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 8/14/2026.
Claims 1-3, 6, 7 have been amended.
Claims 21-28 have been added by amendment.
Claims 1-7, 9, 11-13, 15, 21-28 are pending.
Applicant’s election of group I, claims 1-7, 9-16 , AGGF1P10, sequencing for claim 3, RNA sequencing, removing intact cells from biosample in the reply filed on 11/20/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The response questions claims 18-20. It is clear the claims are drawn to a support, array or kit as set forth in the restriction requirement and were mistakenly placed in group I, as well. MPEP 814 II states: While every claim should be accounted for, the omission to group a claim, or placing a claim in the wrong group will not affect the propriety of a final requirement where the requirement is otherwise proper and the correct disposition of the omitted or erroneously grouped claim is clear.
Claims 8, 14, 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/20/2025.
Claims 1-4, 5-7, 9, 11-13, 15, 21-28 are being examined.
The art rejections and ODP rejections have been withdrawn as the cited prior art does not specifically teach the recited genes.
Further the 101 rejection has been overcome in view of the amendment to require a treating step.
Priority
The instant application was filed 05/31/2023 and claims priority from provisional application 63348846 , filed 06/03/2022.
Information Disclosure Statement
The listing of references in 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, they have not been considered.
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 1-4, 5-7, 9, 11-13, 15, 21-28 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.
Claim 1 has been amended to recite, “a circulating RNA (C- RNA) molecule encoding a sufficient number of amino acids to identify a protein.”
Claim 2 has been amended to recite,” “identifying within the purified population of C-RNA molecules C-RNA molecules encoding a sufficient number of amino acids to identify a protein selected from any one or more, any two or more, any three or more, or all four of HLA Complex Group 4 Pseudogene 8 (HCG4P8), Eyes Shut Homolog (EYS), Angiogenic Factor With G-Patch And FHA Domains 1 Pseudogene 10 (AGGFlP110), and Glycine-N-Acyltransferase Like 2 (GLYATL2).”
Both claims require detecting a pregnant female based on the detection of a circulating RNA encoding a sufficient number of amino acids to identify the recited proteins. Thus the claim using the structure of sufficient number of amino acids to identify the recited proteins to provide for the function of detecting preeclampsia.
The specification teaches, “As used herein, the term "subject" refers to a human subject as well as a non-human mammalian subject.”
Burgin (Journal of Mammalogy, 99(1):1–14, 2018) teaches, “We found 6,495
species of currently recognized mammals.”
The specification recites, “sufficient” twice. The only recitation with respect to the limitation at issue is, “With encoding at least a portion of a protein, also referred to herein as encoding a coding region of a protein, a C-RNA molecule encodes a
sufficient number of amino acids to enable the listed protein(s) to be identified as such.” (page 20).
Thus the claims encompass anything which can be considered a sufficient number of amino acids to identify the recited proteins in over 6400 different mammalian species.
Further applicant has elected, ““Angiogenic Factor With G-Patch And FHA Domains 1 Pseudogene 10 (AGGF1P10}.” As NIH ( https://www.genome.gov/genetics-glossary/Pseudogene, downloaded 10/13/2026) states: A pseudogene is a segment of DNA that structurally resembles a gene but is not capable of coding for a protein. Pseudogenes are most often derived from genes that have lost their protein-coding ability due to accumulated mutations that have occurred over the course of evolution..
The claim encompasses anything which can be considered an RNA encoding Angiogenic Factor With G-Patch And FHA Domains 1 Pseudogene 10 (AGGF1P10) in any of 6400 plus different mammalian species.
The response of 8/14/2026 asserts the teachings of Munchel with respect to AFFG1, do not read on the claimed AGGF1P10. Thus demonstrating a gene that encodes a protein is not encompassed by one of its pseudogene of the instant claims in view of applicants arguments.
Further dependent claim 13 requires a decrease of AGGF1P10 relative to control. Further the specification teaches, “AGGF1P10 trend is quite compelling, with AGGF1P10 convincingly lower in PE samples.” (page 38, lines 4-5)
The specification provides no specific guidance on sufficient number of amino acids required to identify the recited proteins to allow for detection of preeclampsia. The specification fails to provide the amino acid sequences or nucleotide sequences of any of the recited protein. Further the specification and claims appear to teach detection of a sufficient number of amino acid for the detection of preeclampsia is insufficient to detect preeclampsia as the specification teaches lower or downregulation of AGGF1P10 is corelated with preeclampsia.
Thus the claims lack adequate written description.
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 7 has been amended to recite, “detecting and treating early-onset preeclampsia.”
Claim 24 has been added by amendment and recites, “comprising detecting and treating early onset preeclampsia.”
The response provides no indication where support for this amendment can be found. Review and searching of the specification did not reveal antecedent basis for the limitations.
The standard for satisfying the written description requirement is whether the disclosure “allow[s] one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014) (quoting Enzo Biochem, Inc. v. Gen—Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). “[T]he critical inquiry is whether the patentee has provided a description that ‘in a definite way identifies the claimed invention’ in sufficient detail that a person of ordinary skill would understand that the inventor was in possession of it at the time of filing.” Alcon, 745 F.3d 1190-91 (quoting AriadPharm., Inc. v. EliLilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010)). However, “a description that merely renders the invention obvious does not satisfy the requirement.” Ariad, 598 F.3d at 1352.
Applicant is reminded that obviousness is not the standard for the addition new limitations to the disclosure as filed. It is noted that entitlement to a filing date does not extend to subject matter, which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). ...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]his description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
While the specification suggests detecting and treatment of preeclampsia, it does not specifically envision, “detecting and treating early onset preeclampsia.” Further the response and specification provide no specific blaze marks for the detection and treatment of early onset preeclampsia.
Thus the amendment has introduced new matter.
Response to Arguments
This is a new ground of rejection necessitated by amendment.
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 1-4, 5-7, 9, 11-13, 15, 21-28 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 has been amended to recite, “a circulating RNA (C- RNA) molecule encoding a sufficient number of amino acids to identify a protein.” The recitation of sufficient number of amino acids to identify a protein suggests there is an insufficient number of amino acids to identify a protein. The specification and claims provide no standard to differentiated sufficient number of amino acids to identify a protein from an insufficient number of amino acids to identify a protein. This is confounded as applicant elected, “Angiogenic Factor With G-Patch And FHA Domains 1 Pseudogene 10 (AGGF1P10}.” As NIH ( https://www.genome.gov/genetics-glossary/Pseudogene, downloaded 10/13/2026) states: A pseudogene is a segment of DNA that structurally resembles a gene but is not capable of coding for a protein. Pseudogenes are most often derived from genes that have lost their protein-coding ability due to accumulated mutations that have occurred over the course of evolution.. The response of 8/14/2026 asserts the teachings of Munchel with respect to AFFG1, do not read on the claimed AGGF1P10. Thus the metes and bounds are unclear what is required.
Further claim 1 is unclear as it requires detecting preeclampsia by the detection of a sufficient number of amino acids to identify AGGF1P10. However dependent claim 13 requires a decrease of AGGF1P10 relative to control. Further the specification teaches, “AGGF1P10 trend is quite compelling, with AGGF1P10 convincingly lower in PE samples.” (page 38, lines 4-5) Thus the claims are confusing and unclear if merely the detection of sufficient number of amino acids to identify AGGF1P10 is indicative of preeclampsia or decrease of AGGF1P10 relative to control indicated preeclampsia.
Claim 1 recites, “increased frequency of prenatal visits.” The recitation of increased frequency suggests there is normal or decreased frequence visits. The specification does not provide a standard to differentiate increased frequency of prenatal visits for normal or decreased frequency of prenatal visits. Thus the metes and bounds are unclear.
Claim 2 has been amended to recite, “identifying within the purified population of C-RNA molecules C-RNA molecules encoding a sufficient number of amino acids to identify a protein selected from any one or more, any two or more, any three or more, or all four of HLA Complex Group 4 Pseudogene 8 (HCG4P8), Eyes Shut Homolog (EYS), Angiogenic Factor With G-Patch And FHA Domains 1 Pseudogene 10 (AGGFlP110), and Glycine-N-Acyltransferase Like 2 (GLYATL2).” The recitation of sufficient number of amino acids to identify a protein suggests there is an insufficient number of amino acids to identify a protein. The specification and claims provide no standard to differentiated sufficient number of amino acids to identify a protein from an insufficient number of amino acids to identify a protein. This is confounded as applicant elected, “Angiogenic Factor With G-Patch And FHA Domains 1 Pseudogene 10 (AGGF1P10}.” As NIH ( https://www.genome.gov/genetics-glossary/Pseudogene, downloaded 10/13/2026) states: A pseudogene is a segment of DNA that structurally resembles a gene but is not capable of coding for a protein. Pseudogenes are most often derived from genes that have lost their protein-coding ability due to accumulated mutations that have occurred over the course of evolution. The response of 8/14/2026 asserts the teachings of Munchel with respect to AFFG1, do not read on the claimed AGGF1P10. Thus the metes and bounds are unclear what is required.
Further claim 2 is unclear as it requires detecting preeclampsia by the detection of a sufficient number of amino acids to identify AGGF1P10. However dependent claim 13 requires a decrease of AGGF1P10 relative to control. Further the specification teaches, “AGGF1P10 trend is quite compelling, with AGGF1P10 convincingly lower in PE samples.” (page 38, lines 4-5) Thus the claims are confusing and unclear if merely the detection of sufficient number of amino acids to identify AGGF1P10 is indicative of preeclampsia or decrease of AGGF1P10 relative to control indicated preeclampsia.
Claim 2 recites, “increased frequency of prenatal visits.” The recitation of increased frequency suggests there is normal or decreased frequence visits. The specification does not provide a standard to differentiate increased frequency of prenatal visits for normal or decreased frequency of prenatal visits. Thus the metes and bounds are unclear.
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 amendment has introduced new issues.
The rejection with respect to early onset has been withdrawn in view of the amendment.
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.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Steven Pohnert/Primary Examiner, Art Unit 1683
Prosecution Insights