DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment filed August 22, 2025, has been received and entered.
Claims 1-14 are cancelled.
Claims 15-26 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 15-19 and 21-25, and the species for A and X for (a), an antibody for (b), a trophoblast cell for (c), and a microfluidic chip for (d), in the reply filed on August 22, 2025, is acknowledged. The traversal is on the ground(s) that the references cited in the Restriction requirement do not meet the claimed invention. Though the Examiner agrees, the prior art cited below meets the claimed invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 20 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 15-19 and 21-25 are examined on the merits.
Claim Objections
Claims 15-19 and 21-25 are objected to because of the following informalities:
Claims 15, 16, 21, and 22 are objected to because each recite “wherein” followed by a comma. See lines 5 and 7 of claim 15; the first and last lines of claim 16; lines 4, 12, and 14 of claim 21; and the first and last lines of claim 22.
Additionally, claim 21 is objected to because the recitation “which comprising” in line 9 is grammatically incorrect. This objection can be overcome by amending line 9 of claim 21 by amending the recitation to “which comprises” or “comprising” (i.e. deletion of “which”).
Since claims 15 and 21 are objected to, then their dependent claims are objected to.
Appropriate correction is required.
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 15-19 and 21-25 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 15 is rendered indefinite by the recitation “the recognition molecule” in lines 2, 16, and 18. Claim 15 recites “one or more recognition molecules” in line 2 which includes the embodiment of multiple recognition molecules. For that embodiment, it is unclear whether only one, some, or all of the recognition molecules meets the limitations regarding “the recognition molecule” (i.e., attached to the surface of the cell capture carrier via an organic conjugate L comprising one or more disulfide bonds; selected from a nucleic acid aptamer, a polypeptide or an antibody). Furthermore, it is confusing how the “recognition molecule” can be “one or more selected from a nucleic acid aptamer, a polypeptide or an antibody” as recited in the last two lines since that includes the selection of multiple recognition molecules for a single “recognition molecule.”
Regarding claims 15, 16, 21, 22, , the phrase "preferably" 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). In particular, see lines 11, 13, and 17 in claim 15; the last line of claim 16; lines 7, 9, 11, 18, 20, and 24 of claim 21; the last line of claim 22;
Since claims 15 and 21 are indefinite, then their dependent claims are rendered indefinite. Thus, claims 15-19 and 21-25 are rejected under 35 U.S.C. 112(b).
Claim 16 is rendered indefinite by the recitation “wherein, the organic conjugate L is selected from one or more of the following structures” (emphasis added). It is unclear how the organic conjugate L can be more than one of the structures recited in the claim, since the organic conjugate L appears to be limited to a single structure having the formula -A-X-. This rejection can be overcome by deleting “or more” from line 2 of claim 16.
Claim 17 is rendered indefinite by the recitation “the recognition molecule” in the second-to-last line. Parent claim 15 recites “one or more recognition molecules” in line 2 which includes the embodiment of multiple recognition molecules. For that embodiment, it is unclear whether only one, some, or all of the recognition molecules is one or both of an anti-EpCAM antibody or an anti-body CD71 antibody. Furthermore, it is confusing how the “recognition molecule” can be both an anti-EpCAM antibody or an anti-CD71 antibody, as these are two recognition molecules. These grounds of rejection can be overcome by amending the second-to-last line of claim 17 to recite “the one or more recognition molecules.”
Claim 21 is rendered indefinite by the recitation “the cell” in line 4. Line 3 of the claim recites “fetal cell(s)” in line 3 which includes the embodiment of multiple fetal cells. For that embodiment, it is unclear whether only one, some, or all of the cells meets the limitation regarding release (release being achieved by chemically cleaving…).
Claim 21 is rendered indefinite by the recitation “the recognition molecule” in lines 5-6, 23, and 25. Claim 21 recites “one or more recognition molecules” in lines 2-3 which includes the embodiment of multiple recognition molecules. For that embodiment, it is unclear whether only one, some, or all of the recognition molecules meets the limitations regarding “the recognition molecule” (i.e. limitations in lines 4-6; X is directly or indirectly connected to it; selected from a nucleic acid aptamer, a polypeptide or an antibody. Furthermore, it is confusing how the “recognition molecule” can be “one or more selected from a nucleic acid aptamer, a polypeptide or an antibody” as recited in the last two lines since that includes the selection of multiple recognition molecules for a single “recognition molecule.”
Claim 22 is rendered indefinite by the recitation “wherein, the organic conjugate L is selected from one or more of the following structures” (emphasis added). It is unclear how the organic conjugate L can be more than one of the structures recited in the claim, since the organic conjugate L appears to be limited to a single structure having the formula -A-X-. This rejection can be overcome by deleting “or more” from line 2 of claim 22.
Claim 24 is rendered indefinite by the recitation “the recognition molecule” in the second-to-last line. Parent claim 21 recites “one or more recognition molecules” in lines 2-3 which includes the embodiment of multiple recognition molecules. For that embodiment, it is unclear whether only one, some, or all of the recognition molecules is one or both of an anti-EpCAM antibody or an anti-body CD71 antibody. Furthermore, it is confusing how the “recognition molecule” can be both an anti-EpCAM antibody or an anti-CD71 antibody, as these are two recognition molecules. These grounds of rejection can be overcome by amending the second-to-last line of claim 24 to recite “the one or more recognition molecules.”
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 102
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 15-19 and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (Analytical Chemistry. 2020. 92: 9281-9286. Published May 26, 2020).
Zhang discloses an array patterned microfluidic chip (NIPT-Chip) for circulating fetal cells (CFCs) isolation and recovery from untreated whole blood by leveraging immunorecognition-mediated CFCs capture and disulfide cleavage-driven CFCs release (page 9282, left column, second column) which anticipates the claimed invention. In particular, see Figure 1 on page 9283 which shows the first structure recited in instant claims 16 and 22, specifically comprising the first structure recited for ‘A’ in instant claims 15 and 21 in which ‘n’ is 3 (the elected species for ‘n’), the first structure recited for ‘X’ in instant claims 15 and 21 (the elected species for ‘m’), and an antibody as the ‘recognition molecule.’ The antibody immobilization on the microfluidic chip of Zhang involves MPTS and OPSS-PEG2000-SVA (page 9282, right column, second full paragraph). According to Applicant’s Remarks filed August 22, 2025, “Commercial PEG2000 has an average molecular weight of approximately 2000 Da, corresponding to about 45 repeating units (calculated as 2000
÷
44.053
≈
45.4)” (page 14, first full paragraph). Thus, Zhang meets the elected species for ‘m’ which is 45. As such, Zhang anticipates instant claims 15, 16, 19, 21, and 22.
Regarding instant claims 17 and 24, the antibody used in Zhang is anti-EpCAM (page 9282, right column, first and second full paragraphs). Thus, instant claims 17 and 24 are anticipated.
Regarding instant claims 18 and 25, Zhang captured trophoblastic cells with their invention (page 9283, right column, second paragraph). Thus, instant claims 18 and 25 are anticipated.
Regarding instant claim 23, Zhang discloses release the antibody-bound fetal cells using dithiothreitol (page 9282, left column, second and third paragraphs). Thus, instant claim 23 is anticipated.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm.
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, Melenie Gordon can be reached at 571-272-8037. 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.
Sef
/SUSAN E. FERNANDEZ/ Examiner, Art Unit 1651