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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-11 in the reply filed on 12/24/2025 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)).
See attached Interview Summary regarding the Applicant’s election without traverse of species A. 1. Affirmation of this election must be made by applicant in replying to this Office action.
Claims 1-11 are being examined.
Claim Objections
Claim 6 is objected to because of the following informalities: “6. 6.” in L1. Appropriate correction is required.
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 8-10 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.
Claims 8-10 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Claim 8 is unclear reciting “wherein the second end of the cannula is adapted to couple to a filter unit, wherein the filter unit includes a binding agent configured to selectively bind with the selected antigen, wherein the first chamber is configured to receive the sample after the sample passes through the filter unit, wherein the second chamber includes a conjugation agent configured to selectively target the bound antigen, wherein the third chamber includes a detection agent configured to bind to the conjugation agent” because it is unclear if the limitations following the “adapted to” are part of the claimed invention. In addition, claims 8-10 are unclear reciting “configured to”, because it is unclear what structural configurations are being claimed.
Claim limitation adapted to/configured to [...] has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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 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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Lynn et al. (US 5,743,886).
Regarding claim 1, Lynn et al. teach:
1. A multistage fluidic device comprising:
a housing (e.g., syringe 5) comprising a tubular body (e.g., syringe barrel 10) including a first end (i.e., an end of a secondary reservoir 68) and a second end (i.e., an end of a primary reservoir 66), wherein the tubular body includes an inner surface that defines an inner volume (e.g., main bore 22, see Figs. 1-3 for example);
a first sealing member (e.g., distal tip 18) fixedly secured to the tubular body at or near the first end (see Figs. 6B-6C, 10-13, 15-16 for example);
a cannula (e.g., needle or cannula 111) including a first end (i.e., upper end of 111) and a second end (i.e., lower end of 111), wherein the cannula is disposed through the first sealing member (see Fig. 6C for example), wherein the first end of the cannula resides in the inner volume of the housing, and wherein the second end of the cannula extends outwardly of the housing to an external environment (see Fig. 6C & C11/L51-C12/L67 for example);
a plunger (e.g., handle 34) slidably received within the inner volume of the housing proximate to the second end (see C7/L1-8 & Figs. 1, 6C, 7 for example); and
a plurality of spaced apart moveable septums (e.g., main piston 38, cylinder divider piston 58) located within the inner volume of the housing between the first sealing member and the plunger to divide the inner volume into a plurality of chambers (see Fig. 2 for example), wherein each of the plurality of moveable septums are sealingly engaged with the inner surface of the housing (see C7/L1-8; C10/L12-67; C11/L51-C12/L67 for example),
wherein the plurality of spaced apart moveable septums includes a first septum (e.g., cylinder divider piston 58) and a second septum (e.g., main piston 38),
wherein the plurality of chambers includes a first chamber (e.g., container 140, vials 250, 260), a second chamber (e.g., secondary reservoir 68), and a third chamber (e.g., primary reservoir 66),
wherein the first chamber (140, 250, 260) is defined between the first sealing member and the first septum (see Figs. 6C, 7, 10-13 for example),
wherein the second chamber (68) is defined between the first septum and the second septum (see Figs. 6C, 7 for example), and
wherein the third chamber (66) is defined between the second septum and the plunger (see Figs. 6C, 7 for example), and
wherein the first end of the cannula resides within the first chamber and a hollow bore defined by the cannula is capable of providing fluid communication between the inner volume of the housing and the external environment (see Figs. 6C, 7, 10-13 for example).
Regarding claim 1, Lynn et al. meet all the structural limitations recited by the instant invention. Applicant’s preamble recites “for performing biomarker detection of a sample targeting a selected antigen”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding claims 2-3, Lynn et al. teach:
2. The device in accordance with claim 1 wherein the first end of the cannula is tapered to a pointed terminus (e.g., needle or cannula 111), and wherein the pointed terminus is configured to puncture at least one of the first septum and the second septum (see Figs. 6C-7, 10-13 for example).
3. The device in accordance with claim 2 wherein the cannula defines an inlet aperture located at a spaced distance from the pointed terminus, and wherein the inlet aperture is capable of providing the fluid communication between the inner volume of the housing and the external environment (see Figs. 6C-7, 10-13 for example).
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(s) 4 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn et al. (US 5,743,886) in view of Lynn (US 4,838,855) and/or Lynn (US 5,178,607).
Regarding claim 4, Lynn et al. further teach: 4. The device in accordance with claim 1 wherein each of the plurality of spaced apart moveable septums is comprised of rubber (C10/L12-35). In addition, incorporated references (C13/L12-40+), U.S. Pat. No. 4,838,855 by Lynn and U.S. Pat. No. 5,178,607 by Lynn et al. teach a septum (136) made of silicone rubber (‘855 C8/L49-64; ‘607 C11/L58-62, C17/L21-31, C18/L58-66). However, Lynn et al. do not explicitly teach the rubber is silicone rubber.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the moveable septums of Lynn et al., with silicone rubber, as taught by ‘855 and ‘607, as 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.
Regarding claim 5, modified Lynn et al. further teach: 5. The device in accordance with claim 4 wherein each of the plurality of spaced apart moveable septums is comprised of silicone rubber supported by a frame providing structural support to the respective septum (syringe is molded C16/L33-43, wherein the syringe body and distal tapered portion provide structural support for the pistons, see Figs. 1-2 for example). Regarding the product by process limitation e.g., an injection molded frame, is given little patentable weight in the product claim. Even though a product-by-process is defined by the process steps by which the product is made, determination of patentability is based on the product itself and does not depend on its method of production. In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). As the court stated in Thorpe, 777 F.2d at 697, 227 USPQ at 966 (The patentability of a product does not depend on its method of production. In re Pilkington, 411 F.2d 1345, 1348, 162 USPQ 145, 147 (CCPA 1969). If the product in a product-by-process claim is the same or obvious as the product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.), see MPEP 2113 and 2114. Therefore, since the device as recited in claim 5 is the same as the device disclosed by modified Lynn et al., as set forth above, the claim is unpatentable. In re Marosi, 710 F2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn et al. (US 5,743,886) in view of Schreuder (US 4,792,329).
Regarding claim 6, Lynn et al. further teach: 6. The device in accordance with claim 1 further comprising a third septum (e.g., container septum, C11/L51-67). Although Lynn et al. teach a mixing syringe having three separate stoppers for mixing and subsequently injecting two solutions is known (C2/L57-60, U.S. Pat. No. 4,792,329 Schreuder), Lynn et al. do not explicitly teach: that the third septum is located within the inner volume and disposed between the first septum and the second septum, wherein the third septum divides the second chamber into a fourth chamber and a fifth chamber.
Schreuder teaches a multistage fluidic device comprising a third septum (23) that is located within an inner volume and disposed between a first septum (20) and a second septum (12), wherein the third septum divides the inner volume (see Figs. 1-3; C9/L21-39; C10/L45-C11/L27).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Lynn et al. with the teachings of Schreuder in order to mix multiple solutions and a sample (Schreuder C4/L38-49, Lynn et al. C2/L57-60), and for sequential fluid withdrawal or for presetting the volume (Lynn et al. C2/L25-C3/L21+).
Regarding claim 7, modified Lynn et al. do not explicitly teach: 7. The device in accordance with claim 6 further comprising a fourth septum located within the inner volume and disposed between the second septum and the plunger, wherein the fourth septum divides the third chamber into a sixth chamber and a seventh chamber. However, addition of septum for dividing the inner volume, and a wash reagent in a chamber would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the device of Lynn et al. with a fourth septum located within the inner volume for sequential fluid withdrawal or for presetting the volume (C2/L25-C3/L21+). Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn et al. (US 5,743,886) in view of Egan et al. (US 2008/0199851).
Regarding claim 8, Lynn et al. do not explicitly teach: 8. The device in accordance with claim 1 wherein the second end of the cannula is couple to a filter unit.
Egan et al. teach a device wherein an end of a cannula is couple to a filter unit (¶ 0101-0102).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Lynn et al. with a filter coupled to a cannula, as taught by Egan et al. to filter and/or further process the sample (Egan et al. ¶ 0101-0102).
With regard to limitations in claims 8-10 (e.g., [...] to couple to a filter unit, wherein the filter unit includes a binding agent configured to selectively bind with the selected antigen, wherein the first chamber is configured to receive the sample after the sample passes through the filter unit, wherein the second chamber includes a conjugation agent configured to selectively target the bound antigen, wherein the third chamber includes a detection agent configured to bind to the conjugation agent, 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)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). 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 claim 9, Lynn et al. further teach: 9. The device in accordance with claim 8 further comprising a third septum (e.g., container septum, C11/L51-67), wherein the second chamber includes a first wash buffer (see a solution drawn into the secondary reservoir 68” in Figs. 12-13, 15-16 & C14/L58-C15/L46, C16/L55-C18/L6+; and placement of different solutions C7/L9-22 for example; see also the use of a flush solution C3/L13-19+. Although Lynn et al. teach a mixing syringe having three separate stoppers for mixing and subsequently injecting two solutions is known (C2/L57-60, U.S. Pat. No. 4,792,329 Schreuder), Lynn et al. do not explicitly teach: that the third septum is located within the inner volume and disposed between the first septum and the second septum, wherein the third septum divides the second chamber into a fourth chamber and a fifth chamber, wherein the fourth chamber includes a first wash buffer.
Schreuder teaches a multistage fluidic device comprising a third septum (23) that is located within an inner volume and disposed between a first septum (20) and a second septum (12), wherein the third septum divides the inner volume (see Figs. 1-3; C9/L21-39; C10/L45-C11/L27).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Lynn et al. with the teachings of Schreuder in order to mix multiple solutions and a sample (Schreuder C4/L38-49, Lynn et al. C2/L57-60), and for sequential fluid withdrawal or for presetting the volume (Lynn et al. C2/L25-C3/L21+). With respect to the limitation: wherein the third septum divides the second chamber into a fourth chamber and a fifth chamber, modified Lynn et al. would teach this limitation.
Regarding claim 10, modified Lynn et al. do not explicitly teach: 10. The device in accordance with claim 9 further comprising a fourth septum located within the inner volume and disposed between the second septum and the plunger, wherein the fourth septum divides the third chamber into a sixth chamber and a seventh chamber, wherein the sixth chamber includes a second wash buffer. However, addition of septum for dividing the inner volume, and a wash reagent in a chamber would have been obvious to one having ordinary skill in the art at the time the invention was made to further modify the device of Lynn et al. with a fourth septum located within the inner volume for sequential fluid withdrawal or for presetting the volume (C2/L25-C3/L21+). Mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. With respect to the second wash buffer, see a solution drawn into the secondary reservoir 68” in Figs. 12-13, 15-16 & C14/L58-C15/L46, C16/L55-C18/L6+; and placement of different solutions C7/L9-22 for example; see also the use of a flush solution C3/L13-19+.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lynn et al. (US 5,743,886).
Regarding claim 11, Lynn et al. further teach: 11. The device in accordance with claim 1 wherein a moveable septum includes an actuatable valve (e.g., 505), wherein the actuatable valve on the first septum is actuated by the first end of the cannula (see Figs. 15-22 & C13/L12-65). However, Lynn et al. do not explicitly teach: 11. The device in accordance with claim 1 wherein each of the plurality of spaced apart moveable septums includes an actuatable valve, and wherein each successive actuatable valve of each successive spaced apart moveable septum is actuated by the actuatable valve of its immediately preceding spaced apart moveable septum.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Lynn et al. with each of the plurality of spaced apart moveable septums includes an actuatable valve, and wherein each successive actuatable valve of each successive spaced apart moveable septum is actuated by the actuatable valve of its immediately preceding spaced apart moveable septum, for sequential fluid withdrawal or for presetting the volume (Lynn et al. C2/L25-C3/L21+), and to mix multiple solutions and a sample (Lynn et al. C2/L57-60).
Conclusion
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.
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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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798