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 .
DETAILED ACTION
2. The election without traverse filed 12/29/2025 in response to the Office Action of 08/28/2025 is acknowledged and has been entered.
Applicant has elected Group I, claims 1-11, drawn to a method of detection of the presence of a cancer antigen in a patient; including:
(a) obtaining a biological sample from a patient with suspected malignant epithelial
neoplasm, the biological sample comprising a serum sample, blood sample(s), tumor
tissue, cancer cell culture, bone marrow tissue, and/or saliva from a patient with suspected malignant epithelial neoplasms;
(b) obtaining samples of blood and/or saliva from a control group of healthy people
without malignant neoplasms;
(c) treating the samples obtained in (a) and (b) with a method for obtaining a marker
for epithelial carcinomas formed on the surface of cancer cells of epithelial genesis, wherein the marker comprises the cancer antigen;
(d) isolating the marker for epithelial carcinomas from the biological
samples from the patient with suspected malignant epithelial neoplasm; and
(e) if the expression level or concentration measurement of the marker for epithelial
carcinomas in the samples in (a) exceeds the expression level or concentration of the marker for epithelial carcinomas in the samples in (b), then the result means a high probability of the epithelial cancer presence in the patient with suspected malignant
epithelial neoplasm.
3. Claims 1-14 are pending in the application. Claims 12-14 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/29/2025.
4. Claims 1-11 are currently under prosecution.
Priority
5. Applicant’s claim under 35 U.S.C. §§ 365(c) for benefit of the earlier filing date of application, is acknowledged.
6. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
7. Claims 1-11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Claims 1-11 are directed to a correlation of judicial exception, for example, correlation of N-glycoprotein with cancer, this type of correlation is a consequence of natural processes, because it is a consequence of a natural process in the body. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to N-glycoprotein are steps for routine data gathering in order to test for the correlation do not add a meaningful limitation to the method as they would be routinely used by those of ordinary skill in the art in order to apply the correlation. The steps in addition to N-glycoprotein are steps of obtaining a biological sample from a patient with suspected malignant epithelial neoplasm, obtaining samples from a control group of healthy people without malignant neoplasms, determining the level of N-glycoprotein by anti-N-glycoprotein antibody using an immunoassay, which were well understood and routine in the art before the effective filing date of the instant application as demonstrated by Pierce et al. (WO 2009/075883, published on 18 June 2009) teach a method for identifying glycoproteins having a cancer-specific glycoform, cancer-specific glycoforms are useful in diagnostics and therapeutics; see entire document, e.g. title, abstract, pages 2-4.
Claim Rejections – 35 USC § 112
8. 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.
9. 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.
10. Claim 3 is 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the limitation "used for the isolation of a cancer antigen" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim, because the idea of “isolating the cancer antigen” in claim 1 is different from “used for the isolation” of claim 3.
11. 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.
12. Claims 1-3, 5-6 and 9-11 are rejected under 35 U.S.C. 112(a), 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims 1-3, 5-6 and 9-11 are drawn to a method of detection of the presence of a cancer antigen in a patient.
The specification teaches a method of detecting the N-glycoprotein of cancer antigen; see Examples 4-5 and 7.
Thus, the claims are broad drawn to a method of detection a cancer antigen in a patient. However, the specification only teaches a method of detecting the N-glycoprotein of cancer antigen.
The specification does not provide adequate written description of the claimed a genus of cancer antigens. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention the genus of cancer antigens for detecting cancer patient.
The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3).
The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, a genus of cancer antigens for detecting cancer patient. The specification only teaches a method of detecting the N-glycoprotein of cancer antigen. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id.
The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “ Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original).
Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895.
The court in In re Alonso (Fed. Cir. 2008) citing In re Enzo, Enzo, 323 F.3d at 969 stated that
[F]or purposes of satisfying the written description requirement, it is not enough merely to disclose a method of making and identifying compounds capable of being used to practice the claimed invention.
Thus, the instant specification may provide an adequate written description of the genus of cancer antigens for detecting cancer in a patient, per Lilly by describing structural features common to the members of the genus, which features constitute a substantial portion of the genus.
The following quotation from section 2163 of the MPEP is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through
sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A “representative number of species” means that the species which are adequately
described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
It is noted that AbbVie v. Janssen Biotech and Centocor Biologics (Fed. Cir. 2014) confirms a strong Post-Ariad Written Description requirement - especially with regard to genus-species claim situations. In the decision, Judge Lourie focuses particularly on the alleged infringing antibodies and notes that: [While] AbbVie patents need not describe the allegedly infringing [compound] in exact terms . . . [t]he patents must at least describe some species representative of antibodies that are structurally similar to [the accused compound]. Because the patent document lacked any such structural description, the court confirmed that the corresponding claims were invalid under 112(a). In discussing the case, Judge Lourie was clear that one problem here is that the invention was described in terms of its function rather than its structure. Lourie writes:
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed or through disclosure of a functional characteristic of the claimed genus coupled with a known or disclosed non-functional characteristic (structure) that correlates to the function.
Alternatively, per Enzo, the specification can show that the claimed invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In this case, the specification does not describe the genus of cancer antigens that satisfies either the Lilly or Enzo standards. The specification does not disclose a sufficient number of cancer antigens. There are insufficient structural features common to all members of the genus of cancer antigens. However, the Specification only teaches a method of detecting the N-glycoprotein of cancer antigen. One of ordinary skill in the art would not be able to identify the broad claimed genus of cancer antigens. Thus, the Specification does not provide an adequate written description of the genus of cancer antigens for detecting cancer patient that is required to practice the claimed invention.
The instant disclosure does not adequately describe the scope of the claimed genus, which encompasses a substantial variety of subgenera. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
13. 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 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
14. 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.
15. Claims 1 and 3-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pierce et al. (US 20110033875, published on 02/10/2011, IDS).
Claims 1 and 3-11 are herein drawn to a method of detection of the presence of a cancer antigen in a patient; including:
(a) obtaining a biological sample from a patient with suspected malignant epithelial
neoplasm, the biological sample comprising a serum sample, blood sample(s), tumor
tissue, cancer cell culture, bone marrow tissue, and/or saliva from a patient with suspected malignant epithelial neoplasms;
(b) obtaining samples of blood and/or saliva from a control group of healthy people
without malignant neoplasms;
(c) treating the samples obtained in (a) and (b) with a method for obtaining a marker
for epithelial carcinomas formed on the surface of cancer cells of epithelial genesis, wherein the marker comprises the cancer antigen;
(d) isolating the marker for epithelial carcinomas from the biological
samples from the patient with suspected malignant epithelial neoplasm; and
(e) if the expression level or concentration measurement of the marker for epithelial
carcinomas in the samples in (a) exceeds the expression level or concentration of the marker for epithelial carcinomas in the samples in (b), then the result means a high probability of the epithelial cancer presence in the patient with suspected malignant
epithelial neoplasm.
Pierce et al. teach a method for identifying a biomarker associated with cancer comprising: providing a test sample obtained from a subject having cancer or a precancerous condition or from a cancer cell culture, wherein the test sample comprises a cancer-specific glycoform of a glycoprotein comprising a glycan; and contacting the test sample with a glycan-binding molecule specific for the glycan, under conditions that permit binding of the cancer-specific glycoform of the glycoprotein to the glycan-binding molecule to yield a bound glycoprotein/glycan-binding molecule complex, the method further include comparing the amount of biomarker to a reference, wherein altered glycosylation or altered expression of the biomarker relative to the reference is indicative of the presence of cancer or a precancerous condition; see entire document, e.g., [0007-0013], [0096-0111], claims 24-28.
For claim 3, Pierce et al. teach the glycoproteins were purified by immunoaffinity chromatography; see [0073], [0198].
For claim 4, Pierce et al. teach glycoproteins 49-250 kDa, where the glycoprotein is N-glycosylated protein; see [0032], [0201].
For claim 5, Pierce et al. teach immunoassays are used for identifying the biomarker; see [0116].
For claims 7-9, Pierce et al. teach the glycan-binding molecule includes a polyclonal or monoclonal glycospecific antibody, or antibody fragments; see [0086], [0092], claim 26.
For claims 10-11, Pierce et al. teach the biological sample includes blood or a tissue sample; see [0008].
Claim Rejections - 35 USC § 103
16. 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 of this title, 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.
17. 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.
18. Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Pierce et al. (US 20110033875, published on 02/10/2011, IDS).
Claim 2 is herein drawn to the method of claim 1, wherein the method for obtaining a new marker for epithelial carcinomas comprises: using thermal treatment of the biological sample in the range of 50 to 65 °C from patients or cancer cell lines in culture; and an acidic environment with a low pH in the 2.0 to 5.0 range.
The teachings of Pierce et al. have been set forth in the above rejection of claims 1 and 3-11 under 35 U.S.C. 102(a)(1).
Pierce et al. do not teach the pH and temperature for the treatment of the biological sample.
It is well-known in the art that the extraction of biological samples (tissues, blood, urine) for cancer biomarker detection is highly dependent on temperature and pH, which directly affect extraction yield, biomarker stability, and enzymatic degradation.
It is noted that generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), see MPEP 2144.05(II).
Double Patenting
19. 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 double patenting rejection is appropriate where the claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
20. Claims 1-2 and 4-10 provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 3 and 6 of copending Application No. 19/200475. Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
Claims 1-2 and 4-10 are herein drawn to a method of detection of the presence of a cancer antigen in a patient; including:
(a) obtaining a biological sample from a patient with suspected malignant epithelial
neoplasm, the biological sample comprising a serum sample, blood sample(s);
(b) obtaining samples of blood and/or saliva from a control group of healthy people
without malignant neoplasms;
(c) treating the samples obtained in (a) and (b) with a method for obtaining a marker
for epithelial carcinomas formed on the surface of cancer cells of epithelial genesis, wherein the marker comprises the cancer antigen;
(d) isolating the marker for epithelial carcinomas from the biological
samples from the patient with suspected malignant epithelial neoplasm; and
(e) if the expression level or concentration measurement of the marker for epithelial
carcinomas in the samples in (a) exceeds the expression level or concentration of the marker for epithelial carcinomas in the samples in (b), then the result means a high probability of the epithelial cancer presence in the patient with suspected malignant
epithelial neoplasm.
Claims 3 and 6 of copending Application No. 19/200475 are drawn to a method for cancer detection comprising contacting blood serum of a patient with the immobilized monoclonal antibodies of IgM class directed against the N-glycosylic epitope of the CA-62 glycoprotein in the set of reagents prepared according to claim 3.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
21. No claim is allowed.
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/YAN XIAO/Primary Examiner, Art Unit 1642