DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s Preliminary Amendments, filed 07/18/2023 and 08/02/2023, are acknowledged and have been entered.
Status of Claims
3. Claims 1-5, 7-10, and 12-22 are pending in the instant application. Claims 6 and 11 have been canceled.
4. Applicant’s election of Group III, claims 9-10, 12-17 and 22, directed to a method of treating cancer in a subject in need thereof and the species of SEQ ID NO: 16, filed on 04/16/2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
5. Claims 1-5, 7-8 and 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
Information Disclosure Statement
6. The information disclosure statements (IDS) submitted on 07/18/2023, 10/05/2023, 10/31/2023, 10/09/2024, 01/16/2026, and 04/16/2026 are acknowledged and the references cited therein have been considered.
7. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Priority
8. The present application is a 371 National Stage application of PCT International Application No. PCT/US2022/012853, filed 01/19/2022, which claims the benefit of US Provisional Patent Application No. 63/139,115, filed 01/19/2021. Applicant' s claim for the benefit of prior-filed applications is acknowledged.
Specification
9. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which Applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
10. Claims 9-10, 12-17, and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant has broadly claimed:
A method of treating cancer in a subject in need thereof, comprising:
providing a biological sample from the subject;
determining presence or absence of an abnormal accumulation of a high-mannose glycan epitope in the biological sample; and
administering or providing for administration a therapeutically effective amount of a polypeptide that specifically binds the high-mannose-type glycan epitope to the subject if the abnormal accumulation is determined to be present in the biological sample.
As such, the claimed method administers a polypeptide that specifically binds the high-mannose-type glycan epitope. This represents a broad genus as defined in the specification paragraph [0082]-[0087]. The specification does not disclose a representative number of species of such specific epitopes used in the claimed method of treatment, nor sufficient relevant identifying characteristics in the form of structure or functional characteristics coupled with a known or disclosed correlation between structure and function.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas, that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc. 107 F.3d 1565, 1572, 41 USPQ2d 191, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready for patenting” such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v Wells Elecs., Inc., 525 U.S. 55, 68, 119 S. Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by “whatever characteristics sufficiently distinguish it”). “Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’ “ Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612. An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. See MPEP 2163 I.A.
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention i.e., complete or partial structure, other physical or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613 (quoting the Written Description Guidelines, 66 Fed. Reg. at 1106, n. 49, stating that “if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function”.) “Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function.” See MPEP 2163 II.3.
In addition, with regard to the recitation of SEQ ID No: 16 in instant dependent claim 22, the specification fails to disclose a specific epitope for this particular polypeptide. Thus, it is clear that the term “the high-mannose type glycan epitope” in instant claim 9 is much broader than the examples in the specification.
Therefore, it appears that the instant specification does not adequately disclose the breadth of “a polypeptide” or “the high-mannose type glycan epitope” recited in the method of the instant claims. In light of this, a skilled artisan would reasonably conclude that Applicant was not in possession of the genus of all such said polypeptides or epitopes and hence was not in possession of the method that uses them at the time the instant application was filed.
Claim Rejections - 35 USC § 101
11. 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 therefore, subject to the conditions and requirements of this title".
Claims 9, 13-17 and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a law of nature/natural phenomenon, and/or an abstract idea without significantly more. The claims recite conditional treatment if the sample has abnormal accumulation of a high-mannose type glycan epitope relative to a reference standard or healthy control, administer the pharmaceutical composition. The judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than judicial exception for the reasons that follow.
The instant claims exclude the polypeptide treatment if the level of the high-mannose type glycan epitope is low.
In its non-precedential decision in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit agreed with the district court that method of treatment claims reciting “excluding” specific patients from treatment were ineligible for patenting under 35 USC § 101.
The court states that:
Applying this [Alice/Mayo] test, we agree with the district court that claim 1 of the ’741 patent is ineligible. It is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades. The inventors observed an adverse event that iNO gas causes for certain patients. The patent claim does no more than add an instruction to withhold iNO treatment from the identified patients; it does not recite giving any affirmative treatment for the iNO-excluded group, and so it covers a method in which, for the iNO-excluded patients, the body’s natural processes are simply allowed to take place. Consequently, the claim here is directed to the natural phenomenon. The claim, apart from the natural phenomenon itself, involves only well-understood, routine, and conventional steps.
Claim 9 is a conditional claim. The claim requires treating with a polypeptide which specifically binds the high-mannose-type glycan epitope IF the abnormal accumulation is determined to be present relative to a reference standard or healthy control. Thus, the claims do not fall under the guidance provided by the Office in the Vanda Memo related specifically to treatment claims.
Further, the claims include the determining of presence or absence of abnormal accumulation of a high-mannose-type glycan epitope relative to a healthy control. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. V. CLS Bank Int’l, 134 S.Ct 2347, 2354 (2014). Applicant attention is directed to the association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Fed. Cir. 2012) at 56-57. Accordingly, the claims are directed to judicial exceptions.
Regarding Step 2A, prong two, having determined that the claim recites a judicial exception, it is then determined whether the claim recites additional elements that integrate the judicial exception into a practical application. Herein, the claim does not recite additional steps or elements that integrate the recited judicial exceptions into a practical application of the exception(s). While the claim practically apply the recited law of nature / natural phenomenon by including a step of administering a particular drug (i.e., specific polypeptide) to the subject to treat a particular disorder (i.e., cancer) correlated with the abnormal accumulation of high-mannose type glycan epitope, however, the administration is conditional. The full scope of the claimed invention reads on not administering the drug when the level of high-mannose-type glycan epitope is low relative to a reference standard or healthy control. Thus, the claim includes methods in which the level of high-mannose type glycan is not increased relative to a reference standard or healthy control. The claims do not clearly integrate the judicial exception into a practical application.
Therefore, whether viewed individually or as an ordered combination, the claim here does not recite a patent-eligible application under the second step of Mayo/Alice.
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.
12. Claim(s) 9, 13-14, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0117106 A1 (Satomaa et al., pub date 05/07/2009, IDS Reference US Patent #1 07/18/2023, “Satomaa”).
Regarding claim 9, Satomaa teaches a method of treating cancer in a subject in need thereof (methods to detect cancer specific glycans as well as methods for the production of reagents binding to said glycans… the use of said glycans and reagents binding to them for the treatment of cancer and malignancies, Abstract; methods for selecting patients for most effective therapy options according to their individual glycosylation profiles and the glycosylation profiles expressed in the disease, preferentially in the malignant tumor, paragraph [0123]; “patient”, as used herein, relates to any mammal in need of treatment, paragraph [0164]), comprising a) providing a biological sample from the subject (methods to detect cancer specific glycans as well as methods for the production of reagents binding to said glycans, paragraph [0001]; structural analysis of glycan mixtures present in tissue samples and using the cancer-associated glycan structures in cancer therapy, paragraph [0018]) b) determining presence or absence of an abnormal accumulation of a high-mannose glycan epitope in the biological sample (The presence or increased amount of one or more of these glycans in a patient sample indicates cancerous status of the sample… The glycan structures can be divided into three basic groups, paragraph [0091]; group 1 may be further included in a larger group of terminal man-glycans including high-Man glycans, which also represent cancer specific changes, paragraph [0092]); and c) administering or providing for administration a therapeutically effective amount of a polypeptide that specifically binds the high-mannose-type glycan epitope to the subject if the abnormal accumulation is determined to be present in the biological sample (Preferred forms of cancer therapy according to the present invention include glycan specific antibodies and cancer vaccines for passive or active immunotherapy against the cancer-associated glycan molecules, respectively., paragraph [0018]; The therapeutic antibodies described above can be used in pharmaceutical compositions for the treatment or prevention of cancer or tumor, paragraph [0146]; To achieve therapeutic response, it is preferred that the specific cancer type in the patients to be treated expresses cancer-associated glycans according to the present invention, paragraph [0153]; invention is specifically directed to the specific recognition of non-reducing terminal Mang2-structures especially in context of high-mannose structures, paragraph [0534]).
Regarding claim 13, Satomaa teaches the method of claim 9, wherein the cancer is a lung cancer (the inventors detected the presence and/or altered expression levels of the glycans widely in human cancerous tissues, e.g. in the following cancer types: lung cancer, both small cell lung adenocarcinoma and non-small cell lung adenocarcinoma, paragraph [0738]).
Regarding claim 14, Satomaa teaches the method of claim 13, wherein the lung cancer is non-small cell lung cancer (NSCLC) (the inventors detected the present and/or altered expression levels of the glycans widely in cancerous tissues, e.g. in the following cancer types: lung cancer, both small cell lung adenocarcinoma and non-small cell lung adenocarcinoma, paragraph [0738]).
Regarding claim 17, Satomaa teaches the method of claim 9, wherein the therapeutically effective amount of the polypeptide is sufficient to slow tumor growth in the subject. (Preferred forms of cancer therapy according to the present invention include glycan specific antibodies and cancer vaccines for passive or active immunotherapy against the cancer-associated glycan molecules, respectively., paragraph [0018]; The therapeutic antibodies described above can be used in pharmaceutical compositions for the treatment or prevention of cancer or tumor, paragraph [0146]; To achieve therapeutic response, it is preferred that the specific cancer type in the patients to be treated expresses cancer-associated glycans according to the present invention, paragraph [0153]).
The reference teachings anticipate the claimed invention.
13. Claims 10 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato et al. (BMC Cancer 2016, 16(63): 1-13, IDS Reference NPL #44 07/18/2023, “Sato”).
Regarding claim 10, Sato teaches a method of treating cancer in a subject in need thereof (High mannose-binding Pseudomonas fluorescens lectin {PFL} downregulates cell surface integrin/EGFR and induces autophagy in gastric cancer cells, Title; used a mouse model of liver metastasis using portal vein injection of MKN28-EGFP cells, page 8 right column, first paragraph from bottom; tumor volumes or fluorescence derived from EGFP expressed in MKN28 cells in PFL treated groups was dramatically decreased, indicating that growth of tumors, compared with the control, was inhibited by PFL treatment, page 9 right column, first paragraph from top), comprising administering to the subject an effective amount of a polypeptide that specifically binds a high-mannose-type glycan epitope (PFL induces intracellular trafficking of alpha-2 integrin in MKN28 gastric cancer cells through the specific recognition of high-mannose glycans on alpha-2 integrin, page 4 left column second paragraph from top; PFL… in PBS was injected three times intratumorally 1, 3, and 7 days after tumor implantation, page 9 left column first paragraph from bottom; fig. 7B), wherein the cancer is mediated by inappropriate activation of a growth factor receptor (MKN28-EGFP… were subcutaneously injected at both ventral regions of the mice to implant the tumor cells, page 4 left column first paragraph from top; Activated EGFR transiently modulates alpha-2 integrin cell surface expression and stimulates integrin trafficking via caveolae/raft-mediated endocytosis… such crosstalk between integrins and EGFR has been hypothesized to play a critical role in cancer progression, page 10 left column first paragraph from top; Down-regulation of cell surface EGFR by PFL rendered cancer cells susceptible to gefitinib, page 12 left column first paragraph from bottom; Fig 2).
Regarding claim 12, Sato teaches the method of claim 10, wherein the growth factor receptor comprises an epidermal growth factor receptor (EGFR), an insulin-like growth factor I receptor (IGF1R), or a combination thereof (MKN28-EGFP… were subcutaneously injected at both ventral regions of the mice to implant the tumor cells, page 4 left column first paragraph from top; Activated EGFR transiently modulates alpha-2 integrin cell surface expression and stimulates integrin trafficking via caveolae/raft-mediated endocytosis… such crosstalk between integrins and EGFR has been hypothesized to play a critical role in cancer progression, page 10 left column first paragraph from top; Down-regulation of cell surface EGFR by PFL rendered cancer cells susceptible to gefitinib, page 12 left column first paragraph from bottom; Fig 2).
The reference teachings anticipate the claimed invention.
14. Claims 9, 10, 12-14, 17 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO/2018/148541 (IDS reference).
The `541 publication teaches and claims method of treating a cancer, comprising administering a polypeptide comprising an actinohivin variant polypeptide to a subject in need thereof, wherein the cancer is selected from lung cancer, breast cancer, colon cancer, blood cancer, cervical cancer, and prostate cancer, wherein the actinohivin variant polypeptide and the antibody fragment comprise the sequence of SEQ ID NO: 16 (identical to claimed SEQ ID NO: 16), wherein the cancer is characterized by one or more cancer cells having high-mannose-type glycans on a cell membrane of the one or more cancer cells (see claims 26-33).
The `541 publication teaches Immunocytochemistry (for determining the presence of absence of HMG epitope) wherein Fluorescent imaging was used to visualize AvFc binding to N-linked HMGs on the surface of cancer cells. MCF10A or H460 cancer cells (i.e., sample) were incubated overnight in an 8-well chamber slide before fixation with 1% paraformaldehyde. AvFc bound cancer cells were finally detected with anti-human (Fc) FITC secondary antibody, with the nuclei stained with a mounting medium containing DAPI[00119]. Further, immunohistochemistry using AvFc detected an advanced- stage human colon tumor (i.e., sample) (FIG. 2G). These results corroborate previous findings that high levels of HMGs are often displayed on neoplastic cells. To test the anti-cancer potential of AvFc, an in vitro ADCC assay was performed using the lung cancer cell line A549 and human primary effector cells. The lectibody induced a potent ADCC activity, which was comparable to that of cetuximab (FIG. 10B) [00139].
(FIG. 2E) images showing immunocytochemistry assessing the non-tumorigenic mammary epithelial cell line MCF10A and non-small cell lung carcinoma cell line H460 with 1 μg/mL AvFc, where samples were analyzed by fluorescent microscopy [0015]. Immunocytochemistry shows Fluorescent imaging was used to visualize AvFc binding to N-linked HMGs on the surface of cancer cells. MCF10A or H460 cancer cell [00119].
The claimed functional properties in claim 17 are considered inherent properties because the method and the product used in the reference method are the same as the claimed method.
Alignment of claimed/referenced SEQ ID NO: 16.
Qy 1 ASGTIRNAETGRCLDSNYNGNVYTLPCNGGNYQRWTGPGDGTVRNAETGRCLDSNYDGAV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ASGTIRNAETGRCLDSNYNGNVYTLPCNGGNYQRWTGPGDGTVRNAETGRCLDSNYDGAV 60
Qy 61 YTLPCNGGSYQKWTGPGDGTIQNAETGRCLDSNYNGNVYTLPCNGGNYQKWTGGGGSVEP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 YTLPCNGGSYQKWTGPGDGTIQNAETGRCLDSNYNGNVYTLPCNGGNYQKWTGGGGSVEP 120
Qy 121 KSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNW 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 KSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNW 180
Qy 181 YVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTIS 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 YVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTIS 240
Qy 241 KAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 KAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPV 300
Qy 301 LDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 350
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 LDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK 350
The reference teachings anticipate the claimed invention.
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.
15. Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over WO/2018/148541 or US 2009/0117106 A1 (Satomaa et al., pub date 05/07/2009, IDS Reference US Patent #1 07/18/2023, “Satomaa”) as applied to claims 9, 13-14 and 17 above, and further in view of Li et al (Oncogene 2009; 28(43):3801-3813, “Li”).
The teachings of Satomaa and WO/2018/148541 have been discussed, supra.
WO/2018/148541 and Satomaa do not teach a method wherein the cancer is resistant to treatment with an antibody that specifically binds a growth factor receptor, nor does Satomaa teach a method wherein the subject is resistant to treatment with an antibody that specifically binds to an epidermal growth factor receptor (EGFR).
However, in analogous art, Li teaches a cetuximab-resistant model using the non-small cell lung cancer (NSCLC) cell line H226. Furthermore, Li teaches both in vitro and in vivo use of the model cetuximab-resistant cell line.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of WO/2018/148541 and Satomaa et al (e.g., targeting high-mannose glycan epitope) to target a cancer wherein the subject is resistant to treatment with an antibody that specifically binds an epidermal growth factor (EGFR) receptor as taught by Li because the WO/2018/148541 and Satomaa et al teach that the referenced polypeptides would treat lung cancer.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
16. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over US 2009/0117106 A1 (Satomaa et al., pub date 05/07/2009, IDS Reference US Patent #1 07/18/2023, “Satomaa”) as applied to claims 9, 13-14 and 17 above, and further in view of WO 2018/148541 A1 (University of Louisville Research Foundation Inc., pub date 08/16/2018, IDS Reference Foreign Patent #1 07/18/2023, “Louisville”).
The teachings of Satomaa have been discussed previously, supra.
Satomaa does not teach a method wherein the polypeptide comprises an amino acid sequence set forth in SEQ ID NO: 16.
However, in analogous art, Louisville teaches a polypeptide of SEQ ID NO: 16 for anti-viral and anti-cancer use (including lung cancer) which is 100% identical to the instant SEQ ID NO: 16.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method taught by Satomaa using the polypeptide of SEQ ID NO: 16 as taught by Louisville.
One of ordinary skill in the art would have been motivated to do so because it is simple substitution – swapping one known element (a high-mannose-targeting polypeptide) for another, and the substitution would have been predictable.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
17. Claims 9-10, 12, 15-17, and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-9, 12, and 21 of copending Application No. 18/277,684 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application provide a species to the genus of the instant application. At its broadest, the claims of the instant application recite a method of treating any cancer with a polypeptide that specifically binds the high-mannose-type glycan epitope. The reference application provides a method of treating ovarian cancer with an actinohivin variant polypeptide.
The claims of the `684 application anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
18. No claims are allowed.
19. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN ALFANO whose telephone number is (571)272-3092. The examiner can normally be reached M-F 8-5 EST.
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/ALAN ALFANO/Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641
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