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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/17/2025 has been entered.
Claim Status
Currently, claims 301-302, 304, 306-316 and 319-322 are pending in the instant application. Claim 1-300, 303, 305, 317-318 have been canceled. Claims 310-316 and 319-322 have been withdrawn. This action is written in response to applicant' s correspondence submitted 12/17/2025. All the amendments and arguments have been thoroughly reviewed but were found insufficient to place the instantly examined claims in condition for allowance. The following rejections are either newly presented, as necessitated by amendment, or are reiterated from the previous office action. Any rejections not reiterated in this action have been withdrawn as necessitated by applicant' s amendments to the claims. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is Non-FINAL.
Withdrawn Rejections
The rejection of claims 301-302, 304, 306-309 under 35 USC 101 is withdrawn in view of the amendment to the claims.
The rejection of claims 301-302 and 304, 306-309 under 35 U.S.C. 103 as being unpatentable over Lee (Theranostics, 2018, vol 8, pp. 399-409) in view of Mellert (US 2018/0202005 A1) is withdrawn in view of the amendment to the claims.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However it is noted that a certified copy of the foreign priority claims has not been filed as such the EFD of the instant claims is 4/3/2020.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
New Grounds of Rejection
Claim Rejections - 35 USC § 112(b)
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 301-302 and 304, 306-309 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 301 recites the limitation "the marker bound to the probe" in step (d) of the claim. Claim 301 does not recite or require a marker that is bound to a probe. Step (c) recites a step of mixing the isolate with a probe and a marker but this step does not require that the marker is bound to the probe. It is unclear if the marker of step (c) is the marker in step (d) or if there is a materially different marker for the step of detecting. There is insufficient antecedent basis for this limitation in the claim.
Claim 301 recites the limitation "the optical density using the marker" in step (e) of the claim. There is insufficient antecedent basis for this limitation in the claim. The claim does not require that the marker comprises an optical density and it is unclear what optical density is being measured.
Claim 301 recites a method for detecting a gene that is overexpressed in cancer cells from a sample however the active process step of the claims recite a step of mixing a biological sample isolated from an individual comprising cell-free DNA and a positively charged material under conditions in which the double stranded cfDNA is unwound into single strands, a step of isolating the positively charged substance, a step of mixing the isolate with a probe and marker, a step of detecting the marker bound to the probe and a step of measuring the optical using the marker. There are not active process steps that require detecting a gene that is overexpression in cancer cells from a sample and there are no active process steps comprising a sample that comprises cancer cells. While the wherein clause recites the probe having a sequence complementary to cfDNA derived from a gene that is overexpressed in cancer cells but has an appropriate expression level in normal cells complementary binds to the cfDNA this does not require or detect a gene that is overexpressed in a cancer cell from a sample. The body of the claim does not fully or intrinsically set forth all the limitations recited within the preamble. Accordingly the preamble of the claim and the recited active process steps renders the claim indefinite because the claim does not reasonably apprise one of ordinary skill in the art the scope of the claims and the metes and bounds of the claim are unclear and it would not be readily apparent if one was infringing on the claimed invention.
Claim 304 recites the limitation "the probe and the marker" step 1-2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 304 recites to the probe and the marker of step (b) however step (b) of claim 301 does not recite or require a probe or a marker. The claim is indefinite because Step (b) of claim 301 requires a step of isolating the positively charged substance to which the cfDNA is bound and does not require any step of mixing a probe or marker.
Claim 306 depends from claim 301 and it is unclear if the sample refers to the biological sample or the sample of the preamble. This recitation renders the claim indefinite and it is unclear if the sample in the preamble is different than the sample in step (a) and the what sample is being limited by claim 306. The metes and bound of the claim are unclear and one of ordinary skill in the art would not be apprised of the scope of the invention or infringing on the claimed method.
Claim 309 is vague and indefinite over the recitation of a nanoparticle comprising a conductive polymer, hyaluronic acid, avid or streptavidin, fluorescent protein and wherein the markers is detected in step (c) by a color change or UV absorbance. Claim 309 depends from claim 301. Claim 301 requires measuring the optical density of the marker and in step (c) the marker is mixed with a probe. It is unclear how the recited markers of claim 309 will be measured by optical density and if step (c) of claim 301 is being detected by a color change and UV absorbance during the mixing step and then further being measured by optical density. The only markers recited in claim 309 that have an absorbance to generate an optical density are HRP. It is unclear how the markers recited in claim 309 will measure optical density.
Claims 302, 304, 306-309 depend from claim 301 and are indefinite for the reasons applied to claim 301.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 304 and 309 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 304 recites the limitation of method according to claim 301, wherein the step of (b) is sequentially or simultaneously mixing the probe and the marker in the mixture. Step (b) of claim 301 recites a step of isolating the positively charged substance to which the cfDNA is bound. Claim 304 does not further limit claim 301 because step (b) of claim 301 does not recite or require a mixture of a probe and marker.
Claim 309 recites the limitation of a specific markers and wherein the marker is detected in step (c) by a color change or a UV absorbance change. Claim 309 depends from claim 301. Claim 301 requires detecting optical density of marker and is therefore limited to UV absorbance change and a marker that comprises the ability to have UV absorbance change. The markers recited in claim 309 are not markers that have the ability to have an UV absorbance change except for HRP and therefore do not further limit claim 301. The recitation of a color change does not further limit the detection when the detection is limited to optical density.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 301-302, 304, 306-309 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cho (CN107980061A).
It is noted that this document has a common inventor however the foreign priority documents have not been provided a certified copy of the translation. As such CN107980061, published 5/1/2018 which is more than one year from effective filing date of the instant claims.
Cho teaches a method of cancer diagnosis by detecting cfDNA by providing a positively charged surface of a nanostructure, treating the conducting polymer with a biological material to attach cfDNA to the polymer, detecting cfDNA using the polymer and releasing cfDNA from the polymer (See pg. 2). Cho teaches the biological sample may be blood (claim 306) (see pg. 3). Cho teaches cancer is lung cancer (see pg. 3) (claim 302). Cho teaches released cfDNA can be detected by using a marker (see pg. 7). Cho teaches the label on the marker comprises detecting by optical means, including OD and includes HRP (See pg. 7, example) (claim 308-309).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
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, Fereydoun Sajjadi can be reached on 571-272-3311. 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.
/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
Prosecution Insights