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 .
Election/Restrictions
Applicant’s election without traverse of Formula II, SEQ ID NO: 56 and the protein in the reply filed on 5/12/26 is acknowledged.
Claim 14 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claims 1-9, 14-15, 18-23, 28-30 and 34-35 are pending.
Claim 1-9,15,18-23,28-30 and 34-35 read on the elected species and are under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: “leucine” is repeated for X3 on p. 1.
Appropriate correction is required.
Claim Interpretation
The formulas of claim 1 are interpreted to be closed due to the presence of Y1, Y2, Y3 and Y4. Formula I is limited to the 11 amino acids recited in the formula and Y1 and Y2. Formula II is limited to the 15 amino acids recited and Y3 and Y4.
Claim Rejections - 35 USC § 112
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.
Claim 1-9,15,18-23,28-30 and 34-35 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.
MPEP § 2163 states that 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, 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. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Scope of the claimed genus
Claim 1 is drawn to an isolated peptide of Formula I or Formula II. Claim 7 is drawn to the isolated peptide of claim 1, wherein the peptide binds to AIF and/or PPIA. Claim 8 is drawn to the peptide of claim 1, wherein the peptide is an AIF mimetic peptide. Claim 9 is drawn to the polypeptide of claim 7 wherein the peptide inhibits CAPN1 induced cell death. Claim 20 is drawn to a method of preventing myocardial cell death and/or sudden cardiac death in a subject. Claim 28 is drawn to the isolated peptide of claim 20, wherein the peptide binds to AIF and/or PPIA. Claim 29 is drawn to the peptide of claim 28, wherein the peptide is an AIF mimetic peptide. Claim 30 is drawn to the polypeptide of claim 28 wherein the peptide inhibits CAPN1 induced cell death. The USPTO provides claim terms with broadest reasonable interpretation in light of the specification.
Assessment of whether species are support in the original specification
One embodiment of the invention of the claims were reduced to practice at the time of filing. Applicants disclose the AIF-Tat mimetic peptide (370-394) binds and sequesters PPIA [0229]. However, it is unclear from the specification if that corresponds to a specific SEQ ID NO.
Applicants disclosed the amino acid sequence of SEQ ID NOs: 1-60. The specification states that SEQ ID NO: 1-30 are peptides derived from Formula I and based on the sequence of AIF 381-389. The specification discloses that additional peptides were designed based on SEQ ID NO: 69 and were described as having general formula II [0064-0066].
The specification discloses Table 3 (p. 20-21) and states the peptide are AIF and PPIA binding peptides. However, there was no data presented that SEQ ID NO: 1-60 have this function.
There was no disclosure of other peptide sequences that meet the structural limitations of claim 1 that had the function of binding to AIF an/or PPIA, is an AIF mimetic or inhibits CAPN1 induced cell death in myocytes.
In summary, for these reasons, the skilled artisan would reasonably conclude that the inventor(s), at the time the application was filed, had possession of the AIF-tat mimetic (370-394) [0229] at the time the invention was filed.
Assessment of whether disclosed species are representative of the claimed genus
MPEP § 2163 states that a “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
In the instant case, the disclosure of one peptide is not representative of the genus because the genus of Formula I and II is large.
With the aid of a computer, one of ordinary skill in the art could identify all of the peptides that meet the structural limitations of Formula I and II. However, there is no teaching regarding which sequences could still result in a peptide that has the claimed functions. A single mutation can alter the function of a protein. Betts et al. (Biofinformatics for Geneticists, 2003, “Amino acid properties and consequences of substitutions” Chapter 14) teaches that a single nucleotide mutation leads to a substitution of glutamate in normal individuals with valine in those who suffer from sickle cell anemia (p. 291). Therefore, disclosure of a single example with the claimed function is not representative of the genus.
Identifying characteristics and structure/function correlation
In the absence of a reduction to practice of a representative number of species, the written description requirement for a claimed genus may be satisfied 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. To meet this requirement in the instant case, the specification must describe the structural, physical and/or chemical properties of the peptide that leads to the claimed features of binding to AIF and/or PPIA, is an AIF mimetic peptide and inhibitor of CAPN1.
This is an issue of written description. The specification does not make clear which proteins are in the genus and which are not because it does not describe the physical basis for the claimed activity. In other words, the specification does not describe which proteins to make.
In conclusion, for the reasons presented above, the skilled artisan would reasonably conclude that the inventors, at the time the application was filed had full possession of the AIF-tat mimetic (370-394) [0229] at the time the invention was filed.
Claim 1-9,15,18-23,28-30 and 34-35 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 the AIF-Tat mimetic peptide (370-394) ([peptide of [0229]) to bind and sequester PPIA does not reasonably provide enablement for preventing myocardial cell death and sudden cardiac death with Formula I, Formula II or SEQ ID NO: 1-60. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
As stated in MPEP 2164.01(a), “there are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
The factors to be considered when determining whether a disclosure meets the enablement requirement of 35 USC 112, first paragraph, were described in In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) as:
1. the nature of the invention;
2. the breadth of the claims;
3. the state of the prior art;
4. the relative skill of those in the art;
5. the predictability or unpredictability of the art;
6. the amount of direction or guidance presented [by the inventor];
7. the presence or absence of working examples; and
8. the quantity of experimentation necessary [to make and/or use the invention.
(1) The Nature of the Invention and (2) The Breadth of the claims
Claim 1 is drawn to an isolated peptide of Formula I or Formula II. Claim 7 is drawn to the isolated peptide of claim 1, wherein the peptide binds to AIF and/or PPIA. Claim 8 is drawn to the peptide of claim 1, wherein the peptide is an AIF mimetic peptide. Claim 9 is drawn to the polypeptide of claim 7 wherein the peptide inhibits CAPN1 induced cell death. Claim 20 is drawn to a method of preventing myocardial cell death and/or sudden cardiac death in a subject. Claim 28 is drawn to the isolated peptide of claim 20, wherein the peptide binds to AIF and/or PPIA. Claim 29 is drawn to the peptide of claim 28, wherein the peptide is an AIF mimetic peptide. Claim 30 is drawn to the polypeptide of claim 28 wherein the peptide inhibits CAPN1 induced cell death.
The claims will be given its broadest reasonable interpretation. The applicable rule for interpreting the claims is that “each claim must be separately analyzed and given its broadest reasonable interpretation in light of and consistent with the written description.” See MPEP 2163(II)(1), citing In re Morris, 127 F.3d 1048, 1053-1054; 44 USPQ2d 1023, 1027 (Fed. Cir. 1997). In view of this rule, the claims are drawn to Formula I and II which bid to AIF and/or PPIA, are AIF mimetics and inhibits CAPN1 induced cell death of myocytes. The claims are also drawn to preventing myocardial cell death and/or sudden cardiac death in a subject in need thereof.
The instant specification states [PGPUB0125]:
Sudden cardiac death is typically defined as natural, unexpected death from cardiac arrest within one hour of the onset of collapse symptoms, excluding additional time on mechanical life support. Most causes relate to congenital or acquired cardiovascular disease with no symptoms noted before the fatal event. The single most important predictor is fainting or near fainting during exercise, which should require detailed explanation and investigation, as it may reflect the loss of myocardial cell (or myocardial cell death). Sudden cardiac death can be attributed to several causes, including hypertrophic cardiomyopathy, commotio cordis, coronary artery anomalies, left ventricular hypertrophy of undetermined origin, myocarditis, ruptured aortic aneurysm (Marfan syndrome), arrhythmogenic right ventricular cardiomyopathy (ARVC), arrhythmogenic right ventricular dysplasia (ARVD), arrhythmogenic left ventricular cardiomyopathy (ALVC), arrhythmogenic cardiomyopathy (ACM), tunneled coronary artery, aortic valve stenosis, and atherosclerotic coronary artery disease.
The instant specification defines “preventing [PGPUB0126]:
The term “preventing”, as used herein, refers to methods or therapeutic methods that have prophylactic/preventative properties. For example, the therapeutic methods described herein are intended to avoid myocardial cell death in a subject, which can be responsible for sudden cardiac death of the subject.
The instant specification defines “subject” [PGPUB0127]:
The term “subject” as used herein refers to any individual or patient to which the methods of the invention are performed. Generally, the subject is human, although as will be appreciated by those in the art, the subject may be an animal. Thus, other animals, including vertebrate such as rodents (including mice, rats, hamsters, and guinea pigs), cats, dogs, rabbits, farm animals including cows, horses, goats, sheep, pigs, chickens, etc., and primates (including monkeys, chimpanzees, orangutans, and gorillas) are included within the definition of subject.
(3) The state of the prior art and (5) The predictability or unpredictability of the art
The instant application is not enabled for preventing myocardial cell death and/or sudden cardiac death in a subject with the pharmaceutical composition comprising Formula I, II or SEQ ID NO: 1-60. The state of the prior does not support preventing myocardial cell death and/or sudden cardiac death in a subject with Formula I, II or SEQ ID NO: 1-60.
The association between CAPN1, PP1A and the AIF pathway and exercise induced myocyte death in a specific experimental model of arrhythmogenic cardiomyopathy (ACM). However, the art has not established that administering AIF or an AIF binding peptide or AIF mimetic would prevent myocardial cell death or sudden cardiac death in a living subject. Chelko et al. (Sci Tranl Med. 2021, Feb.;13(581)) teach CAPN1-PPIA-AIF pathway using Dsg2 mutant mice, cultured HL-1 cells, Dsg2 mutant embryonic stem cell derived cardiomyocytes (ES-CMs) and human myocardial samples. Although Chelko et al. conducted endurance exercise study in Drg2-mutant mice, the AIF mimetic peptide was not administered to the mice. Thus, the in vivo experiment in Chelko et al. did not establish that AIF mimetic peptide treatment preventing myocardial cell death, arrythmia, exercise induced mortality or sudden cardiac death. Chelko et al. teach a single AIF mimetic peptide corresponding to AIF amino acids 370-394 and fused to Tat under specific condition reduced annexin V positive apoptosis, and certain morphological markers of cells death. These experiments did not establish prevention of myocardial cell death or prevention of sudden cardiac death in a subject in need thereof. Chelko et al. expressly acknowledges that there are limits when using an ES-CM system such as the cultures lacking immune cells present in the diseased myocardium and that isolated primary adult cardiomyocytes could not be maintained for the seven day treatment (limitations and study perspective para.). Chelko et al. also states that other mechanisms such as GSH and ATP synthase disruption may contribute to ACM pathogenesis (limitations and studies in perspective para.). Therefore, a person of ordinary skill in the art would not reasonably conclude that Chelko et al. is supportive of preventing myocardial cell death and sudden cardiac death in a subject.
Therefore, the state of the art at the time of the application is that the etiology and prevention of myocardial cell death and sudden cardiac death in a subject is not well understood and therapy is challenging and complex. It is noted that pharmaceutical and biological art is generally unpredictable, requiring each embodiment to be individually assessed for physiological activity. Given this fact, historically the development of new drugs has been difficult and time-consuming. Adding to the unpredictability is that many treatment options may show promise in animal models, but may fail to show therapeutic improvement in clinical trials. There is no absolute predictability, even in view of the high level of skill in the art.
Furthermore, sudden cardiac death can be attributed to many distinct causes such as hypertrophic cardiomyopathy, coronary artery anomalies…Marfan syndrome…. Atherosclerotic coronary artery disease (see PGPPUB 0125]. The state of the art did not establish that these distinct conditions are uniformly mediated by CAPN1-PPIA-AIF pathway and disruption of that pathway would prevent sudden cardiac death or prevent myocardial death. Importantly, even if a peptide was shown to reduce cell death markers, it would be highly unpredictable to practice the method with a subject in need thereof. Patients at risk of sudden cardiac death are highly heterogenous with differing underlying pathologies and genetic backgrounds. It would require undue experimentation to provide biomarkers, diagnostic criteria or stratification tools that would allow a person of ordinary skill in the art to reliably identify as subject in need of prevention.
Thus, it would be unpredictable and would be require undue experimentation to determine if the large genus of peptides that meet the structural limitations of Formula I and II would be able to prevent myocardial cell death and sudden cardiac death in a subject.
(4) The relative skill of those in the art
MPEP 2141.03 states (in part)” A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At 1396, 82 USPQ2d at 1396. The “hypothetical person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988) (disagreeing with the examiner’s definition of one of ordinary skill in the art (i.e. a doctorate level engineer or scientist working at least 40 hours per week in semiconductor research or development), and finding that the hypothetical person is not definable by way of credentials, and that the evidence in the application did not support the conclusion that such a person would require a doctorate or equivalent knowledge in science or engineering). In the instant case, the skill in the art high with respect to physicians and scientists. The level of skill in the art (physicians and scientists) would be high.
(6) The amount of direction or guidance presented (by the inventor) and (7) The presence or absence of working examples
One embodiment of the invention of the claims were reduced to practice at the time of filing. Applicants disclose the AIF-Tat mimetic peptide (370-394) binds and sequesters PPIA [0229]. Please note that the AIF-tat peptide tested does not meet the limitations of Formula I or Formula II. However, it is unclear from the specification if that corresponds to a specific SEQ ID NO. Applicants also disclosed the amino acid sequence of SEQ ID NOs: 1-60. The specification discloses Table 3 (p. 20-21) and states the peptide are AIF and PPIA binding peptides. However, there was no data presented that SEQ ID NO: 1-60 have this function.
In contrast, the applicant provides little in way of direction or guidance regarding preventing myocardial cell death and/or sudden cardiac death in a subject in need thereof. There was no disclosure of treatment of animal models with the claimed peptides.
(8) The quantity of experimentation necessary (to make and/or use the invention)
Owing to the factors listed above, especially in points 6 and 7, the amount of experimentation needed will be extensive in view of the lack of guidance by the inventor. MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
In conclusion, the instant application is enabled for the AIF-Tat mimetic peptide (370-394) ([peptide of [0229]) to bind and sequester PPIA does not reasonably provide enablement for preventing myocardial cell death and sudden cardiac death with Formula I, Formula II or SEQ ID NO: 1-60.
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 3-6, 18-19, 22-23 and 34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 3 and 22 are indefinite because it is unclear how these additional features are incorporated into or associated with the peptides defined in claim 1. Claim 1 defines the peptide as having the recited amino acid sequence and terminal groups Y1 and Y2 (formula I) or Y3 and Y4 (formula II), wherein Y1 and Y3 is a CPP, a hydrogen atom or an acetyl group and Y2 is a CPP or hydrogen atom and Y4 is a CPP, hydroxyl group or an amino group. Thus the N and C-terminus of the peptides are already defined in claim 1. Claims 3 and 22 do not specify whether the “N-terminal modification” or the “C-terminal modification” correspond to Y1,Y2,Y3 and Y4 or are additional modification attached to Y1, Y2, Y3 an Y4 or replace the terminal groups required by claim 1. Additionally, since Y1,Y2,Y3 and Y4 may already be CPPs, it is unclear if the CPP of claim 3 refers to the CPP of claim 1 or is an additional CPP. If the Applicants intend for claim 3 to be an additional CPP, claims 4-6 and 23 may also lack antecedence because it would be unclear if the CPP of claims 3-6 are referring to the CPP of claims 1 or 3. It is also unclear how the “non-natural amino acid” relates to the peptide of formula I and II because the claim does not specify if the non-natural amino acid is one of the non-natural amino acids represented within the recited sequence or is an additional residue attached to the N or C-terminal or another portion of the peptide. As indicated above, the formulas are interpreted as closed and comprise the recited number of amino acids (11 for Formula I and 15 for Formula II) and adding additional amino acid residues may also be inconsistent with claim 1. Furthermore, the recitation that the peptide comprises “a cyclic” peptide is also unclear. It is unclear whether the peptide of claim 1 is itself cyclized or whether a separate cyclic peptide is attached to the peptide of claim 1. If the peptide is itself cyclized, it is additionally unclear how such cyclization is reconciled with the Y1,Y2, Y3 and Y4 terminal groups required by claim 1. Therefore, it is impossible to determine the metes and bounds of claims 3 and 22.
Claim 4-6 and 23 are rejected for depending from rejected claim 3.
Claims 18 and 34 are indefinite because they depend from a canceled claim. In particular, claim 18 depends from canceled claim 17 and claim 24 depends from canceled claim 25. For purposes of examination, claim 18 is interpreted to depend from claim 15 and claim 24 is interpreted to depend from claim 20.
Regarding claim 19, the phrase "low molecular weight (less than about 10 residues)” renders the claim indefinite because it is unclear whether the limitation in parenthesis are part of the claimed invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 7-9, 15 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-2, 7-9, 15 and 19 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s 2019 Revised Patent subject matter Eligibility Guidance (referred to as 2019 PEG) published January 2019 and the “PEG update” in October 2019.
Claim Interpretation
Claims 1 is drawn to an isolated peptide of Formula I or II. Claim 2 is drawn SEQ ID NO: 1-60.
Subject Matter Eligibility Test for Products and Processes
Step 1: Is the claim to a process, machine, manufacture, or composition of matter (see, e.g., 79 FR 74621)?
Yes, the instant claims are directed to a statutory patent-eligible subject matter category, namely a composition of matter.
Step 2A (1): Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (see, e.g., 79 FR 74621)?
Yes, the claims are directed to a natural phenomenon. In particular, peptides of Formula I and II are fragments of naturally occurring proteins. For example, SEQ ID NO: 45 is a fragment of naturally occurring peptidyl prolyl cis-trans isomerase:
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253
787
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193
687
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Accordingly, the pending claims are directed to a naturally occurring product.
Absent evidence to the contrary, the recitation of “isolated” does not impart a different structure to the claimed peptides that would distinguish it from the natural product.
Step 2A (2): Does the Claim recite additional Elements that integrate the judicial Exception into a Practical Application?
No, the claim does not recite additional elements that integrate the judicial exception into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception (see, e.g., 79 FR 74621)?
No, the claims do not recite additional elements that amount to significantly more than the judicial exception. The claimed peptides are not markedly different from its naturally occurring form because “breaking bonds” to isolate does not change the characteristics. Furthermore, a pharmaceutically acceptable carrier such as methionine and water are naturally occurring.
As indicated above, the claimed peptides are naturally occurring and the claims do not recited additional elements that amount to significantly more.
Factors for determining if the claim directed to a product of nature, as a whole, recites something significantly more than the judicial exception, are provided in the Guidance (74623; see esp. 79 FR 74623 at §I.A.3.b). see also, 79 FR.
In sum, when the relevant considerations are analyzed, they weigh against a significant difference. Accordingly, claims 1-2, 7-9, 15 and 19 do not qualify as eligible subject matter.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TARA L MARTINEZ whose telephone number is (571)270-1470. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TARA L MARTINEZ/Primary Examiner, Art Unit 1654
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