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 .
Status of Claims
The preliminary amendment filed on 10/14/2025 amended claims 1, 2, 5, 7-13, 15-26, 29, 31-34, 36-39 and 44 and cancelled claims 3-4, 6, 14, 27-28, 30, 40-43 and 45-50. Claims 1, 2, 5, 7-13, 15-26, 29, 31-39 and 44 are pending and will be examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The effective filing date of the invention is 5/26/22, the filing date of PCT/CN2022/095171.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The use of company names, such as "AstraZeneca" and others in paragraph [0082], which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 7-13, 16, 26, 35-39, and 44 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 7 recites “wherein the CD73 antagonist of the combination treatment is a CD73 antibody”. One skilled in the art of antibodies will understand that not every CD73-specific antibody will be antagonistic – antibodies may be agonistic or neutral as well. Therefore, one of ordinary skill in the art would not be able to determine the metes and bounds of the claim. Examiner suggests amending the claim language to recite “an anti-CD73 antibody” or “an antagonistic CD73 antibody”. Claims 8-11 inherit this rejection.
Claim 11 contains the trademark/trade names I-Mab Biopharma, AstraZeneca, Corvus Pharma, Bristol-Myers Squibb, and more. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the CD73 antibodies and, accordingly, the identification/description is indefinite. Examiner suggests removing the source of each antibody from the claim.
Claim 12 recites “wherein the PD-1/PD-L1 antagonist of the combination treatment is a PD-1 antibody or a PD-L1 antibody”. One skilled in the art of antibodies will understand that not every PD-1/PD-L1-specific antibody will be antagonistic – antibodies may be agonistic or neutral as well. Therefore, one of ordinary skill in the art would not be able to determine the metes and bounds of the claim. Examiner suggests amending the claim language to recite “an anti-PD-1 antibody or an anti-PD-L1 antibody” or “an antagonistic PD-1 antibody or an antagonistic PD-L1 antibody”. Claim 13 inherits this rejection.
Regarding claim 16, the phrase "for example" 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). Examiner suggests removing the phrases proceeded by e.g. - (e.g., cisplatin, carboplatin) and (e.g., paclitaxel, albumin-bound paclitaxel, docetaxel), specifically.
Regarding claim 26, the phrase "for example" 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). Examiner suggests removing the phrases proceeded by e.g. - (e.g., cisplatin, carboplatin) and (e.g., paclitaxel, albumin-bound paclitaxel, docetaxel), specifically.
Claim 35 recites the limitation "the subject" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 35 depends from claim 5, which recites “a subject with NSCLC” and “a reference subject”, and claim 35 recites “a healthy subject”. It is unclear if “the subject” in line 2 of claim 35 refers to the subject with NSCLC, the reference subject, or the healthy subject. Appropriate clarification is required.
The term “a relative increase” in claim 36, line 2 is a relative term which renders the claim indefinite. The term “a relative increase” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no relational term for "a relative increase", so one of ordinary skill in the art would be unable to determine what to compare the subject to in order to determine if "a relative increase" occurs. Thus, one would not be reasonably apprised of the scope of the claim.
Claims 37 and 38 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: determining a total number of cells, or determining a number of immune cells or tumor cells. Claims 37 and 38 recite “wherein the level of CD73 comprises a proportion of CD73-positive cells among all cells in the sample” and “the level of CD73 comprises a proportion of CD73-positive tumor cells among all tumor cells in the sample, and/or a proportion of CD73-positive immune cells among all immune cells in the sample”. The claims do not disclose determining the total number of cells (in claim 37) or determining the total number of all tumor cells or all immune cells in order to normalize the number of CD73 positive cells. There is no explanation of what markers may be used to determine if a cell is a tumor cell or an immune cell. One of ordinary skill in the art would be unable to ascertain the scope of the claim, as they would not be able to accurately determine the proportions of claims 37 or 38 without the omitted steps.
Claim 38 recites the limitation "the positive" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 37 depends from claims 36 and 1, neither of which recite “a positive”.
The term “moderate positive” in claim 38 is a relative term which renders the claim indefinite. The term “moderate positive” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The term "moderate positive" does not .
The term “a CD73 level of 30%, 35%, 40%, 45%, 50%, or higher” in claim 39 is a relative term which renders the claim indefinite. The term “a CD73 level of 30%, 35%, 40%, 45%, 50%, or higher” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what the percentage of claim 39 is referring to. There is no context as to the percentage – for example, what total from which the percentage will be derived.
Claim 44 recites “wherein the package insert suggests treating the subject with the combination treatment of claim 1”. It is unclear if the instructions of claim 44 require the combination treatment of claim 1 or not, or what situation the combination treatment of claim 1 should be used in. Appropriate correction is required.
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.
Claims 2, 5, and 34-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon and an abstract idea without significantly more. The claim(s) recite(s) methods of sel. This judicial exception is not integrated into a practical application because all steps can be performed by a human using mental steps or basic critical thinking. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis, laid out in accordance with MPEP §2106:
Applicant’s claims 2 and 5 recite methods of selecting a therapy for a subject with NSCLC and methods for identifying a subject with NSCLC as more likely to respond to or benefit from a combination treatment than a reference subject. The claim recites a series of steps or acts. Thus the claim is directed to a process, which is one of the statutory categories of invention. (Step 1: Yes).
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of claim 2 are (a) determining a level of CD73 in a sample, (b) evaluating whether the subject is likely to respond to a treatment regimen, and (c) selecting the combination treatment the subject is likely to respond to. The steps of claim 5 are (a) determining a level of CD73 in a sample of the subject wherein an increase in CD73 compared to a reference sample from the reference subject indicates the subject is more likely to respond to a treatment, and (b) providing a recommendation that the subject will be more likely to respond. Claims 34 and 35 are directed to further specifying the reference sample in claim 5. These claims set forth a judicial exception, because this type of correlation (a level of CD73 and a likelihood to respond to treatment) is a consequence of natural processes, similar to the naturally occurring correlation found to be a law of nature by the Supreme Court in Mayo.
Additionally, the step of evaluating, selecting, determining, and recommending could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams. Thus, the claim is directed to at least one exception (Step 2: Yes), which may be termed a law of nature, an abstract idea, or both.
Barnhart et al. (WO 2017/152085) recite that CD73 is associated with many types of cancer on page 1. Therefore, the correlation between CD73 and cancer is known. Moreover, treatment with an antibody of a disease that expresses that molecule is a common treatment plan. Thus, claims 2, 5 and 34-35 recite diagnostic methods that are well understood, routine, and conventional in the art, and are directed to known markers of cancer. Therefore, the combination of elements is not sufficient to ensure that the claimed method amounts to significantly more than the exception.
On February 6, 2019, the United States Court of Appeals for the Federal Circuit (CAFC) found in Athena Diagnostics V. Mayo Collaborative Services that diagnostic methods are not patent subject matter eligible unless they embody a separate technical improvement beyond the correlation of molecules in bodily fluids to particular diseases/conditions.
Claims drawn to diagnostic uses of underlying natural phenomena regardless of the reagents employed or the starting samples used have been found not patent eligible, because once the newly discovered natural phenomenon is removed from the claims, the remaining elements merely recite routine, conventional, and well-understood steps that cannot provide the inventive concept to transform the methods into patent eligible subject matter. See Myriad Genetics; In re BRCA1 - and BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014); Arisoa Diagnostics, Inc. V. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015) (en banc petition denied) (cert. denied); Genetic Tech. Ltd. V. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Cleveland Clinic Foundation V. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); Roche Molecular Systems, Inc. V. CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018); Genetic Veterinary Sciences, Inc. V. Laboklin GmbH & Co. KG, 933 F.3d 1302 (Fed. Cir. 2019).
Accordingly, claims 2, 5, 34, and 35 are not patent eligible under 35 USC 101.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 7, 8, 11-13, 15-26, 29, 31-38 and 44 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2017/152085 A1, Barnhart et al., published 09/08/2017.
Claims 1, 2, and 5 are drawn to methods comprising evaluating a level of CD73 in a subject with NSCLC and identifying the subject as likely to respond to a combination treatment of an CD73 antagonist and a PD-1/PD-L1 antagonist based on the level of CD73, and administering the combination treatment (in claim 1), selecting the combination treatment (in claim 2), and recommending the combination treatment (in claim 5). These methods are anticipated by Barnhart et al., which discloses methods for treating a subject having cancer, comprising (i) determining the level of expression of CD73 on tumor cells; and if CD73 is present on tumor cells, then (ii) administering to the subject a therapeutically effective amount of an antagonist of CD73 and another immuno-oncology agent (claims 6-7, page 140). Barnhart et al. further disclose the cancer as NSCLC on page 142 and the other agent as a PD1 or PD-L1 antibody on page 142 and in claim 12, anticipating claim 1. Barnhart et al. further disclose methods of determining whether a subject with cancer would respond to treatment with an anti-CD73 antagonist, comprising determining the level of CD73 in a tumor of the subject, wherein the presence of CD73 in the tumor indicates the subject is likely to respond to a treatment with an anti-CD73 antagonist (page 139), anticipating claims 2 and 5. Barnhart et al. disclose, in claim 9 and on page 4, the CD73 antagonist is an anti-CD73 antibody, anticipating claim 7, and disclose the antibody BMS-986179 in Figure 22A2 and on page 142, anticipating claim 11. Barnhart et al. disclose the anti-PD-1 antibody is BMS-936558 (nivolumab) on page 142, anticipating claim 13. Barnhart et al. also disclose the treatment as further comprising a chemotherapy, or anti-proliferative cytotoxic agents, on page 172, reciting paclitaxel and taxane on page 173, anticipating claims 15 and 16. Barnhart et al. disclose these treatments can be administered separately in claims 47-48 or concurrently in claim 49 and on page 142. Barnhart et al. teach that the patient with NSCLC has metastatic and/or unresectable advanced disease on page 136 and 149, anticipating claim 18 and 19, and that the method of treatment can be used for recurrent and refractory cancers on page 144, anticipating claim 20. Barnhart et al. recite that the cancer to be treated may be squamous non-small cell lung cancer (NSCLC) on page 142 and lung squamous cell cancer on page 145, anticipating claim 21.
Page 149 of Barnhart et al. recites that the subject to be treated does not have a prior malignancy, indicating the subject is treatment naïve, anticipating claim 22. Example19, pages 228-230, disclose mice inoculated with tumor cells that were initially treated with an antagonistic CD73 antibody or a combination treatment, anticipating claim 23. Example 7, pages 203-207, discloses ‘high’ levels of CD73 (figure 24 and Table 29), anticipating claim 39. Page 149 indicates the treatment of Barnhart et al. is intended for patients who have had prior treatment with radiation, immunotherapy, or chemotherapy, indicating the patient is ineligible or rejected from the first line treatment, as the treatment is still required, and thus anticipates claim 24-26. Examples 16 and 17, page 225-227, demonstrated the determination of CD73 protein level via IHC, anticipating claim 29. This example uses FFPE tumor cells, anticipating claims 31-32 and 33, as the subject has not yet received treatment. Additionally, page 139 discloses the method comprises obtaining a sample from a subject prior to treatment and contacting the sample with an agent to detect CD73, such as a CD73 antibody, thereby teaching claim 33. Page 145 recites that the patient has a tumor that expresses high levels of CD73, e.g., higher levels of CD73 relative to the level of CD73 in healthy tissue of the same etiology as that of the tumor, anticipating claims 34 and 35. Claim 55 and page 147 of Barnhart et al. recite that the treatment produces the therapeutic effect of complete response, partial response, and/or stable disease, anticipating claim 36. Page 144 of Barnhart et al. recites determining the level of CD73 on tumors or tumor cells and treating with an antibody, anticipating claims 37 and 38. Finally, Barnhart et al. disclose a kit comprising an antiCD73 antibody and an immuno-oncology agent such as an anti-PD-1 antibody and instructions comprising administration schedules on page 174. As page 139 discloses that the anti-CD73 antibody can be used to detect CD73, the kit of Barnhart et al. anticipates claim 44. Therefore, claims 1, 2, 5, 7, 11-13, 15-26, 29, 31-38 and 44 are anticipated by Barnhart et al.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 2, 5, 7-13, 15-26, 29, 31-39 and 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2017/152085 A1, Barnhart et al. in view of WO 2020/020307 A1, Wang et al., published 1/30/2020.
Claims 1, 2, and 5 are drawn to methods comprising evaluating a level of CD73 in a subject with NSCLC and identifying the subject as likely to respond to a combination treatment of an CD73 antagonist and a PD-1/PD-L1 antagonist based on the level of CD73, and administering the combination treatment (in claim 1), selecting the combination treatment (in claim 2), and recommending the combination treatment (in claim 5). These methods are taught by Barnhart et al., which discloses methods for treating a subject having cancer, comprising (i) determining the level of expression of CD73 on tumor cells; and if CD73 is present on tumor cells, then (ii) administering to the subject a therapeutically effective amount of an antagonist of CD73 and another immuno-oncology agent (claims 6-7, page 140). Barnhart et al. further disclose the cancer as NSCLC on page 142 and the other agent as a PD1 or PD-L1 antibody on page 142 and in claim 12, teaching claim 1. Barnhart et al. further disclose methods of determining whether a subject with cancer would respond to treatment with an anti-CD73 antagonist, comprising determining the level of CD73 in a tumor of the subject, wherein the presence of CD73 in the tumor indicates the subject is likely to respond to a treatment with an anti-CD73 antagonist (page 139), teaching claims 2 and 5. Barnhart et al. disclose, in claim 9 and on page 4, the CD73 antagonist is an anti-CD73 antibody, teaching claims 7 and 8, and disclose the antibody BMS-986179 in Figure 22A2 and on page 142, teaching claim 11. Barnhart et al. disclose the anti-PD-1 antibody is BMS-936558 (nivolumab) on page 142, teaching claim 13. Barnhart et al. also disclose the treatment as further comprising a chemotherapy, or anti-proliferative cytotoxic agents, on page 172, reciting paclitaxel and taxane on page 173, teaching claims 15 and 16. Barnhart et al. disclose these treatments can be administered separately in claims 47-48 or concurrently in claim 49 and on page 142. Barnhart et al. teach that the patient with NSCLC has metastatic and/or unresectable advanced disease on page 136 and 149, teaching claim 18 and 19, and that the method of treatment can be used for recurrent and refractory cancers on page 144, teaching claim 20. Barnhart et al. recite that the cancer to be treated may be squamous non-small cell lung cancer (NSCLC) on page 142 and lung squamous cell cancer on page 145, teaching claim 21.
Page 149 of Barnhart et al. recites that the subject to be treated does not have a prior malignancy, indicating the subject is treatment naïve, teaching claim 22. Example 19, pages 228-230, disclose mice inoculated with tumor cells that were initially treated with an antagonistic CD73 antibody or a combination treatment, teaching claim 23. Example 7, pages 203-207, discloses ‘high’ levels of CD73 (figure 24 and Table 29), teaching claim 39. Page 149 indicates the treatment of Barnhart et al. is intended for patients who have had prior treatment with radiation, immunotherapy, or chemotherapy, indicating the patient is ineligible or rejected from the first line treatment, as the treatment is still required, and thus teaches claim 24-26. Examples 16 and 17, page 225-227, demonstrated the determination of CD73 protein level via IHC, teaching claim 29. This example uses FFPE tumor cells, teaching claims 31-32 and 33, as the subject has not yet received treatment. Additionally, page 139 discloses the method comprises obtaining a sample from a subject prior to treatment and contacting the sample with an agent to detect CD73, such as a CD73 antibody, thereby teaching claim 33. Page 145 recites that the patient has a tumor that expresses high levels of CD73, e.g., higher levels of CD73 relative to the level of CD73 in healthy tissue of the same etiology as that of the tumor, teaching claims 34 and 35. Claim 55 and page 147 of Barnhart et al. recite that the treatment produces the therapeutic effect of complete response, partial response, and/or stable disease, teaching claim 36. Page 144 of Barnhart et al. recites determining the level of CD73 on tumors or tumor cells and treating with an antibody, teaching claims 37 and 38. Finally, Barnhart et al. disclose a kit comprising an antiCD73 antibody and an immuno-oncology agent such as an anti-PD-1 antibody and instructions comprising administration schedules on page 174. As page 139 discloses that the anti-CD73 antibody can be used to detect CD73, the kit of Barnhart et al. teaches claim 44.
Barnhart et al. do not teach the anti-CD73 antibody recited in claims 9 and 10. However, the antibody of claims 9 and 10 is known in the art, as taught in Wang et al. in claims 1-6, and table 2. Wang et al. also disclose this antibody can be used to treat cancer, including lung cancer in paragraph [0038] and both squamous cell carcinoma and adenocarcinoma in paragraph [0041], which are alternate names for NSCLC. Therefore, it would be obvious to one of ordinary skill in the art to use the antibody of Wang et al. in the treatment method of Barnhart et al. because these antibody are functional equivalents, in that they both antagonize CD73 activity and can be used to treat the same disease (NSCLC). KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that a claim would have been obvious if the substitution of one known element for another yields predictable results to one of ordinary skill in the art. It would be obvious to substitute a known antibody for another to be used in a known method in the art to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary. Therefore, Barnhart et al. in view of Wang et al. anticipates instant claims 1, 2, 5, 7-13, 15-26, 29, 31-39 and 44.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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/AMELIA STEPHENS/ Examiner, Art Unit 1645
/ANNE M. GUSSOW/ Supervisory Patent Examiner, Art Unit 1683
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