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 Application, Amendments and/or Claims
The amendment of 21 August 2024 has been entered in full. Claims 1-17 are cancelled. Claims 18-26 are added.
Claims 18-26 are under consideration in the instant application.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 16 July 2026, 13 May 2024, and 02 May 2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
1. SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
1a. Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). See pages 7-8.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
1b. Additionally, this application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The Examiner has noted that not only are the numerous nucleotide sequences listed at pages 7-8 of the specification not identified by sequence identifiers, but these sequences are not present in the Sequence Listing XML. Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
2. Claims 18, 19, 21, and 26 are objected to because of the following informalities:
2a. Claim 18 is missing a period at the end of the claim.
2b. Claims 18 and 19 recite the acronyms “MBP” and “MUC1-N” without first defining what they represent in the independent claims. While the claims can reference acronyms, the material presented by the acronym must be clearly set forth at the first use of the acronym and/or in each independent claim.
2c. In claim 18, line 2, there is a word missing after the phrase “vaccine and oxaliplatin”. This issue could be overcome, for example, by inserting the word “wherein” after “oxaliplatin” (i.e., vaccine and oxaliplatin, wherein the fusion protein…”).
2d. In claim 18, the fusion protein sequence is an amino acid sequence, not a sequence identifier (SEQ ID NO:). Thus, for clarity, the claim should be amended to recite, for example, "the fusion protein is set forth in the amino acid sequence of SEQ ID NO. 3" or alternatively, “the fusion protein comprises the amino acid sequence of SEQ ID NO. 3".
2e. In claim 19, line 2, the word “comprising” should be amended to recite “comprises” (i.e., … fusion protein vaccine comprises the fusion protein and a buffer system…”).
2f. In claim 21, line 1, the word “a” should be amended to recite “an” (i.e., [a] an anti PD-1 antibody”).
2g. In claim 26, lines 2-3, parentheses should be inserted around the first recitation of the acronyms “MBP” and “MUC1-N”.
2h. In claim 26, line 1, the phrase “which characterized in that” is awkward and can be simplified to recite, for example, “…method according to claim 22, wherein the MBP-MUC1-N fusion protein is….”.
2i. In claim 26, line 2, the phrase “is expressed” should be amended to recite, for example, “is synthesized”.
2j. In claim 26, line 3, there is a word missing after the phrase “MUC1-N gene in tandem”. This issue could be overcome, for example, by inserting the word “wherein” after “tandem” (i.e., MUC1-N gene in tandem, wherein the nucleotide sequence of the…”).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
3. Claim 26 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
3a. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. Hydrocladium Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “gene” in claim 26 (such as in lines 2-4) is used by the claims to simply mean “a (coding) polynucleotide or nucleic acid,” while the accepted meaning is “the DNA sequence required for synthesis of a functional protein or RNA that includes the coding regions (exons), transcription-control regions, and introns [that is usually located on a chromosome]” (emphasis added by the Examiner; see Lodish et al., Molecular Cell Biology. 4th edition. New YorK: W.H. Freeman; 2000. Section 9.1, Molecular Definition of a Gene;; definition of “gene” from Merriam-Webster dictionary, www.merriam-webster.com/dictionary/gene; accessed 04 September 2019). The “genes” of the instant claim that encode MBP and human MUC1-N have been isolated (i.e., not on a chromosome) and do not comprise transcription control regions or introns (see pages 3, 5, 6 of the instant specification). Therefore, the term “gene” in the instant claim is indefinite because the specification does not clearly redefine the term.
Please note that this issue could be overcome by amending claim 26, lines 2-4 to recite, for example, “by connecting a maltose-binding protein (MBP) nucleotide sequence and a human mucin (MUC1-N) nucleotide sequence in tandem, wherein the nucleotide sequence of nucleotide sequence of
Claim Rejections - 35 USC § 112(a)
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.
4. Claims 18-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for (i) a medicament for treating rectal cancer or colon cancer, wherein the medicament comprises a recombinant MBP-MUC1-N fusion protein and oxaliplatin, and wherein the fusion protein comprises the amino acid sequence set forth in SEQ ID NO: 3; and (ii) a method for treating rectal cancer or colon cancer comprising administering to a subject the claimed medicament, does not reasonably provide enablement for a medicament or methods that recite preventing rectal cancer or colon cancer. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Claim 18 of the instant application is directed to a medicament for treating and/or preventing renal cancer and/or colon cancer, wherein the medicament comprises a recombinant MBP-MUC1-N fusion protein vaccine and oxaliplatin, the fusion protein set forth in SEQ ID NO: 3. It is noted that the Examiner has interpreted the phrase “for treating and/or preventing renal cancer or colon cancer” in claim 18 as an intended use of the claimed medicament.
Instant claims 22-25 recite methods of preventing and/or treating rectal cancer or colon cancer comprising administering medicaments that comprise a recombinant MBP-MUC1-N fusion protein vaccine and oxaliplatin, the fusion protein set forth in SEQ ID NO: 3.
The specification of the instant application teaches the generation of a recombinant MBP-MUC1-N fusion protein vaccine, wherein the MBP-MUC1-N fusion protein comprises the amino acid sequence of SEQ ID NO: 3 (pages 5-6; page 9, lines 3-5). The specification discloses that saline; anti-PD1 antibody; MBP-MUC1-N fusion protein; or MBP-MUC1-N fusion protein in combination with anti-PD1 antibody are administered to mice with MC38 colon cancer cells (page 9). The specification teaches that tumors are separately inhibited in the PD1 and MBP-MUC1-N fusion protein vaccine groups (page 10; Table 1). However, there is a significant tumor inhibition rate in the group administered MBP-MUC1-N fusion protein in combination with anti-PD1 antibody (page 10, Table 1; Figure 1). The specification indicates that the MBP-Muc1-N vaccine takes effect quickly while the PD-1 antibody takes effect more slowly (page 14, lines 11-12). In Example 2, the instant specification discloses that oxaliplatin in combination with MBP-Muc1-N also inhibits the growth of MC38 colon cancer tumors (page 11; Table 2; Figure 2).
However, the specification does not disclose preventing rectal cancer or colon cancer comprising administering a medicament comprising the MCP-MUC1-N fusion protein amino acid sequence of SEQ ID NO: 3 alone or in combination with an anti-PD1 antibody or oxaliplatin. The specification does not define the term “prevent/preventing”, and thus the term is interpreted by the Examiner as meaning that an activity will not occur, i.e. rectal cancer or colon cancer will not occur. Undue experimentation would be required of the skilled artisan to determine the quantity of MCP-MUC1-N fusion protein to be administered and the duration of treatment to prevent rectal cancer or colon cancer. The limited teachings of the specification are not adequate guidance, but are merely an invitation for the artisan to use the current invention as a starting point for further experimentation. Such trial and error experimentation is considered undue. The claimed method may not necessarily prevent rectal or colon cancer. For instance, the prior art discloses that cancer prevention is complex and has had limited success (White et al., J Adolescent Health 52: S1-S7, 2013 (cited on the IDS of 2/14/2020); page S2; page S5, column 1, 2nd full paragraph). White et al. teach that cancer is the result of multiple alterations in processes that control cell proliferation, invasion, and spread (page S2, column 1, 1st full paragraph). White et al. continue to disclose that nearly all cancers result from multiple factors that influence these processes over an extended time, such factors including genetic mutations, environmental interactions, and lifestyle (page S2, column 1, 1st full paragraph).
The courts have also stated that patent protection is granted in return for an enabling disclosure, not for vague intimations of general ideas that may or may not be patentable. Tossing out the mere germ of an idea does not constitute an enabling disclosure. Reasonable detail must be provided in order to enable members of the public to understand and carry out the invention. See Genentech v. Novo Nordick A/S (CAFC) 42 USPQ2d 1001 (1997).
Furthermore, Applicant is reminded that a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. See In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971); In re Soll, 97 F.2d 623, 634, 38 USPQ 189, 191 (CCPA 1938; In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). The present invention is unpredictable and complex wherein one skilled in the art may not necessarily prevent rectal or colon cancer by administration of a medicament comprising a recombinant MBP-MUC1-N fusion protein comprising the amino acid sequence of SEQ ID NO: 3 and oxaliplatin.
Due to the large quantity of experimentation necessary to prevent rectal cancer or colon cancer; the lack of direction/guidance presented in the specification regarding the same; the absence of working examples directed to the same; the complex nature of the invention; the unpredictability of preventing rectal or colon cancer; and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
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.
5. Claim 18 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 of copending Application No. 18/706,832 in view of Tong et al. (Sci Reports 8: 8666, 2018).
Claim 18 of the instant application recites a medicament for treating and/or preventing rectal cancer or colon cancer, wherein the medicament comprises a recombinant MBP-MUC1-N fusion protein vaccine and oxaliplatin, the fusion protein set forth in SEQ ID NO: 3.
Meanwhile, claim 12 of the ‘832 application recites a method for preventing and/or treating pancreatic cancer, wherein the method comprises administering to a subject a fusion protein, characterized in the fusion protein comprises MBP and protein MUC1-N, and the amino acid sequence of the fusion protein is set forth in SEQ ID NO: 3.
Claim 18 of the ‘832 application also recites a pharmaceutical composition for preventing and/or treating pancreatic cancer, comprising a fusion protein, an aluminum hydroxide adjuvant, and a CpG adjuvant, the amino acid sequence of the fusion protein is set forth in SEQ ID NO: 3.
It is noted that the MBP-MUC1-N fusion protein amino acid sequence of SEQ ID NO: 3 of the ‘832 claims is 100% identical to the MBP-MUC1-N fusion protein amino acid sequence of SEQ ID NO: 3 recited in the instant claims (see sequence alignment, below). Therefore, both sets of claims recite the same MBP-MUC1-N fusion protein.
Qy= instant SEQ ID NO: 3
Db= SEQ ID NO: 3 of 18/706, 332
APPLICANT: YUANBEN (ZHUHAI HENGQIN) BIOTECHNOLOGY CO., LTD. (en)
TITLE OF INVENTION: VACCINE AGAINST PANCREATIC CANCER, AND MEDICAL USE THEREOF (en)
CURRENT APPLICATION NUMBER: US/18/706,832
CURRENT FILING DATE: 2024-05-02
NUMBER OF SEQ ID NOS: 3
SEQ ID NO 3
LENGTH: 528
TYPE: PRT
LOCATION: 1..528
QUALIFIERS: mol_type = protein organism = synthetic construct
Query Match 100.0%; Score 2799; Length 528;
Best Local Similarity 100.0%;
Matches 528; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 KIEEGKLVIWINGDKGYNGLAEVGKKFEKDTGIKVTVEHPDKLEEKFPQVAATGDGPDII 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 KIEEGKLVIWINGDKGYNGLAEVGKKFEKDTGIKVTVEHPDKLEEKFPQVAATGDGPDII 60
Qy 61 FWAHDRFGGYAQSGLLAEITPDKAFQDKLYPFTWDAVRYNGKLIAYPIAVEALSLIYNKD 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FWAHDRFGGYAQSGLLAEITPDKAFQDKLYPFTWDAVRYNGKLIAYPIAVEALSLIYNKD 120
Qy 121 LLPNPPKTWEEIPALDKELKAKGKSALMFNLQEPYFTWPLIAADGGYAFKYENGKYDIKD 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 LLPNPPKTWEEIPALDKELKAKGKSALMFNLQEPYFTWPLIAADGGYAFKYENGKYDIKD 180
Qy 181 VGVDNAGAKAGLTFLVDLIKNKHMNADTDYSIAEAAFNKGETAMTINGPWAWSNIDTSKV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 VGVDNAGAKAGLTFLVDLIKNKHMNADTDYSIAEAAFNKGETAMTINGPWAWSNIDTSKV 240
Qy 241 NYGVTVLPTFKGQPSKPFVGVLSAGINAASPNKELAKEFLENYLLTDEGLEAVNKDKPLG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 NYGVTVLPTFKGQPSKPFVGVLSAGINAASPNKELAKEFLENYLLTDEGLEAVNKDKPLG 300
Qy 301 AVALKSYEEELVKDPRIAATMENAQKGEIMPNIPQMSAFWYAVRTAVINAASGRQTVDEA 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AVALKSYEEELVKDPRIAATMENAQKGEIMPNIPQMSAFWYAVRTAVINAASGRQTVDEA 360
Qy 361 LKDAQTNSSSNNNNNNNNNNLGIEGRISGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAP 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 LKDAQTNSSSNNNNNNNNNNLGIEGRISGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAP 420
Qy 421 GSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAP 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 GSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAP 480
Qy 481 GSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAH 528
||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 GSTAPPAHGVTSAPDTRPAPGSTAPPAHGVTSAPDTRPAPGSTAPPAH 528
The claims of the ‘832 application do not recite that the administered composition comprising the MBP-MUC1-N fusion protein also comprises oxaliplatin.
Tong et al. teach that pancreatic cancer has one of the highest cancer mortality rates in the world (page 1, 1st paragraph). Tong et al. disclose that other than surgical resection, systemic chemotherapy is the only major treatment that can improve survival for patients with locally advanced or metastatic pancreatic cancer (page 1, 2nd paragraph). Tong et al. indicate that a four-drug regimen called FOLFIRINOX (consisting of folinic acid, 5-fluorouracil, irinotecan, and oxaliplatin) prolongs overall survival greater than gemcitabine (the gold standard for pancreatic cancer) (page 1, 2nd-3rd full paragraphs). Tong et al. also teach that a modified FOLFIRINOX regimen also provides good survival benefits for patients by increasing overall survival and progression free survival and causing fewer side effects (page 7, last paragraph; abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to modify the pharmaceutical composition comprising a MBP-MUC1-N fusion protein (and methods of treating pancreatic cancer by administering such) of the ‘832 application claims by also including a drug regimen called FOLFIRINOX (that comprises oxaliplatin) as taught by Tong et al. The person of ordinary skill in the art would have been motivated to make that modification to enhance the success of treatment of pancreatic cancer, as it is widely accepted that patients with pancreatic cancer have a high mortality rate (see Tong et al., page 1). The skilled artisan also would have been motivated to make that modification because both the MBP-MUC1-N fusion protein and FOLFIRINOX (that comprises oxaliplatin) are disclosed to treat pancreatic cancer. The person of ordinary skill in the art reasonably would have expected success because chemotherapeutic agents have been successfully combined with other anti-cancer drugs to synergize anti-tumor responses. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” See In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) and MPEP § 2144.06. Additionally, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
It is noted that the MBP-MUC1-N fusion protein amino acid sequence of SEQ ID NO: 3 is free of the prior art.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
References that teach a composition comprising a recombinant MUC1-MBP fusion protein; and Bacillus Calmette–Guerin (BCG) as an adjuvant (and potential of such as a cancer vaccine)
Fang et al. Mol Med Reports 10: 1056-1064, 2014
Hu et al. Int Immunopharmacol 33: 108-118, 2016
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIDGET E BUNNER whose telephone number is (571)272-0881. The examiner can normally be reached Monday-Friday 9:00 am-6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama can be reached at (571) 272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BEB
Art Unit 1647
14 September 2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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