, 18, as shown in Figs. 1-2.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Guirguis (US 4,953,561).
With respect to claim 2, Guirguis does not disclose wherein the volume of fluid comprises blood plasma or PRP. However, Guirguis discloses an apparatus for detecting the presence of specific antigens in biological fluids (see col. 1, lines 9-12 and col. 5, lines 38-39) and that it is generally necessary in diagnosing and testing for many diseases to collect biological fluids from a patient, such as blood, for analysis (see col., lines 35-38). Guirguis teaches that the invention can be used for any body fluid (see col. 3, lines 61-66). It would have been obvious to one of ordinary skill in the art to use the apparatus disclosed by Guirguis to test blood plasma or PRP, as claimed by applicant, in order analyze for diagnosing and testing diseases (see col., lines 35-38) and since Guirguis already suggests that the apparatus can be used for testing any biological fluids (see col. 3, lines 61-66), and blood plasma or PRP are known biological fluids.
With respect to claim 5, Guirguis does not disclose wherein passing the fluid and the volume of desiccant comprises passing the fluid for a period of 30 sec. to 2 min. However, Guirguis teaches that beads 50 can capture the antigen present in 100 ml or even more of the sample, depending on the frequency of filling and emptying the syringe 18 and this will result in 500.times. fold increase in the amount of antigen being captured by the beads (see col. 4, lines 66-68 and col. 5, lines 1-9). It would have been obvious to one of ordinary skill in the art to pass the fluid for a period of 30 sec. to 2 min, since one of ordinary skill would recognize to choose the amount of time to pass the fluid to the syringe according to a desired application.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8, 10 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,605,498. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 12,605,498 recites the claimed subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Leach et al. (US 2014/0071787) discloses a clotting serum preparation and isolation device having desiccating beads. Melsheimer et al. (US 2009/0247985) discloses a syringe device having multiple syringes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE GONZALEZ whose telephone number is (571)272-5502. The examiner can normally be reached M-F 9-5:30.
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/MADELINE GONZALEZ/Primary Examiner, Art Unit 1773
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