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
The Applicant’s amendments to Claims 12-13 and 17-18 have resulted in the claims being dependent on previously withdrawn claim 11, directed to nonelected Group III. Therefore Claims 12-13 and 17-18 are withdrawn from further consideration as being drawn to a nonelected invention.
Response to Arguments
Applicant's arguments filed 07/28/2026 have been fully considered but they are not persuasive.
Regarding the Applicant’s remarks directed towards the rejections under 35 U.S.C. 112(a), the references portions of the Applicant’s 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. Paragraphs [0013-14], [0025-6], [0060-62], [0065-67], [0070-], [0074-0075], [0078-79], [0085-88] and Fig. 5, 6, 11B, rather generically list 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”. 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.
Applicant’s arguments, see pg. 11-15, filed 07/28/2026, with respect to claims 1, 2, and 7, have been fully considered and are persuasive. The rejections of claims 1, 2, and 7 have been withdrawn.
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 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 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.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art of record fails to teach or suggest A method of diagnosis for a disease comprising: obtaining a cell free sample comprising extracellular vesicles; lysing the cell free sample to create a lysate sample; adding at least one of an optical molecular binding solution or a proteolytic reagent to the lysate sample to create a processed lysate sample; analyzing the processed lysate sample by absorbance spectroscopy in the near- and/or mid-infrared range to produce a spectrometric signature, wherein analyzing the processed lysate sample comprises: receiving, by a processor, the spectrometric signature corresponding to the processed lysate sample; determining, by the processor, whether the spectrometric data corresponding to the processed lysate sample indicates a presence of the disease as a result; and outputting, by the processor, the result.
While the closest prior art of record, Yap et al., teaches an analogous method of analyzing extracellular vesicles using IR spectroscopy, it fails to teach or suggest the particulars of the instantly recited sample preparation steps. Additionally, one having ordinary skill in the art would not have been motivated to modify the cited prior art steps as instantly claimed without the use of impermissible hindsight and without rendering the method inoperable for its original purpose.
Claims 2 and 7 depend on claim 1.
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.
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/ROBERT J EOM/Primary Examiner, Art Unit 1797
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