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 .
The amended claims dated 7/10/2026 are under consideration.
Election/Restrictions
The election of species requirement is withdrawn upon search and consideration of the elected species.
Priority
The present application is a 371 national stage entry of PCT/US22/37936 (filed 7/21/2022), which claims benefit of US provisional application 63/224,379 (filed 7/21/2021).
Priority is recognized.
Information Disclosure Statement
The listing of references in the specification or the citation of references throughout the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or cited on a submitted IDS, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because multiple nucleic acid sequences are disclosed in the specification (e.g., p. 173-177).
Required response - Applicant must provide:
• A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with
o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4)
AND
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
o A statement that the substitute specification contains no new matter.
Specification
The use of terms, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 9 is objected to because of the following informalities: the claim recites “(e.g., directly from the bodily fluid-derived sample (e.g., blood-derived sample) nanoparticles having a size range of interest that includes extracellular vesicles”. The recitation is lacking the appropriate number of closed parentheses. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 3, 4, 5, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas (e.g.: mental processes) and a natural phenomenon without significantly more.
The claims are drawn to methods, one of the four statutory categories.
The claim(s) recite(s):
“determining a quantity of the extracellular vesicles that are captured and bound by the first probe and the second probe, wherein the determined quantity is compared to reference information including a first reference threshold level” (claim 1); and
“classifying the subject as having or being susceptible to pancreatic cancer when the determined quantity is elevated relative to a classification cutoff referencing the first reference threshold level” (claim 1).
The claims are directed to the assessment of collected data using the capture and binding reagents of claim 1. These steps represent an abstract idea that is a mental process (MPEP 2106.04.a.2.III.A) because it is the observation and evaluation of information to reach a judgment or conclusion, as set forth in claim 1. Where the evaluation of data to reach a conclusion is based in the asserted correlation between biomarker levels and the presence of a particular pathology, such an association is accepted part of how a biological organism functions (i.e.: proteome:phenotype relationships), and as such this element of the claims is a natural phenomenon (e.g.: MPEP 2106.04(b)(I)).
The judicial exceptions are not integrated into a practical application because the claims do not involve:
improvements to the functioning of a computer or to any other technology or technical field;
applying or using the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition;
applying the judicial exception with, or by use of, a particular machine; or
effecting a transformation or reduction of a particular article to a different state or thing.
The claimed limitations add insignificant extra-solution activity to the judicial exceptions. The steps are mere data gathering steps. See MPEP 2106.05(g).
There are no additional steps of the claims that are directed to applying or using the judicial exception(s) noted above (e.g.: MPEP 2106.04(d)(I)). The claims end with an asserted association between quantity of exosomes capture and bound by first and second probes and the presence of a pathology, which is an abstract idea (as noted above).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only broadly recite steps of capturing extracellular vesicles and binding said extracellular vesicles with probes using techniques the instant specification identifies as being known and previously established (para.134, 212, 218, 268)
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.
Claims 1, 2, 3, 4, 5, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 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.
Regarding claim 1, the claim recites “e.g., blood-derived sample”. The phrase “e.g.” is equivalent to "for example" and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 1, the claim recites “the determined quantity is compared to reference information including a first reference threshold level”. Because of the use of the passive voice, it is unclear whether the claim further requires an active method step of “comparing the determined quantity to reference information including a first reference threshold level”. Further, it is unclear whether the “biomarker” element of the claim is implicitly limited to biomarkers associated with pancreatic cancer.
Claims 2, 3, 4, 5, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 depend from claim 1 and are rejected for the same reason.
Regarding claim 4, the phrase “extracellular vesicle-associated surface biomarker” lacks proper antecedent basis in view of the amendments to claim 1.
Regarding claim 5, the claim states the first and second target signature comprises “surface” biomarkers. The claim then specifies the “surface biomarkers” are selected from a group that includes “intravesicular biomarkers, and intravesicular RNA biomarkers”. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “surface” is used by the claim to mean “intravesicular” or inside of a vesicle, while the accepted meaning is “on the outside surface of a vesicle.” This divergent meaning of the terms is supported by paras. 21, 80 and 407 of the instant specification which distinguishes “intravesicular” elements from “surface” elements. The term is indefinite because the specification does not clearly redefine the term.
Regarding claim 7, the claim recites “the…second reference threshold level”, which lacks proper antecedent basis.
Regarding claim 7, based on the use of the passive voice, it is unclear if the claim requires an active method step of “determining the first or second reference threshold by levels of target biomarker signature-expressing extracellular vesicles observed in comparable samples from a population of non-cancer subjects”.
Claim 8 depends from claim 7 and is rejected for the same reason.
Regarding claim 8, the claim recites “e.g., pancreatitis, diabetes”. The phrase “e.g.” is equivalent to "for example" and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 9, the claim recites “e.g., blood-derived sample” and “e.g., directly from the bodily fluid-derived sample”. The phrase “e.g.” is equivalent to "for example" and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 12 and 14, the claims each recite “the target-capture moiety”, which lacks proper antecedent basis.
Regarding claim 115, the claim recites “the target biomarkers”. It is unclear if the claim is referring to a “first target biomarker”, “second target biomarker” and/or “third target biomarker”.
Regarding claim 115, the claim recites “e.g., MUC1, MUC4, MUC16”. The phrase “e.g.” is equivalent to "for example" and renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 is/are rejected under 35 U.S.C. 103 as being unpatentable over Routenberg (WO 2020/086751 A1) in view of Yue (Molecular & Cellular Proteomics. 2009. 8.7, pages 1697-1707).
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Regarding claims 1, 4 and 115, Routenberg teaches a method as depicted in Figures 1, 2, 7, 19, 32, 33, 34, 35, 36 and 48. Figure 48C is reproduced below with Examiner’s annotations for mapping of claim elements:
Routenberg teaches providing a plasma sample from a subject (para. 313, 462, 465).
Routenberg teaches capturing an “extracellular vesicle” or EV from the sample with the “capture agent” Antibody 4: Capture Antibody, which binds a “first biomarker” on the EV.
Routenberg teaches binding the Antibody 1 with Primer Oligo as a “first probe comprising a first oligonucleotide” to a “second target biomarker” of the “captured” EV.
Routenberg teaches binding the Antibody 2 with Splint Oligo as a “second probe comprising a second oligonucleotide” to a “third target biomarker” of the “captured” EV.
Routenberg teaches determining the quantity of the EV that are captured and bound by the antibodies through a nucleic acid-based assay involving a Detection Region of a Circular DNA template.
Routenberg teaches the detection of EVs is used to “classify” or diagnose a disease of a subject (para. 152), including pancreatic cancer based on detecting CA19.9 and CA15.3/MUC1/CA15-3 (para. 111, 128, 167).
While Routenberg teaches the above methods, Routenberg does not specifically teach “classifying” the subject as having pancreatic cancer with the determined quantity is elevated relative to a classification cutoff reference, the first reference threshold level or the classification is based on the determined quantity of the elected combination of a mucin and CA19-9.
However, Yue teaches using the combination of MUC1 and CA19-9 to distinguish samples from subjects with cancer from samples from healthy subjects (Fig. 4). Yue further teaches the AUC of the combination of MUC1 and CA19-9 is higher than protein alone (Fig. 4).
It would have been prima facie obvious to have looked at the combination of MUC1 and CA19-9 on the capture exosomes and to have established a threshold that distinguishes healthy samples from pancreatic cancer samples. One would have been motivated to do so because it renders the assay of Routenberg able to distinguish and “classify” subjects as having pancreatic cancer. The combination has a reasonable expectation of success as it simply adds a data analysis step to the data gathering method of Routenberg and does not change the fundamental aspects of Routenberg assay.
Regarding claim 2, as depicted above, Routenberg teaches the second and third biomarkers are two different polypeptides on the surface of the EV. See also, para. 269 and 589 referring to 4-marker combination.
Regarding claims 3 and 5, Routenberg teaches detecting multiple types of EVs, e.g., EV Type A or EV Type B, using different combinations of antibodies targeting different surface biomarkers, which produce multiple different signatures. See, e.g., Fig. 36.
Regarding claim 4, Routenberg teaches CEACAM5 as a surface biomarker (para. 128) and MUC1 as noted above.
Regarding claim 6, Routenberg further teaches biomarkers that are surface and intravesicular biomarkers (para. 268 and 526-528).
Regarding claims 7 and 8, the claims do not further limit the positively recited, active method steps of claim 1.
The teachings of Routenberg above are relevant to claims 7 and 8 for the same reasons as claim 1.
Regarding claim 9, Routenberg teaches the sample is subjected to size exclusion chromatography to purify EVs (para. 66, 150, 208 and 223).
Regarding claims 12 and 13, Routenberg teaches a solid substrate in the form of magnetic beads (para. 170, 257, 269 and 270).
Regarding claim 14, as noted above, Routenberg teaches a “target-capture moiety” or “capture agent” in the form of an antibody.
Regarding claim 15, as noted above, Routenberg teaches performing a “detection assay” that is a nucleic acid-based assay involving a Detection Region of a Circular DNA template.
Regarding claim 16, Routenberg teaches a “capture assay” prior to the “detection assay” (see, e.g., para. 427-433).
Regarding claims 19 and 20, Routenberg teaches the “second target biomarker” is intravesicular and fixation and/or permeabilization of the EVs prior to detection (para. 39, 268, 526-528) and as depicted above, the “detection assay” is a “proximity ligation assay”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12-16, 18-20 and 115-116 of copending Application No. 18/580,442 in view of Routenberg (WO 2020/086751 A1) and/or Yue (Molecular & Cellular Proteomics. 2009. 8.7, pages 1697-1707).
The ‘442 claims have an intended use in the context of prostate cancer, but the active method steps are generic and not targeted to prostate cancer.
It would have been prima facie obvious to have modified the method of the ‘442 for the detection of CA19-9 and MUC1 based on the teachings of Routenberg and/or Yue in order to detect pancreatic cancer.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/580,445 (1/18/2024 claims) in view of Routenberg (WO 2020/086751 A1) and/or Yue (Molecular & Cellular Proteomics. 2009. 8.7, pages 1697-1707).
The ‘445 claims have an intended use of being used in the context of generic cancer detection.
It would have been prima facie obvious to have modified the method of the ‘442 for the detection of CA19-9 and MUC1 based on the teachings of Routenberg and/or Yue in order to detect pancreatic cancer.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,674,190 B2 in view of in view of Routenberg (WO 2020/086751 A1) and/or Yue (Molecular & Cellular Proteomics. 2009. 8.7, pages 1697-1707).
The ‘190 claims are a generic analysis method similar to the steps of the present claims.
It would have been prima facie obvious to have modified the method of the ‘442 for the detection of CA19-9 and MUC1 based on the teachings of Routenberg and/or Yue in order to detect pancreatic cancer.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,085,089 B2 in view of in view of Routenberg (WO 2020/086751 A1) and/or Yue (Molecular & Cellular Proteomics. 2009. 8.7, pages 1697-1707).
The ‘089 claims are a generic analysis method similar to the steps of the present claims.
It would have been prima facie obvious to have modified the method of the ‘442 for the detection of CA19-9 and MUC1 based on the teachings of Routenberg and/or Yue in order to detect pancreatic cancer.
Claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, 16, 19, 20 and 115 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 120-143 of copending Application No. 17/435,697 (7/13/2026 claims) in view of Routenberg (WO 2020/086751 A1) and/or Yue (Molecular & Cellular Proteomics. 2009. 8.7, pages 1697-1707).
The ‘697 claims are a generic analysis method similar to the steps of the present claims.
It would have been prima facie obvious to have modified the method of the ‘442 for the detection of CA19-9 and MUC1 based on the teachings of Routenberg and/or Yue in order to detect pancreatic cancer.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH G DAUNER whose telephone number is (571)270-3574. The examiner can normally be reached 7 am EST to 4:30 EST with second Fridays Off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Winston Shen can be reached at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH G. DAUNER/ Primary Examiner, Art Unit 1682
Prosecution Insights