DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments/Amendment
Applicant's arguments filed March 26, 2026 have been fully considered but they are not persuasive.
Applicant asserts that “claims 1 and 18 are further amended to recite that the polymeric pins are solid. Support for this amendment may be found in Applicants' specification, paragraph [0057].” The examiner disagrees. Paragraph [0057] of the specification states:
“[0057] The coated pins may be used in various ionization methods, such as in DART (Direct Analysis in Real Time), DESI (Desorption Electrospray Ionization), OPP (Open Port Probe), SELDI (Surface Enhanced Laser Desorption Ionization), MALDI (Matrix-Assisted Laser Desorption Ionization), Liquid Extraction Surface Analysis (LESA), Liquid Microjunction Surface Sampling Probe (LMJ-SSP), or LAESI (laser ablation electrospray ionization). DART and DESI are atmospheric pressure ion source that ionizes gases, liquids and solids in open air under ambient conditions. SELDI and MALDI are soft ionization techniques that use a laser to obtain ions of the analytes. In electrospray-based devices, ions of the extracted or pre-concentrated analytes are generated directly from the edges of the solid substrate by wetting the coated solid substrate with a solvent and applying a high electric field to the wetted substrate.”
The paragraph provides methods that the pins may be used to perform. There is no description in the paragraph of the pins being solid. Therefore, the claims are directed to new matter.
As to the art rejection based upon Kallury, applicant states:
“In contrast to the hollow fibers and membranes disclosed in Kallury, Applicants' claims are directed to solid, polymeric pins having an adsorptive coating for solid phase microextraction. One of ordinary skill in the art, reading Kallury, would simply not be motivated to take Kallury's teaching that hollow fibers are superior to solid coated silica for SPME, to modify a solid polymer pin with an SPME coating.
Accordingly, Kallury does not teach all elements of Applicants independent claims 1 or 18, nor does it lead one of ordinary skill in the art to combine elements to get Applicants' independent claims 1 and 18. Thus, Kallury cannot render these claims or claims 2, 5, 8, 11, 12, 20-21 or 26, depending therefrom, obvious.”
The examiner disagrees. Without acquiescing to applicant’s arguments, even if Kallury does disclose supposed, opined advantages/improvements of the use of hollow fibers (pins) instead of solid fibers (pins). The fact remains that Kallury does disclose that “a typical SPME method employs devices consisting of a fine, solid fused silica fiber coated with a polymeric stationary phase.” [paragraph 0038]. Therefore, the use of solid pins for SPME methods was previously known in the art and the use of such sold fibers is typical, was conventionally known in the art prior to the effective filing date of the instant application. Therefore, choosing to employ solid fibers (pins) does not require any skills and knowledge beyond that of one of ordinary skill in the art. Therefore, the art rejection is hereby maintained.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There is no description of the polymeric pins being solid as now recited or in claims 1 and 18.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims mention one or more analytes of a plurality of samples, analytes of biological samples. However, none of the prior are not positively claimed as structural elements of the apparatus/device. Such are not required to present and do not structurally define the apparatus. All of such are considered as articles or materials intended to be, can be worked upon. However, it is noted that the apparatuses are defined by the positively claimed structural elements listed in the body of the claims.
The various “for…” clauses recited in the claims are directed to intended use. There is no requirement for the apparatuses to be used in any method at all, including that as may be intended by applicant. An owner, operator, possessor, etc. of the apparatus is not required to use the apparatus in any methods, including that as may indented by applicant.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5, 8, 11-12, 18, 20-21, and 26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner fails to locate any description in the originally filed specification of a plurality of polymer pins being solid as now recited in amended claims 1 and 18. See response to Arguments above.
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 1-2, 5, 8, 11-12, 18, 20-21, and 26 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.
As to claims 1, it is unclear how the apparatus comprises a housing because the upper and lower platforms are not required to be structurally connected, joined together as clearly indicated by the phase “adapted to removably join together”. Separated pieces that are not joined together do not define a single housing. The “when” clauses of claims 1-2 are directed to a conditional process step that is never required to occur, be performed. Therefore, it is also unclear what is required of a platform to be considered as “upper” and “lower” because there is no relative basis provided for in the claim. There is no requirement for the upper platform to be above any claimed structural element nor the lower platform to below, lower than any claimed structural element. Therefore, if applicant intends for the apparatus to comprise an actual housing, then the claim should clearly recite “wherein the upper platform is removably joined from above and to the lower platform” Otherwise such “housing” is not clearly structurally defined in the claim. The “when” (conditional process step) should be deleted and it should be clearly recited that at least one of the plurality of solid, polymeric pins of the upper platform is disposed in a well of the plurality of individual wells of the lower platform.
As to claims 1, 2, 11, and claim 26, it is unclear what is the structural nexus of “the polymeric pins”; “at least one pin of the upper platform” (claim 1) ; “each pin” (claim 2); and “the pins” (claim 11 and claim 26) to each other and the “a plurality of solid, polymeric pins” previously recited in claim 1. If all of such are the same, then consistent terminology should be employed to clearly indicate such.
As to claims 1-2, it is unclear what is the structural nexus of “a well of the lower platform” in the last line of the 4th paragraph of claim 1 and the last line of claim 2 to each other and to the previously recited “a plurality of individual wells” previously recited in claim. It is unclear if the “a well” is amongst or differ from the plurality of individual wells because the claim does not clearly recite such.
The term “about” in claims 1 and 18 is a relative term which renders the claims indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no indication in the claims as to what degrees of freedom from, values other than the exact values are considered as “about” the recited values. What values may be considered as about 10 to one person may not be considered as such to another and vice versa.
Claims 2, 5, 11-12, 20-21, and 26 are rejected via dependency upon a rejected claim.
It is unclear what is further structurally required by claim 2 because the claim is directed to a conditional process step that is never required to be performed as indicated by the “when” clause. See prior rejection of claim 1 above.
It is unclear what is further structurally required by claim 11 because the claim does not provide for any additional structure of the apparatus nor any prior positively claimed structural element. The claim is directed to biological samples that are not structural elements of the apparatus.
Claim 12 recites the limitation "the number of individual wells". There is insufficient antecedent basis for this limitation in the claim. It unclear what is the nexus of such to the previously recited “a plurality of individual wells” recited in claim 1. If applicant intends for the claim to be directed to the plurality of individual wells, then the claim should clearly recite such. See for example claim 21.
As to claims 18 and 21, it is unclear what is the structural nexus of “each polymeric pin”; “polymer pins”; “the polymeric pins” (claim 18) ; and “the plurality of pins” (claim 21); to each other and the “a plurality of solid, polymeric pins” previously recited in claim 18. If all of such are the same, then consistent terminology should be employed to clearly indicate such.
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.
Claims 1-2, 5, 8, 11-12, 18, 20-21 and 26 are rejected under 35 U.S.C. 103 (a) as being unpatentable over KALLURY et al. US 20040171169.
With respect to claims 1, 2, 5, 8, 11, 18, 20 and 26, Kallury discloses devices for performing SPME [see, for example, paragraph [0038]], comprising lower and upper platforms / plates, shown, for example, in Figures 1-3, where the upper platform includes cylindrical fibers [‘pins’] configured for being inserted into respective wells of the lower platform, where, as further explained in paragraph [0055], the fibers / pins can be ‘made of different polymeric materials (such as polypropylene’; and where the pins include coatings having fine, solid fused silica fibers [functionalized micro-particles or microspheres’] and a stable liquid membrane [‘biocompatible binder’] which, as described in paragraph [0111] can be, for example, a polyamide or a polyacrylonitrile [‘PAN’].
Kallury discloses a typical SPME method employs devices consisting of a fine, solid fused silica fiber coated with a polymeric stationary phase. (paragraph [0038]).
Kallury does not teach the thickness value of the coating as recited.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Although Kallury does not teach the thickness of the coatings as recited, it would have been obvious to and within the common sense, knowledge and skills of one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kallury by having varied the coating thickness within a wide range of values [including those recited] in order to optimize the SPME process depending on particular goals of testing, to diversify the tests to be performed and such would yield predictable results.
Furthermore, the thickness value is an obvious matter of design choice that would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art.
Regarding claims 12 and 21, a well plate having 96, 384, or 1534 wells is conventionally known in the art. Furthermore, Figure 4A further shows a 96-pin format.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Brousmiche; Darryl W. et al.; Kallury; Krishna et al.; Kamata; Tatsuo et al.; Gjerde; Douglas T. et al.; Chen, Jin-Ming et al.; Chen; Jin-Ming et al.; and Blevins; Dennis D. et al. disclose extraction devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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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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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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