DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election with traverse of the species of decreased amount of naïve non-senescent CD8 T cells and increased mRNA expression of CD57, CD85j, and/or KLRG1 in CD8 T cells, in the reply filed on 1/22/26 is acknowledged.
Applicant's traversal is on the grounds that it would not be an undue burden to search all of the species. This is not found persuasive because undue burden is irrelevant to the restriction practice for cases filed under 35 U.S.C 371 (see MPEP Chapter 1800). Furthermore, the claims set forth distinct species with different marker phenotypes and searching for all would be an undue burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 36-37 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claims 23 and 25-26 are withdrawn as being directed to non-elected species.
Claims 18-21, 24, 27-35, and 38-41 are being acted upon.
The rejections under 112b and 112d are withdrawn in view of Applicant’s claim amendments.
The rejections have been modified to the extend necessary to address Applicant’s claim amendments.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 18-21, 24, 27-35, and 38-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of DJ-1 inhibitors.
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.
The instant claims are directed to methods of treating or preventing immunoaging or an immunoaging-related disease, or a method of vaccination, comprising administering an inhibitor of DJ-1. The claims encompass a broad range of structurally distinct inhibitors including, for example, nucleic acids, small molecules, aptamers, peptides, soluble receptors, gene editing systems, or antibodies. The claims also encompass a functionally diverse genus of inhibitors, including those that act to bind polypeptide or nucleic acid, and that can treat a wide genus of different diseases. The state of the art is such that drug discovery is extremely complex and unpredictable. For example, inhibitory peptides that inhibit protein-protein interactions are not simple to design, but require high throughput screening assays, and requires extensive characterization of structural, conformations, dynamic and topographical considerations (See Hruby, 2002). Furthermore, protein chemistry is one of the most unpredictable areas of biotechnology. Whisstock et al (Quarterly Review of Biophysics, 2003, 36, pp307-340, of record). Additionally, the development of candidate drugs, such as antibodies, involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (see Scott et al, pages 278-279, of record). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (see Scott et al., 2012, page 278, in particular). Likewise, development of gene editing systems for in vivo use is complex, and requires careful consideration of factors such as ensuring the targeting of desired cells or tissues and avoiding off target events. Additionally, curing genetic disease in particular is still far from achievable (see Wilbie, 2019). The instant specification does not disclose a correlation between structure and function, nor is there an art recognize correlation, for the genus of DJ-1 inhibitors encompassed by the instant claims. The specification does not disclose a representative number of species. For example, no species of antibody, peptide, spiegelmer, chemical substance, antibody like protein scaffold, protein or polypeptide, peptidomimetic, photoaptamer, soluble protein, or gene editing systems are disclosed that inhibit DJ-1.
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 inhibitors 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., 43 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 page 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 at page 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., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Given the broadly claimed class of inhibitors, 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. AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014) and the specification at best describes plan for making inhibitors with the “limitations above” and then identifying those that satisfy claim limitations, but mere “wish or plan” for obtaining claimed invention is not sufficient. 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.
Applicant’s arguments filed 10/21/25 have been fully considered, but they are not persuasive.
Applicant argues that the claims have been amended to recite functional and structural limitations for the claimed inhibitors. Applicant argues that the specification demonstrates possession of the claimed inhibitors by identifying DJ-1 as a therapeutic target in knockout mice, and that the specification explains the role of DJ-1 in aging.
The claims encompass a wide genus of structurally distinct inhibitors including any chemical substance, any antibody, and antibody like protein scaffold, a protein or polypeptide, peptidomimetic, aptamer, photoaptamer, speigelmer and a soluble receptor and no species are disclosed. The disclosure of a relationship between the function of DJ-1 and immunoaging provides no information as to the structure of any compound that can function to inhibit DJ-1 (directly or indirectly).
Applicant also argues that the specification provides several DJ-1 inhibitors, such as an exemplary siRNA of SEQ ID NO: 4. Applicant argues that a clear structure function correlation is disclosed, i.e. inhibition of DJ-1 function directly slows immunoaging.
A single siRNA is not sufficiently representative of the huge genus of structurally distinct inhibitors including any chemical substance, any antibody, and antibody like protein scaffold, a protein or polypeptide, peptidomimetic, aptamer, photoaptamer, speigelmer and a soluble receptor as recited in the present claims. Furthermore, the role of DJ-1 function in immunoaging is not a structure function correlation for the claimed inhibitors, i.e. it does not provide any information as to the structure of any molecule that could function to inhibit DJ-1. 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.
Claims 18-21, 24, 27-35, and 38-41 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the enablement requirement. 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.
The specification disclosure is insufficient to enable one skilled in the art to practice the invention as claimed without an undue amount of experimentation. Undue experimentation must be considered in light of factors including: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill in the art, the level of predictability of the art, the amount of direction provided by the inventor, the existence of working examples, and the quantity of experimentation needed to make or use the invention, see In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) states, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” “The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling” (MPEP 2164.03). The MPEP further states that physiological activity can be considered inherently unpredictable. With these teachings in mind, an enabling disclosure, commensurate in scope with the breadth of the claimed invention, is required.
Claim 18 is directed to treating or preventing immunoaging or any immunoaging related disease comprising administering a therapeutically effective amount of any inhibitor of DJ-1. Therefore, the claims encompass treating a wide genus of different diseases with distinct etiologies and pathological mechanisms, including cancer, infection, Alzheimer’s disease, autoimmune disease, as well as genetic disorders like HGPS. The claims encompass not only treating said disease but also preventing said diseases. The term “prevention” would encompass a complete prevention such that not a single cell becomes infected with a pathogen, which would be highly unpredictable. Likewise preventing or curing cancer is extremely unpredictable due the heterogeneous nature of the disease, the difficulty in identifying at risk individuals, and the numerous challenges in effective treatment (see for example, Carey, 2010). Furthermore, the claims encompass preventing and treating premature aging diseases, which are genetic conditions. For example, HGPS is a rare genetic disorder caused by a defect in LMNA gene (see Chen, 2022). Treating or preventing HGPS using a DJ-1 inhibitor, which would do nothing to correct the underlying genetic defect, would be highly unpredictable. The claim would also encompass inhibiting DJ-1 in a wide range of different cell types, for example in neurons, cancer cells, immune cells, using a wide range of different types of inhibitors.
Additionally, the claims, for example claim 30, encompass vaccinating a subject and increasing an immune response using any DJ-1 inhibitor to enhance any type of immune response. The state of the art is such that DJ-1 is a multifunctional protein that plays a role in numerous physiological processes and is expressed in more than 22 tissues (See Zhang, 2020). For example, DJ-1 is expressed in cancer cells and can enhance cancer cell proliferation and metastasis (see below). Thus, one could envision treating cancer by reducing DJ-1 expression in cancer cells, for example. However, in other cell types, the role of DJ-1 is different. For example, DJ-1 is expressed in neurons and protects them from oxidative stress, and loss of DJ-1 is linked to development of Parkinson’s (see Ariga, 2013) . Likewise, the role of DJ-1 in immunity and inflammation is highly unpredictable. For example, lack of DJ-1 can lead to excess ROS, and can drive CD4 T cell migration (See Zhang, 2020), but it is also expressed in Tregs, wherein its inhibition can increases suppressor cell function of Tregs (see WO 2017/037279, of record). The effect of modulating DJ-1 on the immune system is highly unpredictable and depending on the particular disease process, the cell type targeted for inhibition, and the type of inhibitors (see Zhang). For example, the present claims encompass increasing immune response or the use of DJ-1 inhibitor in vaccination methods, however, due to its effect on Tregs, this would be highly unpredictable. Furthermore, the claims encompass any type of DJ-1 inhibitor. The state of the art is such that drug discovery is extremely complex and unpredictable. For example, inhibitory peptides that inhibit protein-protein interactions are not simple to design, but require high throughput screening assays, and requires extensive characterization of structural, conformations, dynamic and topographical considerations (See Hruby, 2002). Furthermore, protein chemistry is one of the most unpredictable areas of biotechnology. Whisstock et al (Quarterly Review of Biophysics, 2003, 36, pp307-340, of record). Additionally, the development of candidate drugs, such as antibodies, involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (see Scott et al, pages 278-279, of record). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (see Scott et al., 2012, page 278, in particular). For example, the present claims encompass treating genetic diseases with DJ-1 gene editing in any cells, such as neurons or immune cells. However, development of gene editing systems for in vivo use is complex, and requires careful consideration of delivery systems to target desired cells or tissues and avoid off target events, and curing genetic disease in particular is still far from achievable (see Wilbie, 2019). Thus, making and using any DJ-1 inhibitor as broadly claimed would be highly unpredictable.
Given the unpredictability of the art and the breadth of the claims, the instant specification must provide a sufficient an enabling disclosure commensurate in scope with the instant claims. The specification provides no guidance or examples for treating disease or vaccination using any DJ-1 inhibitor. The only examples in the specification involve the use of DJ-1 knockout mice, which is not commensurate in scope with the instant claims. No guidance is provided regarding how a DJ-1 inhibitor would function to treat genetic disease like HSGS, for example.
Applicant’s arguments filed 10/21/25 have been fully considered, but they are not persuasive.
Applicant argues that the knockout studies clearly demonstrate that loss of DJ-1 function reverses immunoaging, and patients with DJ-1 loss of function exhibit a younger immune profile.
The claims are not limited to inhibiting immunoaging or inducing a younger immune profile, but rather encompass treating or preventing any immune-aging disease. As noted above, the claims encompass treating or preventing a wide genus of different diseases with distinct etiologies and pathological mechanisms, including cancer, infection, Alzheimer’s disease, autoimmune disease, as well as genetic disorders like HGPS. The term “prevention” would encompass a complete prevention such that not a single cell becomes infected with a pathogen, which would be highly unpredictable. Likewise preventing or curing cancer is extremely unpredictable due the heterogeneous nature of the disease, the difficulty in identifying at risk individuals, and the numerous challenges in effective treatment (see for example, Carey, 2010). Furthermore, the claims encompass preventing or treating premature aging diseases, which are genetic conditions. For example, HGPS is a rare genetic disorder caused by a defect in LMNA gene (see Chen, 2022). Treating or preventing HGPS using a DJ-1 inhibitor, which would do nothing to correct the underlying genetic defect, would be highly unpredictable.
Applicant further argues that the specification provides clear guidance on how DJ-1 inhibition can be achieved, such as using antibodies, peptides, soluble receptors and chemical substances, and provides an exemplary siRNA as defined in SEQ ID NO: 4.
No examples or species of inhibitor antibodies, peptides, soluble receptors or chemical substances are disclosed. As noted above, the state of the art is such that drug discovery is extremely complex and unpredictable. For example, inhibitory peptides that inhibit protein-protein interactions are not simple to design, but require high throughput screening assays, and requires extensive characterization of structural, conformations, dynamic and topographical considerations (See Hruby, 2002). Furthermore, protein chemistry is one of the most unpredictable areas of biotechnology. Whisstock et al (Quarterly Review of Biophysics, 2003, 36, pp307-340, of record). Additionally, the development of candidate drugs, such as antibodies, involves a complex process of clinical and preclinical evaluation that include identification of the physical and chemical properties of the antibody (see Scott et al, pages 278-279, of record). Antibodies have a wide range of pharmacokinetics, effector functions, size and immunogenicity, affinities and avidities, all of which effect the function of each antibody in vivo (see Scott et al., 2012, page 278, in particular). Thus, given the unpredictability of the art, the breadth of the claims, and the lack of guidance provided by the instant specification, it would require undue experimentation to make and using the DJ-1 inhibitors as broadly claimed.
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.
Claim(s) 18, 21, 24, 27, and 38-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by KR 20160118022 (of record), as evidenced by an English machine translation thereof.
The ’022 publication teaches a method for treating a subject with breast cancer comprising administering a DJ-1 inhibitor to the subject (See pages 1-3 of the translation, in particular). The ‘022 publication teaches nucleic acid inhibitors that bind DJ-1 gene (See page 1-3, in particular). The method is identical to that of the instant claims, and it would inherently treat or prevent “immunoaging”. Regarding the limitation that the subject is suffering from immunoaging, the treated patients in the ‘022 publication are suffering from cancer. As claim 27 recites that cancer is an immunoaging disease, patients suffering from cancer are within the scope of patient suffering from immunoaging. The method would inherently result in one or more properties from claim 41, since these are inherent properties that flow naturally from inhibiting DJ-1. Regarding claim 39-40, the claims specify certain immunoaging phenotypes. The claims encompass an increase or decrease relative to the same subject at an earlier time point. This would be inherent in the prior art. For example, any subject would inherently display an increase or decrease in the relative marker compared to when they were younger. Regarding claim 38, the instant specification defines a “direct” inhibitor as one that binds to DJ-1 protein or polynucleotide encoding DJ-1. The inhibitor of the prior art binds to DJ-1 gene, and therefore is a “direct” inhibitor.
Applicant’s arguments filed 10/21/25 have been fully considered, but they are not persuasive.
Applicant argues that the prior art does not teach that the subject is suffering from immunoaging.
This is not persuasive for the reasons set forth above, i.e. a patient suffering from cancer, which is an immunoaging related disease, is within the scope of a patient suffering from immunoaging.
Claim(s) 18, 21, 24, 27, 29, and 38-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2007/008652.
WO 2007/008652 teaches a method of treating a subject having a disorder associated with an altered oxidative stress response comprising administering to said subject a compound that inhibits DJ-1 (see page 5-7, in particular). WO 2007/008652 teaches that said subject has cancer (see page 6-7, in particular). The method is identical to that of the instant claims, and it would inherently treat or prevent “immunoaging”. WO 2007/008652 teaches using nucleic acid inhibitors that bind to DJ-1 nucleic acid, and that the inhibitors decrease DJ-1 gene expression in cancer cells (see pages 13-14 and 25, in particular). WO 2007/008652 teaches administering said inhibitors as a composition further comprising polyethylene glycol, a preservative, or an anti-microbial (see pages 32-33, i.e. compounds or compositions capable of inducing an immune response). The method would inherently result in one or more properties from claim 41, since these are inherent properties that flow naturally from inhibiting DJ-1. Regarding claim 39-40, the claims specify certain immunoaging phenotypes. The claims encompass an increase or decrease relative to the same subject at an earlier time point. This would be inherent in the prior art. For example, any subject would inherently display an increase or decrease in the relative marker compared to when they were younger. Regarding claim 38, the instant specification defines a “direct” inhibitor as one that binds to DJ-1 protein or polynucleotide encoding DJ-1. The inhibitor of the prior art binds to DJ-1 gene, and therefore is a “direct” inhibitor.
Applicant’s arguments filed 10/21/25 have been fully considered, but they are not persuasive.
Applicant argues that the claims are not anticipated for the same reasons set forth above.
The claims stand rejected for the same reasons set forth above.
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 18-21, 24, 27-29, and 38-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/008652 and KR 20160118022, in view of Ding, 2007.
The teachings of WO 2007/008652 and KR 20160118022 have been described above.
The reference differs from the claimed invention in that it does not explicitly teach treating elderly subjects (i.e. a subject suffering from “immunoaging”) or subjects with Werner’s syndrome.
Ding teaches that age is a risk factor for cancer development and almost all cancers occur in the elderly. Ding also teaches that Werner syndrome is a premature aging disease characterized by a predisposition to cancer.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to select an elderly cancer subject, or a cancer subject with Werner syndrome, as the cancer subject for treatment in the method of WO 2007/008652 or KR 20160118022. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Ding teaches that age is a risk factor for cancer development and almost all cancers occur in the elderly. Ding also teaches that Werner syndrome is a premature aging disease characterized by a predisposition to cancer.
Applicant’s arguments filed 10/21/25 have been fully considered, but they are not persuasive.
Applicant argues that the references do not teach the effect of DJ-1 inhibition on immune aging
This is an inherent or latent property of inhibition of DJ-1, and would flow naturally from the method taught of the prior art.
“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Claims 18, 21, 3-24, 27, 29-30, 33-35, and 38-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/008652, in view of WO2019223039 and JP 2019520394, as evidenced by the machine translation thereof.
The teachings of WO 2007/008652 are described above. Even though the limitation of a subject suffering from immunoaging is anticipated for the reasons set forth above, it would also be obvious that a cancer patient would include adult patients, i.e. subjects suffering from “immunoaging”, as compared to, for example a young child.
The reference differs from the claimed invention in that it does not explicitly teach a gene editing system.
WO2019223039 teaches a gene editing system for use as a drug for inhibiting DJ-1 gene that is efficient and can completely knock down expression at the DNA level, which is a maximum advantage compared to reduction in gene expression (see translation).
The ‘394 publication teaches gene editing systems packaged into an adenovirus particle for use in altering expression of one or more gene products in cancer cells after in vivo administration. The ‘394 publication teaches that it has enhanced specificity as compared to other types of gene inhibition strategies.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use an adenovirus gene editing system as taught by WO2019223039 and the ‘394 publication (i.e. an immunogenic composition), to reduce DJ-1 expression in the method of treating cancer of WO 2007/008652. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because the ‘394 publication and WO2019223039 teach that is has advantages and enhanced specificity as compared to other gene reduction strategies.
Applicant’s arguments filed 10/21/25 have been fully considered, but they are not persuasive.
Applicant argues that the references do not teach the effect of DJ-1 inhibition on immune aging or for enhancing vaccination responses.
This is not persuasive for the same reasons set forth above. Additionally, it is noted that the prior art teaches administering an adenovirus comprising a gene editing system DJ-1 inhibitor (i.e. an immunogenic adjuvant composition). The composition of the prior art is identical to that of the claims, i.e. it is an immunogenic “vaccine” and the method would result in an enhanced immune response
Claim 31-32 is rejected under 35 U.S.C. 103(a) as being unpatentable over WO 2007/008652, in view of WO2019223039, and JP 2019520394, as applied to claim 30 above, and further in view of Ding, 2007.
The combined teachings WO 2007/008652, WO2019223039, and JP 2019520394 are discussed above.
They do not explicitly teach treating elderly subjects or subjects with Werner’s syndrome.
Ding teaches that age is a risk factor for cancer development and almost all cancers occur in the elderly (i.e. patients suffering from immunoaging). Ding also teaches that Werner syndrome is a premature aging disease characterized by a predisposition to cancer.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to select an elderly cancer subject, or a cancer subject with Werner syndrome, as the cancer subject for treatment in the method made obvious above. The ordinary artisan at the time the invention was made would have been motivated to do so with a reasonable expectation of success, because Ding teaches that age is a risk factor for cancer development and almost all cancers occur in the elderly. Ding also teaches that Werner syndrome is a premature aging disease characterized by a predisposition to cancer.
Applicant argues that the claims are not obvious for the same reasons set forth above.
The claims stand rejected for the same reasons set forth above.
The following are new grounds of rejection necessitated by Applicant’s claim amendments.
Claims 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007/008652, KR 20160118022, and Ding, 2007, as applied to claim 18 above, and further in view of Gustafson, 2017.
The teachings of WO 2007/008652, KR 20160118022, and Ding have been described above.
Even thought the limitations of claims 39-40 are inherent/latent properties for the reasons set forth above, they would also be obvious based on the teachings of Gustafson.
Gustafson teaches that aging increases senescent T cells and increases expression of CD85J in CD8 T cells, and also reduces the number of naïve T cells. Thus, it would be obvious that the elderly subjects treated in the prior art method made obvious above, would be characterized by a decreased amount of naïve non-senescent CD8 T cells and an increased in CD85j+ CD8 T cells as compared to the subjects when they were younger, i.e. compared to an earlier time point.
Claims 18-21, 24, 27-35, and 38-41 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The specification and the claims as originally filed do not provide support for the invention as now claimed, specifically:
A method employing a DJ-1 inhibitor that “abolishes” DJ-1 function or expression (Claim 18, 30, and dependent claims).
Applicant indicates that support for the new limitations can be found on page 14 of the specification.
The specification discloses DJ-1 inhibitors that reduce expression or function of DJ-1, but does not disclose abolishing expression or function, as now claimed.
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644