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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 24MAR2026 has been entered.
Claim Status
Applicant’s amendments received 24MAR2026 are acknowledged.
Claims 2-3, 5, 14-15, 24, and 26 have been canceled.
Claims 1, 4, 7-8, 11, 18-19, and 27 have been amended.
Claims 1, 4, 6-13, 16-23, 25, and 27-28 are pending in the instant application (i.e., Claim(s) 1, 7-8, and 11 is/are independent).
Claims 11-13 and 21-22 remain withdrawn.
Claims 1, 4, 6-10, 16-20, 23, 25, and 27-28 are examined on the merits.
Priority
The present application is a 371 National Stage of PCT International Application No. PCT/EP2020/065472, filed 04JUN202, which claims foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of GB1908012.6 filed on 05JUN2019 has been received and is acknowledged.
Drawings
The drawings are objected to because of inconsistencies of the use of a “,” in place of a “.” or decimal point in Fig 1A-1E, Fig 2A, Fig 5A-B, Fig 6A-6D, Fig 7B, Fig 8A-B, Fig 9, Fig 10A-B, Fig 10D, Fig 10F, Fig 11B, Fig 12B-E. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) 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") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) 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 of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences (Fig 1E and Fig 14) must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, 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 disclosure is objected to because of the following informalities:
Table 1 SEQ ID NO: 66 spans 148-157, not 148-167.
Appropriate correction is required.
Withdrawn Rejections
Indefiniteness
Applicant’s arguments, see p 7, Claim rejection - 35 USC §112(b) section, filed 24MAR2026, with respect to the rejection(s) of claim(s) 27 under 35 USC §112(b) have been fully considered and said rejections of claim(s) 27 have been withdrawn in view of the claim amendments filed as part of said response.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 7, and 8 are rejected under 35 U.S.C. 101 because the claimed inventions are not directed to patent eligible subject matter. After consideration of relevant factors with respect to claim(s) 1, 7, and 8 as a whole, the claims are directed to product of nature without significantly more. The rationale for this determination is explained below:
Because abstract ideas, laws of nature, and natural phenomenon "are the basic tools of scientific and technological work", the Supreme Court has expressed concern that monopolizing these tools by granting patent rights may impede innovation rather than promote it. See Alice Corp., 573 U.S. at 216, 110 USPQ2d at 1980; Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). However, the Court has also emphasized that an invention is not considered to be ineligible for patenting simply because it involves a judicial exception. Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1980-81 (citing Diamond v. Diehr, 450 U.S. 175, 187, 209 USPQ 1, 8 (1981)). Accordingly, the Court has said that integration of an abstract idea, law of nature or natural phenomenon into a practical application may be eligible for patent protection. See, e.g., Alice, 573 U.S. at 217, 110 USPQ2d at 1981 (explaining that "in applying the §101 exception, we must distinguish between patents that claim the ‘buildin[g] block[s]’ of human ingenuity and those that integrate the building blocks into something more" (quoting Mayo, 566 U.S. at 89, 110 USPQ2d at 1971) and stating that Mayo "set forth a framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts"); Mayo, 566 U.S. at 80, 84, 101 USPQ2d at 1969, 1971 (noting that the Court in Diamond v. Diehr found "the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole." See MPEP §2016.
STEP 1: Is the claim to a process, machine, manufacture, or composition of matter?
Claims 1, 7, and 8 are drawn to a composition of matter.
[Step 1: Claims 1, 7, and 8: yes]
STEP 2A (1st prong): Do the claims recite a judicially-recognized exception (JE), e.g., a law of nature, a natural phenomenon or product, or an abstract idea?
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including "physical phenomena," "scientific principles", "natural laws," and "products of nature." See MPEP §2106.04(b).
Law of Nature recitation in claims 1, 7, and 8: “a polypeptide which is an immunogenic fragment of human TGFb1” and/or a “a polynucleotide encoding a polypeptide which is an immunogenic fragment of human TGFb1” under BRI this recitation is considered to be a “product of nature” in accordance with Molecular Pathology v. Myriad Genetics Inc., [2013]. In this instance, a polynucleotide encoding a polypeptide or the polypeptide which is an immunogenic fragment of human TGFb1 is considered to be a product of nature because fragmentation does not confer a marked structural difference from the naturally occurring human TGFb1 product whose sequence comprise the claimed fragments.
[Step 2A (1st prong): Claims 1, 7, and 8: yes]
STEP 2A (2nd prong): Do the claims recite additional elements that integrate the judicial exception into a practical application?
The Supreme Court has long distinguished between principles themselves (which are not patent eligible) and the integration of those principles into practical applications (which are patent eligible). See, e.g., Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 80, 84, 101 USPQ2d 1961, 1968-69, 1970 (2012) (noting that the Court in Diamond v. Diehr found ‘‘the overall process patent eligible because of the way the additional steps of the process integrated the equation into the process as a whole,’’ but the Court in Gottschalk v. Benson ‘‘held that simply implementing a mathematical principle on a physical machine, namely a computer, was not a patentable application of that principle’’). The Supreme Court and Federal Circuit have identified a number of considerations as relevant to the evaluation of whether the claimed additional elements demonstrate that a claim is directed to patent-eligible subject matter.
Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);
• Adding insignificant extra-solution activity to the judicial exception, as discussed in MPEP § 2106.05(g); and
• Generally linking the use of a judicial exception to a particular technological environment or field of use, as discussed in MPEP § 2106.05(h).
In this instance, “the immunogenic fragment of TGFb1” does not require the artisan to integrate the JEs into a practical application (i.e., fails to further limit the invention in a manner to use in a practical application). For example, the polypeptides and polynucleotides as claimed do not integrate the judicial exception into a practical application such as prophylaxis or therapy (i.e., vaccine).
[Step 2A (2nd prong): Claims 1, 7, and 8: no]
STEP 2B: Do the claims recite a non-conventional arrangement of additional elements that amounts to significantly more than the judicial exception (i.e., Do the additional elements contribute an “inventive concept”?
The second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 217, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)).
All elements of claims 1, 7, and 8 are part of one or more identified JEs (as described above) and do not contain additional elements that are sufficient to amount to significantly more than the judicial exception because there is no evidence that fragmentation results in markedly different immunogenicity from the full TGFb1, and furthermore any immune response (i.e., immunogenicity) is a property/function of the host and not the protein per se.
[Step 2B: Claims 1, 7, and 8: no]
Summary and conclusion regarding claims 1, 7, and 8:
In conclusion, the above 101 JE analysis of claims 1, 7, and 8, viewed as a whole and considering all elements individually and in combination, no claim recites limitations that transform the claim, finally interpreted as directed to the above-identified JE(s), into patent eligible subject matter.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 6-10, 16-20, 23, 25, and 27-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 7-8 recite the open language “comprising,” which does not exclude additional unrecited elements and also recite the closed language “consisting of,” which does not allow for additional unrecited elements (see MPEP § 2111.03). Therefore, it is unclear how the scope of claims 1 and 7-8 allow for additional unrecited elements and how they can also exclude additional unrecited elements. One of ordinary skill in the art would not be reasonably apprised of the scope of patent protection sought. For example, it is unclear in regards to claims 1 and 7-8 which recite “…comprises or consists of the amino acid sequence of SEQ ID NO: 66.”, if the patent protection sought is limited to i) the full-length of SEQ ID NOs: 66 with or without amino acid residues at either or both ends (i.e., comprising), or ii) the full-length of SEQ ID NOs: 66 and nothing more or less (i.e., consisting of). Claims 4, 6, 9-10, 16-20, 23, 25, and 27-28 are also rejected since they depend from claims 1 and 7-8, but do not remedy this deficiency.
Claims 4 and 18(a)-19(a) appear to recite a Markush group, but the group of alternatives are not closed as required by a proper Markush group in MPEP §2173.05(h). In this instance, claims 4 and 18-19 recite Markush-type claims without reciting proper Markush-type language such as “selected from the group consisting of” and an “and” between the last two species. For example, in claim 4, an “and” should replace the ‘or’ between “28,” and “23.” Claims 18(a) and 19(a) have the same issue.
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.
Claims 1, 6-10, 16, 18-20, 23, and 28 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 and having support for:
“A polypeptide which is an immunogenic fragment of hTGFß1 selected from the group consisting of: SEQ ID NOs: 6, 12, 23, 28, 42, 49, 55, 63, 66, and 67. ” (claim 1);
-AND-
“The polypeptide of claim 1, which comprises a HLA-A2 restricted epitope comprising the amino acid sequence of SEQ ID NO: 66 or 67.” (i.e., claim 6 with the structural limitations of claim 17);
-AND-
“A polynucleotide encoding a polypeptide which is an immunogenic fragment of hTGFß1 selected from the group consisting of: SEQ ID NOs: 6, 12, 23, 28, 42, 49, 55, 63, 66, and 67. ” (claim 7);
-AND-
“The polynucleotide of claim 7, wherein:
(a) the polypeptide which is encoded by the polynucleotide is selected from the group consisting of: SEQ ID NOs: 66, 28, and 23; or
(b) a HLA-A2 restricted epitope which is encoded by the polynucleotide is the amino acid sequence of SEQ ID NO: 66 or 67.” (i.e., claim 18 with the structural limitations of claim 25);
-AND-
“The composition of claim 8, wherein:
(a) the polypeptide is selected from the group consisting of: SEQ ID NOs: 66, 28, and 23; or
(b) the C terminal amino acid of the polypeptide is replaced with the corresponding amide; or
(c) a HLA-A2 restricted epitope which is encoded by the polynucleotide is the amino acid sequence of SEQ ID NO: 66 or 67.” (i.e., claim 19 with the structural limitations of claim 27);
does not reasonably provide enablement or support for more.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims nor does it provide sufficient description to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed had possession of the claimed invention.
The specification discloses 40 amino acid sequences comprising 10 to 20 consecutive amino acids of SEQ ID NO: 1 (i.e., SEQ ID NOs: 5-6, 10-12, 16-23, 27-28, 32-42, 46-49, 53-55, 59-63, and 66-67, which comprise 10 overlapping amino acids, for example SEQ ID NO: 5 spans positions 1-20, SEQ ID NO: 6 spans positions 11-30, etc. of SEQ ID NO: 1 and SEQ ID NOs: 66 and 67 are optimized fragments of SEQ ID NO: 28 and 5, respectively (see Table 1 and Fig 1E). As presently recited in claims 1 and 7-8, there are 4136 possible overlapping immunogenic fragments of SEQ ID NO: 1, wherein the fragments are between 10 and 20 amino acids in length; however, the specification only supports < 1% of the currently claimed fragments. Furthermore, per Fig 1D, only 8 of the 38 original sequences were selected for further investigation (i.e., SEQ ID NOs: 6, 12, 23, 28, 42, 49, 55, and 63) (see Fig 1D) and following screening and optimization it was determined that TGFb-15 peptide-specific T cells (i.e., SEQ ID NO: 28, spanning positions 141-160 of SEQ ID NO: 1) were able to recognize and kill cancer cells (see Example 6). With regard to immunogenic peptide fragments, it is known in the art that synthetic long peptides (i.e., 20 amino acids in length or more) are taken up and processed by APCs to produce peptides to be presented by both HLA class I and II molecules; whereas short peptides, typically 8-12 amino acids bind to the HLA class I groove on the surface of nucleated cells without further processing by APCs; however, shorter peptides are generally HLA-restricted because their lengths do not allow for the diversity necessary for the high polymorphisms of HLA in the general population (Abid-Aziz, et al., J Oncol, 2022, 2022, 1-17, see section 3). Thus, because the TGFb-15 peptide epitope is a 20-mer, it cannot be presented in its full-length on HLA-I molecules, and further experiments were completed to determine the minimal epitope sequence recognized by the TGF15b-specific T cells (i.e., SEQ ID NO: 66, a 10-mer of SEQ ID NO: 28), which is also HLA-restricted (see Example 7). Furthermore, additional screenings to determine alternative HLA-A2-restricted 10-mers were completed and SEQ ID NO: 67 emerged as the top binding 10-mer epitope (see Example 8). Therefore, the selection of eight of the 20-mers and the further selection of HLA-restricted epitopes of SEQ ID NOs: 66 and 67 required significant screening to determine optimal 10-mer or 20-mer sequences from the original 38 20-mer sequences (i.e., < 1% of the immunogenic fragments of SEQ ID NO: 1 as presently claimed) and therefore between the breadth of potential 10-mers, 11-mers,…, and 20-mers, the lack of predictability and undue experimentation in determining the immunogenicity of the 10-mers, 11-mers,…, and 20-mers, and in the instance of 10-mers are also HLA-restricted. Regarding claims 8-10, the specification defines a composition as comprising a polypeptide of the invention and/or a polynucleotide of the invention, and optionally at least one adjuvant, pharmaceutically acceptable carrier, preservative and/or excipient (p 15); however, there are no working examples which supports a composition of the polypeptide and the polynucleotide, nor are there examples of a composition of multiple peptides and/or multiple polynucleotides wherein the at least one different peptide/polynucleotide comprises a sequence of at least 9 consecutive amino acids of SEQ ID NO: 1 (i.e., 9-390 amino acids). Claims 6, 9-10, 16, 18-20, 23, and 28 are also rejected since they depend on claim 1 or 7-8 but do not remedy this deficiency. Therefore, claims 1, 6-10, 16, 18-20, 23, and 28 as presently claimed are rejected because the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims nor does it provide sufficient description to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed had possession of the claimed invention.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4, 6, 8, 17, 19, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2005/105144 A1 (Kyowa Hakko Kogyo Co., et. al, 10NOV2005, included in IDS), herein referred to as “’144.”
‘144 teaches peptides associated with latent TGFß activation as well as control peptides which do not activate latent TGFß. Example 2 of ‘144 teaches peptide 21 as set forth in SEQ ID NO: 18, which does not activate latent TGFß. In this instance, SEQ ID NO: 18 of ‘144, is a 19 amino acid residue peptide, wherein amino acid residues 1-18 consist of amino acid residues 2-19 of SEQ ID NO: 28 of the instant application (i.e., consisting of 18 consecutive amino acids of SEQ ID NO: 1 of the instant application and comprising SEQ ID NO: 66 of the instant application, see OA.APPENDIX).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of human TGFß1 or comprises HLA-A2 restricted epitope)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Applicant argues that SEQ ID NO: 18 of ‘144 comprises TGFb15-short, but does not consist of a consecutive sequence of between 10 and 20 amino acids of SEQ ID NO:1.
RESPONSE
Applicant’s arguments have been fully considered but are found non-persuasive essentially for the reasons of record and as described further below.
In response to Applicant’s argument that SEQ ID NO: 18 of ‘144 does not consist of a consecutive sequence of between 10 and 20 amino acids of SEQ ID NO: 1, the scope of the claim encompasses any sequence of 10-20 amino acid residues fully contained within SEQ ID NO: 1 (i.e., any 10-20 amino acid stretch of SEQ ID NO: 1). In this instance, SEQ ID NO: 18 of ‘144 consists of 18 consecutive amino acid residues of SEQ ID NO: 1 of the instant application and also comprises SEQ ID NO: 66.
Therefore, the prior art anticipates the invention as presently claimed.
Claims 1, 4, 6, 8, 17, 19, and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abe, et al., (Endothelium, 2009, 9, 25-36, included in IDS), herein referred to as “Abe.”
Abe teaches peptide fragments of latency associated peptide (LAP, i.e., exists in a complex with mature TGFß) (see abstract). Specifically, Abe teaches peptide 21, EAVPEPVLLSRAELRLLRR, comprising a sequence of 18 consecutive amino acids of SEQ ID NO: 1 of the instant application and also comprising SEQ ID NO: 66 (Fig 1A). Based on the scope of the claims, the independent claims encompass any sequence of 10-20 amino acid residues fully contained within SEQ ID NO: 1 (i.e., any 10-20 amino acid stretch of SEQ ID NO: 1). In this instance, SEQ ID NO: 18 of Abe consists of 18 consecutive amino acid residues of SEQ ID NO: 1 of the instant application and also comprises SEQ ID NO: 66.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., comprises a HLA-A2 restricted epitope)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claims 1, 7-8, 10, 16, 19-20, 23, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2017/184590 (The Broad Institute, Inc., 26OCT2017), herein referred to as “’590.”
‘590 teaches SEQ ID NO: 43200 (i.e., 100% query match to residues 1-10 of SEQ ID NO: 23 of the instant application, see OA.APPENDIX), polynucleotides encoding the polypeptides and vectors thereof, compositions comprising the peptides or polynucleotides and an adjuvant or pharmaceutically acceptable carrier, wherein the adjuvant can be Montanide ISA51, and the peptides may be modified by amidation (p 482, L5 from the bottom, ¶0029, 00151, 00324, 00327, and 00126).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of TGFb1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 5,420,243 A (Ogawa, et al., 30MAY1995), herein referred to as “’243.”
‘243 teaches SEQ ID NO: 3 (i.e., amino acid residues 16-31 of TGFß1 or residues 1-16 of SEQ ID NO: 49 of the instant application, see OA.APPENDIX) (col 8, lines 10-15) and a composition of the peptide and sterile bovine serum albumin as a carrier (col 9, lines 43-46).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of TGFb1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 7,057,013 B1 (Ezquerro Saenz, et al., 06JUN2006), herein referred to as “’013.”
‘013 teaches SEQ ID NO: 2, 14-15, and 34-35 and compositions thereof (i.e., 100% query match to residues 1-14 of SEQ ID NO: 55; residues 1-14 and residues 7-20 of SEQ ID NO: 49; and residues 1-14 and 7-20 of SEQ ID NO: 63, respectively of the instant application, see OA.APPENDIX) (Table 2, col 14-15).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of TGFb1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 5,650,494 A (Cerletti, et al., 22JUL1997), herein referred to as “’494.”
‘494 teaches SEQ ID NOs: 24 and 25 (i.e., 100% query match to residues 6-18 of SEQ ID NO: 63 and residues 1-13 of SEQ ID NO: 49, respectively of the instant application, see OA.APPENDIX) (col 25, lines 3-54).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of TGFb1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 6,500,920 B1 (Huang, 31DEC2002), herein referred to as “’920.”
‘920 teaches SEQ ID NO: 7 (i.e., 100% query match to residues 7-16 of SEQ ID NO: 55 of the instant application, see OA.APPENDIX) (col 2, lines 21-22).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of TGFb1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2017/0010269 (Pennington, et al., 12JAN2017), herein referred to as “’269.”
‘269 teaches SEQ ID NO: 100 (i.e., 100% query match to residues 2-12 of SEQ ID NO: 28 of the instant application, see OA.APPENDIX) (List D).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that there is a difference between the materials, (i.e., that the claims are directed to new materials and that such a difference would have been considered unexpected by one of ordinary skill in the art, that is, the claimed subject matter (e.g., immunogenic fragment of TGFb1)), if new, is unobvious. In the absence of evidence to the contrary, the burden is on the Applicant to prove that the claimed materials are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, the prior art anticipates the invention as presently claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sekhon, et al., (Eur Resp J, 2004, 23, 906-915), herein referred to as “Sekhon.”
Sekhon teaches the use of complementary DNA (i.e., polynucleotides) for in situ hybridization to detect and visualize the TGFb1 signal sequence (i.e., the first 19 amino acids of SEQ ID NO: 1 or SEQ ID NO: 5 of the instant application) in rhesus macaque samples (i.e., 89% query match to the first 19 amino acids of SEQ ID NO: 5 of the instant application, see OA.APPENDIX), which were deposited in GenBank (see In situ hybridisation section). Additionally, the sequence includes the rhesus macaque version of HLA-A2 restricted epitope of the TGFb-A2-01 peptide sequence of the instant application (i.e., 86% query match to SEQ ID NO: 67 of the instant application, see OA.APPENDIX).
However, they do not teach: 100% query match, which consists of a consecutive sequence of 10-20 amino acids of human TGFb1 (i.e., SEQ ID NO: 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the polynucleotide for in situ hybridization detection of the first 19 amino acids comprising the TGFb1 signal peptide developed to study rhesus macaque disclosed by Sekhon by modifying the polynucleotide for the human variant of the TGFb1 signal peptide because the human variant of TGFb1 would be more accurate in human samples. One would have been motivated to do so, given the teachings of Sekhon that the polynucleotide was developed for determining TGFb1 in rhesus macaque rather than humans. There would have been a reasonable expectation of success, given the knowledge that the modification of the rhesus macaque TGFb1 signal peptide is an obvious variant for the human TGFb1 signal peptide.
Thus, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time of filing.
Allowable Subject Matter
Examiner notes that isolated peptides consisting of the amino acid sequences of SEQ ID NOs: 23, 28, or 66 are free of the art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. HOPKINS whose telephone number is (703)756-4666. The examiner can normally be reached Mon-Thurs 6:00 AM to 4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571)272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAMANTHA LAKE HOPKINS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights