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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/3/25 has been entered.
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 12/3/25 are acknowledged. Any objection or rejection from the 6/4/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 2 and the species of SEQ ID NO:2 and psoriasis were elected.
Claims 1, 3-4, 7, 9-10, 13-14, 16, 20, 23 and 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/18/24.
With respect to claims 57-59 and 61-65, the elected species of SEQ ID NO:2 does not include the features of those claims. Thus claims 57-59 and 61-65 are drawn to non-elected species. Although claim 32 is unclear, the elected species itself does not contain positively charged amino acids. The search was extended to the extent necessary to determine patentability. Since claim 57 appears to recite information already present in claim 32, claim 57 is included in the examination.
Claims 58-59 and 61-65 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/18/24.
Claims 2, 5-6, 8, 11-12, 15, 17-19, 21-22, 24-31, 34-38, 40, 42, 46, 48-50 and 52-55 have been canceled.
Claims 32-33, 39, 41, 43-45, 47, 51, 57 and 60 are being examined.
Priority
The priority information is provided in the filing receipt dated 9/20/22.
Claim Rejections - 35 USC § 112
The rejections below are updated (to correspond to the instant claims) or new rejections necessitated by amendment.
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 32-33, 39, 41, 43-45, 47, 51, 57 and 60 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.
The 4th to last line of claim 32 recites ‘one of more’. The second to last line of claim 32 recites ‘the one or more’. There is a lack of antecedent basis for ‘the one or more’ because the claim uses the phrase ‘one of more’ (the 4th to last line of claim 32). Further, it is unclear if the phrase ‘one of more’ is of the same scope as ‘one or more’. None of the dependent claims clarifies the claim scope.
Claim 32 refers to a peptide that comprises SEQ ID NO:1 or SEQ ID NO:2 or a fragment thereof that has at least 80% amino acid identity ‘and’ one or more modifications or moieties. It is unclear if the percent identity is calculated before or after the modification. For example, TVLTVV is 100% identical to SEQ ID NO:1. When the last 3 residues are modified (the claim does not limit where the modification can occur) to the positively charged amino acid Arg the resulting peptide is TVLRRR. It is unclear is such peptide falls within the scope of the claim. Stated another way, the claim refers to sequences or fragments of sequences with certain identity but then refer to ‘and’ one of more modifications. Such language could be interpreted as being a modification of the previously recited sequence thus resulting in a peptide that does not comprise the sequence or have the required percent identity. None of the dependent claims clarifies the claim scope. As noted in the 112d/4th paragraph rejection below, claim 60 depends on claim 32 and recites SEQ ID NO:59 (IIIIITVITVV). SEQ ID NO:59 does not include any positively charged amino acids.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification and have been interpreted as including no new matter.
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 32-33, 39, 41, 43-45, 47, 51, 57 and 60 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Further, to provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include: a) the scope of the invention; b) actual reduction to practice; c) disclosure of drawings or structural chemical formulas; d) relevant identifying characteristics including complete structure, partial structure, physical and/or chemical properties, and structure/function correlation; e) method of making the claimed compounds; f) level of skill and knowledge in the art; and g) predictability in the art.
(1) Scope of the invention/Partial structure/disclosure of drawings:
Claim 32 recites ‘a fragment thereof that has at least 80% identity thereto and retains the function of treating the inflammatory disease, disorder, or condition’ and recites ‘and one of more modifications’. The word ‘modification’ broadly encompasses substitutions (which are not limited to any particular location) and additions. Claim 32 recites that the peptide can be 50 amino acids in length. SEQ ID NO: 2 is 11 amino acids in length. For 80% identity, 2 amino acids can be removed. Further, the other 39 amino acids are not specifically defined. The peptides of claim 60 do not even necessarily contain a positively charged amino acid (see 112 d/4th rejection below). As such, the genus is large.
The examples appear to relate to the RP23 peptide or peptides comprising SEQ ID NO:2 (see pages 65-69 of the specification). It does not appear that any fragments were tested. It does not appear that any peptides with modifications that correspond to charged substitutions were tested.
Further, claim 32 broadly recites treating an inflammatory skin disease, disorder or condition.
Cleveland clinic web site (‘Inflammation entry’ retrieved from https://my.clevelandclinic.org/health/symptoms/21660-inflammation on 9/24/24, 16 pages) teach that there are a wide variety of conditions associated with inflammation and numerous possible causes of inflammation (pages 9-11).
(2) Level of skill and knowledge in the art/predictability in the art:
The level of skill in the art is high.
Claim 32 recites ‘a fragment thereof that has at least 80% identity thereto and retains the function of treating the inflammatory disease, disorder, or condition’ and recites ‘and one of more modifications’. The word ‘modification’ broadly encompasses substitutions (which are not limited to any particular location) and additions. Claim 32 recites that the peptide can be 50 amino acids in length. SEQ ID NO: 2 is 11 amino acids in length. For 80% identity, 2 amino acids can be removed. Further, the other 39 amino acids are not specifically defined. The peptides of claim 60 do not even necessarily contain a positively charged amino acid (see 112 d/4th rejection below).
Pearson W (‘An introduction to sequence similarity (“Homology”) searching’ Curr Protoc Bioinformatics June 2013 printed as pages 1-9) teach that homologous sequences do not always share significant sequence similarity and there are thousands of homologous protein alignments that are not significant (page 2 2nd complete paragraph). Thus, modifications to a protein do not necessarily lead to functional proteins.
With respect to treatment of inflammation, Cleveland clinic web site (‘Inflammation entry’ retrieved from https://my.clevelandclinic.org/health/symptoms/21660-inflammation on 9/24/24, 16 pages) teach that there are a wide variety of conditions associated with inflammation and numerous possible causes of inflammation (pages 9-11).
(3) Physical and/or chemical properties and (4) Functional characteristics:
Claim 32 recites ‘treating’ as well as ‘retains the function of treating’. Claims 47 and 51 recite additional functionalities.
Applicants own figure 3 caption (page 12) states that the peptide effect is dependent on the peptide sequence.
There is no specific disclosed correlation between structure and function particularly related to what structures are adequate to result in the functions as recited in the claims particularly for sequences that are less than 100% identical to SEQ ID NO:2. Further, there is no adequate direction provided as to what specific amino acids can be substituted or inserted without changing the functionality or which amino acids can be deleted to result in fragments that are functional. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus and that there is a lack of the predictability in the art thus that the applicant was not in possession of the claimed genus.
(5) Method of making the claimed invention/actual reduction to practice:
The examples appear to relate to the RP23 peptide or peptides comprising SEQ ID NO:2 (see pages 65-69 of the specification). However, such examples do not show what substitutions, deletions or insertions would have the same function.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claims 32-33, 39, 41, 43-45, 47, 51, 57 and 60 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treatment of psoriasis in an individual comprising administering a peptide comprising SEQ ID NO:2 to an individual, does not reasonably provide enablement for the full scope of the claims. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
(1) The nature of the invention and (2) The breadth of the claims:
Claim 32 recites ‘a fragment thereof that has at least 80% identity thereto and retains the function of treating the inflammatory disease, disorder, or condition’ and recites ‘and one of more modifications’. The word ‘modification’ broadly encompasses substitutions (which are not limited to any particular location) and additions. Claim 32 recites that the peptide can be 50 amino acids in length. SEQ ID NO: 2 is 11 amino acids in length. For 80% identity, 2 amino acids can be removed. Further, the other 39 amino acids are not specifically defined. The peptides of claim 60 do not even necessarily contain a positively charged amino acid (see 112 d/4th rejection below). As such, the genus is large.
Further, claim 32 broadly recites treating an inflammatory skin disease, disorder or condition. Cleveland clinic web site (‘Inflammation entry’ retrieved from https://my.clevelandclinic.org/health/symptoms/21660-inflammation on 9/24/24, 16 pages) teach that there are a wide variety of conditions associated with inflammation and numerous possible causes of inflammation (pages 9-11).
(3) The state of the prior art and (4) the predictability or unpredictability of the art:
Claim 32 recites ‘a fragment thereof that has at least 80% identity thereto and retains the function of treating the inflammatory disease, disorder, or condition’ and recites ‘and one of more modifications’. The word ‘modification’ broadly encompasses substitutions (which are not limited to any particular location) and additions. Claim 32 recites that the peptide can be 50 amino acids in length. SEQ ID NO: 2 is 11 amino acids in length. For 80% identity, 2 amino acids can be removed. Further, the other 39 amino acids are not specifically defined. The peptides of claim 60 do not even necessarily contain a positively charged amino acid (see 112 d/4th rejection below).
Applicants own figure 3 caption (page 12) states that the peptide effect is dependent on the peptide sequence.
Pearson W (‘An introduction to sequence similarity (“Homology”) searching’ Curr Protoc Bioinformatics June 2013 printed as pages 1-9) teach that homologous sequences do not always share significant sequence similarity and there are thousands of homologous protein alignments that are not significant (page 2 2nd complete paragraph). Thus, modifications to a protein do not necessarily lead to functional proteins.
With respect to treatment of inflammation, Cleveland clinic web site (‘Inflammation entry’ retrieved from https://my.clevelandclinic.org/health/symptoms/21660-inflammation on 9/24/24, 16 pages) teach that there are a wide variety of conditions associated with inflammation and numerous possible causes of inflammation (pages 9-11).
(5) The relative skill of those in the art:
The level of skill in the art is high.
(6) The amount of direction or guidance presented and (7) the presence or absence of working examples:
The examples appear to relate to the RP23 peptide or peptides comprising SEQ ID NO:2 (see pages 65-69 of the specification). However, such examples do not show what substitutions, deletions or insertions would have the same function.
Further, the effects shown in the specification are not necessarily relevant to the many known causes of inflammation (see Cleveland clinic web site (‘Inflammation entry’ retrieved from https://my.clevelandclinic.org/health/symptoms/21660-inflammation on 9/24/24, 16 pages) pages 9-10).
There is no adequate specific disclosed correlation between structure and function particularly related to what structures are adequate to result in the functions as recited in the claims particularly for sequences that are less than 100% identical to SEQ ID NO:2.
(8) The quantity of experimentation necessary:
Experimentation and guidance is required to make peptides with the recited functions and test them against many types of causes of inflammation or diseases related to inflammation. Taken together, such experimentation and guidance is necessary because the prior art cited above teach that the state of the art is highly unpredictable.
Accordingly one would be burdened with undue experimentation to determine how to make the invention. Considering the state of the art as discussed by the references above, particularly with regards to the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to make the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 57 and 60 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 57 recites ‘wherein the one or more modifications or moieties is in the form of one or more positively charged amino acids’. Claim 57 depends on claim 32. Claim 32 already recites ‘wherein the one or more modifications or moieties is in the form of one or more positively charged amino acids’. Thus it appears that claim 57 is referring to a feature that is already recited in claim 32. Claim 57 appears to be of the same scope as claim 32.
Claim 60 depends on claim 32. Claim 32 recites that one or more modifications or moieties is in the form of one or more positively charged amino acids. Claim 60 recites SEQ ID NO:59 (IIIIITVITVV). SEQ ID NO:59 does not include any positively charged amino acids. Numerous other amino acid sequences from the sequences recited in claim 60 do not include a positively charged amino acid.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments - 112
Applicant's arguments filed 12/3/25 have been fully considered but they are not persuasive with respect to the rejections set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue about a limited amount of variability, the most recent amendment to claim 32 recites ‘one of more modifications’ and does not limit the total number or location of the modification.
Although applicants argue that the examples teach multiple variants, the examples appear to relate to the RP23 peptide or peptides comprising SEQ ID NO:2 (see pages 65-69 of the specification). It does not appear that any fragments were tested. It does not appear that any peptides with modifications that correspond to substitutions of charged amino acids were tested.
Claim Rejections - 35 USC § 103
The rejection below is a new rejection.
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.
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.
Claim(s) 32-33, 39, 41, 43-45, 47, 51, 57 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovjazin et al. (as cited with IDS 8/22/22; ‘Kovjazin’) in view of Cascio et al. (‘Intra- and extra-cellular events related to altered glycosylation of MUC1 promote chronic inflammation, tumor progression, invasion, and metastasis’ Biomolecules 2016 pages 1-16; ‘Cascio’) in view of Kim et al. (WO 2016/172219 10-2016 as cited with IDS 12/28/21; ‘Kim’).
Kovjazin teach the use of peptide vaccines specifically for the treatment of MUC1-expressing tumors (abstract). Kovjazin teach a peptide comprising LLLLLTVLTVV (MUC1-SP-L Table 1 on page 4680). Kovjazin teach that MUC1-SP-L was administered to mice (sections 3.7-3.8 on page 4683). Kovjazin teach anti-tumor properties of MUC1-SP-L (abstract). Kovjazin teach that TNF-alpha is a proinflammatory cytokine (section 3.5 2nd paragraph on page 4682). Kovjazin analyzed the levels of cytokine secretion during MUC1-SP-L line development (figure 3B and pages 4681-4682 connecting paragraph). Kovjazin teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph).
Kovjazin does not teach the addition of a positively charged amino acid to the MUC1-SP-L sequence nor does Kovjazin specifically recite arthritis.
Cascio teach that MUC1 can promote chronic inflammation and tumor progression (title and abstract). Cascio teach that MUC1 controls transcription of several pro-inflammatory cytokines including TNF-alpha (page 5 last complete paragraph and figure 3). Cascio recognizes that MUC1 can lead to increased pro-inflammatory cytokines and a pro-tumor microenvironment (page 10 last paragraph). Cascio refers to acute and chronic inflammation and specifically refers to arthritis (pages 7-8 connecting paragraph).
Kim recognizes methods of treating inflammatory disorders (abstract). Kim recognizes MUC1 as playing an anti-inflammatory role (page 2 last paragraph). Kim recognizes the use of a TAT carrier peptide (page 2 last paragraph) which is a known cell penetrating peptide of sequence RRRQRRKKRGY (page 4 first complete paragraph and claim 11). Kim specifically teach using TAT fused to a MUC1 peptide (pages 8-9 connecting paragraph). Kim teach attaching the TAT peptide to a terminal end of the peptide (page 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kovjazin because Kovjazin teach the use of peptide vaccines specifically for the treatment of MUC1-expressing tumors (abstract). Cascio teach that MUC1 can promote chronic inflammation and tumor progression (title and abstract) and teach that MUC1 controls transcription of several pro-inflammatory cytokines including TNF-alpha (page 5 last complete paragraph and figure 3). Since Kovjazin teach treatment of MUC1-expressing tumors (abstract) and teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph) one would have been motivated to use the suggested peptides in applications where such functions are desired such as in those with inflammation such as in arthritis as taught by Cascio. With respect to the peptide, Kovjazin teach a peptide comprising LLLLLTVLTVV (MUC1-SP-L Table 1 on page 4680). Kim recognizes the use of a TAT carrier peptide (page 2 last paragraph) which is a known cell penetrating peptide of sequence RRRQRRKKRGY (page 4 first complete paragraph and claim 11) and specifically teach using TAT fused to a MUC1 peptide (pages 8-9 connecting paragraph). Thus, one would have been motivated to attach TAT to a terminal end of MUC1-SP-L based on the known advantageous effects of TAT. One would have had a reasonable expectation of success since methods of administering were known and Kovjazin teach treatment of MUC1-expressing tumors (abstract) and teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph).
In relation to the peptide of claims 32 and 57, Kovjazin teach a peptide comprising LLLLLTVLTVV (MUC1-SP-L Table 1 on page 4680) which is less than 50 amino acids in length and comprises the elected species and instant SEQ ID NO:2 which is also recited in claim 60 (claim 60 recites ‘peptide is defined by’ which is interpreted as requiring a peptide comprising one of the recited sequences). Kim recognizes the use of a TAT carrier peptide (page 2 last paragraph) which is a known cell penetrating peptide of sequence RRRQRRKKRGY (page 4 first complete paragraph and claim 11) which comprises one or more positively charged amino acids as recited in claims 32 and 57. Since the elected peptide is suggested it would function as recited in claims 45, 47 and 51. Further, Kovjazin teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph).
In relation to the administration and individual of claims 32, 39 and 41-44, Kovjazin teach was administered to mice (sections 3.7-3.8 on page 4683). Cascio refers to acute and chronic inflammation and specifically refers to arthritis (pages 7-8 connecting paragraph).
In relation to claim 33, Kovjazin teach that MUC1-SP-L was combined with GM-CSF (section 3.7 on page 4683).
Claim(s) 32-33, 39, 41, 43-45, 47, 51, 57 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovjazin et al. (as cited with IDS 8/22/22; ‘Kovjazin’) in view of Yost et al. (‘The role of TNF inhibitors in psoriasis therapy: new implications for associated comorbidities’ Medicine Reports 2009 pages 1-4) in view of Kim et al. (WO 2016/172219 10-2016 as cited with IDS 12/28/21; ‘Kim’).
Kovjazin teach the use of peptide vaccines specifically for the treatment of MUC1-expressing tumors (abstract). Kovjazin teach a peptide comprising LLLLLTVLTVV (MUC1-SP-L Table 1 on page 4680). Kovjazin teach that MUC1-SP-L was administered to mice (sections 3.7-3.8 on page 4683). Kovjazin teach anti-tumor properties of MUC1-SP-L (abstract). Kovjazin teach that TNF-alpha is a proinflammatory cytokine (section 3.5 2nd paragraph on page 4682). Kovjazin analyzed the levels of cytokine secretion during MUC1-SP-L line development (figure 3B and pages 4681-4682 connecting paragraph). Kovjazin teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph).
Kovjazin does not teach the addition of a positively charged amino acid to the MUC1-SP-L sequence nor does Kovjazin specifically recite arthritis.
Yost teach TNF inhibitors in psoriasis therapy (title and abstract). Yost teach psoriasis as a chronic inflammatory disease in which the pro-inflammatory cytokine TNF-alpha is elevated (page 1 first paragraph and figure 1). Yost teach that treatments of psoriasis are known (page 1 2nd column) and teach the medications as effective (page 3 last paragraph).
Kim recognizes methods of treating inflammatory disorders (abstract). Kim recognizes MUC1 as playing an anti-inflammatory role (page 2 last paragraph). Kim recognizes the use of a TAT carrier peptide (page 2 last paragraph) which is a known cell penetrating peptide of sequence RRRQRRKKRGY (page 4 first complete paragraph and claim 11). Kim specifically teach using TAT fused to a MUC1 peptide (pages 8-9 connecting paragraph). Kim teach attaching the TAT peptide to a terminal end of the peptide (page 17).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Kovjazin because Kovjazin teach the use of peptide vaccines specifically for the treatment of MUC1-expressing tumors (abstract) and Kovjazin teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph). Yost teach TNF inhibitors in psoriasis therapy (title and abstract) and teach psoriasis as a chronic inflammatory disease in which the pro-inflammatory cytokine TNF-alpha is elevated (page 1 first paragraph and figure 1). Since Kovjazin teach treatment of MUC1-expressing tumors (abstract) and teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph) one would have been motivated to use the suggested peptides in applications where such functions are desired such as in those with psoriasis as taught by Yost. With respect to the peptide, Kovjazin teach a peptide comprising LLLLLTVLTVV (MUC1-SP-L Table 1 on page 4680). Kim recognizes the use of a TAT carrier peptide (page 2 last paragraph) which is a known cell penetrating peptide of sequence RRRQRRKKRGY (page 4 first complete paragraph and claim 11) and specifically teach using TAT fused to a MUC1 peptide (pages 8-9 connecting paragraph). Thus, one would have been motivated to attach TAT to a terminal end of MUC1-SP-L based on the known advantageous effects of TAT. One would have had a reasonable expectation of success since methods of administering were known and Kovjazin teach treatment of MUC1-expressing tumors (abstract) and teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph).
In relation to the peptide of claims 32 and 57, Kovjazin teach a peptide comprising LLLLLTVLTVV (MUC1-SP-L Table 1 on page 4680) which is less than 50 amino acids in length and comprises the elected species and instant SEQ ID NO:2 which is also recited in claim 60 (claim 60 recites ‘peptide is defined by’ which is interpreted as requiring a peptide comprising one of the recited sequences). Kim recognizes the use of a TAT carrier peptide (page 2 last paragraph) which is a known cell penetrating peptide of sequence RRRQRRKKRGY (page 4 first complete paragraph and claim 11) which comprises one or more positively charged amino acids as recited in claims 32 and 57. Since the elected peptide is suggested it would function as recited in claims 45, 47 and 51. Further, Kovjazin teach that TNF-alpha levels ‘completely disappeared after the third stimulation’ (pages 4681-4682 connecting paragraph).
In relation to the administration and individual of claims 32, 39 and 41-44, Kovjazin teach was administered to mice (sections 3.7-3.8 on page 4683). Yost teach psoriasis as a chronic inflammatory disease in which the pro-inflammatory cytokine TNF-alpha is elevated (page 1 first paragraph and figure 1).
In relation to claim 33, Kovjazin teach that MUC1-SP-L was combined with GM-CSF (section 3.7 on page 4683).
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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