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 .
Status of the Claims
Claims 1, 4, 16, 36-38, 49, and 53 are pending and examined herein.
Priority
This application, filed 07/21/2022, is a 371 of PCT/US2021/014299, filed 01/21/2021, with claims benefit of 62/964,449, filed 01/22/2020. This priority is acknowledged and the claims examined herein are treated as having an effecting filing date of 01/22/2020.
Withdrawn Rejections/Objections
The objection to the Drawings has been withdrawn in response to Applicant’s submission of new drawings.
The objection to the Specification has been withdrawn in response to Applicant’s amendment to the Specification.
The rejection of claims 1, 16, 36-38, and 49 under 35 U.S.C. 102 has been withdrawn in response to Applicant’s amendment.
Amended 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 16, 49, and 53 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 53 is indefinite for being a method claim without any active method steps. Claim 53 recites “A method for characterizing placenta accreta spectrum comprising characterizing placenta accreta spectrum biomarkers…using a panel”. However, the recited step of “using” is, itself, indefinite for lacking clarity and is not considered an active step. It is not clear how someone would use the claimed panel to characterize placenta accreta spectrum. Claims 16 and 49 are rejected for being dependent on claim 53 and failing to clarify the method.
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 16 and 49 are 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 a previously presented claim upon which it depends. In this case, claims 16 and 49 are recited as being dependent on claim 53, which is presented after claims 16 and 49. 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.
Amended 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.
Claims 1, 4, 16, 36-38, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Tseng et al., “Differential expression of angiopoietin-1, angiopoietin-2 and Tie receptors in placentas from pregnancies complicated by placenta accreta” American Journal of Obstetrics and Gynecology (published 02/07/2006, referred to herein as Tseng’2006) in view of Tseng et al., “Differential expression of vascular endothelial growth factor, placenta growth factor and their receptors in placentae from pregnancies complicated by placenta accreta” Placenta (published 03/02/2005, referred to herein as Tseng’2005), Tong et al., “Management of postpartum pulmonary embolism combined with retained placenta accreta” Medicine (published 09/2019, referred to herein as Tong), and Shengyi et al., “Research Progress on factors related to placenta accreta” Int. J. of Obs. And Gyn (published August 2018, Machine translation provided, referred to herein as Shengyi).
Claims 1, 36, and 37 are directed to a biomarker panel for characterizing placenta accreta spectrum in a pregnant subject; however, “for characterizing placenta accreta spectrum in a pregnant subject” in the preamble of claim 1 is considered an intended use of the claimed panel. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In order words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 II. In this case, claim 1 recites “for characterizing placenta accreta spectrum in a pregnant subject” which is considered an intended use of the claimed panel and does not provide any structural significance.
Regarding claims 1, 36, and 37, Tseng’2006 teaches a panel with a monoclonal capture antibody bound to a well substrate for binding Tie-2 (p. 566, col. 2, para. 3, lines 1-6).
Regarding claim 38, Tseng’2006 teaches a method of characterizing placenta accreta comprising contacting placental lysates with wells precoated with monoclonal antibodies specific for Tie-2 (p. 566, col. 2, para. 3, lines 1-6).
However, Tseng’2006 does not teach a panel further comprising capture molecules against antithrombin III, plasminogen activator inhibitor 1, or soluble VEGF receptor 2 (claim 1) or a capture molecule from the list recited in claim 4.
Regarding claim 1, Tseng’2005 teaches a panel for characterizing placenta accreta in subjects (abstract), the panel comprising monoclonal capture antibodies against soluble VEGFR-2 (p. 73, col. 1, para. 1, lines 1-6). Tseng’2005 teaches that “women with placenta accreta demonstrated significantly…lower soluble VEGFR-2 concentrations than did women with normal pregnancy” (Abstract, lines 10-13).
Regarding claim 4, Tseng’2005 teaches a panel comprising Epidermal growth factor receptor (EGFR, p. 103, col. 2, para. 1, lines 4-6). Tseng’2005 teaches that “We found that upregulated EGFR…are regulated to the development of placenta accreta” (p. 103, col. 2, para. 1, lines 4-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the panel taught by Tseng’2006 by including capture molecules against soluble VEGFR 2 and EGFR, as taught by Tseng’2005 because doing so would improve the characterization of placenta accreta. One would have a reasonable expectation of success because, as taught by Tseng’2005, VEGFR 2 levels have been found to be lower and EGFR levels are higher in subjects with placenta accreta than in healthy subjects (Tseng’2005 Abstract, lines 10-13).
The combined disclosures of Tseng’2006 and Tseng’2005 teach characterizing placenta accreta in pregnant subjects with a panel comprising monoclonal capture antibodies against Tie-2 (Tseng’2006, p. 566, col. 2, para. 3, lines 1-6) and soluble VEGFR-2 (Tseng’2005, p. 73, col. 1, para. 1, lines 1-6).
However, the combined disclosures of Tseng’2006 and Tseng’2005 do not teach a panel comprising capture molecules against antithrombin III and plasminogen activator inhibitor 1.
Regarding claim 1, Tong teaches that “antithrombin III [activity] was 56%” (p. 2, col. 2, para. 1, lines 9-11) in a patient with placenta accreta (p. 1, col. 2, para. 3, lines 1-3).
It would have been obvious to one of ordinary skill in the art at the time of the claimed invention to modify the panel taught by the combined teachings of Tseng’2006 and Tseng’2005 by including a capture molecule against antithrombin III because doing so would improve the characterization of placenta accreta. A skilled artisan would be motivated to make this modification because one would recognize that decreased antithrombin III activity in a patient with placenta accreta, as taught by Tong (p. 2, col. 2, para. 1, lines 9-11), may be due to reduced protein levels of antithrombin III. One would have a reasonable expectation of success because, as taught by Tong, antithrombin III activity has been found to be lower in subjects with placenta accreta than in healthy subjects (p. 2, col. 2, para. 1, lines 9-11).
However, the combined disclosures of Tseng’2006, Tseng’2005, and Tong do not teach a panel comprising capture molecules against plasminogen activator inhibitor 1.
Regarding claim 1, Shengyi teaches that the level of plasminogen activator inhibitor 1 is reduced in implanted placenta, i.e. placenta accreta (p. 366, col. 1, para. 1, lines 9-13). Shengyi teaches that the factors abnormally expressed in placenta, such as PAI-1, are expected to become biomarkers for diagnosing placenta accreta (p. 367, col. 2, para. 4, lines 5-8).
It would have been obvious to one of ordinary skill in the art at the time of the claimed invention to modify the panel taught by the combined teachings of Tseng’2006, Tseng’2005, and Tong by including a capture molecule against PAI-1 as taught by Shengyi because doing so would further improve the characterization of placenta accreta. An artisan would have been motivated to make this change with an expectation of success because, as taught by Shengyi, PAI-1 plays a role in the molecular mechanism of placenta accreta and is expected to be a biomarker for diagnosing placenta accreta.
Allowable Subject Matter
Claims 16, 49, and 53 are considered free over the prior art. The closest prior art is considered to be Tseng’2005, as described above. Although these markers have been measured in placenta samples, the recitation of measuring these four biomarkers in a maternal plasma sample is considered free of prior art and non-obvious. However, as described in the rejection under 35 U.S.C. 112(b), further clarification about how these four markers are used to characterize placenta accreta spectrum is required.
Response to Arguments
Applicant's arguments filed 10/24/2025 have been fully considered but they are not persuasive.
Regarding the Objection to the Drawings, the objection has been withdrawn in response to Applicant’s submission of new drawings.
Regarding the Objection to the Specification, the objection has been withdrawn in response to Applicant’s amendment to the Specification.
Regarding the rejection of claims 1, 16, 36-38, and 49 under 35 U.S.C. 102 has been withdrawn in response to Applicant’s amendment.
Regarding the remarks on the rejection of claims 3, 4, 52, and 53 under 35 U.S.C. 103, Applicant argues that the previously cited prior art does not teach the four markers in the amended claims. The rejection of the claims under 35 U.S.C. has been amended in response to Applicant’s amendment.
Regarding the remarks on the rejection of claim 53 under 35 U.S.C. 103, the argument is considered moot since the rejection has been withdrawn in response to Applicant’s amendment.
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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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 January 15, 2026