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
Claims 4-5, 8, 11, 15-16, and 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/23/2025.
Applicant's election with traverse of Group I, Claims 1, 2, 7, 9, 10, 12, 13, 17, and 18 in the reply filed on 12/23/2025 is acknowledged. The traversal is on the ground(s) that Yap et al. fails to render special technical feature “not special”, alleging that the restriction requirement filed 11/03/2025 failed to consider the “combination of features” of the special technical feature. This is not found persuasive because the whole of claim 1 is anticipated by Yap et al. (see: rejections under 35 U.S.C. 102 below), and therefore regardless of what “combination of features” the Applicants consider to be the special technical feature, it fails to make a contribution over the prior art in view of Yap et al., which anticipates the scope encompassed by claim 1.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Applicant is advised that should claim 9 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 9-10 and 17-18 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.
Claims 9-10 and 17-18 contain limitations directed towards a “computation engine”, “model architecture”, and “computation algorithm” adapted for indicating the presence of a disease.
However, the original claims and originally filed disclosure fails to describe a computer, programming, equations, and sufficient details such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. See: MPEP 2161.01.
The originally filed disclosure fails to disclose the “computation engine”, “model architecture”, and “a computation algorithm” (e.g., the necessary steps and/or flowcharts with any specificity to the claimed application of indicating diseases) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing.
Rather, the Applicant’s disclosure amounts to the generic listing a plurality of categories of algorithms and models, without any recitation of the specifics of how the presence of any disease, let alone the potential presence of every disease (which is included within the recited scope), would be indicated by the claimed computation engine”, “model architecture”, and “a computation algorithm” (e.g. there is not even an example of a measurement threshold: if the absorbance is greater than value X, then the presence of disease A is confirmed).
Generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand if applicants have invented, and been in possession of, the invention as broadly claimed. In LizardTech, claims to a generic method of making a seamless discrete wavelet transformation (DWT) were held invalid under 35 U.S.C. 112, first paragraph, because the specification taught only one particular method for making a seamless DWT and there was no evidence that the specification contemplated a more generic method. "[T]he description of one method for creating a seamless DWT does not entitle the inventor . . . to claim any and all means for achieving that objective." LizardTech, 424 F.3d at 1346, 76 USPQ2d at 1733.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671,681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015). See MPEP §§ 2161.01.
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, 7, 9-10, 12-13, and 17-18 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.
Claim 1 recites the limitation "the spectrometric data corresponding to the processed lysate sample" in line 9. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the processed lysate spectrometric signature” to be consistent with the language used in the dependent claims 9-10 and 17-18, is one way to resolve the indefiniteness issues.
Claim 1 recites the limitation "the spectrometric data corresponding to the processed lysate sample" in lines 10-11. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “the processed lysate spectrometric signature” to be consistent with the language used in the dependent claims 9-10 and 17-18, is one way to resolve the indefiniteness issues.
Claim 1 recites the limitation "the presence" in line 11. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “presence” is one way to resolve the indefiniteness issues.
Claim 2 depends on claim 1.
Claim 7 recites the limitation "the sample" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear which one of the plurality of samples recited in claim 1 (cell free, lysate, and processed lysate samples), the limitation is referencing.
Claim 9 depends on claim 1.
Claim 10 recites the limitation "the correctness" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “correctness” is one way to resolve the indefiniteness issues.
Claim 12 recites the limitation "The system" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “The method” is one way to resolve the indefiniteness issues.
Claim 13 recites the limitation "The system" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “The method” is one way to resolve the indefiniteness issues.
Claim 17 recites the limitation "The system" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “The method” is one way to resolve the indefiniteness issues.
Claim 18 recites the limitation "The system" in line 1. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “The method” is one way to resolve the indefiniteness issues.
Claim 18 recites the limitation "the memory" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “a memory” is one way to resolve the indefiniteness issues.
Claim 18 recites the limitation "the correctness" in line 3. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “correctness” is one way to resolve the indefiniteness issues.
Appropriate corrections are required.
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.
Claim(s) 1, 7, 9-10, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yap et al. (Study of prostate cancer-derived extracellular vesicles in urine using IR spectroscopy).
Regarding claim 1, Yap discloses a method of diagnosis for a disease (pg. 2-36, see: Procedures for Isolation of urinary extracellular vesicles and Analysis of urinary extracellular vesicles using Attenuated Total Reflection-Fourier Transform Infrared (ATR-FTIR) Spectroscopy) comprising:
obtaining a cell free sample comprising extracellular vesicles (Isolation Procedure, see: steps 1 and 2);
lysing the cell free sample to create a lysate sample (Isolation Procedure, see: step 3);
adding at least one of an optical molecular binding solution or a proteolytic reagent to the lysate sample to create a processed lysate sample (Isolation Procedure, see: steps 4-8);
analyzing the processed lysate sample by absorbance spectroscopy in the near- and/or mid-infrared range to produce a spectrometric signature (see: Analysis of urinary extracellular vesicles using Attenuated Total Reflection-Fourier Transform Infrared (ATR-FTIR) Spectroscopy), wherein analyzing the processed lysate sample comprises:
receiving, by a processor, the spectrometric data corresponding to the processed lysate sample (Analysis Procedure, see: steps 9 and 10);
determining, by the processor, whether the spectrometric data corresponding to the processed lysate sample indicates the presence of the disease as a result (Analysis Procedure, see: steps 13-15); and
outputting, by the processor, the result (Figure 2, Figure 3).
Regarding claim 7, Yap further discloses drying the sample on an IR- reflective or non-IR- absorbing sampling card (Analysis Procedure, see: steps 6 and 7).
Regarding claim 9, Yap further discloses determining, by the processor, whether the processed lysate spectrometric signature indicates the presence of the disease as a result comprises: providing the processed lysate spectrometric signature to a computation engine comprising a model architecture and one or more model parameters (Analysis Procedure, see: step 13); and executing, by the computation engine, a computation algorithm configured to provide the result based on the processed lysate spectrometric signature, the model architecture, and the one or more model parameters (Analysis Procedure, see: step 15).
Regarding claim 10, Yap further discloses providing feedback indicating the correctness of the result to the computation engine; and updating the one or more model parameters based on the result, the processed lysate spectrometric signature, and the feedback (Analysis Procedure, see: steps 11, 12, and 14).
Regarding claim 17, Yap further discloses the processor is configured to determine whether the processed lysate spectrometric signature indicates the presence of the disease by: providing the processed lysate spectrometric signature to a computation engine, comprising a model architecture and one or more model parameters (Analysis Procedure, see: step 13); and executing, by the computation engine, a computation algorithm configured to provide the result based on the processed lysate spectrometric signature, the model architecture, and the one or more model parameters (Analysis Procedure, see: step 15).
Regarding claim 18, Yap further discloses the processor is further configured to execute instructions in the memory in order to: provide feedback indicating the correctness of the result to the computation engine; and update the one or more model parameters based on the result, the processed lysate spectrometric signature, and the feedback (Analysis Procedure, see: steps 11, 12, and 14).
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 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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yap et al. (Study of prostate cancer-derived extracellular vesicles in urine using IR spectroscopy), in view of Litwin et al. (The Diagnosis and Treatment of Prostate Cancer A Review).
Regarding claim 2, Yap does not explicitly disclose administering a treatment to a patient to treat the disease when the result indicates the disease is present.
Litwin teaches that early administration of drugs has improved median survival in patients with prostate cancer (pg. 2533, see: Key Points). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to administer treatment to a patient when the prostate cancer screening method disclosed by Yap indicates the presence of prostate cancer, as taught by Litwin, in order to increase the survivability of the screened patients.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yap et al. (Study of prostate cancer-derived extracellular vesicles in urine using IR spectroscopy).
Regarding claims 12 and 13, Yap doesn’t explicitly disclose the processed lysate sample is derived from a blood serum sample or a whole blood sample.
Yap further discloses that the use of other body fluids, such as blood and semen as samples, to detect prostate cancer was well known in the art, before the effective filing date of the claimed invention (pg. 1/col. 2/para. 1).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to analyze additional body fluid samples with the disclosed method of Yap, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797