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 .
Claim Status
The amended claim set filed 14 June 2024 is acknowledged. Claims 1-9 are currently pending. Of those, claims 6 and 8 are currently amended, and claim 9 is new. No claims are cancelled. Claims 1-9 will be examined on the merits herein.
Priority
The instant application claims priority to foreign priority document KR10-2021-0160382 (filed 19 Nov 2021) and is a CON of PCT/KR2022/018361 (filed 18 Nov 2022). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 (KR10-2021-0160382). The priority document is not filed in English and a translation has not been provided, so the document cannot be examined for supporting the instant claims. Therefore, for the sake of searching the art in this action, the effective filing date used is 18 Nov 2022 for claims 1-9.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20 May 2024 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner. A signed copy of the statement is attached with this action.
Drawings
The drawings filed 28 April 2026 are objected to because the images are mislabeled on all figures appearing on pg. 8 or later. In the previous set of drawings filed 14 June 2024, Figure 10E was on pg. 8. The image for Figure 10E has been pushed to pg. 9, but the label for Figure 10E still remains on pg. 8 (see below). As a result, pg. 9 contains the images of Figures 10E and 11, but labels those images Figures 11 and 12a. The figure labels do not match the descriptions in the specification.
Examiner’s view of figures pg. 8 showing Figure 10D and showing that there is no Figure 10E on the page (left) and partial view of pg. 9 showing “Figure 11”, which is actually the image from Figure 10E (right).
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Also, the drawings are objected to because Figures 11 and 16 (the stained cells, see below) cannot be interpreted in a black-and-white format. There is no apparent difference between the samples (see below). This part of the objection would be withdrawn in view of an argument that all relevant features of the figure are actually visible in the black-and-white drawing.
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Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
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.
Claims 1-8 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.
Regarding claim 1, the claim recites the term “T epitope”. The specification defines: “As used herein, the term "T epitope" refers to a PD-Long1 (SEQ ID NO: 3) peptide comprising 17 amino acids including an HLA-A2 sequence derived from a PD-L1 precursor, and a PD-Long2 (SEQ ID NO: 4) peptide comprising 23 amino acids including an HLA class II sequence, for inducing a cytotoxic T lymphocyte (CTL) immune response” [0043]. The claim scope is indefinite because the specification’s definition of the term is unclear; one of ordinary skill in the art would not be able to determine whether the definition of “T epitope” refers to a sequence chosen from SEQ ID NOs: 3 and 4, or whether a “T epitope” sequence must comprise both SEQ ID NOs: 3 and 4. The definition of the term “T epitope” is even more ambiguous because claim 5 states that SEQ ID NOs: 3 and 4 are PD-L1 sequences as well as T epitope sequences. When the PD-L1 is SEQ ID NO: 3 or 4, can the same sequence in the fusion protein serve as both a PD-L1 and a T epitope, or is the claim requiring that SEQ ID NO: 3 or 4 be duplicated to fill both roles? Therefore, claim 1 is rejected, and claims 2-9 are also rejected because they depend from claim 1 and do not obviate the grounds of rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (KR 102421307 B1, published 4 July 2022; hereafter Lee; PTO-892). Citations refer to locations in the English machine translation included with this action (PTO-892). Applicant cannot rely upon the certified copy of the foreign priority application to overcome this 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.
Regarding claims 1, 4, 6-7, Lee teaches “The present invention provides an anti-cancer vaccine composition, capable of effectively inhibiting occurrence and growth of various cancers, including colorectal cancer by inducing vaccination by expressing a PD-L1-T epitope protein on the surface of a strain of the genus Lactobacillus, and a vaccination method using the same.” [Abstract].
Regarding claims 2-3, Lee teaches “In the recombinant bacteria, the fusion protein can be presented on the surface by binding to a PgsA anchor, and the fusion protein can be inserted into the multiple replication site of the pKV-Pald-PgsA380L vector” [pg. 3 par. 4].
Regarding claim 5, Lee teaches “the PD-L1 may be mammal-derived PD-L1, and the mammal may be a Primate, Carnivora, Protoplast, Carnivore, Progenitor, or Rodentoptera, including humans, primates, dogs (SEQ ID NO: 5), lions, Carnivores, including tigers, and cats (SEQ ID NO: 6); rodents, including rats, hamsters, mice (SEQ ID NO: 9), and guinea pigs; Lepidoptera, including rabbits and crowing rabbits; horses, donkeys, rhinos, and It may be a mammal such as a genus including a tapir, a bovine, a deer, a goat, a sheep, and an antelope including an antelope, and a progenitor including an elephant, but preferably human PD-L1 (SEQ ID NO: 7 or 8) can be SEQ ID NO: 7 is a human PD-L1 mutant 1 sequence and SEQ ID NO: 8 is a human PD-L1 mutant 2 sequence.” [pg. 3 par. 4]. The Lee SEQ ID NO: 5 is identical to instant SEQ ID NO: 5 (see alignment below).
Alignment 1: Alignment of instant SEQ ID NO: 5 and Lee SEQ ID NO: 5.
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Regarding claims 8-9, Lee teaches “there is provided a method for preventing or treating cancer, comprising administering the anti-cancer vaccine composition to an individual suffering from cancer” [pg. 3 par. 8].
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (KR 102401860 B1, published 24 May 2022; hereafter Lee; PTO-892). Citations refer to locations in the English machine translation included with this action (PTO-892). Applicant cannot rely upon the certified copy of the foreign priority application to overcome this 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.
Regarding claims 1, 4, 6-7, Lee teaches “The present invention relates to an anti-cancer vaccine composition capable of effectively inhibiting the occurrence and growth of various cancers including colorectal cancer by expressing PD-L1 protein on the surface of a strain of the genus Lactobacillus and inducing vaccination, and a vaccination method using the same. According to one aspect of the present invention, recombinant bacteria transformed to display programmed death-ligand 1(PD-L1) protein on the surface thereof is provided.” [Abstract].
Regarding claims 2-3, Lee teaches “In the recombinant bacteria, the PD-L1 protein can be presented on the surface by binding to the PgsA anchor and inserted into the multiple replication site of the pKV-Pald-PgsA380L vector.” [pg. 2 par. 6].
Regarding claim 5, Lee teaches “the PD L1 may be mammal-derived PD-L1, and the mammal may be a primate, carnivorous, progenitor, bovine, progenitor, or rodent, including humans, primates, dogs (SEQ ID NO: 3), lions, Carnivores, including tigers, and cats (SEQ ID NO: 4); rodents, including rats, hamsters, mice (SEQ ID NO: 2), and guinea pigs; Lepidoptera, including rabbits and crowing rabbits; horses, donkeys, rhinos, and It may be a mammal, such as a progenitor including a tapir, a bovine, a deer, a goat, a sheep, and an antelope including an antelope, and a progenitor including an elephant, but preferably human PD-L1 (SEQ ID NO: 5 or 6) can be SEQ ID NO: 5 is a human PD-L1 variant I sequence and SEQ ID NO: 6 is a human PD-L1 variant II sequence.” [par bridging pg. 2-3]. The Lee SEQ ID NO: 5 is identical to instant SEQ ID NO: 5 (see alignment below).
Alignment 2: Alignment of instant SEQ ID NO: 5 and Lee SEQ ID NO: 5.
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Regarding claims 8-9, Lee teaches “there is provided a method for preventing or treating cancer, comprising administering the anti-cancer vaccine composition to an individual suffering from cancer” [pg. 3 par. 6].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (US-20140242101-A1; PTO-892) in view of 성문희 et al. (KR-101471043-B1, published 2014; hereafter Sung; PTO-892) as evidenced by Park et al. (WO-2020076079-A2; hereafter Park; PTO-892). Citations refer to locations in the English machine translation included with this action (PTO-892).
Regarding claims 1 and 6, Andersen teaches “vaccine compositions comprising PD-L1 or peptide fragments thereof that are capable of eliciting immune responses useful in treatment of cancer” [Abstract]. “The nucleic acids of the invention may be comprised within any suitable vector, such as an expression vector. … Methods for engineering nucleic acid constructs are well known in the art … The vector may also be a bacterial vector, such as an attenuated bacterial vector.” [0204-0205]. “Many of the peptides of the invention are relatively small molecules and it may therefore be required in compositions as described herein to combine the peptides with various materials such as adjuvants and/or carriers, to produce vaccines, immunogenic compositions, etc. Adjuvants, broadly defined, are substances which promote immune responses. … A carrier may be present independently of an adjuvant. The function of a carrier can for example be to increase the molecular weight of in particular peptide fragments in order to increase their activity or immunogenicity, to confer stability, to increase the biological activity, or to increase serum half-life. Furthermore, a carrier may aid in presenting the PD-L1 polypeptide or said fragment thereof to T-cells.” [0221-0222]. Andersen teaches that substances found in bacteria are known adjuvants [0224].
Regarding claim 4, “Different recombinant bacteria may be used as vectors, for example the bacterial vector may be selected from the group consisting of … Lactococcus, ...” [0205].
Regarding claim 7, the preferred cancers to be treated are “selected from the group of; melanoma, breast cancer, ovarian cancer, lung cancer, pancreatic cancer, hematologic cancers (such as leukemias), colon and renal cell cancers, more preferably from the group consisting of melanoma, renal cell cancer and breast cancer.” [0125].
Regarding claims 8-9, Andersen teaches a method of administering the PD-L1 vaccine composition for prophylaxis and treatment to individuals with cancer [0018, 0248] and describes dosages and administration in the section beginning [0231], including teaching oral delivery [0236].
Andersen does not teach the PD-L1 is specifically presented on the surface of the bacteria, as in claim 1, and does not teach this is accomplished by binding to a PgsA anchor, as in claim 2. Andersen does not teach that the protein is inserted into a multiple cloning site of a pKV-Pald-PgsA380L vector, as in claim 3.
Regarding claim 1, 6, and 8-9, Sung teaches “a vector capable of stably and constantly expressing high levels at the surface of the recombinant lactic acid bacteria” [pg. 4 par. 1]. This vector was used to express a protein on the surface of the bacteria [pg. 4 par. 6] and to use that bacteria as a vaccine for treating cervical cancer [pg. 4 par. 6, 8]. Sung teaches that a benefit of their invention is “The strain can be economically mass-produced and applied directly to an oral vaccine… which is very economical.” [pg. 5 par. 1] and that “it is clear that the lactic acid bacteria are friendly and harmless bacteria in the human body” so using those strains doesn’t require any step of determining whether the bacteria is toxic [pg. 6 par. 2]. Sung demonstrates that a vaccine comprising bacteria expressing an antigen using this vaccine induces an immune response [Example 4 especially pg. 10 par. 5] and reduces tumor size [Example 6 especially pg. 11 par. 9].
Regarding claims 2-4, Sung teaches “a vector pKV-Pald-PgsA-PgsA that can constantly express HPV antigen protein in lactic acid bacteria by constantly fusing a gene encoding psgA and HPV16 E7 so that the HPV16 E7 protein of interest is fused to the PgsA C- E7 was prepared, and the expression vector was inserted into Lactobacillus casei to prepare a transformed recombinant lactic acid bacterium expressing the HPV antigen protein.” [pg. 5 par. 5]. Park provides evidence that the pKV-Pald-PgsA vector in Sung is also known in the art as pKV-Pald-pgsA380L, because it states that Sung (Republic of Korea Patent Registration No. 10-1471043) teaches pKV-Pald-pgsA380L-HPV16E7.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the Andersen cancer vaccine comprising bacteria expressing PD-L1 by choosing the cancer antigen-expressing vector, and optionally also choosing the bacterial species, of Sung, thereby arriving at the claimed invention, because one of ordinary skill would need to choose some plasmid vector in order to express the PD-L1 protein in bacteria as disclosed in Andersen, and the Sung vector has the benefits of being demonstrated to have high, stable antigen expression that results in successful production of an anti-cancer immune response when the vaccine is administered. Sung also teaches that using Lactobacillus as the bacteria as in their examples would have the benefit of being economical and avoiding a step of safety testing. Therefore, the combination would be desirable because the high and stable protein expression from the Sung vector potentially increases the therapeutic efficacy and because using an already validated vector reduces the time and expense of experimentation. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification can be performed with a reasonable expectation of success because Andersen teaches that the genetic manipulations engineering nucleic acid constructs are well known in the art, Sung teaches how to genetically modify the vector and insert it into bacteria. Also, both Sung and Andersen teach methods for orally administering the vaccine to treat cancers.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (Andersen) teaches a product (or method) that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the vector used, and optionally substitution of the bacterial species used); the substituted element (i.e. the vector and bacteria) was already known and already shown to function as a vector for expressing a cancer antigen in a bacteria, and as an attenuated bacteria that does not cause disease in humans, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one vector or bacteria for another with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (US-20140242101-A1; PTO-892) in view of 성문희 et al. (KR-101471043-B1, published 2014; hereafter Sung; PTO-892) as evidenced by Park et al. (WO-2020076079-A2; hereafter Park; PTO-892) as applied to claims 1-4 and 6-9 above, and further in view of Wood et al. (US-20030044768-A1; hereafter Wood; PTO-892). Citations refer to locations in the English machine translation included with this action (PTO-892).
The teachings of Andersen, Sung, and Park were discussed above. Additionally, Andersen teaches that the PD-L1 used is “SEQ ID NO: 1 or a functional homologue thereof at least 70% identical thereto” [0014] and that SEQ ID NO: 1 is the human PD-L1 sequence [0064]. Additionally, Sung teaches that the efficacy of recombinant bacteria can be measured by administering the bacteria to mice [Example 4 on pg. 9, Example 6 on pg. 11].
The combination of Andersen, Sung, and Park does not teach the PD-L1 protein comprises an amino acid sequence selected from the group consisting of SEQ ID NOs: 2 to 6 and 9, as in claim 5.
Wood teaches that the protein B7-4 is also known as PD-L1 [0059]; for clarity, the protein will only be referred to as PD-L1 in this rejection. Wood teaches SEQ ID NO: 23 is the amino acid sequence of murine PD-L1 [0026, Figure 6]. This protein comprises instant SEQ ID NO: 9 (see alignment below). Wood also teaches that the nucleic acids encoding the protein can be contained in expression vectors that can be bacterial vectors [0191]. Also, Wood teaches that the PD-L1 pathway has been studied and shown to behave similarly in both mouse (murine) and human systems [0006].
Alignment 3: Alignment of instant SEQ ID NO: 9 and Wood SEQ ID NO: 23.
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One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the human PD-L1 expressing bacteria, and vaccine composition of the combination by using the mouse PD-L1 sequence disclosed in Wood instead, thereby arriving at the claimed invention, because both Sung and Wood teach that mouse studies are used to understand a therapy’s effect in humans. Therefore, the combination would be desirable because administering a mouse PD-L1 sequence to a mouse would most closely approximate a therapy of administering a human PD-L1 sequence to a human. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” The modification could be performed with a reasonable expectation of success because the nucleic acid modification techniques required to change the vector are well known in the art at the time of filing and because Wood teaches that the mouse PD-L1 sequence can be placed into a bacterial expression vector.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the combination) teaches a product (or method) that only differs from the claimed invention by the substitution of a single component (i.e. substitution of the PD-L1 sequence used); the substituted element (i.e. the mouse PD-L1 sequence) was already known and already shown to function as a PD-L1 sequence, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting one PD-L1 sequence for another with a reasonable expectation of success (i.e. the substitution of the element would lead to predictable results). Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (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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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
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