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
Claim Status
Applicant’s amendment filed November 5, 2025 was received and entered.
Claims 1, 12-13, 15-17, and 27 have been amended.
Claims 2, 9-11, 21-26, 28, 30, 32-33, 35-36, and 38-39 have been canceled.
Claims 1, 3-8, 12-20, 27, 29, 31, 34, and 37 are pending and under consideration.
Election/Restrictions
Applicant's election with partial traverse of Group I (claims 1, 3-8, 12-15, 27, 31, 34) in the reply filed on November 5, 2025 is acknowledged. The traversal is on the ground(s) that Groups I and III and Groups IV and V are unified and should be examined together. Specifically, Group I (claims 1, 3-8, 12-15, 27, 31, 34) has been amended to limit the truncated TGFbR2 extracellular domain molecule to the amino acid sequence set forth in SEQ ID NO: 52 and fusion proteins comprising said ECD molecule. Group III (claims 16-20) is drawn to nucleic acids encoding the truncated TGFDR2 ECD molecule of Group I and expression in host cells; Group IV (claim 37) is drawn to methods of treating neoplastic disease comprising administering the fusion protein of Group I; and Group V (claim 29) is drawn to methods of making a medicament comprising the fusion protein of Group I. The claims drawn to Group II and Group VI have been canceled with this reply.
Applicant’s arguments have been considered and were found persuasive because Group I, Group III, Group IV, and Group V share the same special technical feature, i.e., the truncated TGFbR2 extracellular domain molecule which comprises SEQ ID NO: 52.
Therefore, the previous restriction requirement between Groups I (claims 1, 3-8, 12-15, 27, 31, 34) and III (claims 16-20) and between Groups IV (claim 37) and V (claim 29) has been withdrawn.
In addition, Applicant has elected gastric cancer as the species of cancer to be treated with the instantly claimed truncated TGFbR2 extracellular domain molecule. Applicant’s amendments have rendered all other previous election requirements moot.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/CN2021/089782 filed April 26, 2021, which claims priority to foreign application CN 202010351280.6 filed April 28, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
However, support for the claimed invention cannot be determined because the foreign priority documents provided for Application No. CN 202010351280.6 are not in English. Applicant cannot rely upon the certified copy of the foreign priority application to overcome any prior art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Accordingly, the PCT/CN2021/089782 filing date of April 26, 2021 will be used for the purpose of applying prior art.
Information Disclosure Statements
The information disclosure statements (IDSs) submitted 3/28/2023, 6/25/2024, 12/16/2024, 4/2/2025, 6/18/2025, 8/14/2025, and 3/13/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner EXCEPT for the following documents which do not have a concise explanation in English. See MPEP § 609.04(a)(III). Note, CN110785431 was submitted and cited in two separate information disclosure statements.
6/25/2024 and 12/16/2024 - CN110785431
6/18/2025 - CN10992716
3/13/2026 - JP7570432
Accordingly, the information disclosure statements are being considered by the examiner, except the documents referenced above.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing” as a separate part of the disclosure or a CRF of the “Sequence Listing” for one or more amino acid sequences.
Claim 8 (line 1) there is no Sequence Listing for the following amino acid sequence:
Flexible Linker = G4S (GGGGS)
Required response - Applicant must provide:
An updated "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Amino acid sequences appearing in the claims and the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequences with 4 or more amino acids require a sequence identifier.
Claim 8 recites “the linker is a G4S flexible peptide linker, preferably a (G4S)4 flexible peptide linker”.
According to the instant specification, the amino acid sequence for the (G4S)4 flexible peptide linker (GGGGSGGGGSGGGGSGGGGS) is SEQ ID NO: 66, however, the sequence identifier is not recited in the claim. All amino acid sequences more than 4 amino acids in length must be identified by their sequence identifier (i.e., SEQ ID NO). In addition the (G4S)4 sequence appears in the instant specification without its SEQ ID NO [pg. 42, section 7.1)
As stated above, the amino acid sequence G4S does not appear in the Sequence Listing and does not have a sequence identifier. The sequence identifier must be added to the claim upon submission of a new Sequence Listing.
In addition, the claim should be amended so each flexible peptide is written in full expanded form, (GGGGS) and (GGGGSGGGGSGGGGSGGGGS) accompanied by a sequence identifier. The specification must also be amended to include the SEQ ID NO for the (G4S)4 flexible peptide recited on page 42.
Required response – Applicant must provide:
Amended claims 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.
Specification
The abstract of the disclosure is objected to because additional text appears on the page: “To be published with FIG. 13.”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 7, 12-13, 16, and 20 are objected to for the following informalities:
Claim 7 recites the terms “N-terminal” and “C-terminal”, however, they should read “N-terminus” and “C-terminus”.
Claim 12 recites antibodies Trastuzumab, Bevacizumab, Ramucirumab, Ipilimumab, and Panitumumab, which should not be capitalized.
Claim 13 (lines 7-10) recites “wherein the fusion protein comprises two heavy chains and two light chains; a disulfide bond is formed between a first light chain and a first heavy chain thereof, a disulfide bond is formed between a second light chain and a second heavy chain thereof, and a disulfide bond is formed between a first heavy chain and a second heavy chain thereof”.
The phrase “a disulfide bond is formed” suggests an action step. It is recommended that the claim be amended to read, “wherein the fusion protein comprises two heavy chains and two light chains comprising, a disulfide bond between a first light chain and a first heavy chain thereof, a disulfide bond between a second light chain and a second heavy chain thereof, and a disulfide bond between a first heavy chain and a second heavy chain thereof”.
Claim 16 should read “A nucleic acid comprising a polynucleotide encoding the truncated TGFbR2 extracellular domain molecule of claim 1, wherein the nucleic acid is mRNA or DNA”.
Claim 20 should read “A method for producing the truncated TGF3R2 extracellular domain molecule of claim 1, comprising culturing a host cell comprising a nucleic acid encoding the truncated TGF3R2 extracellular domain molecule of claim 1, wherein the nucleic acid is mRNA or DNA, under conditions suitable for the expression of the truncated TGF3R2 extracellular domain molecule, and recovering the expressed product from the culture medium.”
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.
Claims 7-8, 14, 27, 29, and 34 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 7 recites the N-terminal of the truncated TGFR2 extracellular domain molecule is linked to the C-terminal of the heavy chain of the targeting portion; and optionally, linked by a linker. The preamble of the claim states the N- and C-termini are linked. The claim does not make sense because if the N- and C-termini are not linked by the (optional) linker, how else would they be linked?
Claims 8, 14, and 29 recite the terms “preferably” and “most preferably” which renders the claims indefinite because one cannot ascertain the metes and bounds of what is and what is not allowed. The examiner contends that the use of such preferences may lead to confusion over the intended scope of the claim. See MPEP § 2173.05(d).
Regarding claim 29, Applicant elected gastric cancer as the species of cancer in the reply received November 5, 2025, however, as currently written, the scope of the claim is unclear.
Claim 27 recites the term “optionally”, which renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(h).
Claim 29 is rejected under 35 U.S.C. 112(b) as being indefinite for claiming a use without setting forth any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). Claim 29 is directed to the use of a TGFbR2 ECD fusion protein for the prevention and treatment of cancer, preferably gastric cancer.
Although a claim should be interpreted in light of the specification disclosure, it is generally considered improper to read limitations contained in the specification into the claims. See In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969) and In re Winkhaus, 527 F.2d 637, 188 USPQ 129 (CCPA 1975), which discuss the premise that one cannot rely on the specification to impart limitations to the claim that are not recited in the claim. There are no steps for how to use a TGFbR2 ECD fusion protein for the prevention and treatment of gastric cancer recited in the claim, thus one of ordinary skill in the art would not know if they were infringing on the invention of claim 29. See MPEP § 2173.05(q). For the purpose of examination, the claim is being interpreted as a method of treating cancer comprising administration of the TGFbR2 ECD fusion protein.
Claim 34 recites a “A kit comprising the fusion protein of claim 3; further comprising a device for administering the medicament” ”, however, there is no antecedent basis for the medicament in the claims.
Appropriate correction is required.
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.
Written Description
Claims 13-14 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim 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 had possession of the claimed invention.
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, 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 claimed genus. See MPEP § 2163.
Claim 13 recites the anti-EGFR antibody of claim 12 comprises a heavy chain with an amino acid sequence of SEQ ID NO: 141 or a sequence having at least 85%, 88%, 90%, 95%, 98%, or 99% sequence identity to SEQ ID NO: 141; and a light chain with an amino acid sequence of SEQ ID NO: 23 or a sequence having at least 85%, 88%, 90%, 95%, 98%, or 99% sequence identity to SEQ ID NO: 23.
The claims encompasses a large genus of structurally distinct polypeptides.
However, neither the claims nor the instant specification disclose how (e.g., mutation, deletion, insertion) the heavy and/or light chains may vary to result in up to 15% difference in identity to the claimed amino acid sequences, or where in the amino acid sequences variation may occur.
SEQ ID NO: 141 is 583 amino acids in length and SEQ ID NO: 23 is 214 amino acids in length. When only considering amino acid substitutions, the heavy chain represented by SEQ ID NO: 141 allows for 87 substitutions while the light chain represented by SEQ ID NO: 23 allows for 21 substitutions. This would allow for countless variants of the heavy and/or light chain amino acid sequences. Further, as stated above, the disclosure does not specify where in the amino acid sequence such variation may occur, which would allow for entire CDR regions to be substituted while still being 85% identical to the parent heavy and light chain amino acid sequences, respectively. However, the instant specification only demonstrates the results for one humanized anti-EGFR antibody, EGFR-HPA8.
It is well understood in the art that protein folding and formulation are complex and fairly unpredictable processes, in such that substituting even one amino acid within the sequence can change the structure and function of said protein. For example, Garrett et al. (2009) teaches anti-EGFR antibodies mAb175 and mAb806 have similar CDRs, differing by only one amino in each CDR. Furthermore, of the 20 antibody residues that contact the EGFR target epitope, there are only 2 amino acids that differ between mAb806 and mAb175. And although the antibodies share a high sequence identity, mAb175 treatment against glioma xenografts inhibited tumor growth significantly better than treatment with mAb806 [pg. 5083-5084]. Thus, one cannot readily extrapolate the properties of the polypeptides represented by SEQ ID NO: 141 and SEQ ID NO: 23 to other possible variants encompassed by claim 13, as the properties of the protein having an amino acid sequence of SEQ ID NO: 141 or SEQ ID NO: 23 are not predictive of the full genus of proteins that can be generated.
The instant application has not provided a sufficient description showing possession of the necessary 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 of polypeptides encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. § 112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe, Inc., 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002). In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 48 USPQ2d 1398 (Fed Cir. 1997)). Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description’ inquiry, whatever is now claimed." (See Vas-Cath, p. 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath, p. 1116). Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., Inc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004). Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning —i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3.
Given the claimed broadly class of anti-EGFR antibodies, in the absence of sufficient disclosure of relevant identifying characteristics, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims. Centocor Ortho Biotech Inc. v. Abbott Laboratories, 97 USPQ2d 1870 (Fed. Cir. 2011). There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
Therefore, there is insufficient written description for the genus of antibodies encompassed by the claimed invention to provide sufficient structure for the anti-EGFR antibodies claimed at the time the invention was made and as disclosed in the specification as filed under the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Claim 14 is included in the rejection because it depends from the rejected claim and fails to clarify the issue.
Enablement
Claims 29 and 37 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for treatment of gastric cancer and non-small cell lung cancer; does not reasonably provide enablement for preventing cancer or preventing neoplastic disease as broadly claimed.
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: (1) the nature or the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary. When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(1) The nature of the invention and (5) The breadth of the claims:
Claim 29 is drawn to the prevention and treatment of cancer, wherein preferably the cancer is a gastric cancer, by administering the fusion protein comprising the truncated TGFb2 ECD fusion protein of recited in claim 3.
Claim 37 is drawn to a method of preventing and treating a neoplastic disease comprising administering to a subject the fusion protein of claim 3.
Claim 29 is broad and inclusive of all types of all types of cancer in humans generally.
Claim 37 is also broad, and includes all types of tumors, both cancerous and benign.
The breadth of the claims exacerbates the complex nature of the subject matter to which the present claims are directed. The claims are extremely broad due to the vast number of possible cancer types represented by the terms “prevention of cancer”. Cancer is not a single disease, or cluster of closely related disorders. There are hundreds of cancers, which have in common only some loss of controlled cell growth. Cancers are highly heterogeneous at both the molecular and clinical level, and can occur in most parts of the body. The following are examples of some of the major classes of cancer, each having numerous types:
CNS cancers
Leukemias
Carcinomas of the liver
Lung and pleural cancers
Thyroid cancers
Melanomas
Colorectal cancers
Renal carcinomas
Prostate cancers
Breast cancers
Ovarian and uterine cancers
Testicular cancers
Esophageal cancers
Cervical cancers
Cardiothoracic cancers
Bladder cancers
Additionally, claim 37 is extremely broad due to the multiple neoplasms represented by the terms “prevention of neoplasms”. Like cancer, a neoplasm is not a single disease, or cluster of closely related disorders. A neoplasm is an abnormal growth of tissue that forms a tumor. Neoplasms encompass cancerous tumors and benign tumors. Examples of cancerous neoplasms have been set forth above. Benign neoplasms are noncancerous tumors that do not spread to other parts of the body. The following are examples of some of the major classes of benign neoplasms:
Lipomas
Adenomas
Fibromas
Hemangiomas
Meningiomas
Myomas
(2) The state of the prior art and (4) The predictability or unpredictability of the art:
The state of the art teaches there is no known anticancer agent that can prevent any type of cancer. The art of cancer prevention involves a very high level of unpredictability. While the state of the art is relatively high with regard to the treatment of specific cancers with specific agents, it has long been underdeveloped with regard to the prevention of cancers broadly. The lack of significant guidance from the present specification or prior art with regard to the actual prevention of cancer in a subject, with the claimed active ingredient makes practicing the claimed invention unpredictable.
With regard to cancer prevention, Umar et al. (2012) teaches cancer prevention remains a promising strategy for reducing the mortality and incidence rates of cancer, however, prevention is more about reducing risk factors than it is about eliminating cancer [Abstract]. In addition, both Umar and Bode et al. (2009), teach cancer prevention is not about eliminating cancer altogether, but reducing risk factors and exposure with the goal of inhibiting progression of cancer to more invasive stages [Umar; pg. 835, col. 2, par. 2; pg. 836, col. 1, par. 2; pg. 839, col. 2, par. 2-3] [Bode; pg. 511, col. 3, par. 2]. Moreover, Sarfati et al. (2022) teaches that primary prevention of cancer through eradication or mitigation of modifiable risk factors is the best hope of reducing the future cancer burden [pg. 541, col. 1]. For example, Umar teaches stopping tobacco use is one lifestyle change that can reduce both the risk of selected cancers and other diseases but does not completely (i.e., 100%) prevent cancer [pg. 836, col. 1, par. 2]. Importantly, even vaccination has yet to achieve 100% prevention, as seen with the hepatitis B virus (HBV) vaccine. The vaccine is aimed at reducing HBV infections and subsequent hepatocellular cancer (HCC), and has an estimated 69% reduction rate in prevention HBV-HCC [Umar; pg. 842, col. 1, par. 3), not 100% prevention. Although cancer vaccines can serve as preventive measures in high-risk populations and provide treatment options for individuals already diagnosed with cancer [Kaczmarek et al., 2023; pg. 2, par. 2], they also face a myriad of obstacles depending on the target, type of vaccine, delivery method, and type of cancer (Kaczmarek et al., pg. 21, section 7).
Given the lack of predictability in preventing cancer, one of skill in the art would have to engage in undue experimentation to first identify individuals to which the instant method would apply, and also to identify which heterologous proteins would treat each specific type of cancer.
6) the amount of direction or guidance provided by the inventor; 7) the existence of working examples;
The instant specification sets forth in vivo examples demonstrating the effect of the instantly claimed fusion protein on tumor growth in mouse models of gastric cancer and non-small cell lung cancer (NSCLC) cancer. However, none of the models demonstrate prevention of tumor growth, or prevention of cancer broadly. One of skill in the art would be required to engage in extensive, difficult experimentation to identify the fusion protein that would possess the required functionality for each specific type of cancer. This required experimentation is undue.
In conclusion, the claimed invention does not provide enablement for prevention of any cancer or any type of neoplasm. Thus for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
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.
Claim 29 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 29 is directed to the use of a TGFbR2 ECD fusion protein for the prevention and treatment of cancer, preferably gastric cancer. The claim does not fall within at least one of the four categories of patent eligible subject matter because it does not purport to claim a process, machine, manufacture, or composition of matter. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961) ("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). See MPEP § 2173.05(q).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The instant claims are drawn to a truncated TGFb2 extracellular domain molecule comprising an amino acid sequence of SEQ ID NO: 52 and fusion proteins comprising said TGFb2 extracellular domain molecule.
There is no prior art that teaches or suggests a TGFb2 extracellular domain molecule with the specific amino acid sequence of SEQ ID NO: 52.
The closest prior art, WO 2018/205985 (cited IDS 3/28/2023), is directed towards fusion proteins comprising a TGF-b receptor, however, the truncation point of the TGFb2 extracellular domain molecule differs at the N-terminus from what is presently claimed.
Conclusion
Claims 1, 3-6, 15, 17-19, and 31 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/
Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
Prosecution Insights