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 and Formal Matters
This action is in response to papers filed 10/07/2025.
Claims 1, 3-19 are pending.
Claims 1, 3, 5, 8-10, 13-16 and 18 have been amended.
Claims 1, 3-12, 16-19 are being examined.
Applicant’s election without traverse of group 1, claims 1-12 in the reply filed on 5/27/2025 is acknowledged.
Claims 13-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/27/2025.
Applicant's traversal of species in the reply filed on 5/27/2025is acknowledged. The traversal is on the ground(s) that the response alleges the species election is not clear. This is not found persuasive because the species election requires the starting substance being amplified. The species election further requires Applicant must elect luminescent substance is 3-aminophthalhydrazide and/or 3-nitrophthalhydrazide. Applicant must elect the catalyst is potassium hexacyanoferrate(Ill) and/or manganese peroxide and/or hydroquinone and/or catechol and/or resorcinol and/or horseradish peroxidase (HRP). Applicant must elect fluorophore used is Rhodamine B, another Rhodamine, and/or Yakima Yellow and/or Cy5. It is unclear how these could be clearer. The response further alleges the species election does not indicate how the species lack unity of invention. The response cite MPEP 1893.03(d) This argument has been thoroughly reviewed but is not considered persuasive as MPEP 1893.03(d) provides for unity of invention between groups, not species. Thus this argument is not persuasive. Further it is noted if applicant found the species election confusing or unclear applicant could have called the examiner for clarification.
The art rejection has been withdrawn in view of the amendment of the claim to recite, “a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance.” It is noted this has raised new matter, written description and indefiniteness issues.
Priority
The instant application was filed 06/09/2022 and is a national stage entry of PCT/EP2020/085602 with an international filing date: 12/10/2020 and claims foreign priority to DE10 2019 219 531.8, filed 12/13/2019. It is noted the foreign priority document is not in English, thus priority is only being given to the international filing date.
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: Claims 10 and 18 have been amended to recite, “C48H61Cl4N2O11P.” This lacks antecedent basis in the specification.
Response to arguments .
This is a new ground of objection necessitated by amendment.
Claim Objections
Claims 1, 3-12, 16-19 are objected to because of the following informalities:
Claim 1 has been amended to recite, “method for detecting amplification of nucleic acids in an amplification reaction in a microfluidic device comprising: carrying out the amplification reaction in the microfluidic device using starting substances labeled with a fluorophore and a quencher.” The response asserts the amendment limits the claims to detection of nucleic acids. However, the recitation is confusing and not concise. IF the intent is to limit the claim to require amplification of nucleic acids, the claim should be amended to recite, “carrying out a nucleic acid amplification reaction in the microfluidic device.”
Appropriate correction is required.
Response to Arguments
This is a new ground of objection necessitated by amendment.
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, 3-12, 16-19 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.
New Matter
MPEP 2163 IB New or amended claims section II
With respect to newly added or amended claims, applicant should show support in the original disclosure for the new or amended claims. See, e.g., Hyatt v. Dudas, 492 F.3d 1365, 1370, n.4 (Fed. Cir. 2007) (citing MPEP § 2163.04 which provides that a "simple statement such as ‘applicant has not pointed out where the new (or amended) claim is supported, nor does there appear to be a written description of the claim limitation ‘___’ in the application as filed’ may be sufficient where the claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported."); see also MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure."); and MPEP § 2163.04
Claim 1 has been amended to recite, “detecting reaction products in the amplification reaction by evaluating fluorescence emission resulting from a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance.” Thus the claim as amended requires the separation of the fluorophore and quencher is caused chemiluminescent substance. The originally filed claims require, “detecting reaction products resulting from a separation of the fluorophore and quencher that has taken place in the course of the amplification reaction by adding at least one energy- transferring substance and evaluating the fluorescence emission of the fluorophores that occurs.” Thus the originally filed claims do not require the chemiluminescent substance that causes the separation of the fluorophore and quencher. Further the specification on page 2-3 teaches:
The fluorophore and quencher separate in the course of the amplification reaction, as a result of which it is 35 possible to detect reaction products or to evaluate the amplification that has taken place by way of the detectable fluorescence emission. According to the proposed method, the detection is performed on the basis of the fluorescence emission by adding at least one energy-transferring substance and evaluating the fluorescence emission of the fluorophores that occurs. Unlike in conventional methods, in the proposed method it is not necessary to optically excite the sample volume so as to enable a read-out of the fluorescence. Rather, the fluorophores are excited by transfer of chemical energy 10 with the aid of the energy-transferring substance.
The specification on page 14 teaches
It is only the incorporation of such primer chains or probes into an amplification product that causes either 10 the splitting and spatial separation of fluorophore and quencher or the cleavage of the quencher from the molecule bearing the fluorophore. Such fluorophores can then emit fluorescence radiation after excitation and represent a measure of the amount of amplification 15 products formed. This method makes it possible, by way of the transfer of energy to the fluorophores on the basis of a chemical reaction, to dispense with complicated and expensive optics that were conventionally required for optical excitation in the context of the fluorescence 20 detection reaction. he proposed method can be carried out in particular for an endpoint PCR reaction or an isothermal endpoint amplification reaction in singleplex or multiplex in a silicon microarray or in some other microfluidic device, wherein the amplification reaction involves the described incorporation of molecule pairs consisting of quenchers and fluorophores and/or the hydrolysis of such starting substances during the formation of the amplification products
Thus the amendment to the independent claim has introduced new matter as it requires, “from a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance” which is not supported by the specification as originally filed.
Further claims 10 and 18 have been amended to recite, “C48H61Cl4N2O11P.” The claim previously recited, ”Yakima Yellow.” Review and searching of C48H61Cl4N2O11P revealed it encompasses Yakima yellow phosphoramidite (PubChem (https://pubchem.ncbi.nlm.nih.gov/compound/Yakima-yellow-phosphoramidite, downloaded 9/2/2026). Further the empirical formula encompasses any arrangement of the chemical constituents and thus is not limited to Yakima Yellow. Thus the amendment has changed the scope of the claim and is new matter.
Written description
As set forth in In re Alonso 88 USPQ2d 1849 (Fed. Cir. 2008), at 1851:
The written description requirement of 35 U.S.C. § 112, ¶ 1, is straightforward: “The specification shall contain a written description of the invention ….” To satisfy this requirement, the specification must describe the invention in sufficient detail so “that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought.” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997); see also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1345 [76 USPQ2d 1724] (Fed. Cir. 2005); Eiselstein v. Frank, 52 F.3d 1035, 1039 [34 USPQ2d 1467] (Fed. Cir. 1995).
Alonso at 1852:
A genus can be described by disclosing: (1) a representative number of species in that genus; or (2) its “relevant identifying characteristics,” such as “complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” Enzo, 323 F.3d at 964.
The independent claim has been amended to recite, “A method for detecting amplification of nucleic acids in an amplification reaction in a microfluidic device, comprising: carrying out the amplification reaction in the microfluidic device using starting substances labeled with a fluorophore and a quencher; adding at least one chemiluminescent substance; and detecting reaction products in the amplification reaction by evaluating fluorescence emission resulting from a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance.
In view of the amendment the claim requires a chemiluminescent substance which causes the separation of fluorophore and quencher. Review and searching of the specification did not reveal any chemiluminescent which can cause a quencher to be separated from a fluorophore.
Thus the claims encompasses amplification of anything with anything which can be considered a starting substance labeled by any fluorophore and any quencher. Further the claim encompasses any means of amplification accomplished by any standard. The specification while reciting “starting substance” about 10 times provides no limiting definition. The specification in paragraph (0024 of PGPUB) teaches, “ starting substances labeled with a fluorophore, for example fluorophore-labeled primer chains or TaqMan probes, are incorporated or hybridized or hydrolyzed during the amplification reaction.” However this teaching provides no guidance with respect to a quencher. Thus while the claims encompass an enormous genus of starting substances the specification provides two species, but does not teach the species that require the quencher required of the claims.
The claim provides no limitations with respect to what is being amplified, how it is being amplified, or under what conditions it is being amplified. Thus the carrying out an amplification reaction encompasses an enormous genus of what can be amplified, how it is being amplified and the conditions for amplification. However, the specification appears to be limited to isothermal or PCR amplification of nucleic acids. Thus while the claims encompass as genus of what can be amplified, how it is being amplified and the conditions for amplification, the specification provides a single species.
Thus the claims lack adequate written description.
Response to Arguments
The response traverses the rejection in view of the amendment. This argument has been thoroughly reviewed but is not considered persuasive as the claim has been amended to, “detecting reaction products in the amplification reaction by evaluating fluorescence emission resulting from a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent.” This has introduced new matter.
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, 3-12, 16-19 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 1 is indefinite because it lacks a positive active step relating back to the preamble. The preamble recites a method for detecting amplification of nucleic acids in amplification reaction in a microfluidic device, however the last positive active step is drawn to detecting reaction products in the amplification reaction by evaluating fluorescence emission resulting from a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance. Therefore it is unclear as to whether the method for detecting amplification of nucleic acids in amplification reaction in a microfluidic device or detecting reaction products in the amplification reaction by evaluating fluorescence emission resulting from a separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance. Further it is unclear separation of the fluorophore and quencher caused by the adding of the at least one chemiluminescent substance is done or what chemiluminescent substance provides for this. Further the recitation of microfluidic device appears to be a relative term, implying something small. However the claim and specification provide no limiting definition of what is required of a microfluidic device. Thus it is unclear how to differentiate a microfluidic device from a fluidic device.
Response to Arguments
The response traverses the rejections in view of the amendments. While the amendment addressed some issues, it raised additional issues as detailed above.
Summary
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 STEVEN C POHNERT PhD whose telephone number is (571)272-3803. The examiner can normally be reached Monday- Friday about 6:00 AM-5:00 PM, every second Friday off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at (571)272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Steven Pohnert/ Primary Examiner, Art Unit 1683
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