Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Request for Continued Examination
The request filed on 1/12/2026 for a Continued Examination (RCE) under 37 CFR 1.114 based on Application No. 17/555149 is acceptable, and a RCE has been established. An action on the RCE follows.
Claims 1-55 have been cancelled.
Claims 56-76 are pending.
Claims 57-58 and 61-76 were withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claims.
Claims 56 and 59-60, drawn to a set for capture reagents to measure the levels of biomarkers comprising CA125, CA19-9, ITIH4, and CA15-3, are under consideration.
Note to applicant: The term “ITIH4” set forth in claim 56 was previously presented, which is no need underlining.
The examined claims 56 and 59-60 are all previously presented and there is no amendment to the claims in this response.
Rejection Maintained and Response to Arguments:
Claim Rejections - 35 USC § 102/103
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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
1. Claim(s) 56 and 59-60 remain and are again rejected under 35 U.S.C. 102(a) and 102(e) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Chan et al (US Patent 7,605,003, original application No 10/635308, published as US 2005/0059013, Mar 2005 and priority to Aug 2003).
The applied reference has a common applicant and inventions with the instant application. Based upon the pre-AIA 35 U.S.C. 102(e) date of the reference, it constitutes prior art. This rejection under pre-AIA 35 U.S.C. 102(e) might be overcome either by a showing under 37 CFR 1.132 that any invention disclosed but not claimed in the reference was derived from the inventor or joint inventors (i.e., the inventive entity) of this application and is thus not the invention “by another,” or if the same invention is not being claimed, by an appropriate showing under 37 CFR 1.131(a).
Chan et al first teach ovarian cancer biomarkers and a method of diagnosing ovarian cancer comprising detecting the biomarkers. Chan et al specifically teaches a set of biomarkers, Marker 4, as known traditional ovarian cancer biomarkers that include CA125, CA15-3, and CA19-9… (page 4, line 3+, page 16, list lines). Chan et al teach antibodies specifically binding to antigen/biomarkers as capture reagents in immunoassays and a kit comprising those antibodies as capture reagents (page 31, paragraph 1). Chan’s set of biomarkers comprises more than the three markers CA125, CA15-3, and CA19-9 listed in the instant claims and would have smaller scope than the presently claimed set of markers, therefore would anticipate the present claims.
Regarding with the marker ITIH4, Chan et al teach new ovarian marker IAIH4 heavy chain fragment, which is referred to and accurately called ITIH4 (Inter-α-Trypsin Inhibitory Heavy chain H4, section IAIH4 fragment, page 15, and claim 1, 6, claims). Chan et al teach IAIH4 (ITIH4) fit in the category of Marker 4 for ovarian cancer detection (page 31, left col line 42+) and teach antibody and kit comprising thereof. Thus, Chan et al teach each and every limitation, a set of antibodies binding to biomarkers comprising CA125, CA19-0, ITIH4 and CA15-3, recited in the claims.
For 103 rejection:
In order to increase the accuracy of ovarian cancer detection, one skilled in the art would be motivated with reasonable expectation of success to form a test kit comprising capture antibodies to the set of markers listed in the claims to arrive at current invention without unexpected result.
2. Claim(s) 56 and 59-60 remain and are again rejected under 35 U.S.C. 102(e) as being anticipated by or, in the alternative, under 35 U.S.C. 103 as being unpatentable over Fung et al (WO2006/099126, filed on March 11, 2005).
Fung et al teach ITIH4 being a new ovarian cancer marker and its fragment being detected by SELDI biochips and teach raising antibodies with the fragment for detecting the ITIH4 protein and immunoprecipitation (pages 10, 16-18, 32, and table 1). Fung et al teach that other biomarkers including CA125, CA15-3 and CA19-9 discovered earlier can be combined together with ITIH4 for ovarian cancer detection and diagnosis (page 32, [0110]). Fung et al teach antibodies used for recognizing and capturing the biomarkers for SELDI-based immunoassay ([0096-0098] and figure 3). Fung et al also teach a kit comprising the antibodies as capture reagents for detecting the biomarkers ([0022-0024 and 0136-137] and claims 33+).
For 103 rejection:
In order to increase the accuracy of ovarian cancer detection, one skilled in the art would be motivated with reasonable expectation of success to combine the capture antibodies for detecting the biomarkers ITIH4, CA125, CA15-3 and CA19-9 and form a kit to arrive at current invention without unexpected result.
Response to applicant’s argument and Declaration under 37 C.F.R. §1.130
At page 4, applicant states:
a declaration under 37 C.F.R. §1.130 demonstrating the subject matter of each of Chan and Fung originated with or was obtained from the present inventors. Therefore, Chan and Fung are not available as prior art references.
In response, the 1.130 declaration filed on 1/9/2026 by Dr. Zhen Zhang has been considered, but insufficient to overcome the both rejections above. Dr. Zhang’s declaration is Katz type of declaration under 37 C.F.R. §1.132 for pre-AIA application. To overcome the rejections by disqualifying the prior art cited in the rejection(s), the declaration should provide statement indicating each of the authors or inventors having conceptual contribution or merely technical support etc. for the cited reference/application/patent. However, the declaration by Dr. Chang merely mentioned Daniel W. Chan and Eric T. Fung are co-inventors on the present application, but fail to state whether or not or what contribution of the co-inventor Xiao-Ying Meng provide in Patent No 7,605003 AND fail to state whether or not or what contributions of listed co-inventors Robert BAST, Jin SONG, and Vladimir PODUST did in the reference of WO2006099126. For the reasons, the 1.130 declaration by Dr. Zhen Zhang is insufficient to overcome the rejections above.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 56 and 59-60 remain and are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Grankvist et al (Int. J. Cancer (Pred. Onclo) 74:233-236, 1997), Panidlis et al (J Endocrinological Invest, 11:801-804, 1998), or Joyce Taylor-Papadimitriou et al (Pg US2003/0211521, published on Nov 13, 2003) in view of Fung et al (WO2006/099126, filed on March 11, 2005) or Chan et al (US2005/0059013, filed on March 2003, priority to Aug, 2002).
Grankvist teaches a set of biomarkers for detecting renal-cell carcinoma, wherein the biomarkers comprise CA19-9, CA125 and CA15-3 (abstract). Grankvist teaches an immunoradiometric assay (IRMA) method of detecting the markers, wherein the method comprises antibodies to measure the concentrations/levels of the biomarkers in the serum samples (page 233, right col and table 1). Thus, Grankvist teaches a set of capture reagents (antibodies) to measure the levels of biomarkers in a specimen listed in claim 56 and dependent claims, thereof anticipate the present invention.
Panidlis discloses method of measuring a set of antigens/biomarkers CA125, CA19-9 and CA15-3 in serum samples taken from 8 women before, during and after treatment with danazol (abstract). Panidlis discloses that the antigens are measured with radioimmunoassay, which use antibodies as capture reagents, wherein the set of antibodies are obtained as a kit from international Cis (page 801 right col, line 10 from bottom). Thus, Panidlis discloses a set of capture reagents (antibodies) and a kit comprising the reagents to measure the levels of biomarkers in a specimen listed in claim 56 and dependent claims, thereof anticipate the present invention.
Taylor-Papadimitriou teaches diagnostic method for a cancer in female patients comprising using antibodies as capture reagents to detect a set of biomarkers in cell, tissue or blood sample from the patients [0070, 0160-163], wherein the set of biomarkers comprises CA15-3 (MUC1), CA125 and CA19-9 captured by antibodies in a kit [0289]. Thus, Taylor-Papadimitriou discloses a set of capture reagents (antibodies) and a kit comprising the reagents to measure the levels of those biomarkers in a specimen listed in claim 56 and dependent claims, thereof anticipate the present invention.
None of Grankvist, Panidlis, and Taylor-Papadimitriou teaches biomarker ITIH4 and capture antibody binding to thereof and do not teach the set of the capture reagents or antibodies in a kit.
Fung et al teach ITIH4 being an ovarian cancer marker and its fragment being detected by SELDI biochips and raising antibodies with the fragment for detecting the ITIH4 protein and immunoprecipitation (pages 10, 16-18, 32, and table 1) as well as a kit comprising the capture reagents as set forth above.
Chan et al also teach ITIH4 being an ovarian cancer marker and teach ITIH4 fragment as well as antibody binding thereof and kit comprising thereof as set forth above.
It would have been also prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to add ITIH4 detecting antibody to the list of the biomarker detection in Grankvist, Panidlis, and Taylor-Papadimitriou and to form a kit with expected benefit and result. One would have been motivated with a reasonable expectation of success to assemble the reagents in a kit format to standardize the reagents for the optimization the assay for use in a clinical diagnosis. One of ordinary skill in the art would have been motivated with a reasonable expectation of success to combine the teachings to make a test-kit containing the set of antibodies as capture reagents for diagnosing or monitoring cancer because Grankvist Panidlis, or Taylor-Papadimitriou has shown antibodies, which can be used detecting the expressions of the biomarkers in the tissues or other biological samples and because Fung or Chan has shown additional biomarker ITIH4 for ovarian cancer and an antibody as a detecting reagent for cancer diagnosing and monitoring and kit comprising all the markers. Thus, the references in combination teach and suggest each and every limitation of the claimed invention without unexpected result.
Response to applicant’s argument:
At page 4, application acknowledged the teachings by all the references, but still relies on the Declaration by Zhen Chang to overcome the rejection. Applicant states without Chan and Fung the remainder of the cited references by the action to be deficient.
In response, the claims remain rejected as being unpatentable over all the references in combination provided in the rejection because the Declaration by Zhen Chang is insufficient to eliminate the references by Chan (US2005/0059013) and Fung (WO2006/099126), as addressed above in the response to the declaration.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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 (MPEP 9th Ed, Feb 2023).
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim not is patentably distinct from the reference claim(s) because the examined 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).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 56 and 59-60 remain directed to an invention not patentably distinct from claims 1-35 of commonly assigned US Patent 7,605,003 (original application 10/635308). Specifically, both claim sets are directed to capture reagents comprising antibodies and method of using the same capture reagent for cancer detection.
The U.S. Patent and Trademark Office normally will not institute an interference between applications or a patent and an application of com-mon ownership (see MPEP § 2302). Commonly assigned US Paten 7,605,003 discussed above, would form the basis for a rejection of the noted claims under 35 U.S.C. 103(a) if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(e), (f) or (g) and the conflicting inventions were not commonly owned at the time the invention in this application was made. In order for the examiner to resolve this issue, the assignee can, under 35 U.S.C. 103(c) and 37 CFR 1.78(c), either show that the conflicting inventions were commonly owned at the time the invention in this application was made, or name the prior inventor of the conflicting subject matter.
A showing that the inventions were commonly owned at the time the invention in this application was made will preclude a rejection under 35 U.S.C. 103(a) based upon the commonly assigned case as a reference under 35 U.S.C. 102(f) or (g), or 35 U.S.C. 102(e) for applications filed on or after November 29, 1999.
The instant claims are drawn to Previously presented)
reagents are antibodies.
A set of capture reagents to measure the levels of biomarkers in a sample specimen, wherein the biomarkers comprise CA125, CA19-9, ITIH4 and CA15-3, or measurable fragments thereof,
wherein the capture reagents are antibodies.
a kit comprising the set of reagents of claim 56.
The claims of U.S. Patent ‘003 are drawn to
A method of determining if a subject has ovarian cancer comprising: (a) measuring in a sample from the subject the amount of apolipoprotein A1 (ApoA1) and of a cleavage fragment of inter-.alpha.-trypsin inhibitor heavy chain H4 (IAIH4 fragment), wherein the IAIH4 fragment consists of the amino acid sequence of SEQ ID NO: 1 …..
The method of claim 1 further comprising measuring at least one additional biomarker in the sample from the subject.
wherein the additional biomarker is selected from the group consisting of: CA125, CA125 II, CA15-3, CA19-9, CA72-4, CA 195, …….
The Patent ‘003 also teaches antibodies as capture reagents and kit comprising thereof as set forth in the rejection above.
Both sets of the claims encompass products or a method of using the same products. The product used in a method would anticipate the same product claimed in the present invention.
Response to applicant’s statement:
Applicant requests that the rejection be held in abeyance until after patentable subject matter has been identified.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lei Yao, whose telephone number is (571) 272-3112. The examiner can normally be reached on 8:00am-6:00pm Monday-Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEI YAO/Primary Examiner, Art Unit 1642