Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1, 2, and 5 are pending and examined herein.
Priority
This application, filed 03/28/2022, is a CON of 15/977,284, filed 05/11/2018, which is a CON of 14/192,956, filed 02/28/2014, which is a CON of 13/918,531, filed 06/14/2013, which is a CON of 12/512,479, filed 07/30/2009, which claims benefit of provisional application 61/086,870, filed 08/07/2008. This priority is acknowledged and the claims examined herein are treated as having an effective filing date of 08/07/2008.
Withdrawn Objections/Rejections
The rejection of claims 1, 2, and 5 under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s arguments filed 05/08/2026.
The rejection of claims 1, 2, and 5 under 35 U.S.C. 103 over Bode-Bogen in view of Buechler has been withdrawn in view of Applicant’s arguments filed 05/08/2026.
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.
Claim 2 is 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.
Claim 2 recites “The device…further comprising unbound free SDMA from a patient sample on the solid phase.” It is unclear how “unbound free SDMA” could be a part of the claimed device if it is not in any way attached or connected to the device as evidenced by being “free” and “unbound”. Further, the “patient sample” which contains the free and unbound SDMA, as claimed, is not considered to be a part of the claimed device, but rather a component that contacts the claimed device as part of an intended use of the device.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “device of claim 1, further comprising unbound free SDMA from a patient sample on the solid phase”; however, “unbound free SDMA” is interpreted to include free SDMA merely sitting on the device, which does not modify or limit the device itself. Further, this limitation is seemingly directed to a method of making or using the device including contacting the device with a patient sample comprising free SDMA; however, claim 1 is a device claim. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed device, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction (See MPEP 2111.02 II). Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buechler et al. WO 2006/078813 (published 07/27/2006, IDS submitted 04/12/2022, referred to herein as Buechler) in view of Schulze et al., “Determination of asymmetric dimethylarginine (ADMA) using a novel ELISA assay” Clin Chem Lab Med (published 2004, IDS dated 04/12/2002, referred to herein as Schulze) as evidenced by Valdez, US 2007/0218486 (published 09/20/2007, PTO-892 mailed 03/11/2025).
Regarding claim 1, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, the recited “for determining the presence of free symmetrical dimethylarginine (SDMA) in a sample” is considered an intended use of the claimed device which does not provide any structural specificity to the device beyond the claimed components, i.e. SDMA attached to a solid phase through the claimed modification.
Buechler teaches a device comprising modified arginine analogues attached to a solid phase (para. 0081, lines 1-5). Buechler teaches modifying the arginine analogue, ADMA, by converting the carboxylic acid group to an amide bind (paras. 0006 and 0007) with the following structures:
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Wherein R1 is –H and R2 is a conjugating group having the structure:
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Y is an optionally substituted C1-4 alkylene and Z is a moiety providing a thiol or a protected thiol at its terminus. Notably, the conjugating group R2, taught by Buechler et al., wherein Y = CH2-CH2 (= C2 alkylene) and Z is thiol (= -SH), reads on the conjugating group of the non-elected analog Compound A of Claim 5. Buechler teaches the ADMA analogue is useful for producing antibodies for use in assays for ADMA that can distinguish ADMA from SDMA (para. 0032, lines 8-12).
However, Buechler does not teach a device comprising the specific arginine analogue, SDMA, attached to a solid phase.
Schulze teaches a method making and testing anti-ADMA antibodies (p. 1377, col. 2, para. 3, lines 20-24). Schulze teaches that, when developing assays for the detection of ADMA, it is important to ensure that the anti-ADMA antibody does not bind to SDMA (p. 1378, col. 2, para. 5, line 1 “Specificity of the kit” – p. 1379, col. 1, para. 1, line 5, and Table 1 “Cross reactivity, %” for SDMA). Schulze tests for cross-reactivity of the anti-ADMA antibodies to SDMA with an ELISA by immobilizing SDMA on a solid surface (p. 1378, col. 2, para. 1, lines 1-4).
It would have been prima facie obvious to one of skill in the art before the effective filing date to substitute the ADMA on the solid support, as taught by Buechler, for SDMA, as taught by Schulze. An artisan would have been motivated to attach SDMA to a solid support in order to test the cross-reactivity of anti-ADMA antibodies to SDMA, as taught by Schulze, to ensure that they can distinguish ADMA from SDMA, as taught by Buechler. An artisan would have had a reasonable expectation of success in making this device because the ability to distinguish ADMA from SDMA is an important consideration for developing assays with anti-ADMA antibodies, as taught by both Buechler and Schulze, and the attachment of SDMA to a solid surface is a useful device ensuring the specificity of anti-ADMA antibodies, as taught by Schulze. An artisan would have had a reasonable expectation of success in modifying SDMA in the same way because, as taught by Buechler, these modifications are capable of being used for arginine analogues, such as SDMA, which has the same side groups as ADMA. Buechler teaches that these arginine analogues can be attached to surfaces using this modification for use as affinity substrates (Buechler, para. 0073, lines 1-3).
Claim 5 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buechler in view of Schulze as applied to claim 1 above, and further in view of Valdez et al., US 2007/0218486 (published 09/20/2007, PTO-892 dated 03/11/2025).
The teaching of Buechler in view of Schulze regarding claim 1, as described above, is incorporated herein.
Regarding claim 5, Buechler teaches a conjugate linker for attaching arginine analogues to a solid surface (para. 0007).
However, Buechler in view of Schulze does not teach the specific elected linker comprising an alkylthio group (Claim 5, analog B).
Valdez teaches chemical structures for use with small molecules comprising an alkylthio group, CH2-S (para. 0012, lines 6-7). Valdez teaches that this component, “Y”, can be readily used as an alternative to CH2 within a longer linker structure (para. 0012, lines 1-7).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to substitute the CH3 on the linker taught by Buechler for the CH2-S alkylthio group taught by Valdez. Doing so is considered a Simple Substitution of One Known Element for Another to Obtain Predictable Results (See MPEP 2143(I)(B)). An artisan would recognize that, as taught by Valdez, the CH2 within the linker taught by Buechler could readily be substituted with the CH2-S group taught by Valdez to predictably obtain a functional linker capable of attaching small molecules to a target, such as a solid surface.
Response to Arguments
Applicant’s arguments, see pages 4-12, filed 05/08/2026, with respect to the rejection(s) of claims 1, 2, and 5 under 35 U.S.C. 112(a) and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of a new motivation to attach SDMA to a solid support as taught in Schulze.
Regarding the remarks on pages 4-6 regarding the rejection under 35 U.S.C. 112 first paragraph (pre AIA ), Applicant’s arguments are considered persuasive and the rejection has been withdrawn.
Regarding the remarks regarding the rejection under 35 U.S.C. 103, on pages 7 and 8 (Section A), Applicant argues that the two Declarations of Dr. Böger were not previously addressed. Regarding the first Declaration dated 10/21/2021, Dr. Böger describes that free SDMA was not a relevant biomarker and that there was no antibody against free SDMA; however, this is not relevant to the new rejection. Regarding the second Declaration dated 12/17/2021, Dr. Böger describes that an artisan would not have been motivated or had an expectation of success to make an antibody against free SDMA; however, this is not relevant to the new rejection. Dr. Böger further states that an artisan would not have created a device that had unbound free SDMA from a patient sample; however, as described above in the rejections under 35 U.S.C. 112(b) and 112(d), unbound free SDMA from a patient sample is not considered to be a part of the claimed device.
The further remarks on page 8 under section A are not considered to be relevant to the new rejections.
Regarding the remarks on page 9 under section B, Applicant argues that SDMA was not a relevant biomarker. This argument is not considered relevant to the new rejections.
Regarding the remarks on page 10 under section C, Applicant argues that an artisan would not have had a reasonable expectation of success to use SDMA attached to a solid phase to detect SDMA. This argument is not considered relevant to the new rejections. In particular, the current rejection describes the use of SDMA attached to a solid phase in order to test the cross-reactivity of an anti-ADMA antibody, as taught by Schulze. This is the case regardless of whether the artisan would test any potential anti-ADMA antibodies raised in the methods described by Buechler, or the anti-ADMA antibodies described by Schulze which bind to acrylated ADMA because, as taught by Schulze, they tested the cross-reactivity of their antibody against SDMA attached to a surface.
Regarding the remarks on pages 10 and 11 under section D, Applicant argues that an artisan would have no expectation of success in raising antibodies to SDMA. This argument is not considered relevant to the new rejections.
Regarding the remarks on page 12 under section E, Applicant argues that the previously recognized novelty of anti-SDMA antibodies contradicts the Examiner’s previous argument for obviousness under 35 U.S.C. 103. This argument is not considered relevant to the new rejections.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 31, 2026
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